What changed in this filing

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Item 2. Management’s Discussion and Analysis

2026-08-13 compared with 2026-05-14 · 120 added, 67 removed, 147 unchanged (56% of the section changed)

55 unchanged sentences

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 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.

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.

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

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.

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

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.

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.

believe our proprietary and patented molecular diagnostics technology is paving the way for innovation in disease detection and life

51 unchanged sentences

OF OPERATIONS

Three Months Ended March 31, 2026 Compared to the Three Months ended March 31, 2025

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.

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

Three Months Ended June 30, 2026 Compared to the Three Months ended June 30, 2025

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.

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.

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.

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.

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.

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.

Income or Expense

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.

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.

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.

Six Months Ended June 30, 2026 Compared to the Six Months ended June 30, 2025

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.

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.

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

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

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.

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.

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.

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

The decrease was primarily a result of decreases in stock-based compensation expense, tradeshow and travel expense, and consulting

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.

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.

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.

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

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.

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.

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.

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.

and Capital Resources

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.

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.

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.

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.

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.

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.

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.

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.

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

32 unchanged sentences

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 2. Management’s Discussion and Analysis