Form 8-K

8-K — Co-Diagnostics, Inc.

Accession: 0001493152-26-023059

Filed: 2026-05-14

Period: 2026-05-14

CIK: 0001692415

SIC: 3841 (SURGICAL & MEDICAL INSTRUMENTS & APPARATUS)

Item: Results of Operations and Financial Condition

Item: Regulation FD Disclosure

Item: Financial Statements and Exhibits

Documents

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2026-05-14

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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 ☐

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.

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)

EX-99.1

Filename: ex99-1.htm · Sequence: 2

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

801-438-1036

investors@codiagnostics.com

Investor

Contact:

Valter

Pinto, Managing Director

KCSA

Strategic Communications

212.896.1254

CODX@KCSA.com

Media

Contact:

Jennifer

Webb

ColtrinMethod

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

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

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 )

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 )

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May 14, 2026

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Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 14a

-Subsection 12

+ Details

Name:

dei_SolicitingMaterial

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration

- Definition

Trading symbol of an instrument as listed on an exchange.

+ References

No definition available.

+ Details

Name:

dei_TradingSymbol

Namespace Prefix:

dei_

Data Type:

dei:tradingSymbolItemType

Balance Type:

Period Type:

duration

- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Securities Act

-Number 230

-Section 425

+ Details

Name:

dei_WrittenCommunications

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration