Co-Diagnostics, Inc. (NASDAQ: CODX) (“Co-Diagnostics” or
“the Company”), a molecular diagnostics company with a unique,
proprietary platform for the development of diagnostic tests,
announced corporate developments and financial results for the
third quarter of 2017, ended September 30, 2017.
- The Company and Synbiotics Limited
(“Synbiotics”), a group company of Asence Inc, a U.S. incorporated
company specializing in supplying pharmaceutical products to
international markets, broke ground on its manufacturing facility
in India. The Food & Drug Control Administration Gujarat State
has approved a 3-year license for the manufacturing of six tests
for diagnosing the Zika virus (for export only) and tuberculosis,
to be followed by drug-resistant tuberculosis, malaria, dengue, and
chikungunya.
- The Company’s products were introduced
in several key markets in the Caribbean, including at the 35th
annual International Fair of Havana in Cuba, and meetings with the
Ministry of Public Health and Social Assistance (SESPAS) of the
Dominican Republic.
- The Company is continuing its
ground-breaking research applying its proprietary intellectual
property in multiplexed molecular diagnostic testing. The Company’s
ability to multiplex DNA targets and perform SNP detection has
important ramifications for the future growth into the agricultural
market, in liquid biopsy for cancer detection, and blood bank
screening.
- The Company has been granted ISO
13485:2016 certification following successful completion of an
audit of its quality management system to ensure compliance with
the newest version of the standard.
Dwight Egan, Co-Diagnostics CEO, remarked, “We are pleased to
have completed our initial quarter as a public company. We look
forward to growing the Company and driving operational and
financial performance for the benefit of our shareholders in the
years to come. This quarter's commercial progress in infectious
disease was very exciting. Although not yet reflected in our
reported revenues, we are enjoying a strong commercial launch of
the CODX Molecular Diagnostics System. To date, the combined
populations of the countries in which we have placed systems
represent over 50% of the population of the Caribbean Basin. Most
of these systems are in prominent reference laboratories that
service their respective populations in a “hub and spoke” business
model where a single lab collects patient samples from multiple
collection points. We expect to have systems placed in a majority
of the Caribbean countries by the end of Q1 2018. The Company
expects to ship tests to participating labs during Q4 2017 and Q1
2018 that include Zika virus, tuberculosis, hepatitis C, hepatitis
B, HIV, and malaria.
In India, during Q4 2017 the company will be delivering its
first shipment of tests pursuant to an agreement with MEDCIS
Pathlabs India Pvt. Initial shipments under this agreement will be
manufactured in the Company’s own ISO 13485 compliant facility in
Utah, but will eventually be manufactured and shipped from the new
joint venture manufacturing facility currently under construction
in India. India is projected to become the largest healthcare
market in the world. The Company has taken important steps to
capitalize on the burgeoning dynamics of this market. Management
believes support in India for the Company’s technology and products
is broad-based with qualified prospects coming from across all
market segments; ranging from large centralized labs to mid-size
private labs and government facilities.
During Q3 2017, the Company also devoted a substantial amount of
effort in developing multiplex test opportunities for the
agricultural market. Research and development activities are
yielding very positive results as the Company’s core intellectual
property is enabling materially enhanced multiplexed testing for
the agricultural industry. The research and development involved in
this initiative appears to be opening up a much larger opportunity
to thousands of potential customers with a significant interest in
the attributes of the Company’s technology in numerous market
segments. In particular the fields of liquid biopsy for cancer
detection, blood bank screening and multiplex SNP detection are
areas in which we believe the Company’s technology may be
applicable.”
About Co-Diagnostics,
Inc.:
Co-Diagnostics, Inc., 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),
and to sell diagnostic equipment from other manufacturers as
self-contained lab systems.
Forward-Looking
Statements:
With the exception of historical information contained in
this press release, content herein may contain "forward looking
statements" that are made pursuant to the Safe Harbor Provisions of
the Private Securities Litigation Reform Act of 1995.
Forward-looking statements can be identified by words such as
“believes,” “expects,” “estimates,” “intends,” “may,” “plans,”
“will” and similar expressions, or the negative of these words.
