CODX

Image source: The Motley Fool. Thursday, Aug. 13, 2026 at 4:30 p.m. ET Head of Investor Relations-Andrew Benson Chief Executive Officer-Dwight H. Egan Chief Financial Officer-Brian L. Brown Operator: Thank you for standing by. At this time, I would like to welcome everyone to the Co-Diagnostics, Inc. Second Quarter 26 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 1 on your telephone keypad. I would now like to turn the conference over to Andrew Benson, Head of Investor Relations. The floor is yours. Andrew Benson: Good afternoon, everyone. Thank you all for participating in today's conference call. On the line today from Co-Diagnostics, we have Dwight H. Egan, chief executive officer, and Brian L. Brown, chief financial officer. Earlier today, Co-Diagnostics released financial results from second quarter ended 06/30/2026. 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 are not historical facts, are forward-looking statements. In addition to diagnostic test developments and clinical evaluation time lines, 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 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 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 H. Egan. Dwight. Dwight H. Egan: Thank you everyone for joining us today and for your continued support of CoDiagnostics. 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 discussed 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 would like to begin with our upper respiratory program, where we recently achieved 1 of the most significant milestones in the company's history. Our upper respiratory multiplex assay remains 1 of the company's top strategic priorities and represents an important step toward commercialization of the Co-Dx PCR platform in the United States. 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 thousand upper respiratory PCR test runs on the PCR probe. Including multicenter reproducibility studies evaluating performance across operators, sites, and instruments. Our clinical study enrolled more than 1.4 thousand symptomatic patients across 9 geographically diverse clinical sites throughout the United States. More recently, we officially announced the submission of our dual 510(k) and CLIA-waived application to the FDA for the Flu A/B and RSV assay on the Co-Dx's 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-- we recently welcomed doctor Wesley C. Lindsey as our new chief scientific officer. Wesley 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's 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 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 1 of the world's largest single country tuberculosis markets. And represents an important commercial opportunity for the company. But 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 is 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 prequalification 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 we need 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 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's PCR Pro instrument. This is our first blood based assay designed for the Co-Dx's 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's 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 Centre for Cellular and Molecular Platforms or C-CAMP 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 stand alone diagnostic and 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. We expect the cloud based infrastructure that we have developed and begun deploying to be expanded to every regulatory region we have instruments operating. including India and the Kingdom of Saudi Arabia. Turning to Saudi Arabia, we continued advancing our CoMira joint venture and broader international commercialization strategy. Similar to our strategy in India, CoMira localizes manufacturing and commercialization in key international markets. Where domestic production can provide meaningful competitive advantages. This quarter, we hosted the executive team from CoMira at our Salt Lake City headquarters to prepare for technology transfer activities. We also unveiled our future automated manufacturing line. Which is intended to support increased production capacity as our global footprint expands and which we believe represents an important step toward scaling across multiple international markets. Our partners in CoMira have previously demonstrated their success in facilitating the distribution of Co-Dx's diagnostics across Saudi Arabia. And we look forward to completing the technology transfer and localized manufacturing build out in Saudi Arabia that we believe will support future expansion into additional markets across the Middle East and North Africa. Commercial momentum for our Vector Smart business continues to build expanding our customer footprint across mosquito abatement districts nationwide Vector Smart shows the versatility of our technology. And our ability to address broader public health applications beyond traditional clinical diagnostics while providing real world validation of our decentralized testing strategy As mosquito borne disease threats grow, speed matters. By enabling our abatement districts' customers across the country to perform molecular testing in house, where decisions are made, abatement districts can reduce turnaround times by performing molecular testing in house rather than relying on centralized laboratories and demonstrating an approach that we believe can be extended across multiple public health and infectious disease applications. Overall, the milestones we have discussed today reflect another quarter of meaningful execution across our core strategic priorities. We advanced our regulatory strategy continued progressing our tuberculosis program. Expanded the capabilities of our platform, and strengthened the commercial and operational foundation needed to support future growth. While each of these initiatives is important on its own, together, they demonstrate the progress we are making toward commercialization. Just as importantly, they reinforce that our regulatory, commercial, manufacturing, and technology investments work together as part of a single short and long term strategy. We are pleased that the foundational investments we have made over the past several years are now translating into meaningful operational miles positioning the company for the next phase of growth With that, I will now turn the call over to Brian. Brian L. Brown: Thanks, Dwight. And thank you to everyone who joined today's call. For the second quarter of 2026, total revenue was $166 thousand compared to $163 thousand in the same period last year. Cost of revenue for the quarter was $45 thousand resulting in a gross profit of approximately $121 thousand compared to a gross profit of $131 thousand in the prior year period. As we have discussed previously, our current revenue levels remain limited and cost variability can impact gross margin performance at this stage. Total operating expenses for the quarter was $6.3 million compared to $8.2 million in the same period last year. This decrease was primarily driven by lower general and administrative expenses and research and development expenses, including a reduction in legal, personnel, and stock based compensation expenses. As reflected in our reduced operating expenses, we remain committed to disciplined expense management. Research and development expenses were $4.2 million compared to $4.7 million in the prior year period reflecting lower personnel expenses due to our completed headcount reduction and lower stock based compensation expense. Sales and marketing expenses were $467 thousand compared to $610 thousand in the prior year. And general and administrative expenses were $1.5 million compared to $2.6 million These decreases were primarily driven by lower stock based compensation and legal expenses. Net loss for the quarter was $6.3 million, or $1.46 per basic and diluted share compared to a net loss of $7.7 million, or $7 per basic and diluted share in the same period last year. The decrease in net loss was primarily driven by lower operating expenses partially offset by lower other income. Adjusted EBITDA for the quarter was a loss of $5.8 million compared to a loss of $7.2 million in the prior year period. Turning to the balance sheet. We ended the quarter with $3.6 million in cash and cash equivalents, compared to $11.9 million at the end of 2025. The change reflects continued investment in our clinical programs, and platform development. Partially offset by net proceeds from financing activities during the period. Total assets at quarter end were $16.6 million compared to $24.7 million at year-end. Total liabilities at quarter end were $3.9 million compared to $4.1 million at year-end. We continue to manage our capital resources with discipline prioritizing investments that support key clinical and regulatory milestones. Although we anticipate continued operating losses in the near term, our priorities remain clear. Advancing our clinical pipeline, completing our regulatory submissions, and positioning the business for future revenue growth. To support these objectives, we expect to continue to evaluate available sources of capital which may include equity or debt financings, strategic transactions, and partnerships, while staying mindful of dilution and overall capital efficiency. At the same time, we remain focused on pursuing nondilutive funding such as grants where appropriate. Looking ahead, disciplined capital allocation remains a priority as we have approach several important clinical and regulatory milestones and continue preparations for potential commercialization. With that, I will now turn the call back over to Dwight. Dwight H. Egan: Thank you, Brian. As we close today's call, I want to reiterate that we believe Co-Diagnostics is entering an important new phase in the company's evolution. Over the past several years, we have remained disciplined in building a differentiated molecular diagnostics platform. Investing not only in assays and instrumentation, but also in the personnel and the regulatory, manufacturing, digital, and commercial capabilities needed to support long term success. Today, we are beginning to see those translate into tangible operational milestones. The progress we have made across our regulatory, clinical, commercial, and technology initiatives, reflects years of deliberate investment and reinforces our confidence in the opportunities ahead. As these milestones continue to accumulate, we are also seeing growing engagement from global health organizations, government agencies, commercial partners, and other stakeholders. We believe those conversations reflect increasing recognition of both our platform and the opportunities it creates across multiple markets. While there is still important work ahead, we believe the company is well positioned to execute on the opportunities in front of us. And continue advancing toward commercialization across multiple programs. I want to thank our employees for their continued dedication and hard work. And our shareholders for their ongoing support and confidence in our long term vision. We remain encouraged by the momentum we are seeing across the business, and look forward to updating you on our continued progress in the quarters ahead With that, let's open up the line for questions. Operator: Thank you. We will now begin the question-and-answer session. If you would like to ask a question, please press star then the number 1 on your telephone keypad to raise your hand and join the queue. Your first question comes from Yi Chen with H. C. Wainwright. Your line is open. Jade: Hi. Thanks for taking our question. This is Jade on for Yi. So I just first of all, I just had a little blip in my audio, but did I understand correctly that you plan to submit the tuberculosis for ERPD assessment later this year? Dwight H. Egan: That is correct. Okay. Thank you. Jade: And could you also potentially expand upon the Ebola strategy? I know you said you just completed a proof of concept study, but do you have any context for timelines of this development or, like, potentially how useful how early the test could be used in infection? Dwight H. Egan: Our strategy with Ebola is a strategy that is designed to be ready when it is needed. And we have all everybody on the planet has been watching the Ebola issue evolve. We were very quick to respond to the development need for an Ebola test. We continue to do that, and we got to the point where we were able to respond to a an Indian government related need for the test through our C-CAMP relationship. They initiated this request for 200 tests, which we have taken care of, and we hope to be ready. In fact, this disease continues to grow and present opportunities for our company, even though it would be a devastating thing for the health of the planet. All right. Thank you so much. Operator: That concludes the Q and A session and our webcast. Thank you for your participation. You may now disconnect. And have a wonderful rest of your day. Before you buy stock in Co-Diagnostics, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Co-Diagnostics wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years. 