Co-Diagnostics, Inc. 10-Q

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________ to __________ Commission File No. 001-38148 CO-DIAGNOSTICS, INC. (Exact Name of Registrant as Specified in Its Charter) Utah 46-2609396 (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification Number) 2401 S. Foothill Drive , Suite D , Salt Lake City , Utah 84109 (Address of principal executive offices and zip code) (801) 438-1036 (Registrant’s telephone number, including area code) Securities registered pursuant to Section 12(b) of the Act: Title of each class Trading Symbol(s) Name of each exchange on which registered Common Stock CODX The Nasdaq Capital Market 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. Yes ☒ No ☐ 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). Yes ☒ No ☐ 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 ☐ Non-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 11, 2025, there were 60,892,582 shares of common stock, par value $ 0.001 per share, outstanding. CO-DIAGNOSTICS, INC. AND SUBSIDIARIES TABLE OF CONTENTS PART I FINANCIAL INFORMATION: Item 1. Financial Statements (unaudited): 3 Condensed Consolidated Balance Sheets 3 Condensed Consolidated Statements of Operations 4 Condensed Consolidated Statements of Cash Flows 5 Condensed Consolidated Statements of Stockholders’ Equity 6 Notes to Condensed Consolidated Financial Statements 7 Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations 19 Item 3. Quantitative and Qualitative Disclosures About Market Risk 22 Item 4. Controls and Procedures 22 PART II OTHER INFORMATION: Item 1. Legal Proceedings 23 Item 1A. Risk Factors 23 Item 2. Unregistered Sales of Equity Securities and Use of Proceeds 23 Item 3. Defaults Upon Senior Securities 23 Item 4. Mine Safety Disclosures 23 Item 5. Other Information 23 Item 6. Exhibits 24 Signatures 25 2 PART I. FINANCIAL INFORMATION Item 1. Financial Statements CO – DIAGNOSTICS, INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) September 30, 2025 December 31, 2024 Assets Current assets Cash and cash equivalents $ 11,443,943 $ 2,936,544 Marketable investment securities - 26,811,098 Accounts receivable, net 55,905 132,570 Inventory, net 1,089,956 1,072,724 Income taxes receivable 923,217 - Prepaid expenses and other current assets 541,946 1,338,762 Total current assets 14,054,967 32,291,698 Property and equipment, net 2,485,112 2,761,280 Operating lease right-of-use asset 1,439,779 2,114,876 Intangible assets, net 26,101,000 26,101,000 Investment in joint venture 659,903 731,065 Total assets $ 44,740,761 $ 63,999,919 Liabilities and stockholders’ equity Current liabilities Accounts payable $ 1,458,397 $ 3,294,254 Accrued expenses 1,204,660 2,562,169 Operating lease liability, current 744,156 915,619 Contingent consideration liabilities, current 239,955 502,819 Deferred revenue 45,557 40,857 Total current liabilities 3,692,725 7,315,718 Long-term liabilities Income taxes payable 491,848 713,643 Operating lease liability 727,943 1,236,560 Contingent consideration liabilities - 422,080 Total long-term liabilities 1,219,791 2,372,283 Total liabilities 4,912,516 9,688,001 Commitments and contingencies (Note 10) - Stockholders’ equity Convertible preferred stock, $ 0.001 par value; 5,000,000 shares authorized; 0 shares issued and outstanding as of September 30, 2025 and December 31, 2024, respectively - - Common stock, $ 0.001 par value; 100,000,000 shares authorized; 52,991,260 shares issued and 48,142,582 shares outstanding as of September 30, 2025 and 37,902,222 shares issued and 33,053,544 shares outstanding as of December 31, 2024 52,991 37,902 Treasury stock, at cost; 4,848,678 shares held as of September 30, 2025 and December 31, 2024, respectively ( 15,575,795 ) ( 15,575,795 ) Additional paid-in capital 109,447,214 102,472,210 Accumulated other comprehensive income 94,888 418,443 Accumulated deficit ( 54,191,053 ) ( 33,040,842 ) Total stockholders’ equity 39,828,245 54,311,918 Total liabilities and stockholders’ equity $ 44,740,761 $ 63,999,919 See accompanying notes to unaudited condensed consolidated financial statements 3 CO – DIAGNOSTICS, INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (Unaudited) Three Months Ended September 30, Nine Months Ended September 30, 2025 2024 2025 2024 Product revenue $ 145,380 $ 206,876 $ 358,567 $ 620,723 Grant revenue - 434,265 - 3,145,112 Total revenue 145,380 641,141 358,567 3,765,835 Cost of revenue 26,285 297,403 79,981 744,056 Gross profit 119,095 343,738 278,586 3,021,779 Operating expenses Sales and marketing 568,937 1,059,745 1,835,680 3,664,670 General and administrative 1,815,945 4,287,380 7,189,076 10,338,568 Research and development 4,480,678 4,880,315 14,038,156 16,172,684 Depreciation and amortization 267,383 351,235 839,242 1,020,143 Total operating expenses 7,132,943 10,578,675 23,902,154 31,196,065 Loss from operations ( 7,013,848 ) ( 10,234,937 ) ( 23,623,568 ) ( 28,174,286 ) Other income (expense), net Interest income, net 13,194 263,335 38,953 968,256 Realized gain on investments 41,542 293,067 683,365 595,302 Gain (loss) on disposition of assets 4,000 3,513 ( 5,004 ) 7,013 Gain (loss) on remeasurement of acquisition contingencies ( 42,345 ) ( 11,927 ) 684,944 194,217 Gain (loss) on equity method investment in joint venture ( 55,959 ) 12,683 ( 71,163 ) ( 132,775 ) Total other income (expense), net ( 39,568 ) 560,671 1,331,095 1,632,013 Loss before income taxes ( 7,053,416 ) ( 9,674,266 ) ( 22,292,473 ) ( 26,542,273 ) Income tax provision (benefit) ( 1,166,593 ) 22,189 ( 1,142,262 ) 65,543 Net loss $ ( 5,886,823 ) $ ( 9,696,455 ) $ ( 21,150,211 ) $ ( 26,607,816 ) Other comprehensive income (loss) Change in net unrealized gains (losses) on marketable securities, net of tax ( 39,180 ) 37,158 ( 323,555 ) 261,666 Total other comprehensive income (loss) $ ( 39,180 ) $ 37,158 $ ( 323,555 ) $ 261,666 Comprehensive loss $ ( 5,926,003 ) $ ( 9,659,297 ) $ ( 21,473,766 ) $ ( 26,346,150 ) Loss per common share: Basic and Diluted $ ( 0.16 ) $ ( 0.32 ) $ ( 0.62 ) $ ( 0.88 ) Weighted average shares outstanding: Basic and Diluted 37,890,923 30,494,206 34,370,824 30,155,167 See accompanying notes to unaudited condensed consolidated financial statements 4 CO – DIAGNOSTICS, INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited) Nine Months Ended September 30, 2025 2024 Cash flows from operating activities Net loss $ ( 21,150,211 ) $ ( 26,607,816 ) Adjustments to reconcile net loss to cash used in operating activities: Depreciation and amortization 839,242 1,020,143 Stock-based compensation expense 1,956,078 4,116,475 Common stock issued for financial advisory services 135,000 - Change in fair value of