Co-Diagnostics, Inc. (Nasdaq: CODX), a molecular
diagnostics company with a unique, patented platform for the
development of molecular diagnostic tests, today announced the
filing of their financial results for the fiscal year ending
December 31, 2019, as well as updates on the Company’s growth and
progress for 2019 and 2020 to date in the following areas:
Milestones:
- A license agreement with LGC, Biosearch, an international
leader in the extended life sciences sector whose footprint covers
over 200 countries, was expanded to provide additional licensing
opportunities, which the Company began to see realized in
2019.
- Company launched its vector control vertical in mid-2019 and
experienced growth in that sector throughout the year. Products
launched for the vector control vertical in 2019 to identify the
presence of infectious diseases in mosquito populations included
multiplex tests for Zika/dengue/chikungunya, West Nile/St. Louis
encephalitis/western equine encephalitis (WNV/SLEV/WEE), and West
Nile/St. Louis encephalitis/eastern equine encephalitis
(WNV/SLEV/EEE). EEE had a particularly deadly season in states
along the eastern United States, and the development of this assay
was a direct result of demand for the product.
- Following the outbreak in China beginning at the end of 2019,
the Company was able to successfully leverage its unique,
proprietary test design platform to design a test for COVID-19, to
become the first U.S. company with a CE marking for that test, and
to begin marketing as the pandemic grew. As a result of the
Company’s high-quality test design, Co-Diagnostics was able to
quickly establish a global network of clients, resulting in revenue
in the first quarter of 2020 since the time that the CE marking was
obtained. Sales will be further bolstered following an FDA policy
which facilitated sales of the Company’s clinically evaluated
coronavirus test to U.S. markets.
Strategic Relationships:
- Construction of the facility for CoSara Diagnostics Pvt Ltd.,
the Company’s joint venture with Synbiotics Limited for
manufacturing and sales in India, saw its inaugural opening in
April 2019. Later, CoSara received clearance by the CDSCO to be
used as in vitro diagnostics for tuberculosis, human
papillomavirus, hepatitis B, hepatitis C, and malaria.
- As already mentioned, Co-Diagnostics and LGC, Biosearch
expanded their license agreement for the CoPrimer™ technology, seen
as a major industry validation of the technology in multiplexing
and SNP detection applications.
- The Company received regulatory approvals in the form of CE-IVD
clearance for its Logix Smart™ Zika/dengue/chikungunya multiplex
test.
- CE-IVD clearance facilitates sale of products in Europe, and
all other countries and jurisdictions that accept CE markings as
valid regulatory approval for in vitro diagnostics.
Intellectual Property and
Technology
- Company announced major milestones in scientific advancement of
its CoPrimer technology, demonstrating its potential in liquid
biopsy applications.
- Co-Diagnostics’ suite of intellectual property expanded with
the filing of a provisional patent for a simplified targeted next
generation sequencing (NGS) library preparation, which method
includes proprietary, single-step closed-tube NGS library prep in 3
hours or less.
Financial:
- All debt incurred in 2018 was eliminated in the sale of $3
million of preferred shares in January 2019, which consisted of
negotiating the conversion of a $2M note to preferred stock, and an
additional sale of $1M of preferred shares for cash in 2019,
leaving the Company debt-free. The Company also sold Common Shares
of its stock pursuant to a shelf offering for gross proceeds of
approximately $5.5 million in Q1 2019.
- More recently, the Company sold Common Shares in a series of
offerings pursuant to the shelf registration statement for gross
proceeds of approximately $19.5 million.
Dwight Egan, CEO of Co-Diagnostics, commented, “Our milestones,
steady growth, strengthened strategic relationships, and expanded
product pipeline during 2019 have established a solid foundation
from which Co-Diagnostics can pursue its commitment to providing
the highest quality molecular diagnostic solutions on a global
scale.
“Recent events have dramatically changed our trajectory and
outlook as we leverage our skill set in the field of infectious
disease diagnostics, and we find ourselves in a position to have a
significant positive impact on the COVID-19 pandemic. The work we
have performed to bring a sorely-needed test to market, first as a
CE-marked IVD to countries across the world and now to the United
States, speaks to our commitment to providing diagnostic tools that
have the potential to save lives by providing accurate
diagnoses—the first step in ensuring accurate treatment.
“We are gratified that we have the opportunity to help the
United States and many other countries to benefit from increased
access to testing for COVID-19, a disease that affects not just
patients afflicted with it and their families, but the entire world
as a whole.”
