Co-Diagnostics Reports First Quarter 2026 Financial Results

Original from: Co-Diagnostics

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

Source: Co-Diagnostics Reports First Quarter 2026 Financial Results