Co-Diagnostics, Inc.
For the period ended Jun 30, 2026. Filed Aug 13, 2026.
View on SEC.govAbout this filing
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.
Jun 30, 2026 · Filed Aug 13, 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 2026-03-31; filed 2026-05-14.
0001493152-26-023085
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-06-30; filed 2026-08-13.
0001493152-26-037762
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 44 previous paragraphs and 61 current paragraphs.
31 unchanged; 13 reworded; 14 added; 0 removed; 0 previous and 3 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 (14)
Current report
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.
Current report
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.
Current report
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.
Current report
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.
Current report
Other Income or Expense
Current report
The Six Months Ended June 30, 2026 Compared to the Six Months ended June 30, 2025
Current report
Revenues
Current report
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.
Current report
Cost of Revenues
Current report
Expenses
Current report
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.
Current report
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.
Current report
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.
Reworded paragraphs (13)
Previous 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.
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, 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.
Previous 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.
Current wording
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.
Previous 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.
Current wording
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.
Previous 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.
Current wording
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.
Previous 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.
Current wording
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.
Previous 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.
Current wording
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.
Previous 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.
Current wording
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.
Previous wording
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.
Current wording
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.
Previous 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.
Current wording
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.
Previous 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.
Current wording
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.
Previous 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.
Current wording
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.
Previous 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.
Current wording
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.
Previous 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.
Current wording
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.
Rearranged current paragraphs (3)
Current report — wording carried from elsewhere
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.
Current report — wording carried from elsewhere
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.
Current report — wording carried from elsewhere
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.