8-K - CODX - Equibles

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): August 8, 2024

CO-DIAGNOSTICS,

INC.

(Exact name of small business issuer as specified in its charter)

Utah	1-38148	46-2609363
(State<br> or other jurisdiction of	(Commission	(IRS<br> Employer
incorporation<br> or organization)	File<br> Number)	Identification<br> Number)

2401S. Foothill Drive, Suite D, Salt Lake City, Utah 84109

(Address of principal executive offices)

(801)438-1036

(Issuer’s telephone number)

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<br> communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐	Soliciting<br> material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐	Pre-commencement<br> communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐	Pre-commencement<br> communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title<br> of each class	Trading<br> Symbol(s)	Name<br> of each exchange on which registered
Common<br> Stock, par value $0.001 per share	CODX	The<br> Nasdaq Capital Market

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 ☐

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. ☐

Item2.02. Results of Operations and Financial Condition.

On August 8, 2024, Co-Diagnostics, Inc. (the “Company”) issued a press release announcing financial results for its quarter ended June 30, 2024. The full text of the press release, which includes information regarding the Company’s use of a non-GAAP financial measure, is furnished as Exhibit 99.1 to this Form 8-K.

The information contained in this Item 2.02, including Exhibit 99.1 attached hereto, is being furnished and shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, or otherwise subject to the liabilities of that section. Furthermore, the information contained in this Item 2.02 or Exhibit 99.1 shall not be deemed to be incorporated by reference into any registration statement or other document filed pursuant to the Securities Act of 1933, except as shall be expressly set forth by specific reference in such filing.

Item7.01. Regulation FD. Disclosure.

The information set forth under Item 2.02 is incorporated by reference as if fully set forth herein.

Item9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.:	Description:
99.1	Press Release, dated August 8, 2024
104	Cover<br> Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURE

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.
Date:<br> August 8, 2024	By:	/s/ Brian Brown
	Name:	Brian<br> Brown
	Title:	Chief<br> Financial Officer
		(Principal<br> Financial and Accounting Officer)

Exhibit99.1

Co-Diagnostics,Inc. Reports Second Quarter 2024 Financial Results

SALTLAKE CITY, August 8, 2024— Co-Diagnostics, Inc. (NASDAQ: CODX), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, today announced financial results for the quarter ended June 30, 2024.

SecondQuarter 2024 Financial Results:

●	Revenue<br> of $2.7 million, up from $0.2 million during the prior year primarily due to the achievement of certain milestones under various<br> grant agreements the company was awarded
●	Operating<br> expenses of $10.1 million decreased by 13.7% from the prior year due to lower stock-based compensation expense, bad debt expense,<br> and expenses related to clinical trials for the Co-Dx PCR platform
●	Operating<br> loss of $7.7 million compared to operating loss of $12.0 million in 2023
●	Net<br> loss of $7.6 million, compared to net loss of $8.9 million in the prior year, representing a loss of $0.25 per fully diluted share,<br> compared to a loss of $0.31 per fully diluted share in the prior year
●	Adjusted<br> EBITDA loss of $5.9 million compared to $9.6 million in the prior year
●	Cash,<br> cash equivalents, and marketable securities of $44.9 million as of June 30, 2024

SecondQuarter and Recent 2024 Business Highlights:

●	Submitted<br> first 510(k) application to the U.S. Food and Drug Administration (FDA) for the Co-Dx™ PCR Pro™ Platform, which includes<br> the Co-Dx PCR Pro instrument and the Co-Dx PCR COVID-19 test for over-the-counter (OTC) use
●	Inaugurated<br> a new manufacturing facility in South Salt Lake to manufacture our patented Co-Primers® oligonucleotides, the Co-Dx™ PCR<br> Pro™ instrument, and test cups for the new Co-Dx PCR platform
●	Expanded<br> Co-Dx vector control technology to a 15^th^ U.S. state, Nevada, which includes Vector Smart® PCR tests in environmental<br> surveillance of mosquito pools for mosquito-borne illnesses
●	Attended<br> and participated in the FIME 2024 trade show in Miami Beach, Florida, which included exhibitors from 116 countries and over 15,000<br> professional attendees, to display the new Co-Dx PCR platform

“We are very pleased by the progress Co-Diagnostics has made so far this year,” said Dwight Egan, Co-Diagnostics’ Chief Executive Officer. “Our 510(k) application for our new instrument and COVID-19 test kit, which we submitted to the FDA for over-the-counter (OTC) use, is a significant accomplishment. Medical devices cleared for OTC use are automatically categorized as CLIA-waived, making them also suitable for use at the point-of-care as well. We believe this will help to further expand the market and value of the new platform while we prepare to pursue clearance from the FDA for the Co-Dx PCR COVID-19 test on the new instrument specifically for point-of-care use. We look forward to providing you with updates as they come and continue to work hard to further the development of TB, multiplex respiratory, and HPV tests throughout the year.”

