What changed in this filing

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Item 1A. Risk Factors

2025-03-27 compared with 2024-03-14 · 164 added, 83 removed, 605 unchanged (29% of the section changed)

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We began operations in April 2013.

Our accumulated retained earnings were $4.6 million and $39.9 million

as of December 31, 2023 and 2022, respectively.

During the calendar years ending December 31, 2023 and 2022 we experienced a decline

in demand for our Logix Smart COVID-19 and other COVID-19 tests and operated at a net loss during the periods.

We do not have any way

of predicting when or if we will achieve profitability again.

Potential investors should be aware of the difficulties normally encountered

by a new enterprise, many of which are beyond our control, including substantial risks and expenses in the course of developing new diagnostic

tests, establishing or entering new markets, organizing operations and marketing procedures.

The likelihood of our success must be considered

in light of these risks, expenses, complications and delays, and the competitive environment in which we operate.

There is, therefore,

nothing at this time upon which to base an assumption that our business plan will prove successful, and we may not be able to generate

significant revenue, raise additional capital or operate profitably.

We will continue to encounter risks and difficulties frequently

experienced by early commercial stage companies, including scaling up our infrastructure and headcount, and may encounter unforeseen

expenses, difficulties or delays in connection with our growth.

In addition, as a result of the start-up nature of our business, we expect

to continue to sustain substantial operating expenses and may not be able to continue generating sufficient revenues to cover expenditures.

Any investment in our company is therefore highly speculative and could result in the loss of any investment.

Our accumulated retained earnings (deficit) were ($33.0 million)

and $4.6 million as of December 31, 2024 and 2023, respectively.

We do not have any way of predicting when or if we will achieve profitability

in the future.

Potential investors should be aware of the difficulties normally encountered by early commercial stage companies, many

of which are beyond our control, including substantial risks and expenses in the course of developing new diagnostic tests, obtaining

regulatory approval of clearance to commercialize such tests, establishing or entering new markets, organizing operations and marketing

The likelihood of our success must be considered in light of these risks, expenses, complications and delays, and the competitive

environment in which we operate.

There is, therefore, nothing at this time upon which to base an assumption that our business plan will

prove successful, and we may not be able to generate significant revenue, raise additional capital or operate profitably.

We will continue

to encounter risks and difficulties frequently experienced by early commercial stage companies, including scaling up our infrastructure

and headcount, and may encounter unforeseen expenses, difficulties or delays in connection with our growth.

In addition, as a result

of the start-up nature of our business, we expect to continue to sustain substantial operating expenses and may not be able to continue

generating sufficient revenues to cover expenditures.

Any investment in our company is therefore highly speculative and could result

in the loss of any investment.

future success is dependent on our development of our Co-Dx PCR platform and securing regulatory approval for the platform including

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harm our reputation, disrupt our operations, or result in remedial and other costs, fines or lawsuits.

Related to Our Capital Resources and Impairments

will require additional financing and our failure to obtain additional funding would force us to delay, reduce or eliminate our product

development programs or commercialization efforts.

currently have limited committed sources of capital, and we have limited liquidity.

Our cash, cash equivalents, and marketable investment

securities as of December 31, 2024 were $29.7 million.

We have entered into an Equity Distribution Agreement (the “ATM Agreement”)

with Piper Sandler & Co.

(“Piper Sandler”), 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 acting as our agent, under our prospectus supplement

dated October 18, 2024.

As of December 31, 2024, we have sold 314,707 shares of common stock under the ATM Agreement resulting in net

proceeds to the Company of $0.2 million.

We will require substantial future capital in order to continue operating our business, conduct

the research and development and regulatory clearance and approval activities necessary to bring our products to market, and to establish

effective marketing and sales capabilities.

adequate funds to develop our product candidates and fund operations are not available on a timely basis, we may terminate or delay the

development of one or more of our product candidates, or delay activities necessary to commercialize our product candidates.

funding may not be available to us on acceptable terms, or at all.

Any additional equity financing, if available, may not be available

on favorable terms and will most likely be dilutive to our current stockholders, and debt financing, if available, may involve more restrictive

Our ability to access capital when needed is not assured and, if not achieved on a timely basis, will materially harm our

business, financial condition and results of operations or could cause us to cease operations.

independent registered public accounting firm has included an explanatory paragraph relating to our ability to continue as a going concern

in its report on our audited financial statements.

