Co-Diagnostics Q3 2026 Earnings Call - Two Regulatory Submissions Now Under Review as TB Study Hits 97.3% Sensitivity

Operator: Thank you for standing by. At this time, I would like to welcome everyone to the Co-Diagnostics Inc. Third Quarter 2026 Earnings Webcast. All lines have been placed on mute to prevent any background noise. I would now like to turn the conference over to Rob Kelly, Vice President of Investor Relations at KCSA. Please go ahead.

Rob Kelly, Vice President of Investor Relations, KCSA: Good afternoon, everyone. 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 30, 2026. A copy of the press release is available on the company’s website. Today’s call will consist of prepared remarks from management only, and there will be no question-and-answer session. Before we begin, we would like to remind listeners that certain statements made by Co-Diagnostics during this call, which are not historical facts, are forward-looking statements. This includes statements concerning diagnostic testing development, the status of regulatory reviews by the U.S. Food and Drug Administration and India’s Central Drugs Standard Control Organisation, our collaboration with ReadyGo Diagnostics, and the company’s Co-Dx PCR testing platform, which requires regulatory approval and marketing authorization for diagnostic use and is not currently for sale.

Actual outcomes and results may differ materially from what is expressed or implied in any statement. Important factors which could cause actual results to differ materially from those in these forward-looking statements are detailed in Co-Diagnostics’ filings with the SEC. Co-Diagnostics assumes no obligation and expressly disclaims any duty to update any forward-looking statements to reflect events or circumstances occurring after this call or to reflect the occurrence of unanticipated events. In addition, the company may discuss certain non-GAAP financial measures during today’s call. These non-GAAP financial measures should not be considered a replacement for and should not be read together with GAAP results. We refer you to the company’s earnings release issued shortly before this call, which contains reconciliations 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, Dwight Egan.

Dwight?

Dwight Egan, Chief Executive Officer, Co-Diagnostics Inc.: 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, CoSara Diagnostics, completed the clinical performance study for our point-of-care tuberculosis test in India and submitted the test to India’s Central Drugs Standard Control Organisation, or CDSCO. That submission joins the 510(k) and CLIA Waiver by Application for our Flu A/B & RSV test, which we submitted to the FDA in August. We now have two regulatory submissions under review. We also announced a collaboration with ReadyGo Diagnostics to evaluate blood-based molecular testing at the point of need, launched our integrated cloud and mobile infrastructure in India, and completed the first international deployment of our Vector Smart 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 CoSara PCR MTB test on the CoSara PCR Pro instrument were underway across select laboratories in India. The CoSara team has since completed the testing of clinical samples, and the final clinical study report has been submitted to the CDSCO as part of CoSara’s application. In the samples that were paired with MGIT liquid culture, the reference standard for TB detection, the test demonstrated an average sensitivity of approximately 97.3% and an average specificity of approximately 96% across three lots. 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, the 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(k) and CLIA Waiver by Application to the FDA for our Flu A/B & RSV test on the Co-Dx PCR platform. The submission remains under FDA review. Alongside our regulatory work, in September, we announced a collaboration with ReadyGo Diagnostics, a U.K.-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 Co-Dx 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 Co-Primers 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, Co-Diagnostics advanced its Bundibugyo virus and pan-Ebola tests for centralized laboratories during the quarter and responded to a request from India’s Centre for Cellular and Molecular Platforms, or C-CAMP, for third-party evaluation of its Bundibugyo 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 single scalable ecosystem. Finally, turning to Vector Smart, in September, we completed the first international deployment of the platform through an order from an overseas U.S. Air Force base. Domestically, Vector Smart 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 Vector Smart VZDC assay. Subsequent to quarter end, the Ute Indian Tribe Mosquito Abatement Department in northeastern Utah ordered a full Vector Smart laboratory installation. Together with the U.S. 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 Vector Smart assays. The Co-Diagnostics sales team is actively pursuing these opportunities.

Vector Smart demonstrates the versatility of our platform and our ability to address public health applications beyond traditional clinical diagnostics. Stepping back, the milestones we’ve discussed today reflect another quarter of disciplined execution across our core strategic priorities. During the quarter and in the weeks since, we advanced two major regulatory submissions, completed our TB clinical study in India, began evaluating blood-based testing with ReadyGo, 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 next quarter.

Operator: That concludes our webcast. Thank you for your participation. You may now disconnect, and have a wonderful rest of your day.