Item 1. Financial Statements
Item
1. Financial Statements
CO
– DIAGNOSTICS, INC. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED BALANCE SHEETS
(Unaudited)
September
30, 2025
December
31, 2024
Assets
Current
assets
Cash
and cash equivalents
$ 11,443,943
$ 2,936,544
Marketable
investment securities
-
26,811,098
Accounts
receivable, net
55,905
132,570
Inventory,
net
1,089,956
1,072,724
Income taxes
receivable
923,217
-
Prepaid
expenses and other current assets
541,946
1,338,762
Total
current assets
14,054,967
32,291,698
Property
and equipment, net
2,485,112
2,761,280
Operating
lease right-of-use asset
1,439,779
2,114,876
Intangible
assets, net
26,101,000
26,101,000
Investment
in joint venture
659,903
731,065
Total
assets
$ 44,740,761
$ 63,999,919
Liabilities
and stockholders’ equity
Current
liabilities
Accounts
payable
$ 1,458,397
$ 3,294,254
Accrued
expenses
1,204,660
2,562,169
Operating
lease liability, current
744,156
915,619
Contingent
consideration liabilities, current
239,955
502,819
Deferred
revenue
45,557
40,857
Total
current liabilities
3,692,725
7,315,718
Long-term
liabilities
Income
taxes payable
491,848
713,643
Operating
lease liability
727,943
1,236,560
Contingent
consideration liabilities
-
422,080
Total
long-term liabilities
1,219,791
2,372,283
Total
liabilities
4,912,516
9,688,001
Commitments
and contingencies (Note 10)
-
Stockholders’
equity
Convertible
preferred stock, $ 0.001 par value; 5,000,000 shares authorized; 0 shares issued and outstanding as of September 30, 2025 and December
31, 2024, respectively
-
-
Common
stock, $ 0.001 par value; 100,000,000 shares authorized; 52,991,260 shares issued and 48,142,582 shares outstanding as of September
30, 2025 and 37,902,222 shares issued and 33,053,544 shares outstanding as of December 31, 2024
52,991
37,902
Treasury
stock, at cost; 4,848,678 shares held as of September 30, 2025 and December 31, 2024, respectively
( 15,575,795 )
( 15,575,795 )
Additional
paid-in capital
109,447,214
102,472,210
Accumulated
other comprehensive income
94,888
418,443
Accumulated
deficit
( 54,191,053 )
( 33,040,842 )
Total
stockholders’ equity
39,828,245
54,311,918
Total
liabilities and stockholders’ equity
$ 44,740,761
$ 63,999,919
See
accompanying notes to unaudited condensed consolidated financial statements
3
CO
– DIAGNOSTICS, INC. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(Unaudited)
Three
Months Ended September 30,
Nine
Months Ended September 30,
2025
2024
2025
2024
Product
revenue
$ 145,380
$ 206,876
$ 358,567
$ 620,723
Grant
revenue
-
434,265
-
3,145,112
Total
revenue
145,380
641,141
358,567
3,765,835
Cost
of revenue
26,285
297,403
79,981
744,056
Gross
profit
119,095
343,738
278,586
3,021,779
Operating
expenses
Sales
and marketing
568,937
1,059,745
1,835,680
3,664,670
General
and administrative
1,815,945
4,287,380
7,189,076
10,338,568
Research
and development
4,480,678
4,880,315
14,038,156
16,172,684
Depreciation
and amortization
267,383
351,235
839,242
1,020,143
Total
operating expenses
7,132,943
10,578,675
23,902,154
31,196,065
Loss
from operations
( 7,013,848 )
( 10,234,937 )
( 23,623,568 )
( 28,174,286 )
Other
income (expense), net
Interest
income, net
13,194
263,335
38,953
968,256
Realized
gain on investments
41,542
293,067
683,365
595,302
Gain
(loss) on disposition of assets
4,000
3,513
( 5,004 )
7,013
Gain
(loss) on remeasurement of acquisition contingencies
( 42,345 )
( 11,927 )
684,944
194,217
Gain
(loss) on equity method investment in joint venture
( 55,959 )
12,683
( 71,163 )
( 132,775 )
Total
other income (expense), net
( 39,568 )
560,671
1,331,095
1,632,013
Loss
before income taxes
( 7,053,416 )
( 9,674,266 )
( 22,292,473 )
( 26,542,273 )
Income
tax provision (benefit)
( 1,166,593 )
22,189
( 1,142,262 )
65,543
Net
loss
$ ( 5,886,823 )
$ ( 9,696,455 )
$ ( 21,150,211 )
$ ( 26,607,816 )
Other
comprehensive income (loss)
Change
in net unrealized gains (losses) on marketable securities, net of tax
( 39,180 )
37,158
( 323,555 )
261,666
Total
other comprehensive income (loss)
$ ( 39,180 )
$ 37,158
$ ( 323,555 )
$ 261,666
Comprehensive
loss
$ ( 5,926,003 )
$ ( 9,659,297 )
$ ( 21,473,766 )
$ ( 26,346,150 )
Loss per common share:
Basic
and Diluted
$ ( 0.16 )
$ ( 0.32 )
$ ( 0.62 )
$ ( 0.88 )
Weighted average
shares outstanding:
Basic
and Diluted
37,890,923
30,494,206
34,370,824
30,155,167
See
accompanying notes to unaudited condensed consolidated financial statements
4
CO
– DIAGNOSTICS, INC. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
Nine
Months Ended September 30,
2025
2024
Cash
flows from operating activities
Net
loss
$ ( 21,150,211 )
$ ( 26,607,816 )
Adjustments
to reconcile net loss to cash used in operating activities:
Depreciation
and amortization
839,242
1,020,143
Stock-based
compensation expense
1,956,078
4,116,475
Common
stock issued for financial advisory services
135,000
-
Change
in fair value of acquisition contingencies
( 684,944 )
( 194,217 )
Non-cash
lease expense
( 4,985 )
12,174
Realized
gain on investments
( 683,365 )
( 595,302 )
Loss
from equity method investment
71,163
132,775
(Gain)
loss on disposition of assets
5,004
( 7,013 )
Provision
for credit losses (recoveries of)
( 22,375 )
8,262
Inventory
obsolescence expense (recovery)
( 138,983 )
164,955
Changes
in assets and liabilities:
Accounts
receivable
99,040
117,421
Prepaid
expenses and other assets
( 69,584 )
627,370
Inventory
121,752
233,754
Deferred
revenue
4,700
( 301,972 )
Income
taxes payable
( 221,795 )
60,442
Accounts
