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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 June 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 August 12, 2025, there were 38,523,582
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 |
PART
I. FINANCIAL INFORMATION
Item
1. Financial Statements
CO
– DIAGNOSTICS, INC. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED BALANCE SHEETS
(Unaudited)
| |
June 30, 2025 | | |
December 31, 2024 | |
Assets | |
| | | |
| | |
Current assets | |
| | | |
| | |
Cash and cash equivalents | |
$ | 11,115,181 | | |
$ | 2,936,544 | |
Marketable investment securities | |
| 2,247,638 | | |
| 26,811,098 | |
Accounts receivable, net | |
| 210,968 | | |
| 132,570 | |
Inventory, net | |
| 1,084,627 | | |
| 1,072,724 | |
Prepaid expenses and other current assets | |
| 648,752 | | |
| 1,338,762 | |
Total current assets | |
| 15,307,166 | | |
| 32,291,698 | |
Property and equipment, net | |
| 2,673,390 | | |
| 2,761,280 | |
Operating lease right-of-use asset | |
| 1,668,416 | | |
| 2,114,876 | |
Intangible assets, net | |
| 26,101,000 | | |
| 26,101,000 | |
Investment in joint venture | |
| 715,861 | | |
| 731,065 | |
Total assets | |
$ | 46,465,833 | | |
$ | 63,999,919 | |
Liabilities and stockholders’ equity | |
| | | |
| | |
Current liabilities | |
| | | |
| | |
Accounts payable | |
$ | 1,635,196 | | |
$ | 3,294,254 | |
Accrued expenses | |
| 1,008,127 | | |
| 2,562,169 | |
Operating lease liability, current | |
| 824,458 | | |
| 915,619 | |
Contingent consideration liabilities, current | |
| 197,610 | | |
| 502,819 | |
Deferred revenue | |
| 45,857 | | |
| 40,857 | |
Total current liabilities | |
| 3,711,248 | | |
| 7,315,718 | |
Long-term liabilities | |
| | | |
| | |
Income taxes payable | |
| 736,933 | | |
| 713,643 | |
Operating lease liability | |
| 879,258 | | |
| 1,236,560 | |
Contingent consideration liabilities | |
| - | | |
| 422,080 | |
Total long-term liabilities | |
| 1,616,191 | | |
| 2,372,283 | |
Total liabilities | |
| 5,327,439 | | |
| 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 June 30, 2025 and December 31, 2024, respectively | |
| - | | |
| - | |
Common stock, $0.001 par value; 100,000,000 shares authorized; 41,031,146 shares issued and 36,182,468 shares outstanding as of June 30, 2025 and 37,902,222 shares issued and 33,053,544 shares outstanding as of December 31, 2024 | |
| 41,031 | | |
| 37,902 | |
Treasury stock, at cost; 4,848,678 shares held as of June 30, 2025 and December 31, 2024, respectively | |
| (15,575,795 | ) | |
| (15,575,795 | ) |
Additional paid-in capital | |
| 104,843,320 | | |
| 102,472,210 | |
Accumulated other comprehensive income | |
| 134,068 | | |
| 418,443 | |
Accumulated deficit | |
| (48,304,230 | ) | |
| (33,040,842 | ) |
Total stockholders’ equity | |
| 41,138,394 | | |
| 54,311,918 | |
Total liabilities and stockholders’ equity | |
$ | 46,465,833 | | |
$ | 63,999,919 | |
See
accompanying notes to unaudited condensed consolidated financial statements
CO
– DIAGNOSTICS, INC. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(Unaudited)
| |
2025 | | |
2024 | | |
2025 | | |
2024 | |
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2025 | | |
2024 | | |
2025 | | |
2024 | |
Product revenue | |
$ | 162,910 | | |
$ | 161,102 | | |
$ | 213,187 | | |
$ | 413,847 | |
Grant revenue | |
| - | | |
