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 FY 2018, ending December 31,
2018, as well as updates on the Company’s growth and progress for
2018 in the following areas:
Revenues:
- Development of distributor network in
2018 led to commencement of commercial sales in Q1 2019 to Indian
distributors. The sales consisted of primer sets for the
non-clinical identification of tuberculosis, malaria, and human
papillomavirus (HPV), engineered using the Co-Diagnostics’
proprietary design process and patented CoPrimer™ technology, as
well as other test reagents and components used in polymerase chain
reaction (PCR) testing.
- Company expanded target markets to
include Central and South America, announced exclusive distributor
agreement in the Dominican Republic, and conducted training and
sales seminars with nearly 20 labs and hospitals, setting up
near-term sales potential.
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, progressed towards
completion in 2018; Company representatives are scheduled to attend
the inaugural opening in April 2019.
- Co-Diagnostics signed license agreement
with LGC, Biosearch for use of CoPrimer technology in the
agriculture, livestock, and aquabio markets, seen as a major
industry validation of the technology in multiplexing and SNP
detection applications.
- Company’s vector (mosquito) control
program initiated in the United States; as testing mosquitos and
other animal vectors does not involve human samples, domestic sales
are not dependent on IVD approval (510(k) or Premarket
Authorization) from the Food and Drug Administration (FDA).
Regulatory:
- The Company received two major
regulatory approvals in the form of CV-IVD clearance for their
Logix Smart™ MTB (tuberculosis) test and Logix Smart Zika
test.
- A third CE-IVD clearance for the Logix
Smart ZDC (Zika-dengue-chikunguna) multiplex test, the Company’s
first multi-pathogen assay, was also more recently received.
- 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:
- Co-Diagnostics’ suite of intellectual
property expanded upon receiving US patent protection for its
flagship CoPrimer technology, opening the door for future license
agreements of the technology and offering primer design services
for PCR tests built on the platform.
- The Company further expanded its
international licensing and revenue opportunities following receipt
of UK patent for RapidProbe™ design technology.
Technology:
- Company announced major milestones in
scientific advancement of its CoPrimer technology, demonstrating
its potential in multiplex SNP genotyping applications. The
advancement was a result of an ongoing research and development
study with LGC, Biosearch, which helped to set the stage for a
subsequent license agreement.
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, leaving the Company debt-free.
- Company announced the filing of an S-3
shelf registration to sell an aggregate amount of $25 million
shares of its common stock, of which the Company sold 3,925,716
shares for gross proceeds of approximately $5.5 million in Q1
2019.
Dwight Egan, CEO of Co-Diagnostics, commented, “The milestones
achieved during 2018 underscore the validation and uniqueness of
our platform and our ability to obtain regulatory clearance for our
tests. As a result of the above and our recent financings, we now
have the resources and approvals required to begin commercializing
our technology in several verticals and markets. We look forward to
continuing our positive momentum in 2019 and beyond.”
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,
December 31, 2018 2017 ASSETS: Current
Assets Cash and cash equivalents $ 950,237 $ 3,534,454 Accounts
receivable ,net 13,420 — Inventory 18,153 9,068 Prepaid expenses
70,103 908,352 Total current assets
1,051,913 4,451,874 Property and equipment, net 156,138
165,567 Investment in joint venture 345,121
44,885 Total other long-term assets 501,259
210,452 Total assets $ 1,553,172 $
4,662,326 LIABILITIES AND STOCKHOLER’S EQUITY
(DEFICIT)
: Current Liabilities Accounts payable $ 148,967 $
40,819 Accrued expenses 174,444 96,645 Accrued expenses (related
party) 120,000 480,000 Current notes payable net of $91,428 and $0
discount, respectively 1,908,572 — Deferred income current —
10,792 Total current liabilities 2,351,983
628,256 Long-term Liabilities Accrued liabilities
(related-party) 260,000 — Deferred income long-term —
183,546 Total long-term liabilities 260,000
183,546 Total liabilities 2,611,983
811,802 Commitments and contingencies
STOCKHOLDERS’ EQUITY (DEFICIT): Common stock, $.001 par
value, 100,000,000 shares authorized; 12,923,383 and 12,317,184
shares issued and outstanding, respectively. 12,923 12,317
Preferred stock, $.001 par value, 5,000,000 shares authorized — —
Additional paid-in capital 17,622,433 16,260,651 Accumulated
deficit (18,694,167 ) (12,422,444 ) Total
stockholders’ equity (deficit) (1,058,811 ) 3,850,524
Total liabilities and stockholders’ equity (deficit)
$ 1,553,172 $ 4,662,326
CO-DIAGNOSTICS, INC. AND SUBSIDIARIES CONSOLIDATED
STATEMENTS OF OPERATIONS FOR THE YEARS ENDED DECEMBER 31,
2018 AND 2017 For the years ended
December 31, 2018 2017 Net sales
$ 39,911 $ 7,662 Cost of sales 9,391 302
Gross profit 30,520 7,360 Operating expenses: Selling
and marketing 1,165,631 426,711 Administrative and general
3,570,786 3,095,791 Research and development 1,361,154 1,003,167
Depreciation and amortization 50,765 45,758
Total operating expenses 6,148,336
4,571,427 Total operating loss (6,117,816 )
(4,564,067 ) Other expense: Interest expense (134,947 )
(310,233 ) Interest income 19,804 3,829 Loss on extinguishment of
debt — (2,072,365 ) Net loss from investment in joint venture
(38,764 ) (16,396 ) Total other expense
(153,907 ) (2,395,165 ) Loss before income taxes
(6,271,723 ) (6,959,232 ) Provision for income taxes —
— Net loss $ (6,271,723 ) $ (6,959,232 )
Net loss per share – basic and diluted $ (0.50 ) $ (0.63 )
Weighted average shares – basic and diluted
12,484,617 10,960,326
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version on businesswire.com: https://www.businesswire.com/news/home/20190402005376/en/
Andrew BensonCo-Diagnostics Investor
Relations801-438-1036investors@codiagnostics.com
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