What changed in this filing

/stocks — the workspaceLOADING

Item 2. Management’s Discussion and Analysis

2025-05-08 compared with 2024-11-07 · 147 added, 185 removed, 75 unchanged (82% of the section changed)

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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, liquid biopsy for cancer screening, and agricultural applications.

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, patented approach to PCR test design

of primer and probe structure (“Co-Primers®”) that eliminates one of the key vexing issues of PCR amplification:

exponential growth of primer-dimer pairs (false positives and false negatives) which adversely interferes with identification of the

target DNA/RNA.

Using our proprietary test design system and proprietary 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.

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 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.

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 proprietary diagnostic

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 that is being designed to bring affordable, reliable polymerase chain reaction (“PCR”) testing to patients in

point-of-care and at-home settings.

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.

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Food and Drug Administration (FDA)

application for 510(k) clearance for the Co-Dx™ PCR Pro™ instrument, and the Co-Dx PCR COVID-19 Test for over-the-counter

We have received acknowledgement from the FDA that the 510(k) application was received and is under review.

Additionally,

in December 2023, we submitted the Co-Dx PCR platform for review by the U.S.

Food and Drug Administration (FDA) for Emergency Use Authorization

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.

believe our proprietary 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 a CE Mark as approval for use of the test in

a period of just over 30 days.

This is a real-world example of how the 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 the virus should they not be detectable using currently available tests.

addition, continued development has demonstrated the unique properties of our CoPrimer technology that we believe makes it ideally suited

for a variety of applications where specificity is key to optimal results, including multiplexing several targets, enhanced Single Nucleotide

Polymorphism (“SNP”) detection and enrichment for next generation sequencing.

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 COVID-19 test, 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.

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.

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

suited for a variety of applications where specificity is key to optimal results, including multiplexing several targets, enhanced Single

Nucleotide Polymorphism (“SNP”) detection and enrichment for next generation sequencing.

scientists use the complex mathematics of DNA/RNA PCR test design to engineer and optimize PCR tests and to automate algorithms that

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enabling us to maintain profit margins.

proprietary test design process involves identifying the optimal locations on the target genes for amplification and pair the locations

proprietary test design process involves identifying the optimal locations on the target genes for amplification and pairing the locations

with the optimized primer and probe structure to achieve outputs that meet the design input requirements identified from market research.

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

our proprietary test design system and proprietary 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 Food and Drug Administration, or

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 approved for sale in countries such as the United Kingdom, Australia 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 as self-contained lab systems (which we refer to as the “MDx Device”).

addition to testing for infectious disease, the 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 three multiplexed tests developed to test mosquitos for

the identification of diseases carried by the mosquitos to enable municipalities to concentrate their efforts in managing mosquito populations

on the specific areas known to be breeding the mosquitos that carry deadly viruses.

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

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”.

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.

OF OPERATIONS

Three Months Ended September 30, 2024 Compared to the Three Months ended September 30, 2023

the three months ended September 30, 2024, we generated revenues of $641,141, compared to revenues of $2,457,098 for the three months

ended September 30, 2023.

Grant revenue accounted for $434,265 of revenue for the three months ended September 30, 2024, compared to

$2,320,565 for the three months ended September 30, 2023.

The decrease in grant revenue was primarily due to the timing of the achievement

of certain milestones under various grants the Company was awarded.

recorded cost of revenues of $297,403 for the three months ended September 30, 2024, compared to $255,772 for the three months ended

September 30, 2023.

The increase in cost of revenues is primarily due to higher inventory obsolescence costs recorded in

the current quarter versus the prior year comparable period.

incurred total operating expenses of $10,578,675 for the three months ended September 30, 2024, compared to total operating expenses

of $11,137,277 for the three months ended September 30, 2023.

The decrease in operating expenses was primarily due to decreased stock-based

compensation expense, and expense related to clinical trials for the Co-Dx PCR platform.

