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Date
Thursday, August 14, 2025 at 4:30 p.m. ET
Call participants
Chief Executive Officer — Dwight Egan
Chief Financial Officer — Brian Brown
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Takeaways
Total Revenue-- $200,000 in GAAP revenue for Q2 2025, all derived from product sales compared to $2,700,000 in the same period of the prior year of which $2,500,000 was from grants.
Total Operating Expenses-- $8,200,000, down from $10,100,000 in 2024, reflecting operational efficiency efforts.
Research and Development Expenses-- $4,700,000 compared to $5,600,000 during the prior year comparable period.
Net Loss-- $7,700,000 or $0.23 per fully diluted share, compared to a net loss of $7,600,000 or $0.25 per fully diluted share in the prior year comparable period.
Adjusted EBITDA-- Adjusted EBITDA loss of $7,200,000, higher than the $5,900,000 loss in 2024.
Cash, Equivalents, and Marketable Securities-- $13,400,000 in cash, cash equivalents, and marketable investment securities at the end of Q2 2025.
Kodiak PCR Test Pipeline-- Clinical trials for four panels (COVID-19, multiplex flu A/B/COVID-19/RSV, tuberculosis, and HPV) expected to begin during the remainder of the calendar year, with clinical evaluation sites for COVID-19 already training.
Regulatory Timeline-- 510(k) submissions to the FDA planned after clinical evaluations, with the COVID-19 test targeted as first-up; management expects reasonable chance of FDA clearance by mid-2026.
Geographic Focus-- U.S. commercialization to prioritize physician offices, clinics, nursing facilities, home use, and pharmacies; Indian commercialization to focus on primary health care centers.
Funding Strategy-- Management is utilizing its ATM, evaluating equity and debt structures, and actively pursuing additional grants to support platform development and commercialization.
Summary
Co-Diagnostics(CODX 0.91%) reported a steep revenue decline in Q2 2025, driven by the absence of grant income. Management reiterated the advancement and imminent clinical evaluations across four key test panels for the Kodiak PCR platform, outlining sequential trial initiations throughout calendar year 2025 and a U.S. regulatory roadmap that prioritizes the COVID-19 and multiplex respiratory panels. The company's operational focus remains on reducing expenses and sustaining liquidity while preparing for FDA submission and international launches, particularly in high-burden regions for tuberculosis and HPV. Strategic manufacturing investments in Salt Lake City and coordination with Indian partners are aimed at commercial scaling, subject to final regulatory approvals and trial outcomes.
CEO Egan said, "we remain on track to initiate clinical evaluations for all tests in our pipeline during 2025." underscoring firm timelines without noted delays.
CFO Brown stated, "we are managing our spend to maintain a healthy balance sheet as we position ourselves for commercialization." highlighting cost control priorities while seeking additional financing and grants.
Management detailed planned U.S. distribution channels spanning physician offices, clinics, skilled nursing facilities, home use, and pharmacies, with Indian market entry focused on primary care facilities operating at scale.
Cloud-based, de-identified epidemiological reporting was introduced for the Kodiak PCR Pro, positioned as a differentiating capability supported by major philanthropic and federal grants.
Industry glossary
510(k) Application: A premarket submission to the FDA demonstrating that a new medical device is substantially equivalent to one already legally marketed.
Multiplex Panel: A diagnostic test that detects multiple pathogens or biomarkers simultaneously from a single sample.
ATM (At-the-Market) Program: A financing mechanism allowing companies to raise equity capital incrementally by selling shares through the open market at prevailing prices.
RSV (Respiratory Syncytial Virus): A common respiratory virus targeted by one of the Kodiak PCR multiplex panels.
CDSCO: Central Drug Standard Control Organization, India’s national regulatory authority for drugs and diagnostics.
SAFRA: South Africa Health Products Regulatory Agency, the regulatory authority for medical products in South Africa.
COVID-19 4-Plex Panel (ABCR): The Kodiak PCR respiratory test panel detecting flu A, flu B, COVID-19, and RSV in a single assay.