acquisition contingencies ( 684,944 ) ( 194,217 ) Non-cash lease expense ( 4,985 ) 12,174 Realized gain on investments ( 683,365 ) ( 595,302 ) Loss from equity method investment 71,163 132,775 (Gain) loss on disposition of assets 5,004 ( 7,013 ) Provision for credit losses (recoveries of) ( 22,375 ) 8,262 Inventory obsolescence expense (recovery) ( 138,983 ) 164,955 Changes in assets and liabilities: Accounts receivable 99,040 117,421 Prepaid expenses and other assets ( 69,584 ) 627,370 Inventory 121,752 233,754 Deferred revenue 4,700 ( 301,972 ) Income taxes payable ( 221,795 ) 60,442 Accounts payable, accrued expenses and other liabilities ( 3,193,366 ) 288,510 Net cash used in operating activities ( 22,937,629 ) ( 20,924,039 ) Cash flows from investing activities Purchases of property and equipment ( 568,078 ) ( 675,365 ) Proceeds from maturities of marketable investment securities 33,761,847 45,031,967 Purchases of marketable securities ( 6,590,939 ) ( 27,408,061 ) Investment in joint venture - ( 143,750 ) Net cash provided by investing activities 26,602,830 16,804,791 Cash flows from financing activities Issuance of common stock related to at-the-market offering, net of offering costs 1,313,929 - Issuance of common stock related to registered direct offering, net of offering costs 3,528,269 - Net cash provided by financing activities 4,842,198 - Net increase (decrease) in cash and cash equivalents 8,507,399 ( 4,119,248 ) Cash and cash equivalents at beginning of period 2,936,544 14,916,878 Cash and cash equivalents at end of period $ 11,443,943 $ 10,797,630 Supplemental disclosure of cash flow information Cash paid (received) for income taxes $ 1,656 $ ( 23,350 ) See accompanying notes to unaudited condensed consolidated financial statements 5 CO – DIAGNOSTICS, INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY (Unaudited) 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 - $ - 37,902,222 $ 37,902 $ ( 15,575,795 ) $ 102,472,210 $ 418,443 $ ( 33,040,842 ) $ 54,311,918 Issuance of common stock related to at-the-market offering, net of offering costs - - 519,099 519 - 354,227 - - 354,746 Stock-based compensation - - - - - 875,228 - - 875,228 Other comprehensive loss, net of tax - - - - - - ( 87,790 ) - ( 87,790 ) Net loss - - - - - - - ( 7,533,271 ) ( 7,533,271 ) Balance as of March 31, 2025 - - 38,421,321 38,421 ( 15,575,795 ) 103,701,665 330,653 ( 40,574,113 ) 47,920,831 Issuance of common stock related to at-the-market offering, net of offering costs - - 1,375,325 1,375 - 427,625 - - 429,000 Stock-based compensation - - 734,500 735 - 579,530 - - 580,265 Issuance of common stock related to financial advisory services - - 500,000 500 - 134,500 - - 135,000 Other comprehensive loss, net of tax - - - - - - ( 196,585 ) - ( 196,585 ) Net loss - - - - - - - ( 7,730,117 ) ( 7,730,117 ) Balance as of June 30, 2025 - - 41,031,146 41,031 ( 15,575,795 ) 104,843,320 134,068 ( 48,304,230 ) 41,138,394 Issuance of common stock related to at-the-market offering, net of offering costs - - 2,341,114 2,341 - 584,659 - - 587,000 Stock-based compensation - - - - - 500,585 - - 500,585 Issuance of common stock related to registered direct offering, net of offering costs - - 9,619,000 9,619 - 3,518,650 - - 3,528,269 Other comprehensive income, net of tax - - - - - - ( 39,180 ) - ( 39,180 ) Net loss - - - - - - - ( 5,886,823 ) ( 5,886,823 ) Balance as of September 30, 2025 - $ - 52,991,260 $ 52,991 $ ( 15,575,795 ) $ 109,447,214 $ 94,888 $ ( 54,191,053 ) $ 39,828,245 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, 2023 - $ - 36,108,346 $ 36,108 $ ( 15,575,795 ) $ 96,808,436 $ 146,700 $ 4,598,166 $ 86,013,615 Stock-based compensation - - 18,750 19 - 1,571,215 - - 1,571,234 Other comprehensive income, net of tax - - - - - - 79,855 - 79,855 Net loss - - - - - - - ( 9,312,043 ) ( 9,312,043 ) Balance as of March 31, 2024 - - 36,127,096 36,127 ( 15,575,795 ) 98,379,651 226,555 ( 4,713,877 ) 78,352,661 Stock-based compensation - - 632,584 633 - 1,499,025 - - 1,499,658 Other comprehensive income, net of tax - - - - - - 144,653 - 144,653 Net loss - - - - - - - ( 7,599,318 ) ( 7,599,318 ) Balance as of June 30, 2024 - - 36,759,680 36,760 ( 15,575,795 ) 99,878,676 371,208 ( 12,313,195 ) 72,397,654 Balance - - 36,759,680 36,760 ( 15,575,795 ) 99,878,676 371,208 ( 12,313,195 ) 72,397,654 Stock-based compensation - - 18,750 18 - 1,045,565 - - 1,045,583 Other comprehensive income, net of tax - - - - - - 37,158 - 37,158 Other comprehensive income (loss), net of tax - - - - - - 37,158 - 37,158 Net loss - - - - - - - ( 9,696,455 ) ( 9,696,455 ) Balance as of September 30, 2024 - $ - 36,778,430 $ 36,778 $ ( 15,575,795 ) $ 100,924,241 $ 408,366 $ ( 22,009,650 ) $ 63,783,940 Balance - $ - 36,778,430 $ 36,778 $ ( 15,575,795 ) $ 100,924,241 $ 408,366 $ ( 22,009,650 ) $ 63,783,940 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, 2025 are not necessarily indicative of the results that may be expected for the year ending December 31, 2025. These statements should be read in conjunction with the Company’s audited financial statements and related notes for the year ended December 31, 2024, included in the Company’s Annual Report on Form 10-K filed with the SEC on March 27, 2025. 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, 2024. 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, cash equivalents, and short-term investments as of September 30, 2025, 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 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, 2025 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 doubtful accounts for amounts the Company does not expect to collect. In establishing the required allowance, management considers historical losses, current market condition, 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, 2025 total accounts receivable was $ 101,965 with an allowance for uncollectable accounts of $ 46,060 resulting in a net amount of $ 55,905 . At December 31, 2024 total accounts receivable was $ 242,625 with an allowance for uncollectable accounts of $ 110,055 resulting in a net amount of $ 132,570 . At December 31, 2023 total accounts receivable was $ 504,264 with an allowance for uncollectable accounts of $ 200,338 resulting in a net amount of $ 303,926 . 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, 2025, the Company had $ 1,089,956 in net inventory, of which $ 607,085 was finished goods and $ 482,871 was raw materials. At December 31, 2024, the Company had $ 1,072,724 in net inventory, of which $ 567,281 was finished goods and $ 505,443 was raw materials. The Company establishes reserves to reduce low-moving, obsolete, or unusable inventories to their estimated useful or scrap values. The Company recognized $ 43,681 and $ 144,747 related to the change in inventory reserves during the three and nine months ended September 30, 2025, respectively, compared to $ 72,872 and $ 214,134 during the three and nine months ended September 30, 2024, respectively. 