Co-Diagnostics, Inc 10-Q for FY2026 Q3
Co-Diagnostics, Inc. (CODX)
About this 10-Q
Co-Diagnostics, Inc filed this 10-Q on November 10, 2026, covering the quarter ended September 30, 2026 (FY2026 Q3).
Co-Diagnostics reported $0.7 million cash and cash equivalents at September 30, 2026, versus total current liabilities of $2.5 million, and said additional capital is required, creating substantial doubt about its ability to continue as a going concern. AI summary
Headline figures
Quarter ended September 30, 2026, as reported in this filing, compared with the same period a year earlier where the filing states it.
- Revenue
- $282.88K
- up 94.6% from $145.38K a year earlier
- Net loss
- $6.31M
- compared with a net loss of $5.89M a year earlier
- Diluted EPS
- -$1.01
- compared with -$4.66 a year earlier
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM
For
the quarterly period ended
OR
For the transition period from __________ to __________
Commission
File No.
(Exact Name of Registrant as Specified in Its Charter)
(State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer Identification Number) |
(Address of principal executive offices and zip code)
(Registrant’s telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||
| The |
Indicate
by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Exchange Act of 1934
during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject
to such filing requirements for the past 90 days.
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule
405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or such shorter period that the registrant was
required to submit and post such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
| Large accelerated filer | ☐ | Accelerated filer | ☐ |
| ☒ | Smaller reporting company | ||
| 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. ☐
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes ☐ No
As of November 6, 2026, there were shares of common stock, par value $ per share, outstanding.
CO-DIAGNOSTICS, INC. AND SUBSIDIARIES
TABLE OF CONTENTS
| 2 |
PART I. FINANCIAL INFORMATION
Item 1. Financial Statements
CO – DIAGNOSTICS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
| September 30, 2026 | December 31, 2025 | |||||||
| Assets | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | $ | ||||||
| Accounts receivable, net | ||||||||
| Inventory, net | ||||||||
| Income taxes receivable | ||||||||
| Prepaid expenses and other current assets | ||||||||
| Total current assets | ||||||||
| Property and equipment, net | ||||||||
| Operating lease right-of-use asset | ||||||||
| Intangible assets, net | ||||||||
| Investment in joint ventures | ||||||||
| Total assets | $ | $ | ||||||
| Liabilities and stockholders’ equity | ||||||||
| Current liabilities | ||||||||
| Accounts payable | $ | $ | ||||||
| Accrued expenses | ||||||||
| Operating lease liability, current | ||||||||
| Contingent consideration liabilities, current | ||||||||
| Deferred revenue | ||||||||
| Total current liabilities | ||||||||
| Long-term liabilities | ||||||||
| Operating lease liability | ||||||||
| Total long-term liabilities | ||||||||
| Total liabilities | ||||||||
| Commitments and contingencies (Note 11) | ||||||||
| Stockholders’ equity | ||||||||
| Convertible preferred stock, $ par value; shares authorized; shares issued and outstanding as of September 30, 2026 and December 31, 2025, respectively | ||||||||
| Common stock, $ par value; shares authorized; shares issued and shares outstanding as of September 30, 2026 and shares issued and shares outstanding as of December 31, 2025 | ||||||||
| Treasury stock, at cost; shares held as of September 30, 2026 and December 31, 2025, respectively | ( | ) | ( | ) | ||||
| Additional paid-in capital | ||||||||
| Accumulated deficit | ( | ) | ( | ) | ||||
| Total stockholders’ equity | ||||||||
| Total liabilities and stockholders’ equity | $ | $ | ||||||
See accompanying notes to unaudited condensed consolidated financial statements
| 3 |
CO – DIAGNOSTICS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(Unaudited)
| 2026 | 2025 | 2026 | 2025 | |||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2026 | 2025 | 2026 | 2025 | |||||||||||||
| Product revenue | $ | $ | $ | $ | ||||||||||||
| Total revenue | ||||||||||||||||
| Cost of revenue | ||||||||||||||||
| Gross profit | ( | ) | ||||||||||||||
| Operating expenses | ||||||||||||||||
| Sales and marketing | ||||||||||||||||
| General and administrative | ||||||||||||||||
| Research and development | ||||||||||||||||
| Depreciation and amortization | ||||||||||||||||
| Total operating expenses | ||||||||||||||||
| Loss from operations | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Other income (expense), net | ||||||||||||||||
| Interest income, net | ||||||||||||||||
| Realized gain on investments | ||||||||||||||||
| Gain (loss) on disposition of assets | ( | ) | ||||||||||||||
| Gain (loss) on remeasurement of acquisition contingencies | ( | ) | ||||||||||||||
| Loss on equity method investment in joint ventures | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Total other income (expense), net | ( | ) | ( | ) | ( | ) | ||||||||||
| Loss before income taxes | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Income tax provision (benefit) | ( | ) | ( | ) | ||||||||||||
| Net loss | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| Other comprehensive loss | ||||||||||||||||
| Change in net unrealized gains on marketable securities, net of tax | ( | ) | ( | ) | ||||||||||||
| Total other comprehensive loss | $ | $ | ( | ) | $ | $ | ( | ) | ||||||||
| Comprehensive loss | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| Loss per common share: | ||||||||||||||||
| Basic and Diluted | $ | ) | $ | ) | $ | ) | $ | ) | ||||||||
| Weighted average shares outstanding: | ||||||||||||||||
| Basic and Diluted | ||||||||||||||||
See accompanying notes to unaudited condensed consolidated financial statements
| 4 |
CO – DIAGNOSTICS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
| 2026 | 2025 | |||||||
| Nine Months Ended September 30, | ||||||||
| 2026 | 2025 | |||||||
| Cash flows from operating activities | ||||||||
| Net loss | $ | ( | ) | $ | ( | ) | ||
| Adjustments to reconcile net loss to cash used in operating activities: | ||||||||
| Depreciation and amortization | ||||||||
| Stock-based compensation expense | ||||||||
| Common stock issued for financial advisory services | ||||||||
| Change in fair value of acquisition contingencies | ( | ) | ( | ) | ||||
| Non-cash lease expense | ( | ) | ||||||
| Realized gain on investments | ( | ) | ||||||
| Loss from equity method investment | ||||||||
| Loss on disposition of assets | ||||||||
| Provision for (recoveries of) credit losses | ( | ) | ||||||
| Inventory obsolescence recoveries | ( | ) | ( | ) | ||||
| Changes in assets and liabilities: | ||||||||
| Accounts receivable | ||||||||
| Prepaid expenses and other assets | ( | ) | ||||||
| Inventory | ||||||||
| Deferred revenue | ( | ) | ||||||
| Income taxes payable | ( | ) | ||||||
| Accounts payable, accrued expenses and other liabilities | ( | ) | ( | ) | ||||
| Net cash used in operating activities | ( | ) | ( | ) | ||||
| Cash flows from investing activities | ||||||||
| Purchases of property and equipment | ( | ) | ( | ) | ||||
| Proceeds from maturities of marketable investment securities | ||||||||
| Purchases of marketable securities | ( | ) | ||||||
| Investment in joint ventures | ( | ) | ||||||
| Net cash (used in) provided by investing activities | ( | ) | ||||||
| Cash flows from financing activities | ||||||||
| Issuance of common stock related to private placement transaction and warrant exercises, net of offering costs | ||||||||
| Issuance of common stock related to at-the-market offering, net of offering costs | ||||||||
| Issuance of common stock related to registered direct offering, net of offering costs | ||||||||
| Net cash provided by financing activities | ||||||||
| Net increase (decrease) in cash and cash equivalents | ( | ) | ||||||
| Cash and cash equivalents at beginning of period | ||||||||
| Cash and cash equivalents at end of period | $ | $ | ||||||
| Supplemental disclosure of cash flow information | ||||||||
| Cash received for income taxes | $ | $ | ||||||
| Supplemental disclosure of non-cash investing and financing transactions | ||||||||
| Right-of-use assets obtained in exchange for new operating lease liabilities | $ | $ | ||||||
See accompanying notes to unaudited condensed consolidated financial statements
| 5 |
CO – DIAGNOSTICS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(Unaudited)
| Shares | Amount | Shares | Amount | Stock | Capital | Income | (Deficit) | Equity | ||||||||||||||||||||||||||||
| Convertible Preferred Stock | Common Stock | Treasury | Additional Paid-in | Accumulated Other Comprehensive | Accumulated | Total Stockholders’ | ||||||||||||||||||||||||||||||
| Shares | Amount | Shares | Amount | Stock | Capital | Income | Deficit | Equity | ||||||||||||||||||||||||||||
| Balance as of December 31, 2025 | ( | ) | ( | ) | ||||||||||||||||||||||||||||||||
| Issuance of common stock related to at-the-market offering, net of offering costs | - | |||||||||||||||||||||||||||||||||||
| Stock-based compensation | - | - | ||||||||||||||||||||||||||||||||||
| Net loss | - | - | ( | ) | ( | ) | ||||||||||||||||||||||||||||||
| Balance as of March 31, 2026 | ( | ) | ( | ) | ||||||||||||||||||||||||||||||||
| Stock-based compensation | - | |||||||||||||||||||||||||||||||||||
| Issuance of common stock related to private placement transaction and warrant exercises, net of offering costs | - | |||||||||||||||||||||||||||||||||||
| Net loss | - | - | ( | ) | ( | ) | ||||||||||||||||||||||||||||||
| Balance as of June 30, 2026 | ( | ) | ( | ) | ||||||||||||||||||||||||||||||||
| Issuance of common stock related to at-the-market offering, net of offering costs | - | |||||||||||||||||||||||||||||||||||
| Stock-based compensation | - | - | ||||||||||||||||||||||||||||||||||
| Issuance of common stock related to private placement transaction and warrant exercises, net of offering costs | - | |||||||||||||||||||||||||||||||||||
| Net loss | - | - | ( | ) | ( | ) | ||||||||||||||||||||||||||||||