payable, accrued expenses and other liabilities
( 3,193,366 )
288,510
Net
cash used in operating activities
( 22,937,629 )
( 20,924,039 )
Cash
flows from investing activities
Purchases
of property and equipment
( 568,078 )
( 675,365 )
Proceeds
from maturities of marketable investment securities
33,761,847
45,031,967
Purchases
of marketable securities
( 6,590,939 )
( 27,408,061 )
Investment
in joint venture
-
( 143,750 )
Net
cash provided by investing activities
26,602,830
16,804,791
Cash
flows from financing activities
Issuance
of common stock related to at-the-market offering, net of offering costs
1,313,929
-
Issuance
of common stock related to registered direct offering, net of offering costs
3,528,269
-
Net
cash provided by financing activities
4,842,198
-
Net
increase (decrease) in cash and cash equivalents
8,507,399
( 4,119,248 )
Cash
and cash equivalents at beginning of period
2,936,544
14,916,878
Cash
and cash equivalents at end of period
$ 11,443,943
$ 10,797,630
Supplemental
disclosure of cash flow information
Cash
paid (received) for income taxes
$ 1,656
$ ( 23,350 )
See
accompanying notes to unaudited condensed consolidated financial statements
5
CO
– DIAGNOSTICS, INC. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(Unaudited)
Convertible
Preferred Stock
Common
Stock
Treasury
Additional
Paid-in
Accumulated
Other Comprehensive
Accumulated
Earnings
Total
Stockholders’
Shares
Amount
Shares
Amount
Stock
Capital
Income
(Deficit)
Equity
Balance
as of December 31, 2024
-
$ -
37,902,222
$ 37,902
$ ( 15,575,795 )
$ 102,472,210
$ 418,443
$ ( 33,040,842 )
$ 54,311,918
Issuance
of common stock related to at-the-market offering, net of offering costs
-
-
519,099
519
-
354,227
-
-
354,746
Stock-based
compensation
-
-
-
-
-
875,228
-
-
875,228
Other
comprehensive loss, net of tax
-
-
-
-
-
-
( 87,790 )
-
( 87,790 )
Net
loss
-
-
-
-
-
-
-
( 7,533,271 )
( 7,533,271 )
Balance as of March
31, 2025
-
-
38,421,321
38,421
( 15,575,795 )
103,701,665
330,653
( 40,574,113 )
47,920,831
Issuance
of common stock related to at-the-market offering, net of offering costs
-
-
1,375,325
1,375
-
427,625
-
-
429,000
Stock-based
compensation
-
-
734,500
735
-
579,530
-
-
580,265
Issuance
of common stock related to financial advisory services
-
-
500,000
500
-
134,500
-
-
135,000
Other
comprehensive loss, net of tax
-
-
-
-
-
-
( 196,585 )
-
( 196,585 )
Net
loss
-
-
-
-
-
-
-
( 7,730,117 )
( 7,730,117 )
Balance as of June
30, 2025
-
-
41,031,146
41,031
( 15,575,795 )
104,843,320
134,068
( 48,304,230 )
41,138,394
Issuance
of common stock related to at-the-market offering, net of offering costs
-
-
2,341,114
2,341
-
584,659
-
-
587,000
Stock-based
compensation
-
-
-
-
-
500,585
-
-
500,585
Issuance
of common stock related to registered direct offering, net of offering costs
-
-
9,619,000
9,619
-
3,518,650
-
-
3,528,269
Other
comprehensive income, net of tax
-
-
-
-
-
-
( 39,180 )
-
( 39,180 )
Net
loss
-
-
-
-
-
-
-
( 5,886,823 )
( 5,886,823 )
Balance
as of September 30, 2025
-
$ -
52,991,260
$ 52,991
$ ( 15,575,795 )
$ 109,447,214
$ 94,888
$ ( 54,191,053 )
$ 39,828,245
Convertible
Preferred Stock
Common
Stock
Treasury
Additional
Paid-in
Accumulated
Other Comprehensive
Accumulated
Earnings
Total
Stockholders’
Shares
Amount
Shares
Amount
Stock
Capital
Income
(Deficit)
Equity
Balance
as of December 31, 2023
-
$ -
36,108,346
$ 36,108
$ ( 15,575,795 )
$ 96,808,436
$ 146,700
$ 4,598,166
$ 86,013,615
Stock-based
compensation
-
-
18,750
19
-
1,571,215
-
-
1,571,234
Other
comprehensive income, net of tax
-
-
-
-
-
-
79,855
-
79,855
Net
loss
-
-
-
-
-
-
-
( 9,312,043 )
( 9,312,043 )
Balance as of March
31, 2024
-
-
36,127,096
36,127
( 15,575,795 )
98,379,651
226,555
( 4,713,877 )
78,352,661
Stock-based
compensation
-
-
632,584
633
-
1,499,025
-
-
1,499,658
Other
comprehensive income, net of tax
-
-
-
-
-
-
144,653
-
144,653
Net
loss
-
-
-
-
-
-
-
( 7,599,318 )
( 7,599,318 )
Balance as of June
30, 2024
-
-
36,759,680
36,760
( 15,575,795 )
99,878,676
371,208
( 12,313,195 )
72,397,654
Balance
-
-
36,759,680
36,760
( 15,575,795 )
99,878,676
371,208
( 12,313,195 )
72,397,654
Stock-based
compensation
-
-
18,750
18
-
1,045,565
-
-
1,045,583
Other
comprehensive income, net of tax
-
-
-
-
-
-
37,158
-
37,158
Other
comprehensive income (loss), net of tax
-
-
-
-
-
-
37,158
-
37,158
Net
loss
-
-
-
-
-
-
-
( 9,696,455 )
( 9,696,455 )
Balance
as of September 30, 2024
-
$ -
36,778,430
$ 36,778
$ ( 15,575,795 )
$ 100,924,241
$ 408,366
$ ( 22,009,650 )
$ 63,783,940
Balance
-
$ -
36,778,430
$ 36,778
$ ( 15,575,795 )
$ 100,924,241
$ 408,366
$ ( 22,009,650 )
$ 63,783,940
See
accompanying notes to unaudited condensed consolidated financial statements
6
CO
– DIAGNOSTICS, INC. AND SUBSIDIARIES
NOTES
TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
Note
1 – Overview and Basis of Presentation
Description
of Business
Co-Diagnostics,
Inc., a Utah corporation (the “Company” or “CODX”), is a molecular diagnostics company that develops, manufactures
and markets state-of-the-art diagnostics technologies. The Company’s technologies are utilized for tests that are designed using
the detection and/or analysis of nucleic acid molecules (DNA or RNA). The Company also uses its proprietary technology to design specific
tests for its Co-Dx™ PCR platform and to locate genetic markers for use in applications other than infectious disease. In connection
with the sale of our tests we may sell diagnostic equipment from other manufacturers as self-contained lab systems.
