CODX 10-K & 10-Q changes, risk factors and insider trading
Co-Diagnostics, Inc. · Nasdaq · Surgical & Medical Instruments & Apparatus · CIK 1692415 · All filings on SEC.gov
At a glance
What changed in the latest 10-K
Risk Factors
New heading “We are subject to numerous and evolving data protection, privacy and information security laws in the jurisdictions in which we operate. These laws govern the collection, use, disclosure, transfer and safeguarding of personal information, including health-related information. The regulatory framework for data privacy and data security is rapidly evolving, and interpretation and enforcement practices remain uncertain. New or amended laws, or differing interpretations of existing laws, may require us to incur additional compliance costs, modify our business practices or restrict certain operations.”
Removed heading “We are subject to stringent and changing data protection laws, privacy policies and data protection obligations, which continue to evolve and change over time. The actual or perceived failure by us or our third-party service providers or vendors to comply with such obligations could harm our reputation, subject us to significant fines and liability, or otherwise adversely affect our business.”
Largest changes
“Laws, regulations and standards in many other jurisdictions also apply broadly to the Processing of personal information, which impose significant compliance obligations. …”see in full comparison
“In addition to the possibility of fines, lawsuits, regulatory investigations, public censure, other claims and penalties, and significant costs for remediation and damage to our reputation, we could be materially and adversely affected if legislation or regulations are expanded to require changes in our data processing practices and policies or if governing jurisdictions interpret or implement their legislation or regulations in ways that negatively impact our business. …”see in full comparison
“We currently sell some of our products in the EEA, and the GDPR increases our responsibility and liability in relation to personal data that we process where such processing is subject to the GDPR, and we are required to have in place additional mechanisms and safeguards to ensure compliance with the GDPR, including as implemented by individual countries. …”see in full comparison
“While we maintain general liability insurance coverage, cyber insurance coverage and other insurance, we cannot assure that such coverage will be adequate or otherwise protect us from or adequately mitigate liabilities or damages with respect to claims, costs, expenses, litigation, fines, penalties, business loss, data loss, regulatory actions or material adverse effects arising out of our privacy and security practices, Processing or security breaches we may experience, or that such coverage will continue to be available on acceptable terms or at all. …”see in full comparison
“Many state laws govern the privacy and security of personal information and data in specified circumstances, many of which differ from each other in significant ways, are often not pre-empted by HIPAA, and may have a more prohibitive effect than HIPAA, thus complicating compliance efforts. For example, the California Consumer Privacy Act of 2018 (the “CCPA”), which went into effect in January 2020 and provides new data privacy rights for consumers and new operational requirements for companies, which may increase our compliance costs and potential liability. …”see in full comparison
“In addition to our operations in the United States, which may be subject to health care and other laws relating to the privacy and security of health information and other personal information, we may be or become subject to European data privacy laws, regulations and guidelines. The General Data Protection Regulation, (EU) 2016/679 (“GDPR”) became effective on May 25, 2018, and deals with the collection, use, storage, disclosure, transfer, or other processing of personal data, including personal health data, regarding individuals in the EEA. …”see in full comparison
Full comparison: every changed paragraph (40)
We
have a limited operating history. We began operations in April 2013. Our accumulated retaineddeficit earningswas (deficit) were ($33.0 million)
and $4.6$80.4 million and $33.5 million
as of December 31, 20242025 and 2023,2024, 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
regulatory approval of clearance to commercialize such tests, establishing or entering new markets, organizing operations and marketing procedures.
procedures. The likelihood of our success must be considered in light of these risks, expenses, complications and delays, and the competitive environment
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.
We
currently have limited committed sources of capital, and we have limited liquidity. Our cash,cash and cash equivalents, and marketable investment
securitiesequivalents as of December 31, 2024
2025 were $29.7$11.9 million. WeThe haveCompany enteredpreviously intomaintained an Amended and Restated Equity Distribution Agreement (the “Prior ATM
Agreement”)
with Piper Sandler & Co. (“Piper Sandler”) and Clear Street, LLC (“Clear Street”), pursuant
to which wethe mayCompany could offer and sell shares of ourits 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 oursales agent,agents, under oura prospectus supplement
dated October 18, 2024. As of December
31, 2024,2025, wethe haveCompany had sold 314,707151,675 shares of common stock under the Prior ATM AgreementAgreement, resulting in net
proceeds to the Company
of $0.2approximately million.$1,660,805. WeThe Prior ATM Agreement was subsequently terminated, and no further sales will requirebe substantialmade futureunder capitalthat 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.program.
