Co-Diagnostics, Inc. Aktie

Good morning, everyone. Thank you for joining us here in New York on the webcast and in person. Today, Dwight Egan, Chief Executive Officer of Co-Diagnostics, will discuss the company's new collaboration with U.K.-based ReadyGo Diagnostics, the manufacturing capability supporting future scale, and the progress underway at CoSara in India.

A few housekeeping items before we start. Today's presentation is being recorded, and a replay will be available in the Investor Relations section of the company's website. Following the presentation, we'll take questions.

Please note that certain statements made during today's presentation that are not historical facts are forward-looking statements. These include statements about product development, the ReadyGo collaboration, regulatory submissions and timing, manufacturing capacity, market opportunities, and commercialization. These statements involve significant risks and uncertainties.

Actual results may differ materially, and there can be no assurance that anticipated results will occur on a timely basis or at all. Important risk factors are described in the company's filings with the Securities and Exchange Commission, including its annual report on Form 10-K filed March 31, 2026. Co-Diagnostics undertakes no obligation to update or revise these statements.

The Co-Dx PCR platform is subject to FDA review and is not currently for sale. The blood-based applications discussed today remain in development and require further validation and applicable regulatory authorization.

This presentation is not an offer to sell or a solicitation to buy securities and should not form the basis of an investment decision. Today's presentation also includes information regarding other companies, including public reported market size and valuation data. That information is derived from public sources and third-party estimates that we have not independently verified. It is presented as market context only. It is not a projection, forecast, or indication of Co-Diagnostics' own results, revenue, or valuation.

In addition, the company's collaboration with ReadyGo is a non-exclusive, early-stage development collaboration. Nothing in today's presentation should be understood as a representation that blood-based testing on the Co-Dx PCR platform has been validated or authorized for diagnostic use.

With that, I'll now turn the presentation over to Dwight. Thank you very much.

Thank you, [ Rob ], and thank you, everyone, for your interest in Co-Diagnostics. I'd like to begin with the problem we're working to address, because it explains why we are pursuing this opportunity.

The figures on this slide illustrate the urgency. As of the World Health Organization's most recent situation report, the Democratic Republic of the Congo has reported 6,757 confirmed cases and 3,267 deaths, a case fatality rate of roughly 48% across 61 health zones in 6 provinces. The World Health Organization has described this as the second-largest Ebola outbreak on record and one that is spreading substantially faster than previous outbreaks.

And this is not a problem that stays in Central Africa. Imported cases have already been reported in Germany and in France this year. Outbreaks that begin where diagnostic infrastructure is thinnest do not stay there.

For us, the central question is how to make molecular testing more accessible in the places where response is needed. A test has greater practical value when it can fit the setting where patients seek care. That view is reinforced by the organizations that fund outbreak response. In our conversations with global health foundations, the message has been consistent. The world does not need another centralized laboratory test. There are plenty of those. What is missing is a molecular test that can reach the remote settings where patients actually present and return a result on site.

That has been the objective behind our investment in decentralized PCR. We're developing a platform to bring molecular testing closer to patients, including communities with limited access to centralized laboratories. As we discussed on our second quarter call, we completed an extraction-free proof-of-concept study for Bundibugyo virus detection during -- using diluted plasma on the Co-Dx PCR Pro. That was an important early demonstration of the platform's potential beyond swab-based testing.

There is more development work to do, but I want to be direct about why we are pursuing this, because the significance is considerably larger than Ebola. Until now, the Co-Dx PCR platform has been designed around swab-based samples, nasal swabs, tongue swabs. Establishing blood as a validated sample type would open the platform to an entire category of blood-borne pathogens that a swab simply cannot reach, HIV, hepatitis B, hepatitis C, and others. Each of those applications would require its own development, its own validation, and its own regulatory authorization. But the size of the opportunity in front of this platform changes materially with the introduction of blood-borne pathogen detection.

Put another way, Ebola is where we are proving this out. However, the larger opportunity is the ability to run blood-based molecular testing into a doctor's office or a rural clinic at the price point of our instrument rather than sending the sample to a centralized laboratory.

The next step is to determine how sample preparation and our platform can work together in a practical workflow, and that's where ReadyGo comes in. We're collaborating with ReadyGo Diagnostics, a U.K.-based company, to evaluate a new approach to blood-based testing on the Co-Dx PCR platform, initially focused on Ebola detection. ReadyGo developed a field-capable sample preparation technology, and they concluded that they needed a molecular platform that could actually operate where their product is used. They identified the Co-Dx PCR platform as a viable platform.

To give you a sense of the setting we are both building for, India alone has roughly 650,000 villages with no practical access to molecular diagnostics of any kind. ReadyGo brings its GoCollect sample preparation technology. We bring the PCR platform, the test cartridge, and the connected infrastructure that can support reporting and outbreak response.

We recently entered into a material transfer agreement to support this work, which we disclosed in the Form 8-K filed yesterday afternoon. Over the past several days, we have taken delivery of ReadyGo's materials and devices, and that hands-on evaluation work is now underway. This is a non-exclusive development collaboration, deliberately so.

Both companies remain free to pursue their own grant funding and their own commercial paths, which we consider an advantage rather than a limitation. We rely on the inherent strength of our accessible and affordable platform.

The work builds on our earlier plasma proof of concept that gives us a starting point, while the combined GoCollect and PCR Pro workflow still needs to be demonstrated and validated. What makes this strategically interesting is the potential to expand the applications supported by the platform. If we can establish a suitable blood-based workflow, we believe that could create opportunities well beyond the initial Ebola program.

Let me walk through the sample preparation component first so you can see how the process -- the pieces are intended to fit together. This slide shows the GoCollect Capillary Collector and GoCollect Plasma. Together, they address the preparation of a blood sample for downstream molecular testing. The collector combines capillary blood collection with sample-conditioning chemistry. The plasma device then separates plasma from whole blood to provide a prepared sample for testing.

One feature worth calling out specifically, the collector's chemistry is designed to inactivate the virus at the moment of collection. In a field setting, handling live Ebola samples is itself a serious constraint on who can perform tests and where. A sample that is rendered safe at the point of collection changes what is operationally possible.

We are evaluating 2 possible workflows. In the simpler case, a modified capillary collector could feed our test cartridge directly. The more likely near-term path uses GoCollect Plasma to separate plasma from whole blood, which then goes into the cartridge. Both require real R&D work, and determining which one prevails is precisely what this collaboration is meant to do. We need to establish compatibility across the complete process, including the prepared sample, our chemistry, and the test cartridge.

Successful work on an individual component doesn't automatically establish the performance of the combined workflow. The development objective is a workflow that can be practical at the point of need. Reducing the infrastructure required for sample preparation could help us reach settings that are difficult to serve today.

That's why we view sample preparation as an important part of the commercialization strategy. The customer needs a simple, safe, and effective process from collection through to result.

Once the sample is prepared, the next component is molecular detection on PCR Pro. The Co-Dx PCR platform brings together the instrument, a consumable test cartridge, and connectivity. Our objective is to make PCR more accessible while connecting the result to the people who need it.

