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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): November 13, 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 November 13, 2025, Co-Diagnostics, Inc. (the “Company”) issued a press release announcing financial results for its quarter ended September 30, 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 November 13, 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: November 13, 2025 | By: | /s/ Brian Brown |
| Name: | Brian Brown | |
| Title: | Chief Financial Officer | |
| (Principal Financial and Accounting Officer) | ||
Exhibit 99.1
Co-Diagnostics Reports Third Quarter 2025 Financial Results
Salt Lake City, UT – November 13, 2025 – Co-Diagnostics, Inc. (NASDAQ: CODX) (“Co-Diagnostics,” “Co-Dx,” or “the Company”), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, today announced its financial results for the third quarter ended September 30, 2025.
Third Quarter 2025 Business Highlights:
| ● | Performed in-silico analysis of the primer sets used in its Co-Primers®-based PCR tests for the detection of chikungunya virus (CHIKV), showing high homology against over 1,200 CHIKV sequences and confirming reactivity of CHIKV primers against known recent strains of the virus | |
| ● | Company closed on a Registered Direct Offering (RDO) with gross proceeds of approximately $3.8 million before deducting offering expenses |
Business Highlights Subsequent to Third Quarter 2025:
| ● | Signed definitive agreement with Arabian Eagle Manufacturing to research, develop, manufacture, assemble, distribute, and commercialize Co-Dx technologies and intellectual property in KSA and 18 MENA nations through the JV CoMira Diagnostics, fulfilling the objective of the MOU signed in September 2025. | |
| ● | Announced formation of newly organized artificial intelligence (AI) business unit led by Chief Technology & AI Officer Christopher Thurston, to integrate the Company’s existing and planned AI applications into the Co-Dx™ Primer Ai™ platform | |
| ● | Developed a proprietary sample preparation instrument designed to streamline and simplify workflow for point-of-care (PoC) Co-Dx PCR Mycobacterium Tuberculosis (MTB) Test | |
| ● | Engaged Maxim Group LLC to pursue a strategic transaction which may include a SPAC transaction for CoSara Diagnostics, the Company’s joint venture in India | |
| ● | Subsequent to quarter end, the Company closed on RDO with gross proceeds of approximately $7.0 million before deducting offering expenses |
Third Quarter 2025 Financial Results:
| ● | Revenue of $0.1 million, a decrease as compared to $0.6 million in Q3 2024, primarily related to a reduction in grant revenue recognized compared to the prior period | |
| ● | Operating expenses of approximately $7.1 million, a decrease of 32.6% year-over-year | |
| ● | Operating loss of $7.0 million compared to $10.2 million in Q3 2024 | |
| ● | Net loss of $5.9 million, representing a loss of $0.16 per fully diluted share, compared to net loss of $9.7 million representing a loss of $0.32 per fully diluted share in Q3 2024 | |
| ● | Adjusted EBITDA loss of $6.3 million | |
| ● | Cash, cash equivalents, and marketable securities of $11.4 million as of September 30, 2025 |
“We are entering one of the most active and strategically important periods in our Company’s history,” said Dwight Egan, Co-Diagnostics Chief Executive Officer. “CoMira Diagnostics, our new joint venture in the Kingdom of Saudi Arabia, establishes a strong commercial presence in the KSA and 18 additional MENA markets, expanding our international footprint and supporting the localization of advanced molecular diagnostics in one of the world’s fastest-growing healthcare regions. Additionally, our recently-announced engagement of Maxim to pursue a strategic transaction, including a SPAC transaction with our India joint venture, CoSara, if completed, would represent a significant step toward unlocking value from our India joint venture for our shareholders.”
Mr. Egan continued, “In parallel, we have launched a dedicated AI business unit to unify our proprietary applications under the Co-Dx Primer Ai platform and are preparing to initiate clinical evaluations for our upper-respiratory multiplex test supported by a grant from the NIH’s RADx Tech® program. Together, these initiatives reflect the execution of a cohesive strategy built on financial strength, technological innovation, and scientific leadership that is intended to position Co-Diagnostics for potential sustainable growth, expanded global reach, and long-term value creation.”