On October 20, 2025, the Company entered into a new Equity Distribution Agreement (the “Agreement”) with Maxim Group LLC (“Maxim”) to establish an at-the-market (“ATM”) equity offering program. Pursuant to the Agreement, the Company may offer and sell shares of its common stock, par value $0.001 per share, having an aggregate offering price of up to $10.0 million, from time to time through Maxim, acting as the Company’s sales agent. Under the terms of the Agreement, the Company will pay Maxim a commission equal to 3.0% of the gross proceeds from the sale of any shares and will reimburse Maxim for certain legal and other out-of-pocket expenses incurred in connection with its services. Sales of common stock, if any, may be made in transactions deemed to be “at-the-market” offerings as defined in Rule 415 under the Securities Act of 1933, as amended, including sales made by means of ordinary brokers’ transactions on The Nasdaq Capital Market or otherwise at market prices prevailing at the time of sale or at prices negotiated with Maxim. The Company is not obligated to sell any shares under the Agreement and may terminate the offering at any time in accordance with its terms. The shares will be issued pursuant to the Company’s shelf Registration Statement on Form S-3 (File No. 333-270628), which was declared effective by the Securities and Exchange Commission on April 6, 2023. 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. As of December 31, 2025, the Company had sold 31,667 shares of common stock under the Agreement, resulting in net proceeds to the Company of approximately $258,563.
The
FDA has the authority to grant an EUA to allow unapproved medical products to be used in an emergency to diagnose, treat or prevent serious
or life-threatening diseases or conditions when there are no adequate, approved and available alternatives. During the COVID 19 pandemic
the FDA determined that circumstances existexisted to justify the authorization of emergency use of medical devices, including alternative
products products
used as medical devices, during the COVID-19 pandemic. On April 3, 2020, we received an EUA from the FDA for our Logix Smart
Coronavirus Coronavirus
Disease 2019 (COVID-19) kit for use on individuals who are suspected of COVID-19 by their healthcare provider. We
cannot predict how long the EUA for our COVID-19 test will remain in place. The FDA may revoke an EUA where it is determined that
the underlying health emergency no longer exists or warrants such authorization. The FDA may take such a position at any time and without
notice and, therefore, we cannot predict how long our EUAs will remain in place. The FDA may also revoke an EUA when the circumstances
justifying its issuance no longer exist, such as when an alternative is authorized for marketing through the standard procedures, including
through a 510(k) clearance.
InOur
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.
InThe
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
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. An
application for premarket approval, or PMA, must be submitted to the FDA if the device cannot be cleared through the 510(k) clearance
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 subject to numerous and evolving data protection, privacy and information security laws in the jurisdictions in which we operate. These laws govern the collection, use, disclosure, transfer and safeguarding of personal information, including health-related information. The regulatory framework for data privacy and data security is rapidly evolving, and interpretation and enforcement practices remain uncertain. New or amended laws, or differing interpretations of existing laws, may require us to incur additional compliance costs, modify our business practices or restrict certain operations.
In the United States, we may be subject to the Health Insurance Portability and Accountability Act of 1996, as amended by HITECH (collectively, “HIPAA”), to the extent we act as a covered entity or business associate. HIPAA establishes privacy and security standards for the protection of protected health information and authorizes significant civil and criminal penalties for noncompliance. In addition, all 50 U.S. states and the District of Columbia have enacted breach notification laws, and many states have adopted broader privacy and data security requirements that may impose additional obligations and liabilities.
We may also be subject to international data protection laws, including those in the European Union and other jurisdictions, which impose stringent requirements on the processing and transfer of personal information and authorize significant fines for violations.
A failure or perceived failure by us, our employees, or our third-party service providers to comply with applicable data protection laws or to adequately safeguard personal information could result in regulatory investigations or enforcement actions, fines, litigation, contractual liability, mandatory notifications, reputational harm and loss of customer confidence. We rely on third-party vendors to process and store certain data, and any security breach or noncompliance by such vendors could adversely affect us, even if we are not directly at fault.
We maintain general liability and cyber insurance coverage; however, such coverage may not be adequate to cover all liabilities or may not be available on acceptable terms in the future. Any significant data security incident, regulatory proceeding or enforcement action could materially and adversely affect our business, financial condition and results of operations.
We
are subject to stringent and changing data protection laws, privacy policies and data protection obligations, which continue to evolve
and change over time. The actual or perceived failure by us or our third-party service providers or vendors to comply with such obligations
could harm our reputation, subject us to significant fines and liability, or otherwise adversely affect our business.
We
are subject to numerous data protection laws that govern the processing of individually identifiable information and health information
and other sensitive and personal information in the jurisdictions in which we operate. In many instances, these data protection laws,
regulations and standards apply not only to disclosures to third parties, but also to transfers of information between or among us and
other parties with which we have commercial relationships. The regulatory framework for data privacy, data security and data transfers
worldwide is rapidly evolving and, as a result, interpretation and implementation standards and enforcement practices are likely to remain
uncertain for the foreseeable future. These data protection laws may be interpreted and applied differently over time and from jurisdiction
to jurisdiction, and it is possible that they will be interpreted and applied in ways that will materially and adversely affect our business,
financial condition and results of operations. Failure to comply with any of these data protection laws could result in enforcement actions
against us, including fines, imprisonment of company officials and public censure, claims for damages by affected individuals, damage
to our reputation and loss of goodwill, any of which could have a material adverse effect on our business.