In this proposed cloud-based reporting and visualization application, blood-derived samples would be tested using the Ebola assay under development. The results are uploaded immediately if a Wi-Fi or cellular data connection is available. If no Internet connection is available, the results are temporarily stored on the connected phone or tablet, then uploaded later as soon as a connection can be established.

The instrument and cloud illustration here shows how that data could then be visualized, thus immediately connecting local testing in support of a broader response. The dashboard on this slide is illustrative and uses simulated data. It is not a display of actual Ebola testing performed by our platform in the DRC. The concept is straightforward. Each individual test result can inform a local decision, while connected reporting can help authorized officials to understand and respond to testing activity across multiple locations.

This digital architecture has been part of our strategy from the beginning. Our investment in the mobile application and secure cloud infrastructure supports reporting, remote system management, and access to diagnostic information.

As adoption develops, we also see potential for analytics and artificial intelligence to help make that information more useful. Those opportunities depend on validated capabilities and responsible use of the data.

Commercially, our aim is to build an installed base that supports ongoing test use. A broader menu could give customers more reasons to use the platform and then create recurring demand for consumables over time.

The next slide brings sample preparation, testing, and connected reporting into one view. This is the complete approach we're working toward. Prepare a blood-derived sample, perform molecular testing at the point of need, and connect the information to support a well-targeted and scaled response. ReadyGo's technology addresses the sample preparation step. PCR Pro is the detection platform. The mobile application and Co-Dx Cloud are intended to make results available beyond the instrument itself.

Ebola is our initial focus for the collaboration. Over time, successful blood-based sample preparation could support development of additional assays and expand the settings in which the platform can be useful. There's also a near-term reason to start with Ebola specifically. NGOs, ministries of health, and donor organizations responding to this outbreak have an immediate need for decentralized testing. That's the connection to our long-term business model, expand the useful applications of the instrument, support adoption, and build repeat test use as products achieve the necessary milestones.

To support that model, we also need to manufacture consumables efficiently and consistently. Let me turn to the progress we're making there.

As we prepare for commercialization, we're investing in the manufacturing processes needed to support increasing test volumes. The comparison shown here contrasts our manual lines used to develop the system and our automated work cell, which is already operating. Automation reduced cycle time from 30 seconds to 16 seconds. In the same comparison, it shows production increasing from 757 cartridges to 2,000 cartridges, or roughly 74% more cartridges produced on a single work cell.

The difference that matters most, though, is labor. A manual cartridge line requires roughly 8 people to operate. The automated line requires approximately 3, with future reductions in the plan. These gains greatly facilitate scale-up, with each automated work cell moving twice as fast with half as many people.

These are process results. The commercial benefit will depend on the volume we produce, utilization of the equipment, and the cost of operating at scale. We believe automation can help us support growing consumable demand without having to increase manual work at the same pace. That is important to the economics of an installed base that uses tests repeatedly. It also directly supports our international strategy. Our joint venture model, CoSara in India, CoMira in Saudi Arabia, depends on being able to transfer a production process into another country and have it run reliably there. A line that requires 8 trained operators is difficult to replicate. A line that requires 2 is a process we can hand over. Automation is what makes the joint venture model scalable rather than simply local.

We'll show 2 short videos to make that progress more tangible, beginning with the manual process. This first video shows the manual production process and the hands-on work involved in manufacturing our test cartridges. As you watch, the important point to keep in mind is the number of operator steps involved. This gives you a reference for the automated investment -- and the automation investment that we're making.

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That process has supported our development work.

The next video shows the automated approach we're advancing to support greater production scale. Here, you can see the automated production equipment and how we're bringing more of the process into a repeatable sequence.

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The commercial objective is to produce more usable cartridges efficiently as demand develops. We'll continue refining the process as we prepare for future manufacturing needs.

This investment also fits the work we've discussed through CoMira in Saudi Arabia, where we have been preparing for future technology transfer, and through our established presence in India. India is a good place to see how our manufacturing, clinical, and commercial work come together.

Let me turn to CoSara. CoSara represents nearly 10 years of accumulated investment in manufacturing facility, regulatory approvals, a distribution network, and an established customer base that is only now arriving at the point where it can carry new products. We have been building it quietly for a decade, and we believe it is significantly underappreciated.

That foundation matters as we work toward commercialization of PCR Pro. Local presence helps us understand customer needs and prepare to support products in the future in the market.

CoSara has the capabilities and product opportunities beyond PCR Pro. Its assay business and expanding in-house production give us a broader base on which to build. Some evidence of that momentum since the beginning of this year, we have shipped 24 additional PCR instruments into India, expanding both our installed base and our customer relationships across the country. And CoSara's oligonucleotide synthesis laboratory is now in production, supporting R&D and commercialization activity in the region. We believe that combination is important: a local organization with experience in the market, supported by technology and manufacturing capabilities that continue to develop.

To put that work in context, let's look at the region CoSara is positioned to serve. The estimates on this slide size the diagnostic market across India and its neighboring countries at approximately $13 billion, with India accounting for roughly $11.4 billion of that. Point-of-care diagnostic spending in the region is estimated to be growing at about 8.5% annually. These figures describe a broad regional opportunity. They cover different diagnostic categories and should be treated as market context rather than a precise measure of the addressable market for PCR Pro.

Our commercial focus is more specific, applications and settings where accessible molecular testing can meet a practical need, supported by local product authorization and an effective route to the customer.

Tuberculosis is an important starting point for that work in India. The workflow we're developing is intended to support testing closer to patients, including settings where a centralized laboratory model can be difficult to access. CoSara gives us a firm base from which to pursue that opportunity. We can combine local manufacturing and relationships with the platform and consumable capabilities we've been developing. A large market creates room to participate, but adoption will depend on performance, usability, pricing, and execution.

The next slide gives some context for how investors and customers are looking at this category. I want to spend a moment on this slide because it goes to a question that we get asked frequently. Is decentralized molecular diagnostics really a market? Or is it an idea?

Molbio Diagnostics is a decentralized molecular diagnostic company based out of India and founded more than a decade before we began our work in the region. Earlier this year, it completed an initial public offering at a valuation of approximately $1.05 billion. That offering was reported as roughly 70x oversubscribed. To date, the company has deployed more than 12,500 devices across more than 90 countries.

We see this as strong validation of the market we are entering by the customers, the regulators, and now by public investors. And it has been validated in the exact region where CoSara has spent the last 10 years building. Our Co-Primer technology has also been validated in the market. As a reminder, our tests were distributed in more than 50 countries during the pandemic to centralized labs. Molbio's presence is also principally in centralized and near-centralized laboratory settings at instrument price points that, in our assessment, are difficult to justify at India's primary health care centers.

We designed PCR Pro for that gap specifically, simple enough for non-laboratory staff, accessible at a price appropriate to a clinic, and connected so that a result does not stay on the instrument. We think the PCR Pro is a better fit for this market in every way.

The clinical studies underway in India are an important part of demonstrating this. Let me show you the workflow we're validating. Our tuberculosis clinical studies in India are evaluating the complete decentralized workflow, beginning with the sample and continuing through preparation, PCR testing, and reporting. The process shown here starts with swabbed sputum, or a tongue sample, followed by the heat-based sample preparation step. The sample preparation platform which we have developed is an essential part of the TB workflow, and it is also designed to help extend PCR across future applications where preparing the sample appropriately is critical to making the test useful.