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As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. Co-Dx (CODX) Q2 2026 Earnings Call Transcript was originally published by The Motley Fool

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Transitioned from a platform development phase toward active commercialization, supported by the completion of major analytical and clinical performance studies. Achieved a foundational milestone with the official dual 510(k) and CLIA-waived submission to the FDA for the Flu A/B and RSV assay on the Co-Dx PCR platform. Leveraged the CoSara joint venture in India to advance clinical studies for tuberculosis, utilizing nearly a decade of localized manufacturing and regulatory expertise as a competitive advantage. Demonstrated platform flexibility by successfully completing a proof-of-concept study for an Ebola assay using direct-from-plasma samples, marking the company's first blood-based application. Integrated a digital ecosystem combining mobile applications and secure cloud infrastructure to provide population-level health insights and real-time situational awareness beyond simple diagnostic results. Strengthened the scientific leadership team by appointing a new Chief Scientific Officer with extensive experience in leading successful FDA submissions and commercial launches. Expanded the Vector Smart business to provide mosquito abatement districts with decentralized molecular testing, reducing turnaround times compared to centralized laboratory reliance. Targeting additional tuberculosis milestones later this year, including planned submissions to India's CDSCO and the World Health Organization's Expert Review Panel for Diagnostics (ERPD). Anticipating that established reimbursement codes for influenza and RSV will facilitate go-to-market strategies for point-of-care and near-patient locations in the U.S. Planning technology transfers and localized manufacturing build-outs in Saudi Arabia via the CoMira joint venture to support future expansion into the Middle East and North Africa. Evaluating various capital sources, including equity or debt financings and strategic partnerships, to support upcoming clinical and regulatory milestones while prioritizing non-dilutive grant funding. Developing automated manufacturing lines intended to scale production capacity as the global footprint expands across multiple international markets. Reduced total operating expenses to $6.3 million from $8.2 million in the prior year, driven by disciplined expense management and completed headcount reductions. Noted that current revenue levels remain limited ($166 thousand), which causes cost variability to significantly impact gross margin performance at this stage of development. Highlighted that certain analytical and clinical study validation costs for the TB program are being supported by NGO partner relationships, underscoring the urgent global need for the technology. Acknowledged that the Co-Dx PCR platform and related tests are currently subject to regulatory review and are not yet available for sale. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management confirmed they are on track to submit the tuberculosis assay for ERPD assessment later this year. The strategy is focused on readiness for public health emergencies; the company recently fulfilled a request for 200 tests from an Indian government-related entity (C-CAMP). Management emphasized that the platform's rapid response capability allows them to address emerging infectious disease threats as they evolve globally.

This article first appeared on GuruFocus. Revenue: Total revenue was $166,000 for Q2 2026, compared to $163,000 in the same period last year. Gross Profit: Gross profit was approximately $121,000, compared to $131,000 in the prior year period. Operating Expenses: Total operating expenses were $6.3 million, down from $8.2 million in the prior year period. Research and Development Expenses: R&D expenses were $4.2 million, compared to $4.7 million in the prior year period. Sales and Marketing Expenses: Sales and marketing expenses were $467,000, compared to $610,000 in the prior year. General and Administrative Expenses: G&A expenses were $1.5 million, compared to $2.6 million in the prior year. Net Loss: Net loss was $6.3 million, or $1.46 per basic and diluted share, compared to a net loss of $7.7 million, or $7 per share, in the same period last year. Adjusted EBITDA: Adjusted EBITDA loss was $5.8 million, compared to a loss of $7.2 million in the prior year period. Cash and Cash Equivalents: Ended the quarter with $3.6 million, compared to $11.9 million at the end of 2025. Total Assets: Total assets were $16.6 million, compared to $24.7 million at year-end. Total Liabilities: Total liabilities were $3.9 million, compared to $4.1 million at year-end. Warning! GuruFocus has detected 6 Warning Signs with CODX. Is CODX fairly valued? Test your thesis with our free DCF calculator. Release Date: August 13, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Co-Diagnostics Inc (NASDAQ:CODX) submitted its dual 510(k) and CLIA waiver application to the FDA for its flu A, B and RSV assay on the Co-Dx PCR platform, a major regulatory milestone. The company completed extensive analytical and clinical validation studies, including over 10,000 test runs and a clinical study with more than 1,400 patients across 9 U.S. sites. Co-Diagnostics Inc (NASDAQ:CODX) is advancing its tuberculosis program in India, targeting CDSCO and WHO ERPD submissions later this year, with costs partially supported by NGO partners. The company demonstrated platform versatility by completing a proof-of-concept study for an Ebola assay using direct plasma samples, expanding beyond traditional swab-based testing. Co-Diagnostics Inc (NASDAQ:CODX) reduced total operating expenses to $6.3 million in Q2 2026 from $8.2 million in the prior year, reflecting disciplined cost management. The company is expanding its digital infrastructure and AI-enabled capabilities, aiming to create a connected ecosystem for decentralized testing and population-level health insights. Co-Diagnostics Inc (NASDAQ:CODX) reported minimal revenue of $166,000 in Q2 2026, with limited current revenue levels and variability in gross margin performance. The company's net loss for Q2 2026 was $6.3 million, or $1.46 per share, reflecting continued operating losses. Cash and cash equivalents decreased significantly to $3.6 million at the end of Q2 2026 from $11.9 million at the end of 2025, indicating a tight liquidity position. Co-Diagnostics Inc (NASDAQ:CODX) anticipates continued operating losses in the near term and may need to seek additional capital through equity or debt financings, which could lead to dilution. The company's regulatory submissions, including the FDA application and TB-related filings, are subject to review and approval, with no guarantee of clearance or commercialization timelines. The Ebola assay development is still in early stages, with no clear timeline for regulatory approval or commercial availability, and the company's strategy is to be 'ready when needed' rather than immediate revenue generation. Q: Did I understand correctly that you plan to submit the tuberculosis test for ERPD assessment later this year?A: Yes, that is correct. Dwight Egan, CEO, confirmed the planned submission to the WHO's Expert Review Panel for Diagnostics (ERPD) later this year, following the advancement of clinical studies in India. Q: Could you expand upon the Ebola strategy, including timelines for development and how early the test could be used in infection?A: Dwight Egan, CEO, explained that the Ebola strategy is designed to be ready when needed. The company rapidly responded to the development need, completing a proof-of-concept study for a blood-based assay on the Co-Dx PCR Pro. They have already fulfilled a request from India's C-CAMP for 200 Bundibugyo tests to be evaluated by a third-party laboratory, positioning the company to respond as the disease evolves. Q: What were the key financial results for the second quarter of 2026?A: Brian Brown, CFO, reported total revenue of $166,000, a net loss of $6.3 million ($1.46 per share), and an adjusted EBITDA loss of $5.8 million. Operating expenses decreased to $6.3 million from $8.2 million in the prior year, driven by lower R&D, G&A, and stock-based compensation expenses. The company ended the quarter with $3.6 million in cash. Q: What is the status of the U.S. regulatory submission for the upper respiratory panel?A: Dwight Egan, CEO, highlighted the submission of the dual 510(k) and CLIA waiver application to the FDA for the Flu A, B and RSV assay on the Co-Dx PCR platform. This was supported by 27 analytical studies, over 10,000 test runs, and a clinical study enrolling more than 1,400 symptomatic patients across 9 U.S. sites. Q: How is the company progressing with its tuberculosis program in India?A: Dwight Egan, CEO, noted meaningful progress with clinical studies advancing on the CoSara PCR Pro instrument and MTB test. The company is targeting regulatory milestones later this year, including submissions to India's CDSCO and the WHO's ERPD, leveraging its CoSara joint venture's manufacturing and commercial infrastructure. Q: What is the strategic significance of the recent WHO guidance on near point-of-care TB testing?A: Dwight Egan, CEO, stated that the WHO guidance recommending near point-of-care molecular testing, including tongue swab sampling, aligns closely with the design of the Co-Dx platform and MTB assay. This convergence, combined with CoSara's infrastructure and domestic manufacturing, creates a compelling path to market in high-need regions. Q: How is the company expanding its digital infrastructure and data capabilities?A: Dwight Egan, CEO, discussed the investment in a connected ecosystem combining molecular diagnostics, a mobile app, and secure cloud-based infrastructure. This platform is designed to support decentralized testing, secure reporting, and real-time data access, with plans to expand to all regulatory regions, including India and Saudi Arabia. The data generated is viewed as a valuable long-term strategic asset. Q: What progress is being made with the CoMira joint venture in Saudi Arabia?A: Dwight Egan, CEO, reported hosting the CoMira executive team at headquarters to prepare for technology transfer activities. The company unveiled its future automated manufacturing line to support increased production capacity, aiming to complete localized manufacturing in Saudi Arabia to support expansion into the Middle East and North Africa. Q: How is the Vector Smart business performing?A: Dwight Egan, CEO, noted that commercial momentum for Vector Smart continues to build, expanding the customer footprint across mosquito abatement districts nationwide. The business demonstrates the versatility of the technology beyond clinical diagnostics, enabling in-house molecular testing to reduce turnaround times for public health applications. Q: How is the company managing its capital resources given the continued operating losses?A: Brian Brown, CFO, stated that the company is managing capital with discipline, prioritizing investments for key clinical and regulatory milestones. They expect to evaluate available sources of capital, including equity or debt financings and strategic transactions, while staying mindful of dilution and pursuing non-dilutive funding such as grants. