Co-Diagnostics (CODX) Q3 2025 Earnings Transcript

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DATE

Thursday, Nov. 13, 2025 at 4:30 p.m. ET

CALL PARTICIPANTS

• Chief Executive Officer — Dwight H. Egan
• Chief Financial Officer — Brian L. Brown

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TAKEAWAYS

• Total revenue in fiscal Q3 2025 (period ended Sept. 30, 2025) -- $100,000, down from $600,000 in fiscal Q3 2024, with prior year driven by approximately $400,000 in grant revenue and current revenue fully from product sales.
• Operating expenses in fiscal Q3 2025 -- $7.1 million, decreased from $10.6 million in fiscal Q3 2024, reflecting a focus on operational efficiency.
• Research and development expense in fiscal Q3 2025 -- $4.5 million versus $4.9 million in fiscal Q3 2024.
• Net loss -- $5.9 million, or $0.16 per fully diluted share, in fiscal Q3 2025, narrowed from a $9.7 million loss, or $0.32 per share, in fiscal Q3 2024.
• Adjusted EBITDA -- Loss of $300,000 in fiscal Q3 2025 versus an $8.8 million loss in fiscal Q3 2024.
• Cash, cash equivalents, and marketable investment securities -- $11.4 million at the end of fiscal Q3 2025.
• Recent fundraising -- $10.8 million raised across two strategic direct offerings in the last two months.
• SPAC transaction initiative -- Management initiated with Maxim Group to seek strategic alternatives for the Indian joint venture, Kocera Diagnostics, potentially involving a SPAC listing on a US national exchange.
• Comira joint venture -- New partnership with Arabian Eagle to localize PCR manufacturing and distribution for 19 MENA countries, with headquarters and dedicated manufacturing in Riyadh.
• AI business unit launch -- Formation of a new unit to consolidate all artificial intelligence projects, aiming to accelerate development of proprietary AI-powered diagnostics and data analytics.
• Upper respiratory multiplex test -- Clinical evaluations for a point-of-care test detecting flu A, flu B, COVID-19, and RSV are imminent, supported by an NIH RadixTech grant.
• Kodiak's PCR MTB and HPV tests -- Both tests remain on track to enter clinical evaluations before year-end, supported by Bill & Melinda Gates Foundation grants.

SUMMARY

Management of Co-Diagnostics (NASDAQ:CODX) presented a four-pillar strategic plan, involving an active SPAC initiative to unlock value in India, global joint ventures for regional expansion, AI-driven diagnostic innovation, and new clinical evaluations for proprietary multiplex respiratory tests. Headwinds in revenue were addressed by cost control and fundraising, anchoring future operational stability. The international vision centers on high-volume markets and regulatory progress, with the Saudi Arabia joint venture establishing new local manufacturing and distribution. Management emphasized operational discipline and outlined ongoing financial resource optimization while anticipating multiple commercial launches in 2026. Strategic alternatives for existing joint ventures, including product access synergies in India and the Middle East, are under ongoing assessment.

• CEO Egan said, "Each of these steps brings us closer to our goal, building a stronger, more resilient Co-Diagnostics operationally, financially, and strategically."
• CFO Brown indicated additional funding strategies may include equity, debt, and further grants, with "continued operational efficiencies" as a focus.
• AI platform development is expected to provide predictive epidemiological capabilities, aiming to "anticipate disease patterns and possibly predict outbreaks before they occur."
• Upper respiratory multiplex test is positioned as the company's most comprehensive point-of-care respiratory panel, targeting the US and international regulatory submissions in parallel.
• Discussions confirmed the goal to offer the Kodiak's PCR Pro device at scale at a price point potentially as low as about $300 to $500, seeking market access through affordability, and technical differentiation.

