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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the
Securities
Exchange Act of 1934
Date
of report (Date of earliest event reported): November 10, 2026
CO-DIAGNOSTICS,
INC.
(Exact
name of small business issuer as specified in its charter)
| Utah |
|
1-38148 |
|
46-2609363 |
| (State
or other jurisdiction of |
|
(Commission |
|
(IRS
Employer |
| incorporation
or organization) |
|
File
Number) |
|
Identification
Number) |
2401
S. Foothill Drive, Suite D, Salt Lake City, Utah 84109
(Address
of principal executive offices)
(801)
438-1036
(Issuer’s
telephone number)
Check
the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under
any of the following provisions:
| ☐ |
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| |
|
| ☐ |
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| |
|
| ☐ |
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| |
|
| ☐ |
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
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, par value $0.001 per share |
|
CODX |
|
The
Nasdaq Capital Market |
Indicate
by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405
of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
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. ☐
Item
2.02. Results of Operations and Financial Condition.
On
November 10, 2026, Co-Diagnostics, Inc. (the “Company”) issued a press release announcing financial results for its quarter
ended September 30, 2026. The full text of the press release, which includes information regarding the Company’s use of a non-GAAP
financial measure, is furnished as Exhibit 99.1 to this Form 8-K.
The
information contained in this Item 2.02, including Exhibit 99.1 attached hereto, is being furnished and shall not be deemed to be “filed”
for the purposes of Section 18 of the Securities Exchange Act of 1934, or otherwise subject to the liabilities of that section. Furthermore,
the information contained in this Item 2.02 or Exhibit 99.1 shall not be deemed to be incorporated by reference into any registration
statement or other document filed pursuant to the Securities Act of 1933, except as shall be expressly set forth by specific reference
in such filing.
Item
7.01. Regulation FD. Disclosure.
The
information set forth under Item 2.02 is incorporated by reference as if fully set forth herein.
Item
9.01 Financial Statements and Exhibits.
(d)
Exhibits
| Exhibit
No.: |
|
Description: |
| 99.1 |
|
Press Release, dated November 10, 2026 |
| 104 |
|
Cover
Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURE
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, hereunto duly authorized.
| |
CO-DIAGNOSTICS,
INC. |
| |
|
|
| Date:
November 10, 2026 |
By: |
/s/
Daniel Bohrer |
| |
Name: |
Daniel
Bohrer |
| |
Title: |
Executive
Vice President Finance & Accounting |
| |
|
(Principal
Financial and Accounting Officer) |
Exhibit
99.1
Co-Diagnostics
Reports Third Quarter 2026 Financial Results
Two
Regulatory Submissions Under Review in India and the U.S.
Third
Quarter Operating Expenses Down 12% Year Over Year
Platform
Capabilities Expanding with ReadyGo Collaboration, India Connectivity and Vector Smart Growth
SALT
LAKE CITY, November 10, 2026 – Co-Diagnostics, Inc. (Nasdaq: CODX) (“Co-Dx” or “the Company”),
a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, today announced its
financial results for the third quarter ended September 30, 2026.
