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Co-Diagnostics (NASDAQ: CODX) posts Q1 2026 loss and warns on going concern

Filing Impact
(Moderate)
Filing Sentiment
(Neutral)
Form Type
10-Q

Rhea-AI Filing Summary

Co-Diagnostics, Inc. reported a weak first quarter of 2026, with total revenue of $145,954 and a net loss of $9.14 million compared to a $7.53 million loss a year earlier. Cost of revenue exceeded sales, leading to a negative gross margin, while operating expenses rose to $9.16 million on higher research and development and legal and professional costs.

Cash and cash equivalents fell to $8.23 million at March 31, 2026, after using $7.85 million in operating cash in the quarter, partially offset by $4.33 million raised through an at-the-market stock program. Management concluded that substantial doubt exists about the company’s ability to continue as a going concern over the next 12 months, reflecting dependence on new financing and future profitability.

Positive

  • None.

Negative

  • Going concern uncertainty: Management concludes substantial doubt exists about the company’s ability to continue as a going concern for the 12 months following issuance of these financial statements, given ongoing losses and dependence on new financing.
  • High losses and cash burn: Q1 2026 net loss reached $9.14 million on revenue of only $145,954, with operating cash outflows of $7.85 million, rapidly consuming the $8.23 million cash balance.

Insights

Q1 shows heavy cash burn, going concern warning, and reliance on new capital.

Co-Diagnostics generated only $145,954 of Q1 2026 revenue while posting a net loss of $9.14 million. Operating cash outflow was $7.85 million, highlighting that the business is still far from funding itself. R&D and legal costs are the main expense drivers.

Cash fell to $8.23 million from $11.88 million in three months, despite raising $4.33 million via an at-the-market equity program. The shelf registration supporting that ATM has now expired, limiting this funding source until a new shelf is effective.

Management explicitly states that “substantial doubt” exists about the company’s ability to continue as a going concern for 12 months from issuance of the financials. Future results will hinge on securing additional equity or debt financing and on whether spending on the Co-Dx PCR platform ultimately translates into meaningful, recurring revenue.

Q1 2026 revenue $145,954 Three months ended March 31, 2026 total revenue
Q1 2026 net loss $9,140,038 Three months ended March 31, 2026 net loss
Operating cash outflow $7,846,276 Net cash used in operating activities, Q1 2026
Cash and cash equivalents $8,230,984 Cash balance as of March 31, 2026
Research and development expense $5,934,071 Three months ended March 31, 2026 R&D expense
ATM equity proceeds $4,334,670 Net cash from at-the-market offering, Q1 2026
Total assets $21,499,726 Balance sheet total assets as of March 31, 2026
Shares outstanding 3,602,465 shares Common stock outstanding as of May 12, 2026
going concern financial
"management has concluded that substantial doubt exists about the Company’s ability to continue as a going concern for 12 months"
A going concern is a business that is expected to continue its operations and meet its obligations for the foreseeable future, rather than shutting down or selling off assets. This assumption matters to investors because it indicates stability and ongoing profitability, making the business a more reliable investment. Think of it as believing a restaurant will stay open and serve customers, rather than closing down suddenly.
at-the-market equity offering financial
"entered into a new Equity Distribution Agreement with Maxim to establish an at-the-market (“ATM”) equity offering program"
An at-the-market equity offering is a way for a public company to raise cash by selling newly issued shares directly into the open market at current market prices over time through a broker. Think of it as gradually selling items on an online marketplace at whatever buyers are paying now rather than holding a single big sale; it gives the company flexible access to funds but can lower each existing owner’s share of the company and put gentle downward pressure on the stock price if done in large amounts.
reverse stock split financial
"On January 1, 2026, the Company effected a 1-for-30 reverse stock split of its common stock"
A reverse stock split is when a company reduces the number of its shares outstanding, making each share more valuable. For example, if you own 100 shares worth $1 each, a 1-for-10 reverse split would turn your 100 shares into 10 shares worth $10 each. Companies often do this to boost their stock price and appear more stable to investors.
contingent consideration financial
"recorded a liability for contingent consideration in the form of shares of common stock and warrants to purchase common stock"
Contingent consideration is an additional payment agreed when one company buys another that will be paid later only if specific future targets are met, such as revenue, profit, or regulatory milestones. It matters to investors because it shifts risk between buyer and seller and affects the acquiring company's future cash flow and reported value — like promising a bonus after results are proven.
restricted stock units financial
"The Company had potentially dilutive securities as of March 31, 2026, consisting of: (i) 113,828 restricted stock units"
Restricted stock units are a type of company reward where employees are promised shares of stock, but they only fully own these shares after meeting certain conditions, like staying with the company for a set time. They matter because they can become valuable assets and are often used to motivate employees to help the company succeed.
Emergency Use Authorization regulatory
"we obtained Emergency Use Authorization (“EUA”) for our Logix Smart COVID-19 detection test from the FDA"
A regulatory emergency use authorization allows a government health agency to temporarily permit the use or sale of a medical product—such as a vaccine, test, or treatment—before full formal approval when there is a public health crisis. For investors, an authorization can rapidly open revenue and market access while carrying higher regulatory and demand risk, like a fast-track pass that speeds a product to customers but may still require further review and can affect a company's valuation and future sales prospects.
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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 March 31, 2026

