Co-Diagnostics Inc New

Hello, and thank you for standing by. My name is Tiffany, and I will be your conference operator today. At this time, I would like to welcome everyone to the Co-Diagnostics, Inc. Third Quarter 2025 Earnings Webcast. 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 that time, simply press star then the number one on your telephone keypad. I would now like to turn the call 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 third quarter ended September 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 the call to analyst Q&A. Before we begin, we would like to inform listeners that certain statements made by CoDiagnostics during this call, which are not historical facts, are forward-looking statements. In addition to diagnostic test developments and timing for commencement of clinical evaluations, This includes statements concerning the company's CODIX 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-diagnostic 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 reconciliations 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, everyone, for joining us today and for your continued support of Co-Diagnostics. As we head into the final stretch of the year, it is shaping up to be one of the most active and important times for our business. Over the past 45 days alone, we've shared several important updates, which are all part of our plan to position CoDiagnostics for its next phase of growth. Each of these steps brings us closer to our goal, building a stronger, more resilient CoDiagnostics operationally, financially, and strategically. Importantly, these developments are the effect of cumulative growth, and every initiative that we are currently working on connects to a broader strategy designed to create lasting value for shareholders. Over the coming months, our team is focused on executing across four main growth pillars. First, we recently announced the engagement of Maxim Group to assist in identifying potential strategic alternatives for the company's Indian joint venture, Cosera Diagnostics, which may include a merger with a special purpose acquisition company, or SPAC, or similar entity listed on a U.S. national securities exchange. We believe such a transaction may unlock value from our joint venture project in India and support our long-term funding strategy. Second, the Comira joint venture with Arabian Eagle which marks the next step in our international expansion and commercial footprint as we expand our presence in Saudi Arabia and 18 additional MENA nations. Third, our AI business unit, which is driving innovation, operational efficiency, and new data-driven opportunities. And finally, the initiation of our upcoming upper respiratory multiplex test clinical evaluations, which highlights our scientific leadership and reinforces our domestic credibility. Together, these initiatives form a complete and aligned strategy focused on financial strength, global reach, technological innovation, and disciplined execution. This is how we're approaching the remainder of 2025 and preparing the foundation for 2026 and beyond. This period represents a key inflection point for co-diagnostics and reflects years of execution to reach this stage of momentum and readiness. With that context in mind, let's begin with the first and most time-sensitive development, the SPAC. One of the most exciting updates is our planned COSERA SPAC transaction with Maxim Group. This is a major step that we believe can unlock real value for both our operations in India and for co-diagnostics as a whole. The funds raised in this transaction are expected to represent a significant infusion of growth capital for COSERA operations in India and to increase co-diagnostics value as well. Preparation for the transaction is progressing according to plan. and we expect to share updates on this project over the next several weeks and months. Combined with recent fundraising activities, this transaction has the potential to provide both flexibility and financial stability as we move into 2026 and begin commercialization of the new platform. This is a proactive step that has the potential to strengthen our balance sheet and create a clear path toward long-term, sustainable value creation for our shareholders. I look forward to providing more updates on this transaction as they occur. Shifting focus, the next major component of our growth strategy is the Comira joint venture. Our recently announced joint venture with Arabian Eagle Manufacturing has led to the formation of a new company named Comira Diagnostics, which, along with Costera, will stand as one of the cornerstones of our international expansion strategy. The principles of Arabian Eagle ran the primary distributor in the Middle East and were instrumental in Kingdom of Saudi Arabia, or KSA, being one of the largest international markets for the company's logic smart tests. Under the terms of the definitive agreement signed in the KSA, we have established Comira to localize our Codex PCR platform and other PCR-related intellectual property across the Middle East and North Africa. The partnership covers 19 countries, creating a significant commercial footprint in a high-growth region. FOMERA will be headquartered in Riyadh, with a dedicated manufacturing and assembly facility designed to produce PCR tests for infectious diseases and other applications relevant to the region's healthcare needs. The venture will initially focus on local manufacturing and distribution of the COTIX PCR platform with plans to expand into custom assay development and AI-enhanced diagnostics. The initiative aligns with the KSA's Saudi Vision 2030, supporting technology localization, industrial diversification, and regional healthcare innovation. The regulatory pathway is anchored in obtaining Saudi Food and Drug Authority, SFDA, clearance to facilitate regional distribution and regulatory acceptance across other MENA markets. OMIRA will combine co-diagnostics molecular testing technology with Arabian Eagle's expertise in regional operations, infrastructure, and local market access. The agreement marks a major step in localizing advanced molecular diagnostics within the Middle East and positions co-diagnostics as a strategic partner in regional public health resilience. This milestone demonstrates that our international growth strategy has advanced from concept to execution and reflects the strong, high-value partnerships we continue to build globally. While this global initiative expands our reach outside the United States, we remain equally focused on commercialization and on advancing innovation through our AI business unit and other technology-driven initiatives. Another key part of our strategy is our new AI