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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): May 14, 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
May 14, 2026, Co-Diagnostics, Inc. (the “Company”) issued a press release announcing financial results for its quarter ended
March 31, 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 May 14, 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:
May 14, 2026 |
By: |
/s/
Brian Brown |
| |
Name: |
Brian
Brown |
| |
Title: |
Chief
Financial Officer |
| |
|
(Principal
Financial and Accounting Officer) |
Exhibit
99.1
Co-Diagnostics
Reports First Quarter 2026 Financial Results
Advancing
Global Commercialization Through CoSara Regulatory Progress and Regional Expansion
Executing
Clinical Strategy with Upper Respiratory Submission Preparation and TB Study Initiation
Expanding
International Presence and Reinforcing Platform Differentiation Through Partnerships and IP
Salt
Lake City, UT – May 14, 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 first quarter ended March 31, 2026.
First
Quarter 2026 Business Highlights:
| ● |
Received
CDSCO license to manufacture and sell the CoSara PCR Pro® instrument in India, marking a key regulatory milestone
and supporting commercialization readiness |
| |
|
| ● |
Received
ISO 13485 certification for CoSara’s manufacturing facility in India, supporting regulatory submissions and meeting international
quality standards |
| |
|
| ● |
Entered
into an agreement to expand CoSara Diagnostics’ commercial and distribution territory across South Asia to include Bangladesh,
Pakistan, Nepal, and Sri Lanka, increasing the regional total addressable market to approximately $13 billion |
| |
|
| ● |
Initiated
shipments of PCR Pro* instruments and tuberculosis (TB) test materials to India to support upcoming clinical performance
studies, with the instrument and test kits designed to support testing approaches reflected in recent WHO guidance on TB testing |
| |
|
| ● |
Strengthened
distributor relationships and expanded market presence through CoSara Diagnostics’ participation in regional conferences in
India |
| |
|
| ● |
Showcased
the Co-Dx PCR platform at industry events including Medical Korea 2026 in Seoul, South Korea and World Health Expo Labs Dubai
in Dubai, UAE, highlighting the Company’s point-of-care testing platform and engaging with global stakeholders |
| |
|
| ● |
Expanded
the intellectual property portfolio with the issuance of a new international patent in Japan |
First
Quarter 2026 Financial Results:
| ● |
Revenue
of $0.15 million, compared to $0.05 million in the first quarter of 2025 |
| |
|
| ● |
Operating
expenses of $9.2 million, compared to $8.6 million in the same period last year, driven by research and development spending on clinical
studies and to advance other growth initiatives |
| |
|
| ● |
Operating
loss of $9.2 million, compared to $8.6 million in the first quarter of 2025 |
| |
|
| ● |
Net
loss of $9.1 million, or $4.06 per share, compared to a net loss of $7.5 million, or $7.05 per share, in the same period last year,
primarily driven by higher operating expenses and lower other income, including the absence of certain remeasurement gains recognized
in the prior-year period |
| |
|
| ● |
Adjusted
EBITDA loss of $8.7 million, compared to a loss of $7.4 million in the first quarter of 2025 |
| |
|
| ● |
Cash
and cash equivalents totaled $8.2 million as of March 31, 2026, compared to $11.9 million as of December 31,
2025. The Company expects continued investment in clinical development, regulatory, and commercialization activities as it advances its
strategic initiatives |
“The
progress we’ve made across the business is translating into tangible milestones and expanded opportunities,” said Dwight
Egan, Chief Executive Officer of Co-Diagnostics. “During the quarter, we advanced key initiatives across our clinical pipeline,
strengthened our presence in strategic global markets through CoSara and CoMira, and continued to build the foundation for a scalable,
globally deployable diagnostics platform. These efforts reflect a focused strategy centered on execution, innovation, and expanding our
reach into high-need markets.”
Mr.
Egan continued, “We believe we have generated the data needed to support a regulatory submission for our upper respiratory multiplex
test and are advancing toward a 510(k) filing with the FDA. We are also preparing to initiate clinical performance
studies for our MTB program in India, which we believe represents one of the most significant near-term opportunities for the
platform. Together with continued progress across our international initiatives, these developments demonstrate continued
operational progress against our strategy and that we are entering the next phase of execution with increasing momentum and a clearer
path toward commercialization.”
