UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): October 24, 2018
CO-DIAGNOSTICS, INC.
(Exact name of registrant as specified in its charter)
| Utah | 1-38148 | 46-2609363 | ||
(State
or other jurisdiction |
(Commission File Number) |
(I.R.S. Employer Identification No.) |
2401 S. Foothill Drive, Suite D, Salt Lake City, Utah 84109
(Address of principal executive offices and zip code)
(801) 438-1036
(Registrant’s telephone number, including area code)
Not applicable
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| [ ] | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| [ ] | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| [ ] | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| [ ] | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company [X]
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. [ ]
Item 3.01 Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard.
On October 24, 2018, Co-Diagnostics, Inc. (the “Company”) received a letter (the “Notice”) from the Listing Qualifications staff of The Nasdaq Stock Market LLC (“Nasdaq”) notifying the Company that for the last 30 consecutive business days prior to the date of the letter, the market value of the Company’s listed securities was less than $35 million, which does not meet the requirement for continued listing on The Nasdaq Capital Market, as required by Nasdaq Listing Rule 5550(b)(2) (the “Market Value Rule”). In accordance with Nasdaq Listing Rule 5810(c)(3)(C), Nasdaq has provided the Company with 180 calendar days, or until April 23, 2019, to regain compliance with the Market Value Rule. If the Company regains compliance with the Market Value Rule, Nasdaq will provide written confirmation to the Company and close the matter.
The Notice does not result in the delisting of the Company’s common stock from The Nasdaq Capital Market. To regain compliance with the Market Value Rule, the market value of the Company’s listed securities must meet or exceed $35 million for a minimum of ten consecutive business days during the 180-day grace period ending on or before April 23, 2019. The Company could also regain compliance with Nasdaq’s alternative continued listing requirements by having stockholders’ equity of $2.5 million or more, or net income from continuing operations of $500,000 in the most recently completed fiscal year.
In the event that the Company does not regain compliance within this 180-day period, the Company may be eligible to seek an additional compliance period of 180 calendar days if it meets the continued listing requirement for market value of publicly held shares and all other initial listing standards for the Nasdaq Capital Market, and provides written notice to Nasdaq of its intent to cure the deficiency during this second compliance period.
Item 7.01. Regulation FD Disclosure.
On October 30, 2018, the Company issued a press release announcing the License Agreement. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference. Information contained in or accessible through any website reference in the press release is not part of, or incorporated by reference in, this Current Report on Form 8-K, and the inclusion of such website addresses in this Current Report on Form 8-K by incorporation by reference of the press release is as inactive textual references only.
The information furnished pursuant to this Item 7.01, including Exhibit 99.1, shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and will not be incorporated by reference into any filing under the Securities Act of 1933, as amended, unless specifically identified therein as being incorporated therein by reference. Information contained on or accessible through any website reference in the press release is not part of, or incorporated by reference in, this Current Report on Form 8-K, and the inclusion of any such website address in this Current Report on Form 8-K by incorporation by reference of the press release is as an inactive textual reference only.
Item 9.01 Financial Statements and Exhibits.
| (d) | Exhibits. | |
| Exhibit | Description | |
| 99.1 | Press Release dated October 30, 2018. | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| CO-DIAGNOSTICS, INC. | ||
| Dated: October 31, 2018 | /s/ DWIGHT H. EGAN | |
| By: | Dwight H. Egan, President/CEO | |
Co-Diagnostics, Inc. and LGC, Biosearch Technologies Sign License Agreement for CoPrimer Technology
Co-Diagnostics agrees to license CoPrimers™ for use in agricultural applications
Salt Lake City, Utah – October 30, 2018 - Co-Diagnostics, Inc. (Nasdaq: CODX), a molecular diagnostics company with a unique, proprietary platform for the development of molecular diagnostic tests, and LGC, Biosearch Technologies, a global leader in the design, development, and manufacture of sophisticated, custom oligonucleotide-based tools and associated reagents for applied markets, announced today that they have signed an exclusive license agreement related to the use of the Company’s CoPrimer™ technology for both research and commercial applications.