Third
Quarter 2026 Business Highlights:
| ● | Submitted
a 510(k) premarket notification and concurrent CLIA Waiver by Application in August to the
U.S. Food and Drug Administration (FDA) for the Co-Dx PCR Flu A/B & RSV test on the Co-Dx
PCR Pro instrument, supported by a clinical study of more than 1,400 symptomatic patients
at nine U.S. clinical sites |
| ● | Entered
a collaboration with ReadyGo Diagnostics to evaluate blood-based molecular testing at the
point of need, with an initial focus on decentralized Ebola detection |
| ● | Completed
a proof-of-concept study in July in which an extraction-free Co-Primers Ebola assay using
diluted plasma ran on the Co-Dx PCR Pro instrument, the Company’s first plasma-based
assay designed for the instrument |
| ● | Launched
the Company’s integrated cloud and mobile infrastructure in India, which supports tuberculosis
(TB) clinical work and is designed to analyze results on a mobile device without an internet
connection and synchronize data to the cloud when connectivity is available |
| ● | Shipped
Vector Smart® laboratory equipment, consumables and reagents to an overseas
U.S. Air Force base, marking the first international deployment of the platform |
| ● | Completed
two new Vector Smart® laboratory installations in Florida, with installation
and customer training underway at an additional laboratory in Indiana, expanding a network
that serves customers across 21 U.S. states |
| ● | Demonstrated
automation of the Company’s test-cup manufacturing line at a September press conference,
reducing cycle time by approximately 45% and increasing output by approximately 74% compared
with the manual process |
| ● | Advanced
CoSara’s Bundibugyo virus and pan-Ebola tests for centralized laboratories and responded
to a request from India’s Centre for Cellular and Molecular Platforms for third-party
evaluation of the Bundibugyo test |
| ● | Participated
in global health forums, including the UNOPS near point-of-care TB workshop in Bangkok, the
joint WHO, Unitaid and UNAIDS Annual Consultation in Geneva, and events during UN General
Assembly week |
| ● | Appointed
Wes Lindsey, Ph.D., MBA, as Chief Scientific Officer; Dr. Lindsey brings more than 20 years
of experience in molecular diagnostics and is leading the Company’s work with the FDA
through its review |
“The
third quarter was a period of significant regulatory and operational progress for Co-Diagnostics,” said Dwight Egan, Chief Executive
Officer of Co-Diagnostics. “CoSara completed its clinical performance study for our point-of-care tuberculosis test and submitted
it to India’s Central Drugs Standard Control Organization (CDSCO), and together with our August FDA 510(k) submission for the Flu
A/B & RSV test, we now have two regulatory submissions under review in two important markets for our platform.
We also launched our cloud and mobile infrastructure in India, began evaluating blood-based testing with ReadyGo, and completed the first
international deployment of Vector Smart. With our submissions in India and the U.S. under review, our focus is on supporting those reviews,
advancing our feasibility work with ReadyGo and continuing to grow Vector Smart.”
Recent
Developments:
| ● | Submitted
the CoSara PCR MTB test, a point-of-care tuberculosis test, to the CDSCO through CoSara Diagnostics,
following completion of the clinical performance study. |
| ● | Completed
the CoSara PCR MTB clinical performance study of 676 clinical samples; in the 233 samples
paired with MGIT testing, the test demonstrated average sensitivity of 97.3% and average
specificity of 96.0% across three test batches. |
| ● | Secured
an order for a full Vector Smart® mosquito surveillance laboratory installation
from the Ute Indian Tribe Mosquito Abatement Department, which will enable the Tribe to perform
mosquito pool PCR testing in house. |
| ● | Highlighted
that sputum sample-preparation technology developed for the Company’s TB program could
provide a foundation for plague diagnostics on the Co-Dx PCR Pro® platform,
should a public health need arise. |
Third
Quarter 2026 Financial Results:
| ● | Revenue
of $0.3 million, compared to $0.1 million in the third quarter of 2025 |
| ● | Operating
expenses of $6.2 million, compared to $7.1 million in the third quarter of 2025, primarily
due to decreased personnel and stock-based compensation expense and lower Co-Dx PCR platform
development expense, partially offset by higher legal and professional services expense |
| ● | Operating
loss of $6.3 million, compared to $7.0 million in the third quarter of 2025 |
| ● | Net
loss of $6.3 million, or $1.01 per basic and diluted share, compared to a net loss of $5.9
million, or $4.66 per basic and diluted share, in the third quarter of 2025. The year-over-year increase in net loss was primarily attributable to
an income tax benefit recognized in the prior-year period, partially offset by reduced operating expenses |
| ● | Adjusted
EBITDA loss of $5.9 million, compared to a loss of $6.3 million in the third quarter of 2025 |
| ● | Cash
and cash equivalents totaled $0.7 million as of September 30, 2026 |
| ● | For
the nine months ended September 30, 2026, operating expenses were $21.7 million and net cash
used in operating activities was $20.7 million, compared to $23.9 million and $22.9 million,
respectively, in the prior-year period |
| ● |
Subsequent
to quarter end, the Company completed a senior secured convertible debt financing with J.J.