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Advancing Commercialization Through FDA Submission, Global Clinical Progress and Manufacturing Expansion Strengthening Integrated Co-Dx PCR Platform Through Scientific Innovation, Cloud Connectivity and AI-Enabled Capabilities SALT LAKE CITY, Aug. 13, 2026 /PRNewswire/ -- Co-Diagnostics, Inc. (Nasdaq: CODX) ("Co-Dx," or "the Company"), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, today announced its financial results for the second quarter ended June 30, 2026. Second Quarter 2026 Business Highlights: Advanced CoMira Diagnostics' manufacturing strategy in the Kingdom of Saudi Arabia through Saudi approval for a manufacturing facility industrial site and execution of a lease agreement in Sudair Industrial City, supporting planned localized production and future commercialization across the Middle East and North Africa (MENA) Expanded commercial outreach through participation in a European trade mission with the Utah Governor's Office and World Trade Center Utah, while showcasing the Co-Dx PCR platform and CE-IVD solutions at ESCMID Global 2026 to engage prospective customers, distributors, and strategic partners Presented the Co-Dx PCR tuberculosis (TB) platform at the Stop TB Partnership Summit in Washington, D.C., engaging with global health organizations, government agencies, and other stakeholders focused on expanding access to TB diagnostics Initiated development of a Bundibugyo virus PCR assay and advanced the Company's Ebola strategy through CoSara, including development of a pan-Ebola assay Strengthened the balance sheet through a $3.0 million private placement priced at-the-market under Nasdaq rules, supporting continued execution of the Company's strategic initiatives Advanced Latin American commercialization efforts through a distribution agreement covering Mexico, supporting future commercialization of the Co-Dx PCR platform in the region Hosted representatives from CoMira Diagnostics in Utah for the unveiling of the Company's future automated manufacturing line, supporting scalable production capabilities and localization efforts in Saudi Arabia Expanded the Vector Smart® customer footprint to 21 U.S. states, with four new mosquito abatement district laboratory installations completed during the quarter, reflecting growing adoption of the Company's decentralized vector surveillance platform "Our second quarter marked a period of meaningful operational progress for Co-Diagnostics, as years of investment across our platform are illustrated by these tangible milestones," said Dwight Egan, Chief Executive Officer of Co-Diagnostics. "This progress was reflected across our regulatory, clinical and commercial priorities, including expanding our tuberculosis program in India and strengthening our international manufacturing and commercialization capabilities. More recently, we built on that momentum by submitting our FDA 510(k) application for the Co-Dx™ PCR Flu A/B & RSV upper respiratory multiplex test on the Co-Dx PCR Pro® instrument. Together, these milestones reinforce that we are executing against our strategic priorities and advancing the platform toward commercialization." Mr. Egan continued, "What differentiates Co-Diagnostics is that we have never viewed our opportunity as simply developing another diagnostic test. We have built an integrated molecular diagnostics platform that combines instrumentation, assays, cloud connectivity and artificial intelligence, along with manufacturing, and global commercial infrastructure into a scalable ecosystem. As we continue to advance regulatory milestones and expand deployment across international markets, we believe this strategy has the potential to create long-term value for our shareholders." Second Quarter 2026 Financial Results: Revenue of $0.17 million, compared to $0.16 million in the second quarter of 2025, primarily driven by higher product revenue Operating expenses of $6.3 million, compared to $8.2 million in the second quarter of 2025, primarily due to lower general and administrative and research and development expenses, including reduced legal, personnel and stock-based compensation expenses Operating loss of $6.2 million, compared to $8.1 million in the second quarter of 2025 Net loss of $6.3 million, or $1.46 per basic and diluted share, compared to a net loss of $7.7 million, or $7.00 per basic and diluted share, in the second quarter of 2025 Adjusted EBITDA loss of $5.8 million, compared to a loss of $7.2 million in the second quarter of 2025 Cash and cash equivalents totaled $3.6 million as of June 30, 2026 Recent Developments: Completed the clinical and analytical performance studies supporting the Company's FDA 510(k) submission for the Co-Dx PCR Flu A/B & RSV test on the Co-Dx PCR Pro instrument, including a clinical study enrolling more than 1,400 patients across nine U.S. clinical sites and an analytical program spanning 27 studies and more than 10,000 PCR test runs Submitted a 510(k) premarket notification, together with a concurrent CLIA Waiver by Application, to the U.S. Food and Drug Administration for the Co-Dx PCR Flu A/B & RSV test on the Co-Dx PCR Pro instrument, marking a significant regulatory milestone toward commercialization of the Company's point-of-care molecular diagnostics platform Appointed Wes Lindsey, Ph.D., MBA, as Chief Scientific Officer to lead the Company's scientific and regulatory strategy, including FDA submissions and continued expansion of the Co-Dx product pipeline Initiated clinical performance studies in India for the CoSara PCR MTB test through CoSara Diagnostics, advancing the Company's tuberculosis commercialization strategy in one of the world's largest TB markets The Company's joint venture, CoSara Diagnostics provided Bundibugyo virus test kits for analytical studies in India and continued development of a pan-Ebola assay strategy, while the Company successfully completed a proof-of-concept study evaluating extraction-free plasma-based testing capabilities on the Co-Dx PCR platform Conference Call and Webcast: Co-Diagnostics will host a conference call and webcast at 4:30 p.m. EDT today to discuss its financial results with analysts and institutional investors. The conference call and webcast will be available via: Webcast: ir.co-dx.com on the Events & Webcasts page, or accessible directly here Conference Call: 1-888-880-3330 (Toll Free) or 1-646-357-8766 (Toll) The call will be recorded and later made available on the Company's website. *The Co-Dx PCR platform (including the PCR Home®, PCR Pro®, mobile app, and all associated tests) has not been cleared or authorized by the FDA, is subject to review by the FDA and/or other regulatory bodies and is not yet available for sale. About Co-Diagnostics, Inc. Co-Diagnostics, Inc., a Utah corporation, is a molecular diagnostics company that develops, manufactures and markets state-of-the-art diagnostics technologies. The Company's technologies are utilized for tests that are designed using the detection and/or analysis of nucleic acid molecules (DNA or RNA). The Company also uses its proprietary technology to design specific tests for its Co-Dx PCR at-home and point-of-care platform (subject to regulatory review and not currently for sale) and to identify genetic markers for use in applications other than infectious disease. Non-GAAP Financial Measures: This press release contains adjusted EBITDA, which is a non-GAAP measure defined as net income (loss) adjusted for depreciation, amortization, income tax (benefit) expense, net interest (income) expense, stock-based compensation, change in fair value of contingent consideration, and realized gain (loss) on investments. The Company believes that adjusted EBITDA provides useful information to management and investors relating to its results of operations. The Company's management uses this non-GAAP measure to compare the Company's performance to that of prior periods for trend analyses, and for budgeting and planning purposes. The Company believes that the use of adjusted EBITDA provides an additional tool for investors to use in evaluating ongoing operating results and trends and in comparing the Company's financial measures with other companies, many of which present similar non-GAAP financial measures to investors, and that it allows for greater transparency with respect to key metrics used by management in its financial and operational decision-making. Management does not consider the non-GAAP measure in isolation or as an alternative to financial measures determined in accordance with GAAP. The principal limitation of the non-GAAP financial measure is that it excludes significant expenses that are required by GAAP to be recorded in the Company's financial statements. In order to compensate for these limitations, management presents the non-GAAP financial measure together with GAAP results. Non-GAAP measures should be considered in addition to results prepared in accordance with GAAP, but should not be considered a substitute for, or superior to, GAAP results. A reconciliation table of the net income, the most comparable GAAP financial measure to adjusted EBITDA, is included at the end of this release. The Company urges investors to review the reconciliation and not to rely on any single financial measure to evaluate the company's business. Forward-Looking Statements: This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements can be identified by words such as "believes," "expects," "estimates," "intends," "may," "plans," "will" and similar expressions, or the negative of these words. Such forward-looking statements are based on facts and conditions as they exist at the time such statements are made and predictions as to future facts and conditions. Forward-looking statements in this release include, but are not limited to, statements regarding: (i) the continued development, clinical evaluation, regulatory submission, clearance, authorization, and commercialization of the Co-Dx PCR platform and related tests; (ii) anticipated timing and progress of clinical studies and regulatory submissions; (iii) the Company's ability to develop, scale, and