We may be unable to continue to operate without the threat of liquidation for the

foreseeable future.

report from our independent registered public accounting firm for the year ended December 31, 2024 includes an explanatory paragraph

stating that our recurring losses from operations raises substantial doubt about our ability to continue as a going concern.

unable to obtain sufficient additional funding, our business, prospects, financial condition and results of operations will be materially

and adversely affected, and we may be unable to continue as a going concern.

If we are unable to continue as a going concern, we may

have to liquidate our assets and may receive less than the value at which those assets are carried on our consolidated financial statements,

and it is likely that investors will lose all or a part of their investment.

Future reports from our independent registered public accounting

firm may also contain statements expressing doubt about our ability to continue as a going concern.

If we seek additional financing to

fund our business activities in the future and there remains doubt about our ability to continue as a going concern, investors or other

financing sources may be unwilling to provide additional funding on commercially reasonable terms or at all.

additional capital by issuing securities or through debt financings or licensing arrangements will likely cause dilution to existing

stockholders, restrict our operations or require us to relinquish proprietary rights.

the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interest will likely

be diluted, and the terms may include liquidation or other preferences that adversely affect your rights as a stockholder.

Debt financing,

if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions such as incurring

additional debt, making capital expenditures or declaring dividends.

If we raise additional funds through collaboration and licensing

arrangements with third parties, we may have to relinquish valuable rights to our technologies or products or grant licenses on terms

that are not favorable to us.

Any of these events could adversely affect our ability to achieve our product development and commercialization

goals and have a material adverse effect on our business, financial condition and results of operations.

Related to Regulatory Approval of Our Products and Other Government Regulations

received Emergency Use Authorization or EUA for our COVID-19 test in US.

We applied for Emergency Use Authorization for our PCR platform

which included the PCR Pro instrument and the COVID 19 diagnostic test cup and mobile app.

The FDA may not timely grant the EUA we filed

for the PCR platform or may require that we submit a 510K application rather than EUA.

received Emergency Use Authorization or EUA for our Logix Smart COVID-19 test in the US.

For our existing EUA and any new EUA, the FDA

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through a 510(k) clearance.

applied for Emergency Use Authorization for our PCR platform which included the PCR Pro instrument and the COVID 19 diagnostic test cup

and mobile app.

The FDA may not timely grant the EUA we filed for the PCR platform or may require that we submit a 510K application rather

than EUA which could extend the time for authorization to begin commercializing the PCR platform.

There can be no assurances that the

FDA will authorize any request for additional and/or amended EUAs and if we do not receive the authorization, our business, financial

condition, results of operations and future growth prospects could be materially and adversely affected.

either of our existing EUAs is revoked or our existing EUA applications are denied prior to us having received regulatory approval to

commercialize our COVID-19 test through a traditional pathway, we may not be able to obtain required clearances or approvals in a timely

manner, or at all, and one or more of our competitors may obtain the necessary clearances or approvals for their products before we do.

In addition, we would be required to cease our commercialization efforts, which would substantially and negatively impact our business.

As a result, any such revocation could adversely impact our business, financial condition and results of operations.

long-term success depends substantially on our ability to obtain regulatory clearance or approval and thereafter commercialize our product

our existing EUAs are revoked prior to us having received regulatory approval to commercialize our COVID-19 test through a traditional

pathway, we may not be able to obtain required clearances or approvals in a timely manner, or at all, and one or more of our competitors

may obtain the necessary clearances or approvals for their products before we do.

In addition, we would be required to cease our commercialization

efforts, which would substantially and negatively impact our business.

As a result, any such revocation could adversely impact our business,

financial condition and results of operations.

June 2024, we filed a 510(k) application with the FDA for our PCR platform which we withdrew in February 2025 as a result of discussions

with the FDA.

Our long-term success depends substantially on our ability to obtain regulatory clearance or approval and thereafter commercialize

our product candidates;

we cannot be certain that we will be able to do so in a timely manner or at all.

process of obtaining regulatory clearances or approvals to market a medical diagnostic from the FDA or similar regulatory authorities

outside of the United States can be costly and time consuming, and there can be no assurance that such clearances or approvals will be

granted on a timely basis, or at all.

The FDA’s 510(k) clearance process generally takes one to six months from the date of submission,

depending on whether a special or traditional 510(k) premarket notification has been submitted, but can take significantly longer.

application for premarket approval, or PMA, must be submitted to the FDA if the device cannot be cleared through the 510(k) clearance

process or is not exempt from premarket review by the FDA.

The PMA process almost always requires one or more clinical trials and can

take two to three years from the date of filing, or even longer.

