Co-Diagnostics, Inc. 10-Q

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations Cautionary Note Regarding Forward-Looking Statements This Quarterly Report on Form 10-Q contains “forward-looking statements” that involve risks and uncertainties. All statements other than statements of historical fact contained in this Quarterly Report and the documents incorporated by reference herein, including statements regarding future events, our future financial performance, business strategy, and plans and objectives of management for future operations, are forward-looking statements. We have attempted to identify forward-looking statements by terminology including “anticipates,” “believes,” “can,” “continue,” “could,” “estimates,” “expects,” “intends,” “may,” “plans,” “potential,” “predicts,” “should,” or “will” or the negative of these terms or other comparable terminology. Although we do not make forward-looking statements unless we believe we have a reasonable basis for doing so, we cannot guarantee their accuracy. These statements are only predictions and involve known and unknown risks, uncertainties and other factors and the documents incorporated by reference herein, which may affect our or our industry’s actual results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Moreover, we operate in a highly regulated, very competitive, and rapidly changing environment. New risks emerge from time to time, and it is not possible for us to predict all risk factors, nor can we address the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause our actual results to differ materially from those contained in any forward-looking statements. These forward-looking statements are subject to certain risks and uncertainties that could cause our actual results to differ materially from those reflected in the forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed under the heading “Risk Factors” in other documents we file with the SEC, including our Annual Report on Form 10-K for the year ended December 31, 2025. The following discussion should be read in conjunction with the Annual Report on Form 10-K for the fiscal year ended December 31, 2025, filed with the SEC on March 31, 2026, and the audited financial statements and notes included therein. As used in this Quarterly Report, the terms “we”, “us”, “our”, and “Co-Diagnostics” means Co-Diagnostics, Inc., a Utah corporation and its consolidated subsidiaries (the “Company”), unless otherwise indicated. Executive Overview The following management’s discussion and analysis of financial condition and results of operations describes the principal factors affecting the results of our operations, financial condition, and changes in financial condition. This discussion should be read in conjunction with the accompanying unaudited financial statements and notes thereto included elsewhere in this report. The information contained in this discussion is subject to a number of risks and uncertainties. We urge you to review carefully the section of this report entitled “ Cautionary Note Regarding Forward-Looking Statements. ” Business Overview Co-Diagnostics, Inc., a Utah corporation (the “Company” or “CODX”), develops, manufactures and sells reagents used for diagnostic tests that function via the detection and/or analysis of nucleic acid molecules (DNA or RNA), including molecular tools for detection of infectious diseases. Our diagnostics systems enable dependable, low-cost, molecular testing for organisms and genetic diseases by automating or simplifying historically complex procedures in both the development and administration of tests. CODX’s technical advance involves a novel, proprietary approach to polymerase chain reaction (“PCR”) test design of primer and probe structure (“Co-Primers®”) that dramatically reduces one of the key vexing issues of PCR amplification: the exponential growth of primer-dimer amplification (false positives) which adversely interferes with identification of the target DNA/RNA. Using our proprietary test design system and reagents, we have designed and obtained regulatory approval to sell PCR diagnostic tests for the detection of COVID-19, influenza, tuberculosis, hepatitis B and C, human papillomavirus, malaria, chikungunya, dengue, and the Zika virus. These initial diagnostic tests are cleared for use in clinical labs only and not for point-of-care or at-home use. We have developed a portable diagnostic device and test system designed for point-of-care and at-home use. The system is comprised of our PCR instrument that we refer to as the Co-Dx™ PCR Pro ® instrument and a mobile application to be installed on the user’s mobile device. We refer to the system as the “Co-Dx™ PCR platform” which has been designed to bring affordable, reliable polymerase chain reaction (“PCR”) testing to patients in point-of-care and at-home settings. The Co-Dx PCR platform is subject to U.S. Food and Drug Administration (“FDA”) review and is not available for sale at the time of this filing. In June 2024, we completed our first FDA application for 510(k) clearance for the Co-Dx PCR Pro instrument, the Co-Dx PCR COVID-19 Test, and the Co-Dx PCR mobile app for over-the-counter (OTC) use. Following engagement with the FDA during the review process, the Company voluntarily withdrew the 510(k) submission after discussions regarding the analytical approach for detecting potential degradation of a test component over its intended shelf life. While the Company believes that the matter identified during the review process could have been addressed through additional development and clinical validation activities, management determined that the capital and time required to resubmit the COVID-19 test for 510(k) clearance would be more effectively deployed toward