DATE
Thursday, Aug. 13, 2026 at 4:30 p.m. ET
CALL PARTICIPANTS
- Andrew Benson, Head of Investor Relations
- Dwight H. Egan, Chief Executive Officer
- Brian L. Brown, Chief Financial Officer
Key Takeaways
- Revenue reached $166,131, reflecting a slight increase from $162,910, primarily driven by higher product revenue.
- Net loss narrowed to $6.3 million, or $1.46 per share, from $7.7 million, or $7.00 per share, due to reduced operating costs.
- Operating expenses decreased to $6.3 million from $8.2 million, driven by lower general and administrative and research and development costs.
- Research and development expenses were $4.2 million, down from $4.7 million, reflecting lower personnel and stock-based compensation expenses.
- General and administrative expenses decreased to $1.5 million from $2.6 million, reflecting reduced legal and personnel costs.
- Cash and cash equivalents stood at $3.6 million at quarter end, down from $11.9 million at the end of 2025.
- Adjusted EBITDA loss improved to $5.8 million from $7.2 million in the prior year period.
- Private placement proceeds of $3.0 million were generated through an at-the-market placement under Nasdaq rules to support strategic initiatives.
- Over 1,400 symptomatic patients across nine geographically diverse U.S. clinical sites supported the 510(k) submission for the respiratory multiplex test.
- More than 10,000 individual test runs across 27 studies were conducted to validate the Co-Dx PCR Pro instrument.
- Vector Smart adoption expanded to 21 U.S. states, with four new installations completed during the quarter.
- Gross profit was $120,828, a decrease from $130,804, impacted by cost variability at limited revenue levels.
- Total assets were $16.6 million as of June 30, 2026, compared to $24.7 million at the end of the previous year.
- Total liabilities were $3.9 million, compared to $4.1 million at the end of 2025.
- Inventory value was $841,669, reflecting a reduction from $992,397 as of Dec. 31, 2025.
Risks and Outlook
- Cost variability can impact gross margin performance at this stage while revenue levels remain limited.
- The company anticipates continued operating losses in the near term, with priorities focused on the clinical pipeline and regulatory submissions.
Summary
Management at Co-Diagnostics, Inc. (NASDAQ:CODX) discussed the company’s transition from technology development toward commercialization, anchored by the submission of its respiratory multiplex assay to the FDA for 510(k) clearance and CLIA waiver. The company reported a narrowing net loss and maintained focus on disciplined capital allocation while advancing clinical programs in India and manufacturing capabilities in Saudi Arabia. Management described the strategy as building an integrated molecular diagnostics ecosystem that combines hardware, software, and cloud-based connectivity to support decentralized testing markets.
- CEO Egan noted the company reached a significant milestone with the dual 510(k) and CLIA-waived application for the Flu A/B and RSV assay on the Co-Dx PCR platform.
- The company is targeting submissions to the World Health Organization expert review panel for its tuberculosis test later this year to facilitate international procurement.
- Egan stated, “The integrated molecular diagnostic platform was designed to combine hardware, software, connectivity, and data into a scalable ecosystem to support decentralized testing.”
- A proof-of-concept study for an extraction-free, plasma-based Ebola assay was successfully completed on the Co-Dx PCR Pro instrument.
- Management reported that the Saudi Arabian joint venture, CoMira, has secured a manufacturing site in Sudair Industrial City to support localized production.
- The company appointed Wesley C. Lindsey as Chief Scientific Officer to lead scientific and regulatory strategy for the expanding product pipeline.
Industry Glossary
- 510(k): A premarket submission made to the FDA to demonstrate that a medical device is safe and effective.
- CLIA-waived: A regulatory status for simple laboratory tests with a low risk for an erroneous result, allowing them to be used in non-traditional laboratory settings.
- Co-Dx PCR Pro: The company’s proprietary point-of-care diagnostic instrument.
- Vector Smart: The company’s business line focused on molecular testing for mosquito-borne diseases.
- CE-IVD: A certification marking indicating a product meets European Union safety and performance requirements for in vitro diagnostics.
- ERPD: The World Health Organization’s Expert Review Panel for Diagnostics, which evaluates tests for procurement eligibility.
During the second quarter 2026 earnings call, Co-Diagnostics leadership outlined significant progress in transitioning from platform development to commercialization. CEO Dwight H. Egan highlighted the successful submission of a dual 510(k) and CLIA-waived application to the FDA for the Flu A/B and RSV assay on the Co-Dx PCR platform, marking a pivotal regulatory milestone. The company also advanced its tuberculosis program in India, targeting submissions to CDSCO and the WHO Expert Review Panel for international procurement. Additionally, a proof-of-concept study for an extraction-free, plasma-based Ebola assay was completed on the Co-Dx PCR Pro instrument, demonstrating the platform’s versatility beyond traditional swab-based testing. CFO Brian L. Brown reported financial results including $166,131 in revenue, a narrowed net loss of $6.3 million, and improved adjusted EBITDA figures. The company maintained focus on disciplined capital allocation, with cash reserves of $3.6 million at quarter end, and continued expansion of its Vector Smart mosquito surveillance platform across 21 U.S. states. Strategic initiatives included manufacturing partnerships in Saudi Arabia and India, along with the appointment of Wesley C. Lindsey as Chief Scientific Officer to strengthen regulatory and scientific strategy.