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. Grant Revenue The Company may submit applications to receive grant funding from governmental and non-governmental entities. The Company accounts for grants by analogizing to the contribution accounting model under ASC 958-605, Not-for-Profit Entities (“ASC 958”). Revenues from grants, contracts, and awards provided by governmental and non-governmental agencies are recorded based upon the terms of the specific agreements. The Company recognizes grant funding without conditions or continuing performance obligations as revenue in the consolidated statements of operations and comprehensive income (loss). The Company recognizes grant funding with conditions or continuing performance obligations as deferred revenue in the consolidated balance sheets if the conditions or performance obligations have not yet been met. The Company recognized no grant funding revenue during the three and nine months ended September 30, 2025, respectively, compared to $ 434,265 and $ 3,145,112 during the three and nine months ended September 30, 2024, respectively. At September 30, 2025, and December 31, 2024, the Company has recorded $ 40,857 of deferred revenue related to grant funding for which the cash was received, but the underlying conditions or performance obligations have not yet been met. Cash received from federal grants, contracts, and awards can be subject to audit by the grantor and, if the examination results in a disallowance of any expenditure, repayment could be required. Income Taxes The Company accounts for income taxes in accordance with the liability method of accounting for income taxes. Under this method, d eferred 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 positions, result of operations, or cash flows. Concentrations 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, 2025 and 2024. Three customers accounted for approximately 48 % of product revenue recognized during the three months ended September 30, 2025. Four customers accounted for approximately 75 % of product revenue, and one granting agency accounted for 100 % of grant revenue recognized during the three months ended September 30, 2024. Two customers accounted for approximately 31 % of product revenue, and two granting agencies accounted for approximately 95 % of grant revenue recognized during the nine months ended September 30, 2024. 9 Two customers individually accounted for more than 10 % of accounts receivable at September 30, 2025 and two customers individually accounted for more than 10 % of accounts receivable at December 31, 2024. These customers together accounted for approximately 74 % and 94 % of accounts receivable at September 30, 2025 and December 31, 2024, respectively. 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 2023, the FASB issued Accounting Standards Update (“ASU”) 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, which improves reportable segment disclosure requirements, primarily through enhanced disclosures about significant segment expenses. The standard is effective for full year 2024 reporting, and for interim reporting beginning in 2025. The adoption of this ASU did not change the way the Company evaluates its reportable segments and, as a result, did not have a material impact on the Company’s segment-related disclosures. In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, which requires an entity to disclose annually additional information related to the company’s income tax rate reconciliation and income taxes paid during the period. The guidance should be applied prospectively with the option to apply the standard retrospectively. The standard becomes effective for the Company for full year 2025 reporting. The Company is currently evaluating the impact of this new standard on its consolidated financial statements. 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 becomes effective for the Company for interim and full year 2026 reporting. The Company is currently evaluating the impact of this new standard on its consolidated financial statements. 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, 2025 Adjusted Cost Total Unrealized Gains / (Losses) Fair Value Cash and Cash Equivalents Marketable Investment Securities Cash $ 11,443,943 $ - $ 11,443,943 $ 11,443,943 $ - Total $ 11,443,943 $ - $ 11,443,943 $ 11,443,943 $ - 10 December 31, 2024 Adjusted Cost Total Unrealized Gains / (Losses) Fair Value Cash and Cash Equivalents Marketable Investment Securities Cash $ 2,936,544 $ - $ 2,936,544 $ 2,936,544 $ - Level 2: U.S. treasury securities 26,392,655 418,443 26,811,098 - 26,811,098 Subtotal 26,392,655 418,443 26,811,098 - 26,811,098 Total $ 29,329,199 $ 418,443 $ 29,747,642 $ 2,936,544 $ 26,811,098 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, 2025 and December 31, 2024, by level within the fair value hierarchy: Schedule of Fair Value Assets and Liabilities September 30, 2025 (Level 1) (Level 2) (Level 3) Total Liabilities: Contingent consideration - common stock $ - $ - $ 239,955 $ 239,955 Total liabilities measured at fair value $ - $ - $ 239,955 $ 239,955 11 December 31, 2024 (Level 1) (Level 2) (Level 3) Total Assets: Cash equivalents $ 441,000 $ - $ - $ 441,000 Marketable securities (U.S. treasury bills and notes) - 26,811,098 - 26,811,098 Total assets measured at fair value $ 441,000 $ 26,811,098 $ - $ 27,252,098 Liabilities: Contingent consideration - common stock $ - $ - $ 743,794 $ 743,794 Contingent consideration - warrants - - 181,105 181,105 Total liabilities measured at fair value $ - $ - $ 924,899 $ 924,899 The Company’s financial instruments that are measured at fair value on a recurring basis consist of U.S. treasury bills and notes as of December 31, 2024. 