Co-Diagnostics — Third Quarter 2026 Earnings Summary

Financial Performance:

• Revenue was $0.3 million for the quarter, up from $0.1 million in the third quarter of 2025.
• Operating expenses were $6.2 million, a 12% decrease year-over-year from $7.1 million in Q3 2025, driven by lower personnel and stock-based compensation expenses and reduced Co-Dx PCR platform development costs, partially offset by higher legal and professional services expenses.
• Operating loss was $6.3 million, improved from a $7.0 million loss in the prior-year period.
• Net loss was $6.3 million ($1.01 per basic and diluted share), compared to a net loss of $5.9 million ($4.66 per share) in Q3 2025; the increase in loss was primarily due to an income tax benefit recognized in the prior year, partially offset by reduced operating expenses.
• Adjusted EBITDA loss was $5.9 million, an improvement from a $6.3 million loss in Q3 2025.
• Cash and cash equivalents totaled $0.7 million as of September 30, 2026, down from $11.9 million as of December 31, 2025.
• For the nine months ended September 30, 2026, operating expenses were $21.7 million and net cash used in operating activities was $20.7 million, compared to $23.9 million and $22.9 million, respectively, in the prior-year period.
• Deferred revenue was $2,000 as of September 30, 2026, down from $14,800 as of December 31, 2025.

Business Segments and Product Lines:

• Submitted a 510(k) premarket notification and concurrent CLIA Waiver by Application to the U.S. FDA for the Co-Dx PCR Flu A/B & RSV test on the Co-Dx PCR Pro instrument, supported by a clinical study of over 1,400 symptomatic patients at nine U.S. sites.
• Submitted the CoSara PCR MTB test (point-of-care tuberculosis test) to India's Central Drugs Standard Control Organization (CDSCO) following completion of a clinical performance study on 676 samples, which demonstrated average sensitivity of 97.3% and specificity of 96.0%.
• Entered a collaboration with ReadyGo Diagnostics to evaluate blood-based molecular testing at the point of need, initially focusing on decentralized Ebola detection.
• Completed a proof-of-concept study for an extraction-free Co-Primers Ebola assay using diluted plasma on the Co-Dx PCR Pro instrument, the company's first plasma-based assay for the platform.
• Launched integrated cloud and mobile infrastructure in India to support tuberculosis clinical work, enabling result analysis on mobile devices without internet and cloud synchronization when connectivity is available.
• Shipped Vector Smart laboratory equipment, consumables, and reagents to an overseas U.S. Air Force base, marking the first international deployment of the platform.
• Completed two new Vector Smart laboratory installations in Florida, with installation and training underway at an additional laboratory in Indiana, expanding the network to 21 U.S. states.
• Secured an order for a full Vector Smart mosquito surveillance laboratory installation from the Ute Indian Tribe Mosquito Abatement Department.
• Demonstrated automation of the test-cup manufacturing line, reducing cycle time by approximately 45% and increasing output by approximately 74% compared to manual processes.
• Advanced CoSara's Bundibugyo virus and pan-Ebola tests for centralized laboratories and responded to a request from India's Centre for Cellular and Molecular Platforms for third-party evaluation of the Bundibugyo test.

Management Commentary and Tone:

• Dwight Egan, Chief Executive Officer, stated the third quarter was a period of significant regulatory and operational progress, highlighting two regulatory submissions under review in India and the U.S.
• Management emphasized a focus on supporting regulatory reviews, advancing feasibility work with ReadyGo, and continuing to grow the Vector Smart platform.
• Wes Lindsey, Ph.D., MBA, was appointed Chief Scientific Officer, bringing over 20 years of experience in molecular diagnostics and leading the company's work with the FDA.

Other Key Points:

• Subsequent to the quarter end, the company completed a senior secured convertible debt financing with J.J. Astor & Co., securing approximately $2.1 million in initial funding before transaction expenses, with up to an additional $1.0 million available subject to specified conditions.
• The Co-Dx PCR platform (including PCR Home, PCR Pro, mobile app, and associated tests) remains subject to regulatory review and is not yet available for sale.
• The company participated in global health forums including the UNOPS near point-of-care TB workshop in Bangkok, the joint WHO, Unitaid, and UNAIDS Annual Consultation in Geneva, and events during UN General Assembly week.
• Sputum sample-preparation technology developed for the TB program could provide a foundation for plague diagnostics on the Co-Dx PCR Pro platform if a public health need arises.