Astor & Co., with approximately $2.1 million in initial funding before other transaction expenses, and with up to an additional
$1.0 million available subject to specified conditions |
Conference
Call and Webcast:
Co-Diagnostics
will host a conference call and webcast at 4:30 p.m. ET today to review its third quarter 2026 results. The conference call and webcast
will be available via:
Webcast:
ir.co-dx.com on the Events & Webcasts page, or accessible directly here
Conference
Call: 1-888-880-3330 (Toll Free) or 1-646-357-8766 (Toll)
The
call will be recorded and later made available on the Company’s website.
*The
Co-Dx PCR platform (including the PCR Home®, PCR Pro®, mobile app, and all associated tests) is subject
to review or authorization by applicable regulatory authorities in the jurisdictions in which clearance or approval is sought, including
the US FDA, and is not yet available for sale.
About
Co-Diagnostics, Inc.:
Co-Diagnostics,
Inc., a Utah corporation, 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 at-home and point-of-care platform
(subject to regulatory review and not currently for sale) and to identify genetic markers for use in applications other than infectious
disease.
Non-GAAP
Financial Measures:
This
press release contains adjusted EBITDA, a non-GAAP measure defined as net income (loss) adjusted for depreciation, amortization,
income tax (benefit) expense, net interest (income) expense, stock-based compensation, change in fair value of contingent consideration,
and realized gain (loss) on investments. The Company believes that adjusted EBITDA provides useful information to management and investors
relating to its results of operations. The Company’s management uses this non-GAAP measure to compare the Company’s performance
to that of prior periods for trend analyses, and for budgeting and planning purposes. The Company believes that the use of adjusted EBITDA
provides an additional tool for investors to use in evaluating ongoing operating results and trends and in comparing the Company’s
financial measures with other companies, many of which present similar non-GAAP financial measures to investors, and that it allows for
greater transparency with respect to key metrics used by management in its financial and operational decision-making.
Management
does not consider the non-GAAP measure in isolation or as an alternative to financial measures determined in accordance with GAAP. The
principal limitation of the non-GAAP financial measure is that it excludes significant expenses that are required by GAAP to be recorded
in the Company’s financial statements. In order to compensate for these limitations, management presents the non-GAAP financial
measure together with GAAP results. Non-GAAP measures should be considered in addition to results prepared in accordance with GAAP, but
should not be considered a substitute for, or superior to, GAAP results. A reconciliation table of the net income, the most comparable
GAAP financial measure to adjusted EBITDA, is included at the end of this release. The Company urges investors to review the reconciliation
and not to rely on any single financial measure to evaluate the company’s business.
Forward-Looking
Statements:
This
press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other
federal securities laws. Forward-looking statements can be identified by words such as “believes,” “expects,”
“estimates,” “intends,” “may,” “plans,” “will” and similar expressions, or
the negative of these words. Such forward-looking statements are based on facts and conditions as they exist at the time such statements
are made and predictions as to future facts and conditions. Forward-looking statements in this release include, but are not limited to,
statements regarding: (i) the continued development, clinical evaluation, regulatory submission, clearance, authorization, and commercialization
of the Co-Dx PCR platform and related tests; (ii) anticipated timing and progress of clinical studies, regulatory submissions and regulatory
reviews, including the anticipated timing of CDSCO clearance and the commencement of commercial sales in India; (iii) the Company’s
ability to develop, scale, and commercialize its manufacturing capabilities, including through CoSara and CoMira and other third parties;
(iv) anticipated market opportunities and international expansion initiatives; (v) the expected capabilities, differentiation, and adoption
of the Company’s platform technologies; and (vi) the Company’s strategic, operational, and growth initiatives generally.
Forward-looking statements are subject to inherent uncertainties, risks and changes in circumstances. These risks and uncertainties include,
among others, risks relating to the timing and outcome of FDA and other regulatory review processes; the possibility that clinical or
analytical data may not support regulatory clearance, authorization or commercialization; the Company’s ability to successfully
complete product development, manufacturing scale-up and commercialization activities; market acceptance and adoption of the Company’s
products and technologies; the Company’s dependence on joint ventures, distributors, manufacturers and other third parties; risks
associated with conducting business and obtaining regulatory approvals in international markets; the Company’s ability to obtain
additional capital when needed, maintain sufficient liquidity to execute its business plans and continue as a going concern; and competitive
and technological developments. Actual results may differ materially from those contemplated or anticipated by such forward-looking statements.