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.co-dx.com on the Events & Webcasts page, or accessible directly here
Conference Call: 1-888-880-3330 (Toll Free) or 1-646-357-8766 (Toll)
The call will be recorded and later made available on the Company’s website.
*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 to detect and/or analyze 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 (subject to regulatory review and not currently for sale) 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 and amortization, income tax (benefit) expense, net interest (income) expense, stock-based compensation, change in fair value of contingent consideration, realized gain (loss) on investments, and (gain) loss on disposition of assets. 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. Adjusted EBITDA may differ from similarly titled measures used by other companies and should not be considered in isolation or as a substitute for measures of financial performance prepared in accordance with GAAP. Management uses Adjusted EBITDA solely as a supplemental tool to evaluate operating performance and for internal budgeting and planning purposes.
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) the anticipated benefits, timing, and outcomes of the Company’s strategic initiatives, including its CoMira Diagnostics joint venture and the planned CoSara strategic or SPAC transaction; (ii) the development, regulatory review, and potential commercialization of the Co-Dx PCR platform, Primer Ai™ platform, and related AI or point-of-care technologies; (iii) the Company’s plans to initiate or advance clinical evaluations and regulatory submissions; and (iv) expectations regarding financial strength, strategic positioning, and long-term value creation. 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.
Company Contact:
Andrew Benson
Head of Investor Relations
+1 801-438-1036
investors@codiagnostics.com
Investor Contact:
Valter Pinto, Managing Director
KCSA Strategic Communications
+1 212.896.1254
CODX@KCSA.com
Media Contact:
Jennifer Webb
ColtrinMethod PR
jcoltrin@coltrinmethodpr.com
CO-DIAGNOSTICS, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
(Unaudited)
| September 30, 2025 | December 31, 2024 | |||||||
| Assets | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 11,443,943 | $ | 2,936,544 | ||||
| Marketable investment securities | - | 26,811,098 | ||||||
| Accounts receivable, net | 55,905 | 132,570 | ||||||
| Inventory, net | 1,089,956 | 1,072,724 | ||||||
| Income taxes receivable | 923,217 | - | ||||||
| Prepaid expenses and other current assets | 541,946 | 1,338,762 | ||||||
| Total current assets | 14,054,967 | 32,291,698 | ||||||
| Property and equipment, net | 2,485,112 | 2,761,280 | ||||||
| Operating lease right-of-use asset | 1,439,779 | 2,114,876 | ||||||
| Intangible assets, net | 26,101,000 | 26,101,000 | ||||||
| Investment in joint venture | 659,903 | 731,065 | ||||||
| Total assets | $ | 44,740,761 | $ | 63,999,919 | ||||
| Liabilities and stockholders’ equity | ||||||||
| Current liabilities | ||||||||
| Accounts payable | $ | 1,458,397 | $ | 3,294,254 | ||||
| Accrued expenses | 1,204,660 | 2,562,169 | ||||||
| Operating lease liability, current | 744,156 | 915,619 | ||||||
| Contingent consideration liabilities, current | 239,955 | 502,819 | ||||||
| Deferred revenue | 45,557 | 40,857 | ||||||
| Total current liabilities | 3,692,725 | 7,315,718 | ||||||
| Long-term liabilities | ||||||||
| Income taxes payable | 491,848 | 713,643 | ||||||
| Operating lease liability | 727,943 | 1,236,560 | ||||||
| Contingent consideration liabilities | - | 422,080 | ||||||
| Total long-term liabilities | 1,219,791 | 2,372,283 | ||||||