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, 2024 $ 924,899 Change in fair value of contingent consideration issued for business acquisitions ( 684,944 ) Fair value as of September 30, 2025 $ 239,955 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, 2025 December 31, 2024 Stock price $ 0.34 $ 0.75 Strike price $ 9.13 $ 9.13 Volatility 273.3 % 246.4 % Risk-free rate 3.7 % 4.3 % Expected term (years) 1.3 2.0 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, 2025 Weighted-Average Gross Net Useful Life (1) Carrying Accumulated Carrying (in Years) Amount Amortization Amount In-process research and development Indefinite $ 26,101,000 $ - $ 26,101,000 Non-competition agreements 1,094,000 ( 1,094,000 ) - Total intangible assets $ 27,195,000 $ ( 1,094,000 ) $ 26,101,000 December 31, 2024 Weighted-Average Gross Net Useful Life (1) Carrying Accumulated Carrying (in Years) Amount Amortization Amount In-process research and development Indefinite $ 26,101,000 $ - $ 26,101,000 Non-competition agreements 1,094,000 ( 1,094,000 ) - Total intangible assets $ 27,195,000 $ ( 1,094,000 ) $ 26,101,000 (1) Based on weighted-average useful life established as of the acquisition date. 12 Note 6 – Revenue The following table sets forth revenue by geographic area: Summary of Revenue by Geographic Area Three Months Ended September 30, Nine Months Ended September 30, 2025 2024 2025 2024 United States Product revenue $ 136,740 $ 129,776 $ 339,827 $ 473,482 Grant revenue - 434,265 - 3,145,112 Total United States 136,740 564,041 339,827 3,618,594 Rest of World Product revenue 8,640 77,100 18,740 147,241 Grant revenue - - - - Total Rest of World 8,640 77,100 18,740 147,241 Total $ 145,380 $ 641,141 $ 358,567 $ 3,765,835 Revenue geographic area $ 145,380 $ 641,141 $ 358,567 $ 3,765,835 Percentage of revenue by area: United States 94 % 88 % 95 % 96 % Rest of World 6 % 12 % 5 % 4 % Changes in the Company’s deferred revenue balance for the nine months ended September 30, 2025 were as follows: Schedule of Deferred Revenue Balance as of December 31, 2024 $ 40,857 Revenue recognized included in deferred revenue balance at the beginning of the period - Increase due to prepayments from customers 4,700 Balance as of September 30, 2025 $ 45,557 Note 7 – Loss Per Share The following table reconciles the numerator and the denominator used to calculate basic and diluted loss per share for three and nine months ended September 30, 2025 and 2024, respectively: Schedule of Basis and Diluted Earnings Per Share Three Months Ended September 30, Nine Months Ended September 30, 2025 2024 2025 2024 Numerator Net loss, as reported $ ( 5,886,823 ) $ ( 9,696,455 ) $ ( 21,150,211 ) $ ( 26,607,816 ) Denominator Weighted average shares, basic 37,890,923 30,494,206 34,370,824 30,155,167 Dilutive effect of stock options, warrants and RSUs - - - - Shares used to compute diluted earnings per share 37,890,923 30,494,206 34,370,824 30,155,167 Loss per share, basic and diluted $ ( 0.16 ) $ ( 0.32 ) $ ( 0.62 ) $ ( 0.88 ) 13 The computation of diluted loss per share for the three and nine months ended September 30, 2025 and 2024, respectively, also excludes approximately 1.4 million shares of common stock and approximately 465,000 warrants to purchase shares of common stock that are contingent upon the achievement of certain milestones. As a result of incurring a net loss for the three and nine months ended September 30, 2025 and 2024, respectively, no 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, 2025, consisting of: (i) 2,317,465 restricted stock units and (ii) 978,757 options and warrants. The Company had potentially dilutive securities as of September 30, 2024, consisting of: (i) 1,598,891 restricted stock units and (ii) 532,112 options and warrants. Note 8 – Stock-Based Compensation 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 “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 12,000,000 shares of common stock. The number of awards available for issuance under the Incentive Plan was 655,702 at September 30, 2025. The Incentive Plan will expire on December 31, 2025. The Company’s board of directors adopted in March 2025, and in May 2025 our shareholders approved, the Co-Diagnostics, Inc. 2025 Equity Incentive Plan (the “2025 Plan”) providing for the issuance of stock-based incentive awards to employees, officers, consultants, directors and independent contractors. The number of awards available for issuance under the 2025 Plan was 6,700,000 at September 30, 2025. No awards have been made under the 2025 Plan. Stock Options The following table summarizes option activity during the nine months ended September 30, 2025: 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, 2024 1,040,572 $ 2.19 $ 1.37 3.88 Granted - - - Expired ( 70,002 ) $ 1.29 $ 0.76 Forfeited/Cancelled - - - Exercised - - - Outstanding at September 30, 2025 970,570 $ 2.26 $ 1.41 3.32 Exercisable at September 30, 2025 970,570 $ 2.26 $ 1.41 3.32 The aggregate intrinsic value of outstanding options at September 30, 2025 and 2024 was approximately $ 0 and $ 152,521 , respectively. 14 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, 2025, there were no unvested options and no unrecognized stock-based compensation expense related to options. Restricted Stock Units The grant date fair value of RSUs granted is determined using the closing market price of the Company’s common stock on the grant date with the associated compensation expense amortized over the vesting period of the awards. The following table sets forth the outstanding RSUs and related activity for the nine months ended September 30, 2025: Schedule of Outstanding Restricted Stock Units and Related Party Number of RSUs Weighted Average Grant Date Fair Value Unvested at December 31, 2024 2,742,316 $ 2.50 Granted 2,605,002 0.25 Vested ( 734,500 ) 2.59 Forfeited/Cancelled ( 128,753 ) 5.45 Unvested at September 30, 2025 4,484,065 $ 1.09 As of September 30, 2025, there was approximately $ 3,100,827 of unrecognized stock-based compensation expense related to outstanding RSUs which is expected to be recognized over a weighted-average period of 1.7 years. Warrants The Company has issued warrants related to financings, acquisitions and as compensation to third parties for services provided. The Company estimates the fair value of issued warrants on the date of issuance as determined using a Black-Scholes pricing model. The Company amortizes the fair value of issued warrants using a vesting schedule based on the terms and conditions of each warrant if granted for services. The following table summarizes warrant activity during the nine months ended September 30, 2025: Schedule of Warrant Activity Number of Warrants Weighted Average Exercise Price Weighted Average Fair Value Weighted Average Remaining Contractual Life (Years) Outstanding at December 31, 2024 485,000 $ 8.81 $ 1.00 2.0 Granted - - - Expired ( 20,000 ) 1.40 15.19 Forfeited/Cancelled - - - Exercised - - - Outstanding at September 30, 2025 465,000 $ 9.13 $ - 1.3 The aggregate intrinsic value of outstanding warrants at September 30, 2025 was $ 0 . 