| 2,495,738 | | |
| - | | |
| 2,710,847 | |
Total revenue | |
| 162,910 | | |
| 2,656,840 | | |
| 213,187 | | |
| 3,124,694 | |
Cost of revenue | |
| 32,106 | | |
| 212,148 | | |
| 53,696 | | |
| 446,653 | |
Gross profit | |
| 130,804 | | |
| 2,444,692 | | |
| 159,491 | | |
| 2,678,041 | |
Operating expenses | |
| | | |
| | | |
| | | |
| | |
Sales and marketing | |
| 609,713 | | |
| 1,041,243 | | |
| 1,266,743 | | |
| 2,604,925 | |
General and administrative | |
| 2,599,982 | | |
| 3,132,385 | | |
| 5,373,131 | | |
| 6,051,188 | |
Research and development | |
| 4,687,459 | | |
| 5,612,691 | | |
| 9,557,478 | | |
| 11,292,369 | |
Depreciation and amortization | |
| 291,414 | | |
| 338,335 | | |
| 571,859 | | |
| 668,908 | |
Total operating expenses | |
| 8,188,568 | | |
| 10,124,654 | | |
| 16,769,211 | | |
| 20,617,390 | |
Loss from operations | |
| (8,057,764 | ) | |
| (7,679,962 | ) | |
| (16,609,720 | ) | |
| (17,939,349 | ) |
Other income, net | |
| | | |
| | | |
| | | |
| | |
Interest income, net | |
| 12,158 | | |
| 342,188 | | |
| 25,759 | | |
| 704,921 | |
AGÕæÈ˹ٷ½ized gain on investments | |
| 340,358 | | |
| 74,165 | | |
| 641,823 | | |
| 302,235 | |
Gain (loss) on disposition of assets | |
| (9,004 | ) | |
| 3,500 | | |
| (9,004 | ) | |
| 3,500 | |
Gain (loss) on remeasurement of acquisition contingencies | |
| 10,222 | | |
| (244,116 | ) | |
| 727,289 | | |
| 206,144 | |
Loss on equity method investment in joint venture | |
| (13,760 | ) | |
| (74,503 | ) | |
| (15,204 | ) | |
| (145,458 | ) |
Total other income, net | |
| 339,974 | | |
| 101,234 | | |
| 1,370,663 | | |
| 1,071,342 | |
Income tax provision | |
| 12,327 | | |
| 20,590 | | |
| 24,331 | | |
| 43,354 | |
Net loss | |
$ | (7,730,117 | ) | |
$ | (7,599,318 | ) | |
$ | (15,263,388 | ) | |
$ | (16,911,361 | ) |
Other comprehensive income (loss) | |
| | | |
| | | |
| | | |
| | |
Change in net unrealized gains (losses) on marketable securities, net of tax | |
| (196,585 | ) | |
| 144,653 | | |
| (284,375 | ) | |
| 224,508 | |
Total other comprehensive income (loss) | |
$ | (196,585 | ) | |
$ | 144,653 | | |
$ | (284,375 | ) | |
$ | 224,508 | |
Comprehensive loss | |
$ | (7,926,702 | ) | |
$ | (7,454,665 | ) | |
$ | (15,547,763 | ) | |
$ | (16,686,853 | ) |
| |
| | | |
| | | |
| | | |
| | |
Loss per common share: | |
| | | |
| | | |
| | | |
| | |
Basic and Diluted | |
$ | (0.23 | ) | |
$ | (0.25 | ) | |
$ | (0.47 | ) | |
$ | (0.56 | ) |
Weighted average shares outstanding: | |
| | | |
| | | |
| | | |
| | |
Basic and Diluted | |
| 33,108,399 | | |
| 30,124,696 | | |
| 32,581,603 | | |
| 29,983,785 | |
See
accompanying notes to unaudited condensed consolidated financial statements
CO
– DIAGNOSTICS, INC. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
| |
2025 | | |
2024 | |
| |
Six Months Ended June 30, | |
| |
2025 | | |
2024 | |
Cash flows from operating activities | |
| | | |
| | |
Net loss | |
$ | (15,263,388 | ) | |
$ | (16,911,361 | ) |
Adjustments to reconcile net loss to cash used in operating activities: | |
| | | |
| | |
Depreciation and amortization | |
| 571,859 | | |
| 668,908 | |
Stock-based compensation expense | |
| 1,455,493 | | |
| 3,070,892 | |
Common stock issued for financial advisory services | |
| 135,000 | | |
| - | |
Change in fair value of acquisition contingencies | |
| (727,289 | ) | |
| (206,144 | ) |
