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
Balance
-
$ -
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
Balance
-
-
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:
Schedule of Cash, Cash Equivalents and Marketable Investment Securities
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:
Schedule of Fair Value Assets and Liabilities
(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:
Schedule of Changes in the Fair Value Measurement
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:
Schedule of Contingent Consideration Common Stock and Warrants
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:
Schedule of Intangible Assets, Net
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:
Summary of 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:
Schedule of Deferred Revenue
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:
Schedule of Basis and Diluted Earnings Per Share
2026
2025
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:
Schedule of Option Activity
Number of Options
Weighted Average Exercise Price
Weighted Average Fair Value
Weighted Average Remaining Contractual Life (Years)
Outstanding at December 31, 2025
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:
Schedule of Outstanding Restricted Stock Units and Related Activity
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:
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, 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:
Schedule of Recognized Stock-Based Compensation Expense
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:
Schedule of Lease Expense
2026
2025
Three Months Ended March 31,
2026
2025
Operating lease costs
$ 261,687
$ 258,065
Total lease costs
$ 261,687
$ 258,065
16
As
of March 31, 2026, the maturities of the Company’s lease liabilities are as follows:
Schedule of Maturities on Company Lease Liabilities
Years Ending December 31,
2026 (remainder)
$ 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:
Schedule of Other Information Related to Operating Leases
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.
17
Note
11 – Share Repurchase Program
In
March 2022, the Company’s Board of Directors authorized a share repurchase program that would allow the Company to repurchase up
to $ 30.0 million of CODX common stock. The repurchase program does not obligate the Company to acquire any particular number of common
shares, and the repurchase program may be suspended or discontinued at any time at the Company’s discretion. The timing and amount
of any share repurchases under the share repurchase program will be determined by Co-Diagnostics’ management at its discretion
based on ongoing assessments of the capital needs of the business, the market price of the Company’s common stock, corporate and
regulatory requirements, and general market conditions.
For
accounting purposes, common stock repurchased under the stock repurchase program is recorded based upon the transaction date of the applicable
trade. Such repurchased shares are held in treasury and are presented using the cost method. These shares are not retired and are considered
issued but not outstanding. No shares were repurchased during the three 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.
18
Item
2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
Cautionary
Note Regarding Forward-Looking Statements
This
Quarterly Report on Form 10-Q contains “forward-looking statements” that involve risks and uncertainties. All statements
other than statements of historical fact contained in this Quarterly Report and the documents incorporated by reference herein, including
statements regarding future events, our future financial performance, business strategy, and plans and objectives of management for future
operations, are forward-looking statements. We have attempted to identify forward-looking statements by terminology including “anticipates,”
“believes,” “can,” “continue,” “could,” “estimates,” “expects,”
“intends,” “may,” “plans,” “potential,” “predicts,” “should,”
or “will” or the negative of these terms or other comparable terminology. Although we do not make forward-looking statements
unless we believe we have a reasonable basis for doing so, we cannot guarantee their accuracy. These statements are only predictions
and involve known and unknown risks, uncertainties and other factors and the documents incorporated by reference herein, which may affect
our or our industry’s actual results, levels of activity, performance or achievements expressed or implied by these forward-looking
statements. Moreover, we operate in a highly regulated, very competitive, and rapidly changing environment. New risks emerge from time
to time, and it is not possible for us to predict all risk factors, nor can we address the impact of all factors on our business or the
extent to which any factor, or combination of factors, may cause our actual results to differ materially from those contained in any
forward-looking statements.
These
forward-looking statements are subject to certain risks and uncertainties that could cause our actual results to differ materially from
those reflected in the forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited
to, those discussed under the heading “Risk Factors” in other documents we file with the SEC, including our Annual Report
on form 10-K for the year ended December 31, 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.
19
Technology
We
believe our proprietary and patented molecular diagnostics technology is paving the way for innovation in disease detection and life
sciences research through our enhanced detection of genetic material. For various reasons, including owning our own platform, we believe
we will be able to accomplish this faster and more economically than some competitors, allowing for significant margins while still positioning
ourselves as a low-cost provider of molecular diagnostics and screening services. For example, we were the first US-based company to
receive a CE-marking for a COVID-19 test in early 2020, as we worked to help slow the spread of the pandemic through our global network
of distributors covering clinical labs in more than 50 countries. Our Logix Smart® COVID-19 test was designed, developed, submitted
for regulatory approval and ready to be used as an in vitro diagnostic (“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.
20
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.
21
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.
22
PART
II – OTHER INFORMATION
Item
1. Legal Proceedings
There
have been no material developments to the legal proceedings previously disclosed under Part I. Item 3 of our Annual Report on Form 10-K
for the fiscal year ended December 31, 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.
23
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.
24
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned thereunto duly authorized.
CO-DIAGNOSTICS,
INC.
Date: 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
25
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.