There
are numerous U.S. federal and state laws and regulations related to the privacy and security of personal information. These laws and
regulations include the Health Insurance Portability and Accountability Act of 1996, or HIPAA, as amended by the Health Information Technology
for Economic and Clinical Health Act of 2009, or HITECH, and their implementing regulations, or collectively referred to as the HIPAA
Rules, which establish a set of national privacy and security standards to safeguard Protected Health Information, or PHI, by health
plans, healthcare clearinghouses and certain healthcare providers, referred to as covered entities, and the business associates and their
subcontractors with whom such covered entities contract for services that involve the creation, receipt, maintenance or transmission
of PHI for or on behalf of a covered entity or another business associate. HIPAA requires covered entities and business associates to,
among other things, develop and maintain policies and procedures with respect to PHI that is used or disclosed, including the adoption
of administrative, physical and technical safeguards to protect such information and ensure the confidentiality, integrity and availability
of electronic PHI. As this applies to our business, we are required to maintain security standards for any PHI that we create, receive,
maintain or transmit. For example, we plan to offer cloud-based portal software to help our customers more efficiently use our products.
The software will maintain security safeguards that are designed to be consistent with the HIPAA Rules, but we cannot guarantee that
these safeguards will not fail or that they will not be deemed inadequate in the future. In addition, we could be subject to periodic
audits for compliance with the HIPAA Privacy and Security Standards by the U.S. HHS, and our customers. The U.S. HHS Office for Civil
Rights may impose significant penalties on entities subject to HIPAA for a failure to comply with a requirement of the HIPAA Rules. If
we are unable to properly protect the privacy and security of the PHI of our customers, we could be found to have breached our contracts.
Determining whether PHI has been handled in compliance with applicable privacy standards and our contractual obligations can be complex
and we cannot be sure how these regulations will be interpreted, enforced or applied to our operations.
In
addition, many states in which we operate have laws that protect the privacy and security of sensitive and personal information, including
health-related information. Certain state laws may be more stringent or broader in scope, or offer greater individual rights, with respect
to sensitive and personal information than federal, international or other state laws, and such laws may differ from each other, which
may complicate compliance efforts.
Laws,
regulations and standards in many other jurisdictions also apply broadly to the Processing of personal information, which impose significant
compliance obligations. Complying with these numerous, complex and often changing regulations is expensive and difficult, and failure
to comply with any Data Protection Laws or any security incident or breach involving the misappropriation, loss or other unauthorized
use or disclosure of sensitive or confidential information, whether by us, one of our service providers or another third party, could
negatively affect our business, financial condition and results of operations, including but not limited to: investigation costs, material
fines and penalties; compensatory, special, punitive and statutory damages; litigation; consent orders regarding our privacy and security
practices; requirements that we provide notices, credit monitoring services or credit restoration services or other relevant services
to impacted individuals; adverse actions against our licenses to do business; and injunctive relief.
Many
statutory requirements, both in the United States and abroad, include obligations for companies to notify individuals of security breaches
involving certain personal information, which could result from breaches experienced by us or our third-party service providers. For
example, laws in all 50 U.S. states and the District of Columbia require businesses to provide notice to consumers whose unencrypted
personal information has been disclosed as a result of a data breach. These laws are not consistent, and compliance in the event of a
widespread data breach is difficult and may be costly. Moreover, states have been frequently amending existing laws, requiring attention
to changing regulatory requirements. We also may be contractually required to notify affected customers, regulators, credit reporting
agencies or other affected individuals of a security breach. Such notifications are costly, and the disclosures or the failure to comply
with such requirements, could lead to material adverse effects, including without limitation, negative publicity, a loss of customer
confidence in our services or security measures or breach of contract claims. There can be no assurance that the limitations of liability
in our contracts would be enforceable or adequate or would otherwise protect us from liabilities or damages if we fail to comply with
applicable Data Protection Laws, Data Protection Obligations or other legal obligations. In addition, although we may have contractual
protections with our third-party service providers, contractors and consultants, any actual or perceived security breach by our subcontractors
could harm our reputation and brand, expose us to potential liability or require us to expend significant resources on data security
and in responding to any such actual or perceived breach. Any contractual protections we may have from our third-party service providers,
contractors or consultants may not be sufficient to adequately protect us from any such liabilities and losses, and we may be unable
to enforce any such contractual protections.
We
expect that there will continue to be new proposed laws and regulations concerning data privacy and security, and we cannot yet determine
the impact such future laws, regulations and standards may have on our business. New laws, amendments to or re-interpretations of existing
laws, regulations, standards and other obligations may require us to incur additional costs and restrict our business operations. Because
the interpretation and application of health-related and Data Protection Laws and other obligations are still uncertain, and often contradictory
and in flux, it is possible that the scope and requirements of these laws may be interpreted and applied in a manner that is inconsistent
with our practices and our efforts to comply with the evolving data protection rules may be unsuccessful. If so, this could result in
government-imposed fines or orders requiring that we change our practices, which could adversely affect our business.