| Balance as of September 30, 2026 | $ | $ | $ | ( | ) | $ | $ | $ | ( | ) | $ | |||||||||||||||||||||||||
| Convertible Preferred Stock | Common Stock | Treasury | Additional Paid-in | Accumulated Other Comprehensive | Accumulated Earnings | Total Stockholders’ | ||||||||||||||||||||||||||||||
| Shares | Amount | Shares | Amount | Stock | Capital | Income | (Deficit) | Equity | ||||||||||||||||||||||||||||
| Balance as of December 31, 2024 | $ | $ | $ | ( | ) | $ | $ | $ | ( | ) | $ | |||||||||||||||||||||||||
| Issuance of common stock related to at-the-market offering, net of offering costs | - | |||||||||||||||||||||||||||||||||||
| Stock-based compensation | - | - | ||||||||||||||||||||||||||||||||||
| Other comprehensive loss, net of tax | - | - | ( | ) | ( | ) | ||||||||||||||||||||||||||||||
| Net loss | - | - | ( | ) | ( | ) | ||||||||||||||||||||||||||||||
| Balance as of March 31, 2025 | ( | ) | ( | ) | ||||||||||||||||||||||||||||||||
| Issuance of common stock related to at-the-market offering, net of offering costs | - | |||||||||||||||||||||||||||||||||||
| Stock-based compensation | - | |||||||||||||||||||||||||||||||||||
| Issuance of common stock related to financial advisory services | - | |||||||||||||||||||||||||||||||||||
| Other comprehensive loss, net of tax | - | - | ( | ) | ( | ) | ||||||||||||||||||||||||||||||
| Net loss | - | - | ( | ) | ( | ) | ||||||||||||||||||||||||||||||
| Balance as of June 30, 2025 | ( | ) | ( | ) | ||||||||||||||||||||||||||||||||
| Balance | ( | ) | ( | ) | ||||||||||||||||||||||||||||||||
| Issuance of common stock related to at-the-market offering, net of offering costs | - | |||||||||||||||||||||||||||||||||||
| Stock-based compensation | - | - | ||||||||||||||||||||||||||||||||||
| Issuance of common stock related to registered direct offering, net of offering costs | - | |||||||||||||||||||||||||||||||||||
| Other comprehensive loss, net of tax | - | - | ( | ) | ( | ) | ||||||||||||||||||||||||||||||
| Net loss | - | - | ( | ) | ( | ) | ||||||||||||||||||||||||||||||
| Balance as of September 30, 2025 | $ | $ | $ | ( | ) | $ | $ | $ | ( | ) | $ | |||||||||||||||||||||||||
| Balance | $ | $ | $ | ( | ) | $ | $ | $ | ( | ) | $ | |||||||||||||||||||||||||
See accompanying notes to unaudited condensed consolidated financial statements
| 6 |
CO – DIAGNOSTICS, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
Note 1 – Overview and Basis of Presentation
Description of Business
Co-Diagnostics, Inc., a Utah corporation (the “Company” or “CODX”), 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 platform and to locate genetic markers for use in applications other than infectious disease. In connection with the sale of our tests we may sell diagnostic equipment from other manufacturers as self-contained lab systems.
Unaudited Condensed Consolidated Financial Statements
The accompanying unaudited condensed consolidated financial statements of the Company have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and the rules and regulations of the Securities and Exchange Commission (“SEC”) for interim financial information as they are prescribed for smaller reporting companies. As permitted under those rules and regulations, certain notes or other financial information normally included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted. Accordingly, the accompanying unaudited condensed consolidated financial statements do not include all the information and footnotes required by U.S. GAAP for complete financial statements. In the opinion of management, all adjustments (consisting of normal recurring adjustments) considered necessary to make the financial statements not misleading have been included. Operating results for the three and nine months ended September 30, 2026 are not necessarily indicative of the results that may be expected for the year ending December 31, 2026. These statements should be read in conjunction with the Company’s audited financial statements and related notes for the year ended December 31, 2025, included in the Company’s Annual Report on Form 10-K filed with the SEC on March 31, 2026. A summary of the Company’s significant accounting policies is set forth in Note 2 to the consolidated financial statements in its Annual Report on Form 10-K for the year ended December 31, 2025.
Use of Estimates
The preparation of financial statements in conformity with generally accepted accounting principles requires management to make estimates and assumptions that affect the amounts reported in the financial statements and the accompanying notes. Such estimates include receivables and other long-lived assets, legal contingencies, income taxes, share based arrangements, and others. These estimates and assumptions are based on management’s best estimates and judgments. Actual amounts and results could differ from those estimates.
Liquidity and Going Concern
In accordance with Accounting Standards Codification (“ASC”) 205-40, Going Concern, (“ASC 205-40”) the Company evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date on which this Quarterly Report on Form 10-Q is filed. Based on the Company’s cash and cash equivalents as of September 30, 2026, the Company’s current and forecasted level of operations, and its forecasted cash flows, the Company’s ability to continue as a going concern is dependent upon its ability to obtain the necessary financing to meet its obligations and repay its liabilities arising from normal business operations when they come due, and to generate profitable operations in the future. Management plans to provide for the Company’s capital requirements through equity and/or debt financing, seeking additional grant funding, and through operational efficiencies. Our ability to obtain additional financing in equity capital markets is subject to several factors, including market and economic conditions, our performance and investor sentiment with respect to us and our industry. Accordingly, there can be no assurance that the Company will be able to raise a sufficient amount of additional capital to fund operations with terms acceptable to the Company, or at all. Because certain elements of management’s plans to mitigate the conditions that raised substantial doubt about the Company’s ability to continue as a going concern are outside of the Company’s control, including the ability to raise capital through equity or other financings, those elements cannot be considered probable according to ASC 205-40, and therefore cannot be considered in the evaluation of mitigating factors. As a result, management has concluded that substantial doubt exists about the Company’s ability to continue as a going concern for 12 months from the date these condensed consolidated financial statements are issued.
| 7 |
The condensed consolidated financial statements as of September 30, 2026 have been prepared under the assumption that the Company will continue as a going concern for the next 12 months after these financial statements are issued, and that contemplates the realization of assets and satisfaction of liabilities and commitments in the normal course of business. The Company’s ability to continue as a going concern is dependent upon its uncertain ability to obtain additional capital, reduce expenditures, and execute on its business plans. These consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Note 2 – Summary of Significant Accounting Policies
Reclassifications
Certain prior year amounts have been reclassified to conform with the current year’s presentation. These reclassifications have no impact on the previously reported results.
Operating Segments
The Company operates as one operating segment. Operating segments are defined as components of an entity for which separate financial information is regularly evaluated by the chief operating decision maker (“CODM”), which is the Company’s Chief Executive Officer, in deciding how to allocate resources and assess performance. The Company’s CODM evaluates financial information and resources and assesses the performance of these resources on a consolidated basis. There is no expense or asset information that is supplemental to information disclosed within the condensed consolidated financial statements, that is regularly provided to the CODM. The allocation of resources and assessment of performance of the operating segment is based on consolidated net loss and functional expenses as reported on our condensed consolidated statements of operations and comprehensive loss. Because the Company operates as one operating segment, financial segment information, including expense and asset information, can be found in the condensed consolidated financial statements. All material long-lived assets are located in the United States and India.
Accounts Receivable
Trade
accounts receivable are recorded at the invoiced amount (net of allowance) and do not bear interest. The Company maintains an allowance
for credit losses for amounts the Company does not expect to collect. In establishing the required allowance, management considers historical
losses, current market conditions, customers’ financial condition, the age of receivables, and current payment patterns. Account
balances are written off against the allowance once the receivable is deemed uncollectible. Recoveries of trade receivables previously
written off are recorded when collected. At September 30, 2026 total accounts receivable was $
Inventory
Inventory
is stated at the lower of cost or net-realizable value. Inventory cost is determined on a first-in first-out basis that approximates
average cost in accordance with ASC 330-10-30-12. At September 30, 2026, the Company had $
| 8 |
Revenue Recognition
The Company generates revenue from customers from product and license sales. The Company recognizes revenue from customers when all of the following criteria are satisfied: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations, including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations; and (v) recognition of revenue when, or as the Company satisfies each performance obligation.
The Company constrains revenue by giving consideration to factors that could otherwise lead to a probable reversal of revenue. The Company records any payments received from customers prior to the Company fulfilling its performance obligation(s) as deferred revenue.