This Agreement is the result of a joint development project conducted over the past year to test the performance of CoPrimers in multiplexed reactions when locating specific genetic traits in seed products and genetic mutations, including SNP detection.
Dwight Egan, CEO of Co-Diagnostics, commented, “The importance of the validation for our company and technology provided by this license agreement cannot be overstated. We believe the participation of an industry leading portfolio like Biosearch Technologies speaks volumes about the quality and uniqueness of our CoPrimer platform technology. As Biosearch Technologies clients begin to adopt our technology under the terms of this agreement, we look forward to offering our CoDX Design Services to help streamline and improve their operations, as well as to introducing them to further applications of CoPrimers to widen our customer base.
“Co-Diagnostics anticipates this to be the first of many CoPrimer technology license agreements where the accuracy, time- and cost-saving advantages of true multiplex polymerase chain reaction (“PCR”), without concern of cross-reactivity among primer sets leading to inaccurate results, is critical for the application. We expect that the results of the research and proofs of concept we have demonstrated throughout the course of the development project will have direct applications to any business, industry, or institution that relies on PCR technology, and that all such industries will benefit from an improved, better PCR.”
Mark Dearden, VP Strategy and Marketing, LGC, Biosearch Technologies, said, “The addition of the CoPrimer technology to our portfolio demonstrates our commitment to apply innovative technologies that drive workflow efficiencies and enable our customers to achieve more. We believe the CoPrimer technology overcomes many of the traditional shortfalls of multiplex PCR, and are confident our customers will also realize the added flexibility and scalability this technology can bring to their businesses. The technology is highly complementary to our existing oligonucleotide and PCR reagent portfolio, and aligns with our strategy to develop highly innovative, mission critical tools in this space.
“While this Agreement covers the core CoPrimer technology for PCR applications, we are excited about the growing partnership with Co-Diagnostics. LGC is hopeful our expertise in automation, reagents, and oligonucleotides will help expand the applications for the CoPrimer technology, and look forward to future collaborations with Co-Diagnostics.”
Biosearch Technologies, the complete genomics portfolio from LGC, operates from cGMP and ISO 13485:2016 certified production facilities and has been the sole manufacturer of Co-Diagnostics’ CoPrimers since 2013.
LGC is an international leader in the extended life sciences sector, including human healthcare, agri-food & the environment. LGC provides a comprehensive range of reference materials, proficiency testing schemes, genomics reagents and instrumentation, as well as research and measurement services. Its scientific tools and solutions enable organisations to advance research, develop new products and form an essential part of their quality and compliance procedures.
www.lgcgroup.com
www.codiagnostics.com
Notes
Mark Dearden is available for interview. Biosearch Technologies’ logo and pictures available on request.
About LGC
LGC is an international leader in the extended life sciences sector, including human healthcare, agri-food & the environment. LGC provides a comprehensive range of reference materials, proficiency testing schemes, genomics reagents and instrumentation, as well as research and measurement services. Its scientific tools and solutions enable organisations to advance research, develop new products and form an essential part of their quality and compliance procedures.
LGC’s 2,300 employees include internationally-recognized scientists who are experts in their field. Headquartered in London, it operates out of 19 countries worldwide and is extensively accredited to quality standards such as GMP, GLP, ISO 13485, ISO 17034, ISO 17043, ISO/IEC 17025 and ISO 9001.
LGC has been home to the UK Government Chemist for more than 100 years and is the UK National Measurement Laboratory and Designated Institute for chemical and bio measurement. LGC has been privately-owned since 1996 and has diversified through internal investment and acquisition to be an international leader in its chosen niche markets. LGC is now owned by funds affiliated with KKR.
For more information, please visit www.lgcgroup.com
Media contact details
LGC
Julian Quigley
Media Relations & Social Media Manager
+44 (0)20 8943 8491
julian.quigley@lgcgroup.com
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.
| Company Contact | Investor Contact | |
| Andrew Benson | Joe Diaz, Robert Blum and Joe Dorame | |
| Co-Diagnostics Investor Relations | Lytham Partners, LLC | |
| 801-438-1036 | 602-889-9700 | |
| investors@codiagnostics.com |