The prepared sample then moves to PCR Pro for multiplex real-time PCR testing. The mobile application and cloud database complete the reporting concept. The commercial objective is a workflow that can be practical for the settings in which it will be used.

As of this week, the team has collected more than 500 of the approximately 600 samples required for this phase, including all the positive TB samples we needed. Collection of the remaining negatives is now continuing.

We are targeting completion of this study phase this month. That remains a target, subject to steady progress and completion of the necessary work. These studies are intended to generate evidence supporting regulatory submissions and commercialization. Completing sample collection is one step in that process. The data will need to support the intended use.

Our planned regulatory work includes submission to India's Central Drugs Standard Control Organization, or CDSCO, and to the World Health Organization's Expert Review Panel for Diagnostics pathway known as ERPD. Timing and outcomes remain subject to the requirements of those processes.

Two pieces of external context are worth noting here. Recent WHO guidance recommends near point-of-care molecular testing for tuberculosis, including tongue swab sampling, which is precisely how our MTB assay and our platform were designed. And this past quarter, we were invited to participate in a manufacturer partner in a UNOPS global implementation workshop on near point-of-care TB diagnostics in Bangkok, alongside national TB programs, donors, and technical agencies representing 21 countries. We read that as a recognition of where TB diagnostics is heading.

In addition to the clinical program, CoSara is strengthening the capabilities needed to support its products and serve additional customers. That focus is our final operating update. CoSara is expanding its in-house capabilities in master mix, oligonucleotide production, and sample preparation; each supports Saragene products and creates opportunities to serve additional applications or customers. Master mix contains key components used in PCR testing. Developing this capability internally can give CoSara more control over an important input to its assays and reduce reliance on outside suppliers.

Oligonucleotides are another essential component of our assays. In-house synthesis supports faster development and lower-cost production, with the potential to supply other research and commercial customers as well.

There is a third piece I want to add because it is a straightforward -- straightforward commercial win. CoSara has developed its own in-house extraction kit. Historically, when a customer bought our assays, we had to refer them elsewhere to buy the extraction kit needed to run them. We were sending both revenues and a piece of the customer relationship to a third party. We can now supply it ourselves.

What I want investors to recognize is the business we're building in India. CoSara brings together local capabilities that can support assay development, manufacturing, and customer needs over time. Taken together, these investments give us a stronger foundation for commercialization.

I'd like to close by connecting that progress to the broader strategy we've discussed today. When you look across today's presentation, I hope the connection between these initiatives is clear. We're working to expand what the platform can test, with the workflows that is practical, and build the capacity to support its use. Our ReadyGo collaboration is an opportunity to advance blood-based sample preparation. Successful development could support a broader assay menu and extend the potential usefulness of PCR Pro.

Our connected infrastructure is designed to make diagnostic information available where it can support decisions. Automation is helping us prepare to produce consumables more efficiently as demand develops. In India, CoSara combines an established local presence with clinical work and expanding manufacturing capabilities. That gives us a foundation for pursuing the opportunities we've outlined.

Our U.S. regulatory program remains another important part of the strategy. As we reported on our second quarter call, we submitted the dual 510(k) and CLIA Waiver by Application for our flu A/B & RSV assay. The platform remains subject to FDA review. Ultimately, our objective is to convert this work into authorized products, customer adoption, and recurring test use. That's where the long-term commercial value needs to come from.

There is important work ahead, and we remain focused on completing it. We appreciate the commitment of our employees and partners and the continued support of our shareholders.

Before we go to questions, for those of you who are here in the room, we have a Co-Dx PCR Pro and test cartridges with us, and we'll be happy to walk you through the instrument after we finish.

Thanks for your time today. Rob, let's open the discussion for any questions.

So, I wanted to ask if there's any additional engineering to the cartridge itself that would be required to accept the blood-based samples or if it's purely the prep that allows it to work with the same sort of cartridge.

Thank you for that question. And I -- we put a cartridge in front of your seat there, so you can take a look at it up close. And you'll see on the bottom side of that cartridge, there's a tremendous amount of intellectual property represented there with the placement of the reagents and the actual place where PCR takes place and the -- that's where the lyophilized balls go. And you'll also see some other freeze-dried reagents in those cartridges.

But no, we don't expect to have a redesign of the cartridge in order to conduct blood-based pathogens. We're excited about the possibility of being able to do maybe a direct injection. If you take the slide that showed you the little pipette, there is a possibility -- it hasn't been proven out yet, but there's a possibility that we can take a direct sample from a finger prick. And as you heard me describe, it's treated as soon as it has contact with the blood to kill the virus, whether it's Ebola or something else, and then to directly inject that into the cup.

But the most near-term possibility comes from going from the finger prick into the little collector and then into the separator. There's a little receptacle on the top of the GoCollect, the pipette fits in very nicely. You put it in and 5 minutes later, you've got a separation of the plasma from the red blood cells. And then that plasma sample gets put in directly into the cup.

But as far as the cup is concerned, we expect that technology will remain as it is. And it just opens us up to a whole new area of blood-borne pathogens such as HIV, hepatitis B, hepatitis C, and others over time.

I actually wanted to follow up on the last point that you were making. Do you have a sense of what proportion of the pathogen detection market is represented by blood-based pathogens versus something like a mucus or sputum based?

We spent a lot of time looking at that size of that total addressable market. And I can't give you an actual number standing here today. I have a lot of numbers that I've -- that we've researched and that are swimming around in my head that get up as high as 100 million of these different combines.

So it's very easy for you to get a sense of that by doing a search of the top blood-borne pathogens and you'll see all kinds of details about what percentage each of them -- what percentage HIV is, for example. It's a biggie. That's sort of like at the top of the list. And hepatitis B, hepatitis C, they're all up there.

If you look at the company that I mentioned, and they're a wonderful company, the Molbio company, and they've got more history than we have. But when you see the kind of diseases that they're featuring, in addition to tuberculosis, you'll see those same pathogens specifically mentioned, HIV, hepatitis B, hepatitis C.

Our simple contention here is that in order to fill the gap, in a place like India and other low- and middle-income countries, you've got to have a device, like our device, that costs so little money to put it in a primary health care facility, compared to what it takes to put in a Cepheid device or a Molbio device. We're just a small fraction of the cost of what those other companies have to bear to get an instrument placed. So we have high confidence in that there's a ready market ready to take and give us throughput in that -- those 650,000 type of villages that don't have any access. I mean they have no access whatsoever to molecular.

And that's what's got to change. If you talk to all the key opinion leaders in tuberculosis throughout the world, Dr. Pai, for example, he will assert that the first thing that's got to happen is we've got to stop the smear microscopy and convert it to molecular testing. We intend to make that now possible. It just hasn't been possible in the past because the price of the instruments is too expensive. And even if it's available, if you can't afford it, you can't do it. And we're making it affordable. It's accessible, it's affordable, and it's PCR accuracy, the gold standard, 3 As. Okay.

And then one last one from me. I wanted to ask about the automation of your manufacturing process for the cartridges, how that impacts your cost of goods and throughput? And then also, is this something that would help with consistency if you were to set up domestic manufacturing in the other regions you're working in, like the Middle East or India?