commercialize its manufacturing capabilities, including through CoSara and CoMira and other third parties; (iv) anticipated market opportunities and international expansion initiatives; (v) the expected capabilities, differentiation, and adoption of the Company's platform technologies; and (vi) the Company's strategic, operational, and growth initiatives generally. Forward-looking statements are subject to inherent uncertainties, risks and changes in circumstances. These risks and uncertainties include, among others, risks relating to the timing and outcome of FDA and other regulatory review processes; the possibility that clinical or analytical data may not support regulatory clearance, authorization or commercialization; the Company's ability to successfully complete product development, manufacturing scale-up and commercialization activities; market acceptance and adoption of the Company's products and technologies; the Company's dependence on joint ventures, distributors, manufacturers and other third parties; risks associated with conducting business and obtaining regulatory approvals in international markets; the Company's ability to obtain additional capital when needed and maintain sufficient liquidity to execute its business plans; and competitive and technological developments. Actual results may differ materially from those contemplated or anticipated by such forward-looking statements. Readers of this press release are cautioned not to place undue reliance on any forward-looking statements. There can be no assurance that any regulatory submission, authorization, commercialization milestone, manufacturing initiative, strategic collaboration, or market opportunity will occur on the timelines anticipated by the Company, or at all, due to certain risks and uncertainties, a discussion of which can be found in our Risk Factors disclosure in our Annual Report on Form 10-K, filed with the Securities and Exchange Commission (SEC) on March 31, 2026, and in our other filings with the SEC. Forward-looking statements speak only as of the date of this press release, and the Company undertakes no obligation to update or revise any forward-looking statement as a result of new information, future events or otherwise, except as required by applicable law. View original content to download multimedia:https://www.prnewswire.com/news-releases/co-diagnostics-reports-second-quarter-2026-financial-results-302851294.html

Interested in OraSure Technologies, Inc.? Here are five stocks we like better. Q2 revenue rose 9.7% sequentially to $30.6 million, exceeding guidance, as diagnostic-products revenue increased 14.7% and sample-management revenue grew 9%. Stronger public-health demand, syphilis testing, Sickle SCAN and laboratory recovery supported the results. OraSure achieved key regulatory milestones with FDA clearance for its Colli-Pee Dx STI urine-collection kit and Emergency Use Authorization for the OraQuick Ebola 2.0 test. However, the company delayed its expected 2026 U.S. launch of the IntelliQuick CT/NG test and plans to revise and resubmit its application. Gross margin improved to 43.5%, while the company ended the quarter debt-free with $161 million in cash. Management expects third-quarter revenue of $29.5 million to $32.5 million and continues targeting operating cash-flow break-even as it enters 2027. Is Co-Diagnostics National Security’s Next Diagnostic Pick? OraSure Technologies (NASDAQ:OSUR) reported second-quarter revenue of $30.6 million, exceeding its guidance range and rising 9.7% sequentially, as stronger public-health diagnostics demand and growth in sample-management products supported results. President and Chief Executive Officer Carrie Eglinton Manner said the quarter marked continued progress in the company’s transformation, citing sequential gross-margin improvement, new regulatory milestones and efforts to position the business for growth in the second half of 2026 and beyond. → SpaceX’s First Earnings Report Could Decide Whether Shorts or Bulls Have Control “Q2 demonstrated that transition beginning to take shape through stronger revenue, improving margins, and meaningful innovation milestones,” Eglinton Manner said. Diagnostic-products revenue totaled $19.4 million, increasing 14.7% from the prior quarter. Chief Financial Officer Ken McGrath said U.S. diagnostics revenue exceeded international revenue during the period. The sequential gain reflected stronger public-health demand, including customer purchasing associated with fiscal-year cycles, higher syphilis-test revenue and contributions from BioMedomics’ Sickle SCAN product. → 3 Drone Stocks That Should Soar After the Summer Slump The company said demand for its OraQuick HIV Self-Test was strong in U.S. public-health programs despite ongoing federal funding pressure. OraSure also cited growth in consumer and business-to-business-to-consumer channels, including telehealth and digital-access outlets. Internationally, OraSure said it is seeking to diversify and localize its diagnostics business. The company continues to support long-standing HIV testing customers while pursuing nearshoring and in-country value-added assembly programs for OraQuick HIV Self-Test products. Eglinton Manner said the company expects to provide additional details on localization initiatives later this year. → The Bitcoin Comeback May Already Be Underway—2 ETFs for Exposure Sickle SCAN revenue is growing at twice the rate in 2026 as it did in 2025, according to Eglinton Manner, as OraSure integrates the product into its international commercial channels and pursues national health-program opportunities. Sample Management Solutions revenue was $9.9 million, up 9% sequentially, with growth across segments. OraSure said it saw improving demand among commercial and advanced diagnostic-testing laboratories, microbiome-collection applications and early signs of recovery in academic and research markets. During the question-and-answer session, Eglinton Manner said the company is seeing a “fairly consistent recovery” among advanced genetic-testing laboratories, while noting that the segment has remained muted since the COVID period. In June, OraSure received FDA clearance for its Colli-Pee Dx urine collection kit, which enables at-home self-collection of volumetric first-void urine samples for sexually transmitted infection testing. The clearance covers use of the collection device and its NucleoPrecision technology with Roche cobas tests for chlamydia, gonorrhea, trichomoniasis and M. genitalium in male and female self-collected urine samples. The company said the Colli-Pee Dx launch has started positively, with customers expressing interest in its potential to make STI testing more convenient and private. OraSure also received FDA Emergency Use Authorization for its second-generation OraQuick Ebola 2.0 Rapid Antigen Test. The test detects all four Ebola virus species known to cause human disease, including the Bundibugyo species associated with the current outbreak in Central Africa, according to the company. However, the company said it no longer expects FDA clearance and a U.S. launch for its IntelliQuick CT/NG test on the Sherlock platform during 2026. OraSure withdrew its FDA submission after constructive discussions with the agency and plans to incorporate FDA feedback before resubmitting. Eglinton Manner said the company remains confident in the rapid molecular self-test’s performance and clinical value but did not provide a timetable for resubmission or potential clearance. “This is a recent discussion, and in terms of timing, we plan to come back to share more on that,” she said. McGrath said costs associated with the resubmission effort are not expected to increase the company’s overall operating cash-flow usage. He said incremental spending would be more than offset by a reduction in expected milestone payments, confirming an analyst’s reference to a $20 million contingent payment. GAAP gross margin increased 120 basis points sequentially to 43.5% from 42.3% in the first quarter. Non-GAAP gross margin rose to 44.2% from 43.4%. McGrath attributed the gains to lower scrap and operational efficiencies, partly offset by revenue mix. Second-quarter GAAP operating income was $5.4 million, while non-GAAP operating loss was $14.7 million. OraSure recorded a reduction in its contingent-consideration liability after updating its CT/NG submission plan. The company ended the quarter with no debt and $161 million in cash and cash equivalents. Operating cash flow was negative $9.9 million in the quarter. Management reiterated its expectation to reach break-even cash flow from operations as it enters 2027, supported by anticipated revenue growth, new product launches, cost savings and operating efficiencies. OraSure repurchased 647,000 shares for $2 million during the second quarter. Since beginning its repurchase program last year, the company has spent $22 million to buy back 7.7 million shares, representing nearly 10% of outstanding shares. The company paused further repurchases during the quarter to preserve flexibility for launch-related investments, including Colli-Pee and Ebola 2.0. For the third quarter, OraSure projected revenue of $29.5 million to $32.5 million and said gross margin is expected to be similar to the second quarter. OraSure Technologies, Inc is a Bethlehem, Pennsylvania–based diagnostic and medical device company specializing in the development, manufacture and commercialization of point-of-care and self-testing products. Founded in 1988, OraSure has built a portfolio of oral fluid and other non-invasive specimen collection technologies that support the detection of infectious diseases, drugs of abuse, and health and wellness biomarkers. The company's flagship product, the OraQuick® rapid HIV test, was the first Food and Drug Administration–approved over-the-counter oral fluid test for the detection of HIV-1/2 antibodies. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "OraSure Technologies Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