INDUSTRY GLOSSARY

• SPAC: Special Purpose Acquisition Company, a public shell vehicle for merging with operating businesses to facilitate a public listing.
• Multiplex test: A diagnostic assay capable of detecting multiple pathogens or biomarkers simultaneously in a single sample.
• Kodiak's PCR: Co-Diagnostics' proprietary polymerase chain reaction platform for molecular diagnostics.
• Comira: Joint venture between Co-Diagnostics and Arabian Eagle for localization and distribution of diagnostics in MENA countries.
• Kocera Diagnostics: Co-Diagnostics' Indian joint venture targeted for potential strategic transaction.
• NIH RadixTech grant: National Institutes of Health funding intended to accelerate innovation in diagnostic testing.
• SFDA: Saudi Food and Drug Authority, regulatory body for medical product approvals in Saudi Arabia.
• Point-of-care: Medical diagnostic testing performed at or near the site of patient care.
• Coprimers: Proprietary primer technology enhancing multiplex assay performance by reducing primer dimer formation.

Full Conference Call Transcript

Dwight H. Egan, Chief Executive Officer, and Brian L. Brown, Chief Financial Officer. Earlier today, Co-Diagnostics released financial results from the third quarter ended 09/30/2025. A copy of the press release is available on the company's website. We will begin with management's prepared remarks and then open the call to analysts Q and 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 KodiX 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 H. Egan. Dwight?

Dwight H. Egan: Thank you everyone for joining us today and for your continued support of Co-Diagnostics. As we head into the final stretch of the year, it is shaping up to be one of the most active and important times for our business. Over the past forty-five days alone, we've shared several important updates, which are all part of our plan to position Co-Diagnostics for its next phase of growth. Each of these steps brings us closer to our goal, building a stronger, more resilient Co-Diagnostics operationally, financially, and strategically. Importantly, these developments are the effect of cumulative growth and every initiative that we are currently working on connects to a broader strategy designed to create lasting value for shareholders.

Over the coming months, our team is focused on executing across four main growth pillars. First, we recently announced the engagement of Maxim Group to assist in identifying potential strategic alternatives for the company's Indian joint venture, Kocera Diagnostics, which may include a merger with a special purpose acquisition company or SPAC or similar entity listed on a US National Securities Exchange. We believe such a transaction may unlock value from our joint venture project in India and support our long-term funding strategy. Second, the Comira joint venture with Arabian Eagle, which marks the next step in our international expansion and commercial footprint as we expand our presence in Saudi Arabia, and 18 additional MENA nations.

Third, our AI business unit, which is driving innovation, operational efficiency, and new data-driven opportunities. And finally, the initiation of our upcoming upper respiratory multiplex test clinical evaluations which highlights our scientific leadership and reinforces our domestic credibility. Together, these initiatives form a complete and aligned strategy focused on financial strength, global reach, technological innovation, and disciplined execution. This is how we are approaching the remainder of 2025 and preparing the foundation for 2026 and beyond. This period represents a key inflection point for Co-Diagnostics and reflects years of execution to reach this stage of momentum and readiness. With that context in mind, let's begin with the first and most time-sensitive development. The SPAC.

One of the most exciting updates is our plan, Coursera SPAC transaction with Maxim Group. This is a major step that we believe can unlock real value for both our operations in India and for Co-Diagnostics as a whole. The funds raised in this transaction are expected to represent an infusion of growth capital for Coursera operations in India and to increase Co-Diagnostics' value as well. Preparation for the transaction is progressing according to plan. And we expect to share updates on this project over the next several weeks and months. Combined with recent fundraising activities, this transaction has the potential to provide both flexibility and financial stability as we move into 2026 and begin commercialization of the new platform.

This is a proactive step that has the potential to strengthen our balance sheet and create a clear path toward long-term sustainable value creation for our shareholders. I look forward to providing more updates on this transaction as they occur. Shifting focus, the next major component of our growth strategy is the Chimera joint venture. Our recently announced joint venture with Arabian Eagle Manufacturing has led to the formation of a new company named Comira Diagnostics. Which along with CoSera, will stand as one of the cornerstones of our international expansion strategy.