I mentioned in my presentation the advantages in terms of the labor that's required to do the automated throughput. We're way excited and very proud of our automated system here. This isn't just a hypothetical wish right now. We are producing cups. Altogether, we've made -- if you look at these little cups, we've made approximately 600,000 of these as we've gone through clinical trials and all the things we've had to do to optimize and get things prepared.

So to be able to now have an automated piece that gives us twice the throughput with half as many employees and half the time is really exciting. So you're talking about the ability to take one of those automated lines. And those lines are not very much different than from that wall to about here. That's about how big that automated line is, and not very much wider.

And so you mentioned a key component here, and that is the quality control. When you -- when you have 8 people on the line, it's hard to train them all as to what has to happen. And you're dealing with molecular diagnostics, so it's like rocket science at a molecular level. And this allows us to have the kind of quality control, using AI and other technologies that are inherent in that line, that make us so we don't have to cross our fingers when something comes off the line and it goes into packaging and gets out into the field, because it's all been quality controlled several times through the process of manufacturing it.

And when we talk about that throughput, when we say it's 16, 17 seconds, that's how long between each cartridge that comes off the line through the day. And we showed you the number of 2,000, and that was just in one working shift. These things don't sleep. So you do 2 shifts, you got not 2,000, you got twice that. You got 3 shifts, you got more yet again.

So it's very exciting what this implies in being able to take an automated line to India, to CoMira in the KSA, in Europe, in Mexico, in the Far East. It makes it so our ability to put a quality-controlled, reliable production capability, is really simplified through this process. And this didn't happen overnight. This is not a project we've been working on for a few months. This has taken years and millions and millions of dollars. So it's a very serious project. And we're very happy that our team has gotten it into actual production. We're making cups now.

Any other questions, we can handle?

All right. Thank you, Dwight, and thank you, everyone, who joined us both in person and online. This concludes today's presentation.

Thank you for standing by. At this time, I would like to welcome everyone to the Co-Diagnostics, Inc. Second Quarter 2026 Earnings Webcast. [Operator Instructions] I would now like to turn the conference over to Andrew Benson, Head of Investor Relations. The floor is yours.

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 second quarter ended June 30, 2026. A copy of the press release is available on the company's website. We will begin with management's prepared remarks and then open up the call to analyst Q&A.

Before we begin, we would like to inform listeners that certain statements made by Co-Diagnostics during this call, which are not historical facts, are forward-looking statements. In addition to diagnostic test developments and clinical evaluation 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 and are not currently for sale.

Actual outcomes and results may differ materially from what is expressed or implied in any statement. Important factors which could cause actual results to differ materially from those in these forward-looking statements are described in the company's annual report on Form 10-K, subsequent quarterly reports on Form 10-Q and other filings with the SEC, including under the heading Risk Factors as well as in today's earnings release. Co-Diagnostics assumes no obligation and expressly disclaims any duty to update any forward-looking statements to reflect events or circumstances occurring after this call or to reflect the occurrence of unanticipated events.

In addition, the company may discuss certain non-GAAP financial measures during today's call. These non-GAAP financial measures should not be considered a replacement for and should be read together with GAAP results. We refer you to the company's earnings release issued shortly before this call, which contains reconciliations to the non-GAAP financial measures presented to their most comparable GAAP results.

At this time, I would like to turn the call over to Co-Diagnostics' Chief Executive Officer, Dwight Egan. Dwight?

Thank you, everyone, for joining us today and for your continued support of Co-Diagnostics. This past quarter marked another important step in our transition from platform development toward commercialization. We continue 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'd like to begin with our upper respiratory program, where we recently achieved one of the most significant milestones in the company's history.

Our upper respiratory multiplex assay remains one of the company's top strategic priorities and represents an important step toward commercialization of the Co-Dx PCR platform in the 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 10,000 upper respiratory PCR test runs on the PCR Pro, including multicenter reproducibility studies evaluating performance across operators, sites and instruments.

Our clinical study enrolled more than 1,400 symptomatic patients across 9 geographically diverse clinical sites throughout the United States. More recently, we officially announced the submission of our dual 510(k) and CLIA waiver by application to the FDA for the flu A, B and RSV assay on the Co-Dx PCR platform. This submission represents a major milestone, reflecting years of development, validation and regulatory preparation. We are pleased to have reached this important stage in the regulatory process and look forward to working with FDA during its review of our submission.

To support this submission and our broader regulatory strategy, we recently welcomed Dr. Wes Lindsey as our new Chief Scientific Officer. Wes brings more than 20 years of experience in molecular diagnostics, having led numerous successful FDA submissions and commercial launches. He was specifically recruited to strengthen our scientific organization as we advance the Co-Dx PCR platform through multiple regulatory pathways and expand our product portfolio. We believe his expertise will be an important asset as we continue executing on our regulatory strategy as well as the development of our pipeline of products before potential commercialization in key markets.

Turning to our tuberculosis program. We are making meaningful progress in India as clinical studies advance on the CoSara PCR Pro instrument and CoSara PCR MTB test. As these studies progress, we are targeting additional regulatory milestones later this year, including planned submissions to India's CDSCO and, subject to applicable eligibility requirements and timing, the World Health Organization's Expert Review Panel for Diagnostics, or ERPD. Our work in India builds on nearly a decade of investment through our CoSara joint venture, where we have established manufacturing, regulatory expertise and a growing commercial presence. We believe this provides a distinct competitive advantage as we prepare for commercialization, and we are encouraged by the progress being made.

India is one of the world's largest single country tuberculosis markets and represents an important commercial opportunity for the company, 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's ERPD mechanism is to streamline access to innovative state-of-the-art IVDs that meet the highest standards of quality, but that are still proceeding through the full WHO 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 required to secure an ERPD assessment are largely being supported by our NGO partner relationships, which we believe underscores the urgent need for high-quality point-of-care TB diagnostics. During the quarter, we were invited to participate as a manufacturer partner at the UNOPS Global Implementation Workshop on near point-of-care TB diagnostics in Bangkok. Along with national TB programs, researchers, donors and technical agencies representing 21 countries, we believe this invitation reflects growing international recognition of both our platform and our approach to decentralized molecular diagnostics.

Recent WHO guidance recommending near point-of-care molecular testing, including tongue swab sampling, aligns closely with the design of our platform and our MTB assay. We continue to believe the convergence of this WHO guidance, CoSara's commercial infrastructure and our domestic manufacturing capability and capacity create a compelling path to market in the world's highest need regions.

Beyond tuberculosis, we are expanding the capabilities of the Co-Dx PCR platform across additional disease applications. Earlier this quarter, following the World Health Organization's declaration of a public health emergency for Ebola, our CoSara team rapidly advanced development activities supporting Bundibugyo virus detection. We also successfully completed a proof-of-concept study for an Ebola assay with direct from plasma as a sample type on the Co-Dx PCR Pro instrument. This is our first blood-based assay designed for the Co-Dx PCR Pro, demonstrating the flexibility of the platform beyond traditional swab-based infectious disease testing. We believe this proof of concept demonstrates the potential expansion of addressable applications of the Co-Dx PCR platform by extending its capabilities beyond traditional respiratory and swab-based testing.