Image source: The Motley Fool. Thursday, May 14, 2026 at 4:30 p.m. ET Chief Executive Officer — Dwight Egan Chief Financial Officer — Brian Brown VP, Investor Relations — Andrew Benson Need a quote from a Motley Fool analyst? Email [email protected] Andrew Benson: Good afternoon, everyone. 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 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 include statements concerning the company's Co-Dx 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. 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? Dwight Egan: 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 multipronged 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 remain focused on execution and continue to make meaningful progress across the business. During the reporting period, we advanced several key initiatives that are positioning Co-Diagnostics 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 4 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 CoSara 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 CoMira 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 CoSara strategy and our progress in India. India has been a core component of our business for nearly 8 years and over that time, we have built a meaningful foundation through our CoSara joint venture in one of the largest health care markets in the world. Today, CoSara 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, CoSara has received the CDSCO license to manufacture the PCR Pro instrument, a key regulatory milestone that supports this transition. We have also expanded CoSara'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 CoSara 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 adviser 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 the potential SPAC transaction, CoSara 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 & 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 CoSara 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 prioritizing 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 Co-Diagnostics 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 Co-Dx 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 CoSara 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 time lines 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 time lines 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 Co-Dx 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 Co-Diagnostics 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. Brian Brown: Thanks, Dwight, and thank you to everyone who joined today's call. For the full year 2025, total revenue was $0.6 million compared to $3.9 million in 2024. The year-over-year decrease was primarily driven by lower grant revenue as most of the previously awarded grant funding was recognized in the prior year. Product revenue for the year was $0.4 million compared to $0.8 million in 2024, reflecting our continued focus on platform development and limited commercial activity during the period. Total operating expenses for 2025 were $50.6 million compared to $43.0 million in 2024. This increase was primarily driven by a noncash impairment charge of approximately $18.9 million related to in-process research and development intangible assets. Excluding this noncash charge, operating expenses declined year-over-year, reflecting our continued focus on cost discipline. Research and development expenses were $19.1 million compared to $21.0 million in the prior year reflecting disciplined investment in the Co-Dx PCR platform, partially offset by increased clinical trial activity. Sales and marketing expenses were $2.4 million compared to $4.5 million in 2024, primarily driven by lower personnel, consulting and travel-related expenses. General and administrative expenses were $9.1 million compared to $16.2 million in the prior year, with the decrease primarily driven by lower legal, consulting and stock-based compensation expenses. Net loss for the full year 2025 was $46.9 million or a loss of $35.25 per share compared to a net loss of $37.6 million or $37.22 per share in 2024. The increase in net loss was primarily driven by the noncash impairment charge and lower grant revenue, partially offset by reduced operating expenses and a tax benefit recognized during the year. Excluding the impact of the noncash impairment charge of $18.9 million, full year 2025 net loss would have been $28.0 million. Adjusted EBITDA was a loss of $28.0 million for the full 2025 compared to a loss of $33.5 million in 2024. Turning to the balance sheet. We ended the year with $11.9 million in cash, cash equivalents and marketable investment securities compared to $29.7 million at the end of 2024. Net cash used in operating activities was $29.0 million for 2025, consistent with the prior year as we continue to invest in platform development and clinical programs. Net cash provided by investing activities was $26.3 million, primarily driven by the maturity of marketable securities. Net cash provided by financing activities was $11.7 million, reflecting capital raised through our at-the-market program and registered direct offerings. As discussed previously, we have an active ATM facility in place, which provides additional flexibility to support our capital needs. We continue to carefully manage our liquidity and cost structure as we progress towards commercialization. While we expect to continue generating operating losses in the near term, our focus remains on advancing our clinical pipeline, achieving regulatory milestones and positioning the business for future revenue growth. We will also continue to evaluate financing alternatives, including equity, debt and strategic partnerships to support these objectives. In parallel, we remain focused on securing additional non-dilutive funding opportunities, including grant funding to support continued development of our Co-Dx PCR platform. Looking ahead, we remain focused on disciplined capital allocation as we advance towards key inflection points, including clinical submissions and potential commercialization milestones. I look forward to sharing additional updates as we progress through 2026. With that, I will now turn the call back over to Dwight. Dwight Egan: Thank you, Brian. To close, I want to extend our sincere gratitude to our shareholders for their continued support and to our employees whose dedication and hard work remain one of our most important assets as we execute on the Co-Dx vision. We are focused on delivering against our strategy and advancing the company toward its next phase. With that, we will now open the line for questions. Operator? Operator: [Operator Instructions] We will take our first question today from Yi Chen at H.C. Wainwright. Unknown Analyst: This is Katie on for Yi. Looking at your now 3 target tests, dropping COVID seems like a great idea. Where does the sample accrual stand for the 3 target panel, is first half of '26 still the target? And how quickly could you add COVID back if, for some reason, conditions change and it makes sense to add it back? Dwight Egan: Thank you for your question. First of all, let me emphasize that the taking away the COVID out of the mix of the multiplex test was not -- was a decision based on the availability of COVID in what is a very powered clinical trial in about 8 different locations across the United States, COVID just simply did not show up over a several month period. And so rather than wait to do a submission after a protracted clinical trial. We decided to move forward with the flu A, flu B and RSV components of the test and to leave ourselves the flexibility of putting COVID in later when it shows up with more samples. In the meantime, it doesn't get in the way of us getting a more expeditious submission into the FDA. So I just want to make that logic clear as to why we made that decision. It is a little bit surprising, of course, that COVID doesn't show up the way we would have expected it to show up in terms of its broader characteristics across the country when we just came through a pandemic where there were so many hundreds of millions of tests done on COVID. But that's what reality was during our clinical trial. And if we waited for instance, until the summer to do the -- get more COVID, there's no assurance that it would show up then even though it might be. And so we'll -- we have the flexibility to continue to test for COVID when and if that becomes a viable direction for the company. Was there another part of your question? Unknown Analyst: So I guess, my question is more, what would it look like to add it back? Is it like a quick approval? Or is it you're going to have to put it through another trial? What does it look like to put it back should that time ever come? Dwight Egan: Well, first of all, we would not anticipate that it requires any redesign, for example. And so a lot of that would be a negotiation with the FDA in terms of what they would require. Will they require 30 positive samples, will they require it to be dispersed over demographics and so on and so forth in terms of age. So a lot of that will be defined in our consultation with the FDA as to what they would want us to do to light that up. We don't view it as being a very difficult thing to do. And like I say, it doesn't require that we reengineer or work on the chemistry and those sorts of things. It's just getting it up and going. How many sites would we have to put in, arguably not as many as we did with the 8 sites or so that we did during our normal clinical trial. But I think it's a change that we can add and that it won't be onerous on the company to do that. Operator: [Operator Instructions] We will hear next from the line of Michael Okunewitch at Maxim Group. Michael Okunewitch: Congrats on the speedy resolution of the listing challenges. Good to see you back on the NASDAQ. So I guess just to kick off. I wanted to see if you could talk a little bit about the South Asia distribution expansion to the other countries like Nepal, Pakistan and Bangladesh. Is this more for supporting the existing commercial test? Or would this be to expand the opportunity for PCR Pro, particularly on TB? Is that a similar issue in those countries as it is in India? Dwight Egan: I think the kind of disease burden that you have in those other countries is very similar to the disease burden in India. Altogether, our motive is driven by the fact that we go from about $11 billion in total addressable market to more like $13 billion by adding those countries. And it just made geographical sense for us to have all of that handled through the CoSara joint venture. The CoSara joint venture is a mature business at this point. We've been doing it for almost 8 years. And so we have manufacturing capabilities there. We have a number of employees. We have salespeople covering the -- pretty much the entire continent -- subcontinent of India, and it's just a natural progression to go into these others as we then also move into the CoMira joint venture in the Kingdom of Saudi Arabia. So it's just a sort of strategic move to let the CoSara group do everything they could do on that subcontinent, and we think it makes a lot of sense for the company. Michael Okunewitch: Thank you for the additional clarity on that. And then for the U.S. FDA study in particular, can you just comment on how many samples you're expecting to need to support that study? Dwight Egan: Well, this -- when we do a study like that, this is something that we hire a CRO to do, and it's a very structured sort of clinical trial. The FDA knows what we're doing. They know how many samples that we're going to collect, and I would represent to you that it's in excess of 1,200 different patients that have already been through the enrollment. So we're nearing conclusion here of the entire test and getting ready to do analytical studies and do our submission to the FDA. Now that's one of the reasons that we are waiting to add COVID to the mix when there is COVID. When COVID shows up in enough -- with enough force that we can get the kind of samples we need to satisfy the FDA. Michael Okunewitch: All right. And then 1 last one for me and I'll hop back into the queue. I saw that you've gained the clearance to sell the PCR Pro device now in India. You started shipping devices over there. Could you talk about what are the immediate next steps and time lines for getting that study up and running and then moving on to commercialization? Dwight Egan: Yes. Our expectation in India, and as I mentioned, it's a mature joint venture at this point, having spent about 8 years doing it. And we have 15 tests that are already cleared through the CDSCO there. We have a very good track record with the regulatory bodies there in India. We have manufacturing facilities. We have sales and marketing, and we have a very, very good group of individuals that support that business. And so when we look at taking this new Co-Dx PCR Pro box there, it has -- it's a technology transfer operation. We have already established an oligonucleotide lab there where we are making our own oligonucleotides, and that's not -- that's rocket science. That's pretty sophisticated molecular science. And that's already in process. We put that in the last -- a year ago, December, actually. So it's a matter of getting the technology over there and set up and trained. We will be manufacturing product here in Utah, while we're doing that at a measured pace because we've already gone through all the processes in Utah making it so that we can produce cups that are the consumables with integrity, and we can do it at scale. So we have a lot of capacity here in Utah. We'll continue to use that capacity as we start what's going on in India and begin the clinical trials. As you can imagine, since India is the hotspot for tuberculosis worldwide. We will not have any trouble whatsoever getting the type of clinical samples that we need to do the clinical trial for tuberculosis since such a high percentage of the country is infected already with latent TB and a certain percentage of those erupt into full-blown TB on an active basis every year. So we believe that this clinical trial will proceed quickly and then that the study will go before the CDSCO in pretty short order, we actually expect to have commercialization of the TB test in India, let's say, by the third quarter of '26. Operator: And we would like to thank each of our analysts who had signaled for a question today. Ladies and gentlemen, this does conclude the Co-Diagnostics, Inc. Full Year 2025 Earnings Call. We thank you all for your participation, and you may now disconnect your lines. Enjoy the rest of your day. Before you buy stock in Co-Diagnostics, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Co-Diagnostics wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you’d have $472,852!