Unaudited
Condensed Consolidated Financial Statements
The
accompanying unaudited condensed consolidated financial statements of the Company have been prepared in accordance with accounting principles
generally accepted in the United States of America (“U.S. GAAP”) and the rules and regulations of the Securities and Exchange
Commission (“SEC”) for interim financial information as they are prescribed for smaller reporting companies. As permitted
under those rules and regulations, certain notes or other financial information normally included in financial statements prepared in
accordance with U.S. GAAP have been condensed or omitted. Accordingly, the accompanying unaudited condensed consolidated financial statements
do not include all the information and footnotes required by U.S. GAAP for complete financial statements. In the opinion of management,
all adjustments (consisting of normal recurring adjustments) considered necessary to make the financial statements not misleading have
been included. Operating results for the three and nine months ended September 30, 2025 are not necessarily indicative of the results
that may be expected for the year ending December 31, 2025. These statements should be read in conjunction with the Company’s audited
financial statements and related notes for the year ended December 31, 2024, included in the Company’s Annual Report on Form 10-K
filed with the SEC on March 27, 2025. A summary of the Company’s significant accounting policies is set forth in Note 2 to the
consolidated financial statements in its Annual Report on Form 10-K for the year ended December 31, 2024.
Use
of Estimates
The
preparation of financial statements in conformity with generally accepted accounting principles requires management to make estimates
and assumptions that affect the amounts reported in the financial statements and the accompanying notes. Such estimates include receivables
and other long-lived assets, legal contingencies, income taxes, share based arrangements, and others. These estimates and assumptions
are based on management’s best estimates and judgments. Actual amounts and results could differ from those estimates.
Liquidity
and Going Concern
In
accordance with Accounting Standards Codification (“ASC”) 205-40, Going Concern, (“ASC 205-40”) the Company evaluated
whether there are conditions and events, considered in the aggregate, that raise substantial doubt about the Company’s ability
to continue as a going concern within one year after the date on which this Quarterly Report on Form 10-Q is filed. Based on the Company’s
cash, cash equivalents, and short-term investments as of September 30, 2025, the Company’s current and forecasted level of operations,
and its forecasted cash flows, the Company’s ability to continue as a going concern is dependent upon its ability to obtain the
necessary financing to meet its obligations and repay its liabilities arising from normal business operations when they come due, and
to generate profitable operations in the future. Management plans to provide for the Company’s capital requirements through equity
financing, seeking additional grant funding, and through operational
efficiencies. Our ability to obtain additional financing in equity capital markets is subject to several factors, including market and
economic conditions, our performance and investor sentiment with respect to us and our industry. Accordingly, there can be no assurance
that the Company will be able to raise a sufficient amount of additional capital to fund operations with terms acceptable to the Company,
or at all. Because certain elements of management’s plans to mitigate the conditions that raised substantial doubt about the Company’s
ability to continue as a going concern are outside of the Company’s control, including the ability to raise capital through equity
or other financings, those elements cannot be considered probable according to ASC 205-40, and therefore cannot be considered in the
evaluation of mitigating factors. As a result, management has concluded that substantial doubt exists about the Company’s ability
to continue as a going concern for 12 months from the date these condensed consolidated financial statements are issued.
7
The
condensed consolidated financial statements as of September 30, 2025 have been prepared under the assumption that the Company will continue
as a going concern for the next 12 months after these financial statements are issued, and that contemplates the realization of assets
and satisfaction of liabilities and commitments in the normal course of business. The Company’s ability to continue as a going
concern is dependent upon its uncertain ability to obtain additional capital, reduce expenditures, and execute on its business plans.
These consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Note
2 – Summary of Significant Accounting Policies
Reclassifications
Certain
prior year amounts have been reclassified to conform with the current year’s presentation. These reclassifications have no impact
on the previously reported results.
Operating
Segments
The
Company operates as one operating segment. Operating segments are defined as components of an entity for which separate financial information
is regularly evaluated by the chief operating decision maker (“CODM”), which is the Company’s Chief Executive Officer,
in deciding how to allocate resources and assess performance. The Company’s CODM evaluates financial information and resources
and assesses the performance of these resources on a consolidated basis. There is no expense or asset information that is supplemental
to information disclosed within the condensed consolidated financial statements, that is regularly provided to the CODM. The allocation
of resources and assessment of performance of the operating segment is based on consolidated net loss and functional expenses as reported
on our condensed consolidated statements of operations and comprehensive loss. Because the Company operates as one operating segment,
financial segment information, including expense and asset information, can be found in the condensed consolidated financial statements.
All material long-lived assets are located in the United States and India.
