CODX Co Diagnostics Inc

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

 

 

View source 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