Recent
Developments:
| ● |
Completed enrollment in the upper respiratory Co-Dx
test clinical studies, with more than 1,400 patients enrolled |
| |
|
| ● |
Advanced
CoMira Diagnostics’ manufacturing facility in Sudair Industrial City in the Kingdom of Saudi Arabia (“KSA”) through
regulatory approval and lease execution, supporting localized manufacturing and expansion across the Middle East and North Africa
(“MENA”) |
| |
|
| ● |
Participated
in a European trade mission across Switzerland and Germany with the Utah Governor’s Office and World Trade Center Utah, engaging
with prospective customers and distributors, including at ESCMID Global 2026 |
| |
|
| ● |
Presented
at the Stop TB Partnership Summit in Washington, D.C., showcasing the Company’s Co-Dx PCR tuberculosis (TB) test during a roundtable
with U.S. government agencies and global health stakeholders |
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 HomeTM, PCR ProTM,
mobile app, and all associated tests) 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 excluding 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. 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) commercialization and manufacturing activities involving CoSara and CoMira; (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. 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. The Company does not undertake any obligation to update any
forward-looking statement relating to matters discussed in this press release, except as may be required by applicable securities laws.
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)
| | |
March 31, 2026 | | |
December 31, 2025 | |
| Assets | |
| | | |
| | |
| Current assets | |
| | | |
| | |
| Cash and cash equivalents | |
$ | 8,230,984 | | |
$ | 11,884,607 | |
| Accounts receivable, net | |
| 82,339 | | |
| 190,375 | |
| Inventory, net | |
| 846,119 | | |
| 992,397 | |
| Income taxes receivable | |
| 49 | | |
| 44,559 | |
| Prepaid expenses and other current assets | |
| 622,760 | | |
| 581,527 | |
| Total current assets | |
| 9,782,251 | | |
| 13,693,465 | |
| Property and equipment, net | |
| 2,158,670 | | |
| 2,272,098 | |
| Operating lease right-of-use asset | |
| 2,002,597 | | |
| 1,207,453 | |
| Intangible assets, net | |
| 7,219,000 | | |
| 7,219,000 | |
| Investment in joint ventures | |
| 337,208 | | |
| 350,569 | |
| Total assets | |
$ | 21,499,726 | | |
$ | 24,742,585 | |
| Liabilities and stockholders’ equity | |
| | | |
| | |
| Current liabilities | |
| | | |
| | |
| Accounts payable | |
$ | 2,017,852 | | |
$ | 1,878,225 | |
| Accrued expenses | |
| 1,364,754 | | |
| 865,301 | |
| Operating lease liability, current | |
| 857,638 | | |
| 662,258 | |
| Contingent consideration liabilities, current | |
| 43,756 | | |
| 119,036 | |
| Deferred revenue | |
| 600 | | |
| 14,800 | |
| Total current liabilities | |
| 4,284,600 | | |
| 3,539,620 | |
| Long-term liabilities | |
| | | |
| | |
| Operating lease liability | |
| 1,172,716 | | |
| 574,301 | |
| Total long-term liabilities | |
| 1,172,716 | | |
| 574,301 | |
| Total liabilities | |
| 5,457,316 | | |
| 4,113,921 | |
| Commitments and contingencies (Note 10) | |
| | | |
| | |
| Stockholders’ equity | |
| | | |
| | |
| Convertible preferred stock, $0.001 par value; 5,000,000 shares authorized; 0 shares issued and outstanding as of March 31, 2026 and December 31, 2025, respectively | |
| - | | |