Full Conference Call Transcript
Dwight Egan, Chief Executive Officer, and Brian Brown, Chief Financial Officer. Earlier today, Co-Diagnostics, Inc. released financial results from the second quarter ended 06/30/2025. 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. We begin, we would like to inform listeners that certain statements made by Co-Diagnostics, Inc. during this call, which are not historical facts, are forward-looking statements. This includes statements concerning the company's Kodiak PCR testing platform, which requires regulatory approval and marketing authorization for diagnostic use and is not currently for sale. In addition to diagnostic test developments and timing for commencement of clinical evaluations.
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, Inc.'s filings with the SEC. Co-Diagnostics, Inc. 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 should be read together with GAAP results.
We refer you to the company's earnings release issued shortly before this call which contains reconciliations of 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, Inc.'s Chief Executive Officer, Dwight Egan. Dwight? Thank you, Andrew, and good afternoon, everyone.
Dwight Egan: Thank you for joining Co-Diagnostics, Inc.'s second quarter 2025 earnings call. The second quarter of this year continued to bring steady advancements of our Kodiak PCR point-of-care platform and thanks to the diligent efforts of our team working towards our goal to bring the instrument and test to market, we remain on track to initiate clinical evaluations for all tests in our pipeline during 2025.
In addition to the Kodiak PCR COVID-19 test, which is expected to imminently begin enrolling participants for its clinical evaluations, the test pipeline for the new platform includes real-time PCR tests for flu A and B, COVID, and RSV in a four-plex respiratory panel supported by a grant from the Institute of Health's RADx Tech program. As well as tests for tuberculosis or TB and an HPV eight-type multiplex panel. Both of which are supported by grants from the Bill and Melinda Gates Foundation. These indications were identified as amongst the best opportunities in the near term to bring our unique technology and platform to market.
And to help advance the Co-Diagnostics, Inc. vision of increasing the accessibility of affordable high-quality diagnostics in The United States, India, and around the world. Our focus remains on bringing the Kodiak PCR platform to the point-of-care market which has included incorporating ongoing advancements developed by our scientific, engineering, and software development teams as we prepare for our upcoming regulatory submissions in the appropriate jurisdictions for each indication. As mentioned in our previous call, the augmented Kodiak PCR COVID-19 test underwent extensive verification testing. And we are pleased to report that the clinical evaluation sites for this updated test are currently being trained. With testing of trial participants expected to begin imminently.
Our plans continue to be to submit a 510(k) application to the FDA for this updated version of our COVID-19 test. After the completion of the clinical evaluations. We look forward to the platform's initial introduction to the market next year and to the disruptive potential of this new diagnostic solution. Perhaps the greatest opportunity for the platform to disrupt the current testing paradigm is through tuberculosis. TB caused an estimated 1.25 million deaths in 2023, according to the World Health Organization, making it the number one infectious disease killer globally. Several preliminary analytical and preclinical studies for the Kodiak PCR MTB test have been completed or are currently in process.
And testing on clinical samples has demonstrated the high-performance properties of the test. We believe that the efficient, affordable workflow process supported by the straightforward mobile app will help to speed adoption at the point of care in areas across India and Africa that have previously had little to no access to gold standard PCR diagnostic technology for a disease that is highly treatable if diagnosed early and accurately. The company remains on track to begin clinical evaluations for our TB test in both India and South Africa before the end of 2025. Which will gather data to support regulatory submissions to the South Africa Health Products Regulatory Agency or SAFRA.
And the Central Drug Standard Control Organization or CDSCO in India. Helping to increase the accessibility of high-quality real-time PCR diagnostics in India has been a focus of the company since the early days of its founding. Twenty-seven percent of global TB cases and twenty-six percent of global TB deaths were found in India alone in 2023. And the country continues to be our top priority market for TB testing. Our footprint in India is significantly strengthened by our joint venture Kocera Diagnostics, who provides substantial experience in regulatory, commercial, and manufacturing infrastructure in India. Principal manufacturing for tests and instruments will take place in our domestic manufacturing facility in South Salt Lake inaugurated a little over a year ago.