business unit led by our chief technology and AI officer, Christopher Thurston. This team is bringing all our current and future AI projects under one umbrella, the Codex Primer AI platform. Additionally, our AI business unit is designed to accelerate the development of proprietary AI-powered diagnostics, enhance data analytics, and improve operational efficiency across the organization. Integrating AI into our workflows will enable faster, smarter, and more scalable testing processes while minimizing human error and improving efficiency at the point of care. These tools will support real-time PCR diagnostics, advanced co-primers design and optimization, and automate interpretation to improve outcomes in both lab and field environments. Our AI models are also being designed to deliver predictive epidemiological insights, giving healthcare providers and public health authorities earlier warning signals and improve situational awareness during potential outbreaks. Over time, The system is expected to leverage analytics from widespread deployment of the CodeX PCR Pro to anticipate disease patterns and possibly predict outbreaks before they occur. As necessary, some of these models will be built on a secure HIPAA-compliant cloud platform with a new business unit form to integrate internal data, workflow orchestration, and AI-driven analysis into a single cohesive framework. This initiative underscores our commitment to staying at the forefront of innovation by combining advanced AI technology with our proven PCR expertise. Importantly, this program will position co-diagnostics to participate in one of the most dynamic growth areas in healthcare technology while building valuable new intellectual property and data assets. This is not simply an upgrade to existing systems. It is a transformational step that redefines what diagnostics can achieve in speed, accuracy, and real-time intelligence. As we continue to innovate technologically, we are also executing scientifically through our Flu A, B, COVID-19, and RSV multiplex test clinical evaluation program, which further validates our progress and credibility in core diagnostics. We are preparing to initiate clinical evaluations for the upper respiratory multiplex test in the immediate future, a key milestone for co-diagnostics. This test is designed to simultaneously detect flu A, flu B, COVID-19, and RSV, making it the most comprehensive respiratory panel in our portfolio. The test has been supported by a Radix Tech grant from the National Institutes of Health, or NIH, underscoring both the credibility and importance of this work. RADx tech program was created to accelerate innovation in diagnostic testing and our participation validates the strength of our technology and its public health relevance. This trial represents the culmination of extensive planning and development and marks the first CODIx multi-pathogen test to enter human clinical evaluation. The upper respiratory panel addresses a critical need in the domestic market by combining accuracy, speed, and multiplex capability within a single point-of-care platform, and we are pleased to be delivering on our commitment to initiate clinical evaluations in this flu season. The data from this trial will be used to support future regulatory submissions and commercial readiness for the U.S. market and potentially for regulatory submissions in other markets as well. such as the SFDA in parallel with the US FDA submission. Initiating this study is a major step forward for our domestic business and a meaningful validation of our scientific and technical leadership. This test has generated consistent interest from both investors and potential partners, particularly those focused on high volume US respiratory testing demand. The global market size for infectious disease diagnostics is expected to grow to 73.56 billion by 2030, and the demand for rapid, accurate point-of-care diagnostics is driving an expanded opportunity for multiplex tests in the infectious disease testing market. The largest single geographical market for these tests is in North America, although the market for respiratory infections disease testing in the Middle East is also expanding. This is largely influenced by substantial investments in the Kingdom of Saudi Arabia and the KSA's commitment to improving public health in alignment with the Saudi Vision 2030 program. This program represents a rigorous NIH-supported multiplex evaluation with strong commercial potential and is a key component in reinforcing our reputation for execution and reliability within the diagnostics industry. In short, this milestone demonstrates that co-diagnostics is executing, not just planning, and delivering tangible scientific progress that supports both near-term and long-term growth. Looking at our other programs, like CODIAC's PCR-MTB or tuberculosis test and CODIAC's PCR-HPV8-type multiplex test both remain on track to initiate clinical evaluations before year-end, as stated in previous communications. Both tests have been supported by grants from the Bill and Melinda Gates Foundation and are anticipated to significantly contribute to our international expansion ambitions and represent key components in our goals to provide gold standard solutions for unmet needs in various markets that are only anticipated to expand over the coming years. We believe that the introduction of competitively priced diagnostics into markets anxious to gain the upper hand against the spread of deadly and often devastating infections, will position Codex as a leader in innovation and point-of-care PCR diagnostics. Taken together, the initiatives we have discussed today, including the Coursera SPAC transaction, the Comirat joint venture, the launch of our AI business unit, the imminent domestic clinical evaluations, and the upcoming clinical evaluations of the other tests in our pipeline, all reflect the significant progress CoDiagnostics has made over the past several months. Each of these milestones strengthens a different part of our business, from capital structure and international growth to innovation and scientific validation. Collectively, they demonstrate that our strategy is working, our execution is on track, and our team remains focused on creating lasting value for shareholders. Over the last few months, we also closed two strategic direct offerings, totaling gross proceeds of $10.8 million. We are entering the next phase of growth from a position of strength, supported by a robust balance sheet, a growing pipeline, and a clear path toward both near-term and long-term milestones. With that, I'll now turn the call over to Brian Brown, our Chief Financial Officer, to provide an update on our financial performance and outlook.