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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): May 8, 2025
CO-DIAGNOSTICS, INC.
(Exact name of small business issuer as specified in its charter)
| Utah | 1-38148 | 46-2609363 | ||
| (State or other jurisdiction of | (Commission | (IRS Employer | ||
| incorporation or organization) | File Number) | Identification Number) |
2401 S. 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 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)) |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||
| Common Stock, par value $0.001 per share | CODX | The 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. ☐
Item 2.02. Results of Operations and Financial Condition.
On May 8, 2025, Co-Diagnostics, Inc. (the “Company”) issued a press release announcing financial results for its quarter ended March 31, 2025. 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.
Item 7.01. Regulation FD. Disclosure.
The information set forth under Item 2.02 is incorporated by reference as if fully set forth herein.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
| Exhibit No.: | Description: | |
| 99.1 | Press Release, dated May 8, 2025 | |
| 104 | Cover 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: May 8, 2025 | By: | /s/ Brian Brown |
| Name: | Brian Brown | |
| Title: | Chief Financial Officer | |
| (Principal Financial and Accounting Officer) | ||
Exhibit 99.1
Co-Diagnostics, Inc. Reports First Quarter 2025 Financial Results
SALT LAKE CITY, May 8, 2025— 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 March 31, 2025.
First Quarter 2025 Financial Results:
| ● | Revenue of $0.1 million, which declined from $0.5 million during the Q1 2024 primarily due to timing of grant revenue recognition. The Company did not recognize any grant revenue during the first quarter 2025 | |
| ● | Operating expenses of $8.6 million decreased by 18.2% from the prior year first quarter | |
| ● | Operating loss of $8.6 million compared to operating loss of $10.3 million in Q1 2024 | |
| ● | Net loss of $7.5 million, compared to net loss of $9.3 million in Q1 2024, representing a loss of $0.24 per fully diluted share, compared to a loss of $0.31 per fully diluted share in Q1 2024 | |
| ● | Adjusted EBITDA loss of $7.4 million | |
| ● | Cash, cash equivalents, and marketable securities of $21.5 million as of March 31, 2025 |
First Quarter Business Highlights:
| ● | Remain on track for initiation of clinical evaluations for 4 tests in product pipeline and completion of manufacturing facility in India by year-end 2025 | |
| ● | Hosted a symposium to honor International HPV Awareness Day 2025 in India, in collaboration with CoSara, as the Company prepares for pre-clinical and pre-analytical studies for its HPV test to be utilized on the Co-Dx™ PCR Pro™ instrument* | |
| ● | Hosted a booth at BioUtah’s Life Sciences Day on the Hill at the Utah State Capitol Rotunda, which showcased Co-Dx’s upcoming at-home and point-of-care Co-Dx PCR platform* |
“During the quarter, Co-Diagnostics continued to make significant progress in the development of our test pipeline,” said Dwight Egan, Co-Diagnostics’ Chief Executive Officer. “Our priority remains bringing the Co-Dx PCR platform to market, as we advance towards clinical evaluations and regulatory submissions for the 4 main tests in our pipeline. We believe our tuberculosis, respiratory multiplex, HPV multiplex, and COVID-19 tests, to be utilized on the Co-Dx PCR Pro, will play a key role in transforming the global accessibility of diagnostic testing solutions. I am proud of the progress our team has made and look forward to building upon our momentum throughout the rest of the year.”
“Our team made strong progress on our development pipeline during the quarter. Co-Diagnostics remains focused on maintaining operational efficiency as we advance towards several development milestones, including the commencement of clinical evaluations. We look forward to providing you with updates as they come,” said Brian Brown, Co-Diagnostics’ Chief Financial Officer.
Conference Call 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, or accessible directly here
Conference Call: 800-715-9871 (Toll Free) or (646) 307-1963 (Toll) with participant passcode 1977478
The call will be recorded and later made available on the Company’s website: https://codiagnostics.com.
*The Co-Dx PCR platform (including the PCR Home™, PCR Pro™, mobile app, and all associated tests) is subject to review by the FDA and/or other regulatory bodies and is not yet available for sale.
About Co-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 identify genetic markers for use in applications other than infectious disease.