We
cannot assure you that our third-party partners and service providers with access to our or our customers’, suppliers’ and
employees’ personally identifiable and other sensitive or confidential information in relation to which we are responsible will
not breach contractual obligations imposed by us or violate Data Protection Laws, or that they will not experience security breaches
or attempts thereof, which could have a corresponding effect on our business, including putting us in breach of our obligations under
the Data Protection Laws, which could in turn adversely affect our business, results of operations and financial condition. We cannot
assure you that our contractual measures and our own privacy- and security-related safeguards will protect us from the risks associated
with the third-party processing, storage and transmission of such information.
We
may receive inquiries or be subject to investigations, proceedings or actions, by various government entities regarding our privacy and
information security practices and Processing (“Regulatory Proceedings”). These Regulatory Proceedings could result in a
material adverse effect, including without limitation, interruptions of, or required changes to, our business practices, the diversion
resources and the attention of management from our business, regulatory oversights and audits, discontinuance of necessary Processing,
or other remedies that adversely affect our business.
In
addition to the possibility of fines, lawsuits, regulatory investigations, public censure, other claims and penalties, and significant
costs for remediation and damage to our reputation, we could be materially and adversely affected if legislation or regulations are expanded
to require changes in our data processing practices and policies or if governing jurisdictions interpret or implement their legislation
or regulations in ways that negatively impact our business. Complying with these various laws could cause us to incur substantial costs
or require us to change our business practices and compliance procedures in a manner adverse to our business. Any inability to adequately
address data privacy or security-related concerns, even if unfounded, or to comply with applicable laws, regulations, standards and other
obligations relating to data privacy and security, could result in additional cost and liability to us, harm our reputation and brand,
damage our relationships with customers and have a material and adverse impact on our business.
While
we maintain general liability insurance coverage, cyber insurance coverage and other insurance, we cannot assure that such coverage will
be adequate or otherwise protect us from or adequately mitigate liabilities or damages with respect to claims, costs, expenses, litigation,
fines, penalties, business loss, data loss, regulatory actions or material adverse effects arising out of our privacy and security practices,
Processing or security breaches we may experience, or that such coverage will continue to be available on acceptable terms or at all.
The successful assertion of one or more large claims against us that exceeds our available insurance coverage, or results in changes
to our insurance policies (including premium increases or the imposition of large deductible or co-insurance requirements), could have
an adverse effect on our business. In addition, we cannot be sure that our existing insurance coverage will continue to be available
on acceptable terms or that our insurers will not deny coverage as to any future claim.
We
mayare incur substantial costs in our effortssubject to comply with evolving global data protection lawsand privacy laws, and regulations, and any failure or perceived
failure by us to complycompliance with such laws may be costly and regulations may harmexpose ourus businessto and operations.liability.
We collect and process personal information in connection with our operations, including clinical research activities and interactions with healthcare providers. As a result, we may be subject to various U.S. federal and state laws governing the privacy and security of personal information, including, where applicable, the Health Insurance Portability and Accountability Act of 1996, as amended (“HIPAA”), state breach notification laws, and state consumer privacy laws such as the California Consumer Privacy Act, as amended by the California Consumer Rights Act. These laws impose requirements relating to the collection, use, disclosure and safeguarding of personal information and may provide for significant civil penalties and, in some cases, private rights of action.
We may also be subject to international data protection laws, including the European Union General Data Protection Regulation (“GDPR”) and the United Kingdom GDPR, which impose strict requirements regarding the processing and transfer of personal data and authorize substantial fines for non-compliance.
The data protection regulatory environment is rapidly evolving, and new or amended laws, differing interpretations, and increased enforcement activity may require us to incur additional compliance costs, implement new safeguards, or change our business practices. A failure or perceived failure to comply with applicable privacy and data protection laws, or any data security incident involving personal information, whether by us or our third-party service providers, could result in regulatory investigations, fines, litigation, contractual liability, reputational harm and loss of customer confidence, any of which could materially and adversely affect our business, financial condition and results of operations.
The
global data protection landscape is rapidly evolving, and we may be or become subject to or affected by numerous federal, state and foreign
laws and regulations, as well as regulatory guidance, governing the collection, use, disclosure, transfer, security and processing of
personal data, such as information that we collect about subjects and health care providers in connection with clinical trials. Implementation
standards and enforcement practices are likely to remain uncertain for the foreseeable future, which may create uncertainty in our business;
affect our or our service providers’ ability to operate in certain jurisdictions or to collect, store, transfer use and share personal
data; result in liability; or impose additional compliance or other costs on us. Any failure or perceived failure by us to comply with
federal, state, or foreign laws or self-regulatory standards could result in negative publicity, diversion of management time and effort
and proceedings against us by governmental entities or others.
In
the United States, numerous federal and state laws and regulations, including federal health information privacy laws (e.g., the Health
Insurance Portability and Accountability Act, as amended by the Health Information Technology for Economic and Clinical Health Act, or
collectively HIPAA), state data breach notification laws, state health information privacy laws, and federal and state consumer protection
laws (e.g., Section 5 of the Federal Trade Commission Act), that govern the collection, use, disclosure and protection of health-related
and other personal information could apply to our operations or the operations of our collaborators. In addition, we may obtain health
information from third parties (including research institutions from which we obtain clinical trial data) that are subject to privacy
and security requirements under HIPAA or other privacy and data security laws. Depending on the facts and circumstances, we could be
subject to criminal penalties if we knowingly obtain, use, or disclose protected health information maintained by a HIPAA-covered entity
in a manner that is not authorized or permitted by HIPAA. However, determining whether protected health information has been handled
in compliance with applicable privacy standards and our contractual obligations can be complex and may be subject to changing interpretation.
