false
0001692415
0001692415
2026-08-13
2026-08-13
iso4217:USD
xbrli:shares
iso4217:USD
xbrli:shares
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): August 13, 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
August 13, 2026, Co-Diagnostics, Inc. (the “Company”) issued a press release announcing financial results for its quarter
ended June 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 August 13, 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:
August 13, 2026 |
By: |
/s/
Brian Brown |
| |
Name: |
Brian
Brown |
| |
Title: |
Chief
Financial Officer |
| |
|
(Principal
Financial and Accounting Officer) |
Exhibit
99.1
Co-Diagnostics
Reports Second Quarter 2026 Financial Results
Advancing
Commercialization Through FDA Submission, Global Clinical Progress and Manufacturing Expansion
Strengthening
Integrated Co-Dx PCR Platform Through Scientific Innovation, Cloud Connectivity and AI-Enabled Capabilities
SALT
LAKE CITY, August 13, 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 second quarter ended June 30, 2026.
Second
Quarter 2026 Business Highlights:
| ● |
Advanced
CoMira Diagnostics’ manufacturing strategy in the Kingdom of Saudi Arabia through Saudi approval for a manufacturing facility
industrial site and execution of a lease agreement in Sudair Industrial City, supporting planned localized production and
future commercialization across the Middle East and North Africa (MENA) |
| ● |
Expanded
commercial outreach through participation in a European trade mission with the Utah Governor’s Office and World Trade Center
Utah, while showcasing the Co-Dx PCR platform and CE-IVD solutions at ESCMID Global 2026 to engage prospective customers, distributors,
and strategic partners |
| ● |
Presented
the Co-Dx PCR tuberculosis (TB) platform at the Stop TB Partnership Summit in Washington, D.C., engaging with global health organizations,
government agencies, and other stakeholders focused on expanding access to TB diagnostics |
| ● |
Initiated
development of a Bundibugyo virus PCR assay and advanced the Company’s Ebola strategy through CoSara, including development
of a pan-Ebola assay |
| ● |
Strengthened
the balance sheet through a $3.0 million private placement priced at-the-market under Nasdaq rules, supporting continued execution
of the Company’s strategic initiatives |
| ● |
Advanced
Latin American commercialization efforts through a distribution agreement covering Mexico, supporting future commercialization of
the Co-Dx PCR platform in the region |
| ● |
Hosted
representatives from CoMira Diagnostics in Utah for the unveiling of the Company’s future automated manufacturing line, supporting
scalable production capabilities and localization efforts in Saudi Arabia |
| ● |
Expanded
the Vector Smart® customer footprint to 21 U.S. states, with four new mosquito abatement district laboratory installations
completed during the quarter, reflecting growing adoption of the Company’s decentralized vector surveillance platform |
“Our
second quarter marked a period of meaningful operational progress for Co-Diagnostics, as years of investment across our platform are
illustrated by these tangible milestones,” said Dwight Egan, Chief Executive Officer of Co-Diagnostics. “This progress was
reflected across our regulatory, clinical and commercial priorities, including expanding our tuberculosis program in India and strengthening
our international manufacturing and commercialization capabilities. More recently, we built on that momentum by submitting our FDA 510(k)
application for the Co-Dx™ PCR Flu A/B & RSV upper respiratory multiplex test on the Co-Dx PCR Pro® instrument.
Together, these milestones reinforce that we are executing against our strategic priorities and advancing the platform
toward commercialization.”
Mr.
Egan continued, “What differentiates Co-Diagnostics is that we have never viewed our opportunity as simply developing another diagnostic
test. We have built an integrated molecular diagnostics platform that combines instrumentation, assays, cloud connectivity and artificial
intelligence, along with manufacturing, and global commercial infrastructure into a scalable ecosystem. As we continue to advance regulatory
milestones and expand deployment across international markets, we believe this strategy has the potential to create long-term
value for our shareholders.”
