Form 8-K

8-K — Co-Diagnostics, Inc.

Accession: 0001493152-26-014129

Filed: 2026-03-31

Period: 2026-03-31

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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2026-03-31

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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): March 31, 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.

March 31, 2026, Co-Diagnostics, Inc. (the “Company”) issued a press release announcing financial results for its year ended

December 31, 2025. 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 March 31, 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:

March 31, 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 Full Year 2025 Financial Results

Advancing

Global Commercialization Strategy Through CoSara and CoMira Joint Ventures

Progressing

Clinical Pipeline and Regulatory Pathways for PCR Platform

Strengthening

Technology Leadership with AI Integration and Expanding IP Portfolio

Salt

Lake City, UT – March 31, 2026 – Co-Diagnostics, Inc. (NASDAQ: CODX) (“Co-Diagnostics,” “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 full year ended December 31, 2025.

Full

Year 2025 Financial Results:

●

Revenue

of $0.6 million, compared to $3.9 million in 2024, primarily due to lower grant revenue

●

Operating

expenses of $50.6 million, compared to $43.0 million in 2024, driven by a non-cash impairment charge of $18.9 million from revaluation

of intangible assets

●

Operating

loss of $50.2 million, compared to $40.1 million in 2024

●

Net

loss of $46.9 million, or $35.25 per share, compared to net loss of $37.6 million, or $37.22 per share in 2024, primarily due to

intangible asset impairment charges and lower grant revenue, partially offset by decreases in operating expenses and a benefit from

income taxes

●

Adjusted

EBITDA loss of $28.0 million, compared to a loss of $33.5 million in 2024

●

Cash,

cash equivalents, and marketable investment securities totaled $11.9 million as of December 31, 2025, compared to $29.7 million as

of December 31, 2024

Full

Year 2025 Business Highlights:

●

Closed

$3.8 million offering of 9.62 million shares of common stock at an offering price of $0.40 per share on a pre-reverse split basis

●

Closed

$7.0 million offering of 12.7 million shares of common stock at an offering price of $0.55 per share on a pre-reverse split basis

●

Continued

advancement of CoSara Diagnostics joint venture in India, including regulatory progress and manufacturing readiness for PCR Pro®

instrument*

●

Signed

definitive agreement with Arabian Eagle to establish CoMira Diagnostics joint venture in Saudi Arabia; currently progressing on execution

and finalizing lease for manufacturing facility

●

Initiated

and advanced clinical evaluations of upper respiratory multiplex test

●

Further

progressed development across pipeline programs, including tuberculosis (TB) and HPV tests

●

Expanded

the AI business unit, integrating machine learning capabilities into the Co-Dx™ Primer Ai™ platform

●

Strengthened

the intellectual property portfolio with a new international patent granted in Australia

●

Engaged

Maxim Group to pursue SPAC transaction for CoSara Diagnostics

●

Received

recognition from Utah Governor’s Office and BioUtah for the formation of CoMira Diagnostics

Recent

Developments:

●

Received

CDSCO license to manufacture and sell the CoSara PCR Pro® instrument in India, representing a key regulatory milestone

and enabling commercialization readiness

●

Signed

an agreement to expand CoSara Diagnostics’ commercial and distribution territory across South Asia to include Bangladesh, Pakistan,

Nepal, and Sri Lanka, increasing the regional 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 being aligned with new WHO guidance on TB testing

●

Strengthened

the intellectual property portfolio with a new international patent granted in Japan

“Over

the past year, we made meaningful progress across multiple initiatives that have positioned the Company for its next phase of growth,

including advancing our clinical pipeline, expanding our global footprint, and preparing for commercialization of the platform in 2026,”

said Dwight Egan, Chief Executive Officer of Co-Diagnostics. “Importantly, we have remained focused on execution and continued

to build momentum across the business. Our strategy is centered on four key pillars: advancing CoSara and our broader opportunity in

India, executing on our CoMira joint venture in the Middle East and Northern Africa, progressing our clinical programs toward key regulatory

milestones, and expanding our AI-driven capabilities. Together, these initiatives support our scalable, globally deployable diagnostics

platform and reinforce our focus on long-term value creation.”

Mr.

Egan continued, “Based on dramatically reduced rates of COVID prevalence in our clinical study locations, we are currently planning

on an initial FDA 510(k) submission for our upper respiratory test focused on flu A, flu B, and RSV. As we move forward, we remain committed

to disciplined performance as we advance toward commercialization, and we anticipate that this modified approach will allow us to accelerate

regulatory and commercialization timelines while retaining the flexibility to incorporate COVID into the test at a later stage if conditions

change.

“We

believe the progress we’ve made in our clinical studies and on all other initiatives are creating a clear path to unlock the full

potential of our platform as we enter the next phase of execution in 2026.”

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) 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 to detect and/or analyze 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 loss excluding depreciation, amortization, (gain)

loss on disposition of assets, income tax (benefit) expense, net interest (income) expense, stock-based compensation, change in fair

value of contingent consideration, impairment charges 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

statements regarding (i) advancement into clinical evaluations and continued development and regulatory submissions for the Co-Dx PCR

platform and (ii) our belief that the platform will play a key role in transforming the global accessibility of diagnostic testing solutions.