development and clinical validation of the Co-Dx PCR Flu A/B, and RSV multiplex test (“ABR”). Moving focus to this test allows the Company to incorporate more recent Co-Dx PCR platform developments into the design and test manufacturing process. The Company has completed clinical and analytical performance studies for the Co-Dx™ PCR Flu A/B and RSV upper respiratory multiplex test on the Co-Dx PCR Pro® instrument that the Company included in a submission package for a Dual 510(k) and CLIA Waiver by Application submission to the U.S. Food and Drug Administration in August 2026. There is no guarantee that our Co-Dx PCR platform will receive the necessary regulatory approvals for commercialization, or that, if regulatory approval is received, we will be able to successfully commercialize this platform. In January 2017, the Company entered into an agreement to manufacture diagnostics tests for seven infectious diseases with a pharmaceutical manufacturing company in India and formed CoSara Diagnostics Pvt. Ltd. as a joint venture. The agreement provided for the construction of a manufacturing plant, the manufacture of the PCR tests using the Company’s primer technology, and the sales and marketing of those tests in India. The Company also has a services agreement with CoSara under which CoSara provides certain research and development consulting and support services, specifically pertaining to the ongoing development of the Co-Dx PCR platform. During July 2026, CoSara initiated clinical studies for a tuberculosis test on the PCR Pro® instrument. Additionally, in October 2025, the Company entered into an agreement with Arabian Eagle Manufacturing, a regional manufacturing and distribution company based in the Kingdom of Saudi Arabia (“KSA”) to form CoMira Diagnostics (“CoMira”), a joint venture dedicated to research, develop, manufacture, assemble, distribute, and commercialize Co-Dx technologies and intellectual property, including the Company’s Co-Dx PCR platform, within KSA and 18 other countries throughout the Middle East and North Africa. Similar to the Company’s agreement with CoSara, Co-Dx will provide CoMira an exclusive license to use, manufacture, and commercialize the licensed IP in the region, which will include the Co-Dx PCR platform as well as the Company’s existing suite of lab-based PCR diagnostic products. The Company believes that its cutting-edge PCR technology, along with the respective scopes and missions of CoSara and CoMira, will allow Co-Diagnostics to be a critical contributor of healthcare innovations in regions with large and growing markets for medical devices and point-of-care diagnostics, while simultaneously establishing a transformative platform for molecular diagnostics and reinforcing the Company’s mission to increase the accessibility of high-quality PCR diagnostics. 20 Technology We believe our proprietary and patented molecular diagnostics technology is paving the way for innovation in disease detection and life sciences research through our enhanced detection of genetic material. For various reasons, including owning our own platform, we believe we will be able to accomplish this faster and more economically than some competitors, allowing for significant margins while still positioning ourselves as a low-cost provider of molecular diagnostics and screening services. For example, we were the first US-based company to receive a CE-marking for a COVID-19 test in early 2020, as we worked to help slow the spread of the pandemic through our global network of distributors covering clinical labs in more than 50 countries. Our Logix Smart® COVID-19 test was designed, developed, submitted for regulatory approval and ready to be used as an in vitro diagnostic (“IVD”) in countries that accept CE marking for regulatory clearance in a period of just over 30 days. This is a real-world example of how CODX technology can be used in an evolving epidemic or pandemic to get diagnostic tools in the hands of medical professionals in a timely manner. It can be similarly used to design a test for mutated strains of SARS-CoV-2 or other viruses should they not be detectable using currently available tests. In addition, continued development has demonstrated the unique properties of our Co-Primers technology that we believe makes it ideally suited for a variety of applications where specificity is key to optimal results, including multiplexing several targets, enhanced Single Nucleotide Polymorphism (“SNP”) detection and enrichment for next generation sequencing. Our scientists use the complex mathematics of DNA/RNA PCR test design to engineer and optimize PCR tests and to automate algorithms that rapidly screen millions of possible options to pinpoint the optimum design. The intellectual property we use in our business consists of the predictive mathematical algorithms and patented molecular structure used in the testing process, which together represent a major advance in PCR testing systems. CODX technologies are now protected by more than 20 granted or pending US and foreign patents, as well as certain trade secrets and copyrights. Ownership of our proprietary platform permits us the advantage of avoiding payment of patent royalties required by other PCR test systems, which may allow for the sale of diagnostic PCR tests at a lower price than competitors, while enabling us to maintain profit margins. Our proprietary test design process involves identifying the optimal locations on the target genes for amplification and pairing the locations with the optimized primer and probe structure to achieve outputs that meet the design input requirements identified from market research. This is done by following planned and documented processes, procedures and testing. In other words, we