Co-Diagnostics, Inc.
For the period ended Mar 31, 2026. Filed May 14, 2026.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Mar 31, 2026 · Filed May 14, 2026
CODX$0.26-3.9%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-09-30; filed 2025-11-13.
0001493152-25-022300
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-03-31; filed 2026-05-14.
0001493152-26-023085
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 62 previous paragraphs and 44 current paragraphs.
27 unchanged; 16 reworded; 1 added; 18 removed; 1 previous and 0 current paragraphs rearranged.
Tables are not compared: 0 previous and 0 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (1)
Current report
Net loss for the three months ended March 31, 2026 was $9.1 million, compared to $7.5 million for the three months ended March 31, 2025. The larger net loss was primarily the result of higher operating expenses and decreased other income, including changes in the fair value of contingent consideration liabilities and decreased realized gains on investments.
Removed paragraphs (18)
Previous report
Other Income or Expense
Previous report
We realized a net loss for the three months ended September 30, 2025 of $5.9 million, compared to $9.7 million for the three months ended September 30, 2024. The smaller net loss was primarily the result of lower operating expenses and a benefit from income taxes, partially offset by decreased grant revenues and lower interest income and realized gains on investments. The income tax benefit recognized during the three months ended September 30, 2025 relates primarily to new United States tax legislation which was signed into law on July 4, 2025, which resulted in the Company being eligible for certain federal and state tax refunds related to prior years. The Company expects to receive these refunds by the end of the year.
Previous report
The Nine Months Ended September 30, 2025 Compared to the Nine Months ended September 30, 2024
Previous report
Revenues
Previous report
For the nine months ended September 30, 2025, we generated revenues of $0.4 million, compared to revenues of $3.8 million for the nine months ended September 30, 2024. The decrease in revenue was due to lower product and grant revenues recognized in the nine month current period.
Previous report
Cost of Revenues
Previous report
Expenses
Previous report
Total operating expenses were $23.9 million for the nine months ended September 30, 2025 compared to total operating expenses of $31.2 million for the nine months ended September 30, 2024. The decrease in operating expenses was primarily due to decreased legal expenses, stock-based compensation expense, and personnel related expenses.
Previous report
Sales and marketing expenses for the nine months ended September 30, 2025 were $1.8 million compared to $3.7 million for the nine months ended September 30, 2024. The decrease was primarily a result of decreased stock-based compensation expense, tradeshow and travel expenses, consulting and professional services expenses, and personnel related expenses.
Previous report
General and administrative expenses for the nine months ended September 30, 2025 were $7.2 million compared to $10.3 million for the nine months ended September 30, 2024. Decreases in legal expense, stock-based compensation expense and consulting and professional services expense were partially offset by increased expenses related to transaction advisory services and fees.
Previous report
Research and development expenses for the nine months ended September 30, 2025 were $14.0 million compared to $16.2 million for the nine months ended September 30, 2024. The decrease was primarily a result of decreased expenses related to development of the Co-Dx PCR platform, personnel related expenses, and stock-based compensation expense, partially offset by increases in professional services expense.
Previous report
Other income was $1.3 million for the nine months ended September 30, 2025, compared to other income of $1.6 million for the nine months ended September 30, 2024. Decreases in interest income were partially offset by increases in realized gains from investments in marketable securities and increases in the change in the fair value of contingent consideration liabilities.
Previous report
Net Loss
Previous report
We realized a net loss for the nine months ended September 30, 2025 of $21.2 million, compared to $26.6 million for the nine months ended September 30, 2024. The smaller net loss was primarily the result of decreases in operating expenses and a benefit from income taxes, partially offset by decreases in grant revenues. The income tax benefit recognized during the nine months ended September 30, 2025 relates primarily to new United States tax legislation which was signed into law on July 4, 2025, which resulted in the Company being eligible for certain federal and state tax refunds related to prior years. The Company expects to receive these refunds by the end of the year.
Previous report
During and subsequent to the third quarter of 2025, the Company took several actions to strengthen its liquidity position and enhance financial flexibility. In October 2025, the Company terminated its Amended and Restated Equity Distribution Agreement with Piper Sandler & Co. and Clear Street, LLC, under which limited sales of common stock had previously been made, and entered into a new Equity Distribution Agreement with Maxim Group LLC to establish an at-the-market (“ATM”) equity offering program permitting sales of up to $10.0 million of common stock from time to time. In addition, the Company completed two registered direct offerings with institutional investors — one in September 2025 for gross proceeds of approximately $3.8 million and another in October 2025 for gross proceeds of approximately $7.0 million, in each case before deducting placement agent fees and offering expenses. The Company intends to use the net proceeds from these equity financings for working capital and general corporate purposes.