Income Taxes
The Company accounts for income taxes in accordance with the liability method of accounting for income taxes. Under this method, deferred income tax assets and deferred income tax liabilities represent the tax effect of temporary differences between financial reporting and tax reporting measured at enacted tax rates in effect for the year in which the differences are expected to reverse. The Company recognizes only the impact of tax positions that, based on their technical merits, are more likely than not to be sustained upon an audit by the taxing authority.
Valuation allowances are provided when it is more-likely-than-not that some or all of the deferred income tax assets may not be realized. In assessing the need for a valuation allowance, the Company has considered its historical levels of income, expectations of future taxable income and ongoing tax planning strategies.
Developing the provision for income taxes, including the effective tax rate and analysis of potential tax exposure items, if any, requires significant judgment and expertise in federal and state income tax laws, regulations and strategies, including the determination of deferred income tax assets and liabilities and any estimated valuation allowances deemed necessary to value deferred income tax assets. Judgments and tax strategies are subject to audit by various taxing authorities. The Company has uncertain income tax positions in the condensed consolidated financial statements, and adverse determinations by these taxing authorities could have a material adverse effect on the condensed consolidated financial position, results of operations, or cash flows.
Concentration Risk and Significant Customers
The
Company had certain customers which were each responsible for generating 10% or more of the total revenue for the three and nine months
ended September 30, 2026 and 2025. Five customers accounted for approximately
| 9 |
One customer accounted for approximately 36% of accounts receivable as of September 30, 2026. Two customers accounted for approximately 82% of accounts receivable in the aggregate as of December 31, 2025.
Recently Issued Accounting Standards
From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”) that are adopted by the Company as of the specified effective date. If not discussed, management believes that the impact of recently issued standards, which are not yet effective, will not have a material impact on the Company’s financial statements upon adoption.
In November 2024, the FASB issued ASU 2024-03, Income Statement (Subtopic 220-40): Reporting Comprehensive Income - Expense Disaggregation Disclosures, which requires an entity to disclose on an annual and interim basis, disaggregated information about specific income statement expense categories. The guidance should be applied prospectively with the option to apply the standard retrospectively. The standard becomes effective for the Company for full year 2027 reporting. The Company is currently evaluating the impact of this new standard on its consolidated financial statements.
In July 2025, the FASB issued ASU 2025-05, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses for Accounts Receivable and Contract Assets, which provides all entities with a practical expedient when estimating expected credit losses for current accounts receivable and current contract assets arising from transactions accounted for under Topic 606. Early adoption is permitted and entities should apply the practical expedient, if elected, prospectively to financial statements issued for reporting periods after the effective date. The standard became effective for the Company for interim and full year 2026 reporting. The adoption of this standard did not have a material impact on the Company’s consolidated financial statements.
In December 2025, the FASB issued ASU 2025-10, Government Grants (Topic 832): Accounting for Government Grants Received by Business Entities, which provides authoritative guidance for the accounting and presentation of government grants received by business entities, distinguishing between grants related to assets and grants related to income. Early adoption is permitted and entities may apply the standard using a modified prospective, modified retrospective, or full retrospective transition approach, subject to the specific criteria outlined in the ASU. The standard becomes effective for the Company for full year 2029 reporting. The Company is currently evaluating the impact of this new standard on its consolidated financial statements.
In December 2025, the FASB issued ASU 2025-11, Interim Reporting (Topic 270): Narrow-Scope Improvements, which clarifies and improves the guidance in Accounting Standards Codification Topic 270, Interim Reporting. Early adoption is permitted and entities may apply the standard prospectively or retrospectively. The standard becomes effective for the Company for interim 2028 reporting. The Company is currently evaluating the impact of this new standard on its consolidated financial statements.
In December 2025, the FASB issued ASU 2025-12, Codification Improvements, which includes narrow-scope amendments to the FASB Accounting Standards Codification to clarify, correct errors, and make minor improvements to existing U.S. GAAP. This standard becomes effective for the Company for interim and full year 2027 reporting. As the amendments are not expected to introduce new recognition or measurement principles, the Company does not expect a material impact on its consolidated financial statements related to ASU 2025-12.
Note 3 – Cash, Cash Equivalents, and Financial Instruments
The following table shows the Company’s cash, cash equivalents, and marketable investment securities by significant investment category:
Schedule of Cash, Cash Equivalents and Marketable Investment Securities
| September 30, 2026 | ||||||||||||||||||||
| Adjusted Cost | Total Unrealized Gains / (Losses) | Fair Value | Cash and Cash Equivalents | Marketable Investment Securities | ||||||||||||||||
| Cash | $ | $ | $ | $ | $ | |||||||||||||||
| Total | $ | $ | $ | $ | $ | |||||||||||||||
| December 31, 2025 | ||||||||||||||||||||
| Adjusted Cost | Total Unrealized Gains / (Losses) | Fair Value | Cash and Cash Equivalents | Marketable Investment Securities | ||||||||||||||||
| Cash | $ | $ | $ | $ | $ | |||||||||||||||
| Total | $ | $ | $ | $ | $ | |||||||||||||||
| 10 |
Note 4 – Fair Value Measurements
The Company measures and records certain financial assets and liabilities at fair value on a recurring basis. Fair value is based on the price that would be received from selling an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date.
The following three levels of inputs are used to measure the fair value of financial assets and liabilities:
Level 1: Quoted market prices in active markets for identical assets or liabilities.
Level 2: Observable market-based inputs or unobservable inputs that are corroborated by market data.
Level 3: Unobservable inputs that are not corroborated by market data.
The following table summarizes the assets and liabilities measured at fair value on a recurring basis as of September 30, 2026 and December 31, 2025, by level within the fair value hierarchy:
Schedule of Fair Value Assets and Liabilities
| (Level 1) | (Level 2) | (Level 3) | Total | |||||||||||||
| September 30, 2026 | ||||||||||||||||
| (Level 1) | (Level 2) | (Level 3) | Total | |||||||||||||
| Liabilities: | ||||||||||||||||
| Contingent consideration - common stock | $ | $ | $ | $ | ||||||||||||
| Total liabilities measured at fair value | $ | $ | $ | $ | ||||||||||||
| (Level 1) | (Level 2) | (Level 3) | Total | |||||||||||||
| December 31, 2025 | ||||||||||||||||
| (Level 1) | (Level 2) | (Level 3) | Total | |||||||||||||
| Liabilities: | ||||||||||||||||
| Contingent consideration - common stock | $ | $ | $ | $ | ||||||||||||
| Total liabilities measured at fair value | $ | $ | $ | $ | ||||||||||||
| 11 |
In connection with previous acquisitions, the Company recorded a liability for contingent consideration in the form of shares of common stock and warrants to purchase common stock, both to be issued when certain milestones are achieved. The fair value of contingent consideration is calculated using a discounted probability weighted valuation model. Discount rates used in such calculations are a significant assumption that are not observed in the market, and therefore, the resulting fair value represents a Level 3 measurement.
The changes for Level 3 items measured at fair value on a recurring basis are as follows:
Schedule of Changes in the Fair Value Measurement
| Fair value as of December 31, 2025 | $ | |||
| Change in fair value of contingent consideration issued for business acquisitions | ( | ) | ||
| Fair value as of September 30, 2026 | $ |
The fair value of the contingent consideration is based on the fair value of the contingent consideration-common stock and contingent consideration-warrants. The fair value of the contingent consideration-common stock is equal to the probability-adjusted value of the Company’s common stock as of the valuation date. The fair value of the contingent consideration-warrants is equal to the probability adjusted value of a call option with terms consistent with the terms of the warrants as of the valuation date. Prior to the probability adjustments, the warrants were valued based on the following inputs:
Schedule of Contingent Consideration Common Stock and Warrants
| September 30, 2026 | December 31, 2025 | |||||||
| Stock price | $ | $ | ||||||
| Strike price | $ | $ | ||||||
| Volatility | % | % | ||||||
| Risk-free rate | % | % | ||||||
| Expected term (years) | ||||||||
Fair Value of Other Financial Instruments
The carrying amounts of certain financial instruments, including cash held in banks, accounts receivable, notes receivable, accounts payable, accrued liabilities, and other liabilities approximate fair value due to their short-term maturities and are excluded from the fair value tables above.