| Total liabilities | 4,912,516 | 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 September 30, 2025 and December 31, 2024, respectively | - | - | ||||||
| Common stock, $0.001 par value; 100,000,000 shares authorized; 52,991,260 shares issued and 48,142,582 shares outstanding as of September 30, 2025 and 37,902,222 shares issued and 33,053,544 shares outstanding as of December 31, 2024 | 52,991 | 37,902 | ||||||
| Treasury stock, at cost; 4,848,678 shares held as of September 30, 2025 and December 31, 2024, respectively | (15,575,795 | ) | (15,575,795 | ) | ||||
| Additional paid-in capital | 109,447,214 | 102,472,210 | ||||||
| Accumulated other comprehensive income | 94,888 | 418,443 | ||||||
| Accumulated deficit | (54,191,053 | ) | (33,040,842 | ) | ||||
| Total stockholders’ equity | 39,828,245 | 54,311,918 | ||||||
| Total liabilities and stockholders’ equity | $ | 44,740,761 | $ | 63,999,919 | ||||
CO-DIAGNOSTICS, INC. AND SUBSIDIARES
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(Unaudited)
| Three Months Ended September 30, | ||||||||
| 2025 | 2024 | |||||||
| Product revenue | $ | 145,380 | $ | 206,876 | ||||
| Grant revenue | - | 434,265 | ||||||
| Total revenue | 145,380 | 641,141 | ||||||
| Cost of revenue | 26,285 | 297,403 | ||||||
| Gross profit | 119,095 | 343,738 | ||||||
| Operating expenses | ||||||||
| Sales and marketing | 568,937 | 1,059,745 | ||||||
| General and administrative | 1,815,945 | 4,287,380 | ||||||
| Research and development | 4,480,678 | 4,880,315 | ||||||
| Depreciation and amortization | 267,383 | 351,235 | ||||||
| Total operating expenses | 7,132,943 | 10,578,675 | ||||||
| Loss from operations | (7,013,848 | ) | (10,234,937 | ) | ||||
| Other income (expense), net | ||||||||
| Interest income, net | 13,194 | 263,335 | ||||||
| Realized gain on investments | 41,542 | 293,067 | ||||||
| Gain (loss) on disposition of assets | 4,000 | 3,513 | ||||||
| Gain (loss) on remeasurement of acquisition contingencies | (42,345 | ) | (11,927 | ) | ||||
| Gain (loss) on equity method investment in joint venture | (55,959 | ) | 12,683 | |||||
| Total other income (expense), net | (39,568 | ) | 560,671 | |||||
| Loss before income taxes | (7,053,416 | ) | (9,674,266 | ) | ||||
| Income tax provision (benefit) | (1,166,593 | ) | 22,189 | |||||
| Net loss | $ | (5,886,823 | ) | $ | (9,696,455 | ) | ||
| Other comprehensive income (loss) | ||||||||
| Change in net unrealized gains (losses) on marketable securities, net of tax | (39,180 | ) | 37,158 | |||||
| Total other comprehensive income (loss) | $ | (39,180 | ) | $ | 37,158 | |||
| Comprehensive loss | $ | (5,926,003 | ) | $ | (9,659,297 | ) | ||
| Loss per common share: | ||||||||
| Basic and Diluted | $ | (0.16 | ) | $ | (0.32 | ) | ||
| Weighted average shares outstanding: | ||||||||
| Basic and Diluted | 37,890,923 | 30,494,206 | ||||||
CO-DIAGNOSTICS, INC. AND SUBSIDIARES
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(Unaudited)
Reconciliation of net loss to adjusted EBITDA:
| Three Months Ended September 30, | ||||||||
| 2025 | 2024 | |||||||
| Net loss | $ | (5,886,823 | ) | $ | (9,696,455 | ) | ||
| Interest income, net | (13,194 | ) | (263,335 | ) | ||||
| Realized gain on investments | (41,542 | ) | (293,067 | ) | ||||
| Depreciation and amortization | 267,383 | 351,235 | ||||||
| Gain on disposition of assets | (4,000 | ) | (3,513 | ) | ||||
| Change in fair value of contingent consideration | 42,345 | 11,927 | ||||||
| Stock-based compensation expense | 500,585 | 1,045,583 | ||||||
| Income tax provision (benefit) | (1,166,593 | ) | 22,189 | |||||
| Adjusted EBITDA | $ | (6,301,839 | ) | $ | (8,825,436 | ) | ||