Co-Diagnostics, Inc.

Good day, everyone, and thank you all for joining today's CoDiagnostics, Inc. Full Year 2025 Earnings Webcast. As a reminder, all phone participants are in a listen-only mode, but later you will be provided with the opportunity to ask a question during our question and answer session. As a reminder, today's session is being recorded. And it is now my pleasure to turn the floor over to Head of Investor Relations, Mr. Andrew Benson. Please go ahead, sir.

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 fourth quarter and full year ended December 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 listeners that certain statements made by co-diagnostics 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-diagnostics filings with the SEC, including risks related to our ability to obtain regulatory approvals, successfully complete clinical evaluations, secure adequate financing, and achieve commercial adoption of our products. CoDiagnostics 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 contained 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. This continues to be one of the most active and strategically important periods in our company's history. as we execute on the significant opportunity ahead of us and continue to implement our multi-pronged growth strategy. Before we begin, I'd like to briefly touch on our NASDAQ listing status. We want to thank our shareholders for their patience and continued support throughout this process. We were pleased to successfully complete the appeal and have our shares relisted, and we are now firmly focused on moving forward. Importantly, despite this temporary disruption, we remained focused on execution and continued to make meaningful progress across the business. During the reporting period, we advanced several key initiatives that are positioning CoDiagnostics for its next phase of growth. Each of these developments support our goal of strengthening the company, both operationally and financially, as we move closer to commercialization. These efforts are not isolated. They represent cumulative progress with each initiative contributing to a broader integrated strategy designed to create long-term shareholder value. As we look ahead, our focus remains centered on four primary growth pillars. First, progressing our clinical pipeline toward key regulatory milestones, including our upper respiratory program, and additional tests such as TB and HPV. Second, advancing COSERA and our broader strategy in India, including regulatory progress, manufacturing readiness, and evaluating potential strategic alternatives such as a SPAC transaction. Third, continuing execution of our Comir joint venture with Arabian Eagle. which is expanding our international footprint across Saudi Arabia and the broader MENA region. And finally, expanding our AI-driven capabilities to enhance innovation, efficiency, and data-driven insights across our platform. Together, these pillars form a cohesive strategy built around global reach, technological innovation, financial discipline, and scalable execution. This is the framework guiding how we are approaching 2026 and laying the foundation for commercialization and long-term growth. With that context, I'll begin with our COSERA strategy and our progress in India. India has been a core component of our business for nearly eight years. And over that time, we have built a meaningful foundation through our COSERA joint venture in one of the largest healthcare markets in the world. Today, COSERA has established a nationwide commercial presence, serves hundreds of laboratory customers, and has 15 PCR tests cleared through India's regulatory pathway. We are now preparing to manufacture the PCR Pro instrument and associated consumables locally in India, which represents an important step towards commercialization. Importantly, COSERA has received the CDSCO license to manufacture the PCR-PRO instrument, a key regulatory milestone that supports this transition. We have also expanded COSERA's commercial and distribution territory across South Asia to include Bangladesh, Pakistan, Nepal, and Sri Lanka, increasing our addressable market to approximately 13 billion and strengthening our long-term opportunity in the region. As Coursera continues to mature, we believe it has reached a stage where it can stand on its own as a public entity, which we believe may provide an alternative path to access capital and support future growth. We have engaged a financial advisor and are actively exploring strategic alternatives, including a potential SPAC transaction, to support the capital needs required to fully execute on this opportunity. which we expect will enhance value for our shareholders. While we are not in a position to announce a transition today, we have completed multiple presentations with prospective partners, and the process remains active and ongoing. There can be no assurance that any transaction will be completed or on what terms. Beyond a potential SPAC transaction, Coursera represents a key engine for long-term growth We are also preparing to initiate TB clinical performance studies in India, which is the largest single country market for TB diagnostics. This represents one of the most significant near-term commercial opportunities for our platform. Earlier this month, the World Health Organization issued updated guidance recommending near point of care molecular tests for TB diagnosis. along with the use of tongue swab samples for patients who cannot produce sputum. This is an important development for the field, as we believe both our PCR-Pro instrument and our MTB test are directly aligned with this guidance. The importance of tongue swab sampling has been building over time, including throughout our own development efforts supported by the Bill and Melinda Gates Foundation. We designed our test specifically to accommodate this approach, in addition to traditional sputum samples. We believe our platform is well positioned to