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you’d have $1,317,207!* Now, it’s worth noting Stock Advisor’s total average return is 984% — a market-crushing outperformance compared to 210% for the S&P 500. Don't miss the latest top 10 list, available with Stock Advisor, and join an investing community built by individual investors for individual investors. See the 10 stocks » *Stock Advisor returns as of May 27, 2026. This article is a transcript of this conference call produced for The Motley Fool. While we strive for our Foolish Best, there may be errors, omissions, or inaccuracies in this transcript. As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. Co-Diagnostics (CODX) Q4 2025 Earnings Transcript was originally published by The Motley Fool

Image source: The Motley Fool. May 14, 2026 at 4:30 p.m. ET Chief Executive Officer — Dwight Egan Chief Financial Officer — Brian Brown Need a quote from a Motley Fool analyst? Email [email protected] Dwight Egan, Chief Executive Officer; and Brian Brown, Chief Financial Officer. Earlier today, Co-Diagnostics 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 analysts for 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 Co-Dx 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. 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? Dwight Egan: 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 CoSara, 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 1,400 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 time lines 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(k) 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 9 years. And over that time, we have built a meaningful foundation through our CoSara joint venture in one of the largest health care markets in the world. Today, CoSara 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 towards commercialization. CoSara 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 CoSara's commercial and distribution territory across South Asia, increasing our total addressable market to approximately $13 billion. As CoSara 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 Co-Dx 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 advisers 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, CoSara is also central to the advancement of our TB 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, CoMira secured approval for an industrial land allocation in Sudair Industrial City following approval by MODON, marking an important step forward as Sudair 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 Co-Dx tests received 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. Brian Brown: Thanks, Dwight, and thank you to everyone who joined today's call. For the first quarter of 2026, total revenue was $146,000, compared to $50,000 in the same period last year. Cost of revenue for the quarter was $194,000, resulting in a loss of approximately $48,000, compared to a gross profit of $29,000 in the prior year period. As we have discussed previously, our current revenue levels remain limited and cost variability can impact gross margin performance at this stage as we continue to scale. Total operating expenses for the quarter were $9.2 million, compared to $8.6 million in the same period last year. This increase was primarily driven by higher research and development spending. Research and development expenses were $5.9 million, compared to $4.9 million in the prior year period, with the increase largely driven by spending on the upper respiratory test clinical studies. Sales and marketing expenses were $0.5 million, compared to $0.7 million in the prior year. And general and administrative expenses were $2.5 million, compared to $2.8 million in Q1 2025. These decreases were primarily driven by lower consulting and personnel-related costs. Net loss for the quarter was $9.1 million or $4.06 per fully diluted share, compared to a net loss of $7.5 million or $7.05 per fully diluted share in the same period last year. The increase in net loss was primarily driven by higher operating expenses and lower other income, including the absence of certain onetime remeasurement gains recognized in the prior year period. Adjusted EBITDA for the quarter was a loss of $8.7 million, compared to a loss of $7.4 million in the prior year period. Turning to the balance sheet. We ended the quarter with $8.2 million in cash and cash equivalents, compared to $11.9 million at the end of 2025. The change reflects continued investment in our clinical programs and platform development. While we expect to continue generating operating losses in the near term, our focus remains on advancing our clinical pipeline, completing regulatory submissions and positioning the business for future revenue growth. At the same time, we remain disciplined in managing our cost structure and prioritizing investments to support key clinical and regulatory milestones. We expect that additional capital will likely be required to fully execute our commercialization and development plans. We will also continue to evaluate financing alternatives, including equity, debt and strategic partnerships to support these objectives, while remaining mindful of dilution and overall capital efficiency. In parallel, we remain focused on securing nondilutive funding opportunities, including grants, where appropriate. Looking ahead, we remain focused on disciplined capital allocation as we move towards several key inflection points, including clinical submissions and the initial stages of commercialization. With that, I will now turn the call back over to Dwight. Dwight Egan: Thank you, Brian. To close, I want to reiterate that the progress we are making across the business is beginning to translate into broader recognition of the value of what we have built. Over the past several weeks, we have had the opportunity to engage with a growing number of important stakeholders, including global health organizations, government agencies and other decision-makers. We believe those conversations are a clear indication of increasing interest in both our platform and the opportunities ahead of us. What is especially encouraging is that interest in TB testing is not limited to international markets. We are also seeing signs that the Co-Dx PCR platform and TB test may have meaningful relevance and broader point-of-care applications here in the United States. We believe that position is the result of years of focused development, deliberate investment and a willingness to act on opportunities that align with our long-term vision. We did not arrive at this point by accident. We made intentional decisions to build a platform designed to address important unmet needs across multiple markets. And we believe those efforts are now beginning to open new opportunities for the company. I also want to thank our shareholders for their continued support and patience, and our employees for their dedication and hard work. Their commitment continues to be one of the company's greatest strengths. We are encouraged by the momentum we are seeing and remain focused on execution. With that, let's open the line for questions. Operator? Operator: [Operator Instructions] Your first question comes from Michael Okunewitch with Maxim Group. Michael Okunewitch: It looks like there's a lot of exciting stuff going on, great progress. I guess to start off, my question lies around scalability and your scale-up plans, since these are pretty big markets and you're approaching them fast. What's your current capacity for producing the test kits? And then what steps are you taking to enhance those capabilities? Dwight Egan: We believe that we are very well positioned to scale for initial commercial demand. Our Utah facility has already produced hundreds of thousands of test cups for clinical studies and in-house R&D. And we've been manufacturing and have manufacturing plans already designed and ready to implement in both the U.S., Saudi Arabia and also in India. As you may recall, CoSara, our India joint venture, inaugurated its oligo synthesis manufacturing facility in India at the end of 2024, and that will support Co-Primers' oligonucleotides manufacturing and commercialization in India. And over time, we think that the facility in India will also drive efficiency in our manufacturing process. I'd point out that in the initial launch phase, the CoSara facility will be completing the final assembly of TB, HPV and upper respiratory test kits and instruments that are principally manufactured in Utah. The plan is over time to replicate portions of the Utah manufacturing process locally in India. As you know, India represents one of the largest TB markets globally with high testing demand, strong alignment with WHO guidance. And our approach is simply to deliver the quality of PCR to significantly lower cost, and with greater accessibility, which we believe positions us competitively versus incumbent centralized solutions. One other very interesting element of our preparation for scaling is that the Utah facility has been preparing an automated test cup manufacturing line that we expect will improve efficiency by approximately 4x in terms of time and overhead. So this is a very exciting development, and it not only increases our throughput capabilities by 4x, but it also gets rid of a lot of the potential human error factors that would happen along a line that would typically involve maybe 14 different human beings, which will now require the assistance of 1 or 2 on an automated line. So we're very excited about the prospects of the automated test cup. And it's not ready to go right now, but I've seen it demonstrated. And we expect that by the time we get to a certain point of deployment in Asia and in Saudi Arabia, that we'll be able to deploy the automated line. Michael Okunewitch: And then I do want to follow up on that because it seems like a large portion of your global strategy here