| - | |
| Common stock, $0.001 par value; 100,000,000 shares authorized; 3,764,088 shares issued and 3,602,465 shares outstanding as of March 31, 2026 and 2,256,654 shares issued and 2,095,031 shares outstanding as of December 31, 2025 | |
| 69,207 | | |
| 67,700 | |
| Treasury stock, at cost; 161,623 shares held as of March 31, 2026 and December 31, 2025, respectively | |
| (15,575,795 | ) | |
| (15,575,795 | ) |
| Additional paid-in capital | |
| 121,062,575 | | |
| 116,510,298 | |
| Accumulated deficit | |
| (89,513,577 | ) | |
| (80,373,539 | ) |
| Total stockholders’ equity | |
| 16,042,410 | | |
| 20,628,664 | |
| Total liabilities and stockholders’ equity | |
$ | 21,499,726 | | |
$ | 24,742,585 | |
CO-DIAGNOSTICS,
INC. AND SUBSIDIARIES
CONSOLIDATED
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(Unaudited)
| | |
Three Months Ended March 31, | |
| | |
2026 | | |
2025 | |
| Product revenue | |
$ | 145,954 | | |
$ | 50,277 | |
| Total revenue | |
| 145,954 | | |
| 50,277 | |
| Cost of revenue | |
| 193,768 | | |
| 21,590 | |
| Gross profit (loss) | |
| (47,814 | ) | |
| 28,687 | |
| Operating expenses | |
| | | |
| | |
| Sales and marketing | |
| 467,955 | | |
| 657,030 | |
| General and administrative | |
| 2,503,126 | | |
| 2,773,149 | |
| Research and development | |
| 5,934,071 | | |
| 4,870,019 | |
| Depreciation and amortization | |
| 255,445 | | |
| 280,445 | |
| Impairment charges | |
| - | | |
| - | |
| Total operating expenses | |
| 9,160,597 | | |
| 8,580,643 | |
| Loss from operations | |
| (9,208,411 | ) | |
| (8,551,956 | ) |
| Other income, net | |
| | | |
| | |
| Interest income, net | |
| 6,974 | | |
| 13,601 | |
| Realized gain on investments | |
| - | | |
| 301,465 | |
| Gain on remeasurement of acquisition contingencies | |
| 75,280 | | |
| 717,067 | |
| Loss on equity method investment in joint ventures | |
| (13,361 | ) | |
| (1,444 | ) |
| Total other income, net | |
| 68,893 | | |
| 1,030,689 | |
| Loss before income taxes | |
| (9,139,518 | ) | |
| (7,521,267 | ) |
| Income tax provision | |
| 520 | | |
| 12,004 | |
| Net loss | |
$ | (9,140,038 | ) | |
$ | (7,533,271 | ) |
| Other comprehensive income (loss) | |
| | | |
| | |
| Change in net unrealized gains (losses) on marketable securities, net of tax | |
| - | | |
| (87,790 | ) |
| Total other comprehensive income (loss) | |
$ | - | | |
$ | (87,790 | ) |
| Comprehensive loss | |
$ | (9,140,038 | ) | |
$ | (7,621,061 | ) |
| | |
| | | |
| | |
| Loss per common share: | |
| | | |
| | |
| Basic and Diluted | |
$ | (4.06 | ) | |
$ | (7.05 | ) |
| Weighted average shares outstanding: | |
| | | |
| | |
| Basic and Diluted | |
| 2,253,474 | | |
| 1,068,299 | |
CO-DIAGNOSTICS,
INC. AND SUBSIDIARIES
GAAP
AND NON-GAAP MEASURES
(Unaudited)
Reconciliation of net loss to adjusted EBITDA:
| | |
Three Months Ended March 31, | |
| | |
2026 | | |
2025 | |
| Net loss | |
$ | (9,140,038 | ) | |
$ | (7,533,271 | ) |
| Interest income, net | |
| (6,974 | ) | |
| (13,601 | ) |
| Realized gain on investments | |
| - | | |
| (301,465 | ) |
| Depreciation and amortization | |
| 255,445 | | |
| 280,445 | |
| Change in fair value of contingent consideration | |
| (75,280 | ) | |
| (717,067 | ) |
| Stock-based compensation expense | |
| 219,114 | | |
| 875,228 | |
| Income tax provision | |
| 520 | | |
| 12,004 | |
| Adjusted EBITDA | |
$ | (8,747,213 | ) | |
$ | (7,397,727 | ) |