Accounts
Receivable
Trade
accounts receivable are recorded at the invoiced amount (net of allowance) and do not bear interest. The Company maintains an allowance
for doubtful accounts for amounts the Company does not expect to collect. In establishing the required allowance, management considers
historical losses, current market condition, customers’ financial condition, the age of receivables, and current payment patterns.
Account balances are written off against the allowance once the receivable is deemed uncollectible. Recoveries of trade receivables previously
written off are recorded when collected. At September 30, 2025 total accounts receivable was $ 101,965 with an allowance for uncollectable
accounts of $ 46,060 resulting in a net amount of $ 55,905 . At December 31, 2024 total accounts receivable was $ 242,625 with an allowance
for uncollectable accounts of $ 110,055 resulting in a net amount of $ 132,570 . At December 31, 2023 total accounts receivable was $ 504,264
with an allowance for uncollectable accounts of $ 200,338 resulting in a net amount of $ 303,926 .
Inventory
Inventory
is stated at the lower of cost or net-realizable value. Inventory cost is determined on a first-in first-out basis that approximates
average cost in accordance with ASC 330-10-30-12. At September 30, 2025, the Company had $ 1,089,956 in net inventory, of which $ 607,085
was finished goods and $ 482,871 was raw materials. At December 31, 2024, the Company had $ 1,072,724 in net inventory, of which $ 567,281
was finished goods and $ 505,443 was raw materials. The Company establishes reserves to reduce low-moving, obsolete, or unusable inventories
to their estimated useful or scrap values. The Company recognized $ 43,681 and $ 144,747 related to the change in inventory reserves during
the three and nine months ended September 30, 2025, respectively, compared to $ 72,872 and $ 214,134 during the three and nine months ended
September 30, 2024, respectively.
8
Revenue
Recognition
The
Company generates revenue from customers from product and license sales. The Company recognizes revenue from customers when all of the
following criteria are satisfied: (i) identification of the promised goods or services in the contract; (ii) determination of whether
the promised goods or services are performance obligations, including whether they are distinct in the context of the contract; (iii)
measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to
the performance obligations; and (v) recognition of revenue when, or as the Company satisfies each performance obligation.
The
Company constrains revenue by giving consideration to factors that could otherwise lead to a probable reversal of revenue. The Company
records any payments received from customers prior to the Company fulfilling its performance obligation(s) as deferred revenue.
Grant
Revenue
The
Company may submit applications to receive grant funding from governmental and non-governmental entities. The Company accounts for grants
by analogizing to the contribution accounting model under ASC 958-605, Not-for-Profit Entities (“ASC 958”). Revenues from
grants, contracts, and awards provided by governmental and non-governmental agencies are recorded based upon the terms of the specific
agreements. The Company recognizes grant funding without conditions or continuing performance obligations as revenue in the consolidated
statements of operations and comprehensive income (loss). The Company recognizes grant funding with conditions or continuing performance
obligations as deferred revenue in the consolidated balance sheets if the conditions or performance obligations have not yet been met.
The Company recognized no grant funding revenue during the three and nine months ended September 30, 2025, respectively, compared to
$ 434,265 and $ 3,145,112 during the three and nine months ended September 30, 2024, respectively. At September 30, 2025, and December
31, 2024, the Company has recorded $ 40,857 of deferred revenue related to grant funding for which the cash was received, but the underlying
conditions or performance obligations have not yet been met. Cash received from federal grants, contracts, and awards can be subject
to audit by the grantor and, if the examination results in a disallowance of any expenditure, repayment could be required.
Income
Taxes
The
Company accounts for income taxes in accordance with the liability method of accounting for income taxes. Under this method, d eferred
income tax assets and deferred income tax liabilities represent the tax effect of temporary differences between financial reporting and
tax reporting measured at enacted tax rates in effect for the year in which the differences are expected to reverse. The Company recognizes
only the impact of tax positions that, based on their technical merits, are more likely than not to be sustained upon an audit by the
taxing authority.
Valuation
allowances are provided when it is more-likely-than-not that some or all of the deferred income tax assets may not be realized. In assessing
the need for a valuation allowance, the Company has considered its historical levels of income, expectations of future taxable income
and ongoing tax planning strategies.
Developing
the provision for income taxes, including the effective tax rate and analysis of potential tax exposure items, if any, requires significant
judgment and expertise in federal and state income tax laws, regulations and strategies, including the determination of deferred income
tax assets and liabilities and any estimated valuation allowances deemed necessary to value deferred income tax assets. Judgments and
tax strategies are subject to audit by various taxing authorities. The Company has uncertain income tax positions in the condensed consolidated
financial statements, and adverse determinations by these taxing authorities could have a material adverse effect on the condensed consolidated
financial positions, result of operations, or cash flows.
Concentrations
Risk and Significant Customers
The
Company had certain customers which were each responsible for generating 10 % or more of the total revenue for the three and nine months
ended September 30, 2025 and 2024. Three customers accounted for approximately 48 % of product revenue recognized during the three months
ended September 30, 2025. Four customers accounted for approximately 75 % of product revenue, and one granting agency accounted for 100 %
of grant revenue recognized during the three months ended September 30, 2024. Two customers accounted for approximately 31 % of product
revenue, and two granting agencies accounted for approximately 95 % of grant revenue recognized during the nine months ended September
30, 2024.
9
Two
customers individually accounted for more than 10 % of accounts receivable at September 30, 2025 and two customers individually accounted
for more than 10 % of accounts receivable at December 31, 2024. These customers together accounted for approximately 74 % and 94 % of accounts
receivable at September 30, 2025 and December 31, 2024, respectively.
Recently
Issued Accounting Standards
From
time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”) that are adopted
by the Company as of the specified effective date. If not discussed, management believes that the impact of recently issued standards,
which are not yet effective, will not have a material impact on the Company’s financial statements upon adoption.
In
November 2023, the FASB issued Accounting Standards Update (“ASU”) 2023-07, Segment Reporting (Topic 280): Improvements to
Reportable Segment Disclosures, which improves reportable segment disclosure requirements, primarily through enhanced disclosures about
significant segment expenses. The standard is effective for full year 2024 reporting, and for interim reporting beginning in 2025. The
adoption of this ASU did not change the way the Company evaluates its reportable segments and, as a result, did not have a material impact
on the Company’s segment-related disclosures.
