Co-Diagnostics Reports First Quarter 2026 Financial Results

Published: 2026-05-14 16:02:09 ET CODX

Published on 05/14/2026 at 04:02 pm EDT

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, May 14, 2026 /PRNewswire/ -- 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:

First Quarter 2026 Financial Results:

"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:

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 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.

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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SOURCE Co-Diagnostics