Company Announcements

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:

• 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 LabsDubai 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 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.

 

 

 

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SOURCE Co-Diagnostics