use the data resulting from our tests to verify whether we succeeded in designing what we intended. Verification involves a series of testing that concludes that the product is ready to proceed to validation in an evaluation either in our laboratory or in an independent laboratory setting using initial production tests to confirm that the product as designed meets the user’s needs. Using our proprietary test design system and reagents, we have designed and obtained regulatory clearance in the European Community and in India (along with our joint venture, CoSara) to sell PCR diagnostic tests for the detection of COVID-19, influenza, tuberculosis, hepatitis B and C, human papillomavirus, malaria, chikungunya, dengue, and the Zika virus. In the United States, we obtained Emergency Use Authorization (“EUA”) for our Logix Smart® COVID-19 detection test from the FDA, and we sell that test to qualified labs. In addition, our COVID-19 detection test and certain of our other suite of COVID-19 products have been cleared for sale in countries such as the United Kingdom, Australia, India, and Mexico by the regulatory bodies in those countries and have been registered for sale in many more countries. In connection with the sale of our tests we may sell diagnostic equipment from other manufacturers, including an OEM’s PCR instrument which we refer to here as the “Co-Dx Box™”. In addition to testing for infectious diseases, Co-Primers technology lends itself to identifying any section of a DNA or RNA strand that describes any type of genetic trait, which creates several significant applications. We, in conjunction with our customers, have designed tests that identify genetic traits in plant and animal genomes. We also have commercialized three multiplexed tests to test mosquitos for the presence of diseases they carry, which enables municipalities to concentrate their efforts in managing mosquito populations in specific areas where mosquitos carrying deadly viruses are known to breed. 21 RESULTS OF OPERATIONS The Three Months Ended June 30, 2026 Compared to the Three Months ended June 30, 2025 Revenues For the three months ended June 30, 2026, we generated revenues of $0.2 million, compared to revenues of $0.2 million for the three months ended June 30, 2025. Cost of Revenues We recorded cost of revenues of approximately $0.05 million for the three months ended June 30, 2026, compared to approximately $0.03 million for the three months ended June 30, 2025. Included within cost of revenues is a decrease of approximately $0.03 million for the three months ended June 30, 2026, and a decrease of approximately $0.1 million for the three months ended June 30, 2025, related to reserves against certain raw materials and finished goods inventories. Expenses Total operating expenses for the three months ended June 30, 2026 were $6.3 million, compared to total operating expenses of $8.2 million for the three months ended June 30, 2025. The decrease in operating expenses was primarily due to decreased legal and professional services expense, as well as decreased personnel and stock-based compensation expense, partially offset by increased expense related to clinical trials for the Co-Dx PCR platform. Sales and marketing expenses for the three months ended June 30, 2026 were $0.5 million, compared to $0.6 million for the three months ended June 30, 2025. The decrease was primarily a result of decreased stock-based compensation expense and consulting expense. General and administrative expenses for the three months ended June 30, 2026 were $1.5 million, compared to $2.6 million for the three months ended June 30, 2025. The decrease resulted primarily from decreased stock-based compensation expense and decreased legal and professional services expense. Research and development expenses for the three months ended June 30, 2026 were $4.2 million, compared to $4.7 million for the three months ended June 30, 2025. The decrease was primarily a result of expenses related to decreased personnel related expense, partially offset by increased expense related to clinical trials for the Co-Dx PCR platform. Other Income or Expense Other expense for the three months ended June 30, 2026 was $0.1 million, compared to other income of $0.3 million for the three months ended June 30, 2025. The decrease was primarily a result of decreased realized gains from investments in marketable securities, as well as changes in the fair value of contingent consideration liabilities. Net Loss Net loss for the three months ended June 30, 2026 was $6.3 million, compared to $7.7 million for the three months ended June 30, 2025. The smaller net loss was primarily the result of lower operating expenses, partially offset by decreased other income, including changes in the fair value of contingent consideration liabilities and decreased realized gains on investments. 22 The Six Months Ended June 30, 2026 Compared to the Six Months ended June 30, 2025 Revenues For the six months ended June 30, 2026, we generated revenues of $0.3 million, compared to revenues of $0.2 million for the six months ended June 30, 2025. Cost of Revenues We recorded cost of revenues of approximately $0.2 million for the six months ended June 30, 2026, compared to approximately $0.1 million for the six months ended June 30, 2025. Included within cost of revenues is a decrease of approximately $0.2 million for the six months ended June 30, 2026, and a decrease of approximately $0.1 million for the six months ended June 30, 2025, related to reserves against certain raw materials and finished goods inventories. Expenses Total operating expenses for the six months ended June 30, 2026 were $15.5 million, compared to total operating expenses of $16.8 million for the six months ended June 30, 