If
we are unable to properly protect the privacy and security of protected health information or other personal, sensitive, or confidential
information in our possession, we could be found to have breached our contracts. Further, if we fail to comply with applicable privacy
laws, including applicable HIPAA privacy and security standards, we could face significant administrative, civil and criminal penalties.
Enforcement activity can also result in financial liability and reputational harm, and responses to such enforcement activity can consume
significant internal and outside resources. Furthermore, state attorneys general are authorized to bring civil actions seeking either
injunctions or damages in response to violations that threaten the privacy of state residents. In addition, our ongoing efforts to comply
with evolving laws and regulations at the federal and state level may be costly and require continuous modifications to our compliance
policies, procedures, and systems.
Many
state laws govern the privacy and security of personal information and data in specified circumstances, many of which differ from each
other in significant ways, are often not pre-empted by HIPAA, and may have a more prohibitive effect than HIPAA, thus complicating compliance
efforts. For example, the California Consumer Privacy Act of 2018 (the “CCPA”), which went into effect in January 2020 and
provides new data privacy rights for consumers and new operational requirements for companies, which may increase our compliance costs
and potential liability. The CCPA gives California residents expanded rights to access and delete their personal information, opt out
of certain personal information sharing, and receive detailed information about how their personal information is used. The CCPA provides
for civil penalties for violations, as well as a private right of action for data breaches that is expected to increase data breach litigation.
While there is currently an exception for protected health information that is subject to HIPAA and clinical trial regulations, as currently
written, the CCPA may impact certain of our business activities. In addition, the California Consumer Rights Act, or CPRA, was recently
enacted to strengthen elements of the CCPA and became effective on January 1, 2023. The CPRA imposes additional data protection obligations
on covered businesses, including additional consumer rights processes, limitations on data uses, new audit requirements for higher risk
data, and opt outs for certain uses of sensitive data and expands the application of the CCPA to all human resources personal information
of California-based employees. In addition, the CPRA created a new California data protection agency authorized to issue substantive
regulations and is expected to result in increased privacy and information security enforcement. A number of other states have considered
similar privacy proposals, and states have recently enacted their own privacy laws. 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.
In
addition to our operations in the United States, which may be subject to health care and other laws relating to the privacy and security
of health information and other personal information, we may be or become subject to European data privacy laws, regulations and guidelines.
The General Data Protection Regulation, (EU) 2016/679 (“GDPR”) became effective on May 25, 2018, and deals with the collection,
use, storage, disclosure, transfer, or other processing of personal data, including personal health data, regarding individuals in the
EEA. The GDPR imposes a broad range of strict requirements on companies subject to the GDPR, including requirements relating to having
legal bases for processing personal information relating to identifiable individuals and transferring such information outside the EEA,
including to the United States, providing details to those individuals regarding the processing of their personal health and other sensitive
data, obtaining consent of the individuals to whom the personal data relates, keeping personal information secure, having data processing
agreements with third parties who process personal information, responding to individuals’ requests to exercise their rights in
respect of their personal information, reporting security breaches involving personal data to the competent national data protection
authority and affected individuals, appointing data protection officers, conducting data protection impact assessments, and record-keeping.
The GDPR increases substantially the penalties to which we could be subject in the event of any non-compliance, including fines of up
to €10,000,000 or up to 2% of our total worldwide annual turnover for certain comparatively minor offenses, or up to €20,000,000
or up to 4% of our total worldwide annual turnover, whichever is greater, for more serious offenses. The GDPR also confers a private
right of action on data subjects and consumer associations to lodge complaints with supervisory authorities, seek judicial remedies,
and obtain compensation for damages resulting from violations of the GDPR. In addition, the GDPR includes restrictions on cross-border
data transfers.
Following
the United Kingdom’s withdrawal from the European Union (i.e., Brexit), and the expiry of the Brexit transition period, which ended
on December 31, 2020, the EU GDPR has been implemented in the United Kingdom (as the UK GDPR). The UK GDPR sits alongside the UK Data
Protection Act 2018 which implements certain derogations in the EU GDPR into UK law. Under the UK GDPR, companies not established in
the UK but who process personal data in relation to the offering of goods or services to individuals in the UK, or to monitor their behavior
will be subject to the UK GDPR – the requirements of which are (at this time) largely aligned with those under the EU GDPR and
as such, may lead to similar compliance and operational costs with potential fines of up to £17.5 million or 4% of global turnover.
In 2022, the government of the United Kingdom proposed and debated the Data Protection and Digital Information Bill to harmonize the
2018 Data Protection Act, UK GDPR, and the Privacy and Electronic Communications Regulations under one legislative framework. However,
progress on the bill stalled as the government continues to assess the most optimal approach to data protection reform.