Our partners at CoSara have also continued their development of Bundibugyo virus and a pan-Ebola test for centralized laboratories, and their foresight in developing this product allowed them to quickly respond to a recent request by the India's Center 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 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 towards scaling across multiple international markets.

Our partners in CoMira have previously demonstrated their success in facilitating the distribution of Co-Dx 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 district 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've 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 milestones, positioning the company for the next phase of growth.

With that, I'll now turn the call over to Brian.

Thanks, Dwight, and thank you to everyone who joined today's call. For the second quarter of 2026, total revenue was $166,000 compared to $163,000 in the same period last year. Cost of revenue for the quarter was $45,000, resulting in a gross profit of approximately $121,000 compared to a gross profit of $131,000 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. Total operating expenses for the quarter were $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 $467,000 compared to $610,000 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 non-dilutive funding such as grants where appropriate. Looking ahead, disciplined capital allocation remains a priority as we 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.

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 investments translate into tangible operational milestones. The progress we've 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 Instructions] Your first question comes from Yi Chen with H.C. Wainwright.

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?

That is correct.

Okay. And could you also potentially expand upon the Ebola strategy? I know you said you just completed the proof-of-concept study, but do you have any context for time lines of this development or, like, potentially how useful -- how early the test could be used in infection?

Our strategy with Ebola is a strategy that is designed to be ready when if needed. And we've 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 an Indian government-related need for the test through our C-CAMP relationship. They initiated this request for 200 tests, which we have -- are 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 will be a devastating thing for the health of the planet.

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.

Thank you for standing by. At this time, I would like to welcome everyone to the Co-Diagnostics, Inc. First Quarter 2026 Earnings Webcast. [Operator Instructions]

I would now like to turn the conference over to Andrew Benson, Head of Investor Relations. The floor is yours.

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 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?

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.

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.

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 Instructions] Your first question comes from Michael Okunewitch with Maxim Group.

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?

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.

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?

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.

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.

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 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 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.

Good day, everyone, and thank you all for joining today's Co-Diagnostics, Inc. Full Year 2025 Earnings Webcast. [Operator Instructions] As a reminder, today's session is being recorded. And it is now my pleasure to turn the floor over to Head of Investor Relations, Mr. Andrew Benson. Please go ahead, sir.

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?

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.

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.

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 Instructions] We will take our first question today from Yi Chen at H.C. Wainwright.

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?

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?

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?

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 Instructions] We will hear next from the line of Michael Okunewitch at Maxim Group.

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?

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.

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?

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.

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?

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.

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.

Hello, and thank you for standing by. My name is Tiffany, and I will be your conference operator today. At this time, I would like to welcome everyone to the Co-Diagnostics, Inc. Third Quarter 2025 Earnings Webcast. [Operator Instructions] I would now like to turn the call over to Andrew Benson, Head of Investor Relations. Andrew, please go ahead.

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 third quarter ended September 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 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 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?

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 45 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, CoSara Diagnostics, which may include a merger with a Special Purpose Acquisition Company, or SPAC, or similar entity listed on a U.S. 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 planned CoSara 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 a significant infusion of growth capital for CoSara 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 CoMira 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 CoSara 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 Logix Smart Test. Under the terms of the definitive agreement signed in the KSA, we have established CoMira to localize our Co-Dx 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. CoMira 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 healthcare needs. The venture will initially focus on local manufacturing and distribution of the Co-Dx 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 healthcare 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. CoMira 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 molecular 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 Co-Dx Primer AI platform. Additionally, our AI business unit is designed to accelerate the development of proprietary AI-powered diagnostics, enhance 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, advance Co-Primers 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 healthcare providers and public health authorities earlier warning signals and improve situational awareness during potential outbreaks.

Over time, the system is expected to leverage analytics from widespread deployment of the Co-Dx PCR 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 healthcare 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 technologically, 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. Test has been supported by a RADx Tech grant from the National Institutes of Health, or NIH, underscoring both the credibility and importance of this work.

RADx 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 Co-Dx 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 U.S. market and potentially for regulatory submissions in other markets as well, such as the SFDA in parallel with the U.S. 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 U.S. respiratory testing demand.

The global market size for infectious disease diagnostics is expected to grow to $73.56 billion by 2030, and the demand for rapid accurate point-of-care diagnostics is driving an expanded opportunity for multiplex tests in the infectious disease testing market. The largest single geographical market for these tests is in North America, although the market for respiratory infectious 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 in alignment with the Saudi Vision 2030 program. This program represents a rigorous NIH-supported multiplex 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 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 Co-Dx PCR MTB or tuberculosis test and Co-Dx PCR HPV8-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 & 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 Co-Dx as a leader in innovation and point-of-care PCR diagnostics. Taken together, the initiatives we have discussed today, including the CoSara SPAC 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 2 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.

With that, I'll now turn the call over to Brian Brown, our Chief Financial Officer, to provide an update on our financial performance and outlook.

Thanks, Dwight, and thank you to everyone who joined today's call. For the quarter, total revenue was $0.1 million compared to $0.6 million in the same period last year. In the prior year period, revenue from grants represented approximately $0.4 million, 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 $6.3 million 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 Co-Dx PCR 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.

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 Co-Dx vision. Let's now open the line up for questions. Operator?

[Operator Instructions] Your first question comes from the line of [ Katherine Degen ] with H.C. Wainwright.

This is [ Katherine ] on for Yi. My question centers around performance of CoSara and CoMira. For CoSara, 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?

[ Katherine, ] thank you for the question. With respect to the performance of both CoSara and CoMira, we're very pleased with the performance of both of those entities. Keep in mind that the CoMira entity is newly formed, and it was formed with leadership from previous interactions that we have 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 Co-Dx PCR Pro. So they played a huge role in what we're doing and what we have been doing for the last several years at Co-Diagnostics, and we expect that they will be a wonderful partner to this joint venture in moving our agenda forward in what, again, has been our largest international customer.

With respect to CoSara, we have been involved in this joint venture with CoSara for about 8 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 Sarabhai family properties where we established our first laboratory for manufacturing in 2019 when we cut the ribbon on that facility.

And then last December, if 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 we'll continue to progress the manufacturing opportunity there so that they are manufacturing 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 of the Sarabhai 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 CoSara and also the people at Co-Diagnostics. We think this will be a mutual benefit to both entities, and we're very enthusiastic about our prospects there.

Your next question comes from the line of Mike Okunewitch with Maxim Group.

Congrats on all the great progress. I guess to kick things off, I'd just like to see if you could talk a little bit about how a potential spinout of CoSara 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.

Well, thanks for the question, Mike. Tuberculosis is a disease that is the #1 killer in terms of infectious diseases in the world. And about 25% roughly of those deaths are coming from India. And a similar number is coming from Africa. And so between those two areas of the world, you have about half of all the deaths from -- 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 the therapeutics. So we have a very concrete plan in India with respect to CoSara 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 -- that doesn't believe that the main solution to that problem of tuberculosis comes from replacing smear microscopy, which is about 125-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 have to be able to get it down to the end of the row.