Non-cash lease expense | |
| (2,003 | ) | |
| 10,613 | |
AGÕæÈ˹ٷ½ized gain on investments | |
| (641,823 | ) | |
| (302,235 | ) |
Loss from equity method investment | |
| 15,204 | | |
| 145,458 | |
(Gain) loss on disposition of assets | |
| 9,004 | | |
| (3,500 | ) |
Provision for (recoveries of) credit losses | |
| (13,248 | ) | |
| (40,944 | ) |
Inventory obsolescence expense (recovery) | |
| (95,302 | ) | |
| 84,430 | |
Changes in assets and liabilities: | |
| | | |
| | |
Accounts receivable | |
| (65,150 | ) | |
| (206,634 | ) |
Prepaid expenses and other assets | |
| 690,010 | | |
| 299,970 | |
Inventory | |
| 83,399 | | |
| 116,335 | |
Deferred revenue | |
| 5,000 | | |
| (141,519 | ) |
Income taxes payable | |
| 23,290 | | |
| 39,927 | |
Accounts payable, accrued expenses and other liabilities | |
| (3,213,100 | ) | |
| (318,728 | ) |
Net cash used in operating activities | |
| (17,033,044 | ) | |
| (13,694,532 | ) |
Cash flows from investing activities | |
| | | |
| | |
Purchases of property and equipment | |
| (492,973 | ) | |
| (500,922 | ) |
Proceeds from maturities of marketable investment securities | |
| 31,509,485 | | |
| 26,836,743 | |
Net cash provided by investing activities | |
| 24,427,935 | | |
| 12,636,520 | |
Cash flows from financing activities | |
| | | |
| | |
Issuance of common stock related to at-the-market offering, net of offering costs | |
| 783,746 | | |
| - | |
Net cash provided by financing activities | |
| 783,746 | | |
| - | |
Net increase (decrease) in cash and cash equivalents | |
| 8,178,637 | | |
| (1,058,012 | ) |
Cash and cash equivalents at beginning of period | |
| 2,936,544 | | |
| 14,916,878 | |
Cash and cash equivalents at end of period | |
$ | 11,115,181 | | |
$ | 13,858,866 | |
Supplemental disclosure of cash flow information | |
| | | |
| | |
Income taxes paid | |
$ | - | | |
$ | 800 | |
See
accompanying notes to unaudited condensed consolidated financial statements
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, 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 | |
| |
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 | |
Balance | |
| - | | |
| - | | |
| 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 | |
Other comprehensive income (loss), 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 | |
See
accompanying notes to unaudited condensed consolidated financial statements
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 six months ended June 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 June 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, including through selling shares under the Company’s ATM Agreement, 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.
The
condensed consolidated financial statements as of June 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 June 30, 2025 total accounts receivable was $297,991 with an allowance for uncollectable
accounts of $87,023 resulting in a net amount of $210,968. 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 June 30, 2025, the Company had $1,084,627 in net inventory, of which $601,756 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 $59,591 and $101,065 related to the change in inventory reserves during
the three and six months ended June 30, 2025, respectively, compared to $24,333 and $287,006 during the three and six months ended June
30, 2024, respectively.