About Co-Diagnostics, Inc.:
Co-Diagnostics, Inc., a Utah corporation, is a molecular
diagnostics company that develops, manufactures and markets a new,
state-of-the-art diagnostics technology. The Company’s technology
is utilized for tests that are designed using the detection and/or
analysis of nucleic acid molecules (DNA or RNA). The Company also
uses its proprietary technology to design specific tests to locate
genetic markers for use in industries other than infectious disease
and license the use of those tests to specific customers.
Forward-Looking Statements:
This press release contains forward-looking statements.
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. Forward-looking statements in
this release include statements regarding the (i) use of funding
proceeds, (ii) expansion of product distribution, (iii)
acceleration of initiatives in liquid biopsy and SNP detection,
(iv) use of the Company’s liquid biopsy tests by laboratories, (v)
capital resources and runway needed to advance the Company’s
products and markets, (vi) increased sales in the near-term, (vii)
flexibility in managing the Company’s balance sheet, (viii)
anticipation of business expansion, and (ix) benefits in research
and worldwide accessibility of the CoPrimer technology and its
cost-saving and scientific advantages. Forward-looking statements
are subject to inherent uncertainties, risks and changes in
circumstances. Actual results may differ materially from those
contemplated or anticipated by such forward-looking statements.
Readers of this press release are cautioned not to place undue
reliance on any forward-looking statements. The Company does not
undertake any obligation to update any forward-looking statement
relating to matters discussed in this press release, except as may
be required by applicable securities laws.
CO-DIAGNOSTICS, INC. AND
SUBSIDIARIES
CONSOLIDATED BALANCE
SHEETS
December 31, 2019
December 31, 2018
ASSETS:
Current Assets
Cash and cash equivalents
$
893,138
$
950,237
Accounts receivable, net
131,382
13,420
Inventory
197,168
18,153
Prepaid expenses
362,566
70,103
Total current assets
1,584,254
1,051,913
Property and equipment, net
196,832
156,138
Investment in joint venture
434,240
345,121
Total other long-term assets
631,072
501,259
Total assets
$
2,215,326
$
1,553,172
LIABILITIES AND STOCKHOLDERS’ EQUITY
(DEFICIT):
Current Liabilities
Accounts payable
$
5,959
$
148,967
Accrued expenses
200,788
174,444
Accrued expenses (related party)
120,000
120,000
Current notes payable net of $0 and
$91,427 discount, respectively
—
1,908,572
Deferred income current
1,323
—
Total current liabilities
328,070
2,351,983
Long-term Liabilities
Accrued liabilities (related-party)
150,000
260,000
Total long-term liabilities
150,000
260,000
Total liabilities
478,070
2,611,983
Commitments and contingencies
STOCKHOLDERS’ EQUITY (DEFICIT):
Preferred stock, $.001 par value,
5,000,000 shares authorized; 25,600 and no shares issued and
outstanding, respectively
26
—
Common stock, $.001 100,000,000 shares
authorized; 17,342,922 and 12,923,383 shares issued and
outstanding, respectively
17,343
12,923
Additional paid-in capital
26,687,701
17,622,433
Accumulated deficit
(24,967,814
)
(18,694,167
)
Total stockholders’ equity (deficit)
1,737,256
(1,058,811
)
Total liabilities and stockholders’ equity
(deficit)
$
2,215,326
$
1,553,172
CO-DIAGNOSTICS, INC. AND
SUBSIDIARIES
CONSOLIDATED STATEMENTS OF
OPERATIONS
For the years ended
December 31,
2019
2018
Net sales
$
214,974
$
39,911
Cost of sales
112,431
9,391
Gross profit
102,543
30,520
Operating expenses:
Selling and marketing
1,061,676
1,165,631
Administrative and general
3,497,273
3,570,786
Research and development
1,371,433
1,361,154
Depreciation and amortization
65,902
50,765
Total operating expenses
5,996,284
6,148,336
Total operating loss
(5,893,741
)
(6,117,816
)
Other expense:
Interest expense
(106,437
)
(134,947
)
Interest income
36,652
19,804
Gain on disposition of assets
850
—
Net loss from investment in joint
venture
(232,881
)
(38,764
)
Total other expense
(301,816
)
(153,907
)
Loss before income taxes
(6,195,557
)
(6,271,723
)
Provision for income taxes
—
—
Net loss
$
(6,195,557
)
$
(6,271,723
)
Net loss per share – basic and diluted
$
(0.36
)
$
(0.50
)
Weighted average shares – basic and
diluted
16,756,912
12,484,617
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version on businesswire.com: https://www.businesswire.com/news/home/20200331005526/en/
Company Contact: Andrew Benson Head of Investor Relations
+1 801-438-1036 investors@codiagnostics.com
Media Contact: Jennifer Webb Coltrin & Associates,
Inc +1.267.912.1173 jennifer_webb@coltrin.com
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