You can't make it too unaffordable. So we are the -- we -- 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. And 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, for CoSara.

Mike, if I can add something, this is Brian. 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.

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, I want to 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.

Again, an excellent question, Mike. And I think one of the reasons that we're able to produce a product at the price point that we've done is that's what we set out to do initially. Shortly after the COVID pandemic kicked in, we looked forward saying, where is this going to go? And we brought in a very, very good team of engineers that -- 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 the 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 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 that -- the Co-Primer advantages revolve mainly around its ability to multiplex.

So for instance, when you look at the human papillomavirus, this is an 8-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 Co-Primers kick in. They allow us to do this sort of multiplexing in a class by ourselves because of the way Co-Primers 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 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 market. There's a huge gap.

Absolutely. And then one more for me, if 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?

I believe that all of our current pipeline are very relevant to the CoMira market. It's not just tuberculosis and HPV. It also includes the #1 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 A, B 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.

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

Good morning, and welcome, everyone, to the Co-Diagnostics fireside chat. My name is Valter Pinto. I'm Managing Director at KCSA Strategic Communications. I'm joined today by Chief Executive Officer, Dwight Egan. We're all looking forward to hearing an update from Dwight on the company's diagnostics technology, its history, where we are today in our clinical pathway and our commercialization efforts.

First, I want to congratulate the entire team on the joint venture in Saudi Arabia announced just last week. And this past Monday, the company also announced its initiatives in artificial intelligence. We'll be going through each announcement in further detail today.

But before we begin, let me quickly remind everyone that statements made during today's fireside chat may be deemed forward-looking statements within the meaning of the safe harbor of the Private Securities Litigation Reform Act of 1995, and applicable federal securities laws and that actual results may differ materially from what is contemplated by such forward-looking statements due to a variety of risks, uncertainties and other factors.

For a detailed discussion of some of the ongoing risks and uncertainties, I refer you to the company's quarterly report on Form 10-Q as well as the company's investor presentation and other reports filed periodically with the SEC. The company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, unless otherwise required by law.

I want to thank everyone again for joining us today. It's clearly an exciting time for the company, and we're going to be discussing several interesting topics today with Dwight.

As many of you know, Co-Diagnostics is a molecular diagnostics company that develops, manufactures and markets state-of-the-art diagnostics technologies. This global diagnostics technology is accurate, affordable, fast, easy to use, noninvasive and covers a variety of indications. At the conclusion of our fireside chat, we'll have a live Q&A. We received a lot of questions from our audience today, so I appreciate that. If for some reason, you didn't submit your questions beforehand, we will do our best to get to each of your questions within the time frame allotted for today's call.

Again, if we don't get to your question, just e-mail our team at [email protected].

Please note, this call is being recorded today, Wednesday, November 5, 2025, at 11:00 a.m. Eastern.

The recording will be available on the company's Investor Relations website under the Events section at the conclusion of this call.

With that, let me give Mr. Dwight a warm welcome on today's call. Dwight, good morning. It's great to see you.

Good morning to you, Valter.

Dwight, I think I echo the gratitude from your shareholders for hosting today's chat, especially given the recent news and progress you've made on so many fronts that we'll be going through today. If I may, I want to set the stage for our conversation by quickly going through the timeline and background of how the company got to where it is today, when the company was established, the origination of the technology and certainly walk us through what happened for the company during COVID.

Valter, this is a very exciting story in terms of where we've been and where we have come. We started this company in 2013, and it was founded on the concept of a very cool molecular technology that we refer to as Co-Primers.

It was invented by Dr. Brent Satterfield, who worked for a long period of time with the company. This technology enables us to do a lot of very unique things in the context of PCR. But the thing that it manifests itself the most to -- for individual investors to understand is that it enables us to multiplex kind of in a class by ourselves. By that, I mean that it enables us to test for more than one indication at a time.

Of note, for example, would be our forthcoming ABCR test, which is an acronym that stands for the testing of flu A, flu B, COVID-19 and RSV, all in one test, one patient, one sample, approximately 30-minute time to result when the test has started.

So back in 2013, when we started this adventure, we originally had just wet reagents. And of course, we had the technology of the Co-Primer and all the things that go along with that. And because of that, we were able to respond very rapidly to the COVID pandemic.

In fact, we developed a test within 3 days after the GISAID actually published the molecular map of this pathogen. And we then quickly made it an actual usable product. We were the very first U.S.-based company to have a molecular test that was approved by the European Union with a CE Mark. Shortly thereafter, we were one of the first companies to have an emergency use authorization from the FDA. And then we went on to sell approximately 35 million of these tests worldwide in about 50 markets. So that was an incredibly dynamic period for the company where we proved our ability to scale significantly and to take our place in the international and national market of what was going on during the pandemic.

Nobody knew how long the pandemic was going to last. We set out almost immediately after we started with the wet reagents to develop a sort of miniaturized PCR device or instrument, which we refer to as the Co-Dx PCR Pro. This is an incredibly robust and wonderful instrument. It's taken us longer to get it ready to go than we expected, but it is a really awesome device along with the tremendous amount of IP that's contained in the cartridges or cups as we colloquially call them.

And this is a device which makes it so we have an accessible, affordable and accurate product to take worldwide, and it suits a very large diagnostic gap, not only here in the United States, but in places like India, which we believe ultimately will become the largest healthcare market in the world and in places like Saudi Arabia and other places. So it's a wonderful technology. I'm pleased to report the progress that we've made with it. As we have indicated, we'll begin clinical trials starting with our APCR test during this month, in fact, and we expect to have on the tails of that, a human papillomavirus and TB clinical trials start as well.

I appreciate that. And obviously, COVID was an unfortunate period that affected us all. But as you articulated, I feel it was a significant inflection point for the company. It certainly validated the technology, show that you all can scale quickly. And as a result, you generate significant cash flow. You talked about it a little bit, but can you give us an idea if we fast forward, the cash flow that you had certainly gave you the opportunity to invest. Where did you focus your investments to where you are today and a lot of the things that we can look forward to in the future?

Well, let me state at the outset here that we don't want to be a COVID company. And so the reason that we began developing the broader technology, what we would refer to as a platform technology with the Co-Dx PCR Pro is that we wanted to be able to fit in where we could have an ongoing robust diagnostics business that covered a whole bunch of different indications.

So while we're currently focused on the ABCR test, which, of course, you have to breathe to be alive. So that is always a very, very important group of tests and the tuberculosis test, which is one of the -- that is the deadliest infectious disease in the world. And it has particular relevance in India and Africa and other markets where we are advancing our cause.

We also are advancing what we're doing in human papillomavirus. And some of the tests that we're doing we were aided by important NGOs and government entities to create the tests. For example, the ABCR test, which I mentioned, was supported by a grant from the NIH RADx Tech program and our programs for TB and HPV were both supported by significant grants from the Bill & Melinda Gates Foundation.

And we appreciate the help and financing that they provided in the form of grants to move this along and in other ways that they helped us in terms of preclinical trials and other things that have been going on in the background. So this is an environment where we now have a device and a menu of tests that will be coming forward, and that will be enhanced by tests that will go into development here in the future that will cover things like sexually transmitted infections or STIs.