 

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 May 12, 2026, there were 3,602,465 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)

 

  

March 31, 2026

  

December 31, 2025

 
Assets          
Current assets          
Cash and cash equivalents  $8,230,984   $11,884,607 
Accounts receivable, net   82,339    190,375 
Inventory, net   846,119    992,397 
Income taxes receivable   49    44,559 
Prepaid expenses and other current assets   622,760    581,527 
Total current assets   9,782,251    13,693,465 
Property and equipment, net   2,158,670    2,272,098 
Operating lease right-of-use asset   2,002,597    1,207,453 
Intangible assets, net   7,219,000    7,219,000 
Investment in joint ventures   337,208    350,569 
Total assets  $21,499,726   $24,742,585 
Liabilities and stockholders’ equity          
Current liabilities          
Accounts payable  $2,017,852   $1,878,225 
Accrued expenses   1,364,754    865,301 
Operating lease liability, current   857,638    662,258 
Contingent consideration liabilities, current   43,756    119,036 
Deferred revenue   600    14,800 
Total current liabilities   4,284,600    3,539,620 
Long-term liabilities          
Operating lease liability   1,172,716    574,301 
Total long-term liabilities   1,172,716    574,301 
Total liabilities   5,457,316    4,113,921 
Commitments and contingencies (Note 10)   -    - 
Stockholders’ equity          
Convertible preferred stock, $0.001 par value; 5,000,000 shares authorized; 0 shares issued and outstanding as of March 31, 2026 and December 31, 2025, respectively   -    - 
Common stock, $0.001 par value; 100,000,000 shares authorized; 3,764,088 shares issued and 3,602,465 shares outstanding as of March 31, 2026 and 2,256,654 shares issued and 2,095,031 shares outstanding as of December 31, 2025   69,207    67,700 
Treasury stock, at cost; 161,623 shares held as of March 31, 2026 and December 31, 2025, respectively   (15,575,795)   (15,575,795)
Additional paid-in capital   121,062,575    116,510,298 
Accumulated deficit   (89,513,577)   (80,373,539)
Total stockholders’ equity   16,042,410    20,628,664 
Total liabilities and stockholders’ equity  $21,499,726   $24,742,585 

 

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 
  

Three Months Ended

March 31,

 
   2026   2025 
Product revenue  $145,954   $50,277 
Total revenue   145,954    50,277 
Cost of revenue   193,768    21,590 
Gross profit (loss)   (47,814)   28,687 
Operating expenses          
Sales and marketing   467,955    657,030 
General and administrative   2,503,126    2,773,149 
Research and development   5,934,071    4,870,019 
Depreciation and amortization   255,445    280,445 
Total operating expenses   9,160,597    8,580,643 
Loss from operations   (9,208,411)   (8,551,956)
Other income, net          
Interest income, net   6,974    13,601 
Realized gain on investments   -    301,465 
Gain on remeasurement of acquisition contingencies   75,280    717,067 
Loss on equity method investment in joint ventures   (13,361)   (1,444)
Total other income, net   68,893    1,030,689 
Loss before income taxes   (9,139,518)   (7,521,267)
Income tax provision   520    12,004 
Net loss  $(9,140,038)  $(7,533,271)
Other comprehensive income (loss)          
Change in net unrealized gains (losses) on marketable securities, net of tax   -    (87,790)
Total other comprehensive income (loss)  $-   $(87,790)
Comprehensive loss  $(9,140,038)  $(7,621,061)
           
