Co-Diagnostics Inc New

Thank you for standing by. My name is Cass and I will be your conference operator today. At this time, I would like to welcome everyone to the co-diagnostics first quarter 2025 earnings call. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. If you would like to ask a question during this time, simply press star followed by the number one on your telephone keypad. If you would like to withdraw your question, simply press star 1 again. I would now like to turn the call over to Andrew Benson, Head of Investor Relations. 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 first quarter and in March 31, 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, are forward-looking statements. This includes statements concerning the company's CoDx 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 Co-Diagnostics Chief Executive Officer Dwight Egan. Dwight.

Thank you, Andrew, and good afternoon, everyone. Thank you for joining CoDiagnostics' first quarter 2025 earnings call. During the first quarter, we continued to advance our CODIX PCR platform and associated test pipeline towards initiating clinical evaluations. I am proud of the work our team has done as we seek to bring our low-cost, rapid, and easy-to-use platform to the point-of-care market. Our mission at CoDiagnostics is to increase the accessibility of affordable, high-quality diagnostics in the United States, India, and around the world, and we are nearing several important development milestones in pursuit of that vision, including the commencement of clinical studies for critical indications. As discussed in previous calls, the test pipeline for the new platform includes our diagnostic tests for tuberculosis, or TB, COVID-19, four-plex respiratory panel, and eight-plex HPV panel. Over the past several years, these indications have developed into the most immediate opportunities for our unique technology and platform to impact the current standard of care and ultimately patient outcomes. Throughout our development efforts, we have been supported by several leading organizations who share in our passion for improving the global health infrastructure including the Bill and Melinda Gates Foundation, Smart4TB, and the National Institute of Health's RADx Tech Program. We remain highly focused on bringing our COTIX PCR platform to market, including several advancements that have been developed by our scientific, engineering, and software development teams. These new platform developments will be incorporated into our instrument and test kits as part of upcoming regulatory submissions which we anticipate will drive operating and manufacturing efficiencies down the line for our current and future tests. The design for the augmented COTIX PCR COVID-19 test has been completed, and the test has undergone extensive verification testing, and we have full confidence in the test performance and stability. We plan to submit this updated version of our COVID-19 test to the FDA with a 510K application after updated clinical data has been collected. We are excited about the disruptive potential of our platform and will continue to work tirelessly to introduce this powerful new diagnostic solution to the market. We are pleased by the work that we have done on our TB test so far this year. As discussed last quarter, we have already completed several preliminary analytical studies as well as testing on clinical samples to confirm performance. Moreover, we have identified instruments for the TB sample prep, which takes place prior to samples being added to the COTIX PCR-MTB test cup, enabling an efficient and affordable workflow process. This step is crucial to the commercial launch and success of the TB test, and we believe we are in a great position as we prepare for upcoming clinical evaluations. We are very excited about the potential of this testing solution to provide low cost, high accuracy, real time point of care diagnostics around the world to combat tuberculosis, which remains the leading global infectious disease killer. We see particular need for our TB test in locations like India, our top priority market for TB testing, where we have significant experience, including regulatory, commercial, and manufacturing infrastructure through our joint venture, COSERA Diagnostics. We expect to begin clinical evaluations in India and South Africa in the back half of 2025, gathering data that will be utilized to support regulatory submissions to the Central Drug Standard Control Organization, or CDSCO, in India, and the South Africa Health Products Regulatory Agency, or SAFRA, in Africa. In our clinical evaluation preparations, we continue to engage with local health officials in those regions and potential customers to evaluate the most effective and efficient commercialization strategy. Elsewhere, our team continues to make significant progress on our fourplex respiratory panel, which has been developed with a grant support from the NIH's Radix Tech Initiative. The test has been designed to deliver simultaneous real-time PCR test results for flu A and B, COVID-19, and RSV. Market research has identified a considerable amount of interest in this panel, which we believe is warranted by the burden these diseases place on everyday life in the United States and around the world. Core to our value proposition is the capability to provide de-identified data to health departments at the local, regional, national, or international level to help track outbreaks of infectious diseases, thanks to the cloud-based analysis of tests performed on the CODIX PCR Pro. This situational awareness can provide health officials with key data and insights that could save lives and stop outbreaks. In March, we completed a pre-submission to the FDA for the CODIX PCR-PRO Respiratory Multiplex Panel Test Kit. We have been assigned a reviewer and plan to initiate clinical evaluations for this assay in the second half of this year. Rounding out our pipeline, we continue to make good progress in preparing the APLEX HPV panel for upcoming clinical evaluations. This development has been supported by a grant from the Bill and Melinda Gates Foundation, as there is a vast need for HPV testing around the world. HPV is one of the most widespread and common sexually transmitted infections worldwide. Several human papillomavirus subtypes are linked to cervical cancer, which causes hundreds of thousands of deaths annually. We believe the CODIAX 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. Utilizing our co-primaries technology, our HPV assay can simultaneously detect eight different high-risk HPV subtypes from a single cervical swab sample, providing an affordable and accessible tool for patients around the world. During the first quarter, our teams continued to generate performance data for our test, which has met or exceeded internal expectations. With support from our funding partners and key stakeholders, we look forward to initiation of our clinical evaluations, our regulatory submissions, and platform commercialization. We plan to initially pursue regulatory clearance in India for this test before moving to South Africa and other regions. Leveraging our existing footprint in India through COSERA, we believe we are uniquely positioned to serve the Indian market. Before wrapping up, I would like to highlight events that CoDiagnostics attended in the first quarter to build further awareness of the CODIX PCR platform. Following the inauguration of the oligonucleotide synthesis facility in December, in March, we hosted an HPV and cancer symposium to honor International HPV Awareness Day 2025 in India. This was hosted in collaboration with COSERA, which helped to set the stage as we prepare for analytical and clinical studies for our HPV test. We also hosted a booth at BioUtah's Life Sciences Day on the Hill at the Utah State Capitol Rotunda, which showcased our CodexPCR platform for local health constituents and government officials. These events were well attended with a high level of engagement and interest in our platform, We welcome opportunities to engage with local and international potential customers and key stakeholders, which made these events a productive and collaborative experience for the company. To close out, I want to emphasize our commitment to achieving our regulatory objectives and to successfully launching the Codex PCR Pro instrument and test kits to the world. Our team has been working diligently to advance our pipeline of diagnostic solutions which has resulted in a successful first quarter. We are nearing several critical milestones, including clinical evaluations for all of the indications discussed here and a new submission to the FDA for COVID-19. In India, we remain on track to complete the build out of our manufacturing facility before the end of the year, which has already included an oligonucleotide synthesis facility inaugurated last December. giving us additional manufacturing capability in that region. We believe the Kodiak's PCR platform can revolutionize and set a new bar for the affordability, accessibility, and decentralization of infectious disease testing. I am 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.