It will cover things like Strep A. And of course, we have other markets where we have real opportunity, including personal pets, dogs and cats and cattle that are not personal pets, of course. But there's a lot of other things that we can do in agriculture and in these other types of veterinary type tests. So you're just seeing the very beginning of our development of the platform itself and the ongoing test pipeline that will be coming online.

I want to take a moment, Dwight, if we can talk now more specifically, you talked about India last week, everyone saw the JV that you all signed in Saudi Arabia. I know you and a lot of team members were there to sign that agreement. Both are large underserved market opportunities. You talked about a little bit with tuberculosis and other indications that certainly need as much testing as it can possibly be.

But talk us through kind of the agreements in each market. If you want to talk about your trip to Saudi Arabia, which I'm sure we're all curious about and the market opportunity for both, that would be great?

Yes. So let me start with India because we began the India joint venture in 2017, right around the time that we took the company on to NASDAQ through an IPO. So we've been involved in India now for about 8 years, and we have a significant infrastructure in India. We have laboratories, and we're doing more laboratories on a very nice campus of the Sarabhai family who is our partner in the venture in India.

We also have 15 tests, which are being sold in the Indian market now. So we have a lot of experience in getting tests cleared through the CDSCO, which is their version of the FDA. And we're very enthusiastic about our coverage in the country. We have sales personnel virtually throughout India. And it's a big country. It's now the most populous country in the world, the world's largest democracy. And we're as excited as we can be about the progress that has been made there.

What we learned early on is there was no way we were going to be able to penetrate an Indian market without having boots on the ground and having infrastructure and personnel and leadership at every level. And we've done that. We've now matured it through 8 years of development. And as you may have noted this morning, we announced a furtherance of our financing objectives with this very important JV.

Going on to Saudi Arabia. The reason we pursued this agreement in Saudi Arabia for another joint venture is that we have had the advantage of being involved with a team in Saudi Arabia, which has been our largest international customer all through the COVID pandemic. And since then, they are -- they have been our largest customer. And they have resources in Saudi Arabia. They have great leadership, and they really know the territory. So it's similar to India in terms of you want to do business there, go in and participate with their national objectives, their 2030 objectives like in India, the same kind of thing going on with Make it in India with Prime Minister Modi.

And so we're really involved with the governments there and our teams there understand the territory, and we're very excited about what the future portends for both of these joint ventures.

So we -- there's a lot of horsepower there. We spend a lot of time deciding how we're going to properly leverage it for both those joint venture partners and for our own shareholders. And I think as you see the news flow develop and you follow along what we're doing, I think our shareholders will become a big fan of what our initiatives are and what we hope to accomplish through them.

And so clearly, you have multiple shots on goal with Saudi Arabia, India, but certainly, the U.S. is a large market as well. How does the U.S. differ in terms of market dynamics? And how are we planning to be able to commercialize in the U.S. versus India or Saudi Arabia or other regions of the world?

Yes. So clearly, our regulatory path, let's take, for instance, our ABCR test, that will be cleared through a regulatory pathway through the FDA here in the United States, whereas tuberculosis and the human papillomavirus will be cleared through regulatory paths in India through the CDSCO and [ ENS ] in Africa, in South Africa through the [ SAHPRA ]. So we have different regulatory paths that we're doing that will unleash the power of those indications in those respective regions of the world.

With respect to the United States, particularly, we are very enthused about our opportunities in several key markets, point-of-care markets, and that includes physicians and clinics. It includes pharmacies, of which there are over 60,000 locations in the United States. It includes skilled nursing facilities where they have vulnerable populations that need to be regularly tested for these types of things. And of course, the home market, which we are also in pursuit of.

Now we're approaching our initial commercialization from the standpoint of where we get the biggest bang per device. So specifically, we're looking for locations like pharmacies and clinics and things that give us an opportunity to test half a dozen people a day as opposed to a home market, which may test half a dozen or a dozen a year. So we think there's a significant home market because there are just so many homes, and we think we'll do well with a certain segment of the population.

But the point-of-care market is where our initial focus is going to be. We've done a tremendous amount of internal research to validate the -- these markets and why they are our preferred targets for initial commercialization.

We have also hired some significant players that are outside field marketing companies to give us additional data and input so that we know that when we spend our marketing dollars that we're going after the right places.

I appreciate that, Dwight. And we received -- we have a full house and we received a lot of questions. [Operator Instructions]

Let's talk about artificial intelligence, probably my favorite topic, and it's obviously top of mind for a lot of investors. Clearly, billions are being invested into AI across the board. I personally don't think that diagnostic testing is any different. And on Monday, you just announced for me a new business unit focused on AI. It's fascinating that you're doing this. Please tell us more.

Thank you, Valter. This is not an exercise in catch-up for us. We've been involved in artificial intelligence constructs for a long time. And as you know, dealing with artificial intelligence has a lot to do with patterns. And very few things that have as many patterns associated with them as the human DNA, which has 3.2 billion pairs of nucleic acids that make up our genomic structure. And so we've been using this for quite some time.

We think of it in these terms. We think of it in things that we've already completed in terms of artificial intelligence models, and that includes the fact that we scan genomic datasets and comparing conservation and mutation rates and cross-reactivity to pinpoint the most stable and diagnostically relevant targets. I would point out to that, for instance, with our COVID test, we're selling the same COVID test today as we were selling 5 years ago because our software and our analysis makes it, so we pick the right targets.

We also analyze reagent chemistries and our consumable designs. There's a tremendous amount of IP in our consumables. Our instrument tolerances, we are always fine-tuning the system components and reducing variability and strengthening reproducibility at scale.

Finally, in terms of things that we've already completed, our adaptive algorithms that continuously learn from amplification and melt curve data, and it filters noise and sharpens the result calling for an ever-greater accuracy.

Then we think of it in terms of the AI models that are currently in development. And that includes additional analysis with melt and mutation and synergy and regional entropy, our instrument performance and our customer service.

And then in the future, we look to future plan AI models that include sophisticated surveillance viral transmission, breakout detection syndromic transit. It's amazing that we've gone all the way through the pandemic, and we still don't have a way to figure out where we are as kind of -- we don't know where the breakouts are, what pharmacies are experiencing a lot of trouble at the doctors' offices.

We aim to address all of those things through our whole journey over the last 5 years in developing this very powerful platform. So AI is something that we have embraced in the past very rigorously.

We're doing some really wonderful things that are sort of perspective in the context of automation in our manufacturing processes and things. And these all involve some level of artificial intelligence.

It's certainly very fascinating to me. And before we turn the call over to our audience, I would be remiss if we didn't touch on this morning's news. You talked about it a little earlier regarding the pursuit of spinning off CoSara JV in India via potentially a SPAC. It seems like this opportunity is a little early, but is there anything you can comment on for our audience today regarding the news this morning?

Well, what we wanted to announce this morning is to let our shareholder base understand that we have big plans for CoSara. Like I said, we have spent 8 years there building the infrastructure. It is a significant infrastructure. We have a significant number of employees there. And in order to help CoSara reach its full goals -- it's going to require a certain amount of capitalization so that we can really put the pedal to the metal here. And so in discussing this with our investment banker, which we identified in this morning's press release, we anticipate pursuing the opportunity for a SPAC transaction that involves CoSara. And it also involves the company in important ways that I'm not going to go into detail on this morning, but you'll see those kind of details of what we have in mind from a structure standpoint evolving, but we think it will bring a great deal of additional value to our current stakeholders and certainly to our partners.

