CODX Q3 2026 earnings call transcript, November 10, 2026

Thank you all for participating in today's conference call. On the line today from co-diagnostics, we have Dwight. Egan, Chief Executive Officer. Earlier today, co-diagnostics released financial results for the third quarter ended September 30th, 2026. A copy of the press release is available on the company's website. Today's call will consist of

shortly before this call, which contains reconciliation to the non-GAAP financial measures presented to the most comparable GAAP results. At this time, I would like to turn the call over to co-diagnostics chief executive officer.

Thank you, everyone, for joining us today and for your continued support of co-diagnostics. We're going to keep today's remarks brief and focused on... what we've accomplished during the third quarter and in the weeks since. Since we last spoke, our joint venture, Cocera Diagnostics, completed the clinical... ...performance study for our point-of-care tuberculosis test in India and submitted the test to India's Central Drug Standard Control Organization, or CDSCO. That submission joins the... ...510 and CLIA waiver by application for our Flu A, B, and RSV test, which we submitted to the FDA in August. We now have two regulatory submissions under review. We also announced a collaboration with Ready-Go Diagnostics to evaluate blood-based molecular testing at the point of need. Launched our integration... ...credited cloud and mobile infrastructure in India and completed the first international deployment of our VectorSmart platform. Let me start with India, where we recently achieved one of the... ...most significant milestones in the company's history. When we spoke in August, clinical studies of the COSERA PCR MTB test on the COSERA PCR Pro instrument were underway. ...across select laboratories in India. The COSERA team has since completed the testing of clinical samples, and the final clinical study report has been submitted to the CDSCO as part of COSERA... ...application. In the samples that were paired with MGIT liquid culture, the reference standard for TB detection...

...tests demonstrated an average sensitivity of approximately 97.3% and an average specificity of approximately 96% across three loss. The scale of the need in India is what makes this milestone so important. India accounts for approximately one quarter of the world's tuberculosis cases. Highest burden of any country, according to the World Health Organization's Global Tuberculosis Report 2025. Globally, TB remains the world's leading cause of death from a single... ...infectious agent, with an estimated 10.7 million people falling ill and 1.23 million deaths in 2024, according to the World Health Organization. Turning to the U.S., in August, we submitted our dual 510 and CLIA waiver by application to the FDA for our flu, A, B, and RSV tests on the CODX. PCR platform. The submission remains under FDA review. Alongside our regulatory work, in September, we announced a collaboration with ReadyGo Diagnostics. A UK-based developer of field sample preparation technology to evaluate blood-based molecular testing at the point of need, with an initial focus on decentralized Ebola detection and outbreak. response. To date, the CODX-PCR platform has been designed around swab-based samples. The collaboration is evaluating whether blood can be added as a compatible sample type. The collaboration builds on the proof-of-concept study we completed in July, in which an extraction-free CODX-PCR primer's Ebola assay using diluted plasma RAN on the PCR Pro, our first plasma-based assay designed for the instrument. We have taken delivery of ReadyGo's materials and devices.

Under a material transfer agreement and feasibility work is underway. This is a non-exclusive early stage development collaboration and compatibility of the two technologies has not yet been established. Separately on Ebola, COSERA advanced its Bundabugio virus and pan-Ebola tests for centralized laboratories during the quarter and responded to a request. From India's Center for Cellular and Molecular Platforms, or C-CAMP, for third-party evaluation of its Bundabugio test. In September, we launched our integrated... cloud and mobile infrastructure in India, which supports our TB clinical work. Here is how it works in practice. Samples are processed on the... PCR Pro results are analyzed directly on a mobile device, even in decentralized settings without an internet connection. And data from the test... are synchronized to the cloud when connectivity is available. The India deployment is supported in part by funding from the Gates Foundation. That architecture is designed to securely connect molecular testing, clinical workflows, and population-level health insights. Our strategy was never just to develop a standalone diagnostic instrument. We built an integrated molecular diagnostics platform that combines hardware, software, connectivity, and data into a system. a single scalable ecosystem. Finally, turning to VectorSmart, in September, we completed the first international deployment of the platform.

through an order from an overseas U.S. Air Force base. Domestically, VectorSmart has served approximately 40 customers across 21 U.S. states. During the quarter, we completed two full laboratory installations in Florida, and began installation and customer training in Indiana. An additional state public health laboratory also completed an independent evaluation of our VectorSmart. VZDC assay. Subsequent to quarter end, the Ute Indian Tribe Mosquito Abatement Department in northeastern Utah ordered a full VectorSmart. Laboratory installation. Together with the Air Force order, it shows our customer base extending beyond traditional state and county programs. Executive. Order 14433, signed in September, establishes a national initiative to address tick and mosquito-borne diseases and directs the department. of Health and Human Services to pursue prize competitions or research and development programs for rapid diagnostics within 90 days. Several of the diseases identified. in the order are already targeted by VectorSmart assays. The CODX sales team is actively pursuing these opportunities. VectorSmart demonstrates the versatility of our. platform and our ability to address public health applications beyond traditional clinical diagnostics. Stepping back the milestones we. discussed today reflect another quarter of disciplined execution across our core strategic priorities. During the quarter and in the week since, we advanced two major regulatory submissions completed our.

TB clinical study in India began evaluating blood based testing with ready go launched our connected infrastructure in India and completed the first international deployment of vector smart. Before I close, a brief word on our financial results, which are detailed in the press release we issued earlier today and in our Form 10-Q. Over the past several quarters, we have taken deliberate steps to make the company more efficient. This is reflected in our results. Third quarter operating expenses were 6.2. million compared to 7.1 million in the third quarter of 2025, a 12% decrease. For the first nine months of the year, net cash used in operating activities was 20.7 million. compared with 22.9 million in the same period last year. That concludes our prepared remarks.

Thank you again for joining us today, and we look forward to updating you now. next quarter.

rest of your day.