Loss per common share:          
Basic and Diluted  $(4.06)  $(7.05)
Weighted average shares outstanding:          
Basic and Diluted   

2,253,474

    

1,068,299

 

 

 

See accompanying notes to unaudited condensed consolidated financial statements

 

4

 

 

CO – DIAGNOSTICS, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

 

   2026   2025 
  

Three Months Ended

March 31,

 
   2026   2025 
Cash flows from operating activities          
Net loss  $(9,140,038)  $(7,533,271)
Adjustments to reconcile net loss to cash used in operating activities:          
Depreciation and amortization   255,445    280,445 
Stock-based compensation expense   219,114    875,228 
Change in fair value of acquisition contingencies   (75,280)   (717,067)
Non-cash lease expense   (1,349)   438 
Realized gain on investments   -    (301,465)
Loss from equity method investment   13,361    1,444 
Provision for credit losses   4,164    4,143 
Inventory obsolescence recoveries   (27,884)   (37,321)
Changes in assets and liabilities:          
Accounts receivable   103,872    (7,964)
Prepaid expenses and other assets   3,277    205,907 
Inventory   174,162    26,736 
Deferred revenue   (14,200)   - 
Income taxes payable   -    11,484 
Accounts payable, accrued expenses and other liabilities   639,080    (1,553,951)
Net cash used in operating activities   (7,846,276)   (8,745,214)
Cash flows from investing activities          
Purchases of property and equipment   (142,017)   (91,913)
Proceeds from maturities of marketable investment securities   -    13,893,675 
Purchases of marketable securities   -    (6,444,804)
Net cash (used in) provided by investing activities   (142,017)   7,356,958 
Cash flows from financing activities          
Issuance of common stock related to at-the-market offering, net of offering costs   4,334,670    354,746 
Net cash provided by financing activities   4,334,670    354,746 
Net decrease in cash and cash equivalents   (3,653,623)   (1,033,510)
Cash and cash equivalents at beginning of period   11,884,607    2,936,544 
Cash and cash equivalents at end of period  $8,230,984   $1,903,034 
Supplemental disclosure of cash flow information          
           
Cash received for income taxes  $46,136  $- 
Supplemental disclosure of non-cash investing and financing transactions          
           
Right-of-use assets obtained in exchange for new operating lease liabilities  $1,029,215   $- 

 

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 Earnings   Total Stockholders’ 
   Shares   Amount   Shares   Amount   Stock   Capital   Income   (Deficit)   Equity 
Balance as of December 31, 2025   -    -    2,256,654    67,700    (15,575,795)   116,510,298    -    (80,373,539)   20,628,664 
Issuance of common stock related to at-the-market offering, net of offering costs   -    -    1,507,434    1,507    -    4,333,163    -    -    4,334,670 
Stock-based compensation   -    -    -    -    -    219,114    -    -    219,114 
Net loss   -    -    -    -    -    -    -    (9,140,038)   (9,140,038)
Balance as of March 31, 2026   -   $-    3,764,088   $69,207   $(15,575,795)  $121,062,575   $-   $(89,513,577)  $16,042,410 

 

   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   -   $-    1,263,408   $37,902   $(15,575,795)  $102,472,210   $418,443   $(33,477,603)  $53,875,157 
Issuance of common stock related to at-the-market offering, net of offering costs   -    -    17,303    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   -    -    1,280,711    38,421    (15,575,795)   103,701,665    330,653    (41,010,874)   47,484,070 

 

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 months ended March 31, 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 March 31, 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 March 31, 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 doubtful accounts 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 March 31, 2026 total accounts receivable was $126,881 with an allowance for uncollectable accounts of $44,542 resulting in a net amount of $82,339. At December 31, 2025 total accounts receivable was $230,752 with an allowance for uncollectable accounts of $40,377 resulting in a net amount of $190,375. 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.