We will anticipate we will remain a significant shareholder in the company, similar to the shareholding that would be held by our partners at the Sarabhai family. And then, of course, we'll have new partners through the SPAC initiative. And we're very enthusiastic about this. It's been in the works for a while, and we're going to be excited to bring it to reality.

It's interesting, and I think it's really creative of you all to explore that opportunity for your shareholders. So we'll see how that progresses over time. And Dwight, honestly, you have a really interesting company and I think a timely company. It's been great to know you to say the least, and congrats to you and your entire team on all the progress you all have made.

We've been polling questions from our audience. So I'd like to spend the rest of our time today going through some of those questions.

And the first question is regarding pricing. How does your technology compare to existing technology in terms of pricing for your device?

And then for the test itself, how should we think about our margin profile?

Well, it's a very good question, and the answer is very simple and a wonderful answer. We are significantly less expensive than really anything I can think of in the market. And I don't mean just a little bit, I mean, by a lot. Our -- many people know that the standard sort of PCR device out there can cost anywhere from $4,000 to $10,000 to $20,000. And many of them need cold chains and different temperature types of restrictions to even operate. Ours in contrast does not need to be calibrated.

We're talking about a $300 to $500 device at scale compared to something that costs $10,000 or $20,000. And that means that you can go to a place like India and take a look at the limited number of people that they have now that can get a PCR test. And there are almost half of the country that have no access to diagnostics at all. But with what we're doing, this makes it go right down to the primary healthcare centers, of which there are tens of thousands.

And we believe that we can replace things like smear microscopy, which is a 125-year-old technology that's only accurate 20% to 80% of the time. So it's inaccurate a lot of the time.

And then it feeds into -- if you treat people and you have inaccurate results, then you end up with drug-resistant problems that are really onerous.

So we're going to be a leader with a very robust -- this is not a toy. This is a very significant PCR device that when we talk about human papillomavirus, for example, we're testing for 8 different indications, which were identified for us by the Bill & Melinda Gates Foundation. And it includes all the major primary cancer-causing mutations that are in the human papillomavirus complex. This is able to be done because of our Co-Primer technology, allowing a very massive multiplexing capabilities. And so you have 9 different pathogens plus a human DNA control, all done in one test, one sample in 30 minutes. So it's a very powerful technology. We're just very excited to be on the lip of the cup of getting it into the market through our commercialization. And we've spent so much time getting ready for this event that we're ready to jump on it.

Appreciate that. And we talked about the U.S., we talked about India, Saudi Arabia. How do you think about the largest unmet needs in each market that our technology can support from a diagnostics perspective?

Well, it really comes down to filling the gap, Valter. There's -- you just can't push a $20,000 or $10,000 or $18,000 PCR instrument down into the environments like the environments in India or in Africa where they need to get access. This is why they have no access now. And the key opinion leaders around the world are uniform in asserting that we've got to get rid of smear microscopy and replace it with molecular tests. That's exactly what we are.

And the nice thing is that we can do it at a price that makes it relevant in these markets. And that's just going to continue to be a great strong point for us. I didn't mention our cups or our consumables, but they also will be very, very competitively priced compared to the competition. And I think I would also add that this is something that just overcomes a lot of the barriers that have made us all these big systems can't help with what is ailing us in lots of different areas of the country.

And in the U.S., as we go in to make this available at places like pharmacies and skilled nursing facilities and doctors' offices and clinics, it's the same thing. When you look at the margins that we produce, we are anticipating essentially the same types of margins in this product line that we have experienced previously in our wet reagents. And that is approximately about a 30% margin on the instruments. That's not really the main business. It's really the cartridges or consumable cups, which have a 70% to 80% margin in them.

And of course, when we go overseas in places like India, there will be a compassionate pricing that's deployed, but the market is so huge. We're looking forward to our value proposition being extremely competitive no matter who it is we're coming up against.

And Dwight, as we conclude 2025, we have a few months left heading into '26. How do we think about upcoming milestones that investors should look forward to?

Well, you should look forward, first and foremost, I think, to the introduction of our tests into clinical trials, both in the United States with respect to ABCR and in India and in Africa with our human papillomavirus test and our TB test. Those will be important milestones that we're looking forward to getting through, and we're -- we've spent a lot of time getting ready so that we can do that with aplomb and we're looking forward to the results of that. Those are the primary initiatives, along with the initiatives that we've already announced that have to do with our artificial intelligence initiatives, our joint venture in Saudi Arabia and what we're doing in terms of pursuing our SPAC financing at CoSara.

So there's a lot of -- it's a very dynamic period from us. I can't express to our shareholders how much processing this takes of senior level management to be on top of all of this and to -- and we're very enthusiastic about the results that we're getting and the interest we're getting around the world. And so I think there are plenty of catalysts to be interested in and to keep an eye on us.

Yes. And that's a good segue. So it was one of my favorite questions speaking about catalysts. Why do you think your stock is undervalued?

Well, when I'm asked that question, I always sort of respond with, look, it's really the market's responsibility to price us. We, of course, believe that we're significantly undervalued. We think our value proposition speaks for itself. And in some ways, we feel like we were thrown out the baby with the bathwater as COVID normalized. And people -- I think people have misinterpreted what's going on even with COVID. And that's why it's part of our multiplex test that's being going into clinical trials shortly here. And that is that COVID is still the number -- it's the #1 problem in terms of infectious disease in the world.

Tuberculosis is the #1 killer. But in terms of just numbers of diseases, COVID is still raging like crazy. And COVID fatigue or whatever you want to call it, made it so it was largely abandoned emotionally by the population, but it's still a real problem.

And we think we're going to be able to fill a very cool diagnostic gap at the markets that I've articulated so that this is a technology that can be done all the way down to the home with real sophisticated PCR diagnostics, what the CDC refers to as the gold standard. This is not isothermal technology. This is not antigen technology. This is the real McCrory "Lock Stock & Barrel".

So we're excited about people being able to have access to it for very little cost and the ongoing revenue from the cartridges, we think will make a very sustainable and growing business for our shareholders.

Well, I appreciate that. That's right. And we're just about up on the time for today's fireside chat. I really appreciate your time, and I know that your shareholders are grateful as well. Really appreciate the detail that you gave us, and I hope that we can do this again.

Any last comments before we conclude today's chat?

Just that it's been a thrilling ride for us to be able to develop and build this significant technology, which we think will improve the quality of life for a lot of people and maybe even save some lives. We certainly hope that.

And we appreciate the support of our shareholders and those who share our vision. which is a very important vision in terms of creating real value in the healthcare sector. So we look forward to doing this again, too, and thank you for the opportunity to get on this fireside chat. Thanks to our shareholders as well.

I appreciate it, Dwight. It was a great time spending with you. And for -- and thank you for all of our investors for joining us today. If we didn't get to your question, again, please just e-mail us [email protected]. Really appreciate everybody's time until next time. Thank you so much.