Readers of this press release are cautioned not to place undue reliance on any forward-looking statements. There can be no assurance
that any regulatory submission, authorization, commercialization milestone, manufacturing initiative, strategic collaboration, or market
opportunity will occur on the timelines anticipated by the Company, or at all, due to certain risks and uncertainties, a discussion of
which can be found in our Risk Factors disclosure in our Annual Report on Form 10-K, filed with the Securities and Exchange Commission
(SEC) on March 31, 2026, and in our other filings with the SEC. Forward-looking statements speak only as of the date of this press release,
and the Company undertakes no obligation to update or revise any forward-looking statement as a result of new information, future events
or otherwise, except as required by applicable law.
Investor
Contact:
Valter
Pinto, Managing Director
KCSA
Strategic Communications
+1
212.896.1254
CODX@KCSA.com
Media
Contact:
Jennifer
Webb
ColtrinMethod
PR
jcoltrin@coltrinmethodpr.com
CO-DIAGNOSTICS,
INC. AND SUBSIDIARIES
CONSOLIDATED
BALANCE SHEETS
(Unaudited)
| | |
September 30, 2026 | | |
December 31, 2025 | |
| Assets | |
| | | |
| | |
| Current assets | |
| | | |
| | |
| Cash and cash equivalents | |
$ | 714,803 | | |
$ | 11,884,607 | |
| Accounts receivable, net | |
| 51,828 | | |
| 190,375 | |
| Inventory, net | |
| 672,950 | | |
| 992,397 | |
| Income taxes receivable | |
| - | | |
| 44,559 | |
| Prepaid expenses and other current assets | |
| 498,517 | | |
| 581,527 | |
| Total current assets | |
| 1,938,098 | | |
| 13,693,465 | |
| Property and equipment, net | |
| 1,767,749 | | |
| 2,272,098 | |
| Operating lease right-of-use asset | |
| 1,531,986 | | |
| 1,207,453 | |
| Intangible assets, net | |
| 7,219,000 | | |
| 7,219,000 | |
| Investment in joint ventures | |
| 335,015 | | |
| 350,569 | |
| Total assets | |
$ | 12,791,848 | | |
$ | 24,742,585 | |
| Liabilities and stockholders’ equity | |
| | | |
| | |
| Current liabilities | |
| | | |
| | |
| Accounts payable | |
$ | 937,294 | | |
$ | 1,878,225 | |
| Accrued expenses | |
| 850,200 | | |
| 865,301 | |
| Operating lease liability, current | |
| 709,754 | | |
| 662,258 | |
| Contingent consideration liabilities, current | |
| 12,572 | | |
| 119,036 | |
| Deferred revenue | |
| 2,000 | | |
| 14,800 | |
| Total current liabilities | |
| 2,511,820 | | |
| 3,539,620 | |
| Long-term liabilities | |
| | | |
| | |
| Operating lease liability | |
| 854,749 | | |
| 574,301 | |
| Total long-term liabilities | |
| 854,749 | | |
| 574,301 | |
| Total liabilities | |
| 3,366,569 | | |
| 4,113,921 | |
| Commitments and contingencies (Note 11) | |
| | | |
| | |
| Stockholders’ equity | |
| | | |
| | |
| Convertible preferred stock, $0.001 par value; 5,000,000 shares authorized; 0 shares issued and outstanding as of September 30, 2026 and December 31, 2025, respectively | |
| - | | |
| - | |
| Common stock, $0.001 par value; 100,000,000 shares authorized; 7,450,224 shares issued and 7,288,601 shares outstanding as of September 30, 2026 and 2,256,654 shares issued and 2,095,031 shares outstanding as of December 31, 2025 | |
| 72,893 | | |
| 67,700 | |