“We truly believe that we are one-step closer to delivering the most low-cost, easy to use, and highly accessible diagnostics point of care platform. We also look forward to beginning clinical evaluations for our multiplex test later this year,” said Brian Brown, Co-Diagnostics’ Chief Financial Officer.

ConferenceCall and Webcast

Co-Diagnostics will host a conference call and webcast at 4:30 p.m. EDT today to discuss its financial results with analysts and institutional investors. The conference call and webcast will be available via:

Webcast: ir.codiagnostics.com on the Events & Webcasts page

Conference Call: 844-481-2661 (domestic) or 412-317-0652 (international)

The call will be recorded and later made available on the Company’s website: https://codiagnostics.com.

*TheCo-Dx PCR platform (including the PCR Home™, PCR Pro™, mobile app, and all associated tests) is subject to review by theFDA and/or other regulatory bodies and is not yet available for sale. The Co-Dx PCR Pro instrument and Co-Dx COVID-19 Test are currentlyunder review by the FDA.

AboutCo-Diagnostics, Inc.:

Co-Diagnostics, Inc., a Utah corporation, is a molecular diagnostics company that develops, manufactures and markets state-of-the-art diagnostics technologies. The Company’s technologies are 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 for its Co-Dx PCR at-home and point-of-care platform and to locate genetic markers for use in applications other than infectious disease.

Non-GAAPFinancial Measures:

Thispress release contains adjusted EBITDA, which is a non-GAAP measure defined as net income excluding depreciation, amortization, incometax (benefit) expense, net interest (income) expense, realized gains on investments, stock-based compensation, change in fairvalue of contingent consideration, gain or loss on disposition of assets, and one-time transaction related costs. The Company believesthat adjusted EBITDA provides useful information to management and investors relating to its results of operations. The Company’smanagement uses this non-GAAP measure to compare the Company’s performance to that of prior periods for trend analyses, and forbudgeting and planning purposes. The Company believes that the use of adjusted EBITDA provides an additional tool for investors to usein evaluating ongoing operating results and trends and in comparing the Company’s financial measures with other companies, manyof which present similar non-GAAP financial measures to investors, and that it allows for greater transparency with respect to key metricsused by management in its financial and operational decision-making.

Managementdoes not consider the non-GAAP measure in isolation or as an alternative to financial measures determined in accordance with GAAP. Theprincipal limitation of the non-GAAP financial measure is that it excludes significant expenses that are required by GAAP to be recordedin the Company’s financial statements. In order to compensate for these limitations, management presents the non-GAAP financialmeasure together with GAAP results. Non-GAAP measures should be considered in addition to results prepared in accordance with GAAP, butshould not be considered a substitute for, or superior to, GAAP results. A reconciliation table of the net income, the most comparableGAAP financial measure to adjusted EBITDA, is included at the end of this release. The Company urges investors to review the reconciliationand not to rely on any single financial measure to evaluate the company’s business.

Forward-LookingStatements:

Thispress release contains forward-looking statements. Forward-looking statements can be identified by words such as “believes,”“expects,” “estimates,” “intends,” “may,” “plans,” “will” andsimilar expressions, or the negative of these words. Such forward-looking statements are based on facts and conditions as they existat the time such statements are made and predictions as to future facts and conditions. Forward-looking statements in this release includestatements regarding our belief that, because medical devices cleared for OTC use are automatically categorized as CLIA-waived, makingthem also suitable for use at the point-of-care as well, such clearance will help to further expand the market and value of the new platformwhile we prepare to pursue clearance from the FDA for the Co-Dx PCR COVID-19 test on the new instrument specifically for point-of-careuse and our anticipation that we will begin clinical evaluations for our multiplex test later this year. Forward-looking statementsare subject to inherent uncertainties, risks and changes in circumstances. Actual results may differ materially from those contemplatedor anticipated by such forward-looking statements. Readers of this press release are cautioned not to place undue reliance on any forward-lookingstatements. There can be no assurance that any of the anticipated results will occur on a timely basis or at all due to certain risksand uncertainties, a discussion of which can be found in our Risk Factors disclosure in our Annual Report on Form 10-K, filed with theSecurities and Exchange Commission (SEC) on March 14, 2024, and in our other filings with the SEC. The Company does not undertake anyobligation to update any forward-looking statement relating to matters discussed in this press release, except as may be required byapplicable securities laws.