 

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 March 31, 2026, the Company had $846,119 in net inventory, of which $358,209 was finished goods and $487,910 was raw materials. At December 31, 2025, the Company had $992,397 in net inventory, of which $512,186 was finished goods and $480,211 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 $154,989 and $41,174 related to the change in inventory reserves during the three months ended March 31, 2026 and 2025, 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.

 

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.

 

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 months ended March 31, 2026 and 2025. Five customers accounted for approximately 84% of product revenue recognized during the three months ended March 31, 2026. Three customers accounted for approximately 59% of product revenue recognized during the three months ended March 31, 2025.

 

9

 

 

Two customers accounted for more than 10% of accounts receivable at March 31, 2026, and two customers accounted for more than 10% of accounts receivable at December 31, 2025. These customers together accounted for approximately 49% and 82% of accounts receivable at March 31, 2026 and December 31, 2025, 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 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, 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:

 

   March 31, 2026 
   Adjusted Cost   Total Unrealized Gains / (Losses)   Fair Value   Cash and Cash Equivalents   Marketable Investment Securities 
Cash  $8,230,984   $-   $8,230,984   $8,230,984   $- 
Total  $8,230,984   $-   $8,230,984   $8,230,984   $- 

 

   December 31, 2025 
   Adjusted Cost   Total Unrealized Gains / (Losses)   Fair Value   Cash and Cash Equivalents   Marketable Investment Securities 
Cash  $11,884,607   $-   $11,884,607   $11,884,607   $- 
Total  $11,884,607   $-   $11,884,607   $11,884,607   $- 

 

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 March 31, 2026 and December 31, 2025, by level within the fair value hierarchy:

 

   (Level 1)   (Level 2)   (Level 3)   Total 
   March 31, 2026 
   (Level 1)   (Level 2)   (Level 3)   Total 
Liabilities:                    
Contingent consideration - common stock  $-   $-   $43,756   $43,756 
Total liabilities measured at fair value  $-   $-   $43,756   $43,756 

 

                 
   December 31, 2025 
   (Level 1)   (Level 2)   (Level 3)   Total 
Liabilities:                    
Contingent consideration - common stock  $-   $-   $119,036   $119,036 
Total liabilities measured at fair value  $-   $-   $119,036   $119,036 

 

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:

 

      
Fair value as of December 31, 2025  $119,036 
Change in fair value of contingent consideration issued for business acquisitions   (75,280)
Fair value as of March 31, 2026  $43,756 

 

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:

 

   March 31,
2026
   December 31,
2025
 
Stock price  $1.86   $5.10 
Strike price  $273.75   $273.75 
Volatility   16.3%   21.4%
Risk-free rate   3.7%   3.5%
Expected term (years)   0.8    1.0 

 

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:

 

   March 31, 2026
   Weighted-Average  Gross       Net 
   Useful Life  Carrying   Accumulated   Carrying 
   (in Years)  Amount   Amortization   Amount 
In-process research and development  Indefinite  $7,219,000   $-   $7,219,000 
Total intangible assets     $7,219,000   $-  $7,219,000 

 

   December 31, 2025
   Weighted-Average  Gross       Net 
   Useful Life  Carrying   Accumulated   Carrying 
   (in Years)  Amount   Amortization   Amount 
In-process research and development  Indefinite  $7,219,000   $-   $7,219,000 
Total intangible assets     $7,219,000   $-  $7,219,000 

 

12

 

 

Note 6 – Revenue

 

The following table sets forth revenue by geographic area:

 

   2026   2025 
  

Three Months Ended

March 31,

 
   2026   2025 
United States          
Product revenue  $81,054   $40,177 
Grant revenue   -    - 
Total United States   81,054    40,177 
Rest of World          
Product revenue   64,900    10,100 
Grant revenue   -    - 
Total Rest of World   64,900    10,100 
Total  $145,954   $50,277 
Percentage of revenue by area:          
United States   56%   80%
Rest of World   44%   20%

 

Changes in the Company’s deferred revenue balance for the three months ended March 31, 2026 were as follows:

 

Balance as of December 31, 2025  $14,800 
Revenue recognized included in deferred revenue balance at the beginning of the period   (14,800)
Increase due to prepayments from customers   600 
Balance as of March 31, 2026  $600 

 

Note 7 – Loss Per Share

 

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.