We
currently sell some of our products in the EEA, and the GDPR increases our responsibility and liability in relation to personal data
that we process where such processing is subject to the GDPR, and we are required to have in place additional mechanisms and safeguards
to ensure compliance with the GDPR, including as implemented by individual countries. Compliance with the GDPR is a rigorous and time-intensive
process that increase our cost of doing business or require us to change our business practices, and despite those efforts, there is
a risk that we may be subject to fines and penalties, litigation, and reputational harm in connection with our European activities. We
expect that we will continue to face uncertainty as to whether our efforts to comply with any obligations under European privacy laws
will be sufficient. If we are investigated by a European data protection authority, we may face fines and other penalties. Any such investigation
or charges by European data protection authorities could have a negative effect on our existing business and on our ability to attract
and retain new clients or partners.
On
As previously disclosed, on January 10, 2025, wethe
Company received a notice from the Listing Qualifications Department of The NASDAQ Stock Market (the “Staff”)
stating that
the bid price of ourthe Company’s common stock for the previous 30 consecutive trading days had closed below the minimum $1.00 per
share share
required for continued listing on The NASDAQ Capital Market under NASDAQ Listing Rule 5550(a)(2). The Company hashad aan initial period
of 180 calendar
days, or until July 9, 2025 (the “Compliance Date”)days 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
ComplianceJuly Date.9, 2025.
On July 10, 2025, the Company received notification from the Staff indicating that the Company would have an additional 180-day grace period, until January 5, 2026, to regain compliance with NASDAQ’s $1.00 minimum bid requirement. The notification indicated that the Company did not regain compliance during the initial 180-day grace period provided under the rule. In accordance with NASDAQ Marketplace Rule 5810(c)(3)(A), the Company was eligible for the additional grace period because it met the continued listing requirement for market value of publicly held shares and all other applicable requirements for initial listing on the Nasdaq Capital Market with the exception of the bid price requirement, and provided written notice of its intention to cure the deficiency during the second compliance period by effecting a reverse stock split, if necessary.
In order to regain compliance with the $1.00 minimum bid price requirement, on January 1, 2026 we effected a 1-for-30 reverse stock split (the “Reverse Stock Split”). The Reverse Stock Split reduced the number of shares of common stock outstanding from approximately 62.9 million shares to approximately 2.1 million shares. On January 7, 2026, the Company received written notice from the Staff indicating that the Staff had determined to delist the Company’s common stock from The Nasdaq Capital Market due to the Company’s continued non-compliance with the minimum bid price requirement set forth in Nasdaq Listing Rule 5550(a)(2). The Company subsequently requested a hearing before the Nasdaq Hearings Panel to address the bid price deficiency; however, the Company’s securities were suspended from trading on The Nasdaq Capital Market effective at the open of trading on January 14, 2026, in accordance with Nasdaq Listing Rule 5815(a)(1)(B)(ii)(d).
On February 12, 2026, the Company participated in a hearing with the Nasdaq Hearings Panel. On March 9, 2026, the Company was formally notified by Nasdaq that it had demonstrated compliance with the $1.00 bid price requirement set forth in Nasdaq Listing Rule 5550(a)(2) and all other applicable criteria for continued listing on The Nasdaq Capital Market. Accordingly, the Company’s securities resumed trading on Nasdaq effective with the open of the market on March 11, 2026, and the previously disclosed listing matter before the Nasdaq Hearing Panel was closed.
The Nasdaq Hearings Panel imposed a Discretionary Panel Monitor for a period of one year, through March 9, 2027. If, during the monitoring period, the Company’s closing bid price falls below $1.00 per share for 30 consecutive business days, the Company will not be eligible for a 180-day compliance period otherwise available under the Nasdaq Listing Rules. Rather, Nasdaq would issue a delist determination, which the Company could then appeal by requesting a hearing before the Panel. Such request would stay any further action by Nasdaq pending the conclusion of the hearing process. Although we have regained compliance with Nasdaq’s continued listing requirements, there can be no assurance that we will maintain compliance with all applicable listing standards in the future.
If
the Company does not regain compliance with Rule 5550(a)(2) by July 9, 2025, the Company may be eligible for additional time. To qualify,
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. If the
Company meets these requirements, the Staff will inform the Company that it has been granted an additional 180 calendar days. However,
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.
If
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:
Management's Discussion & Analysis (MD&A)
Largest changes
We realized a net loss for the year ended December 31,see in full comparison20242025 of$37.6$46.9 million compared to$35.3$37.6 million for the year ended December 31,2023.2024. The larger net loss of$2.3$9.3 million was primarily the result of the recognition of intangible asset impairment charges and decreases in grantrevenue, changes in the fair value of acquisition contingencies, and decreases in realized gains from investments in marketable securities,revenues, partially offset bya decreasedecreases in operatingoperatingexpenses. Additionally, we recorded an income tax benefit of $1.6 million during the year ended December 31, 2025, compared to an income tax expense of $0.1million during the year ended December 31, 2024, compared to an income tax benefit of $2.8million for the year ended December 31,2023.2024. Theprimarycurrentreasonyearforincomethetax benefitchangerelates primarily to new United States tax legislation which was signed into law during 2025 which resulted in theprovisionCompany being eligible forincomecertaintaxes isfederalaandresultstateoftaxtherefundsCompanyrelatednowtorecordingpriora full valuation allowance.years.
