What changed in this filing

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Item 2. Management’s Discussion and Analysis

2026-05-14 compared with 2025-11-13 · 117 added, 204 removed, 97 unchanged (77% of the section changed)

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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.

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.

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.

initial diagnostic tests are cleared for use in clinical labs only and not for point-of-care or at-home use

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.

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.

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 productive engagement with the FDA related to the regulatory submission, the Company withdrew its 510(k) application.

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.

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.

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

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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.

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.

addition, continued development has demonstrated the unique properties of our Co-Primers technology that we believe makes it ideally

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production tests to confirm that the product as designed meets the user’s needs.

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

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”.

addition to testing for infectious disease, Co-Primers technology lends itself to identifying any section of a DNA or RNA strand that

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.

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™”.

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

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.

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.

OF OPERATIONS

Three Months Ended September 30, 2025 Compared to the Three Months ended September 30, 2024

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.

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.

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.

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.

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.

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.

Income or Expense

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

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.

Nine Months Ended September 30, 2025 Compared to the Nine Months ended September 30, 2024

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.

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.

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.

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.

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.

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.

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.

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.

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

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.

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.

and Capital Resources

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.

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.

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.

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.

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.

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.

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

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to those that have provided funding in the past or debt financing.

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.

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.

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.

12 – At the Market Agreement to the condensed consolidated financial statements for additional information regarding this transaction.

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.

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

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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.

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

Forward-Looking

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.

Sheet Arrangements

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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