June 2024, we filed a 510(k) application with the FDA for our PCR platform which we withdrew in February 2025 as a result of discussions

with the FDA.

The process of obtaining regulatory clearances or approvals to market a medical diagnostic from the FDA or similar regulatory

authorities outside of the United States can be costly and time consuming, and there can be no assurance that such clearances or approvals

will be granted on a timely basis, or at all.

The FDA’s 510(k) clearance process generally takes one to six months from the date

of submission, depending on whether a special or traditional 510(k) premarket notification has been submitted, but can take significantly

An application for premarket approval, or PMA, must be submitted to the FDA if the device cannot be cleared through the 510(k)

clearance process or is not exempt from premarket review by the FDA.

The PMA process almost always requires one or more clinical trials

and can take two to three years from the date of filing, or even longer.

we are required to obtain approval of any of our products through the PMA process, the costs associated with such a process will be significant,

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For example, the Virginia Consumer Data Protection

Act became effective on January 1, 2023, and Colorado and Utah enacted similar laws that became effective in 2023, increasing

the complexity of compliance and the risk of failures to comply.

These privacy laws may impact our business activities and exemplify

the vulnerability of our business to the evolving regulatory environment related to personal data.

Act became effective on January 1, 2023, and Colorado and Utah enacted similar laws that became effective in 2023, increasing the complexity

of compliance and the risk of failures to comply.

These privacy laws may impact our business activities and exemplify the vulnerability

of our business to the evolving regulatory environment related to personal data.

addition to our operations in the United States, which may be subject to health care and other laws relating to the privacy and security

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Related to Litigation from Operating Our Business

may become subject to potential product liability claims, and we may be required to pay damages that exceed our insurance coverage.

business exposes us to potential product liability claims that are inherent in the design, testing, manufacture, sale and distribution

of our currently marketed products and each of our product candidates that we are seeking to introduce to the market.

Someone may allege

that our diagnostic tests identified inaccurate or incomplete information or otherwise failed to perform as designed.

We may also be

subject to liability for errors in, a misunderstanding of or inappropriate reliance upon, the information we provide in the ordinary

course of our business activities.

In addition, we may be subject to product liability claims resulting from misuse or off-label use

of our products and product candidates.

Any product liability claim brought against us, with or without merit, could result in an increase

of our product liability insurance rates or in our inability to secure coverage in the future on commercially reasonable terms, if at

In addition, if our product liability insurance proves to be inadequate to pay a damage award, we may have to pay the excess of

this award out of our cash reserves, which could significantly harm our financial condition.

A product liability claim, even one without

merit, could harm our reputation in the industry, lead to significant legal fees, and result in the diversion of management’s attention

from managing our business.

or future litigation, government investigations and other legal proceedings may harm our business.

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we may be or become subject to include patent and other intellectual property claims, product liability claims, employee claims, tort

or contract claims, federal or state regulatory investigations, securities class actions, and other legal proceedings, investigations

For example, we are currently parties to two securities class action claims and three derivative actions.

Litigation and other

legal proceedings are inherently unpredictable and can result in excessive or unanticipated verdicts and/or injunctive relief that affect

how we operate our business.

We could incur judgments or enter into settlements of claims for monetary damages or for agreements to change

the way we operate our business, or both.

There may be an increase in the scope of these matters or there may be additional lawsuits,

claims, proceedings or investigations in the future, which could harm our business, financial condition and results of operations.

publicity about regulatory or legal action against us could damage our reputation and brand image, undermine our customers’ confidence

and reduce long-term demand for any of our products or other offerings, even if the regulatory or legal action is unfounded or not material

to our operations.

or contract claims, federal or state regulatory investigations, securities class actions and shareholder derivative actions, and other

legal proceedings, investigations or claims.

For example, we are currently parties to two securities class action claims and three derivative

Litigation and other legal proceedings are inherently unpredictable and can result in excessive or unanticipated verdicts and/or

injunctive relief that affect how we operate our business.

We obtain business insurance, including executive and corporate securities

liability insurance to insure against such claims should they arise.

The insurance we have in place for such events may prove to be inadequate

to pay a damage award, we may have to pay the excess of this award out of our cash reserves, which could significantly harm our financial

A legal proceeding claim, even one without merit, could harm our reputation in the industry, lead to significant legal fees,

and result in the diversion of management’s attention from managing our business.

We could incur judgments or enter into settlements

of claims for monetary damages or for agreements to change the way we operate our business, or both.