In
December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, which requires an entity
to disclose annually additional information related to the company’s income tax rate reconciliation and income taxes paid during
the period. The guidance should be applied prospectively with the option to apply the standard retrospectively. The standard becomes
effective for the Company for full year 2025 reporting. The Company is currently evaluating the impact of this new standard on its consolidated
financial statements.
In
November 2024, the FASB issued ASU 2024-03, Income Statement (Subtopic 220-40): Reporting Comprehensive Income - Expense Disaggregation
Disclosures, which requires an entity to disclose on an annual and interim basis, disaggregated information about specific income statement
expense categories. The guidance should be applied prospectively with the option to apply the standard retrospectively. The standard
becomes effective for the Company for full year 2027 reporting. The Company is currently evaluating the impact of this new standard on
its consolidated financial statements.
In July 2025, the FASB issued ASU 2025-05,
Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses for Accounts Receivable and Contract Assets, which
provides all entities with a practical expedient when estimating expected credit losses for current accounts receivable and current contract
assets arising from transactions accounted for under Topic 606. Early adoption is permitted and entities should apply the practical expedient,
if elected, prospectively to financial statements issued for reporting periods after the effective date. The standard becomes effective
for the Company for interim and full year 2026 reporting. The Company is currently evaluating the impact of this new standard on its
consolidated financial statements.
Note
3 – Cash, Cash Equivalents, and Financial Instruments
The
following table shows the Company’s cash, cash equivalents, and marketable investment securities by significant investment category:
Schedule of Cash, Cash Equivalents and Marketable Investment Securities
September
30, 2025
Adjusted
Cost
Total
Unrealized
Gains
/
(Losses)
Fair
Value
Cash
and
Cash
Equivalents
Marketable
Investment
Securities
Cash
$ 11,443,943
$ -
$ 11,443,943
$ 11,443,943
$ -
Total
$ 11,443,943
$ -
$ 11,443,943
$ 11,443,943
$ -
10
December
31, 2024
Adjusted
Cost
Total
Unrealized
Gains
/
(Losses)
Fair
Value
Cash
and
Cash
Equivalents
Marketable
Investment
Securities
Cash
$ 2,936,544
$ -
$ 2,936,544
$ 2,936,544
$ -
Level
2:
U.S.
treasury securities
26,392,655
418,443
26,811,098
-
26,811,098
Subtotal
26,392,655
418,443
26,811,098
-
26,811,098
Total
$ 29,329,199
$ 418,443
$ 29,747,642
$ 2,936,544
$ 26,811,098
Note
4 – Fair Value Measurements
The
Company measures and records certain financial assets and liabilities at fair value on a recurring basis. Fair value is based on the
price that would be received from selling an asset or paid to transfer a liability in an orderly transaction between market participants
at the measurement date.
The
following three levels of inputs are used to measure the fair value of financial assets and liabilities:
Level
1: Quoted market prices in active markets for identical assets or liabilities.
Level
2: Observable market-based inputs or unobservable inputs that are corroborated by market data.
Level
3: Unobservable inputs that are not corroborated by market data.
The
following table summarizes the assets and liabilities measured at fair value on a recurring basis as of September 30, 2025 and December
31, 2024, by level within the fair value hierarchy:
Schedule of Fair Value Assets and Liabilities
September
30, 2025
(Level
1)
(Level
2)
(Level
3)
Total
Liabilities:
Contingent
consideration - common stock
$ -
$ -
$ 239,955
$ 239,955
Total
liabilities measured at fair value
$ -
$ -
$ 239,955
$ 239,955
11
December
31, 2024
(Level
1)
(Level
2)
(Level
3)
Total
Assets:
Cash
equivalents
$ 441,000
$ -
$ -
$ 441,000
Marketable
securities (U.S. treasury bills and notes)
-
26,811,098
-
26,811,098
Total
assets measured at fair value
$ 441,000
$ 26,811,098
$ -
$ 27,252,098
Liabilities:
Contingent
consideration - common stock
$ -
$ -
$ 743,794
$ 743,794
Contingent
consideration - warrants
-
-
181,105
181,105
Total
liabilities measured at fair value
$ -
$ -
$ 924,899
$ 924,899
The
Company’s financial instruments that are measured at fair value on a recurring basis consist of U.S. treasury bills and notes as
of December 31, 2024.
The
fair value of contingent consideration is calculated using a discounted probability weighted valuation model. Discount rates used in
such calculations are a significant assumption that are not observed in the market, and therefore, the resulting fair value represents
a Level 3 measurement.
The
changes for Level 3 items measured at fair value on a recurring basis are as follows:
Schedule of Changes in the Fair Value Measurement
Fair
value as of December 31, 2024
$ 924,899
Change
in fair value of contingent consideration issued for business acquisitions
( 684,944 )
Fair
value as of September 30, 2025
$ 239,955
The
fair value of the contingent consideration is based on the fair value of the contingent consideration-common stock and contingent consideration-warrants.
The fair value of the contingent consideration-common stock is equal to the probability-adjusted value of the Company’s common
stock as of the valuation date. The fair value of the contingent consideration-warrants is equal to the probability adjusted value of
a call option with terms consistent with the terms of the warrants as of the valuation date. Prior to the probability adjustments, the
warrants were valued based on the following inputs:
Schedule of Contingent Consideration Common Stock and Warrants
September
30, 2025
December
31, 2024
Stock
price
$ 0.34
$ 0.75
Strike price
$ 9.13
$ 9.13
Volatility
273.3 %
246.4 %
Risk-free
rate
3.7 %
4.3 %
Expected
term (years)
1.3
2.0
Fair
Value of Other Financial Instruments
The
carrying amounts of certain financial instruments, including cash held in banks, accounts receivable, notes receivable, accounts payable,
accrued liabilities, and other liabilities approximate fair value due to their short-term maturities and are excluded from the fair value
tables above.
