Co-Diagnostics, Inc. Common Stock 2026 Q2 Earnings Call

Thank you all for participating in today's conference call. On the line today from Co-Diagnostics, we have Dwight Egan, Chief Executive Officer, and Brian Brown, Chief Financial Officer. Earlier today, Co-Diagnostics released financial results from the second quarter ended June 30, 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 Co-Diagnostics during this call, which are not historical facts, are forward-looking statements. In addition to diagnostic test developments and clinical evaluation timelines, this includes statements concerning regulatory review and clearance, commercialization plans and timing, international regulatory and manufacturing initiatives, financing and liquidity, and the capabilities and potential uses of the company's technology and data infrastructure.

The company's Co-Dx PCR testing platform and related tests are subject to regulatory review, clearance, or authorization and are 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 described in the company's annual report on Form 10-K, subsequent quarterly reports on Form 10-Q, and other filings with the SEC, including under the heading Risk Factors, as well as in today's earnings release. 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.

This past quarter marked another important step in our transition from platform development toward commercialization. We continued to advance the regulatory, clinical, commercial, and technology initiatives that support our long-term growth strategy. Over the past several years, we have invested in building a differentiated molecular diagnostics platform. Recently, those investments have translated into solid execution across our highest strategic priorities. The milestones we discuss today reflect continued execution against our long-term strategy. As we look ahead, our focus remains centered on advancing regulatory milestones, expanding our global commercial opportunities, enhancing our platform capabilities, and positioning the company for commercialization. Taken together, these priorities reflect a business that is increasingly focused on execution and scalability as we move closer to market.

With that context, I'd like to begin with our upper respiratory program, where we recently achieved one of the most significant milestones in the company's history. Our upper respiratory multiplex assay remains one of the company's top strategic priorities and represents an important step toward commercialization of the Co-Dx PCR platform in the U.S. Influenza and RSV panels remain key drivers of the seasonal respiratory disease testing market, with a well-established reimbursement code, which we expect will facilitate our go-to-market strategies for point of care near patient locations. As we have discussed previously, bringing the Co-Dx PCR platform to the U.S. market remains a foundational component of our commercialization strategy and creates opportunities well beyond respiratory testing over time. As the quarter concluded, we announced the successful completion of the analytical and clinical performance studies included in support of our regulatory submission.

Our analytical validation program included 27 individual studies and more than 10,000 upper respiratory PCR test runs on the PCR Pro, including multicenter reproducibility studies evaluating performance across operators, sites, and instruments. Our clinical study enrolled more than 1,400 symptomatic patients across nine geographically diverse clinical sites throughout the U.S. More recently, we officially announced the submission of our dual 510(k) and CLIA Waiver by Application to the FDA for the Flu A/B & RSV assay on the Co-Dx PCR platform. This submission represents a major milestone reflecting years of development, validation, and regulatory preparation. We are pleased to have reached this important stage in the regulatory process and look forward to working with FDA during its review of our submission. To support this submission and our broader regulatory strategy, we recently welcomed Dr. Wes Lindsey as our new Chief Scientific Officer.

Wes brings more than 20 years of experience in molecular diagnostics, having led numerous successful FDA submissions and commercial launches. He was specifically recruited to strengthen our scientific organization as we advance the Co-Dx PCR platform through multiple regulatory pathways and expand our product portfolio. We believe his expertise will be an important asset as we continue executing on our regulatory strategy, as well as the development of our pipeline of products before potential commercialization in key markets. Turning to our tuberculosis program, we are making meaningful progress in India as clinical studies advance on the CoSara PCR Pro instrument and CoSara PCR MTB test. As these studies progress, we are targeting additional regulatory milestones later this year, including planned submissions to India's CDSCO and, subject to applicable eligibility requirements and timing, the World Health Organization's Expert Review Panel for Diagnostics, or ERPD.

Our work in India builds on nearly a decade of investment through our CoSara joint venture, where we have established manufacturing, regulatory expertise, and a growing commercial presence. We believe this provides a distinct competitive advantage as we prepare for commercialization, and we are encouraged by the progress being made. India is one of the world's largest single country tuberculosis markets and represents an important commercial opportunity for the company. The African region continues to bear a substantial share of the global TB burden, making expanded access to rapid molecular diagnostics for TB an important public health priority. The aim of the WHO's ERPD mechanism is to streamline access to innovative, state-of-the-art IVDs that meet the highest standards of quality, but that are still proceeding through the full WHO pre-qualification process, which is considerably more time intensive.

A favorable ERPD assessment allows diagnostics manufacturers to list the outcome of the assessment on their website, including indicating that the diagnostic is considered part of The Global Fund list of eligible IVDs, which greatly facilitates the procurement process for IVDs in countries like those in Africa that are highly burdened by specific diseases. Certain costs associated with the analytical and clinical study validations required to secure an ERPD assessment are largely being supported by our NGO partner relationships, which we believe underscores the urgent need for high-quality point-of-care TB diagnostics. During the quarter, we were invited to participate as a manufacturer partner at the UNOPS Global Implementation Workshop on Near Point of Care TB Diagnostics in Bangkok, along with national TB programs, researchers, donors, and technical agencies representing 21 countries. We believe this invitation reflects growing international recognition of both our platform and our approach to decentralized molecular diagnostics.

Recent WHO guidance recommending near point-of-care molecular testing, including tongue swab sampling, aligns closely with the design of our platform and our MTB assay. We continue to believe the convergence of this WHO guidance, CoSara's commercial infrastructure, and our domestic manufacturing capability and capacity create a compelling path to market in the world's highest-need regions. Beyond tuberculosis, we are expanding the capabilities of the Co-Dx PCR platform across additional disease applications. Earlier this quarter, following the World Health Organization's declaration of a public health emergency for Ebola, our CoSara team rapidly advanced development activities supporting Bundibugyo virus detection. We also successfully completed a proof-of-concept study for an Ebola assay with direct from plasma as a sample type on the Co-Dx PCR Pro instrument. This is our first blood-based assay designed for the Co-Dx PCR Pro, demonstrating the flexibility of the platform beyond traditional swab-based infectious disease testing.

We believe this proof of concept demonstrates the potential expansion of addressable applications of the Co-Dx PCR platform by extending its capabilities beyond traditional respiratory and swab-based testing. Our partners at CoSara have also continued their development of Bundibugyo virus and a pan-Ebola test for centralized laboratories, and their foresight in developing this product allowed them to quickly respond to a recent request by the India Centre for Cellular and Molecular Platforms, or CCAMP, for 200 Bundibugyo tests to be evaluated by a third-party laboratory. As our diagnostic portfolio grows, we are also expanding the digital infrastructure that supports the platform. We have invested in a connected ecosystem designed to combine molecular diagnostics, a mobile application, and secure cloud-based infrastructure while we continue to develop and evaluate AI-enabled capabilities into a single integrated platform.

This architecture was intentionally designed to extend beyond the diagnostic instrument itself, creating a platform designed to connect molecular testing, clinical workflows, and population-level health insights. Our strategy was never just to develop a standalone diagnostic instrument. The integrated molecular diagnostic platform was designed to combine hardware, software, connectivity, and data into a scalable ecosystem to support decentralized testing while enabling secure reporting, remote system management, and real-time data access, which together can help create valuable situational awareness as pockets of infection occur and spread. Beyond supporting secure connectivity and surveillance, we believe the diagnostic data generated across our connected platform represents a valuable long-term strategic asset. As adoption expands, we are evaluating opportunities to responsibly commercialize these capabilities while supporting healthcare providers, public health agencies, and other stakeholders with actionable diagnostic insights.