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 of the anticipated results will occur on a timely basis

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

December 31, 2025

December 31, 2024

Assets

Current assets

Cash and cash equivalents

$ 11,884,607

$ 2,936,544

Marketable investment securities

26,811,098

Accounts receivable, net

190,375

132,570

Inventory, net

992,397

1,072,724

Income taxes receivable

44,559

Prepaid expenses and other current assets

581,527

1,338,762

Total current assets

13,693,465

32,291,698

Property and equipment, net

2,272,098

2,761,280

Operating lease right-of-use asset

1,207,453

2,114,876

Intangible assets, net

7,219,000

26,101,000

Investment in joint ventures

350,569

294,304

Total assets

$ 24,742,585

$ 63,563,158

Liabilities and stockholders’ equity

Current liabilities

Accounts payable

$ 1,878,225

$ 3,294,254

Accrued expenses

865,301

2,562,169

Operating lease liability, current

662,258

915,619

Contingent consideration liabilities, current

119,036

502,819

Deferred revenue

14,800

40,857

Total current liabilities

3,539,620

7,315,718

Long-term liabilities

Income taxes payable

713,643

Operating lease liability

574,301

1,236,560

Contingent consideration liabilities

422,080

Total long-term liabilities

574,301

2,372,283

Total liabilities

4,113,921

9,688,001

Commitments and contingencies (Note 13)

Stockholders’ equity

Convertible preferred stock, $0.001 par value; 5,000,000 shares authorized; 0 shares issued and outstanding as of December 31, 2025 and December 31, 2024, respectively

Common stock, $0.001 par value; 100,000,000 shares authorized; 2,256,654 shares issued and 2,095,031 shares outstanding as of December 31, 2025 and 1,263,408 shares issued and 1,101,785 shares outstanding as of December 31, 2024

67,700

37,902

Treasury stock, at cost; 161,623 shares held as of December 31, 2025 and December 31, 2024, respectively

(15,575,795 )

Additional paid-in capital

116,510,298

102,472,210

Accumulated other comprehensive income

418,443

Accumulated deficit

(80,373,539 )

(33,477,603 )

Total stockholders’ equity

20,628,664

53,875,157

Total liabilities and stockholders’ equity

$ 24,742,585

$ 63,563,158

CO-DIAGNOSTICS,

INC. AND SUBSIDIARIES

CONSOLIDATED

STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

Years Ended December 31,

2025

2024

Product revenue

$ 418,205

$ 770,048

Grant revenue

204,284

3,145,112

Total revenue

622,489

3,915,160

Cost of revenue

222,377

999,124

Gross profit

400,112

2,916,036

Operating expenses

Sales and marketing

2,381,131

4,483,339

General and administrative

9,058,283

16,157,152

Research and development

19,137,242

20,979,589

Depreciation and amortization

1,106,808

1,377,266

Impairment charges

18,882,000

Total operating expenses

50,565,464

42,997,346

Loss from operations

(50,165,352 )

(40,081,310 )

Other income, net

Interest income, net

292,932

1,091,825

Realized gain on investments

683,365

870,745

Gain (loss) on disposition of assets

(82,421 )

8,291

Gain on remeasurement of acquisition contingencies

805,863

714,876

Loss on equity method investment in joint ventures

(46,301 )

(186,067 )

Total other income, net

1,653,438

2,499,670

Loss before income taxes

(48,511,914 )

(37,581,640 )

Income tax provision (benefit)

(1,615,978 )

57,368

Net loss

$ (46,895,936 )

$ (37,639,008 )

Other comprehensive income (loss)

Change in net unrealized gains (losses) on marketable securities, net of tax

(418,443 )

271,743

Total other comprehensive income (loss)

$ (418,443 )

$ 271,743

Comprehensive loss

$ (47,314,379 )

$ (37,367,265 )

Loss per common share:

Basic and Diluted

$ (35.25 )

$ (37.22 )

Weighted average shares outstanding:

Basic and Diluted

1,330,200

1,011,179

CO-DIAGNOSTICS,

INC. AND SUBSIDIARIES

GAAP

AND NON-GAAP MEASURES

Reconciliation of net loss to adjusted EBITDA:

Years Ended December 31,

2025

2024

Net loss

$ (46,895,936 )

$ (37,639,008 )

Interest income, net

(292,932 )

(1,091,825 )

Realized gain on investments

(683,365 )

(870,745 )

Depreciation and amortization

1,106,808

1,377,266

(Gain) loss on disposition of assets

82,421

(8,291 )

Change in fair value of contingent consideration

(805,863 )

(714,876 )

Stock-based compensation expense

2,248,053

5,434,904

Income tax provision

(1,615,978 )

57,368

Impairment charges

18,882,000

Adjusted EBITDA

$ (27,974,792 )

$ (33,455,207 )

Reconciliation of net loss to adjusted net loss:

Net loss

$ (46,895,936 )

$ (37,639,008 )

Impairment charges

18,882,000

Adjusted net loss

$ (28,013,936 )

$ (37,639,008 )

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- Definition

Name of the Exchange on which a security is registered.

+ References

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

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection d1-1

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- Definition

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

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- Definition

Trading symbol of an instrument as listed on an exchange.

+ References

No definition available.

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- 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

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