Such forward-looking statements are based on facts and conditions
as they exist at the time such statements are made and predictions
as to future facts and conditions. These statements are based on
management's current expectations and are subject to uncertainty
and changes in circumstances. Investors are cautioned that
forward-looking statements involve risks and uncertainties that
could cause actual results to differ materially from the statements
made. Readers of this press release are cautioned not to place
undue reliance on any forward-looking statements. Risks,
uncertainties and other factors are discussed in the Company's
filings with the U.S. Securities and Exchange Commission on Annual
Report Form 10-K, Quarterly Reports on Form 10-Q and Current
Reports on Form 8-K. The Company disclaims any obligation to update
its forward-looking relationships.
CO–DIAGNOSTICS, INC.
CONDENSED CONSOLIDATED BALANCE
SHEETS
September 30,
2017
(Unaudited)
December 31,2016
ASSETS: Current Assets Cash $ 4,625,238 $ 998,737 Other
receivables 1,483 3,183 Inventory 45,340 -- Prepaid expenses
1,240,361 206,478 Total current assets 5,912,422
1,208,398 Property and equipment, net 139,749
87,429 Total assets $ 6,052,171 $ 1,295,827
LIABILITIES AND STOCKHOLDERS’ EQUITY
(DEFICIT): Current Liabilities Accounts payable $ 80,504
$ 29,934 Accounts payable (related party) -- 75,000 Accrued
expenses 65,722 101,239 Accrued expenses (related party) 520,000
690,168 Current notes payable net of $0 and $87,605 discount,
respectively -- 2,111,895 Current notes payable (related party) net
of $0 and $263 discount, respectively -- 837,177 Deferred revenue
10,792 -- Total current liabilities 677,018 3,845,413
Long-term Liabilities, net of current portion Notes payable --
445,000 Deferred revenue long-term 186,144 -- Total
long-term liabilities 186,144 445,000 Total
liabilities 863,162 4,290,413 Commitments and
contingencies STOCKHOLDERS’ EQUITY (DEFICIT): Common stock,
$.001 par value, 180,000,000 shares authorized; 12,282,975 and
9,882,395 and shares issued and outstanding as of September 30,
2017 and December 31, 2016, respectively. 12,283 9,882 Additional
paid-in capital 16,094,194 2,458,744 Accumulated deficit
(10,917,468 ) (5,463,212 ) Total stockholders’ equity (deficit)
5,189,009 (2,994,586 ) Total liabilities and
stockholders’ equity (deficit) $ 6,052,171 $ 1,295,827
CO–DIAGNOSTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS
(Unaudited)
For the
Three MonthsEnded September
30,
For the
Nine Months Ended September
30,
2017 2016 2017 2016
Revenues: $ 2,598 $ -- $ 5,064 $ -- Cost of sales --
-- 302 -- Gross profit 2,598 -- 4,762 --
Operating expenses: Sales and marketing 117,078 28,890 306,921
76,600 General and administrative 1,405,955 183,363 2,013,213
597,505 Research and development 272,209 172,804 721,777 539,818
Depreciation and amortization 12,416 7,295
33,228 29,466 Total operating expenses 1,807,658
392,352 3,075,139 1,243,389 Loss from
operations (1,805,060 ) (392,352 ) (3,070,377
) (1,243,389 ) Other expense: Interest expense (14,801 )
(57,598 ) (310,233 ) (160,052 ) Loss on extinguishment of debt
(2,072,365 ) -- (2,072,365 ) -- Loss on disposition of assets
(1,281 ) -- (1,281 ) -- Total other expense (2,088,447 ) (57,598 )
(2,383,879 ) (160,052 ) Loss before income taxes (3,893,507 )
(449,950 ) (5,454,256 ) (1,403,441 ) Provision for income taxes --
-- -- -- Net Loss $ (3,893,507 ) $ (449,950 ) $ (5,454,256 ) $
(1,403,441 ) Basic and diluted income (loss) per common
share $ (0.33 ) $ (0.05 ) $ (0.53 ) $ (0.14 ) Weighted
average common shares outstanding 11,751,649
9,882,395 10,512,327 9,882,395
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version on businesswire.com: http://www.businesswire.com/news/home/20171115005524/en/
Co-Diagnostics, Inc.Andrew Benson, 801-438-1036Investor
Relationsinvestors@codiagnostics.comorLytham PartnersJoe Diaz,
Robert Blum, Joe Dorame602-889-9700codx@lythampartners.com
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