SALT LAKE CITY--(BUSINESS WIRE)--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:
- 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.
- 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).
- 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.
- 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.
- 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.
- 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.
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,|
|Cash and cash equivalents||$||950,237||$||3,534,454|
|Accounts receivable ,net||13,420||—|
|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|
|LIABILITIES AND STOCKHOLER’S EQUITY (DEFICIT):|
|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|
|Accrued liabilities (related-party)||260,000||—|
|Deferred income long-term||—||183,546|
|Total long-term liabilities||260,000||183,546|
|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, $.001 par value, 5,000,000 shares authorized||—||—|
|Additional paid-in capital||17,622,433||16,260,651|
|Total stockholders’ equity (deficit)||(1,058,811||)||3,850,524|
|Total liabilities and stockholders’ equity (deficit)||$||1,553,172||$||4,662,326|
|CO-DIAGNOSTICS, INC. AND SUBSIDIARIES|
|CONSOLIDATED STATEMENTS OF OPERATIONS|
|FOR THE YEARS ENDED DECEMBER 31, 2018 AND 2017|
|For the years ended|
|Cost of sales||9,391||302|
|Selling and marketing||1,165,631||426,711|
|Administrative and general||3,570,786||3,095,791|
|Research and development||1,361,154||1,003,167|
|Depreciation and amortization||50,765||45,758|
|Total operating expenses||6,148,336||4,571,427|
|Total operating loss||(6,117,816||)||(4,564,067||)|
|Loss on extinguishment of debt||—||(2,072,365||)|
|Net loss from investment in joint venture||(38,764||)||(16,396||)|
|Total other expense||(153,907||)||(2,395,165||)|
|Loss before income taxes||(6,271,723||)||(6,959,232||)|
|Provision for income taxes||—||—|
|Net loss per share – basic and diluted||$||(0.50||)||$||(0.63||)|
|Weighted average shares – basic and diluted||12,484,617||10,960,326|