Note 5 – Intangible Assets, Net
Intangible assets, net consisted of the following:
Schedule of Intangible Assets, Net
| September 30, 2026 | ||||||||||||||
| Weighted-Average | Gross | Net | ||||||||||||
| Useful Life | Carrying | Accumulated | Carrying | |||||||||||
| (in Years) | Amount | Amortization | Amount | |||||||||||
| In-process research and development | $ | $ | $ | |||||||||||
| Total intangible assets | $ | $ | $ | |||||||||||
| December 31, 2025 | ||||||||||||||
| Weighted-Average | Gross | Net | ||||||||||||
| Useful Life | Carrying | Accumulated | Carrying | |||||||||||
| (in Years) | Amount | Amortization | Amount | |||||||||||
| In-process research and development | $ | $ | $ | |||||||||||
| Total intangible assets | $ | $ | $ | |||||||||||
| 12 |
Note 6 – Revenue
The following table sets forth revenue by geographic area:
Summary of Revenue by Geographic Area
| 2026 | 2025 | 2026 | 2025 | |||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2026 | 2025 | 2026 | 2025 | |||||||||||||
| United States | ||||||||||||||||
| Product revenue | $ | $ | $ | $ | ||||||||||||
| Total United States | ||||||||||||||||
| Rest of World | ||||||||||||||||
| Product revenue | ||||||||||||||||
| Total Rest of World | ||||||||||||||||
| Total | $ | $ | $ | $ | ||||||||||||
| Percentage of revenue by area: | ||||||||||||||||
| United States | % | % | % | % | ||||||||||||
| Rest of World | % | % | % | % | ||||||||||||
Changes in the Company’s deferred revenue balance for the nine months ended September 30, 2026 were as follows:
Schedule of Deferred Revenue
| Balance as of December 31, 2025 | $ | |||
| Revenue recognized included in deferred revenue balance at the beginning of the period | ( | ) | ||
| Increase due to prepayments from customers | ||||
| Balance as of September 30, 2026 | $ |
All share and per-share data, including basic and diluted loss per share and weighted average shares outstanding, have been retroactively adjusted to reflect the 1-for-30 reverse stock split effected on January 1, 2026, as if the reverse stock split had occurred at the beginning of the earliest period presented.
Schedule of Basis and Diluted Earnings Per Share
| 2026 | 2025 | 2026 | 2025 | |||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2026 | 2025 | 2026 | 2025 | |||||||||||||
| Numerator | ||||||||||||||||
| Net loss, as reported | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| Denominator | ||||||||||||||||
| Weighted average shares, basic | ||||||||||||||||
| Dilutive effect of stock options, warrants and RSUs | ||||||||||||||||
| Shares used to compute diluted earnings per share | ||||||||||||||||
| Loss per share, basic and diluted | $ | ) | $ | ) | $ | ) | $ | ) | ||||||||
| 13 |
The underlying common shares that were issued upon exercise of the pre-funded warrants issued in the May 2026 Private Placement were included in the calculation of basic weighted average number of common shares outstanding as of the date of issuance of the pre-funded warrants as the underlying common shares were issuable for little to no consideration and there were no vesting conditions or contingencies associated with the warrants.
As a result of incurring a net loss for the three and nine months ended September 30, 2026 and 2025, respectively, potentially dilutive securities are included in the calculation of diluted loss per share because such effect would be anti-dilutive. The Company had potentially dilutive securities as of September 30, 2026, consisting of: (i) restricted stock units, (ii) options, and (iii) warrants. The Company had potentially dilutive securities as of September 30, 2025, consisting of: (i) restricted stock units, (ii) options, and (iii) warrants.
Note 8 – Equity Transactions
Reverse Stock Split
On
January 1, 2026, the Company effected a
Proportionate adjustments were made to the number of shares of common stock underlying the Company’s outstanding equity awards and warrants, as well as to the applicable exercise prices. All historical and per-share information has been retroactively adjusted to reflect the Reverse Stock Split.
At-the-Market Agreement
The
Company previously maintained an Amended and Restated Equity Distribution Agreement (the “Prior ATM Agreement”) with Piper
Sandler & Co. (“Piper Sandler”) and Clear Street, LLC (“Clear Street”), pursuant to which the Company could
offer and sell shares of its common stock having an aggregate offering price of up to $
On
October 20, 2025, the Company entered into an Equity Distribution Agreement (the “Equity Distribution Agreement”) with Maxim
Group LLC (“Maxim”) to establish an at-the-market (“ATM”) equity offering program. Pursuant to the Equity Distribution
Agreement, the Company was authorized to offer and sell shares of its common stock, par value $ per share, having an aggregate offering
price of up to $
On
May 12, 2026, the Company filed a new shelf registration statement on Form S-3 (File No. 333-295803), which was declared effective by
the Securities and Exchange Commission on May 15, 2026. On July 27, 2026, the Company amended the Equity Distribution Agreement and filed
a prospectus supplement under the new shelf registration statement pursuant to which the Company may offer and sell shares of its common
stock having an aggregate offering price of up to approximately $
| 14 |
Private Placement Transaction
On
May 19, 2026, the Company entered into a private placement transaction (the “Private Placement”), pursuant to a Securities
Purchase Agreement (the “Purchase Agreement”) with certain institutional and accredited investors (the “Purchasers”)
for aggregate gross proceeds of $
As
part of the Private Placement, the Company agreed to issue (i) shares of the Company’s common stock (the “Shares”),
par value $ per share (“Common Stock”), (ii) pre-funded warrants to purchase
Warrant Inducement
On
July 30, 2026, the Company entered into warrant inducement agreements (the “Inducement Agreements”) with certain holders
of common stock purchase warrants issued in connection with the Company’s May 2026 private placement. Pursuant to the Inducement Agreements,
the holders agreed to exercise for cash existing warrants to purchase an aggregate of
The transaction closed in August 2026 and
resulted in aggregate gross proceeds of approximately $
The New Warrants are exercisable only after the
Company obtains the shareholder approval required under applicable Nasdaq rules and, once exercisable, will expire
In accordance with ASC 815-40, Derivatives and Hedging-Contracts in Entity’s own Equity, the Company determined that all the warrants issued in the Private Placement and warrant inducement met the conditions for equity classification and were included as a component of total stockholders’ equity.
Warrants
The Company has issued warrants related to acquisition and financing transactions.
The following table provides the weighted-average exercise price and remaining contractual life for each warrant outstanding as of September 30, 2026 and December 31, 2025:
Schedule of Weighted-Average Exercise Price and Remaining Contractual Life for Each Warrant Outstanding
| September 30, 2026 | ||||||||||||
| Weighted-Average | ||||||||||||
| Number of | Weighted-Average | Remaining Contractual | ||||||||||
| Warrants | Exercise Price | Life (in Years) | ||||||||||
| 2021 Acquisition Related Warrants | $ | |||||||||||
| May 2026 Warrants | $ | |||||||||||
| July 2026 Warrants | $ | |||||||||||
| December 31, 2025 | ||||||||||||
| Weighted-Average | ||||||||||||
| Number of | Weighted-Average | Remaining Contractual | ||||||||||
| Warrants | Exercise Price | Life (in Years) | ||||||||||
| 2021 Acquisition Related Warrants | $ | |||||||||||
The following table summarizes warrant activity for the nine months ended September 30, 2026:
Schedule of Warrant Activity
| 2021 Acquisition Related Warrants | May 2026 Pre-Funded Warrants | May 2026 Warrants | July 2026 Warrants | |||||||||||||
| Outstanding at December 31, 2025 | ||||||||||||||||
| Issued | ||||||||||||||||
| Expired | ||||||||||||||||
| Forfeited/Cancelled | ||||||||||||||||
| Exercised | ( | ) | ( | ) | ||||||||||||
| Outstanding at September 30, 2026 | ||||||||||||||||
| 15 |
As of September 30, 2026, the Company had common stock purchase warrants outstanding, of which
Share Repurchase Program
In
March 2022, the Company’s Board of Directors authorized a share repurchase program that would allow the Company to repurchase up
to $
For accounting purposes, common stock repurchased under the stock repurchase program is recorded based upon the transaction date of the applicable trade. Such repurchased shares are held in treasury and are presented using the cost method. These shares are not retired and are considered issued but not outstanding. No shares were repurchased during the three and nine months ended September 30, 2026.
Stock Incentive Plans
The Company’s board of directors adopted, and shareholders approved, the Co-Diagnostics, Inc. Amended and Restated 2015 Long Term Incentive Plan (the “2015 Incentive Plan”) providing for the issuance of stock-based incentive awards to employees, officers, consultants, directors and independent contractors. On August 31, 2022, the shareholders approved an increase in the number of awards available for issuance under the Incentive Plan to an aggregate of shares of common stock.
The 2015 Incentive Plan expired on December 31, 2025. The Company’s board of directors adopted in March 2025, and in May 2025 shareholders approved, the Co-Diagnostics, Inc. 2025 Equity Incentive Plan (the “2025 Plan”) providing for the issuance of up to shares of common stock plus any shares that become available in connection with the cancellation or forfeiture of awards issued under the 2015 Incentive Plan. The 2025 Plan provides for the award of stock-based incentive awards to employees, officers, consultants, directors and independent contractors. At September 30, 2026, the number of awards available for issuance under the 2025 Plan was , including unused awards which rolled over from the 2015 Incentive Plan upon its expiration.
Stock Options
Schedule of Option Activity
| Number of Options | Weighted Average Exercise Price | Weighted Average Fair Value | Weighted Average Remaining Contractual Life (Years) | |||||||||||||
| Outstanding at December 31, 2025 | $ | $ | ||||||||||||||
| Granted | ||||||||||||||||
| Expired | ( | ) | $ | $ | ||||||||||||
| Forfeited/Cancelled | ||||||||||||||||
| Exercised | ||||||||||||||||
| Outstanding at September 30, 2026 | $ | $ | ||||||||||||||
| Exercisable at September 30, 2026 | $ | $ | ||||||||||||||
The aggregate intrinsic value of outstanding options at September 30, 2026 and 2025 was approximately $.
| 16 |
Stock-based compensation cost is measured at the grant date based on the fair value of the award granted and recognized as expense over the vesting period using the straight-line method. The Company uses the Black-Scholes model to value options granted. As of September 30, 2026, there were no unvested options and unrecognized stock-based compensation expense related to options.