The principles of Arabian Eagle ran the primary distributor in The Middle East and were instrumental in Kingdom Of Saudi Arabia or KSA being one of the largest international markets for the company's logic smart tests. Under the terms of the definitive agreement signed in the KSA, we have established Chimera to localize our Kodiak PCR platform and other PCR-related intellectual property across The Middle East and North Africa. The partnership covers 19 countries, creating a significant commercial footprint in a high-growth region. Premier will be headquartered in Riyadh. With a dedicated manufacturing and assembly facility designed to produce PCR tests for infectious diseases and other applications relevant to the region's health care needs.

The venture will initially focus on local manufacturing and distribution of the Kodiak's PCR platform. With plans to expand into custom assay development and AI-enhanced diagnostics. The initiative aligns with the KSA's Saudi Vision 2030. Supporting technology localization, industrial diversification, and regional health care innovation. The regulatory pathway is anchored in obtaining Saudi Food and Drug Authority, SFDA clearance to facilitate regional distribution and regulatory acceptance across other MENA markets. OMIRA will combine Co-Diagnostics' molecular testing technology with Arabian Eagle's expertise in regional operations, infrastructure, and local market access. The agreement marks a major step in localizing advanced diagnostics within The Middle East and positions Co-Diagnostics as a strategic partner in regional public health resilience.

This milestone demonstrates that our international growth strategy has advanced from concept to execution. And reflects the strong high-value partnerships we continue to build globally. While this global initiative expands our reach outside The United States, we remain equally focused on commercialization and on advancing innovation through our AI business unit and other technology-driven initiatives. Another key part of our strategy is our new AI business unit. Led by our Chief Technology and AI Officer, Christopher Thurston. This team is bringing all our current and future AI projects under one umbrella, the Kodiak's Primer AI platform.

Additionally, our AI business unit is designed to accelerate the development of proprietary AI-powered diagnostics, enhanced data analytics, and improve operational efficiency across the organization. Integrating AI into our workflows will enable faster, smarter, and more scalable testing processes while minimizing human error and improving efficiency at the point of care. These tools will support real-time PCR diagnostics, advanced coprimers design and optimization, and automate interpretation to improve outcomes in both lab and field environments. Our AI models are also being designed to deliver predictive epidemiological insights giving health care providers and public health authorities earlier warning signals and improved situational awareness during potential outbreaks.

Over time, the system is expected to leverage analytics from widespread deployment of the Kodiak PC Pro to anticipate disease patterns and possibly predict outbreaks before they occur. As necessary, some of these models will be built on a secure HIPAA-compliant cloud platform with a new business unit formed to integrate internal data, workflow orchestration, and AI-driven analysis into a single cohesive framework. This initiative underscores our commitment to staying at the forefront of innovation by combining advanced AI technology with our proven PCR expertise. Importantly, this program will position Co-Diagnostics to participate in one of the most dynamic growth areas in health care technology while building valuable new intellectual property and data assets.

This is not simply an upgrade to existing systems. It is a transformational step that redefines what diagnostics can achieve in speed, accuracy, and real-time intelligence. As we continue to innovate, we are also executing scientifically through our flu A, B, COVID-19, and RSV multiplex test clinical evaluation program which further validates our progress and credibility in core diagnostics. We are preparing to initiate clinical evaluations for the upper respiratory multiplex test in the immediate future. A key milestone for Co-Diagnostics. This test is designed to simultaneously detect flu A, flu B, COVID-19, and RSV. Making it the most comprehensive respiratory panel in our portfolio. TESS has been supported by a RadixTech grant from the National Institutes Health or NIH.

Underscoring both the credibility and importance of this work. RADEC's tech program, was created to accelerate innovation in diagnostic testing. And our participation validates the strength of our technology and its public health relevance. This trial represents the culmination of extensive planning and development and marks the first Kodiak's multi-pathogen test to enter human clinical evaluation. The upper respiratory panel addresses a critical need in the domestic market, by combining accuracy, speed, and multiplex capability within a single point of care platform and we are pleased to be delivering on our commitment to initiate clinical evaluations in this flu season. The data from this trial will be used to support future regulatory submissions and commercial readiness for The US market.