These decreases were partially offset by increased

legal expenses.

sales and marketing expenses for the three months ended September 30, 2024 were $1,059,745, compared to $1,904,395 for the three months

ended September 30, 2023.

The decrease was primarily a result of decreased stock-based compensation expense, tradeshow and travel expenses,

and outside consulting and professional services expenses.

and administrative expenses were $4,287,380 for the three months ended September 30, 2024, compared to $3,147,753 for the three months

ended September 30, 2023.

The increase in general and administrative expenses was primarily due to increased legal expenses, partially

offset by decreases in stock-based compensation expense and professional services expenses.

research and development expenses were $4,880,315 for the three months ended September 30, 2024, compared to $5,788,789 for the three

months ended September 30, 2023.

The decrease was primarily a result of decreased expenses related to development of and clinical trials

for the Co-Dx PCR platform and stock-based compensation expense, partially offset by increases in consulting and professional

services expenses.

the three months ended September 30, 2024 we had total other income of $560,671, compared to total other income of $840,176 for the three

months ended September 30, 2023.

The decrease in other income is primarily due to a change in the fair value of contingent consideration

liabilities and decreased realized gains from investments in marketable securities.

realized a net loss for the three months ended September 30, 2024 of $9,696,455, compared to a net loss for the three months ended September

30, 2023 of $5,982,194.

The increase in net loss was primarily the result of a decrease in grant revenue, partially offset by a decrease

in operating expenses, as well as changes in the fair value of acquisition contingencies and income related to investments in marketable

Additionally, we recorded income tax expense of $22,189 for the three months ended September 30, 2024, compared to an income

tax benefit of $2,113,581 for the three months ended September 30, 2023.

The primary reason for the change in the provision for income

taxes is a result of the Company now being in a full valuation allowance.

Nine Months Ended September 30, 2024 Compared to the Nine Months ended September 30, 2023

the nine months ended September 30, 2024, we generated revenues of $3,765,835, compared to revenues of $3,256,861 for the nine months

ended September 30, 2023.

Grant revenue accounted for $3,145,112 of revenue for the nine months ended September 30, 2024, compared to

$2,320,565 for the nine months ended September 30, 2023.

The decrease in product revenue of $315,573 was primarily due to lower sales

of our Logix Smart COVID-19 test throughout the world.

The increase in grant revenue was primarily due to the achievement of certain

milestones under various grants the Company was awarded.

recorded cost of revenues of $744,056 for the nine months ended September 30, 2024, compared to $1,217,108 for the nine months ended

September 30, 2023.

The decrease in cost of revenues of $473,052 is primarily due to lower inventory obsolescence reserves being recorded

in the current year versus the prior year comparable period.

incurred total operating expenses of $31,196,065 for the nine months ended September 30, 2024, compared to total operating expenses of

$32,920,793 for the nine months ended September 30, 2023.

The decrease in operating expenses was primarily due to decreased stock-based

compensation expense, bad debt expense and expense related to development of and clinical trials for the Co-Dx PCR platform.

These decreases

were partially offset by increased personnel related expenses and legal expenses.

sales and marketing expenses for the nine months ended September 30, 2024 were $3,664,670, compared to $5,343,692 for the nine months

ended September 30, 2023.

The decrease was primarily a result of decreased stock-based compensation expense, tradeshow and travel expenses,

website development expenses and personnel related expenses.

and administrative expenses were $10,338,568 for the nine months ended September 30, 2024, compared to $9,875,613 for the nine months

ended September 30, 2023.

The increase in general and administrative expenses was primarily due to increased legal expenses, partially

offset by decreases in stock-based compensation expense, bad debt expense, professional services expense and insurance expense.

research and development expenses were $16,172,684 for the nine months ended September 30, 2024, compared to $16,783,892 for the nine

months ended September 30, 2023.

The decrease was primarily a result of decreased expenses related to development of and clinical trials

for the Co-Dx PCR platform and stock-based compensation expense, partially offset by increases in personnel, consulting and professional

services expenses.

the nine months ended September 30, 2024, we had total other income of $1,632,013, compared to total other income of $3,612,918 for the

nine months ended September 30, 2023.