“During the fourth quarter of 2025, we identified impairment indicators for our in-process research and development intangible assets, primarily due to a significant and sustained decline in our stock price and market capitalization compared to the assets’ net book value. We remeasured the fair value of these assets and recognized non-cash impairment charges of $18.9 million. This amount is reflected as impairment charges in the consolidated statements of operations and comprehensive loss for 2025. We did not recognize any impairment charges during 2024.”see in full comparison
see in full comparisonResearchTotaland developmentoperating expenses were $50.6 million for the year ended December 31,2024 were $21.0 million2025, compared to$23.0total operating expenses of $43.0 million for the year ended December 31,2023.2024. Thedecreaseincreaseofin$2.0operatingmillionexpenses was primarilya result of decreased expenses relateddue todevelopmenttheofimpairment charge recognized for in-process research andclinicaldevelopmenttrialsintangiblefor the Co-Dx PCR platform and stock-based compensation expense,assets, partially offset byincreasesdecreasedinlegal expenses, stock-based compensation expense, and personnelexpenserelatedand professional services expense.expenses.
At December 31,see in full comparison2024,2025, we had cash and cash equivalents of$2.9 million and marketable investment securities of $26.8$11.9 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 December 31,2024,2025, were$32.3$13.7 million compared to total current liabilities of$7.3$3.5 million.
“During the year ended December 31, 2025, the Company recognized impairment charges of $18.9 million related to in-process research and development intangible assets recorded in conjunction with the acquisitions of Idaho Molecular, Inc. and Advanced Conceptions, Inc. in 2021.”see in full comparison
Wesee in full comparisonarehavecurrently developingdeveloped aunique, groundbreakingportable 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. 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 firstU.S.FDAFood and Drug Administration (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. Followingproductiveengagement with the FDArelated toduring theregulatoryreviewsubmission,process, the Company voluntarily withdrewits 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 inthe 510(k)reviewsubmissionprocess.afterThediscussions regarding the analytical approach for detecting potential degradation of a test component over its intended shelf life. While the Companyplansbelieves 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 tosubmitresubmit thenext iteration of the Co-Dx PCRCOVID-19 test for 510(k)OTCclearanceclearance,wouldfollowingbe more effectively deployed toward development and clinical validation of thecollectionCo-DxofPCRclinicalFluevaluationA/B,dataCOVID-19, RSV multiplex test (“ABCR”). Moving focus tosupport the new test’s performance.thisA new submission alsotest allows the Company to incorporate more recent Co-Dx PCR platform developments into theCOVID-19designtest,andwhichtest 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 theCompany believes will also help create greater operational and manufacturing efficiencies, such as consolidating manufacturing processes to utilize the next generation ofABCR testkitsareand instruments across all tests on the at-home and point-of-care Co-Dx PCR platform.currently underway. There is no guarantee that our Co-Dx PCR platform will receive the necessary regulatory approvals for commercialization, or that, if regulatory approval is received, we will be able to successfully commercialize this platform.
Full comparison: every changed paragraph (28)
Co-Diagnostics,
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 robustmolecular 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. CODX’s technical
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.
We
arehave currently developingdeveloped 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. 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 U.S.FDA Food and Drug Administration (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 toduring the regulatoryreview submission,process, the Company voluntarily 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) reviewsubmission process.after Thediscussions regarding the analytical
approach for detecting potential degradation of a test component over its intended shelf life. While the Company plansbelieves 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 submitresubmit the next iteration of the Co-Dx
PCR COVID-19 test for 510(k) OTCclearance clearance,would followingbe more effectively deployed toward
development and clinical validation of the collectionCo-Dx ofPCR clinicalFlu evaluationA/B, dataCOVID-19, RSV multiplex test (“ABCR”). Moving focus to support the new test’s performance.this
A new submission alsotest allows the Company to incorporate more recent Co-Dx PCR platform developments into the COVID-19design test,and whichtest 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 Company
believes will also help create greater operational and manufacturing efficiencies, such as consolidating manufacturing processes to utilize
the next generation ofABCR test kitsare and instruments across all tests on the at-home and point-of-care Co-Dx PCR platform.currently
underway. There is no guarantee
that our Co-Dx PCR platform will receive the necessary regulatory approvals for commercialization, or
that, if regulatory approval is
received, we will be able to successfully commercialize this platform.
We
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.
Our
scientists use the complex mathematics of DNA/RNA PCR test design to engineer and optimize PCR tests and to automate algorithms that
rapidly screen millions of possible options to pinpoint the optimum design. The intellectual property we use in our business consists
of the predictive mathematical algorithms and patented molecular structure used in the testing process, which together represent a major
advance in PCR testing systems. CODX technologies are now protected by more than 20 granted or pending US and foreign patents, as well
as certain trade secrets and copyrights. Ownership of our proprietary platform permits us the advantage of avoiding payment of patent
royalties required by other PCR test systems, which may allow for the sale of diagnostic PCR tests at a lower price than competitors,
while while
enabling us to maintain profit margins.