Restricted Stock Units
Schedule of Outstanding Restricted Stock Units and Related Activity
| Number of RSUs | Weighted Average Grant Date Fair Value | |||||||
| Unvested at December 31, 2025 | $ | |||||||
| Granted | ||||||||
| Vested | ( | ) | ||||||
| Forfeited/Cancelled | ( | ) | ||||||
| Unvested at September 30, 2026 | $ | |||||||
As of September 30, 2026, there was approximately $ of unrecognized stock-based compensation expense related to outstanding RSUs which is expected to be recognized over a weighted-average period of years.
Stock-Based Compensation Expense
Schedule of Recognized Stock-Based Compensation Expense
| 2026 | 2025 | 2026 | 2025 | |||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2026 | 2025 | 2026 | 2025 | |||||||||||||
| Sales and marketing | $ | $ | $ | $ | ||||||||||||
| General and administrative | ||||||||||||||||
| Research and development | ||||||||||||||||
| Total stock-based compensation expense | $ | $ | $ | $ | ||||||||||||
Note 10 – Income Taxes
For
the three months ended September 30, 2026, the Company recognized expense from income taxes of $
Note 11 – Commitments and Contingencies
Lease Obligations
The Company leases administrative, R&D, sales and marketing and manufacturing facilities under non-cancellable operating leases.
The components of lease expense are summarized as follows:
Schedule of Lease Expense
| 2026 | 2025 | 2026 | 2025 | |||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2026 | 2025 | 2026 | 2025 | |||||||||||||
| Operating lease costs | $ | $ | $ | $ | ||||||||||||
| Total lease costs | $ | $ | $ | $ | ||||||||||||
| 17 |
As of September 30, 2026, the maturities of the Company’s lease liabilities are as follows:
Schedule of Maturities on Company Lease Liabilities
| Years Ending December 31, | ||||
| 2026 (remainder) | $ | |||
| 2027 | ||||
| 2028 | ||||
| Thereafter | ||||
| Total lease payments | ||||
| Less: imputed interest | ||||
| Present value of operating lease liabilities | ||||
| Less: current portion | ||||
| Long-term portion | $ | |||
Other information related to operating leases was as follows:
Schedule of Other Information Related to Operating Leases
| Nine Months Ended September 30, 2026 | ||||
| Cash paid for operating leases included in operating cash flows | $ | |||
| Remaining lease term of operating leases | ||||
| Discount rate of operating leases | % | |||
Litigation
Liabilities for loss contingencies arising from claims, assessments, litigation, fines, and penalties and other sources are recorded when it is probable that a liability has been incurred and the amount can be reasonably estimated. Legal costs incurred in connection with loss contingencies are expensed as incurred.
Stadium Capital Securities Class Action
The Company and certain of its officers are defendants in a securities class action filed in the United States District Court for the Southern District of New York alleging that the Company made false or misleading statements regarding demand for its Logix Smart COVID-19 test, resulting in alleged losses to investors.
On
August 14, 2026, the parties executed a definitive Stipulation and Agreement of Settlement providing for the resolution of the action
for an aggregate settlement amount of $
Under the terms of the settlement agreement, the defendants are required to pay, or cause to be paid, the settlement amount into an escrow account for distribution in accordance with the settlement agreement and applicable court orders. The settlement remains subject to final court approval and satisfaction of certain other conditions. If the settlement becomes effective, the claims asserted in the action will be dismissed with prejudice. The settlement does not constitute an admission of wrongdoing or liability by the Company or the other defendants. The settlement amount is expected to be funded through applicable insurance coverage.
Other Litigation
The Company is a party to a commercial lawsuit in the Third Judicial District Court, Salt Lake County, Utah, against Hukui Technology, Inc. In May 2026, the Company received an amended final judgment and favorable ruling in its litigation with Hukui Technology, Inc., in which the trial court found in favor of the Company on its declaratory judgment claim and on all remaining counterclaims, concluding that the Company had no payment obligations and that the defendants were not entitled to damages. Hukui Technology, Inc. subsequently appealed the judgment and has filed its opening appellate brief. The appeal remains pending.
The Company is also a defendant in an additional civil action involving claims arising from an alleged breach of contract.
The Company believes the claims asserted against it in these other proceedings are without merit and intends to continue defending them vigorously. The Company is unable to estimate a range of loss, if any, that could result from an adverse final decision in these proceedings. Based on currently available information, the Company does not believe an unfavorable outcome in these other proceedings is probable; however, an unfavorable outcome could have a material adverse effect on the Company’s financial condition or results of operations.
| 18 |
Note 12 – Related Party Transactions
The
Company has a services agreement with CoSara Diagnostics Pvt Ltd (“CoSara”), one of the Company’s equity method investments,
under which CoSara provides certain research and development consulting and support services. The Company recognized $
Note 13 – Subsequent Events
On
October 9, 2026, the Company entered into a Loan Agreement (the “Loan Agreement”) with J.J. Astor & Co. (the “Lender”),
pursuant to which the Lender agreed to provide loans to the Company in an aggregate principal funding amount of up to $
In connection with the transaction, the Company issued the Lender shares of common stock as commitment shares (the “Commitment Shares”) at the closing date, subject to a make-whole provision, which provides that the company will issue make-whole shares if the Commitment Shares are sold on a day when the closing price of the Company’s stock is less than $.
Subsequent to September 30, 2026, the Company has sold an additional shares of common stock through the at-the-market program
under the Equity Distribution Agreement, resulting in net proceeds of approximately $
| 19 |
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
Cautionary Note Regarding Forward-Looking Statements
This Quarterly Report on Form 10-Q contains “forward-looking statements” that involve risks and uncertainties. All statements other than statements of historical fact contained in this Quarterly Report and the documents incorporated by reference herein, including statements regarding future events, our future financial performance, business strategy, and plans and objectives of management for future operations, are forward-looking statements. We have attempted to identify forward-looking statements by terminology including “anticipates,” “believes,” “can,” “continue,” “could,” “estimates,” “expects,” “intends,” “may,” “plans,” “potential,” “predicts,” “should,” or “will” or the negative of these terms or other comparable terminology. Although we do not make forward-looking statements unless we believe we have a reasonable basis for doing so, we cannot guarantee their accuracy. These statements are only predictions and involve known and unknown risks, uncertainties and other factors and the documents incorporated by reference herein, which may affect our or our industry’s actual results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Moreover, we operate in a highly regulated, very competitive, and rapidly changing environment. New risks emerge from time to time, and it is not possible for us to predict all risk factors, nor can we address the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause our actual results to differ materially from those contained in any forward-looking statements.
These forward-looking statements are subject to certain risks and uncertainties that could cause our actual results to differ materially from those reflected in the forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed under the heading “Risk Factors” in other documents we file with the SEC, including our Annual Report on Form 10-K for the year ended December 31, 2025. The following discussion should be read in conjunction with the Annual Report on Form 10-K for the fiscal year ended December 31, 2025, filed with the SEC on March 31, 2026, and the audited financial statements and notes included therein.
As used in this Quarterly Report, the terms “we”, “us”, “our”, and “Co-Diagnostics” means Co-Diagnostics, Inc., a Utah corporation and its consolidated subsidiaries (the “Company”), unless otherwise indicated.
Executive Overview
The following management’s discussion and analysis of financial condition and results of operations describes the principal factors affecting the results of our operations, financial condition, and changes in financial condition. This discussion should be read in conjunction with the accompanying unaudited financial statements and notes thereto included elsewhere in this report. The information contained in this discussion is subject to a number of risks and uncertainties. We urge you to review carefully the section of this report entitled “Cautionary Note Regarding Forward-Looking Statements.”
Business Overview
Co-Diagnostics, Inc., a Utah corporation (the “Company” or “CODX”), develops, manufactures and sells reagents used for diagnostic tests that function via the detection and/or analysis of nucleic acid molecules (DNA or RNA), including molecular tools for detection of infectious diseases. Our diagnostics systems enable dependable, low-cost, molecular testing for organisms and genetic diseases by automating or simplifying historically complex procedures in both the development and administration of tests. CODX’s technical advance involves a novel, proprietary approach to polymerase chain reaction (“PCR”) test design of primer and probe structure (“Co-Primers®”) that dramatically reduces one of the key vexing issues of PCR amplification: the exponential growth of primer-dimer amplification (false positives) which adversely interferes with identification of the target DNA/RNA. Using our proprietary test design system and reagents, we have designed and obtained regulatory approval to sell PCR diagnostic tests for the detection of COVID-19, influenza, tuberculosis, hepatitis B and C, human papillomavirus, malaria, chikungunya, dengue, and the Zika virus. These initial diagnostic tests are cleared for use in clinical labs only and not for point-of-care or at-home use.