And potentially for regulatory submissions in other markets as well. Such as the SFDA in parallel with the US FDA submission. Initiating this study is a major step forward for our domestic business, and a meaningful validation of our scientific and technical leadership. This test has generated consistent interest from both investors and potential partners. Particularly those focused on high-volume US respiratory testing demand.

Operator: The market for respiratory infections disease testing in The Middle East is also expanding. This is largely influenced by substantial investments in The Kingdom Of Saudi Arabia. And the KSA's commitment to improving public health alignment with the Saudi Vision 2030 program. This program represents a rigorous NIH-supported evaluation with strong commercial potential. And is a key component in reinforcing our reputation for execution and reliability within the diagnostics industry. In short, this milestone demonstrates that Co-Diagnostics is executing, not just planning. And delivering tangible scientific progress that supports both near-term and long-term growth.

Looking at our other programs like Kodiak's PCR MTB or tuberculosis test, and Kodiak's PCR HPV eight type multiplex test both remain on track to initiate clinical evaluations before year-end. As stated in previous communications, Both tests have been supported by grants from the Bill and Melinda Gates Foundation and are anticipated to significantly contribute to our international expansion ambitions and represent key components in our goals to provide gold standard solutions for unmet needs in various markets that are only anticipated to expand over the coming years.

We believe that the introduction of competitively priced diagnostics into markets anxious to gain the upper hand against the spread of deadly and often devastating infections will position Kodiak's as a leader in innovation and point of care PCR diagnostics. Taken together, the initiatives we have discussed today, including the COSERA transaction, the Comira joint venture, the launch of our AI business unit, the imminent domestic clinical evaluations, and the upcoming clinical evaluations of the other tests in our pipeline all reflect the significant progress Co-Diagnostics has made over the past several months. Each of these milestones strengthens a different part of our business, from capital structure and international growth to innovation and scientific validation.

Collectively, they demonstrate that our strategy is working. Our execution is on track. And our team remains focused on creating lasting value for shareholders. Over the last two months, we also closed two strategic direct offerings totaling gross proceeds of $10.8 million. We are entering the next phase of growth from a position of strength supported by a robust balance sheet, a growing pipeline, and a clear path toward both near-term and long-term milestones.

Andrew Benson: With that, I'll now turn the call over to Brian L. Brown, our Chief Financial Officer.

Operator: To provide an update on our financial performance and outlook.

Brian L. Brown: Thanks, Dwight. And thank you to everyone who joined today's call. For the quarter, total revenue was $100,000 compared to $600,000 in the same period last year. In the prior year period, revenue from Gram represented approximately $400,000 while in Q3 2025, all revenue recognized came from product sales. Total operating expenses for Q3 2025 decreased to $7.1 million compared to $10.6 million in Q3 2024. This reduction reflects our continued focus on becoming more operationally efficient. Research and development expenses were $4.5 million compared to $4.9 million in the prior year comparable period.

Net loss for Q3 2025 was $5.9 million or a loss of $0.16 per fully diluted share compared to a $9.7 million loss or $0.32 per fully diluted share in the same period last year. Adjusted EBITDA was a loss of $300,000 in Q3 2025 compared to a loss of $8.8 million in Q3 2024. We ended the quarter with $11.4 million in cash, cash equivalents, and marketable investment securities. As always, we are carefully managing our spending to maintain a healthy balance sheet while positioning the company for commercialization. Throughout the year, we will continue to optimize our operating footprint to drive efficiency gains and cost savings.

In addition to the strategies outlined by Dwight earlier, we plan to meet other capital requirements through a combination of equity and debt financing, additional grant funding, and continued operational efficiencies. We are also evaluating other financing structures to strengthen our financial position and maintain flexibility. In parallel, we continue to pursue grant funding opportunities to support the advancement of our Kodiak TCR platform. In the near term, our focus remains on progressing our development pipeline, completing clinical evaluations, and preparing for regulatory submissions. We are allocating our resources and time strategically to support these priorities. Looking ahead, we are optimistic about multiple commercial launches expected in 2026 and the ongoing development within our test pipeline.