Before being completed in the upgraded Coursera Manufacturing Campus prior to distribution and commercialization in India. As we proceed with the preparations for the clinical evaluations, we continue to engage with local health officials and potential customers in both India and Africa to evaluate the most effective and efficient commercialization strategy in specific target markets. We are pleased to report that the Kodiak PCR ABCR four-plex respiratory panel is nearly prepared for clinical evaluations. Expected to begin concurrent with the 2025 North American fall and winter flu season. The test has been designed to deliver simultaneous differentiated real-time PCR test results for patients suspected of having flu A and B, COVID-19, or RSV.
It remains the test with the highest domestic demand in our pipeline. Driven by the burden these diseases place on everyday life in The United States and around the world. Once complete, the data collected by the clinical evaluations will be used in a 510(k) application to the FDA. 510(k) clearance will not only allow the test to be commercialized as an infectious disease in vitro diagnostic in The United States. But also in other countries around the world. Who accept US FDA clearance as valid regulatory approval. Following a straightforward registration process in those countries. This international person commercialization model allowed Kodiak to achieve significant growth during the pandemic.
Thanks to the sales of our centralized lab COVID-19 PCR tests. And we believe we will be able to follow a similar pathway for this new platform. Finally, the Kodiak PCR HPV eight-type multiplex panel is also on track to initiate clinical evaluations before year-end. HPV is the most widespread and common sexually transmitted infection worldwide. And despite the widespread availability of an HPV vaccine, there remains a vast need for HPV testing around the world. Human papillomavirus has many subtypes. Several of which are linked to cervical cancer. Which causes hundreds of thousands of deaths annually.
We believe the Kodiak PCR platform can have a significant impact on testing accessibility and efficiency which remain key constraints to mitigating the impact of HPV on global health. Supported by a grant from the Bill and Melinda Gates Foundation and powered by our coprimers technology, this HPV assay is designed to simultaneously detect eight different high-risk HPV subtypes from a single self-collected vaginal swab sample. And differentiate between HPV 16, HPV 18, and HPV 45. These are considered to be the three most carcinogenic HPV variations collectively responsible for roughly seventy-five percent of cervical cancers worldwide.
Early detection of HPV can improve intervention and treatment of precancerous cells and lesions before they develop into cervical or other types of cancer. And we believe that a test with these performance characteristics has the potential to dramatically increase the availability of HPV PCR diagnostics around the world. Like TB, the regulatory pathway for this test will follow areas of greatest need in India and Africa. And clinical evaluations to support submissions to the CDSCO and SAFRA are anticipated to begin this year. We look forward to the initiation and completion of the upcoming clinical evaluations. Regulatory submissions, and commercialization of this test on the Kodiak PCR Pro.
One of the most original and inventive features of the Kodiak PCR platform is the cloud-based analysis of tests performed on the Kodiak PCR Pro. Which allows de-identified epidemiological data to be made available to health departments at the local, regional, national, or international level. The ability to track the spread of infectious diseases in real-time is often compartmentalized in other testing paradigms. Or even absent outright. And we anticipate this situational awareness can provide health officials with key data and insights that could save lives, and limit outbreaks. We believe that this feature was a key factor in receiving the support of several leading organizations who share in our passion for improving the global health infrastructure.
Including the Bill and Melinda Gates Foundation, Smart for TB, and the National Institute of Health's RADx tech program. As we near the initiation of clinical evaluations for all four tests currently in our Kodiak PCR product pipeline, and firm up our pathway to commercialization, we anticipate increasing activity at trade shows and other events to continue engaging with local and international potential customers. And key stakeholders. Over the past couple of years, we have developed solid relationships with local trade and commerce organizations. Some of which support the growth of Utah's businesses by offering grants for their travel and participation in trade shows and conferences.
