CODX

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 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. 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 Diagnostics, progressing our CoMira Diagnostics 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. 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 timelines while maintaining the ability to incorporate COVID at a later stage, if appropriate, and 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. 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 nine years, and over that time, we have built a meaningful foundation through our CoSara joint venture in one of the largest healthcare 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 toward 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 advisors 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, 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, 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. 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 receive 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. 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, 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. 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 one-time 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 that 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 non-dilutive 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've 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. 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?

Thank you. We will now begin the question-and-answer session. If you would like to ask a question, please press star, then the number one on your telephone keypad to raise your hand and join the queue. If you would like to withdraw your question, simply press star one again. Once again, to ask a question at this time, press star, then the number one on your telephone keypad. Your first question comes from Michael Okunewitch with Maxim Group. Your line is open.

Hey, guys. Thank you so much for taking my questions today. 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?

Thanks for the question. You know, we believe that we are very well-positioned to scale for initial commercial demand. Our Utah facility has already produced 100s of 1,000s of test cups for clinical studies and in-house R&D. We've been manufacturing and have manufacturing plans already designed and ready to implement in the, 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'll support CoPrimer's oligonucleotides manufacturing and commercialization in India. 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 Diagnostics facility will be completing the final assembly of TB, HBV, and upper respiratory test kits and instruments that are principally manufactured in Utah, with plans 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 and strong alignment with WHO guidance. Our approach is simply to deliver the quality of PCR at a 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 four times in terms of time and overhead.

This is a very exciting development, and it not only increases our throughput capabilities by four times, 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 one or two on an automated line. We're very excited about the prospects of the automated test cup. 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.

Thank you. 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 infrastructures. Could you talk a little bit about the advantages that you're seeking to leverage by going after these local regional manufacturing facilities?

We originally picked, you know, India as a joint venture partner basically nine years ago when we identified India as what was going to be, if not the biggest, certainly one of the biggest healthcare markets in the world. That was a very good decision. Now we have a mature business entity that's been operating for nine 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, 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. We're gonna be taking it to them and filling a huge gap. It's not only accessibility, it's affordability. Our tests are competitively priced, of course, but our platform and 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. We fill a huge gap. We're very excited to take it on.

All right, thank you. Then one more from 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. I'd like to see if you 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. 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. We're very comfortable with the way that that's done and have a excellent track record in executing on it.

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 healthcare 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. You know, 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%-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.

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. We're very excited about our ability to go there. We've spent a ton of time and have a fully staffed, you know, group over there that has already been selling a route throughout the country. I think we're very ready to go as soon as we get the clearance.

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.

Today's session is being recorded. 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 31st, 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 includes statements concerning the company's Kodiak PCR testing platform, which requires regulatory approval and marketing authorization for diagnostic use and is not currently for sale.

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 contained 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 multi-pronged 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 remained focused on execution and continued 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 four 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. 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 eight years, and over that time, we have built a meaningful foundation through our CoSara joint venture in one of the largest healthcare 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 advisor 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 a 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 and 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. Pre-clinical 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 prioritized in 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 Kodiak 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 timelines 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 timelines 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 Kodiak 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 non-cash impairment charge of approximately $18.9 million related to in-process research and development intangible assets.

Excluding this non-cash 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 Kodiak 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 non-cash 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 non-cash 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 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 Kodiak 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 Kodiak vision. We are focused on delivering against our strategy and advancing the company toward its next phase. With that, we'll now open the line for questions. Operator?

Gentlemen, thank you. To our phone audience joining today, at this time, if you would like to ask a question, simply press the star followed by the digit one on your telephone keypad. Pressing star and one will place your line into a queue, and we will open your lines one at a time, and you will be invited to share your questions. Once again, ladies and gentlemen, that is star and one on your telephone keypad, and we'll pause for just a few seconds to allow our audience the opportunity to signal. Thank you. Ladies and gentlemen, we'll take our first question today from Yi Chen at H.C. Wainwright. Please go ahead. Your line is open.

Hi. Thank you. This is Katie on for Yi. Looking at your now three target tests, dropping COVID seems like a great idea. Where does the sample accrual stand for the three target panel? Is first half of 2026 still the target? 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 taking away the COVID out of the mix of the multiplex test was not a decision based on the availability of COVID in what is a very powered clinical trial in about eight different locations across the United States. COVID just simply did not show up over a several-month period. 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.

I just wanna 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, you know, 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. That's what reality was during our clinical trial. You know, if we waited, for instance, until the summer to get more COVID, there's no assurance that it would show up then, even though it might be. 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?

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 gonna 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. A lot of that would be a negotiation with the FDA in terms of what they would require. You know, 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? 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. Like I say, it doesn't require that we re-engineer or work on the chemistry or 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, you know, 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.

Perfect. Thank you.

A reminder to our audience, that is star and one. We will hear next from the line of Michael Okunewitch at Maxim Group.

All right. Thank you for taking my questions, and congrats on the speedy resolution of the listing challenges. Good to see you back on the Nasdaq.

Thank you.

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 tests, 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. 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. You know, we've been doing it for almost eightyears. We have manufacturing capabilities there. We have a number of employees. We have salespeople covering pretty much the entire subcontinent of India.

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. 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.

Mm-hmm. Thank you for the additional clarity on that. 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, you know, 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. I would represent to you that it's in excess of 1,200 different patients that have already been through the enrollment. 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 with enough force that we can get the kind of samples we need to satisfy the FDA.

All right. Thank you. Then one last one from 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 timelines for getting that study up and running and then moving on to commercialization?

Yeah. Our expectation in India, and as I mentioned, it's a mature joint venture at this point, having spent about eight years doing it. 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. You know, we have manufacturing facilities, we have sales and marketing, and we have a very, very good group of individuals that support that business. So, you know, when we look at taking this new Kodiak PCR Pro box there, 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 rocket science. That's pretty sophisticated molecular science. That's already in process. We put that in a year ago December, actually.

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 of making it so that we can produce cups that are the consumables with integrity, and we can do it at scale. 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. We believe that this clinical trial will proceed quickly, and then the study will go before the CDSCO in pretty short order. We actually expect to have commercialization of the TB tests in India, let's say, by the third quarter of 2026.

All right. Thank you. I really appreciate the update.

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.