15 There are no warrants exercisable at September 30, 2025. The ability to exercise the 465,000 warrants issued in connection with acquisitions in prior years is contingent upon the achievement of certain development and revenue milestones on or before January 1, 2027. There was no unrecognized stock-based compensation expense related to warrants. Stock-Based Compensation Expense The Company recognized stock-based compensation expense as follows: Schedule of Recognized Stock-Based Compensation Expense Three Months Ended September 30, Nine Months Ended September 30, 2025 2024 2025 2024 Cost of revenue $ - $ 3,306 $ - $ 17,501 Sales and marketing 60,372 181,190 301,911 844,553 General and administrative 379,981 924,539 1,647,603 3,057,184 Research and development 60,232 ( 63,452 ) 6,564 197,237 Total stock-based compensation expense $ 500,585 $ 1,045,583 $ 1,956,078 $ 4,116,475 Note 9 – Income Taxes For the three months ended September 30, 2025, the Company recognized a benefit from income taxes of $ 1,166,593 , representing an effective tax rate of 16.5 %. For the nine months ended September 30, 2025, the Company recognized a benefit from income taxes of $ 1,142,262 , representing an effective tax rate of 5.1 %. The Company’s effective tax rate will generally differ from the U.S. Federal statutory rate of 21.0 %, primarily due to the full valuation allowance as well as state taxes, permanent items, and discrete items. For the three and nine months ended September 30, 2024, the Company recognized expense from income taxes of $ 22,189 and $ 65,543 , respectively. Note 10 – 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 Three Months Ended September 30, Nine Months Ended September 30, 2025 2024 2025 2024 Operating lease costs $ 259,642 $ 258,145 $ 775,830 $ 761,986 Short-term lease costs - 8,250 - 46,039 Total lease costs $ 259,642 $ 266,395 $ 775,830 $ 808,025 16 As of September 30, 2025, the maturities of the Company’s lease liabilities are as follows: Schedule of Maturities on Company Lease Liabilities Years Ending December 31, 2025 (remainder) $ 255,759 2026 714,630 2027 300,591 2028 308,462 Total lease payments 1,579,442 Less: imputed interest 107,343 Present value of operating lease liabilities 1,472,099 Less: current portion 744,156 Long-term portion $ 727,943 Other information related to operating leases was as follows: Schedule of Other Information Related to Operating Leases Nine Months Ended September 30, 2025 Cash paid for operating leases included in operating cash flows $ 780,814 Remaining lease term of operating leases 2.4 Discount rate of operating leases 6.2 % 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. The Company is a defendant in one class action claim and three derivative actions claiming that the Company promulgated false and misleading press releases to increase the price of our stock to improperly benefit the officers and directors of the Company. The plaintiffs demand compensatory damages sustained as a result of the Company’s alleged wrongdoing in an amount to be proven at trial. The Company is also a party to three civil actions, two in the US and the other in the United Kingdom. Each of the civil actions is based on breach of contract claims against the Company. The Company believes these lawsuits are without merit and is defending the cases vigorously. The Company is unable to estimate a range of loss, if any, that could result were there to be an adverse final decision in these cases. As of the date of this report, the Company does not believe it is probable that these cases will result in an unfavorable outcome; however, if an unfavorable outcome were to occur in these cases, it is possible that the impact could be material to the Company’s results of operations in the period(s) in which any such outcome becomes probable and estimable. 17 Note 11 – 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 $ 30.0 million of CODX common stock. The repurchase program does not obligate the Company to acquire any particular number of common shares, and the repurchase program may be suspended or discontinued at any time at the Company’s discretion. The timing and amount of any share repurchases under the share repurchase program will be determined by Co-Diagnostics’ management at its discretion based on ongoing assessments of the capital needs of the business, the market price of the Company’s common stock, corporate and regulatory requirements, and general market conditions. 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, 2025. Note 12 – 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 $ 17,111,650 from time to time through Piper Sandler and Clear Street, acting as sales agents, under a prospectus supplement dated October 18, 2024. As of September 30, 2025, the Company had sold 4,550,245 shares of common stock under the Prior ATM Agreement, resulting in net proceeds to the Company of approximately $ 1,660,805 . The Prior ATM Agreement was subsequently terminated, and no further sales will be made under that program. On October 20, 2025, the Company entered into a new Equity Distribution Agreement (the “Agreement”) with Maxim Group LLC (“Maxim”) to establish an at-the-market (“ATM”) equity offering program. Pursuant to the Agreement, the Company may offer and sell shares of its common stock, par value $ 0.001 per share, having an aggregate offering price of up to $ 10.0 million, from time to time through Maxim, acting as the Company’s sales agent. Under the terms of the Agreement, the Company will pay Maxim a commission equal to 3.0% of the gross proceeds from the sale of any shares and will reimburse Maxim for certain legal and other out-of-pocket expenses incurred in connection with its services. Sales of common stock, if any, may be made in transactions deemed to be “at-the-market” offerings as defined in Rule 415 under the Securities Act of 1933, as amended, including sales made by means of ordinary brokers’ transactions on The Nasdaq Capital Market or otherwise at market prices prevailing at the time of sale or at prices negotiated with Maxim. The Company is not obligated to sell any shares under the Agreement and may terminate the offering at any time in accordance with its terms. The shares will be issued pursuant to the Company’s shelf Registration Statement on Form S-3 (File No. 333-270628), which was declared effective by the Securities and Exchange Commission on April 6, 2023. On October 20, 2025, the Company filed a prospectus supplement with the SEC relating to the new ATM program, registering up to approximately $ 4.1 million of shares under the shelf registration statement. Note 13 – Registered Direct Offering On September 17, 2025, the Company entered into a Securities Purchase Agreement (the “Purchase Agreement”) with two institutional investors (the “Investors”) named therein, pursuant to which the Company