Second
Quarter 2026 Financial Results:
| ● |
Revenue
of $0.17 million, compared to $0.16 million in the second quarter of 2025, primarily driven by higher product revenue |
| ● |
Operating
expenses of $6.3 million, compared to $8.2 million in the second quarter of 2025, primarily due to lower general and administrative
and research and development expenses, including reduced legal, personnel and stock-based compensation expenses |
| ● |
Operating
loss of $6.2 million, compared to $8.1 million in the second quarter of 2025 |
| ● |
Net
loss of $6.3 million, or $1.46 per basic and diluted share, compared to a net loss of $7.7 million, or $7.00 per basic
and diluted share, in the second quarter of 2025 |
| ● |
Adjusted
EBITDA loss of $5.8 million, compared to a loss of $7.2 million in the second quarter of 2025 |
| ● |
Cash
and cash equivalents totaled $3.6 million as of June 30, 2026 |
Recent
Developments:
| ● |
Completed
the clinical and analytical performance studies supporting the Company’s FDA 510(k) submission for the Co-Dx PCR Flu A/B &
RSV test on the Co-Dx PCR Pro instrument, including a clinical study enrolling more than 1,400 patients across nine U.S. clinical
sites and an analytical program spanning 27 studies and more than 10,000 PCR test runs |
| ● |
Submitted
a 510(k) premarket notification, together with a concurrent CLIA Waiver by Application, to the U.S. Food and Drug Administration
for the Co-Dx PCR Flu A/B & RSV test on the Co-Dx PCR Pro instrument, marking a significant regulatory milestone toward commercialization
of the Company’s point-of-care molecular diagnostics platform |
| ● |
Appointed
Wes Lindsey, Ph.D., MBA, as Chief Scientific Officer to lead the Company’s scientific and regulatory strategy, including FDA
submissions and continued expansion of the Co-Dx product pipeline |
| ● |
Initiated
clinical performance studies in India for the CoSara PCR MTB test through CoSara Diagnostics, advancing the Company’s tuberculosis
commercialization strategy in one of the world’s largest TB markets |
| ● |
The
Company’s joint venture, CoSara
Diagnostics provided Bundibugyo virus test kits for analytical studies in India and continued development of a pan-Ebola assay strategy,
while the Company successfully completed a proof-of-concept study evaluating extraction-free plasma-based testing capabilities on
the Co-Dx PCR platform |
Conference
Call and Webcast:
Co-Diagnostics
will host a conference call and webcast at 4:30 p.m. EDT today to discuss its financial results with analysts and institutional investors.
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) has not been cleared or authorized by the FDA, is subject to review by the FDA and/or other regulatory bodies
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, which is 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 and regulatory submissions; (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 and maintain sufficient liquidity to execute its business plans; 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.
Company
Contact:
Andrew
Benson
Head
of Investor Relations
+1
801.438.1036
investors@codiagnostics.com
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)
| | |
June 30, 2026 | | |
December 31, 2025 | |
| Assets | |
| | | |
| | |
| Current assets | |
| | | |
| | |
| Cash and cash equivalents | |
$ | 3,649,632 | | |
$ | 11,884,607 | |
| Accounts receivable, net | |
| 52,059 | | |
| 190,375 | |
| Inventory, net | |
| 841,669 | | |
| 992,397 | |
| Income taxes receivable | |
| 425 | | |
| 44,559 | |
| Prepaid expenses and other current assets | |
| 648,673 | | |
| 581,527 | |
| Total current assets | |
| 5,192,458 | | |
| 13,693,465 | |
| Property and equipment, net | |
| 1,975,111 | | |
| 2,272,098 | |
| Operating lease right-of-use asset | |
| 1,769,011 | | |
| 1,207,453 | |
| Intangible assets, net | |
| 7,219,000 | | |
| 7,219,000 | |
| Investment in joint ventures | |
| 435,051 | | |
| 350,569 | |
| Total assets | |
$ | 16,590,631 | | |
$ | 24,742,585 | |
| Liabilities and stockholders’ equity | |
| | | |
| | |
| Current liabilities | |
| | | |
| | |
| Accounts payable | |
$ | 1,078,380 | | |