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 six months ended June 30, 2025, respectively, compared to $2,495,738
and $2,710,847 during the three and six months ended June 30, 2024, respectively. At June 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, 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 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 six months ended June 30, 2025 and 2024. Three customers accounted for approximately 53%
of product revenue recognized during the three months ended June 30, 2025. Three customers accounted for approximately 41%
of product revenue recognized during the six months ended June 30, 2025. Two customers accounted for approximately 37%
of product revenue, and two granting agencies accounted for approximately 94%
of grant revenue recognized during the three months ended June 30, 2024. One customer accounted for approximately 29%
of product revenue, and two granting agencies accounted for approximately 95%
of grant revenue recognized during the six months ended June 30, 2024.
Three
customers individually accounted for more than 10% of accounts receivable at June 30, 2025 and two customers individually accounted for
more than 10% of accounts receivable at December 31, 2024. These customers together accounted for approximately 82% and 94% of accounts
receivable at June 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.
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
| |
June 30, 2025 | |
| |
Adjusted Cost | | |
Total Unrealized Gains / (Losses) | | |
Fair Value | | |
Cash and Cash Equivalents | | |
Marketable Investment Securities | |
Cash | |
$ | 11,115,181 | | |
$ | - | | |
$ | 11,115,181 | | |
$ | 11,115,181 | | |
$ | - | |
Level 2: | |
| | | |
| | | |
| | | |
| | | |
| | |
U.S. treasury securities | |
| 2,113,570 | | |
| 134,068 | | |
| 2,247,638 | | |
| - | | |
| 2,247,638 | |
Subtotal | |
| 2,113,570 | | |
| 134,068 | | |
| 2,247,638 | | |
| - | | |
| 2,247,638 | |
Total | |
$ | 13,228,751 | | |
$ | 134,068 | | |
$ | 13,362,819 | | |
$ | 11,115,181 | | |
$ | 2,247,638 | |
| |
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 | |
Marketable
investment securities held as of June 30, 2025 mature over the next 12 months.
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 June 30, 2025 and December 31,
2024, by level within the fair value hierarchy:
Schedule of Fair Value Assets and Liabilities
| |
(Level 1) | | |
(Level 2) | | |
(Level 3) | | |
Total | |
| |
June 30, 2025 | |
| |
(Level 1) | | |
(Level 2) | | |
(Level 3) | | |
Total | |
Assets: | |
| | | |
| | | |
| | | |
| | |
Cash equivalents | |
$ | 10,301,832 | | |
$ | - | | |
$ | - | | |
$ | 10,301,832 | |
Marketable securities (U.S. treasury bills and notes) | |
| - | | |
| 2,247,638 | | |
| - | | |
| 2,247,638 | |
Total assets measured at fair value | |
$ | 10,301,832 | | |
$ | 2,247,638 | | |
$ | - | | |
$ | 12,549,470 | |
Liabilities: | |
| | | |
| | | |
| | | |
| | |
Contingent consideration - common stock | |
$ | - | | |
$ | - | | |
$ | 197,610 | | |
$ | 197,610 | |
Contingent consideration - warrants | |
| - | | |
| - | | |
| - | | |
| - | |
Total liabilities measured at fair value | |
$ | - | | |
$ | - | | |
$ | 197,610 | | |
$ | 197,610 | |
| |
(Level 1) | | |
(Level 2) | | |
(Level 3) | | |
Total | |
| |
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 June 30, 2025 and 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 | |
| (727,289 | ) |
Fair value as of June 30, 2025 | |
$ | 197,610 | |
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
| |
June 30, 2025 | | |
December 31, 2024 | |
Stock price | |
$ | 0.28 | | |
$ | 0.75 | |
Strike price | |
$ | 9.13 | | |
$ | 9.13 | |
Volatility | |