agreed to issue and sell, in a registered direct offering priced at-the-market under Nasdaq rules by the Company directly to the Investors (the “Offering”) an aggregate of 9,619,000 shares (the “Shares”) of the Company’s common stock, par value $ 0.01 per share, at an offering price of $ 0.40 per share. The offering closed on September 18, 2025. The gross proceeds to the Company from the offering were approximately $ 3,847,600 , before deducting the placement agent’s fees and other offering expenses. The Offering Shares were offered and sold by the Company pursuant to an effective shelf registration statement on Form S-3 (File No. 333-270628). The Company agreed to pay Maxim Group LLC (“Maxim”), as placement agent, an aggregate fee equal to 7.0 % of the gross proceeds received by the Company from the sale of the securities in the offering as well as up to $ 50,000 for fees and expenses of legal counsel. Note 14 – Related Party Transactions The Company has a services agreement with CoSara Diagnostics Pvt Ltd (“CoSara”), our joint venture for manufacturing in India, under which CoSara provides certain research and development consulting and support services. The Company recognized $ 192,958 and $ 615,425 of expense related to this agreement during the three and nine months ended September 30, 2025, respectively, compared to $ 181,878 and $ 361,843 of expense during the three and nine months ended September 30, 2024, respectively. Note 15 – Subsequent Events Subsequent to September 30, 2025, on October 20, 2025, the Company entered into an Equity Distribution Agreement with Maxim Group LLC to establish an at-the-market equity offering program, as described in Note 12 – At-the-Market Offering. On October 28, 2025, the Company entered into a Securities Purchase Agreement (the “Purchase Agreement”) with two institutional investors (the “Investors”) pursuant to which the Company agreed to issue and sell, in a registered direct offering priced at-the-market under Nasdaq rules (the “Offering”), (i) 12,002,272 shares of its common stock, par value $ 0.001 per share (the “Shares”), at an offering price of $ 0.55 per share, and (ii) pre-funded common stock purchase warrants (the “Pre-Funded Warrants”) to purchase an aggregate of 725,000 shares of common stock at an offering price of $ 0.5499 per Pre-Funded Warrant. The Pre-Funded Warrants have an exercise price of $ 0.0001 per share, are exercisable immediately upon issuance, and will remain exercisable until exercised in full. The Offering closed on October 29, 2025. Gross proceeds to the Company were approximately $ 7.0 million , before deducting placement agent fees and other offering expenses. The securities were offered and sold pursuant to the Company’s shelf Registration Statement on Form S-3 (File No. 333-270628), which was declared effective by the Securities and Exchange Commission on April 6, 2023. Maxim Group LLC (“Maxim”) acted as placement agent for the Offering. The Company agreed to pay Maxim a fee equal to 7.0 % of the gross proceeds from the sale of the securities, as well as up to $ 50,000 for the fees and expenses of its legal counsel. The Company intends to use the net proceeds from the Offering for working capital and general corporate purposes. 18 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, 2024. The following discussion should be read in conjunction with the Annual Report on Form 10-K for the fiscal year ended December 31, 2024, filed with the SEC on March 27, 2025, 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 robust and innovative 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 are currently developing a unique, groundbreaking 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, our patent-pending diagnostic test cup system 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 productive engagement with the FDA related to the regulatory submission, the Company withdrew its 510(k) application. The decision to withdraw the submission was based on discussions with the FDA regarding the ability to detect a potential deterioration of one component of the test, related to shelf-life stability. Following dialogue with the FDA and exploring the various courses of action available, we determined that the best long-term solution would be to submit a version of the test that has been enhanced to address the matter raised in the 510(k) review process. The Company plans to submit the next iteration of the Co-Dx PCR COVID-19 test for 510(k) OTC clearance, following the collection of clinical evaluation data to support the new test’s performance. A new submission also allows the Company to incorporate more recent Co-Dx PCR platform developments into the tests, which Co-Dx believes will also help create greater operational and manufacturing efficiencies, such as consolidating manufacturing processes to utilize the next generation of test kits and instruments across all tests on the at-home and point-of-care Co-Dx PCR platform. 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. On October 27, 2025, we entered into an agreement with Arabian Eagle Manufacturing to form a joint venture to research, develop, manufacture, assemble, distribute, and commercialize Co-Dx technologies and intellectual property, including our upcoming PCR point-of-care platform, within the Kingdom of Saudi Arabia and 18 other countries through the Middle East and North Africa. 19 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 or 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 approval in the European Community and in India 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 disease, 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 and licensed 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. 