The decrease in other income is primarily due to a change in the fair value of contingent consideration

liabilities, an increased loss related to the Company’s joint venture investment, and decreased realized gains from investments

in marketable securities, partially offset by increased interest income.

realized a net loss for the nine months ended September 30, 2024 of $26,607,816, compared to a net loss for the nine months ended September

30, 2023 of $20,656,410.

The larger net loss was primarily the result of changes in the fair value of acquisition contingencies and income

taxes, partially offset by an increase in grant revenue combined with a decrease in operating expenses.

We recorded income tax expense

of $65,543 for the nine months ended September 30, 2024, compared to an income tax benefit of $6,611,712 for the nine months ended September

The primary reason for the change in the provision for income taxes is a result of the Company now recording a full valuation

Three Months Ended March 31, 2025 Compared to the Three Months ended March 31, 2024

the three months ended March 31, 2025, we generated revenues of $0.1 million, compared to revenues of $0.5 million for the three months

ended March 31, 2024.

The decrease in revenue was due to lower product and grant revenues recognized in the current period.

recorded cost of revenues of approximately $22,000 for the three months ended March 31, 2025, compared to $0.2 million for the three

months ended March 31, 2024.

Included within cost of revenues is a decrease of approximately $41,000 for the three months ended March

31, 2025, and a decrease of approximately $0.3 million for the three months ended March 31, 2024, related to reserves against certain

raw materials and finished goods inventories.

operating expenses were $8.6 million for the three months ended March 31, 2025 compared to total operating expenses of $10.5 million

for the three months ended March 31, 2024.

The decrease in operating expenses was primarily due to decreased stock-based compensation

expense, personnel related expenses, tradeshow and travel expense, and expense related to development of the Co-Dx PCR platform.

decreases were partially offset by increased legal expenses.

and marketing expenses for the three months ended March 31, 2025 were $0.7 million compared to $1.6 million for the three months ended

March 31, 2024.

The decrease of $0.9 million 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 three months ended March 31, 2025 were $2.8 million compared to $2.9 million for the three months

ended March 31, 2024.

Decreases in stock-based compensation expense and consulting and professional services expense were partially offset

by increased legal expenses.

and development expenses for the three months ended March 31, 2025 were $4.9 million compared to $5.7 million for the three months ended

March 31, 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 $1.0 million for the three months ended March 31, 2025, compared to other income of $1.0 million for the three months ended

March 31, 2024.

Decreases in interest income and realized gains from investments in marketable securities were offset by increases in

the change in the fair value of contingent consideration liabilities.

realized a net loss for the three months ended March 31, 2025 of $7.5 million, compared to $9.3 million for the three months ended

March 31, 2024.

The smaller net loss was primarily the result of decreases in sales and marketing expenses and research and development expenses.

Additionally, we

recorded income tax expense of $12 thousand for the three months ended March 31, 2025, compared to $22 thousand for the three months

ended March 31, 2024.

and Capital Resources

September 30, 2024, we had cash and cash equivalents of $10,797,630.

Additionally, we had $26,864,571 of marketable investment securities

that could readily be converted into cash if needed.

Additionally, our total current assets of September 30, 2024, were $40,103,158 compared

to total current liabilities of $5,797,977.

cash used in operating activities during the nine months ended September 30, 2024 was $20,924,039, compared to $17,303,239 for the

nine months ended September 30, 2023.

The increase in cash used in operating activities was primarily due to a decrease in cash

collections from customers and granting agencies and the impact of non-cash items.

cash provided by investing activities during the nine months ended September 30, 2024 was $16,804,791, primarily from maturities of marketable

investment securities, compared to $5,773,590 during the nine months ended September 30, 2023.

cash used in financing activities was $0 for the nine months ended September 30, 2024, compared to $1,204,256 for the same period in

the prior year.