| 332.5 | % | |
| 246.4 | % |
Risk-free rate | |
| 3.8 | % | |
| 4.3 | % |
Expected term (years) | |
| 1.5 | | |
| 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
| |
June 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 | |
Note
6 – Revenue
The
following table sets forth revenue by geographic area:
Summary of Revenue by Geographic Area
| |
2025 | | |
2024 | | |
2025 | | |
2024 | |
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2025 | | |
2024 | | |
2025 | | |
2024 | |
United States | |
| | | |
| | | |
| | | |
| | |
Product revenue | |
$ | 162,910 | | |
$ | 137,411 | | |
$ | 203,087 | | |
$ | 223,706 | |
Grant revenue | |
| - | | |
| 2,495,738 | | |
| - | | |
| 2,710,847 | |
Total United States | |
| 162,910 | | |
| 2,633,149 | | |
| 203,087 | | |
| 2,934,553 | |
Rest of World | |
| | | |
| | | |
| | | |
| | |
Product revenue | |
| - | | |
| 23,691 | | |
| 10,100 | | |
| 190,141 | |
Grant revenue | |
| - | | |
| - | | |
| - | | |
| - | |
Total Rest of World | |
| - | | |
| 23,691 | | |
| 10,100 | | |
| 190,141 | |
Total | |
$ | 162,910 | | |
$ | 2,656,840 | | |
$ | 213,187 | | |
$ | 3,124,694 | |
Revenue geographic area | |
$ | 162,910 | | |
$ | 2,656,840 | | |
$ | 213,187 | | |
$ | 3,124,694 | |
Percentage of revenue by area: | |
| | | |
| | | |
| | | |
| | |
United States | |
| 100 | % | |
| 99 | % | |
| 95 | % | |
| 94 | % |
Rest of World | |
| 0 | % | |
| 1 | % | |
| 5 | % | |
| 6 | % |
Changes
in the Company’s deferred revenue balance for the six months ended June 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 | |
| 5,000 | |
Balance as of June 30, 2025 | |
$ | 45,857 | |
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 six months
ended June 30, 2025 and 2024, respectively:
Schedule of Basis and Diluted Earnings Per Share
| |
2025 | | |
2024 | | |
2025 | | |
2024 | |
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2025 | | |
2024 | | |
2025 | | |
2024 | |
Numerator | |
| | | |
| | | |
| | | |
| | |
Net loss, as reported | |
$ | (7,730,117 | ) | |
$ | (7,599,318 | ) | |
$ | (15,263,388 | ) | |
$ | (16,911,361 | ) |
| |
| | | |
| | | |
| | | |
| | |
Denominator | |
| | | |
| | | |
| | | |
| | |
Weighted average shares, basic | |
| 33,108,399 | | |
| 30,124,696 | | |
| 32,581,603 | | |
| 29,983,785 | |
Dilutive effect of stock options, warrants and RSUs | |
| - | | |
| - | | |
| - | | |
| - | |
Shares used to compute diluted earnings per share | |
| 33,108,399 | | |
| 30,124,696 | | |
| 32,581,603 | | |
| 29,983,785 | |
| |
| | | |
| | | |
| | | |
| | |
Loss per share, basic and diluted | |
$ | (0.23 | ) | |
$ | (0.25 | ) | |
$ | (0.47 | ) | |
$ | (0.56 | ) |
The
computation of diluted loss per share for the three and six months ended June 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 six months ended June 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 June 30, 2025, consisting of: (i) 2,535,184 restricted stock units and (ii) 982,918 options and warrants. The Company
had potentially dilutive securities as of June 30, 2024, consisting of: (i) 1,758,323 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 3,237,236 at June 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 June 30, 2025. No awards have been made under the 2025 Plan.
Stock
Options
The
following table summarizes option activity during the six months ended June 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 June 30, 2025 | |
| 970,570 | | |
$ | 2.26 | | |
$ | 1.41 | | |
| 3.57 | |
| |
| | | |
| | | |
| | | |
| | |
Exercisable at June 30, 2025 | |
| 970,570 | | |
$ | 2.26 | | |
$ | 1.41 | | |
| 3.57 | |
The
aggregate intrinsic value of outstanding options at June 30, 2025 and 2024 was approximately $0 and $152,521, respectively.
