Form 8-K

8-K — Co-Diagnostics, Inc.

Accession: 0001493152-26-037739

Filed: 2026-08-13

Period: 2026-08-13

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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2026-08-13

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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): 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 ☐

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.

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)

EX-99.1

Filename: ex99-1.htm · Sequence: 2

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

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)

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

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 )

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 )

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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 pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act.

+ References

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

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Title of a 12(b) registered security.

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

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Name of the Exchange on which a security is registered.

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

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

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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

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Trading symbol of an instrument as listed on an exchange.

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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 written communications pursuant to Rule 425 under the Securities Act.

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

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