address emerging needs in TB diagnostics. Preclinical studies conducted by third parties have shown performance that is comparable to, and in some cases exceeds, other commercially available molecular TB tests. We are confident that upcoming clinical studies will further validate the role our tests can play in supporting these new WHO guidelines. We look forward to providing additional updates as COSERA continues to advance. Turning to our Comira joint venture, this initiative remains a cornerstone of our international expansion strategy. Saudi Arabia has historically been our largest international market, and Comira represents the next step in localizing our technology within the region. This model builds on the same approach we have used in India with the goal of establishing local manufacturing and distribution capabilities so products can be produced closer to end markets. We are currently progressing on execution, including finalizing a lease for a manufacturing facility and progressing toward operational readiness across Saudi Arabia in 18 additional MENA markets. Domestically manufactured medical products are typically prioritized in Saudi Arabia's procurement processes, and we anticipate this to extend to molecular diagnostics. Once operational, Comira is expected to be the first domestic manufacturer of molecular diagnostics in the kingdom, which would provide a meaningful competitive advantage. This initiative aligns with Saudi Arabia's broader goals around healthcare innovation. local manufacturing, and supply chain resilience. It also positions CoDiagnostics as a strategic partner in the region's healthcare infrastructure. More broadly, Comira reinforces the scalability of our platform and our ability to deploy it globally in a capital-efficient way. In parallel with our operational progress, we continue to strengthen the intellectual property foundation that supports our platform. Over the past several months, we have received international patents covering key components of the Kodi X PCR platform, including recent patent grants in Australia and Japan. These patents cover core systems, methods, and technologies underlying our PCR Pro instrument and proprietary test cups. The Japanese patent was granted by one of the most rigorous patent offices in the world, further validating the strength and uniqueness of our platform. Expanding our IP portfolio is critical as we move toward commercialization, particularly as we scale internationally through initiatives like COSERA and Comira. These protections help secure our competitive positioning and support our long-term strategy of building a differentiated, globally deployable diagnostics platform. Turning to our clinical pipeline, our upper respiratory multiplex test represents a critical step in advancing our platform toward market readiness. This test was originally designed to detect flu A, flu B, COVID-19, and RSV, and clinical evaluations are progressing well. Based on current epidemiological trends, including lower than expected COVID prevalence across our multiple study locations, we are planning to pursue an initial regulatory submission focused on flu A, flu B, and RSV. Importantly, this decision is driven by limited availability of COVID-positive samples rather than any limitation of the platform or performance of the COVID-19 target. This approach allows us to accelerate timelines while maintaining the flexibility to incorporate COVID at a later stage if conditions change and to prioritize speed to market while remaining adaptable demonstrating our ability to execute in a disciplined and pragmatic way. Beyond this program, our broader pipeline continues to advance. Our TB and HPV programs remain key areas of focus, with TB representing a significant global opportunity, particularly in India. The global TB diagnostics market is expected to grow meaningfully over the coming years, and we believe our platform is well positioned to participate in that growth Our HPV program is progressing through preclinical development and process qualification with additional updates to come as timelines are further defined. In addition, our vector program continues to expand with increased adoption across public health applications. Collectively, these programs highlight the versatility of our technology and its relevance across multiple high-need markets. Finally, Our AI business unit represents one of the most forward-looking aspects of our strategy. We have been leveraging machine learning and algorithmic analysis within our platform for many years, and we are now expanding these capabilities more broadly. The Codex Primer AI platform is designed to unify our efforts across diagnostics, data analytics, and operational efficiency. Integrating AI enhances our ability to design assays, interpret results, and improve system performance. Over time, we believe these capabilities may support predictive insights, including identifying emerging outbreaks and improving real-time situational awareness. We already have multiple AI models in place with additional development underway, and we believe this represents a significant long-term opportunity This initiative strengthens our competitive position while complementing the scientific progress we are making across our clinical programs. In closing, the initiatives we've discussed today reflect the continued progress CoDiagnostics has made over the past year. From international expansion and manufacturing readiness to clinical advancement and technological innovation, each milestone strengthens a different aspect of our business taken together They demonstrate that our strategy is working, our execution is on track, and we are building a scalable platform with global relevance. We are entering the next phase of growth with a strong foundation, expanding opportunities, and a clear path toward commercialization. With that, I'll now turn the call over to Brian Brown, our Chief Financial Officer, to review our financial results and outlook.