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 June 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 six months ended June 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 | |
| - | | |
| - | |
Vested | |
| (734,500 | ) | |
| 2.59 | |
Forfeited/Cancelled | |
| (105,285 | ) | |
| 5.32 | |
Unvested at June 30, 2025 | |
| 1,902,531 | | |
$ | 2.30 | |
As
of June 30, 2025, there was approximately $3,000,770 of unrecognized stock-based compensation expense related to outstanding RSUs which
is expected to be recognized over a weighted-average period of 1.5 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 six months ended June 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 June 30, 2025 | |
| 465,000 | | |
$ | 9.13 | | |
$ | - | | |
| 1.5 | |
The
aggregate intrinsic value of outstanding warrants at June 30, 2025 was $0.
There
are no warrants exercisable at June 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
| |
2025 | | |
2024 | | |
2025 | | |
2024 | |
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2025 | | |
2024 | | |
2025 | | |
2024 | |
Cost of revenue | |
$ | - | | |
$ | 6,054 | | |
$ | - | | |
$ | 14,195 | |
Sales and marketing | |
| 105,342 | | |
| 292,983 | | |
| 241,539 | | |
| 663,363 | |
General and administrative | |
| 531,707 | | |
| 1,046,148 | | |
| 1,267,622 | | |
| 2,132,644 | |
Research and development | |
| (56,784 | ) | |
| 154,473 | | |
| (53,668 | ) | |
| 260,690 | |
Total stock-based compensation expense | |
$ | 580,265 | | |
$ | 1,499,658 | | |
$ | 1,455,493 | | |
$ | 3,070,892 | |
Note
9 – Income Taxes
For
the three months ended June 30, 2025, the Company recognized expense from income taxes of $12,327, representing an effective tax rate
of 0.2%. For the six months ended June 30, 2025, the Company recognized expense from income taxes of $24,331, representing an effective
tax rate of 0.2%. 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 six months ended June
30, 2024, the Company recognized expense from income taxes of $20,590 and $43,354, 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 and leases
cancellable with one month notice. The Company expenses the cancellable leases in the period incurred in accordance with the practical
expedient elected.
The
components of lease expense are summarized as follows:
Schedule of Lease Expense
| |
2025 | | |
2024 | | |
2025 | | |
2024 | |
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2025 | | |
2024 | | |
2025 | | |
2024 | |
Operating lease costs | |
$ | 258,122 | | |
$ | 252,646 | | |
$ | 516,188 | | |
$ | 503,841 | |
Short-term lease costs | |
| - | | |
| 12,250 | | |
| - | | |
| 37,789 | |
Total lease costs | |
$ | 258,122 | | |
$ | 264,896 | | |
$ | 516,188 | | |
$ | 541,630 | |
As
of June 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) | |
$ | 511,287 | |
2026 | |
| 714,630 | |
2027 | |
| 300,591 | |
2028 | |
| 308,462 | |
Total lease payments | |
| 1,834,970 | |
Less: imputed interest | |
| 131,254 | |
Present value of operating lease liabilities | |
| 1,703,716 | |
Less: current portion | |
| 824,458 | |
Long-term portion | |
$ | 879,258 | |
Other
information related to operating leases was as follows:
Schedule of Other Information Related to Operating Leases
| |
Six Months Ended June 30, 2025 | |
Cash paid for operating leases included in operating cash flows | |
$ | 518,191 | |
Remaining lease term of operating leases | |
| 2.5 | |
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 four 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 intends to defend 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.
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 six months ended June 30, 2025.
Note
12 – At-the-Market Agreement
The
Company has entered into an Amended and Restated Equity Distribution Agreement (the “ATM Agreement”) with Piper Sandler &
Co. (“Piper Sandler”) and Clear Street, LLC (“Clear Street”), pursuant to which it may 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 agents, under the prospectus supplement dated October 18, 2024. As of June 30, 2025, the Company has sold 2,209,131 shares
of common stock under the ATM Agreement resulting in net proceeds to the Company of $1,016,988. As of June 30, 2025, the Company has
up to $16,063,209 remaining in aggregate gross proceeds that can be issued through the ATM Agreement.
