Co-Diagnostics Inc New

Thank you. I'd like to turn the conference over to Andrew Benson, Head of Investor Relations. Andrew, please go ahead.

Good afternoon, everyone. Thank you all for participating in today's conference call. On the line today from CoDiagnostics, we have Dwight Egan, Chief Executive Officer, and Brian Brown, Chief Financial Officer. Earlier today, CoDiagnostics released financial results from the second quarter and in June 30, 2025. A copy of the press release is available on the company's website. We will begin with management's prepared remarks and then open up the call to analyst Q&A. Before we begin, we would like to inform the listeners that certain statements made by CoDiagnostics during this call, which are not historical facts or forward-looking statements. This includes statements concerning the company's CoDiagnostics PCR testing platform, which requires regulatory approval and marketing authorization for diagnostic use and is not currently for sale. in addition to diagnostic test developments and timing for commencement of clinical evaluations. 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 be read together with GAAP results. We refer you to the company's earnings release issued shortly before this call, which contains reconciliation to the non-GAAP financial measures presented to their most comparable GAAP results. At this time, I would like to turn the call over to Code Diagnostics Chief Executive Officer Dwight Egan.

Thank you, Andrew, and good afternoon, everyone. Thank you for joining CoDiagnostics' second quarter 2025 earnings call. The second quarter of this year continued to bring steady advancements of our Codex PCR point of care platform, and thanks to the diligent efforts of our team working towards our goal to bring the instrument and test to market, we remain on track to initiate clinical evaluations for all tests in our pipeline during 2025. In addition to the Codex PCR COVID-19 test, which is expected to imminently begin enrolling participants for its clinical evaluations, the test pipeline for the new platform includes real-time PCR tests for flu A and E, COVID, and RSV. in a four-plex respiratory panel supported by a grant from the National Institute of Health's Radix Tech Program, as well as tests for tuberculosis, or TB, and an HPV eight-type multiplex panel, both of which are supported by grants from the Bill and Melinda Gates Foundation. These indications were identified as amongst the best opportunities in the near term to bring our unique technology and platform to market. and to help advance the co-diagnostics vision of increasing the accessibility of affordable, high-quality diagnostics in the United States, India, and around the world. Our focus remains on bringing the COTIX PCR platform to the point-of-care market, which has included incorporating ongoing advancements developed by our scientific, engineering, and software development teams as we prepare for our upcoming regulatory submissions in the appropriate jurisdictions for each indication. As mentioned in our previous call, the augmented COTIX PCR COVID-19 test underwent extensive verification testing. And we are pleased to report that the clinical evaluation sites for this updated test are currently being trained with testing of trial participants expected to begin imminently. Our plans continue to be to submit a 510K application to the FDA for this updated version of our COVID-19 test after the completion of the clinical evaluations. We look forward to the platform's initial introduction to the market next year and to the disruptive potential of this new diagnostic solution. Perhaps the greatest opportunity for the platform to disrupt the current testing paradigm is through tuberculosis. TB caused an estimated 1.25 million deaths in 2023, according to the World Health Organization, making it the number one infectious disease killer globally. Several preliminary analytical and preclinical studies for the Kodiak's PCR-MTB test have been completed or are currently in process, and testing on clinical samples have demonstrated the high performance properties of the test. We believe that the efficient, affordable workflow process supported by the straightforward mobile app will help to speed adoption at the point of care in areas across India and Africa that have previously had little to no access to gold standard PCR diagnostic technology. For a disease that is highly treatable, if diagnosed early and accurately, The company remains on track to begin clinical evaluations for our TB test in both India and South Africa before the end of 2025, which will gather data to support regulatory submissions to the South Africa Health Products Regulatory Agency, or SAFRA, and the Central Drug Standard Control Organization, or CDSCO, in India, helping to increase the accessibility of high-quality, real-time PCR diagnostics in India has been a focus of the company since the early days of its founding. 27% of global TB cases and 26% of global TB deaths were found in India alone in 2023. And the country continues to be our top priority market for TB testing. Our footprint in India is significantly strengthened by our joint venture, Coursera Diagnostics, who provides substantial experience and regulatory commercial and manufacturing infrastructure in India. Principal manufacturing for tests and instruments will take place in our domestic manufacturing facility in South Salt Lake, inaugurated a little over a year ago, before being completed in the upgraded Kosera Manufacturing Campus prior to distribution and commercialization in India. As we proceed with the preparations for the clinical evaluations, we continue to engage with local health officials and potential customers in both India and Africa to evaluate the most effective and efficient commercialization strategy in specific target markets. We are pleased to report that the Codex PCR-ABCR