Co-Diagnostics (NASDAQ:CODX) reported higher first-quarter revenue but a wider net loss as the molecular diagnostics company continued investing in clinical studies, regulatory submissions and international commercialization plans.
Chief Executive Officer Dwight Egan told investors that the company remains focused on advancing its Co-Dx PCR testing platform, expanding through joint ventures in India and Saudi Arabia, and improving its technology through connectivity, automation and artificial intelligence-driven capabilities. The company noted that the Co-Dx PCR platform requires regulatory approval and marketing authorization for diagnostic use and is not currently for sale.
Upper respiratory test moves toward FDA submission
Because COVID prevalence was lower than expected during the study period, Egan said the company is planning an initial submission focused on flu A, flu B and RSV. He said the approach is intended to advance timelines while leaving open the possibility of incorporating COVID later, if appropriate.
“Based on the company’s assessment, management believes the study has generated the data intended to support a 510(k) submission with the FDA,” Egan said. He added that Co-Diagnostics has kept the clinical study infrastructure in a paused state in case additional data is requested.
The company is now finalizing analytical studies and documentation for a submission seeking clearance for CLIA-waived point-of-care use. Egan said Co-Diagnostics anticipates filing in the third quarter of this year, subject to internal validation, submission preparation and ongoing regulatory assessment.
India strategy centers on CoSara and tuberculosis testing
Egan described India as a core part of the company’s strategy, citing nearly nine years of development through its CoSara Diagnostics joint venture. He said CoSara has a nationwide commercial presence, has served hundreds of laboratory customers and has 15 clinical laboratory PCR tests cleared by the CDSCO, India’s regulatory body.
CoSara has received a CDSCO license to manufacture the PCR Pro instrument, which Egan called an important regulatory milestone. The company is preparing to manufacture the instrument and associated consumables locally in India. Co-Diagnostics also said it has expanded CoSara’s commercial and distribution territory across South Asia, increasing its total addressable market to approximately $13 billion.
Egan said CoSara has reached a stage where it could stand on its own as a public entity, potentially providing another path to capital and creating value for Co-Diagnostics shareholders. He said the company continues to evaluate strategic alternatives, including a potential SPAC transaction, with advisors and potential counterparties under nondisclosure agreements and accessing a data room. No transaction has been agreed to, and Egan said there is no assurance one will result.
CoSara is also central to Co-Diagnostics’ tuberculosis program. Egan said clinical performance studies for TB are scheduled to begin before the end of the month, supporting a future submission to the CDSCO. He said India has the highest global burden of tuberculosis and is the largest country market for TB testing by testing volume.
Egan said recent World Health Organization guidance recommending near point-of-care molecular testing for TB diagnosis, along with tongue swab samples, aligns with the company’s platform and MTB test. He said commercialization in India could begin as early as the end of the third quarter, depending on progress.
Saudi joint venture advances localization plan
Co-Diagnostics is also advancing its CoMira joint venture in Saudi Arabia and the broader Middle East and North Africa region. Egan said Saudi Arabia has historically been the company’s largest international market, and the CoMira initiative is intended to localize the company’s platform within the kingdom and surrounding region.
Last month, CoMira received approval for an industrial land allocation in Sudair Industrial City from MODON. Egan said the company has moved to the next phase of execution, including proceeding with a facility lease and site development. Co-Diagnostics has completed its initial required funding contributions under the joint venture agreement.
Egan said CoMira could become one of the early domestic manufacturers of molecular diagnostics in Saudi Arabia once operational. He noted that domestically manufactured medical products are typically preferred in government procurement processes and said the company expects that preference to extend to molecular diagnostics.
First-quarter financial results
Chief Financial Officer Brian Brown said total revenue for the first quarter of 2026 was $146,000, compared with $50,000 in the same period last year. Cost of revenue was $194,000, resulting in a loss of approximately $48,000, compared with gross profit of $29,000 in the prior-year period.
Total operating expenses rose to $9.2 million from $8.6 million a year earlier, primarily due to higher research and development spending. Research and development expenses were $5.9 million, compared with $4.9 million in the prior-year period, largely driven by spending on upper respiratory test clinical studies.
Sales and marketing expenses decreased to $0.5 million from $0.7 million, while general and administrative expenses fell to $2.5 million from $2.8 million. Brown said those decreases were primarily driven by lower consulting and personnel-related costs.
Net loss for the quarter was $9.1 million, or $4.06 per fully diluted share, compared with a net loss of $7.5 million, or $7.05 per fully diluted share, in the same period last year. Adjusted EBITDA was a loss of $8.7 million, compared with a loss of $7.4 million a year earlier.
Co-Diagnostics ended the quarter with $8.2 million in cash and cash equivalents, compared with $11.9 million at the end of 2025. Brown said the company expects to continue generating operating losses in the near term and that additional capital will likely be required to fully execute its commercialization and development plans. He said the company will evaluate financing alternatives, including equity, debt and strategic partnerships, while also seeking non-dilutive funding opportunities such as grants.
Manufacturing scale-up discussed in Q&A
During the question-and-answer session, Maxim Group analyst Michael Okunewitch asked about manufacturing capacity and scale-up plans. Egan said the company’s Utah facility has produced hundreds of thousands of test cups for clinical studies and internal research and development.
Egan said CoSara’s India facility will initially complete final assembly of TB, HBV and upper respiratory test kits and instruments that are principally manufactured in Utah, with plans to replicate portions of the Utah manufacturing process locally in India over time.
He also said the Utah facility has been preparing an automated test cup manufacturing line that the company expects could improve efficiency by approximately four times in terms of time and overhead. Egan said the automated line is not yet ready but could be deployed by the time the company reaches a certain level of deployment in Asia and Saudi Arabia.
Asked about the India go-to-market strategy, Egan said the company intends to address gaps in access to molecular diagnostics, particularly in primary healthcare facilities and villages where smear microscopy is still used for TB testing. He said CoSara already has a staffed team and established sales routes throughout India, positioning the joint venture to move ahead after regulatory clearance.
About Co-Diagnostics (NASDAQ:CODX)
Co-Diagnostics, Inc is a molecular diagnostics company headquartered in Salt Lake City, Utah, known for its proprietary CoPrimer™ technology. Founded in 2016, the company focuses on the design, development and distribution of molecular diagnostic test kits for the detection of infectious diseases, genetic mutations and other health-relevant biomarkers. Its core platform leverages patented cooperative primers, which are engineered to enhance specificity, sensitivity and cost-effectiveness compared to conventional PCR-based assays.
Through its in-house manufacturing and global supply chain partnerships, Co-Diagnostics produces a range of real-time polymerase chain reaction (qPCR) kits, reagents and customized assay development services.