Note
13 – 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 $182,364 and $422,467
of expense related to this agreement during the three and six months ended June 30, 2025, respectively, compared to $74,040 and $179,965
of expense during the three and six months ended June 30, 2024, respectively.
Note
14 – Subsequent Events
New
United States tax legislation was signed into law on July 4, 2025. Income tax effects of changes in tax law or rates on deferred tax
assets or liabilities are recognized at the date of enactment. The Company is still evaluating the impact of the changes included in
this new legislation but does expect to realize material future benefits from certain aspects of the new law.
On
July 10, 2025, the Company received notification from the NASDAQ Stock Market indicating that the Company will have an additional 180-day
grace period, until January 5, 2026, to regain compliance with NASDAQ’s $1.00 minimum bid requirement. The notification indicated
that the Company did not regain compliance during the initial 180-day grace period provided under the rule. In accordance with NASDAQ
Marketplace Rule 5810(c)(3)(A), the Company is eligible for the additional grace period because it meets the continued listing requirement
for market value of publicly held shares and all other applicable requirements for initial listing on the Nasdaq Capital Market with
the exception of the bid price requirement, and provided written notice of its intention to cure the deficiency during the second compliance
period by effecting a reverse stock split, if necessary.
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 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 U.S. Food and Drug Administration (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 COVID-19 test, 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.
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 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 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.
RESULTS
OF OPERATIONS
The
Three Months Ended June 30, 2025 Compared to the Three Months ended June 30, 2024
Revenues
For
the three months ended June 30, 2025, we generated revenues of $0.2 million, compared to revenues of $2.7 million for the three months
ended June 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 $.03 million for the three months ended June 30, 2025, compared to $0.2 million for the three
months ended June 30, 2024. Included within cost of revenues is a decrease of approximately $0.1 million for the three months ended June
30, 2025, and an increase of approximately $.02 million for the three months ended June 30, 2024, related to reserves against certain
raw materials and finished goods inventories.
Expenses
Total
operating expenses were $8.2 million for the three months ended June 30, 2025 compared to total operating expenses of $10.1 million for
the three months ended June 30, 2024. The decrease in operating expenses was primarily due to decreased stock-based compensation expense,
personnel related expenses, and expense related to development of the Co-Dx PCR platform.
Sales
and marketing expenses for the three months ended June 30, 2025 were $0.6 million compared to $1.0 million for the three months ended
June 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 June 30, 2025 were $2.6 million compared to $3.1 million for the three months
ended June 30, 2024. The decrease resulted primarily from lower stock-based compensation expense.
Research
and development expenses for the three months ended June 30, 2025 were $4.7 million compared to $5.6 million for the three months ended
June 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.
Other
Income
Other
income was $0.3 million for the three months ended June 30, 2025, compared to other income of $0.1 million for the three months ended
June 30, 2024. Decreases in interest income were offset by increases in realized gains from investments in marketable securities and
the change in the fair value of contingent consideration liabilities.
Net
Loss
We
realized a net loss for the three months ended June 30, 2025 of $7.7 million, compared to $7.6 million for the three months ended
June 30, 2024. The larger net loss was primarily the result of decreased grant revenues, partially offset by lower operating
expenses.
The
Six Months Ended June 30, 2025 Compared to the Six Months ended June 30, 2024
Revenues
For
the six months ended June 30, 2025, we generated revenues of $0.2 million, compared to revenues of $3.1 million for the six months ended
June 30, 2024. The decrease in revenue was due to lower product and grant revenues recognized in the current period.
Cost
of Revenues
We
recorded cost of revenues of approximately $0.1 million for the six months ended June 30, 2025, compared to $0.4 million for the six
months ended June 30, 2024. Included within cost of revenues is a decrease of approximately $0.1 million for the six months ended June
30, 2025, and a decrease of approximately $0.3 million for the six months ended June 30, 2024, related to reserves against certain raw
materials and finished goods inventories.