is setting up specifically local manufacturing and local sales infrastructure. So can you talk a little bit about the advantages that you're seeking to leverage by going after these local regional manufacturing facilities? Dwight Egan: Well, we originally picked India as a joint venture partner basically 9 years ago when we identified India as what was going to be, if not the biggest, certainly one of the biggest health care markets in the world. And that was a very good decision. And now we have a mature business entity that's been operating for 9 years. And we're ready now to transfer technology so they can locally manufacture the product and distribute it throughout the country. We've already serviced hundreds of laboratories in India. And so it's well prepped. There's a lot of expectation, we believe, for the initiation of our new wonderful platform, which emphasizes accessibility in terms of being able to get down to the end of the row. There are 650,000 villages roughly in India that have no access or very little access to these types of diagnostics. And so we're going to be taking it to them and filling a huge gap. And it's not only accessibility. It's affordability. Our tests are competitively priced, of course. But our platform, the box that is used to actually perform the test, is a fraction of the cost of the competitive elements which are -- competitors, which are mainly targeted towards centralized hospitals and district hospitals in places like India. So we fill a huge gap. We're very excited to take it on. Michael Okunewitch: All right. And then one more for me before I hop back into the queue. I wanted to see if you could expand a little bit on the actual go-to-market strategy in India. I imagine the clinical trial is largely going to be done in some of those larger medical centers rather than the smaller distributed microscopy centers that are the primary initial market here. So I'd like to see if you could talk a little bit about how you plan to bridge that gap, build those relationships with the smaller centers, and if you have some of those relationships already established based on your existing work in India. Dwight Egan: Well, let me address the clinical trial first, which will begin shortly. We actually get assigned institutions that will perform the clinical trial. That is the locations, hospitals, district hospitals that will participate in the generation of the data and the testing that goes on there. Then once that finishes and we do the analytical studies, it's submitted to the CDSCO. I would point out that we've already been through this process a lot in India. We've got 15 tests that have been cleared through the CDSCO and that are molecular diagnostic tests. So we're very comfortable with the way that's done and have an excellent track record in executing on it. So with respect to the kind of places where this is going to go, to fill the aforementioned gap that I referenced of 650,000 villages, and the primary health care facilities or PHCs where we intend these to land, this is an area where if you go into them, and I've been in these in my trips to India and looked at the actual types of facilities that we intend to be going into, and these are places where you go into them, there's a bunch of materials that are being used for smear microscopy, which is a 125-year-old technology. It's only accurate 20% to 80% of the time, call it, a 50-50 gamble if you take one of those tests. It takes a lot of time. It takes time to get results. And this is what has to be replaced. The key opinion leaders around the world have designated going from smear microscopy to the kind of testing that we're doing, that is molecular diagnostics, as being the key driver in helping India overcome the epidemic of tuberculosis, which results in nearly 1,000 deaths every day. That's not 1,000 people who get TB, it's 1,000 people who die from it. And so we're very excited about our ability to go there. We've spent a ton of time and have a fully-staffed group over there that has already been selling throughout the country. And I think we're very ready to go as soon as we get the clearance. Operator: [Operator Instructions] That concludes the Q&A session and our webcast. Thank you for your participation. You may now disconnect, and have a wonderful rest of your day. 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This article is a transcript of this conference call produced for The Motley Fool. While we strive for our Foolish Best, there may be errors, omissions, or inaccuracies in this transcript. As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. Co-Diagnostics (CODX) Q1 2026 Earnings Transcript was originally published by The Motley Fool

Advancing Global Commercialization Through CoSara Regulatory Progress and Regional Expansion Executing Clinical Strategy with Upper Respiratory Submission Preparation and TB Study Initiation Expanding International Presence and Reinforcing Platform Differentiation Through Partnerships and IP SALT LAKE CITY, May 14, 2026 /PRNewswire/ -- Co-Diagnostics, Inc. (Nasdaq: CODX) ("Co-Dx," or "the Company"), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, today announced its financial results for the first quarter ended March 31, 2026. First Quarter 2026 Business Highlights: Received CDSCO license to manufacture and sell the CoSara PCR Pro® instrument in India, marking a key regulatory milestone and supporting commercialization readiness Received ISO 13485 certification for CoSara's manufacturing facility in India, supporting regulatory submissions and meeting international quality standards Entered into an agreement to expand CoSara Diagnostics' commercial and distribution territory across South Asia to include Bangladesh, Pakistan, Nepal, and Sri Lanka, increasing the regional total addressable market to approximately $13 billion Initiated shipments of PCR Pro* instruments and tuberculosis (TB) test materials to India to support upcoming clinical performance studies, with the instrument and test kits designed to support testing approaches reflected in recent WHO guidance on TB testing Strengthened distributor relationships and expanded market presence through CoSara Diagnostics' participation in regional conferences in India Showcased the Co-Dx PCR platform at industry events including Medical Korea 2026 in Seoul, South Korea and World Health Expo Labs Dubai in Dubai, UAE, highlighting the Company's point-of-care testing platform and engaging with global stakeholders Expanded the intellectual property portfolio with the issuance of a new international patent in Japan First Quarter 2026 Financial Results: Revenue of $0.15 million, compared to $0.05 million in the first quarter of 2025 Operating expenses of $9.2 million, compared to $8.6 million in the same period last year, driven by research and development spending on clinical studies and to advance other growth initiatives Operating loss of $9.2 million, compared to $8.6 million in the first quarter of 2025 Net loss of $9.1 million, or $4.06 per share, compared to a net loss of $7.5 million, or $7.05 per share, in the same period last year, primarily driven by higher operating expenses and lower other income, including the absence of certain remeasurement gains recognized in the prior-year period Adjusted EBITDA loss of $8.7 million, compared to a loss of $7.4 million in the first quarter of 2025 Cash and cash equivalents totaled $8.2 million as of March 31, 2026, compared to $11.9 million as of December 31, 2025. The Company expects continued investment in clinical development, regulatory, and commercialization activities as it advances its strategic initiatives "The progress we've made across the business is translating into tangible milestones and expanded opportunities," said Dwight Egan, Chief Executive Officer of Co-Diagnostics. "During the quarter, we advanced key initiatives across our clinical pipeline, strengthened our presence in strategic global markets through CoSara and CoMira, and continued to build the foundation for a scalable, globally deployable diagnostics platform. These efforts reflect a focused strategy centered on execution, innovation, and expanding our reach into high-need markets." Mr. Egan continued, "We believe we have generated the data needed to support a regulatory submission for our upper respiratory multiplex test and are advancing toward a 510(k) filing with the FDA. We are also preparing to initiate clinical performance studies for our MTB program in India, which we believe represents one of the most significant near-term opportunities for the platform. Together with continued progress across our international initiatives, these developments demonstrate continued operational progress against our strategy and that we are entering the next phase of execution with increasing momentum and a clearer path toward commercialization." Recent Developments: Completed enrollment in the upper respiratory Co-Dx test clinical studies, with more than 1,400 patients enrolled Advanced CoMira Diagnostics' manufacturing facility in Sudair Industrial City in the Kingdom of Saudi Arabia ("KSA") through regulatory approval and lease execution, supporting localized manufacturing and expansion across the Middle East and North Africa ("MENA") Participated in a European trade mission across Switzerland and Germany with the Utah Governor's Office and World Trade Center Utah, engaging with prospective customers and distributors, including at ESCMID Global 2026 Presented at the Stop TB Partnership Summit in Washington, D.C., showcasing the Company's Co-Dx PCR tuberculosis (TB) test during a roundtable with U.S. government agencies and global health stakeholders Conference Call and Webcast: Co-Diagnostics will host a conference call and webcast at 4:30 p.m. EDT today to discuss its financial results with analysts and institutional investors. The conference call and webcast will be available via: Webcast: ir.co-dx.com on the Events & Webcasts page, or accessible directly here Conference Call: 1-888-880-3330 (Toll Free) or 1-646-357-8766 (Toll) The call will be recorded and later made available on the Company's website. *The Co-Dx PCR platform (including the PCR Home™, PCR Pro™, mobile app, and all associated tests) is subject to review by the FDA and/or other regulatory bodies and is not yet available for sale. About Co-Diagnostics, Inc. Co-Diagnostics, Inc., a Utah corporation, is a molecular diagnostics company that develops, manufactures and markets state-of-the-art diagnostics technologies. The Company's technologies are utilized for tests that are designed using the detection and/or analysis of nucleic acid molecules (DNA or RNA). The Company also uses its proprietary technology to design specific tests for its Co-Dx PCR at-home and point-of-care platform (subject to regulatory review and not currently for sale) and to identify genetic markers for use in applications other than infectious disease. Non-GAAP Financial Measures: This press release contains adjusted EBITDA, which is a non-GAAP measure defined as net income excluding depreciation, amortization, income tax (benefit) expense, net interest (income) expense, stock-based compensation, change in fair value of contingent consideration, and realized gain (loss) on investments. The Company believes that adjusted EBITDA provides useful information to management and investors relating to its results of operations. The Company's management uses this non-GAAP measure to compare the Company's performance to that of prior periods for trend analyses, and for budgeting and planning purposes. The