We have been successful in securing grants to help offset the cost of some recent and upcoming events. And we will continue to pursue these and other opportunities to be mindful of our spend while we prepare for our expansion. To conclude, I want to emphasize our commitment to achieving our clinical evaluations and regulatory submission objectives. As the next critical steps to successfully launching the Kodiak PCR Pro instrument and test kits to the world. This pathway remains the most expeditious way to return value to our shareholders and the foundation we have built for near and long-term success is possible thanks to the investments in infrastructure, technology, and people that we have made along the way.
We believe this framework will allow us to replicate the process more quickly and efficiently for other critical infectious disease test panels in the future. And can be applied to other areas of interest such as veterinary, agricultural, and livestock applications. The company remains on schedule to reach the critical milestones discussed here. As well as to expand our manufacturing capacity domestically and in India. To be able to scale to meet market demand upon platform launch. We believe the Kodiak PCR platform can revolutionize and set a new bar for the affordability, accessibility, and decentralization of accurate gold standard PCR infection disease testing.
I'm very proud of the work of our team and look forward to another quarter of success. With that, I will now turn the call over to Brian to discuss our financial results.
Brian Brown: Thanks, Dwight. And thanks to everyone who joined today's call. For the 2025, total revenue decreased to $200,000 as compared to $2,700,000 in the prior year same period. In the prior year same period, revenue from grants represented $2,500,000 while all revenue recognized during the 2025 came from product sales. Total operating expenses for the 2025 decreased to $8,200,000 from $10,100,000 in the 2024. This decrease continues to reflect our efforts to become more operationally efficient. Research and development expenses in the 2025 were $4,700,000 compared to $5,600,000 during the prior year comparable period.
Net loss for the 2025 was $7,700,000 or a loss of $0.23 per fully diluted share compared to a net loss of $7,600,000 or a loss of $0.25 per fully diluted share in the prior year comparable period. Adjusted EBITDA was a loss of $7,200,000 compared to an adjusted EBITDA loss of $5,900,000 in the 2024. We ended the second quarter with $13,400,000 in cash, cash equivalents, and marketable investment securities. As always, we are managing our spend to maintain a healthy balance sheet as we position ourselves for commercialization. Throughout the year, we will continue to make improvements to our operating footprint that will drive efficiency gains and cost savings.
We plan to provide for the company's capital requirements through equity and or debt financing, additional grant funding, and operational efficiencies. More specifically, we're using our ATM to generate capital when appropriate, We are evaluating various debt and equity financing structures. And we'll continue to press forward with seeking grant support for our Kodiak PCR platform. In the near term, we are focused on progressing our development pipeline towards completing clinical evaluations and preparations for regulatory submission and are managing our allocation of time and resources accordingly. We're very excited about our continued progress and remain optimistic about 2025 multiple commercial launches in 2026, and future developments within our test pipeline.
I look forward to providing you with more updates on next quarter's call. With that, I will now turn the presentation back over to Dwight.
Dwight Egan: Thank you, Brian. To close, we want to extend our gratitude to Co-Diagnostics, Inc. shareholders and to our employees whose consistent dedication and hard work is one of our most valuable assets to achieving the Kodiak's vision. We will now take questions from our analysts.
Operator: Thank you. We will now begin the question and answer session. Your first question comes from Yi Chen with H. C. Wainwright. Please go ahead.
Dwight Egan: Hi. This is Eduardo on for Yi. I was hoping if you could just kind of repeat your expected timeline. You mentioned that all sites are being trained, and you're gonna start recruitment imminently. I was just hoping if I could get a timeline for the specific tests in order, which one you expect to have earlier completion of those trials, and then the consequent 510(k) applications. Just kind of get a feel for the progression of and cadence of things.