2025. The decrease in operating expenses was primarily due to decreased legal and professional services expense, as well as decreased personnel and stock-based compensation expense, partially offset by increased expense related to clinical trials for the Co-Dx PCR platform. Sales and marketing expenses for the six months ended June 30, 2026 were $0.9 million, compared to $1.3 million for the six months ended June 30, 2025. The decrease was primarily a result of decreases in stock-based compensation expense, tradeshow and travel expense, and consulting expense. General and administrative expenses for the six months ended June 30, 2026 were $4.0 million, compared to $5.4 million for the six months ended June 30, 2025. The decrease resulted primarily from decreased personnel related expense and stock-based compensation expense, as well as decreased legal and professional services expense. Research and development expenses for the six months ended June 30, 2026 were $10.1 million, compared to $9.6 million for the six months ended June 30, 2025. The increase was primarily a result of expenses related to clinical trials for the Co-Dx PCR platform, partially offset by decreased personnel related expense. Other Income Other income for the six months ended June 30, 2026 was nominal, compared to other income of $1.4 million for the six months ended June 30, 2025. The decrease was primarily a result of changes in the fair value of contingent consideration liabilities, as well as decreased realized gains from investments in marketable securities. Net Loss Net loss for the six months ended June 30, 2026 was $15.4 million, compared to $15.3 million for the six months ended June 30, 2025. The larger net loss was primarily the result of decreased other income, including changes in the fair value of contingent consideration liabilities and decreased realized gains on investments, partially offset by lower operating expenses. 23 Liquidity and Capital Resources At June 30, 2026, we had cash and cash equivalents of $3.6 million. Additionally, our total current assets at June 30, 2026, were $5.2 million compared to total current liabilities of $2.9 million. Net cash used in operating activities during the six months ended June 30, 2026 was $15.0 million, compared to $17.0 million for the six months ended June 30, 2025. The decrease in cash used in operating activities was primarily due to reduced operating expenses and a lower usage of cash to pay accounts payable and accrued liabilities from the end of the previous year. Net cash used in investing activities was $0.3 million for the six months ended June 30, 2026, compared to cash provided by investing activities of $24.4 million during the six months ended June 30, 2025. The decrease in cash provided by investing activities is primarily due to higher proceeds from redemptions of investments during the prior year. Net cash provided by financing activities was $7.1 million for the six months ended June 30, 2026, compared to $0.8 million for the six months ended June 30, 2025. The cash provided by financing activities during 2026 relates to issuances of common stock under the ATM and proceeds related to a private placement transaction. Since commencing sales of our Logix Smart COVID-19 test in March 2020, we have used our cash generated from those sales to fund the purchase of inventories and the development of our Co-Dx PCR Platform, and to pay our operating expenses. Our available capital resources may be consumed more rapidly than currently expected and we may need or want to raise additional financing for strategic opportunities. It is anticipated that the Company will continue to generate operating losses and use cash in operations in the near term. If needed, we expect additional investment capital to come from additional issuances of our common stock or other equity-based securities with existing and new investors similar to those that have provided funding in the past or debt financing. Although we are seeking to obtain additional equity and/or debt financing, such funding is not assured and may not be available to us on favorable or acceptable terms and may involve significant restrictive covenants. Any additional equity financing, if available to us at all, will most likely be dilutive to our current stockholders. If we are not able to obtain additional debt or equity financing on a timely basis, the impact on us will be material and adverse. These uncertainties create substantial doubt about our ability to continue as a going concern. The condensed consolidated financial statements do not include any adjustments that might result from the outcome of these uncertainties . Forward-Looking Statements This Liquidity and Capital Resources discussion contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the Company’s liquidity runway, anticipated use of proceeds, potential sales under the at-the-market program, and the Company’s financing plans and capital needs. Forward-looking statements are based on current expectations and assumptions and are subject to risks and uncertainties that could cause actual results to differ materially, including those described under “Risk Factors” and elsewhere in this Quarterly Report on Form 10-Q. There can be no assurance regarding the timing, amount, or terms of any future securities offerings or sales under the at-the-market program, or that such transactions will be available on acceptable terms or at all. The Company undertakes no obligation to update any forward-looking statements, except as required by law. Off-Balance Sheet Arrangements We have no off-balance sheet arrangements. Item 3. Quantitative and Qualitative Disclosures about Market Risk Not required under Regulation S-K for “smaller reporting companies.”