We have developed a portable diagnostic device and test system designed for point-of-care and at-home use. The system is comprised of our PCR instrument that we refer to as the Co-Dx™ PCR Pro® instrument and a mobile application to be installed on the user’s mobile device. We refer to the system as the “Co-Dx™ PCR platform” which has been designed to bring affordable, reliable polymerase chain reaction (“PCR”) testing to patients in point-of-care and at-home settings. The Co-Dx PCR platform is subject to U.S. Food and Drug Administration (“FDA”) review and is not available for sale at the time of this filing. In June 2024, we completed our first FDA application for 510(k) clearance for the Co-Dx PCR Pro instrument, the Co-Dx PCR COVID-19 Test, and the Co-Dx PCR mobile app for over-the-counter (OTC) use. Following engagement with the FDA during the review process, the Company voluntarily withdrew the 510(k) submission after discussions regarding the analytical approach for detecting potential degradation of a test component over its intended shelf life. While the Company believes that the matter identified during the review process could have been addressed through additional development and clinical validation activities, management determined that the capital and time required to resubmit the COVID-19 test for 510(k) clearance would be more effectively deployed toward development and clinical validation of the Co-Dx PCR Flu A/B, and RSV multiplex test (“ABR”). Moving focus to this test allows the Company to incorporate more recent Co-Dx PCR platform developments into the design and test manufacturing process. The Company has completed clinical and analytical performance studies for the Co-Dx™ PCR Flu A/B and RSV upper respiratory multiplex test on the Co-Dx PCR Pro® instrument that the Company included in a submission package for a Dual 510(k) and CLIA Waiver by Application submission to the U.S. Food and Drug Administration in August 2026. There is no guarantee that our Co-Dx PCR platform will receive the necessary regulatory approvals for commercialization, or that, if regulatory approval is received, we will be able to successfully commercialize this platform.
In January 2017, the Company entered into an agreement to manufacture diagnostics tests for seven infectious diseases with a pharmaceutical manufacturing company in India and formed CoSara Diagnostics Pvt. Ltd. as a joint venture. The agreement provided for the construction of a manufacturing plant, the manufacture of the PCR tests using the Company’s primer technology, and the sales and marketing of those tests in India. The Company also has a services agreement with CoSara under which CoSara provides certain research and development consulting and support services, specifically pertaining to the ongoing development of the Co-Dx PCR platform. During July 2026, CoSara initiated clinical studies for a tuberculosis test on the PCR Pro® instrument. During October 2026, these clinical studies were completed and the tuberculosis test was submitted to India’s Central Drugs Standard Control Organization (the “CDSCO”) for regulatory clearance.
Additionally, in October 2025, the Company entered into an agreement with Arabian Eagle Manufacturing, a regional manufacturing and distribution company based in the Kingdom of Saudi Arabia (“KSA”) to form CoMira Diagnostics (“CoMira”), a joint venture dedicated to research, develop, manufacture, assemble, distribute, and commercialize Co-Dx technologies and intellectual property, including the Company’s Co-Dx PCR platform, within KSA and 18 other countries throughout the Middle East and North Africa. Similar to the Company’s agreement with CoSara, Co-Dx will provide CoMira an exclusive license to use, manufacture, and commercialize the licensed IP in the region, which will include the Co-Dx PCR platform as well as the Company’s existing suite of lab-based PCR diagnostic products.
The Company believes that its cutting-edge PCR technology, along with the respective scopes and missions of CoSara and CoMira, will allow Co-Diagnostics to be a critical contributor of healthcare innovations in regions with large and growing markets for medical devices and point-of-care diagnostics, while simultaneously establishing a transformative platform for molecular diagnostics and reinforcing the Company’s mission to increase the accessibility of high-quality PCR diagnostics.
| 20 |
Technology
We believe our proprietary and patented molecular diagnostics technology is paving the way for innovation in disease detection and life sciences research through our enhanced detection of genetic material. For various reasons, including owning our own platform, we believe we will be able to accomplish this faster and more economically than some competitors, allowing for significant margins while still positioning ourselves as a low-cost provider of molecular diagnostics and screening services. For example, we were the first US-based company to receive a CE-marking for a COVID-19 test in early 2020, as we worked to help slow the spread of the pandemic through our global network of distributors covering clinical labs in more than 50 countries. Our Logix Smart® COVID-19 test was designed, developed, submitted for regulatory approval and ready to be used as an in vitro diagnostic (“IVD”) in countries that accept CE marking for regulatory clearance in a period of just over 30 days. This is a real-world example of how CODX technology can be used in an evolving epidemic or pandemic to get diagnostic tools in the hands of medical professionals in a timely manner. It can be similarly used to design a test for mutated strains of SARS-CoV-2 or other viruses should they not be detectable using currently available tests.
In addition, continued development has demonstrated the unique properties of our Co-Primers technology that we believe makes it ideally suited for a variety of applications where specificity is key to optimal results, including multiplexing several targets, enhanced Single Nucleotide Polymorphism (“SNP”) detection and enrichment for next generation sequencing.
Our scientists use the complex mathematics of DNA/RNA PCR test design to engineer and optimize PCR tests and to automate algorithms that rapidly screen millions of possible options to pinpoint the optimum design. The intellectual property we use in our business consists of the predictive mathematical algorithms and patented molecular structure used in the testing process, which together represent a major advance in PCR testing systems. CODX technologies are now protected by more than 20 granted or pending US and foreign patents, as well as certain trade secrets and copyrights. Ownership of our proprietary platform permits us the advantage of avoiding payment of patent royalties required by other PCR test systems, which may allow for the sale of diagnostic PCR tests at a lower price than competitors, while enabling us to maintain profit margins.
Our proprietary test design process involves identifying the optimal locations on the target genes for amplification and pairing the locations with the optimized primer and probe structure to achieve outputs that meet the design input requirements identified from market research. This is done by following planned and documented processes, procedures and testing. In other words, we use the data resulting from our tests to verify whether we succeeded in designing what we intended. Verification involves a series of testing that concludes that the product is ready to proceed to validation in an evaluation either in our laboratory or in an independent laboratory setting using initial production tests to confirm that the product as designed meets the user’s needs.
Using our proprietary test design system and reagents, we have designed and obtained regulatory clearance in the European Community and in India (along with our joint venture, CoSara) to sell PCR diagnostic tests for the detection of COVID-19, influenza, tuberculosis, hepatitis B and C, human papillomavirus, malaria, chikungunya, dengue, and the Zika virus. In the United States, we obtained Emergency Use Authorization (“EUA”) for our Logix Smart® COVID-19 detection test from the FDA, and we sell that test to qualified labs. In addition, our COVID-19 detection test and certain of our other suite of COVID-19 products have been cleared for sale in countries such as the United Kingdom, Australia, India, and Mexico by the regulatory bodies in those countries and have been registered for sale in many more countries. In connection with the sale of our tests we may sell diagnostic equipment from other manufacturers, including an OEM’s PCR instrument which we refer to here as the “Co-Dx Box™”.
In addition to testing for infectious diseases, Co-Primers technology lends itself to identifying any section of a DNA or RNA strand that describes any type of genetic trait, which creates several significant applications. We, in conjunction with our customers, have designed tests that identify genetic traits in plant and animal genomes. We also have commercialized three multiplexed tests to test mosquitos for the presence of diseases they carry, which enables municipalities to concentrate their efforts in managing mosquito populations in specific areas where mosquitos carrying deadly viruses are known to breed.
| 21 |
RESULTS OF OPERATIONS
The Three Months Ended September 30, 2026 Compared to the Three Months Ended September 30, 2025
Revenues
For the three months ended September 30, 2026, we generated revenues of $0.3 million, compared to revenues of $0.1 million for the three months ended September 30, 2025.
Cost of Revenues
We recorded cost of revenues of approximately $0.3 million for the three months ended September 30, 2026, compared to approximately $0.03 million for the three months ended September 30, 2025.
Expenses
Total operating expenses for the three months ended September 30, 2026 were $6.2 million, compared to total operating expenses of $7.1 million for the three months ended September 30, 2025. The decrease in operating expenses was primarily due to decreased personnel and stock-based compensation expense, as well as decreased expense related to development of the Co-Dx PCR platform, partially offset by increases in legal and professional services expense.
Sales and marketing expenses for the three months ended September 30, 2026 were $0.6 million, compared to $0.6 million for the three months ended September 30, 2025.
General and administrative expenses for the three months ended September 30, 2026 were $1.9 million, compared to $1.8 million for the three months ended September 30, 2025. Decreases in stock-based compensation expense were offset by increased legal and professional services expense.
Research and development expenses for the three months ended September 30, 2026 were $3.6 million, compared to $4.5 million for the three months ended September 30, 2025. The decrease was primarily a result of decreased personnel related expense and decreased expenses related to development and clinical trials for the Co-Dx PCR platform, partially offset by increased professional services expense.
Other Income or Expense
Other expense for the three months ended September 30, 2026 was $0.04 million, compared to other expense of $0.04 million for the three months ended September 30, 2025.
Net Loss
Net loss for the three months ended September 30, 2026 was $6.3 million, compared to $5.9 million for the three months ended September 30, 2025. The larger net loss was primarily attributable to the decreased income tax benefit, partially offset by lower operating expenses.