Note
5 – Intangible Assets, Net
Intangible
assets, net consisted of the following:
Schedule of Intangible Assets, Net
September
30, 2025
Weighted-Average
Gross
Net
Useful
Life (1)
Carrying
Accumulated
Carrying
(in
Years)
Amount
Amortization
Amount
In-process
research and development
Indefinite
$ 26,101,000
$ -
$ 26,101,000
Non-competition
agreements
1,094,000
( 1,094,000 )
-
Total
intangible assets
$ 27,195,000
$ ( 1,094,000 )
$ 26,101,000
December
31, 2024
Weighted-Average
Gross
Net
Useful
Life (1)
Carrying
Accumulated
Carrying
(in
Years)
Amount
Amortization
Amount
In-process
research and development
Indefinite
$ 26,101,000
$ -
$ 26,101,000
Non-competition
agreements
1,094,000
( 1,094,000 )
-
Total
intangible assets
$ 27,195,000
$ ( 1,094,000 )
$ 26,101,000
(1)
Based
on weighted-average useful life established as of the acquisition date.
12
Note
6 – Revenue
The
following table sets forth revenue by geographic area:
Summary of Revenue by Geographic Area
Three
Months Ended September 30,
Nine
Months Ended September 30,
2025
2024
2025
2024
United
States
Product
revenue
$ 136,740
$ 129,776
$ 339,827
$ 473,482
Grant
revenue
-
434,265
-
3,145,112
Total
United States
136,740
564,041
339,827
3,618,594
Rest
of World
Product
revenue
8,640
77,100
18,740
147,241
Grant
revenue
-
-
-
-
Total
Rest of World
8,640
77,100
18,740
147,241
Total
$ 145,380
$ 641,141
$ 358,567
$ 3,765,835
Revenue geographic area
$ 145,380
$ 641,141
$ 358,567
$ 3,765,835
Percentage
of revenue by area:
United
States
94 %
88 %
95 %
96 %
Rest
of World
6 %
12 %
5 %
4 %
Changes
in the Company’s deferred revenue balance for the nine months ended September 30, 2025 were as follows:
Schedule of Deferred Revenue
Balance
as of December 31, 2024
$ 40,857
Revenue
recognized included in deferred revenue balance at the beginning of the period
-
Increase
due to prepayments from customers
4,700
Balance
as of September 30, 2025
$ 45,557
Note
7 – Loss Per Share
The
following table reconciles the numerator and the denominator used to calculate basic and diluted loss per share for three and nine months
ended September 30, 2025 and 2024, respectively:
Schedule of Basis and Diluted Earnings Per Share
Three
Months Ended September 30,
Nine
Months Ended September 30,
2025
2024
2025
2024
Numerator
Net
loss, as reported
$ ( 5,886,823 )
$ ( 9,696,455 )
$ ( 21,150,211 )
$ ( 26,607,816 )
Denominator
Weighted average
shares, basic
37,890,923
30,494,206
34,370,824
30,155,167
Dilutive
effect of stock options, warrants and RSUs
-
-
-
-
Shares
used to compute diluted earnings per share
37,890,923
30,494,206
34,370,824
30,155,167
Loss
per share, basic and diluted
$ ( 0.16 )
$ ( 0.32 )
$ ( 0.62 )
$ ( 0.88 )
13
The
computation of diluted loss per share for the three and nine months ended September 30, 2025 and 2024, respectively, also excludes approximately
1.4
million shares of common stock and approximately 465,000
warrants to purchase shares of common stock that are contingent
upon the achievement of certain milestones.
As
a result of incurring a net loss for the three and nine months ended September 30, 2025 and 2024, respectively, no potentially dilutive
securities are included in the calculation of diluted loss per share because such effect would be anti-dilutive. The Company had potentially
dilutive securities as of September 30, 2025, consisting of: (i) 2,317,465 restricted stock units and (ii) 978,757 options and warrants.
The Company had potentially dilutive securities as of September 30, 2024, consisting of: (i) 1,598,891 restricted stock units and (ii)
532,112 options and warrants.
Note
8 – Stock-Based Compensation
Stock
Incentive Plans
The
Company’s board of directors adopted, and shareholders approved, the Co-Diagnostics, Inc. Amended and Restated 2015 Long Term Incentive
Plan (the “Incentive Plan”) providing for the issuance of stock-based incentive awards to employees, officers, consultants,
directors and independent contractors. On August 31, 2022, the shareholders approved an increase in the number of awards available for
issuance under the Incentive Plan to an aggregate of 12,000,000 shares of common stock. The number of awards available for issuance under
the Incentive Plan was 655,702 at September 30, 2025.
The
Incentive Plan will expire on December 31, 2025. The Company’s board of directors adopted in March 2025, and in May 2025 our shareholders
approved, the Co-Diagnostics, Inc. 2025 Equity Incentive Plan (the “2025 Plan”) providing for the issuance of stock-based
incentive awards to employees, officers, consultants, directors and independent contractors. The number of awards available for issuance
under the 2025 Plan was 6,700,000 at September 30, 2025. No awards have been made under the 2025 Plan.
Stock
Options
The
following table summarizes option activity during the nine months ended September 30, 2025:
Schedule of Option Activity
Number of Options
Weighted Average Exercise
Price
Weighted Average Fair
Value
Weighted Average Remaining
Contractual Life (Years)
Outstanding
at December 31, 2024
1,040,572
$ 2.19
$ 1.37
3.88
Granted
-
-
-
Expired
( 70,002 )
$ 1.29
$ 0.76
Forfeited/Cancelled
-
-
-
Exercised
-
-
-
Outstanding
at September 30, 2025
970,570
$ 2.26
$ 1.41
3.32
Exercisable
at September 30, 2025
970,570
$ 2.26
$ 1.41
3.32
The
aggregate intrinsic value of outstanding options at September 30, 2025 and 2024 was approximately $ 0
and $ 152,521 ,
respectively.
14
Stock-based
compensation cost is measured at the grant date based on the fair value of the award granted and recognized as expense over the vesting
period using the straight-line method. The Company uses the Black-Scholes model to value options granted. As of September 30, 2025, there
were no unvested options and no unrecognized stock-based compensation expense related to options.