Company believes that the use of adjusted EBITDA provides an additional tool for investors to use in evaluating ongoing operating results and trends and in comparing the Company's financial measures with other companies, many of which present similar non-GAAP financial measures to investors, and that it allows for greater transparency with respect to key metrics used by management in its financial and operational decision-making. Management does not consider the non-GAAP measure in isolation or as an alternative to financial measures determined in accordance with GAAP. The principal limitation of the non-GAAP financial measure is that it excludes significant expenses that are required by GAAP to be recorded in the Company's financial statements. In order to compensate for these limitations, management presents the non-GAAP financial measure together with GAAP results. Non-GAAP measures should be considered in addition to results prepared in accordance with GAAP, but should not be considered a substitute for, or superior to, GAAP results. A reconciliation table of the net income, the most comparable GAAP financial measure to adjusted EBITDA, is included at the end of this release. The Company urges investors to review the reconciliation and not to rely on any single financial measure to evaluate the company's business. Forward-Looking Statements: This press release contains forward-looking statements. Forward-looking statements can be identified by words such as "believes," "expects," "estimates," "intends," "may," "plans," "will" and similar expressions, or the negative of these words. Such forward-looking statements are based on facts and conditions as they exist at the time such statements are made and predictions as to future facts and conditions. Forward-looking statements in this release include, but are not limited to, statements regarding: (i) the continued development, clinical evaluation, regulatory submission, clearance, authorization, and commercialization of the Co-Dx PCR platform and related tests; (ii) anticipated timing and progress of clinical studies and regulatory submissions; (iii) commercialization and manufacturing activities involving CoSara and CoMira; (iv) anticipated market opportunities and international expansion initiatives; (v) the expected capabilities, differentiation, and adoption of the Company's platform technologies; and (vi) the Company's strategic, operational, and growth initiatives generally. Forward-looking statements are subject to inherent uncertainties, risks and changes in circumstances. Actual results may differ materially from those contemplated or anticipated by such forward-looking statements. Readers of this press release are cautioned not to place undue reliance on any forward-looking statements. There can be no assurance that any regulatory submission, authorization, commercialization milestone, manufacturing initiative, strategic collaboration, or market opportunity will occur on the timelines anticipated by the Company, or at all, due to certain risks and uncertainties, a discussion of which can be found in our Risk Factors disclosure in our Annual Report on Form 10-K, filed with the Securities and Exchange Commission (SEC) on March 31, 2026, and in our other filings with the SEC. The Company does not undertake any obligation to update any forward-looking statement relating to matters discussed in this press release, except as may be required by applicable securities laws. View original content to download multimedia:https://www.prnewswire.com/news-releases/co-diagnostics-reports-first-quarter-2026-financial-results-302772842.html

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Management is pivoting the upper respiratory multiplex test submission to focus on Flu A, Flu B, and RSV due to lower-than-expected COVID-19 prevalence in clinical studies. The company is transitioning from development to execution by localizing manufacturing in India and Saudi Arabia to gain preferential status in government procurement. Strategic positioning in India leverages a 9-year foundation through the CoSara joint venture, targeting a $13 billion addressable market across South Asia. The TB program is designed to align with new WHO guidance favoring near point-of-care molecular testing and non-invasive tongue swab samples. Operational efficiency is being driven by a cloud-connected architecture and machine learning to provide real-time situational awareness and remote system management. The company is evaluating a potential SPAC transaction for CoSara to provide an alternative capital path and unlock shareholder value. Management anticipates filing for FDA 510(k) clearance for the upper respiratory multiplex test in the third quarter of 2026. Clinical performance studies for the TB program in India are scheduled to commence before the end of May 2026. Commercialization of the TB test in India is projected to begin as early as the end of the third quarter of 2026, pending regulatory clearance. The company expects to require additional capital to fully execute its commercialization and development plans, exploring equity, debt, and grants. Future manufacturing scalability will be supported by an automated test cup line in Utah designed to increase throughput by approximately 4x. Net loss increased to $9.1 million, primarily due to higher R&D spending related to clinical studies and the absence of prior-year remeasurement gains. Cash reserves decreased to $8.2 million from $11.9 million at year-end 2025, reflecting intensive investment in clinical programs. Clinical study infrastructure for the respiratory test is being held in a 'paused state' to allow for rapid data collection if the FDA requests additional information. The CoMira joint venture in Saudi Arabia secured industrial land allocation, a critical step for local manufacturing under the Vision 2030 initiative. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. The Utah facility has already produced hundreds of thousands of test cups and is implementing an automated line to increase efficiency by 4x. Automation is expected to reduce human error by replacing a 14-person manual process with a line requiring only 1 or 2 assistants. Initial international launches will involve final assembly in India using components principally manufactured in Utah. Local manufacturing in India and Saudi Arabia provides a competitive edge in government procurement processes that prioritize domestic products. The strategy targets the 'end of the row' accessibility gap in 650,000 Indian villages that currently lack diagnostic infrastructure. The platform is priced at a fraction of the cost of incumbent centralized hospital solutions, focusing on affordability. The company aims to replace 125-year-old smear microscopy technology, which management claims is only accurate 20% to 80% of the time. Co-Dx will leverage its existing track record of 15 CDSCO-cleared tests to navigate the regulatory and distribution landscape in India. The primary target is Primary Health Care facilities (PHCs) to address the high mortality rate of tuberculosis in the region.

This article first appeared on GuruFocus. Release Date: May 14, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Co-Diagnostics Inc (NASDAQ:CODX) has completed enrollment in a clinical study for their upper respiratory multiplex test, with over 1,400 patients enrolled. The company is advancing its strategy in India through its Coursera joint venture, which has a nationwide commercial presence and 15 clinical laboratory PCR tests cleared by India's regulatory body. Co-Diagnostics Inc (NASDAQ:CODX) is progressing its Comira joint venture in Saudi Arabia, securing industrial land allocation and moving forward with facility development. The company is leveraging machine learning and algorithmic analysis within its platform, enhancing operational efficiency and real-time monitoring capabilities. Co-Diagnostics Inc (NASDAQ:CODX) is preparing to manufacture the PCRPro instrument and consumables locally in India, representing a significant step toward commercialization. Total revenue for the first quarter of 2026 was only $146,000, compared to $50,000 in the same period last year, indicating limited revenue growth. The company reported a net loss of $9.1 million for the quarter, an increase from a net loss of $7.5 million in the same period last year. Operating expenses increased to $9.2 million, driven by higher research and development spending, impacting profitability. Co-Diagnostics Inc (NASDAQ:CODX) expects to continue generating operating losses in the near term, indicating ongoing financial challenges. The company anticipates that additional capital will be required to fully execute its commercialization and development plans, highlighting potential funding needs. Warning! GuruFocus has detected 7 Warning Signs with CODX. Is CODX fairly valued? Test your thesis with our free DCF calculator. Q: What is Co-Diagnostics' current capacity for producing test kits, and what steps are being taken to enhance these capabilities? A: Co-Diagnostics is well-positioned to scale for initial commercial demand. The Utah facility has produced hundreds of thousands of test cups for clinical studies and R&D. Manufacturing plans are in place for the U.S., Saudi Arabia, and India. The Coursera joint venture in India supports local manufacturing and commercialization. An automated test cup manufacturing line in Utah is expected to improve efficiency by four times, reducing potential human error and increasing throughput capabilities. (Dwight Egan, CEO) Q: What advantages does Co-Diagnostics seek by setting up local manufacturing and sales infrastructures? A: Co-Diagnostics identified India as a major healthcare market and established a joint venture there nine years ago. The mature business entity is ready to locally manufacture and distribute products throughout India, servicing hundreds of laboratories. The focus is on accessibility and affordability, providing diagnostics to underserved areas at a lower cost compared to centralized solutions. (Dwight Egan, CEO) Q: Can you expand on the go-to-market strategy in India, particularly regarding relationships with smaller centers? A: Clinical trials will be conducted in assigned institutions, and Co-Diagnostics has experience with the CDSCO process, having cleared 15 molecular diagnostic tests. The strategy involves replacing outdated smear microscopy with molecular diagnostics in primary healthcare facilities across India's 650,000 villages. The company has a fully staffed team in India, ready to execute once clearance is obtained. (Dwight Egan, CEO) Q: How does Co-Diagnostics plan to bridge the gap between clinical trials in larger centers and smaller distributed microscopy centers? A: Clinical trials will generate data in assigned hospitals, and Co-Diagnostics has a strong track record with the CDSCO. The focus is on deploying molecular diagnostics in primary healthcare facilities, replacing smear microscopy. The company has a dedicated team in India, prepared to implement the strategy upon receiving clearance. (Dwight Egan, CEO) Q: What is the significance of the automated test cup manufacturing line in Utah? A: The automated test cup manufacturing line in Utah is expected to improve efficiency by approximately four times, reducing potential human error and increasing throughput capabilities. This development is crucial for scaling production and meeting demand in Asia and Saudi Arabia. (Dwight Egan, CEO) For the complete transcript of the earnings call, please refer to the full earnings call transcript.