I look forward to sharing additional updates and milestones on our next call. With that, I will now turn the time back over to Dwight.

Operator: Thank you, Brian. To close, we want to extend our gratitude to Co-Diagnostics shareholders and to our employees whose consistent dedication and hard work is one of our most valuable assets to achieving the Kodiak's vision. Let's now open the line up for questions. Operator?

Andrew Benson: A question, press star, then the number one on your telephone keypad. To withdraw your question, simply press star 1 again. We will pause for just a moment to compile the Q and A roster. Your first question comes from the line of Catherine Beguin with H. C. Wainwright. Please go ahead.

Catherine Beguin: Hi. This is Catherine Anfoyi. My question centers around the performance of Khoceira and Khoemira. For COSERA, are they meeting your performance expectations? And if not, what's causing that discrepancy? And how do you kind of expect Comira to perform financially in comparison?

Dwight H. Egan: Catherine, thank you for the question. With respect to the performance of both COSERA and COMIRA, we're very pleased with the performance of both of those entities. Keep in mind that the Thelmyra entity is newly formed. And it was formed with leadership from previous interactions that we had from a business standpoint with the distributors of our product in Saudi Arabia. Saudi Arabia has been consistently the largest international customer for Co-Diagnostics. And so it made a lot of sense for us to establish a joint venture where we could participate more actively in the forward-going opportunity in Saudi Arabia.

Especially as it revolves around the introduction of our new and revolutionary point of care device, the Kodiak's PCR Pro. So they played a huge role in what we're doing, what we have been doing. For the last several years at Co-Diagnostics. We expect that they will be a wonderful partner through this joint venture in moving our agenda forward in what, again, has been our largest international customer. With respect to Coceira, we have been involved in this joint venture with Coursera for about eight years. We have established a real solid footprint in that country. We have sales personnel that cover largely the entire country. We have significant manufacturing operations there.

Mostly on the Serebi family properties where we established our first laboratory manufacturing in 2019. When we cut the ribbon on that facility. And then last December, you'll recall we established on that same acreage another more sophisticated property for the development of our oligonucleotides, which we can now produce there in-country. And will continue to progress the manufacturing opportunity there so that they are manufactured in connection with the make it in India initiative of Prime Minister Modi. They will be making the cups or the cartridges along with the instrumentation. And so we're very pleased with the kind of market development that has occurred over there.

Co-Diagnostics is a real fan of the leadership the Serebi family and the other scientists and workers have brought to our company in India. We are well respected in India at the government level. In the academic area and in being able to supply our products to lots of different labs throughout the country. So we have developed a mature business there. That is now capable to kind of go off and bring additional value both to the people at CoSera and also the people at Co-Diagnostics. We think this will be mutual benefit to both entities and we're very enthusiastic about our prospects there.

Catherine Beguin: Thank you.

Andrew Benson: Your next question comes from the line of Mike Okunovich with Maxim Group. Please go ahead.

Mike Okunovich: Hey, guys. Thank you so much for taking my questions today, and congrats on all the great progress. I guess to kick things off, just like to see if you would talk a little bit about how a potential spin-out of COSERA might interact with the MTB and HPV point of care programs. Is this something where they might be licensed over, or you get some sort of distribution agreement signed? I'm just curious since it seems like there's quite a significant market in India for these programs.

Dwight H. Egan: Well, thanks for the question, Mike. You know, tuberculosis is a disease that is the number one killer in terms of infectious diseases in the world. And about twenty-five percent roughly of those deaths are coming from India. And a similar number is coming from Africa. And so, you know, between those two areas of the world, you have about half of all the deaths coming from tuberculosis, and tuberculosis is something that is curable. So it's really a shame not to be able to diagnose it effectively and get people treatment because it can be cured. If it's caught in time and properly dealt with therapeutics.