Restricted
Stock Units
The
grant date fair value of RSUs granted is determined using the closing market price of the Company’s common stock on the grant date
with the associated compensation expense amortized over the vesting period of the awards. The following table sets forth the outstanding
RSUs and related activity for the nine months ended September 30, 2025:
Schedule of Outstanding Restricted Stock Units and Related Party
Number
of RSUs
Weighted
Average Grant Date Fair Value
Unvested
at December 31, 2024
2,742,316
$ 2.50
Granted
2,605,002
0.25
Vested
( 734,500 )
2.59
Forfeited/Cancelled
( 128,753 )
5.45
Unvested
at September 30, 2025
4,484,065
$ 1.09
As
of September 30, 2025, there was approximately $ 3,100,827 of unrecognized stock-based compensation expense related to outstanding RSUs
which is expected to be recognized over a weighted-average period of 1.7 years.
Warrants
The
Company has issued warrants related to financings, acquisitions and as compensation to third parties for services provided. The Company
estimates the fair value of issued warrants on the date of issuance as determined using a Black-Scholes pricing model. The Company amortizes
the fair value of issued warrants using a vesting schedule based on the terms and conditions of each warrant if granted for services.
The
following table summarizes warrant activity during the nine months ended September 30, 2025:
Schedule of Warrant Activity
Number
of Warrants
Weighted
Average Exercise Price
Weighted
Average Fair Value
Weighted
Average Remaining Contractual Life (Years)
Outstanding
at December 31, 2024
485,000
$ 8.81
$ 1.00
2.0
Granted
-
-
-
Expired
( 20,000 )
1.40
15.19
Forfeited/Cancelled
-
-
-
Exercised
-
-
-
Outstanding
at September 30, 2025
465,000
$ 9.13
$ -
1.3
The
aggregate intrinsic value of outstanding warrants at September 30, 2025 was $ 0 .
15
There
are no warrants exercisable at September 30, 2025. The ability to exercise the 465,000 warrants issued in connection with acquisitions
in prior years is contingent upon the achievement of certain development and revenue milestones on or before January 1, 2027. There was
no unrecognized stock-based compensation expense related to warrants.
Stock-Based
Compensation Expense
The
Company recognized stock-based compensation expense as follows:
Schedule of Recognized Stock-Based Compensation Expense
Three
Months Ended September 30,
Nine
Months Ended September 30,
2025
2024
2025
2024
Cost
of revenue
$ -
$ 3,306
$ -
$ 17,501
Sales
and marketing
60,372
181,190
301,911
844,553
General
and administrative
379,981
924,539
1,647,603
3,057,184
Research
and development
60,232
( 63,452 )
6,564
197,237
Total
stock-based compensation expense
$ 500,585
$ 1,045,583
$ 1,956,078
$ 4,116,475
Note
9 – Income Taxes
For
the three months ended September 30, 2025, the Company recognized a benefit from income taxes of $ 1,166,593 , representing an effective
tax rate of 16.5 %. For the nine months ended September 30, 2025, the Company recognized a benefit from income taxes of $ 1,142,262 , representing
an effective tax rate of 5.1 %. The Company’s effective tax rate will generally differ from the U.S. Federal statutory rate of 21.0 %,
primarily due to the full valuation allowance as well as state taxes, permanent items, and discrete items. For the three and nine months
ended September 30, 2024, the Company recognized expense from income taxes of $ 22,189 and $ 65,543 , respectively.
Note
10 – Commitments and Contingencies
Lease
Obligations
The
Company leases administrative, R&D, sales and marketing and manufacturing facilities under non-cancellable operating leases.
The
components of lease expense are summarized as follows:
Schedule of Lease Expense
Three
Months Ended September 30,
Nine
Months Ended September 30,
2025
2024
2025
2024
Operating
lease costs
$ 259,642
$ 258,145
$ 775,830
$ 761,986
Short-term
lease costs
-
8,250
-
46,039
Total
lease costs
$ 259,642
$ 266,395
$ 775,830
$ 808,025
16
As
of September 30, 2025, the maturities of the Company’s lease liabilities are as follows:
Schedule of Maturities on Company Lease Liabilities
Years
Ending
December
31,
2025
(remainder)
$ 255,759
2026
714,630
2027
300,591
2028
308,462
Total
lease payments
1,579,442
Less:
imputed interest
107,343
Present
value of operating lease liabilities
1,472,099
Less:
current portion
744,156
Long-term
portion
$ 727,943
Other
information related to operating leases was as follows:
Schedule of Other Information Related to Operating Leases
Nine
Months Ended
September
30, 2025
Cash
paid for operating leases included in operating cash flows
$ 780,814
Remaining
lease term of operating leases
2.4
Discount
rate of operating leases
6.2 %
Litigation
Liabilities
for loss contingencies arising from claims, assessments, litigation, fines, and penalties and other sources are recorded when it is probable
that a liability has been incurred and the amount can be reasonably estimated. Legal costs incurred in connection with loss contingencies
are expensed as incurred.
The
Company is a defendant in one class action claim and three derivative actions claiming that the Company promulgated false and misleading
press releases to increase the price of our stock to improperly benefit the officers and directors of the Company. The plaintiffs demand
compensatory damages sustained as a result of the Company’s alleged wrongdoing in an amount to be proven at trial. The Company
is also a party to three civil actions, two in the US and the other in the United Kingdom. Each of the civil actions is based on breach
of contract claims against the Company. The Company believes these lawsuits are without merit and is defending the cases vigorously.
The Company is unable to estimate a range of loss, if any, that could result were there to be an adverse final decision in these cases.
As of the date of this report, the Company does not believe it is probable that these cases will result in an unfavorable outcome; however,
if an unfavorable outcome were to occur in these cases, it is possible that the impact could be material to the Company’s results
of operations in the period(s) in which any such outcome becomes probable and estimable.