This is due to the repurchase of outstanding common shares during the prior period, compared to no such repurchases in

the current period.

March 31, 2025, we had cash and cash equivalents of $1.9 million and marketable investment securities of $19.6 million.

We consider our

marketable investment securities an important part of our liquidity and focus such investments in securities that can readily be converted

into cash if needed.

Additionally, our total current assets at March 31, 2025, were $23.8 million compared to total current liabilities

of $5.4 million.

cash used in operating activities during the three months ended March 31, 2025 was $8.7 million, compared to $8.5 million for the three

months ended March 31, 2024.

The increase in cash used in operating activities was primarily due to decreases in revenue, grant funding,

net interest income, and realized gains on investments.

cash provided by investing activities was $7.4 million for the three months ended March 31, 2025, compared to $16.7 million during the

three months ended March 31, 2024.

The decrease 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 $0.4 million for the three months ended March 31, 2025, compared to $0 for the three months

ended March 31, 2024.

The cash provided by financing activities during 2025 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

of inventories and the development of our Co-Dx PCR Platform, and to pay our operating expenses.

We have increased our work force most

significantly in research and development in order to continue development of the Co-Dx PCR platform and additional tests that will enable

continued use of our distributor network to sell additional products throughout the world.

believe that our existing capital resources and the cash generated from future sales will be sufficient to meet our projected operating

requirements for the next 12 months.

However, our available capital resources may be consumed more

rapidly than currently expected and we may need or want to raise additional financing for strategic opportunities.

It is anticipated

that the Company will continue to generate operating losses and use cash in operations in the near term.

needed, we expect additional investment capital to come from additional issuances of our common stock or other equity-based securities

with existing and new investors similar to those that have provided funding in the past.

On March 16, 2023, the Company entered into

an Equity Distribution Agreement with Piper Sandler & Co.

(“Piper”), pursuant to which we may sell from time to time,

shares of our common stock, having an aggregate offering price of up to $50.0 million through Piper, as agent.

The Company is subject

to General Instruction I.B.6 of Form S-3 which limits the amounts that we may sell under the Equity Distribution Agreement over a 12-month

period to an amount equal to or less than one-third of our public float.

On October 18, 2024, the Company filed a Prospectus Supplement

with the SEC reducing the amount available for sale under the Equity Distribution Agreement to $17.1 million.

No shares have been sold

under the distribution agreement as of September 30, 2024.

We may not be able to secure financing in a timely manner or on favorable

terms, if at all.

Our available

capital resources may be consumed more rapidly than currently expected and we may need or want to raise additional financing for

strategic opportunities.

It is anticipated that the Company will continue to generate operating losses and use cash in

operations in the near term.

If needed, we expect additional investment capital to come from

additional issuances of our common stock or other equity based securities with existing and new investors similar to those that have

provided funding in the past or debt financing.

We have entered into an Amended and Restated Equity Distribution Agreement

(the “ATM Agreement”) with Piper Sandler & Co.

(“Piper Sandler”) and Clear Street, LLC (“Clear

Street”), pursuant to which we may offer and sell shares of our common stock having an aggregate offering price of up to

$17,111,650 from time to time through Piper Sandler and Clear Street acting as our agents, under our prospectus supplement dated

October 18, 2024.

As of March 31, 2025, we have sold 833,806 shares of common stock under the ATM Agreement resulting in net

proceeds to the Company of $0.6 million.

we are seeking to obtain additional equity and/or debt financing, such funding is not assured and may not be available to us on

favorable or acceptable terms and may involve significant restrictive covenants.

Any additional equity financing, if available to us

at all, will most likely be dilutive to our current stockholders.

If we are not able to obtain additional debt or equity financing on a

timely basis, the impact on us will be material and adverse.

These uncertainties create substantial doubt about our ability to

continue as a going concern.

The condensed consolidated financial statements do not include any adjustments that might result from

the outcome of these uncertainties .

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