Non-GAAP Financial Measures:
This press release contains adjusted EBITDA, which is a non-GAAP measure defined as net income excluding depreciation, amortization, income tax (benefit) expense, net interest (income) expense, stock-based compensation, change in fair value of contingent consideration, and realized gain (loss) on investments . The Company believes that adjusted EBITDA provides useful information to management and investors relating to its results of operations. The Company’s management uses this non-GAAP measure to compare the Company’s performance to that of prior periods for trend analyses, and for budgeting and planning purposes. The Company believes that the use of adjusted EBITDA provides an additional tool for investors to use in evaluating ongoing operating results and trends and in comparing the Company’s financial measures with other companies, many of which present similar non-GAAP financial measures to investors, and that it allows for greater transparency with respect to key metrics used by management in its financial and operational decision-making.
Management does not consider the non-GAAP measure in isolation or as an alternative to financial measures determined in accordance with GAAP. The principal limitation of the non-GAAP financial measure is that it excludes significant expenses that are required by GAAP to be recorded in the Company’s financial statements. In order to compensate for these limitations, management presents the non-GAAP financial measure together with GAAP results. Non-GAAP measures should be considered in addition to results prepared in accordance with GAAP, but should not be considered a substitute for, or superior to, GAAP results. A reconciliation table of the net income, the most comparable GAAP financial measure to adjusted EBITDA, is included at the end of this release. The Company urges investors to review the reconciliation and not to rely on any single financial measure to evaluate the company’s business.
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 (i) advancement into clinical evaluations and continued development and regulatory submissions for the Co-Dx PCR platform and (ii) our belief that the platform will play a key role in transforming the global accessibility of diagnostic testing solutions. 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. There can be no assurance that any of the anticipated results will occur on a timely basis or at all due to certain risks and uncertainties, a discussion of which can be found in our Risk Factors disclosure in our Annual Report on Form 10-K, filed with the Securities and Exchange Commission (SEC) on March 27, 2025, and in our other filings with the SEC. 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.
Investor Relations Contact:
Andrew Benson
Head of Investor Relations
+1 801-438-1036
investors@codiagnostics.com
| CO-DIAGNOSTICS, INC. AND SUBSIDIARIES | ||||||||
| CONSOLIDATED BALANCE SHEETS | ||||||||
| (Unaudited) | ||||||||
| March 31, 2025 | December 31, 2024 | |||||||
| Assets | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 1,903,034 | $ | 2,936,544 | ||||
| Marketable investment securities | 19,575,902 | 26,811,098 | ||||||
| Accounts receivable, net | 136,391 | 132,570 | ||||||
| Inventory, net | 1,083,309 | 1,072,724 | ||||||
| Income taxes receivable | 574 | - | ||||||
| Prepaid expenses and other current assets | 1,132,281 | 1,338,762 | ||||||
| Total current assets | 23,831,491 | 32,291,698 | ||||||
| Property and equipment, net | 2,593,808 | 2,761,280 | ||||||
| Operating lease right-of-use asset | 1,893,422 | 2,114,876 | ||||||
| Intangible assets, net | 26,101,000 | 26,101,000 | ||||||
| Investment in joint venture | 729,621 | 731,065 | ||||||
| Total assets | $ | 55,149,342 | $ | 63,999,919 | ||||
| Liabilities and stockholders’ equity | ||||||||
| Current liabilities | ||||||||
| Accounts payable | $ | 2,712,642 | $ | 3,294,254 | ||||
| Accrued expenses | 1,610,890 | 2,562,169 | ||||||
| Operating lease liability, current | 902,881 | 915,619 | ||||||