InvestorRelations Contact:

AndrewBenson

Head of Investor Relations

+1 801-438-1036

investors@codiagnostics.com

CO-DIAGNOSTICS,INC. AND SUBSIDIARIES

CONSOLIDATEDBALANCE SHEETS

(Unaudited)

			December 31, 2023
Assets
Current assets
Cash and cash equivalents	13,858,866		$	14,916,878
Marketable investment securities	31,020,811			43,631,510
Accounts receivable, net	551,504			303,926
Inventory, net	1,463,960			1,664,725
Income taxes receivable	-			26,955
Prepaid expenses and other current assets	1,324,098			1,597,114
Total current assets	48,219,239			62,141,108
Property and equipment, net	3,054,487			3,035,729
Operating lease right-of-use asset	2,547,485			2,966,774
Intangible assets, net	26,252,333			26,403,667
Investment in joint venture	627,924			773,382
Total assets	80,701,468		$	95,320,660
Liabilities and stockholders’ equity
Current liabilities
Accounts payable	1,863,499		$	1,482,109
Accrued expenses	1,504,750			2,172,959
Operating lease liability, current	878,174			838,387
Contingent consideration liabilities, current	838,032			891,666
Deferred revenue	220,930			362,449
Total current liabilities	5,305,385			5,747,570
Long-term liabilities
Income taxes payable	699,113			659,186
Operating lease liability	1,703,717			2,152,180
Contingent consideration liabilities	595,599			748,109
Total long-term liabilities	2,998,429			3,559,475
Total liabilities	8,303,814			9,307,045
Commitments and contingencies (Note 10)
Stockholders’ equity
Convertible preferred stock, 0.001 par value; 5,000,000 shares authorized; 0 shares issued and outstanding as of June 30, 2024 and December 31, 2023, respectively	-			-
Common stock, 0.001 par value; 100,000,000 shares authorized; 36,759,680 shares issued and 31,911,002 shares outstanding as of June 30, 2024 and 36,108,346 shares issued and 31,259,668 shares outstanding as of December 31, 2023	36,760			36,108
Treasury stock, at cost; 4,848,678 shares held as of June 30, 2024 and December 31, 2023, respectively	(15,575,795	)		(15,575,795	)
Additional paid-in capital	99,878,676			96,808,436
Accumulated other comprehensive income	371,208			146,700
Accumulated earnings (deficit)	(12,313,195	)		4,598,166
Total stockholders’ equity	72,397,654			86,013,615
Total liabilities and stockholders’ equity	80,701,468		$	95,320,660

All values are in US Dollars.

CO-DIAGNOSTICS,INC. AND SUBSIDIARIES

CONSOLIDATEDSTATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(Unaudited)

	Three Months Ended June 30,
	2024			2023
Product revenue	$	161,102		$	197,806
Grant revenue		2,495,738			-
Total revenue		2,656,840			197,806
Cost of revenue		212,148			459,095
Gross profit		2,444,692			(261,289	)
Operating expenses
Sales and marketing		1,041,243			1,732,966
General and administrative		3,132,385			3,713,895
Research and development		5,612,691			5,981,043
Depreciation and amortization		338,335			305,246
Total operating expenses		10,124,654			11,733,150
Loss from operations		(7,679,962	)		(11,994,439	)
Other income, net
Interest income		342,188			191,892
Realized gain on investments		74,165			411,190
Gain on disposition of assets		3,500			-
Gain (loss) on remeasurement of acquisition contingencies		(244,116	)		359,405
Gain (loss) on equity method investment in joint venture		(74,503	)		(125,193	)
Total other income, net		101,234			837,294
Loss before income taxes		(7,578,728	)		(11,157,145	)
Income tax provision (benefit)		20,590			(2,238,320	)
Net loss	$	(7,599,318	)	$	(8,918,825	)
Other comprehensive loss
Change in net unrealized gains on marketable securities, net of tax		144,653			107,366
Total other comprehensive income	$	144,653		$	107,366
Comprehensive loss	$	(7,454,665	)	$	(8,811,459	)
Loss per common share:
Basic and Diluted	$	(0.25	)	$	(0.31	)
Weighted average shares outstanding:
Basic and Diluted		30,124,696			29,088,159

CO-DIAGNOSTICS,INC. AND SUBSIDIARIES

GAAPAND NON-GAAP MEASURES

(Unaudited)

Reconciliationof net loss to adjusted EBITDA:

	Three Months Ended June 30,
	2024			2023
Net loss	$	(7,599,318	)	$	(8,918,825	)
Interest income		(342,188	)		(191,892	)
Realized gain on investments		(74,165	)		(411,190	)
Depreciation and amortization		338,335			305,246
Gain on disposition of assets		(3,500	)		-
Change in fair value of contingent consideration		244,116			(359,405	)
Stock-based compensation expense		1,499,658			2,169,801
Income tax provision (benefit)		20,590			(2,238,320	)
Adjusted EBITDA	$	(5,916,472	)	$	(9,644,585	)