 

The following table reconciles the numerator and the denominator used to calculate basic and diluted loss per share for three months ended March 31, 2026 and 2025, respectively:

 

       
  

Three Months Ended

March 31,

 
   2026   2025 
Numerator          
Net loss, as reported  $(9,140,038)  $(7,533,271)
           
Denominator          
Weighted average shares, basic   2,253,474    1,068,299 
Dilutive effect of stock options, warrants and RSUs   -    - 
Shares used to compute diluted loss per share   2,253,474    1,068,299 
           
Loss per share, basic and diluted  $(4.06)  $(7.05)

 

13

 

 

The computation of diluted loss per share for the three months ended March 31, 2026 and 2025, respectively, also excludes approximately 47,000 shares of common stock and 15,500 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 months ended March 31, 2026 and 2025, 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 March 31, 2026, consisting of: (i) 113,828 restricted stock units and (ii) 30,009 options and warrants. The Company had potentially dilutive securities as of March 31, 2025, consisting of: (i) 90,081 restricted stock units and (ii) 31,282 options and warrants.

 

Note 8 – Stock-Based Compensation

 

Reverse Stock Split

 

On January 1, 2026, the Company effected a 1-for-30 reverse stock split of its common stock. The Reverse Stock Split did not change the par value of the Company’s common stock, which remains $0.001 per share, nor did it change the number of authorized shares of common stock.

 

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.

 

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 400,000 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 223,333 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 March 31, 2026, the number of awards available for issuance under the 2025 Plan was 250,747, including unused awards which rolled over from the 2015 Incentive Plan upon its expiration. No awards have been made under the 2025 Plan.

 

Stock Options

 

The following table summarizes option activity during the three months ended March 31, 2026:

 

   Number of Options   Weighted Average Exercise Price   Weighted Average Fair Value   Weighted Average Remaining Contractual Life (Years) 
Outstanding at December 31, 2025   31,603   $68.91   $43.05    3.14 
Granted   -    -    -      
Expired   (2,981)  $24.19   $15.00      
Forfeited/Cancelled   -    -    -      
Exercised   -    -    -      
Outstanding at March 31, 2026   28,622   $73.57   $45.97    3.04 
                     
Exercisable at March 31, 2026   28,622   $73.57   $45.97    3.04 

 

The aggregate intrinsic value of outstanding options at March 31, 2026 and 2025 was approximately $0.

 

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 March 31, 2026, 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 three months ended March 31, 2026:

 

   Number of RSUs   Weighted Average Grant Date Fair Value 
Unvested at December 31, 2025   114,025   $34.51 
Granted   -    - 
Vested   -    - 
Forfeited/Cancelled   (833)   7.58 
Unvested at March 31, 2026   113,192   $34.71 

 

As of March 31, 2026, there was approximately $2,270,853 of unrecognized stock-based compensation expense related to outstanding RSUs which is expected to be recognized over a weighted-average period of 2.2 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 three months ended March 31, 2026:

 

   Number of Warrants   Weighted Average Exercise Price   Weighted Average Fair Value   Weighted Average Remaining Contractual Life (Years) 
Outstanding at December 31, 2025   15,500   $273.75   $-    1.0 
Granted   -    -    -      
Expired   -    -    -      
Forfeited/Cancelled   -    -    -      
Exercised   -    -    -      
Outstanding at March 31, 2026   15,500   $273.75   $-    0.8 

 

The aggregate intrinsic value of outstanding warrants at March 31, 2026 was $0.

 

15

 

 

There are no warrants exercisable at March 31, 2026. The ability to exercise the 15,500 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:

 

   2026   2025 
   Three Months Ended March 31, 
   2026   2025 
Sales and marketing  $31,420   $136,197 
General and administrative   221,101    735,915 
Research and development   (33,407)   3,116 
Total stock-based compensation expense  $219,114   $875,228 

 

Note 9 – Income Taxes

 

For the three months ended March 31, 2026, the Company recognized expense from income taxes of $520, representing an effective tax rate of 0.0%. 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 months ended March 31, 2025, the Company recognized expense from income taxes of $12,004.