So we have a very concrete plan in India with respect to Khoesera capitalizing on being able to fill the gap between where they currently have access to PCR tests and where they need to have access. I don't think there's any credible key opinion leader in the world that believes that the main doesn't believe that the main solution to that problem of tuberculosis comes from replacing smear microscopy which is about a hundred and twenty-five-year-old diagnostic tool. Replacing that with molecular diagnostics is really what has to happen. And in order to make that happen, you have to have a product that has accessibility that has the kind of accuracy that molecular has.

And it also is something that you know, you have to be able to get it down to the end of the row. You can't make it too unaffordable. So we are, in our mind, the perfect solution to being able to fill that gap between where they currently have and it's not a lot of places, but where they currently have molecular diagnostics and where it will be able to be taken by virtue of the new accessible, affordable, and accurate solution that we have. So that applies both to tuberculosis and the human papillomavirus. Which has a large presence in India. I don't want you to think of India or Africa as being just TB and MTB markets.

They have a lot of other issues that need to be addressed and we intend to make those part of what we're addressing in these joint ventures and in the forthcoming transaction that we anticipate and hope for CoSera.

Brian L. Brown: Mike, if I can add something, this is Brian. You know, we are talking about different structures internally and what this might look like, but we don't have anything concrete to share to the market, and we will as we move forward in the process.

Mike Okunovich: Thank you. I appreciate the additional color here. I did want to follow-up just on the angle of affordability, and in particular, for the PCR Pro, wanna see if you could give a little bit more color on how you're actually able to reach a price point that is so much more affordable than your competitors. Does this have something to do with co primers allowing you to use a more less complex device? Any additional clarity you could provide on that would be helpful.

Dwight H. Egan: Again, an excellent question, Mike. And I think you know, one of the reasons that we're able to produce a product at the price point that we've done is that what we set out to do initially. Shortly after the COVID pandemic kicked in you know, we looked forward saying, where is this going to go? And we brought in a very, very good team of engineers and scientists with the express idea that they would create a product that could have a price point potentially as low as about $300 to $500 at scale. And that's been our goal from the beginning.

And one of the remarkable things about the research and development of this product is that in large measure, we've been able to keep a lid on what we think we will be able to produce this for at scale. And so as to whether other companies why they haven't been able to do this I think some of that has to do with the fact that they were making boxes before we even existed. And so, you know, they didn't really come at it with a fresh open clean slate like we did. And so we had certain important discrete goals that we wanted to accomplish. As we set out to engineer both scientifically and mechanically. This wonderful device.

Of course, co primers play a role in the effectiveness of the assays, but the co primer advantages revolve mainly around its ability to multiplex. So for instance, when you look at the human papillomavirus, this is an eight-plex test for certain specific cancer markers associated with human papillomavirus plus a ninth marker that is a human DNA control. So that's where coprimers kick in. They allow us to do this sort of multiplexing in class by ourselves because of the way coprimers get rid of the formulation of primer dimers. So I think that's the kind of guidance I could give you and the information about why we've been able to hold the price line.

And, you know, if you can't make the product at a price point that's relevant to the people that you're trying to serve, it doesn't matter. So we've really held the lid on that. We're excited to take it into the There's a huge gap.

Mike Okunovich: Absolutely. Thank you very much. And then one more for me, you don't mind, and I'll hop back into the queue. When looking at the Comira JV in Saudi Arabia and The Middle East, are there any particular products particularly from the PCR Pro, that you believe are most relevant for that market?

Dwight H. Egan: I believe that all of our current pipeline are very relevant to the Comira market. You know, it's not just tuberculosis and HPV. It also includes the number one problem in infectious disease. It's not the most deadly, but it's the most cases. And that's the upper respiratory. So our flu AB, you know, plus COVID plus RSV is a very, very important test for that market as well. And then that's just the beginning. We'll continue to develop more and more.

Mike Okunovich: Well, thank you so much for your answers today, and lots to look forward to going forward, it seems.

Andrew Benson: Thanks, Mike. That concludes our question and answer session. Ladies and gentlemen, this concludes today's call. Thank you all for joining. You may now disconnect.

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