There may be an increase in the

scope of these matters or there may be additional lawsuits, claims, proceedings or investigations in the future, which could harm our

business, financial condition and results of operations.

Adverse publicity about regulatory or legal action against us could damage our

reputation and brand image, undermine our customers’ confidence and reduce long-term demand for any of our products or other offerings,

even if the regulatory or legal action is unfounded or not material to our operations.

For additional information, see “Item 3.

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to meet external expectations or management guidance;

in our capital structure or dividend policy, including as a result of future issuances of securities and sales of large blocks of

common stock by our shareholders;

in our capital structure or dividend policy, including future issuances of securities and sales of large blocks of common stock by

our shareholders;

announcements

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who may call special meetings of shareholders

for a staggered board of directors

provisions could have the effect of delaying or preventing a change of control, whether or not it is desired by, or beneficial to, our

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stock on The NASDAQ Capital Market, which would likely have a material adverse effect on the trading price of our common stock.

incur substantial costs as a result of being a public company and are subject to the continued listing requirements of the NASDAQ Capital

Market, our management expects to devote substantial time to public company compliance programs.

a public company, we incur significant legal, insurance, accounting and other expenses, including costs associated with public company

We intend to invest resources to comply with evolving laws, regulations and standards, and this investment will result in

increased general and administrative expenses and may divert management’s time and attention from product development and commercialization

If our efforts to comply with new laws, regulations and standards differ from the activities intended by regulatory or governing

bodies due to ambiguities related to practice, regulatory authorities may initiate legal proceedings against us, and our business may

These laws and regulations could make it more difficult and costlier for us to obtain director and officer liability insurance

for our directors and officers, and we may be required to accept reduced coverage or incur substantially higher costs to obtain coverage.

These factors could also make it more difficult for us to attract and retain qualified executive officers and qualified members of our

board of directors, particularly to serve on our audit and compensation committees.

In addition, if we are unable to continue to meet

the legal, regulatory and other requirements related to being a public company, we may not be able to maintain the listing of our common

stock on The NASDAQ Capital Market, which would likely have a material adverse effect on the trading price of our common stock.

our common stock is quoted on the NASDAQ Capital Market under the symbol “CODX”.

We must satisfy certain minimum listing

maintenance requirements to maintain the NASDAQ Capital Market quotation, including certain governance requirements and a series of financial

tests relating to stockholders’ equity or net income or market value, public float, number of market makers and stockholders, market

capitalization, and maintaining a minimum bid price of $1.00 per share.

January 10, 2025, we received a notice from the Listing Qualifications Department of The NASDAQ Stock Market (the “Staff”)

stating that the bid price of our common stock for the previous 30 consecutive trading days had closed below the minimum $1.00 per share

required for continued listing on The NASDAQ Capital Market under NASDAQ Listing Rule 5550(a)(2).

The Company has a period of 180 calendar

days, or until July 9, 2025 (the “Compliance Date”) to regain compliance with Listing Rule 5550(a)(2).

To regain compliance,

the bid price of the Company’s common stock must close at $1 or more for a minimum of ten consecutive business days before the

Compliance Date.

the Company does not regain compliance with Rule 5550(a)(2) by July 9, 2025, the Company may be eligible for additional time.

the Company will be required to meet the continued listing requirement for market value of publicly held shares and all other initial

listing standards for The Nasdaq Capital Market, with the exception of the bid price requirement, and will need to provide written notice

of its intention to cure the deficiency during the second compliance period, by effecting a reverse stock split, if necessary.

Company meets these requirements, the Staff will inform the Company that it has been granted an additional 180 calendar days.

if it appears to the Staff that the Company will not be able to cure the deficiency, or if the Company is otherwise not eligible, the

Staff will provide notice that its securities will be subject to delisting.

We intend to actively monitor our bid price and will consider

available options to resolve the deficiency and regain compliance with the Nasdaq Listing Rules.

Nasdaq delists our common stock from trading on its exchange and we are not able to list our securities on another national securities

exchange, we expect our securities could be quoted on an over-the-counter market.

If this were to occur, we could face significant material

adverse consequences, including:

limited availability of market quotations for our securities;

liquidity for our securities;

determination that our common stock is a “penny stock” which will require brokers trading in our common stock to adhere

to more stringent rules and possibly result in a reduced level of trading activity in the secondary trading market for our securities;

limited amount of news and analyst coverage;

decreased ability to issue additional securities or obtain additional financing in the future.

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-K

Item 1A. Risk Factors