fourplex respiratory panel is nearly prepared for clinical evaluations expected to begin concurrent with the 2025 North American fall and winter flu season. The test has been designed to deliver simultaneous differentiated real-time PCR test results for patients suspected of having flu A and B, COVID-19, or RSV. It remains the test with the highest domestic demand in our pipeline. driven by the burden these diseases place on everyday life in the United States and around the world. Once complete, the data collected by the clinical evaluations will be used in a 510K application to the FDA. 510K clearance will not only allow the test to be commercialized as an infectious disease in vitro diagnostic in the United States, but also in other countries around the world. to accept US FDA clearance as valid regulatory approval, following a straightforward registration process in those countries. This international commercialization model allowed Codex to achieve significant growth during the pandemic, thanks to the sales of our centralized lab COVID-19 PCR tests. And we believe we'll be able to follow a similar pathway for this new platform. Finally, the Kodiak's PCR HPV 8-type multiplex panel is also on track to initiate clinical evaluations before year-end. HPV is the most widespread and common sexually transmitted infection worldwide. And despite the widespread availability of an HPV vaccine, there remains a vast need for HPV testing around the world. Human papillomavirus has many subtypes. several of which are linked to cervical cancer, which causes hundreds of thousands of deaths annually. We believe the Codex PCR platform can have a significant impact on testing accessibility and efficiency, which remain key constraints to mitigating the impact of HPV on global health. Supported by a grant from the Bill and Melinda Gates Foundation and powered by our co-primers technology, This HPV assay is designed to simultaneously detect eight different high-risk HPV subtypes from a single self-collected vaginal swab sample and differentiate between HPV 16, HPV 18, and HPV 45. These are considered to be the three most carcinogenic HPV variations, collectively responsible for roughly 75% of cervical cancers worldwide. Early detection of HPV can improve intervention and treatment of precancerous cells and lesions before they develop into cervical or other types of cancer. And we believe that a test with these performance characteristics has the potential to dramatically increase the availability of HPV PCR diagnostics around the world. Like TB, the regulatory pathway for this test will follow areas of greatest need in India and Africa. and clinical evaluations to support submissions to the CDSCO and SAFRA are anticipated to begin this year. We look forward to initiation and completion of the upcoming clinical evaluations, regulatory submissions, and commercialization of this test on the Codex PCR Pro. One of the most original and inventive features of the Codex PCR platform is the cloud-based analysis of tests performed on the CODIX PCR Pro, which allows de-identified epidemiological data to be made available to health departments at the local, regional, national, or international level. The ability to track the spread of infectious diseases in real time is often compartmentalized in other testing paradigms, or even absent outright. And we anticipate this situational awareness can provide health officials with key data and insights that could save lives and limit outbreaks. We believe that this feature was a key factor in receiving the support of several leading organizations who share in our passion for improving the global health infrastructure, including the Bill and Melinda Gates Foundation, Smart for TB, and the National Institute of Health's Radix Tech Program. As we near the initiation of clinical evaluations for all four tests currently in our Codex PCR product pipeline and firm up our pathway to commercialization, we anticipate increasing activity at trade shows and other events to continue engaging with local and international potential customers and key stakeholders. Over the past couple of years, we have developed solid relationships with local trade and commerce organizations. some of which support the growth of Utah's businesses by offering grants for their travel and participation in trade shows and conferences. We have been successful in securing grants to help offset the cost of some recent and upcoming events. And we will continue to pursue these and other opportunities to be mindful of our spend while we prepare for our expansion. To conclude, I want to emphasize our commitment to achieving our clinical evaluations and regulatory submission objectives as the next critical steps to successfully launching the Codex PCR Pro instrument and test kits to the world. This pathway remains the most expeditious way to return value to our shareholders, and the foundation we have built for near and long-term success is possible thanks to the investments in infrastructure, technology, and people that we have made along the way. We believe this framework will allow us to replicate the process more quickly and efficiently for other critical infectious disease test panels in the future and can be applied to other areas of interest, such as veterinary, agricultural, and livestock applications. The company remains on schedule to reach the critical milestones discussed here. as well as to expand our manufacturing capacity domestically and in India to be able to scale to meet market demand upon platform launch. We believe the COTIX PCR platform can revolutionize and set a new bar for the affordability, accessibility, and decentralization of accurate gold standard PCR infectious disease testing. I'm very proud of the work of our team and look forward to another quarter of success. With that, I will now turn the call over to Brian to discuss our financial results.