20 RESULTS OF OPERATIONS The Three Months Ended September 30, 2025 Compared to the Three Months ended September 30, 2024 Revenues For the three months ended September 30, 2025, we generated revenues of $0.1 million, compared to revenues of $0.6 million for the three months ended September 30, 2024. The decrease in revenue was due to lower grant revenues recognized in the current period. Cost of Revenues We recorded cost of revenues of approximately $0.03 million for the three months ended September 30, 2025, compared to $0.3 million for the three months ended September 30, 2024. Included within cost of revenues is a decrease of approximately $0.04 million for the three months ended September 30, 2025, and an increase of approximately $0.1 million for the three months ended September 30, 2024, related to reserves against certain raw materials and finished goods inventories. Expenses Total operating expenses were $7.1 million for the three months ended September 30, 2025 compared to total operating expenses of $10.6 million for the three months ended September 30, 2024. The decrease in operating expenses was primarily due to decreased legal expense, stock-based compensation expense, personnel related expense, and expense related to development of the Co-Dx PCR platform. Sales and marketing expenses for the three months ended September 30, 2025 were $0.6 million compared to $1.1 million for the three months ended September 30, 2024. The decrease was primarily a result of decreased stock-based compensation expense, consulting and professional services expenses, and personnel related expenses. General and administrative expenses for the three months ended September 30, 2025 were $1.8 million compared to $4.3 million for the three months ended September 30, 2024. The decrease resulted primarily from lower legal expense and stock-based compensation expense. Research and development expenses for the three months ended September 30, 2025 were $4.5 million compared to $4.9 million for the three months ended September 30, 2024. The decrease was primarily a result of decreased expenses related to development of the Co-Dx PCR platform, and personnel related expenses, partially offset by an increase in stock-based compensation expense. Other Income or Expense Other expense was $0.04 million for the three months ended September 30, 2025, compared to other income of $0.6 million for the three months ended September 30, 2024. The decrease was primarily a result of lower interest income and realized gains from investments in marketable securities. Net Loss We realized a net loss for the three months ended September 30, 2025 of $5.9 million, compared to $9.7 million for the three months ended September 30, 2024. The smaller net loss was primarily the result of lower operating expenses and a benefit from income taxes, partially offset by decreased grant revenues and lower interest income and realized gains on investments. The income tax benefit recognized during the three months ended September 30, 2025 relates primarily to new United States tax legislation which was signed into law on July 4, 2025, which resulted in the Company being eligible for certain federal and state tax refunds related to prior years. The Company expects to receive these refunds by the end of the year. The Nine Months Ended September 30, 2025 Compared to the Nine Months ended September 30, 2024 Revenues For the nine months ended September 30, 2025, we generated revenues of $0.4 million, compared to revenues of $3.8 million for the nine months ended September 30, 2024. The decrease in revenue was due to lower product and grant revenues recognized in the nine month current period. Cost of Revenues We recorded cost of revenues of approximately $0.1 million for the nine months ended September 30, 2025, compared to $0.7 million for the nine months ended September 30, 2024. Included within cost of revenues is a decrease of approximately $0.1 million for the nine months ended September 30, 2025, and a decrease of approximately $0.2 million for the nine months ended September 30, 2024, related to reserves against certain raw materials and finished goods inventories. Expenses Total operating expenses were $23.9 million for the nine months ended September 30, 2025 compared to total operating expenses of $31.2 million for the nine months ended September 30, 2024. The decrease in operating expenses was primarily due to decreased legal expenses, stock-based compensation expense, and personnel related expenses. Sales and marketing expenses for the nine months ended September 30, 2025 were $1.8 million compared to $3.7 million for the nine months ended September 30, 2024. The decrease was primarily a result of decreased stock-based compensation expense, tradeshow and travel expenses, consulting and professional services expenses, and personnel related expenses. General and administrative expenses for the nine months ended September 30, 2025 were $7.2 million compared to $10.3 million for the nine months ended September 30, 2024. Decreases in legal expense, stock-based compensation expense and consulting and professional services expense were partially offset by increased expenses related to transaction advisory services and fees. Research and development expenses for the nine months ended September 30, 2025 were $14.0 million compared to $16.2 million for the nine months ended September 30, 2024. The decrease was primarily a result of decreased expenses related to development of the Co-Dx PCR platform, personnel related expenses, and stock-based compensation expense, partially offset by increases in professional services expense. 21 Other Income Other income was $1.3 million for the nine months ended September 30, 2025, compared to other income of $1.6 million for the nine months ended September 30, 2024. Decreases in interest income were partially offset by increases in realized gains from investments in marketable securities and increases in the change in the fair value of contingent consideration liabilities. Net Loss We realized a net loss for the nine months ended September 30, 2025 of $21.2 million, compared to $26.6 million for the nine months ended September 30, 2024. The smaller net loss was primarily the result of decreases in operating expenses and a benefit from income taxes, partially offset by decreases in grant revenues. The income tax benefit recognized during the nine months ended September 30, 2025 relates primarily to new United States tax legislation which was signed into law on July 4, 2025, which resulted in the Company being eligible for certain federal and state tax refunds related to prior years. The Company expects to receive these refunds by the end of the year. Liquidity and Capital Resources During and subsequent to the third quarter of 2025, the Company took several actions to strengthen its liquidity position and enhance financial flexibility. In October 2025, the Company terminated its Amended and Restated Equity Distribution Agreement with Piper Sandler & Co. and Clear Street, LLC, under which limited sales of common stock had previously been made, and entered into a new Equity Distribution Agreement with Maxim Group LLC to establish an at-the-market (“ATM”) equity offering program permitting sales of up to $10.0 million of common stock from time to time. In addition, the Company completed two registered direct offerings with institutional investors — one in September 2025 for gross proceeds of approximately $3.8 million and another in October 2025 for gross proceeds of approximately $7.0 million, in each case before deducting