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The Nine Months Ended September 30, 2026 Compared to the Nine Months Ended September 30, 2025
Revenues
For the nine months ended September 30, 2026, we generated revenues of $0.6 million, compared to revenues of $0.4 million for the nine months ended September 30, 2025.
Cost of Revenues
We recorded cost of revenues of approximately $0.5 million for the nine months ended September 30, 2026, compared to approximately $0.1 million for the nine months ended September 30, 2025. Included within cost of revenues is a decrease of approximately $0.2 million for the nine months ended September 30, 2026, and a decrease of approximately $0.1 million for the nine months ended September 30, 2025, related to reserves against certain raw materials and finished goods inventories.
Expenses
Total operating expenses for the nine months ended September 30, 2026 were $21.7 million, compared to total operating expenses of $23.9 million for the nine months ended September 30, 2025. The decrease in operating expenses was primarily due to decreased personnel and stock-based compensation expense, as well as decreased legal expense, partially offset by increased expense related to development and clinical trials for the Co-Dx PCR platform and increased professional services expense.
Sales and marketing expenses for the nine months ended September 30, 2026 were $1.5 million, compared to $1.8 million for the nine months ended September 30, 2025. The decrease was primarily a result of decreases in stock-based compensation expense and consulting expense.
General and administrative expenses for the nine months ended September 30, 2026 were $5.9 million, compared to $7.2 million for the nine months ended September 30, 2025. The decrease resulted primarily from decreased personnel related expense and stock-based compensation expense, along with decreased legal expense, partially offset by increased professional services expense.
Research and development expenses for the nine months ended September 30, 2026 were $13.7 million, compared to $14.0 million for the nine months ended September 30, 2025. The decrease was primarily a result of decreased personnel related expense, partially offset by increased expenses related to development and clinical trials for the Co-Dx PCR platform.
Other Income or Expense
Other expense for the nine months ended September 30, 2026 was $0.03 million, compared to other income of $1.3 million for the nine months ended September 30, 2025. The decrease was primarily a result of changes in the fair value of contingent consideration liabilities, as well as decreased realized gains from investments in marketable securities.
Net Loss
Net loss for the nine months ended September 30, 2026 was $21.7 million, compared to $21.2 million for the nine months ended September 30, 2025. The larger net loss was primarily the result of decreased other income, including changes in the fair value of contingent consideration liabilities and decreased realized gains on investments, along with a lower income tax benefit, partially offset by lower operating expenses.
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Liquidity and Capital Resources
At September 30, 2026, we had cash and cash equivalents of $0.7 million. Additionally, our total current assets at September 30, 2026, were $1.9 million compared to total current liabilities of $2.5 million.
Net cash used in operating activities during the nine months ended September 30, 2026 was $20.7 million, compared to $22.9 million for the nine months ended September 30, 2025. The decrease in cash used in operating activities was primarily due to reduced operating expenses.
Net cash used in investing activities was $0.3 million for the nine months ended September 30, 2026, compared to cash provided by investing activities of $26.6 million during the nine months ended September 30, 2025. The decrease in cash provided by investing activities is primarily due to higher proceeds from redemptions of investments during the prior year.
Net cash provided by financing activities was $9.8 million for the nine months ended September 30, 2026, compared to $4.8 million for the nine months ended September 30, 2025. The cash provided by financing activities during 2026 relates to issuances of common stock under the ATM and proceeds related to a private placement transaction and its related warrant exercises.
Since commencing sales of our Logix Smart COVID-19 test in March 2020, we have used our cash generated from those sales to fund the purchase of inventories and the development of our Co-Dx PCR Platform, and to pay our operating expenses.
Our available capital resources may be consumed more rapidly than currently expected and we may need or want to raise additional financing for strategic opportunities. It is anticipated that the Company will continue to generate operating losses and use cash in operations in the near term and, therefore, will need to obtain additional capital. We expect additional investment capital to come from additional issuances of our common stock or other equity-based securities with existing and new investors, which will likely be highly dilutive to existing investors.
Although we are seeking to obtain additional equity and/or debt financing, such funding is not assured and may not be available to us on favorable or acceptable terms and may involve significant restrictive covenants. Any additional equity financing, if available to us at all, will most likely be dilutive to our current stockholders. If we are not able to obtain additional debt or equity financing on a timely basis, the impact on us will be material and adverse. These uncertainties create substantial doubt about our ability to continue as a going concern. The condensed consolidated financial statements do not include any adjustments that might result from the outcome of these uncertainties.
Subsequent to September 30, 2026, the Company entered into a senior secured convertible debt financing arrangement with J.J. Astor & Co., pursuant to which the Company received approximately $2.0 million in initial net cash proceeds before other transaction expenses. The financing provides for up to an additional $1.0 million in funding, subject to the satisfaction of specified conditions. The financing imposes certain restrictions on the Company’s liquidity, including minimum cash requirements, installment payment obligations and the application of proceeds from sales under the Company’s at-the-market equity offering program toward repayment of the indebtedness. As a result, the proceeds available to the Company from future sales under its at-the-market program may be substantially reduced. Although this financing provided additional near-term liquidity, the Company will require additional capital to fund its ongoing operations, and there can be no assurance that additional financing will be available on acceptable terms, or at all.
Forward-Looking Statements
This Liquidity and Capital Resources discussion contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the Company’s liquidity runway, anticipated use of proceeds, potential sales under the at-the-market program, and the Company’s financing plans and capital needs. Forward-looking statements are based on current expectations and assumptions and are subject to risks and uncertainties that could cause actual results to differ materially, including those described under “Risk Factors” and elsewhere in this Quarterly Report on Form 10-Q. There can be no assurance regarding the timing, amount, or terms of any future securities offerings or sales under the at-the-market program, or that such transactions will be available on acceptable terms or at all. The Company undertakes no obligation to update any forward-looking statements, except as required by law.
Off-Balance Sheet Arrangements
We have no off-balance sheet arrangements.
Item 3. Quantitative and Qualitative Disclosures about Market Risk
Not required under Regulation S-K for “smaller reporting companies.”
Item 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
We maintain “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company’s management, including its principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure. Our management, with the participation of our Chief Executive Officer and our Principal Financial Officer, evaluated the effectiveness of our disclosure controls and procedures as of September 30, 2026. Based on the evaluation of our disclosure controls and procedures as of September 30, 2026, our Chief Executive Officer and Principal Financial Officer concluded that, as of such date, our disclosure controls and procedures were effective.
Changes in Internal Control over Financial Reporting
There have been no changes in our internal control over financial reporting during the three months ended September 30, 2026, that have materially affected or, are reasonably likely to materially affect, our internal control over financial reporting.
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PART II – OTHER INFORMATION
Item 1. Legal Proceedings
Stadium Capital Securities Class Action (Southern District of New York)
On July 28, 2026, the parties entered into a binding term sheet setting forth the material terms of a proposed settlement of the Stadium Capital securities class action. On August 14, 2026, the parties executed a definitive Stipulation and Agreement of Settlement (the “Settlement Agreement”), pursuant to which the defendants agreed to pay, or cause to be paid, an aggregate of $6.5 million into a settlement fund in exchange for the settlement and release of claims asserted in the action. The proposed settlement does not constitute an admission of wrongdoing or liability by the Company or the other defendants.
On August 17, 2026, the United States District Court for the Southern District of New York entered an order preliminarily approving the proposed settlement and directing that notice be provided to members of the settlement class. The Court has scheduled a settlement fairness hearing for December 8, 2026, at which it will consider whether to grant final approval of the settlement. The settlement remains subject to final court approval, satisfaction of applicable conditions and entry of a final judgment dismissing the action with prejudice. There can be no assurance that the settlement will receive final approval or become effective.
Co-Diagnostics, Inc. v. Hukui Technology, Inc., et al. Third Judicial District Court, Salt Lake County, Utah
As previously disclosed, on March 25, 2026, the trial court issued Findings of Fact, Conclusions of Law, and a ruling in favor of the Company on its declaratory judgment claim and on all remaining counterclaims asserted by Hukui Technology, Inc., Hukui Tech, Inc. and Hukui Bio Co., Ltd. The court concluded, among other things, that the Company did not breach any agreement with the defendants and that the defendants were not entitled to damages. Final judgment was entered on April 10, 2026 and was amended on April 27, 2026 to include costs.
On May 11, 2026, the defendants filed a notice of appeal seeking review of the final judgment in its entirety. On June 2, 2026, the Utah Supreme Court transferred the appeal to the Utah Court of Appeals for disposition pursuant to Rule 42(a) of the Utah Rules of Appellate Procedure. The defendants have since filed their opening brief in support of the appeal. The appeal remains pending. The Company believes the trial court’s judgment was correct and intends to defend the judgment vigorously, but there can be no assurance as to the outcome of the appeal.
Robert Salna v. Co-Diagnostics, Inc., et al. Third Judicial District Court, Salt Lake County, Utah
As previously disclosed, in February 2024, Robert Salna filed an action against the Company and certain current or former officers arising from a 2018 loan transaction and the alleged failure to issue warrants or other equity-based compensation in connection with that transaction. The original complaint asserted claims including breach of contract, breach of fiduciary duty, fraud, negligent misrepresentation, and violations of federal and Utah securities laws. The plaintiff seeks compensatory and other damages.