| Treasury stock, at cost; 161,623 shares held as of September 30, 2026 and December 31, 2025, respectively | |
| (15,575,795 | ) | |
| (15,575,795 | ) |
| Additional paid-in capital | |
| 127,031,952 | | |
| 116,510,298 | |
| Accumulated deficit | |
| (102,103,771 | ) | |
| (80,373,539 | ) |
| Total stockholders’ equity | |
| 9,425,279 | | |
| 20,628,664 | |
| Total liabilities and stockholders’ equity | |
$ | 12,791,848 | | |
$ | 24,742,585 | |
CO-DIAGNOSTICS,
INC. AND SUBSIDIARIES
CONSOLIDATED
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(Unaudited)
| | |
Three Months Ended September 30, | |
| | |
2026 | | |
2025 | |
| Product revenue | |
$ | 282,881 | | |
$ | 145,380 | |
| Total revenue | |
| 282,881 | | |
| 145,380 | |
| Cost of revenue | |
| 303,344 | | |
| 26,285 | |
| Gross profit | |
| (20,463 | ) | |
| 119,095 | |
| Operating expenses | |
| | | |
| | |
| Sales and marketing | |
| 579,902 | | |
| 568,937 | |
| General and administrative | |
| 1,871,838 | | |
| 1,815,945 | |
| Research and development | |
| 3,574,784 | | |
| 4,480,678 | |
| Depreciation and amortization | |
| 222,363 | | |
| 267,383 | |
| Total operating expenses | |
| 6,248,887 | | |
| 7,132,943 | |
| Loss from operations | |
| (6,269,350 | ) | |
| (7,013,848 | ) |
| Other income (expense), net | |
| | | |
| | |
| Interest income, net | |
| 3,123 | | |
| 13,194 | |
| Realized gain on investments | |
| - | | |
| 41,542 | |
| Gain (loss) on disposition of assets | |
| - | | |
| 4,000 | |
| Gain (loss) on remeasurement of acquisition contingencies | |
| 60,355 | | |
| (42,345 | ) |
| Loss on equity method investment in joint ventures | |
| (100,036 | ) | |
| (55,959 | ) |
| Total other income (expense), net | |
| (36,558 | ) | |
| (39,568 | ) |
| Loss before income taxes | |
| (6,305,908 | ) | |
| (7,053,416 | ) |
| Income tax provision (benefit) | |
| 500 | | |
| (1,166,593 | ) |
| Net loss | |
$ | (6,306,408 | ) | |
$ | (5,886,823 | ) |
| Other comprehensive loss | |
| | | |
| | |
| Change in net unrealized gains on marketable securities, net of tax | |
| - | | |
| (39,180 | ) |
| Total other comprehensive loss | |
$ | - | | |
$ | (39,180 | ) |
| Comprehensive loss | |
$ | (6,306,408 | ) | |
$ | (5,926,003 | ) |
| | |
| | | |
| | |
| Loss per common share: | |
| | | |
| | |
| Basic and Diluted | |
$ | (1.01 | ) | |
$ | (4.66 | ) |
| Weighted average shares outstanding: | |
| | | |
| | |
| Basic and Diluted | |
| 6,272,635 | | |
| 1,263,031 | |
CO-DIAGNOSTICS,
INC. AND SUBSIDIARIES
GAAP
AND NON-GAAP MEASURES
(Unaudited)
Reconciliation
of net loss to adjusted EBITDA:
| | |
Three Months Ended September 30, | |
| | |
2026 | | |
2025 | |
| Net loss | |
$ | (6,306,408 | ) | |
$ | (5,886,823 | ) |
| Interest income, net | |
| (3,123 | ) | |
| (13,194 | ) |
| Realized gain on investments | |
| - | | |
| (41,542 | ) |
| Depreciation and amortization | |
| 222,363 | | |
| 267,383 | |
| Gain (loss) on disposition of assets | |
| - | | |
| (4,000 | ) |
| Change in fair value of contingent consideration | |
| (60,355 | ) | |
| 42,345 | |
| Stock-based compensation expense | |
| 255,184 | | |
| 500,585 | |
| Income tax provision | |
| 500 | | |
| (1,166,593 | ) |
| Adjusted EBITDA | |
$ | (5,891,839 | ) | |
$ | (6,301,839 | ) |