Previous report
On September 18, 2025, the Company completed a registered direct offering of 9,619,000 shares of its common stock to two institutional investors at an offering price of $0.40 per share, resulting in gross proceeds of approximately $3.8 million before deducting placement agent fees and other offering expenses. The shares were offered and sold pursuant to the Company’s effective shelf Registration Statement on Form S-3 (File No. 333-270628). Maxim Group LLC acted as placement agent for the transaction. The Company intends to use the net proceeds from the offering for working capital and general corporate purposes. See Note 13 – Registered Direct Offering to the condensed consolidated financial statements for additional information regarding this transaction.
Previous report
In October 2025, the Company terminated its Amended and Restated Equity Distribution Agreement with Piper Sandler & Co. and Clear Street, LLC, under which it had previously sold an aggregate of 4,550,245 shares of common stock for net proceeds of approximately $1.7 million. Concurrently, the Company entered into a new Equity Distribution Agreement with Maxim Group LLC to establish an at-the-market (“ATM”) equity offering program, under which the Company may offer and sell shares of its common stock having an aggregate offering price of up to $10.0 million from time to time. On October 20, 2025, the Company filed a prospectus supplement with the SEC relating to the new ATM program, registering up to approximately $4.1 million of shares under the shelf registration statement. The Company expects that any proceeds from sales under the new ATM program, if utilized, would provide additional financial flexibility to support its working capital requirements and general corporate purposes. There can be no assurance as to the timing or amount of any sales under the new ATM program. See Note 12 – At the Market Agreement to the condensed consolidated financial statements for additional information regarding this transaction.
Previous report
Subsequent to quarter end, on October 29, 2025, the Company completed a registered direct offering of its common stock and pre-funded warrants to two institutional investors for gross proceeds of approximately $7.0 million, before deducting placement agent fees and other offering expenses. The Company intends to use the net proceeds from the offering for working capital and general corporate purposes. See Note 15 – Subsequent Events to the condensed consolidated financial statements for additional information regarding this transaction.
Reworded paragraphs (16)
Previous wording
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 robust and innovative 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
Current wording
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.
Previous wording
We are currently developing a unique, groundbreaking 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, our patent-pending diagnostic test cup system 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 productive engagement with the FDA related to the regulatory submission, the Company withdrew its 510(k) application. The decision to withdraw the submission was based on discussions with the FDA regarding the ability to detect a potential deterioration of one component of the test, related to shelf-life stability. Following dialogue with the FDA and exploring the various courses of action available, we determined that the best long-term solution would be to submit a version of the test that has been enhanced to address the matter raised in the 510(k) review process. The Company plans to submit the next iteration of the Co-Dx PCR COVID-19 test for 510(k) OTC clearance, following the collection of clinical evaluation data to support the new test’s performance. A new submission also allows the Company to incorporate more recent Co-Dx PCR platform developments into the tests, which Co-Dx believes will also help create greater operational and manufacturing efficiencies, such as consolidating manufacturing processes to utilize the next generation of test kits and instruments across all tests on the at-home and point-of-care Co-Dx PCR platform. 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. On October 27, 2025, we entered into an agreement with Arabian Eagle Manufacturing to form a joint venture to research, develop, manufacture, assemble, distribute, and commercialize Co-Dx technologies and intellectual property, including our upcoming PCR point-of-care platform, within the Kingdom of Saudi Arabia and 18 other countries through the Middle East and North Africa.
Current wording
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, COVID-19, RSV multiplex test (“ABCR”). Moving focus to this test allows the Company to incorporate more recent Co-Dx PCR platform developments into the design and test manufacturing process. Management believes that a multiplex test targeting influenza A/B, COVID-19, and RSV better aligns with current clinical demand for comprehensive upper respiratory infection testing in point-of-care settings. Accordingly, clinical performance studies for the ABCR test are currently underway. 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.
Previous wording
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 or 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.
Current wording
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.
Previous wording
Using our proprietary test design system and reagents, we have designed and obtained regulatory approval in the European Community and in India 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”.
Current wording
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™”.
Previous wording
In addition to testing for infectious disease, 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 and licensed 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.
Current wording
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.
Previous wording
For the three months ended September 30, 2025, we generated revenues of $0.1 million, compared to revenues of $0.6 million for the three months ended September 30, 2024. The decrease in revenue was due to lower grant revenues recognized in the current period.
Current wording
For the three months ended March 31, 2026, we generated revenues of $0.1 million, compared to revenues of $0.1 million for the three months ended March 31, 2025.
Previous wording
We recorded cost of revenues of approximately $0.03 million for the three months ended September 30, 2025, compared to $0.3 million for the three months ended September 30, 2024. Included within cost of revenues is a decrease of approximately $0.04 million for the three months ended September 30, 2025, and an increase of approximately $0.1 million for the three months ended September 30, 2024, related to reserves against certain raw materials and finished goods inventories.
Current wording
We recorded cost of revenues of approximately $0.2 million for the three months ended March 31, 2026, compared to approximately $22,000 for the three months ended March 31, 2025. Included within cost of revenues is a decrease of approximately $0.2 million for the three months ended March 31, 2026, and a decrease of approximately $41,000 for the three months ended March 31, 2025, related to reserves against certain raw materials and finished goods inventories.
