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DATE

Thursday, Aug. 13, 2026 at 4:30 p.m. ET

CALL PARTICIPANTS

  • Head of Investor Relations-Andrew Benson
  • Chief Executive Officer-Dwight H. Egan
  • Chief Financial Officer-Brian L. Brown

TAKEAWAYS

  • Revenue -- $166,131, representing a slight increase from $162,910, primarily driven by higher product revenue.
  • Net Loss -- $6.3 million, or $1.46 per share, narrowing from a net loss of $7.7 million, or $7.00 per share, due to reduced operating costs.
  • Operating Expenses -- $6.3 million, reflecting a reduction from $8.2 million driven by lower general and administrative and research and development expenses.
  • Research and Development Expenses -- $4.2 million, decreasing from $4.7 million as a result of lower personnel and stock-based compensation costs.
  • General and Administrative Expenses -- $1.5 million, compared to $2.6 million in the prior year period, reflecting lower legal and personnel expenses.
  • Cash and Cash Equivalents -- $3.6 million at quarter end, down from $11.9 million at the end of 2025.
  • Adjusted EBITDA -- A loss of $5.8 million, versus a loss of $7.2 million in the prior year period.
  • Private Placement Proceeds -- $3.0 million, generated through an at-the-market placement under Nasdaq rules to support strategic initiatives.
  • FDA Clinical Study Participation -- Over 1,400 symptomatic patients across nine geographically diverse U.S. clinical sites supported the 510(k) submission for the respiratory multiplex test.
  • FDA Analytical Program Scale -- More than 10,000 individual test runs across 27 studies were conducted to validate the Co-Dx PCR Pro instrument.
  • Vector Smart Adoption -- 21 U.S. states now utilize the decentralized vector surveillance platform, with four new installations completed during the quarter.
  • Gross Profit -- $120,828, representing a decrease from $130,804 as cost variability impacted margins during limited revenue levels.
  • Total Assets -- $16.6 million as of June 30, 2026, compared to $24.7 million at the end of the previous year.
  • Total Liabilities -- $3.9 million, compared to $4.1 million at the end of 2025.
  • Inventory Value -- $841,669, reflecting a reduction from $992,397 as of Dec. 31, 2025.

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RISKS

  • Brown warned that "cost variability can impact gross margin performance at this stage" while revenue levels remain limited.
  • Brown stated, "Although we anticipate continued operating losses in the near term, our priorities remain clear," noting the focus on clinical pipeline and regulatory submissions.

SUMMARY

Management at Co-Diagnostics, Inc. (CODX +4.54%) discussed the company's transition from technology development toward commercialization, anchored by the submission of its respiratory multiplex assay to the FDA for 510(k) clearance and CLIA waiver. The company reported a narrowing net loss and maintained focus on disciplined capital allocation while advancing clinical programs in India and manufacturing capabilities in Saudi Arabia. Management described the strategy as building an integrated molecular diagnostics ecosystem that combines hardware, software, and cloud-based connectivity to support decentralized testing markets.

  • CEO Egan noted the company reached a significant milestone with the dual 510(k) and CLIA-waived application for the Flu A/B and RSV assay on the Co-Dx PCR platform.
  • The company is targeting submissions to the World Health Organization expert review panel for its tuberculosis test later this year to facilitate international procurement.
  • Egan stated, "The integrated molecular diagnostic platform was designed to combine hardware, software, connectivity, and data into a scalable ecosystem to support decentralized testing."
  • A proof-of-concept study for an extraction-free, plasma-based Ebola assay was successfully completed on the Co-Dx PCR Pro instrument.
  • Management reported that the Saudi Arabian joint venture, CoMira, has secured a manufacturing site in Sudair Industrial City to support localized production.
  • The company appointed Wesley C. Lindsey as Chief Scientific Officer to lead scientific and regulatory strategy for the expanding product pipeline.

INDUSTRY GLOSSARY

  • 510(k): A premarket submission made to the FDA to demonstrate that a medical device is safe and effective.
  • CLIA-waived: A regulatory status for simple laboratory tests with a low risk for an erroneous result, allowing them to be used in non-traditional laboratory settings.
  • Co-Dx PCR Pro: The company's proprietary point-of-care diagnostic instrument.
  • Vector Smart: The company's business line focused on molecular testing for mosquito-borne diseases.
  • CE-IVD: A certification marking indicating a product meets European Union safety and performance requirements for in vitro diagnostics.
  • ERPD: The World Health Organization's Expert Review Panel for Diagnostics, which evaluates tests for procurement eligibility.

Full Conference Call Transcript

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.