 

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:

 

   2026   2025 
   Three Months Ended March 31, 
   2026   2025 
Operating lease costs  $261,687   $258,065 
Total lease costs  $261,687   $258,065 

 

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As of March 31, 2026, the maturities of the Company’s lease liabilities are as follows:

 

   Years Ending December 31, 
2026 (remainder)  $775,605 
2027   691,311 
2028   710,904 
Thereafter   - 
 Total lease payments   2,177,820 
 Less: imputed interest   147,466 
 Present value of operating lease liabilities   2,030,354 
 Less: current portion   857,638 
 Long-term portion  $1,172,716 

 

Other information related to operating leases was as follows:

 

 

   Three Months Ended March 31, 2026 
Cash paid for operating leases included in operating cash flows  $263,035 
Remaining lease term of operating leases   2.5 
Discount rate of operating leases   5.9%

 

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 suit claiming that the Company overstated the demand for its Logix Smart COVID-19 test and that the plaintiffs suffered losses when the Company’s stock dropped after the Company disclosed its financial results. 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 one civil action 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. The Company was previously a party to two commercial lawsuits, one in the Third Judicial District Court, Salt Lake County, Utah against Hukui Technology, Inc., and another in the United Kingdom against Pantheon International Advisors, Ltd. In March 2026, the Company received a 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. In addition, on March 31, 2026, the Company entered into a settlement agreement with Pantheon International Advisors Ltd. to fully resolve all disputes, including related proceedings in the United Kingdom. Under the terms of the agreement, the Company agreed to pay $140,000, and the parties agreed to dismiss all claims with prejudice and exchange mutual releases.

 

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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 months ended March 31, 2026.

 

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 December 31, 2025, the Company had sold 151,675 shares of common stock under the Prior ATM Agreement, resulting in net proceeds to the Company of $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 $10,000,000, 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. As of March 31, 2026, the Company had sold 1,539,101 shares of common stock under the Agreement, resulting in net proceeds to the Company of approximately $4,593,234.

 

The Company’s shelf Registration Statement on Form S-3 expired on April 6, 2026, and, as a result, the Company is no longer able to offer or sell shares under the Agreement unless and until a new registration statement is filed with and declared effective by the Securities and Exchange Commission. Accordingly, no further sales may be made under the ATM program at this time.

 

Note 13 – 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 $226,396 and $240,103 of expense related to this agreement during the three months ended March 31, 2026 and 2025, respectively.

 

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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, COVID-19, RSV multiplex test (“ABCR”). Moving focus to this test allows the Company to incorporate more recent Co-Dx PCR platform developments into the design and test manufacturing process. Management believes that a multiplex test targeting influenza A/B, COVID-19, and RSV better aligns with current clinical demand for comprehensive upper respiratory infection testing in point-of-care settings. Accordingly, clinical performance studies for the ABCR test are currently underway. 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.

 

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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.

 

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RESULTS OF OPERATIONS

 

The Three Months Ended March 31, 2026 Compared to the Three Months ended March 31, 2025

 

Revenues

 

For the three months ended March 31, 2026, we generated revenues of $0.1 million, compared to revenues of $0.1 million for the three months ended March 31, 2025.

 

Cost of Revenues

 

We recorded cost of revenues of approximately $0.2 million for the three months ended March 31, 2026, compared to approximately $22,000 for the three months ended March 31, 2025. Included within cost of revenues is a decrease of approximately $0.2 million for the three months ended March 31, 2026, and a decrease of approximately $41,000 for the three months ended March 31, 2025, related to reserves against certain raw materials and finished goods inventories.

 

Expenses

 

Total operating expenses for the three months ended March 31, 2026 were $9.2 million, compared to total operating expenses of $8.6 million for the three months ended March 31, 2025. The increase in operating expenses was primarily due to expenses related to clinical trials for the Co-Dx PCR platform and increased legal expense and professional services expense, partially offset by decreased stock-based compensation expense.

 

Sales and marketing expenses for the three months ended March 31, 2026 were $0.5 million, compared to $0.7 million for the three months ended March 31, 2025. The decrease was primarily a result of decreased stock-based compensation expense and decreased tradeshow and travel expense.

 

General and administrative expenses for the three months ended March 31, 2026 were $2.5 million, compared to $2.8 million for the three months ended March 31, 2025. The decrease resulted primarily from decreased personnel related expense and stock-based compensation expense, partially offset by increased legal and professional services expense.