| Contingent consideration liabilities, current | 109,275 | 502,819 | ||||||
| Deferred revenue | 40,857 | 40,857 | ||||||
| Total current liabilities | 5,376,545 | 7,315,718 | ||||||
| Long-term liabilities | ||||||||
| Income taxes payable | 725,127 | 713,643 | ||||||
| Operating lease liability | 1,028,282 | 1,236,560 | ||||||
| Contingent consideration liabilities | 98,557 | 422,080 | ||||||
| Total long-term liabilities | 1,851,966 | 2,372,283 | ||||||
| Total liabilities | 7,228,511 | 9,688,001 | ||||||
| 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 March 31, 2025 and December 31, 2024, respectively | - | - | ||||||
| Common stock, $0.001 par value; 100,000,000 shares authorized; 38,421,321 shares issued and 33,572,643 shares outstanding as of March 31, 2025 and 37,902,222 shares issued and 33,053,544 shares outstanding as of December 31, 2024 | 38,421 | 37,902 | ||||||
| Treasury stock, at cost; 4,848,678 shares held as of March 31, 2025 and December 31, 2024, respectively | (15,575,795 | ) | (15,575,795 | ) | ||||
| Additional paid-in capital | 103,701,665 | 102,472,210 | ||||||
| Accumulated other comprehensive income | 330,653 | 418,443 | ||||||
| Accumulated earnings (deficit) | (40,574,113 | ) | (33,040,842 | ) | ||||
| Total stockholders’ equity | 47,920,831 | 54,311,918 | ||||||
| Total liabilities and stockholders’ equity | $ | 55,149,342 | $ | 63,999,919 | ||||
| CO-DIAGNOSTICS, INC. AND SUBSIDIARIES | ||||||||
| CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | ||||||||
| (Unaudited) | ||||||||
| Three Months Ended March 31, | ||||||||
| 2025 | 2024 | |||||||
| Product revenue | $ | 50,277 | $ | 252,745 | ||||
| Grant revenue | - | 215,109 | ||||||
| Total revenue | 50,277 | 467,854 | ||||||
| Cost of revenue | 21,590 | 234,505 | ||||||
| Gross profit | 28,687 | 233,349 | ||||||
| Operating expenses | ||||||||
| Sales and marketing | 657,030 | 1,563,682 | ||||||
| General and administrative | 2,773,149 | 2,918,803 | ||||||
| Research and development | 4,870,019 | 5,679,678 | ||||||
| Depreciation and amortization | 280,445 | 330,573 | ||||||
| Total operating expenses | 8,580,643 | 10,492,736 | ||||||
| Loss from operations | (8,551,956 | ) | (10,259,387 | ) | ||||
| Other income, net | ||||||||
| Interest income, net | 13,601 | 362,733 | ||||||
| Realized gain on investments | 301,465 | 228,070 | ||||||
| Gain on remeasurement of acquisition contingencies | 717,067 | 450,260 | ||||||
| Loss on equity method investment in joint venture | (1,444 | ) | (70,955 | ) | ||||
| Total other income, net | 1,030,689 | 970,108 | ||||||
| Loss before income taxes | (7,521,267 | ) | (9,289,279 | ) | ||||
| Income tax provision | 12,004 | 22,764 | ||||||
| Net loss | $ | (7,533,271 | ) | $ | (9,312,043 | ) | ||
| Other comprehensive income (loss) | ||||||||
| Change in net unrealized gains on marketable securities, net of tax | (87,790 | ) | 79,855 | |||||
| Total other comprehensive income (loss) | $ | (87,790 | ) | $ | 79,855 | |||
| Comprehensive loss | $ | (7,621,061 | ) | $ | (9,232,188 | ) | ||
| Loss per common share: | ||||||||
| Basic and Diluted | $ | (0.24 | ) | $ | (0.31 | ) | ||
| Weighted average shares outstanding: | ||||||||
| Basic and Diluted | 32,048,953 | 29,842,874 | ||||||
| CO-DIAGNOSTICS, INC. AND SUBSIDIARIES | ||||||||
| GAAP AND NON-GAAP MEASURES | ||||||||
| (Unaudited) | ||||||||
| Reconciliation of net loss to adjusted EBITDA: | ||||||||
| Three Months Ended March 31, | ||||||||
| 2025 | 2024 | |||||||
| Net loss | $ | (7,533,271 | ) | $ | (9,312,043 | ) | ||
| Interest income, net | (13,601 | ) | (362,733 | ) | ||||
| Realized gain on investments | (301,465 | ) | (228,070 | ) | ||||
| Depreciation and amortization | 280,445 | 330,573 | ||||||
| Change in fair value of contingent consideration | (717,067 | ) | (450,260 | ) | ||||
| Stock-based compensation expense | 875,228 | 1,571,234 | ||||||
| Income tax provision | 12,004 | 22,764 | ||||||
| Adjusted EBITDA | $ | (7,397,727 | ) | $ | (8,428,535 | ) | ||