Co-Diagnostics, Inc.

Thank you for standing by. At this time, I would like to welcome everyone to the Co-Diagnostics Inc. First Quarter 2026 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 this time, simply press star followed by the number one on your telephone keypad. I would now like to turn the conference over to Andrew Benson, Head of Investor Relations The floor is yours.

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 ended March 31, 2026. 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 CoDiagnostics during this call, which are not historical facts or forward-looking statements. In addition to diagnostic test developments and timing for commencement of clinical evaluations, 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. 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 Code Diagnostics' filings with the SEC. Code 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. This continues to be an active and important period for our business as we execute on the opportunities ahead and remain focused on positioning the company for its next phase of growth. The work we are doing across the organization is connected, and together it reflects the progress we are making towards commercialization, as well as the broader strategy we have put in place to create long-term value. As we look ahead, our efforts remain centered on a few key areas, advancing our clinical and commercialization pipeline, continuing to build out our strategy in India through COSERA, progressing our Comira joint venture in Saudi Arabia and the broader MENA region, and further enhancing our platform through connectivity, automation, and AI-driven capabilities. Taken together, these priorities reflect a business that is increasingly focused on execution, scalability, and market readiness. Let me start with our clinical and commercialization pipeline. Our upper respiratory multiplex test remains a key step toward market readiness. As a reminder, this test was originally designed to detect flu A, flu B, COVID-19, and RSV on a single platform. We have now completed enrollment in the clinical study with more than 1400 patients enrolled. Based on current epidemiological conditions, COVID prevalence was lower than expected. And as we have shared previously, we are planning an initial submission focused on flu A Flu B, and RSV. This approach allows us to advance timelines while maintaining the ability to incorporate COVID at a later stage if appropriate, and it reflects market dynamics rather than any limitation of the platform itself. Based on the company's assessment, management believes the study has generated the data intended to support a 510 submission with the FDA. At the same time, We have maintained the clinical study infrastructure in a paused state to preserve flexibility in the event additional data is requested. Our immediate focus is now on finalizing the analytical studies and documentation for submission to the FDA. We are preparing the submission to obtain clearance for CLIA waived point of care use. And based on our current progress, We anticipate filing in the third quarter of this year, subject to completion of internal validation, submission preparation activities, and ongoing regulatory assessment. Turning to India, this has been a core part of our strategy for nearly nine 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 a nationwide commercial presence, has served hundreds of laboratory customers, and has 15 clinical laboratory PCR tests cleared by the CDSCO, India's regulatory body. We are now preparing to manufacture the PCR-Pro instrument and associated consumables locally in India, which represents an important step toward commercialization. COSERA has also now received a CDSCO license to manufacture the PCR-PRO instrument, an important regulatory milestone that supports this transition. In addition, we have expanded COSERA's commercial and distribution territory across South Asia, increasing our total addressable market to approximately 13 billion. As COSERA continues to mature, We believe it has reached a stage where it can stand on its own as a public entity, which could provide an alternative path to access capital and support future growth while also creating additional value for CoDX shareholders. We continue to evaluate the strategic alternatives, including a potential SPAC transaction to support the capital needs required to fully execute on this opportunity. This process remains active with ongoing engagement from advisors and potential counterparties, including parties now under NDA with access to the data room. While discussions remain ongoing, no transaction has been agreed to, and there can be no assurance that any transaction will result from these discussions. Beyond any potential transaction, COSERA is also central to the advancement of our TV program, Clinical performance studies for TB are scheduled to begin before the end of the month, and we are continuing to make operational progress toward that start. The time and place of this program is particularly compelling, as India has the highest global burden of tuberculosis and represents the single largest country market for TB testing in the world by testing volume. Recent WHO guidance recommending near point of care molecular testing for TB diagnosis, along with the use of tongue swab samples, aligns well with the design of our platform and MTB test. We specifically designed our test to accommodate these types of sample approaches, and we believe this reflects a convergence between our development strategy, supported in part by the Gates Foundation, and the evolving standards now being adopted by major global health organizations. As clinical studies begin in support of a submission to the CDSCO, we expect them to represent an important validation point for the program and a meaningful step toward commercialization in India, which we believe we will be positioned to commence as early as the end of the third quarter. Turning to the Kingdom of Saudi Arabia, our Comira joint venture continues to progress and remains an important part of our international expansion strategy. Saudi Arabia has historically been our largest international market, and this initiative is designed to build on that position by localizing our platform within the kingdom and across the broader MENA region. The Comira model builds on the same localization approach we have used in India, with the goal of establishing manufacturing and distribution capabilities closer to end markets. Last month, Comiris secured approval for an industrial land allocation in Sudir Industrial City, following approval by Modan, marking an important step forward as Sudir plays a central role in Saudi Arabia's Vision 2030 initiative. We have also progressed to the next phase of execution, including moving forward with the facility lease and development of the site. We have completed our initial required funding contributions under the joint venture agreement, and the broader project continues to advance. Once operational, Comira has the potential to be among the early domestic manufacturers of molecular diagnostics in Saudi Arabia, which could provide a meaningful advantage in a market that prioritizes local production. Domestically, manufactured medical products are typically given preference in government procurement processes, and we expect that to extend to molecular diagnostics. While certain operational steps are still in progress, the broader strategic opportunity remains intact. Importantly, as COTI-X tests receive FDA clearance in the U.S., the path into Saudi Arabia may be more direct than in some other markets. which could allow for commercial activity ahead of full manufacturing build-out. Looking more broadly at the pipeline, we continue to make progress across several important programs as we assess the needs of our target markets and plan for upcoming commercialization. This includes seeing increasing overlapping use cases across certain channels, particularly where the need for upper respiratory testing and TB testing coexist within the same settings. such as skilled nursing and assisted living facilities within the U.S., potentially opening additional domestic commercialization opportunities for the MTB test. In addition to TB, our HPV program continues to advance through preclinical development and qualification work. We are encouraged by the pace of progress and continue to believe it will become an important part of our test menu. Our vector program also continues to expand with additional system placements and increasing adoption across public health applications. From a technology perspective, we have been leveraging machine learning and algorithmic analysis within our platform for many years, and we continue to expand those capabilities. A key component of this strategy is our cloud-connected architecture. which allows us to capture and monitor testing activity in real time across deployed systems. These capabilities support improved operational efficiency, remote system management, and broader situational awareness. And over time, we believe they may support enhanced analytical capabilities relating to testing trends and operational insights. We are also continuing to make progress in automation within our manufacturing processes, particularly around consumable production where advances could become increasingly important as we scale. Taken together, these efforts demonstrate the versatility of our platform and its ability to address multiple high-need markets. In closing, the initiatives we have discussed today reflect the continued progress co-diagnostics has made over the past several months. Each of these areas strengthens a different part of the business from international expansion and manufacturing readiness to clinical advancement and platform development. Overall, they demonstrate that we are continuing to move the business forward and position the platform for commercialization. We believe we are entering the next phase of growth with a stronger foundation, increasing visibility, and a clear path toward key milestones. With that, I'll now turn the call over to Brian Brown, our Chief Financial Officer, to review our financial results and outlook.