 

Research and development expenses for the three months ended March 31, 2026 were $5.9 million, compared to $4.9 million for the three months ended March 31, 2025. The increase was primarily a result of expenses related to clinical trials for the Co-Dx PCR platform, partially offset by decreased personnel related expense.

 

Other Income

 

Other income for the three months ended March 31, 2026 was $0.1 million, compared to other income of $1.0 million for the three months ended March 31, 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 three months ended March 31, 2026 was $9.1 million, compared to $7.5 million for the three months ended March 31, 2025. The larger net loss was primarily the result of higher operating expenses and decreased other income, including changes in the fair value of contingent consideration liabilities and decreased realized gains on investments.

 

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Liquidity and Capital Resources

 

At March 31, 2026, we had cash and cash equivalents of $8.2 million. Additionally, our total current assets at March 31, 2026, were $9.8 million compared to total current liabilities of $4.3 million.

 

Net cash used in operating activities during the three months ended March 31, 2026 was $7.8 million, compared to $8.7 million for the three months ended March 31, 2025. The decrease in cash used in operating activities was primarily due to a lower usage of cash to pay accounts payable and accrued liabilities from the end of the previous year.

 

Net cash used in investing activities was $0.1 million for the three months ended March 31, 2026, compared to cash provided by investing activities of $7.4 million during the three months ended March 31, 2025. The decrease in cash provided by investing activities is primarily due to proceeds from redemption less purchases of investments during the prior year.

 

Net cash provided by financing activities was $4.3 million for the three months ended March 31, 2026, compared to $0.4 million for the three months ended March 31, 2025. The cash provided by financing activities during 2026 relates to issuances of common stock under the ATM.

 

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.

 

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 March 31, 2026. Based on the evaluation of our disclosure controls and procedures as of March 31, 2026, 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 March 31, 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

 

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, 2025.

 

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.

 

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Item 6. Exhibits

 

Exhibit Index

 

(a) Exhibits

 

Exhibit   Number Description
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.

 

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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: May 14, 2026 By: /s/ Dwight H. Egan
  Name: Dwight H. Egan
  Title: Chief Executive Officer and Principal Executive Officer
     
Date: May 14, 2026 By: /s/ Brian Brown
  Name: Brian Brown
  Title: Chief Financial Officer and Principal Financial and Accounting Officer

 

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FAQ

How did Co-Diagnostics (CODX) perform financially in Q1 2026?

Co-Diagnostics posted Q1 2026 revenue of $145,954 and a net loss of $9.14 million. Operating expenses rose to $9.16 million, and cost of revenue exceeded sales, leading to a negative gross margin and continued significant operating losses.

What is Co-Diagnostics (CODX) cash position and burn rate as of March 31, 2026?

At March 31, 2026, Co-Diagnostics held $8.23 million in cash and cash equivalents. During Q1 2026 it used $7.85 million in operating cash, indicating a high burn rate that significantly reduces available liquidity without additional financing.

Did Co-Diagnostics (CODX) issue a going concern warning in this 10-Q?

Yes. Management concluded that substantial doubt exists about Co-Diagnostics’ ability to continue as a going concern for 12 months from issuance. This reflects reliance on obtaining new capital, reducing expenditures, and achieving profitable operations, none of which are assured.

How is Co-Diagnostics (CODX) funding operations given ongoing losses?

Co-Diagnostics is funding operations through existing cash and equity issuance. In Q1 2026 it raised $4.33 million net via an at-the-market equity program, but the underlying shelf registration has since expired, limiting further ATM sales until a new registration is effective.

What were Co-Diagnostics (CODX) research and development expenses in Q1 2026?

Research and development expenses were $5.93 million in Q1 2026, up from $4.87 million a year earlier. The increase mainly reflects clinical trial costs for the Co-Dx PCR platform, as the company continues investing heavily in its diagnostic technology pipeline.

How many Co-Diagnostics (CODX) shares are outstanding after the reverse split?

Following a 1-for-30 reverse stock split effective January 1, 2026, Co-Diagnostics reported 3,602,465 common shares outstanding as of May 12, 2026. All share and per-share data in the filing have been retroactively adjusted to reflect this reverse split.