17
Note
11 – Share Repurchase Program
In
March 2022, the Company’s Board of Directors authorized a share repurchase program that would allow the Company to repurchase up
to $ 30.0 million of CODX common stock. The repurchase program does not obligate the Company to acquire any particular number of common
shares, and the repurchase program may be suspended or discontinued at any time at the Company’s discretion. The timing and amount
of any share repurchases under the share repurchase program will be determined by Co-Diagnostics’ management at its discretion
based on ongoing assessments of the capital needs of the business, the market price of the Company’s common stock, corporate and
regulatory requirements, and general market conditions.
For
accounting purposes, common stock repurchased under the stock repurchase program is recorded based upon the transaction date of the applicable
trade. Such repurchased shares are held in treasury and are presented using the cost method. These shares are not retired and are considered
issued but not outstanding. No shares were repurchased during the three and nine months ended September 30, 2025.
Note
12 – At-the-Market Agreement
The Company previously maintained
an Amended and Restated Equity Distribution Agreement (the “Prior ATM Agreement”) with Piper Sandler & Co. (“Piper
Sandler”) and Clear Street, LLC (“Clear Street”), pursuant to which the Company could offer and sell shares of its common
stock having an aggregate offering price of up to $ 17,111,650 from time to time through Piper Sandler and Clear Street, acting as sales
agents, under a prospectus supplement dated October 18, 2024. As of September 30, 2025, the Company had sold 4,550,245 shares of common
stock under the Prior ATM Agreement, resulting in net proceeds to the Company of approximately $ 1,660,805 . The Prior ATM Agreement was
subsequently terminated, and no further sales will be made under that program.
On October 20, 2025, the Company entered into a new Equity Distribution Agreement (the “Agreement”) with
Maxim Group LLC (“Maxim”) to establish an at-the-market (“ATM”) equity offering program. Pursuant to the Agreement,
the Company may offer and sell shares of its common stock, par value $ 0.001 per share, having an aggregate offering price of up to $ 10.0
million, from time to time through Maxim, acting as the Company’s sales agent. Under the terms of the Agreement, the Company will
pay Maxim a commission equal to 3.0% of the gross proceeds from the sale of any shares and will reimburse Maxim for certain legal and
other out-of-pocket expenses incurred in connection with its services. Sales of common stock, if any, may be made in transactions deemed
to be “at-the-market” offerings as defined in Rule 415 under the Securities Act of 1933, as amended, including sales made
by means of ordinary brokers’ transactions on The Nasdaq Capital Market or otherwise at market prices prevailing at the time of
sale or at prices negotiated with Maxim. The Company is not obligated to sell any shares under the Agreement and may terminate the offering
at any time in accordance with its terms. The shares will be issued pursuant to the Company’s shelf Registration Statement on Form
S-3 (File No. 333-270628), which was declared effective by the Securities and Exchange Commission on April 6, 2023. On October 20, 2025,
the Company filed a prospectus supplement with the SEC relating to the new ATM program, registering up to approximately $ 4.1 million of
shares under the shelf registration statement.
Note
13 – Registered Direct Offering
On
September 17, 2025, the Company entered into a Securities Purchase Agreement (the “Purchase Agreement”) with two institutional
investors (the “Investors”) named therein, pursuant to which the Company agreed to issue and sell, in a registered direct
offering priced at-the-market under Nasdaq rules by the Company directly to the Investors (the “Offering”) an aggregate of
9,619,000 shares (the “Shares”) of the Company’s common stock, par value $ 0.01 per share, at an offering price of $ 0.40
per share. The offering closed on September 18, 2025. The gross proceeds to the Company from the offering were approximately $ 3,847,600 ,
before deducting the placement agent’s fees and other offering expenses. The Offering Shares were offered and sold by the Company
pursuant to an effective shelf registration statement on Form S-3 (File No. 333-270628). The Company agreed to pay Maxim Group LLC (“Maxim”),
as placement agent, an aggregate fee equal to 7.0 % of the gross proceeds received by the Company from the sale of the securities in the
offering as well as up to $ 50,000 for fees and expenses of legal counsel.
Note
14 – Related Party Transactions
The
Company has a services agreement with CoSara Diagnostics Pvt Ltd (“CoSara”), our joint venture for manufacturing in India,
under which CoSara provides certain research and development consulting and support services. The Company recognized $ 192,958 and $ 615,425
of expense related to this agreement during the three and nine months ended September 30, 2025, respectively, compared to $ 181,878 and
$ 361,843 of expense during the three and nine months ended September 30, 2024, respectively.
Note
15 – Subsequent Events
Subsequent to September 30, 2025, on
October 20, 2025, the Company entered into an Equity Distribution Agreement with Maxim Group LLC to establish an at-the-market equity
offering program, as described in Note 12 – At-the-Market Offering.
On
October 28, 2025, the Company entered into a Securities Purchase Agreement (the “Purchase Agreement”) with two
institutional investors (the “Investors”) pursuant to which the Company agreed to issue and sell, in a registered direct
offering priced at-the-market under Nasdaq rules (the “Offering”), (i) 12,002,272 shares
of its common stock, par value $ 0.001 per
share (the “Shares”), at an offering price of $ 0.55 per
share, and (ii) pre-funded common stock purchase warrants (the “Pre-Funded Warrants”) to purchase an aggregate
of 725,000
shares of common stock at an offering price of $ 0.5499
per Pre-Funded Warrant. The Pre-Funded Warrants have an exercise price of $ 0.0001
per share, are exercisable immediately upon issuance, and will remain exercisable until exercised in full. The Offering closed on
October 29, 2025. Gross proceeds to the Company were approximately $ 7.0
million , before deducting placement agent fees and other offering expenses. The securities were offered and sold pursuant to
the Company’s shelf Registration Statement on Form S-3 (File No. 333-270628), which was declared effective by the Securities
and Exchange Commission on April 6, 2023. Maxim Group LLC (“Maxim”) acted as placement agent for the Offering. The
Company agreed to pay Maxim a fee equal to 7.0 %
of the gross proceeds from the sale of the securities, as well as up to $ 50,000
for the fees and expenses of its legal counsel. The Company intends to use the net proceeds from the Offering for working capital
and general corporate purposes.
18
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.