Dwight Egan: Yes. Thank you for the question. Our clinical trials for all four of the indications that we've cited with our COVID-19, our multiplex flu A, B, COVID-19, and RSV test, our MTB or tuberculosis test, and then our HPV or human papillomavirus test, we expect all of those indications to be into clinical trials during the remainder of this calendar year. We anticipate to begin with the COVID-19 test which has already begun its site visits and training prior to putting customers through the trial. Applicants through the trial. We believe that the next test up will be our ABCR or multiplex flu A, B, over the RSV test.
And probably the next one after that would be our tuberculosis test followed by HPV. That order could change with respect to the final treatment we expect at least those for all of them to commence. Clinical trials during the remainder of this calendar year.
Eduardo: Got it. That's really helpful. And you expect applications are you gonna prioritize them in that order as they finish as well, or do you think you'd prioritize TB or multiplex given the acute need both internationally and domestically for those two respectively?
Dwight Egan: Well, we believe that there is a solid need for all four of those panels. The MGB and HBV tests are targeted mainly to India and the African nations. Including South Africa, We also believe that COVID still has a vibrant market including in The US, and we're seeking FDA approval for a 510(k) application for both the COVID-19 test and for the multiplex ABCR test. Again, flu A, B, COVID, and RSV.
Eduardo: So
Dwight Egan: We know that COVID is and there was a lot of COVID fatigue out there, but it's still the number two killer in terms of infectious disease pathogens out there. So we think there's still a robust market for COVID and we anticipate that will be the first one up.
Eduardo: Got it. So COVID first. Got it. Thanks for the clarity there. And curious if you have some visibility towards commercial launch I know maybe that might be a ways down, but if you have any visibility there and how you plan on deploying, your marketing strategy, you're planning on you know, point of care, or over the counter? Are you in conversations with distributors at this point in time, or are you planning on executing in regard to commercial launch?
Dwight Egan: Well, with respect to getting into commercial commercialization, we plan to do that as soon as we have. A clearance from the FDA case of COVID-19. We don't expect that the clinical trial submission to the FDA will be protracted. The FDA generally has about a hundred and day period in which they endeavor to clear a test. Always happen that way, but we believe that what we will be that is a reasonable time frame after we get this commission done. As to the clinical trial, that depends largely on how many people come to the testing sites actually have COVID.
Because we will need to have a certain number of positive and negative applicants in order to, you know, conclude the clinical trial. The other part of your test would of your question with respect to where we will deploy it from a commercialization standpoint is really as follows. In The United States, we are targeting physician offices and clinics. This is a point of care application. We're also targeting skilled nursing facilities, less than so they have a vulnerable population. That has a need for, you know, extensive testing. We also anticipate doing marketing into the home market. We are seeking a clearance for a home use. And finally, we are expecting to have activity in the pharmacy market.
There's tens of thousands of pharmacies in The United States. Many of them are up to test and treat. And we believe that will also be a fertile market for us. So those are the those are the areas in The United States where we're targeting for the COVID and for the ABCR test. In India, we're mainly targeting the primary health care facilities where they're almost 30,000 different primary care centers. That were primarily due hair microscopy. It really needs to be replaced with all type technology that is a molecular technology. We have the gold standard technology for that type of application. Including, you know, its accessibility, its affordability, and its accuracy.
Eduardo: Got it. And would you expect just trying to add the timelines together. So, obviously, there's some variability in the readout for the COVID trial, like you mentioned. I'm curious So would this be commercial launch potentially 2026? Early 2027?
Dwight Egan: Well, I hope we have good commercialization before the 2026. I would think that we'll be because we're imminently beginning the clinical trial in COVID, I believe we'll be wrapping that up near year-end and that sometime in that by the end of the second quarter, we have a reasonable possibility of having it cleared through the FDA. That's not something we can guarantee, of course. But I would be surprised if it takes us clear out until the end of the year to get something into the market. I've I'd look more to midyear.
Eduardo: Got it. So much for the clarity and for taking the questions.
Brian Brown: Thank you.
Operator: And that concludes our question and answer session. And that does conclude today's conference call. Thank you for your participation. And you may now disconnect.