$ | 1,878,225 | |
| Accrued expenses | |
| 899,183 | | |
| 865,301 | |
| Operating lease liability, current | |
| 784,261 | | |
| 662,258 | |
| Contingent consideration liabilities, current | |
| 72,927 | | |
| 119,036 | |
| Deferred revenue | |
| 28,644 | | |
| 14,800 | |
| Total current liabilities | |
| 2,863,395 | | |
| 3,539,620 | |
| Long-term liabilities | |
| | | |
| | |
| Operating lease liability | |
| 1,014,887 | | |
| 574,301 | |
| Total long-term liabilities | |
| 1,014,887 | | |
| 574,301 | |
| Total liabilities | |
| 3,878,282 | | |
| 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 June 30, 2026 and December 31, 2025, respectively | |
| - | | |
| - | |
| Common stock, $0.001 par value; 100,000,000 shares authorized; 5,040,580 shares issued and 4,878,957 shares outstanding as of June 30, 2026 and 2,256,654 shares issued and 2,095,031 shares outstanding as of December 31, 2025 | |
| 70,484 | | |
| 67,700 | |
| Treasury stock, at cost; 161,623 shares held as of June 30, 2026 and December 31, 2025, respectively | |
| (15,575,795 | ) | |
| (15,575,795 | ) |
| Additional paid-in capital | |
| 124,015,023 | | |
| 116,510,298 | |
| Accumulated deficit | |
| (95,797,363 | ) | |
| (80,373,539 | ) |
| Total stockholders’ equity | |
| 12,712,349 | | |
| 20,628,664 | |
| Total liabilities and stockholders’ equity | |
$ | 16,590,631 | | |
$ | 24,742,585 | |
CO-DIAGNOSTICS,
INC. AND SUBSIDIARIES
CONSOLIDATED
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(Unaudited)
| | |
Three Months Ended June 30, | |
| | |
2026 | | |
2025 | |
| Product revenue | |
$ | 166,131 | | |
$ | 162,910 | |
| Total revenue | |
| 166,131 | | |
| 162,910 | |
| Cost of revenue | |
| 45,303 | | |
| 32,106 | |
| Gross profit | |
| 120,828 | | |
| 130,804 | |
| Operating expenses | |
| | | |
| | |
| Sales and marketing | |
| 466,681 | | |
| 609,713 | |
| General and administrative | |
| 1,500,803 | | |
| 2,599,982 | |
| Research and development | |
| 4,152,287 | | |
| 4,687,459 | |
| Depreciation and amortization | |
| 201,840 | | |
| 291,414 | |
| Total operating expenses | |
| 6,321,611 | | |
| 8,188,568 | |
| Loss from operations | |
| (6,200,783 | ) | |
| (8,057,764 | ) |
| Other income (expense), net | |
| | | |
| | |
| Interest income, net | |
| 17,493 | | |
| 12,158 | |
| Realized gain on investments | |
| - | | |
| 340,358 | |
| Loss on disposition of assets | |
| - | | |
| (9,004 | ) |
| Gain (loss) on remeasurement of acquisition contingencies | |
| (29,171 | ) | |
| 10,222 | |
| Loss on equity method investment in joint ventures | |
| (52,157 | ) | |
| (13,760 | ) |
| Total other income (expense), net | |
| (63,835 | ) | |
| 339,974 | |
| Loss before income taxes | |
| (6,264,618 | ) | |
| (7,717,790 | ) |
| Income tax provision | |
| 19,168 | | |
| 12,327 | |
| Net loss | |
$ | (6,283,786 | ) | |
$ | (7,730,117 | ) |
| Other comprehensive loss | |
| | | |
| | |
| Change in net unrealized gains on marketable securities, net of tax | |
| - | | |
| (196,585 | ) |
| Total other comprehensive loss | |
$ | - | | |
$ | (196,585 | ) |
| Comprehensive loss | |
$ | (6,283,786 | ) | |
$ | (7,926,702 | ) |
| | |
| | | |
| | |
| Loss per common share: | |
| | | |
| | |
| Basic and Diluted | |
$ | (1.46 | ) | |
$ | (7.00 | ) |
| Weighted average shares outstanding: | |
| | | |
| | |
| Basic and Diluted | |
| 4,309,997 | | |
| 1,103,614 | |
CO-DIAGNOSTICS,
INC. AND SUBSIDIARIES
GAAP
AND NON-GAAP MEASURES
(Unaudited)
Reconciliation
of net loss to adjusted EBITDA:
| | |
Three Months Ended June 30, | |
| | |
2026 | | |
2025 | |
| Net loss | |
$ | (6,283,786 | ) | |
$ | (7,730,117 | ) |
| Interest income, net | |
| (17,493 | ) | |
| (12,158 | ) |
| Realized gain on investments | |
| - | | |
| (340,358 | ) |
| Depreciation and amortization | |
| 201,840 | | |
| 291,414 | |
| Loss on disposition of assets | |
| - | | |
| 9,004 | |
| Change in fair value of contingent consideration | |
| 29,171 | | |
| (10,222 | ) |
| Stock-based compensation expense | |
| 213,752 | | |
| 580,265 | |
| Income tax provision | |
| 19,168 | | |
| 12,327 | |
| Adjusted EBITDA | |
$ | (5,837,348 | ) | |
$ | (7,199,845 | ) |