Previous wording
Total operating expenses were $7.1 million for the three months ended September 30, 2025 compared to total operating expenses of $10.6 million for the three months ended September 30, 2024. The decrease in operating expenses was primarily due to decreased legal expense, stock-based compensation expense, personnel related expense, and expense related to development of the Co-Dx PCR platform.
Current wording
Total operating expenses for the three months ended March 31, 2026 were $9.2 million, compared to total operating expenses of $8.6 million for the three months ended March 31, 2025. The increase in operating expenses was primarily due to expenses related to clinical trials for the Co-Dx PCR platform and increased legal expense and professional services expense, partially offset by decreased stock-based compensation expense.
Previous wording
Sales and marketing expenses for the three months ended September 30, 2025 were $0.6 million compared to $1.1 million for the three months ended September 30, 2024. The decrease was primarily a result of decreased stock-based compensation expense, consulting and professional services expenses, and personnel related expenses.
Current wording
Sales and marketing expenses for the three months ended March 31, 2026 were $0.5 million, compared to $0.7 million for the three months ended March 31, 2025. The decrease was primarily a result of decreased stock-based compensation expense and decreased tradeshow and travel expense.
Previous wording
General and administrative expenses for the three months ended September 30, 2025 were $1.8 million compared to $4.3 million for the three months ended September 30, 2024. The decrease resulted primarily from lower legal expense and stock-based compensation expense.
Current wording
General and administrative expenses for the three months ended March 31, 2026 were $2.5 million, compared to $2.8 million for the three months ended March 31, 2025. The decrease resulted primarily from decreased personnel related expense and stock-based compensation expense, partially offset by increased legal and professional services expense.
Previous wording
Research and development expenses for the three months ended September 30, 2025 were $4.5 million compared to $4.9 million for the three months ended September 30, 2024. The decrease was primarily a result of decreased expenses related to development of the Co-Dx PCR platform, and personnel related expenses, partially offset by an increase in stock-based compensation expense.
Current wording
Research and development expenses for the three months ended March 31, 2026 were $5.9 million, compared to $4.9 million for the three months ended March 31, 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.
Previous wording
Other expense was $0.04 million for the three months ended September 30, 2025, compared to other income of $0.6 million for the three months ended September 30, 2024. The decrease was primarily a result of lower interest income and realized gains from investments in marketable securities.
Current wording
Other income for the three months ended March 31, 2026 was $0.1 million, compared to other income of $1.0 million for the three months ended March 31, 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.
Previous wording
At September 30, 2025, we had cash and cash equivalents of $11.4 million. Additionally, our total current assets at September 30, 2025, were $14.1 million compared to total current liabilities of $3.7 million.
Current wording
At March 31, 2026, we had cash and cash equivalents of $8.2 million. Additionally, our total current assets at March 31, 2026, were $9.8 million compared to total current liabilities of $4.3 million.
Previous wording
Net cash used in operating activities during the nine months ended September 30, 2025 was $22.9 million, compared to $20.9 million for the nine months ended September 30, 2024. The increase in cash used in operating activities was primarily due to a higher usage of cash to pay accounts payable and accrued liabilities related to higher legal expenses, along with decreases in product revenue, grant funding, net interest income, and realized gains on investments.
Current wording
Net cash used in operating activities during the three months ended March 31, 2026 was $7.8 million, compared to $8.7 million for the three months ended March 31, 2025. The decrease in cash used in operating activities was primarily due to a lower usage of cash to pay accounts payable and accrued liabilities from the end of the previous year.
Previous wording
Net cash provided by investing activities was $26.6 million for the nine months ended September 30, 2025, compared to $16.8 million during the nine months ended September 30, 2024. The increase in cash provided by investing activities is primarily due to the timing of the redemption of certain investments as they matured.
Current wording
Net cash used in investing activities was $0.1 million for the three months ended March 31, 2026, compared to cash provided by investing activities of $7.4 million during the three months ended March 31, 2025. The decrease in cash provided by investing activities is primarily due to proceeds from redemption less purchases of investments during the prior year.
Previous wording
Net cash provided by financing activities was $4.8 million for the nine months ended September 30, 2025, compared to $0 for the nine months ended September 30, 2024. The cash provided by financing activities during 2025 relates to issuances of common stock under the ATM and through a registered direct offering.
Current wording
Net cash provided by financing activities was $4.3 million for the three months ended March 31, 2026, compared to $0.4 million for the three months ended March 31, 2025. The cash provided by financing activities during 2026 relates to issuances of common stock under the ATM.
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
We recorded cost of revenues of approximately $0.1 million for the nine months ended September 30, 2025, compared to $0.7 million for the nine months ended September 30, 2024. Included within cost of revenues is a decrease of approximately $0.1 million for the nine months ended September 30, 2025, and a decrease of approximately $0.2 million for the nine months ended September 30, 2024, related to reserves against certain raw materials and finished goods inventories.