On May 26, 2026, the court granted the Company’s motion to dismiss. The court dismissed with prejudice the breach-of-contract claim against the individual defendants. The court dismissed without prejudice the breach-of-contract claim against the Company and the claims for breach of fiduciary duty, fraud, negligent misrepresentation, and violations of the Utah Securities Act. The court also determined that it lacked subject-matter jurisdiction over the plaintiff’s claim under the Securities Act of 1933 and dismissed that claim without prejudice. The court permitted the plaintiff to seek leave to amend the complaint.
On July 9, 2026, the plaintiff filed a motion for leave to file a proposed first amended complaint. The proposed amended complaint would remove two individual defendants and the federal securities claim and would assert claims against the Company, Dwight H. Egan, and Reed L. Benson for breach of contract, fraud or intentional misrepresentation, negligent misrepresentation, breach of fiduciary duty or an alleged transaction-specific duty, violation of the Utah Uniform Securities Act, and declaratory relief. The proposed amended complaint continues to allege that the plaintiff was promised warrants in connection with the $2.0 million loan transaction and seeks damages and other relief based on the alleged failure to issue those warrants.
The defendants have opposed the motion for leave to amend, arguing that the proposed amendment is unjustifiably delayed and that the proposed claims remain legally deficient and would be futile. The motion remains pending. The Company believes the plaintiff’s claims are without merit and intends to continue defending the action vigorously, but there can be no assurance as to the outcome.
Item 1A. Risk Factors.
Not required under Regulation S-K for “smaller reporting companies.”
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
Unregistered Sales of Equity Securities
On July 30, 2026, the Company entered into warrant inducement agreements pursuant to which it agreed to issue new common stock purchase warrants to purchase up to an aggregate of 3,404,724 shares of common stock in consideration for the cash exercise of certain previously issued warrants. The new warrants were issued in reliance upon the exemption from registration provided by Section 4(a)(2) of the Securities Act of 1933, as amended. The transaction, including the material terms of the new warrants and the applicable exemption from registration, was previously reported in the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on July 31, 2026, under Items 1.01 and 3.02.
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Issuer Purchases of Equity Securities
None.
Rule 10b5-1 Trading Arrangements
During the three months ended September 30, 2026, no director or officer of the Company adopted or terminated a Rule 10b5-1 trading arrangement or a non-Rule 10b5-1 trading arrangement, as each term is defined in Item 408 of Regulation S-K.
Dividends
We have never declared or paid any cash dividends on our capital stock. The payment of dividends on our common stock in the future will depend on our earnings, capital requirements, operating and financial condition and such other factors as our board of directors may consider appropriate. We currently expect to use all available funds to finance the future development and expansion of our business and do not anticipate paying dividends on our common stock in the foreseeable future.
Pursuant to Section 16-10a-640 of the Utah Revised Business Corporation Act, no distribution may be made if, after giving it effect:
| (a) | the corporation would not be able to pay its debts as they become due in the usual course of business; or | |
| (b) | the corporation’s total assets would be less than the sum of its total liabilities plus, unless the articles of incorporation permit otherwise, the amount that would be needed, if the corporation were to be dissolved at the time of the distribution, to satisfy the preferential rights upon dissolution of shareholders whose preferential rights are superior to those receiving the distribution. |
Item 3. Defaults Upon Senior Securities
None.
Item 4. Mine Safety Disclosures
Not applicable.
Item 5. Other Information
None.
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Item 6. Exhibits
Exhibit Index
(a) Exhibits
| Exhibit | Exhibit Description | Filed Herewith | Incorporated by Reference herein from Form or Schedule | Filing Date | SEC File/Reg. Number | |||||
| 1.1 | Placement Agency Agreement, dated as of July 30, 2026, by and between the Company and Maxim Group LLC | Form 8-K (Exhibit 1.1) | 07/31/26 | 001-38148 | ||||||
| 4.1 | Form of New Warrant | Form 8-K (Exhibit 4.1) | 07/31/26 | 001-38148 | ||||||
| 10.1 | Amendment to Equity Distribution Agreement, by and between Co-Diagnostics, Inc. and Maxim Group LLC, dated July 27, 2026. | Form 8-K (Exhibit 10.1) | 07/27/26 | 001-38148 | ||||||
| 10.2 | Form of Inducement Letter | Form 8-K (Exhibit 10.1) | 07/31/26 | 001-38148 | ||||||
| 31.1 | Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 | X | ||||||||
| 31.2 | Certification of Principal Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 | X | ||||||||
| 32.1 | Certification of Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 | X | ||||||||
| 32.2 | Certification of Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 | X | ||||||||
| 101.INS | Inline XBRL Instance Document | X | ||||||||
| 101.SCH | Inline XBRL Taxonomy Extension Schema Document | X | ||||||||
| 101.CAL | Inline XBRL Taxonomy Extension Calculation Linkbase Document | X | ||||||||
| 101.DEF | Inline XBRL Taxonomy Extension Definition Linkbase Document | X | ||||||||
| 101.LAB | Inline XBRL Taxonomy Extension Label Linkbase Document | X | ||||||||
| 101.PRE | Inline XBRL Taxonomy Extension Presentation Linkbase Document | X | ||||||||
| 104 | Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101) |
* *Schedules and exhibits have been omitted from this exhibit pursuant to Item 601(a)(5) of Regulation S-K. The registrant hereby undertakes to furnish copies of any of the omitted schedules and exhibits upon request by the U.S. Securities and Exchange Commission.
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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 thereunto duly authorized.
| CO-DIAGNOSTICS, INC. | ||
| Date: November 10, 2026 | By: | /s/ Dwight H. Egan |
| Name: | Dwight H. Egan | |
| Title: | Chief Executive Officer and Principal Executive Officer | |
| Date: November 10, 2026 | By: | /s/ Daniel Bohrer |
| Name: | Daniel Bohrer | |
| Title: | Executive Vice President Finance & Accounting and Principal Financial and Accounting Officer | |
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Exhibit 31.1
CERTIFICATION OF THE CHIEF EXECUTIVE OFFICER
PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
AND RULE 13a-14 OF THE EXCHANGE ACT OF 1934
I, Dwight H. Egan, certify that:
| 1. | I have reviewed this Quarterly Report on Form 10-Q of Co-Diagnostics, Inc.; |
| 2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
| 3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
| 4. | The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
| a. | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; | |
| b. | Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; | |
| c. | Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and | |
| d. | Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting. |
| 5. | The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): |
| a. | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and | |
| b. | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
| Date: November 10, 2026 | By: | /s/ Dwight H. Egan |
| Dwight H. Egan | ||
| Chief Executive Officer and Principal Executive Officer |
Exhibit 31.2
CERTIFICATION OF THE PRINCIPAL FINANCIAL OFFICER
PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
AND RULE 13a-14 OF THE EXCHANGE ACT OF 1934
I, Daniel Bohrer, certify that:
| 1. | I have reviewed this Quarterly Report on Form 10-Q of Co-Diagnostics, Inc.; |
| 2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
| 3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
| 4. | The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
| a. | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; | |
| b. | Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; | |
| c. | Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and | |
| d. | Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting. |
| 5. | The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): |
| a. | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and | |
| b. | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
| Date: November 10, 2026 | By: | /s/ Daniel Bohrer |
| Daniel Bohrer | ||
| Executive Vice President Finance & Accounting and Principal Financial and Accounting Officer |
Exhibit 32.1
CERTIFICATION OF THE CHIEF EXECUTIVE OFFICER
PURSUANT TO 18 U.S. C. SECTION 1350
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Quarterly Report of Co-Diagnostics, Inc. (the “Company”) on Form 10-Q for the period ended September 30, 2026, as filed with the Securities and Exchange Commission on the date hereof, I, Dwight H. Egan, Chief Executive Officer of the Company, hereby certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that, to my knowledge:
| (1) | The Form 10-Q fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and | |
| (2) | The information contained in the Form 10-Q fairly presents, in all material respects, the financial condition and results of operations of the Company. |
| Date: November 10, 2026 | By: | /s/ Dwight H. Egan |
| Dwight H. Egan | ||
| Chief Executive Officer and Principal Executive Officer |
Exhibit 32.2
CERTIFICATION OF THE PRINCIPAL FINANCIAL OFFICER
PURSUANT TO 18 U.S. C. SECTION 1350
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Quarterly Report of Co-Diagnostics, Inc. (the “Company”) on Form 10-Q for the period ended September 30, 2026, as filed with the Securities and Exchange Commission on the date hereof, I, Daniel Bohrer, Principal Financial Officer of the Company, hereby certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that, to my knowledge:
| (1) | The Form 10-Q fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and | |
| (2) | The information contained in the Form 10-Q fairly presents, in all material respects, the financial condition and results of operations of the Company. |
| Date: November 10, 2026 | By: | /s/ Daniel Bohrer |
| Daniel Bohrer | ||
| Executive Vice President Finance & Accounting and Principal Financial and Accounting Officer |