placement agent fees and offering expenses. The Company intends to use the net proceeds from these equity financings for working capital and general corporate purposes. At September 30, 2025, we had cash and cash equivalents of $11.4 million. Additionally, our total current assets at September 30, 2025, were $14.1 million compared to total current liabilities of $3.7 million. Net cash used in operating activities during the nine months ended September 30, 2025 was $22.9 million, compared to $20.9 million for the nine months ended September 30, 2024. The increase in cash used in operating activities was primarily due to a higher usage of cash to pay accounts payable and accrued liabilities related to higher legal expenses, along with decreases in product revenue, grant funding, net interest income, and realized gains on investments. Net cash provided by investing activities was $26.6 million for the nine months ended September 30, 2025, compared to $16.8 million during the nine months ended September 30, 2024. The increase in cash provided by investing activities is primarily due to the timing of the redemption of certain investments as they matured. Net cash provided by financing activities was $4.8 million for the nine months ended September 30, 2025, compared to $0 for the nine months ended September 30, 2024. The cash provided by financing activities during 2025 relates to issuances of common stock under the ATM and through a registered direct offering. 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. If needed, we expect additional investment capital to come from additional issuances of our common stock or other equity-based securities with existing and new investors similar to those that have provided funding in the past or debt financing. On September 18, 2025, the Company completed a registered direct offering of 9,619,000 shares of its common stock to two institutional investors at an offering price of $0.40 per share, resulting in gross proceeds of approximately $3.8 million before deducting placement agent fees and other offering expenses. The shares were offered and sold pursuant to the Company’s effective shelf Registration Statement on Form S-3 (File No. 333-270628). Maxim Group LLC acted as placement agent for the transaction. The Company intends to use the net proceeds from the offering for working capital and general corporate purposes. See Note 13 – Registered Direct Offering to the condensed consolidated financial statements for additional information regarding this transaction. In October 2025, the Company terminated its Amended and Restated Equity Distribution Agreement with Piper Sandler & Co. and Clear Street, LLC, under which it had previously sold an aggregate of 4,550,245 shares of common stock for net proceeds of approximately $1.7 million. Concurrently, the Company entered into a new Equity Distribution Agreement with Maxim Group LLC to establish an at-the-market (“ATM”) equity offering program, under which the Company may offer and sell shares of its common stock having an aggregate offering price of up to $10.0 million from time to time. On October 20, 2025, the Company filed a prospectus supplement with the SEC relating to the new ATM program, registering up to approximately $4.1 million of shares under the shelf registration statement. The Company expects that any proceeds from sales under the new ATM program, if utilized, would provide additional financial flexibility to support its working capital requirements and general corporate purposes. There can be no assurance as to the timing or amount of any sales under the new ATM program. See Note 12 – At the Market Agreement to the condensed consolidated financial statements for additional information regarding this transaction. Subsequent to quarter end, on October 29, 2025, the Company completed a registered direct offering of its common stock and pre-funded warrants to two institutional investors for gross proceeds of approximately $7.0 million, before deducting placement agent fees and other offering expenses. The Company intends to use the net proceeds from the offering for working capital and general corporate purposes. See Note 15 – Subsequent Events to the condensed consolidated financial statements for additional information regarding this transaction. 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 . 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-15I 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 Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures as of September 30, 2025. Based on the evaluation of our disclosure controls and procedures as of September 30, 2025, our Chief Executive Officer and Chief 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, 2025, that have materially affected or, are reasonably likely to materially affect, our internal control over financial reporting. 22 PART II – OTHER INFORMATION Item 1. Legal Proceedings There have been no material developments to the legal proceedings previously disclosed under Part I. Item 3 of our Annual Report on Form 10-K for the fiscal year ended December 31, 2024. 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 None. 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. 23 Item 6. Exhibits Exhibit Index (a) Exhibits Exhibit Number Description 1.1*** Placement Agency Agreement, dated as of September 17, 2025, by and between the Company and Maxim Group LLC 10.1** Form of Securities Purchase Agreement 31.1* Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 31.2* Certification of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 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 32.2* Certification of Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 101.INS Inline XBRL Instance Document 101.SCH Inline XBRL Taxonomy Extension Schema Document 101.CAL Inline XBRL Taxonomy Extension Calculation Linkbase Document 101.DEF Inline XBRL Taxonomy Extension Definition Linkbase Document 101.LAB Inline XBRL Taxonomy Extension Label Linkbase Document 101.PRE Inline XBRL Taxonomy Extension Presentation Linkbase Document 104 Cover Page Interactive Data File * Filed herewith. **Incorporated herein by reference to Exhibit 10.1 of Form 8-K, filed September 18, 2025, File No. 001-38148. *** Incorporated herein by reference to Exhibit 1.1 of Form 8-K, filed September 18, 2025, File No. 001-38148 . 24 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 13, 2025 By: /s/ Dwight H. Egan Name: Dwight H. Egan Title: Chief Executive Officer and Principal Executive Officer Date: November 13, 2025 By: /s/ Brian Brown Name: Brian Brown Title: Chief Financial Officer and Principal Financial and Accounting Officer 25