Expenses
Total
operating expenses were $16.8 million for the six months ended June 30, 2025 compared to total operating expenses of $20.6 million for
the six months ended June 30, 2024. The decrease in operating expenses was primarily due to decreased stock-based compensation expense,
personnel related expenses, tradeshow and travel expense, and expense related to development of the Co-Dx PCR platform. These decreases
were partially offset by increased legal expenses.
Sales
and marketing expenses for the six months ended June 30, 2025 were $1.3 million compared to $2.6 million for the six months ended June
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 six months ended June 30, 2025 were $5.4 million compared to $6.1 million for the six months ended
June 30, 2024. Decreases in stock-based compensation expense and consulting and professional services expense were partially offset by
increased legal expenses.
Research
and development expenses for the six months ended June 30, 2025 were $9.6 million compared to $11.3 million for the six months ended
June 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.
Other
Income
Other
income was $1.4 million for the six months ended June 30, 2025, compared to other income of $1.1 million for the six months ended June
30, 2024. Decreases in interest income were 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 six months ended June 30, 2025 of $15.3 million, compared to $16.9 million for the six months ended June
30, 2024. The smaller net loss was primarily the result of decreases in operating expenses.
Liquidity
and Capital Resources
At
June 30, 2025, we had cash and cash equivalents of $11.1 million and marketable investment securities of $2.2 million. We consider our
marketable investment securities an important part of our liquidity and focus such investments in securities that can readily be converted
into cash if needed. Additionally, our total current assets at June 30, 2025, were $15.3 million compared to total current liabilities
of $3.7 million.
Net
cash used in operating activities during the six months ended June 30, 2025 was $17.0 million, compared to $13.7 million for the six
months ended June 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 revenue, grant funding, net interest income,
and realized gains on investments.
Net
cash provided by investing activities was $24.4 million for the six months ended June 30, 2025, compared to $12.6 million during the
six months ended June 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 $0.8 million for the six months ended June 30, 2025, compared to $0 for the six months ended
June 30, 2024. The cash provided by financing activities during 2025 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. We have entered into an Amended and Restated Equity Distribution
Agreement (the “ATM Agreement”) with Piper Sandler & Co. (“Piper Sandler”) and Clear Street, LLC (“Clear
Street”), pursuant to which we may offer and sell shares of our 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 our agents, under our prospectus supplement dated October 18, 2024.
As of June 30, 2025, we have sold 2,209,131 shares of common stock under the ATM Agreement resulting in net proceeds to the Company of
$1.0 million.
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.
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 June 30, 2025. Based on the evaluation of our disclosure controls and procedures as of June
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 June 30, 2025, that have materially
affected or, are reasonably likely to materially affect, our internal control over financial reporting.
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
Effective
June 16, 2025, the Company entered into an Advisory Services Agreement pursuant to which the Company agreed to issue 500,000 shares of
its common stock to the advisor who will provide general financial advisory and investment banking services to the Company. The shares
were offered and sold in a private placement pursuant to exemptions from registration available under Section 4(a)(2) of the Securities
Act of 1933, as amended.
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.
Item
6. Exhibits
Exhibit
Index
(a)
Exhibits
Exhibit |
|
Number
Description |
10.1** |
|
Amended and Restated Equity Distribution Agreement, dated as of April 25, 2025, by and among Co-Diagnostics, Inc., Piper Sandler & Co., and Clear Street LLC. |
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 April 28, 2025, File No. 001-38148.
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: August 14, 2025 |
By: |
/s/
Dwight H. Egan |
|
Name: |
Dwight H. Egan |
|
Title: |
Chief Executive Officer
and Principal Executive Officer |
|
|
|
Date: August 14, 2025 |
By: |
/s/
Brian Brown |
|
Name: |
Brian Brown |
|
Title: |
Chief Financial Officer
and Principal Financial and Accounting Officer |