Our
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.
This is done by following planned and documented processes, procedures and testing. In other words, we use the data resulting from our
tests to verify whether we succeeded in designing what we intended. Verification involves a series of testing that concludes that the
product is ready to proceed to validation in an evaluation either in our laboratory or in an independent laboratory setting using initial
production tests to confirm that the product as designed meets the useruser’s needs.
Using
our proprietary test design system and reagents, we have designed and obtained regulatory approvalclearance in the European Community and in
India 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.
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™”.
In
addition to testing for infectious disease,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.
Cost
of revenues decreased by $3.2$0.8 million from $4.2$1.0 million for the year ended December 31, 20232024 to $1.0$0.2 million for the year ended December
31, 2024.2025. Included within cost of revenues is a decrease of approximately $0.1 million for the year ended December 31, 2024,2025, and ana increasedecrease
of approximately $2.8$0.1 million for the year ended December 31, 2023,2024, related to reserves against certain raw materials and finished goods
inventories. The initial recording of the reserves for obsolete inventory in the prior year, partially offset by the decrease in revenues
in the current year, resulted in a higher gross margin percentage.
Total
operating expenses were $43.0 million for the year ended December 31, 2024 compared to total operating expenses of $45.3 million for
the year ended December 31, 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 and legal expenses.
Sales
and marketing expenses for the year ended December 31, 2024 were $4.5 million compared to $6.9 million for the year ended December 31,
2023. The decrease of $2.4 million was primarily a result of decreased stock-based compensation expense, tradeshow and travel expenses,
consulting and professional services expenses, and personnel related expenses.
General
and administrative expenses for the year ended December 31, 2024 were $16.2 million compared to $14.3 million for the year ended December
31, 2023. The increase of $1.9 million was primarily due to increased legal expenses, partially offset by decreases in stock-based compensation
expense, bad debt expense, consulting and professional services expense, and insurance expense.
ResearchTotal
and developmentoperating expenses were $50.6 million for the year ended December 31, 2024 were $21.0 million2025, compared to $23.0total operating expenses of $43.0 million for
the year ended December
31, 2023.2024. The decreaseincrease ofin $2.0operating millionexpenses was primarily a result of decreased expenses relateddue to developmentthe ofimpairment charge recognized for in-process research and clinicaldevelopment trialsintangible for
the Co-Dx PCR platform and stock-based compensation expense,assets, partially offset by increasesdecreased inlegal expenses, stock-based compensation
expense, and personnel expenserelated and professional services
expense.expenses.
Sales and marketing expenses for the year ended December 31, 2025, were $2.4 million compared to $4.5 million for the year ended December 31, 2024. The decrease of $2.1 million primarily a result of decreased stock-based compensation expense, tradeshow and travel expenses, consulting and professional services expenses, and personnel related expenses.
General and administrative expenses for the year ended December 31, 2025, were $9.1 million compared to $16.2 million for the year ended December 31, 2024. The decrease of $7.1 million was primarily due to decreases in legal expense, stock-based compensation expense and consulting and professional services expense, partially offset by increased expenses related to transaction advisory services and fees.
Research and development expenses for the year ended December 31, 2025, were $19.1 million compared to $21.0 million for the year ended December 31, 2024. The decrease of $1.8 million 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 expenses related to clinical trials for the Co-Dx PCR platform and professional services expense.
During the year ended December 31, 2025, the Company recognized impairment charges of $18.9 million related to in-process research and development intangible assets recorded in conjunction with the acquisitions of Idaho Molecular, Inc. and Advanced Conceptions, Inc. in 2021.
Other
income was $1.7 million for the year ended December 31, 2025, compared to other income of $2.5 million for the year ended December 31, 2024, compared to other income of $4.6 million for the year ended December 31,
2023.2024. The decrease in other income of $2.1$0.8 million was primarily due to a changedecreases in theinterest fair value of contingent consideration liabilities,
an increased loss related to the Company’s joint venture investment,income and decreased realized gains from investments
in marketable
securities.
We
realized a net loss for the year ended December
31, 20242025 of $37.6$46.9 million compared to $35.3$37.6 million for the year ended December 31, 2023.
2024. The larger net loss of $2.3$9.3 million was primarily
the result of the recognition of intangible asset impairment charges and decreases in grant revenue, changes in the fair value of acquisition
contingencies, and decreases in realized gains from investments in marketable securities,revenues, partially offset by a decreasedecreases in
operating operating
expenses. Additionally, we recorded an income tax benefit of $1.6 million during the year ended
December 31, 2025, compared to an income tax expense of $0.1 million during the year ended December 31, 2024, compared to an income
tax benefit of $2.8 million for the year ended December 31, 2023.2024. The primarycurrent reasonyear forincome thetax
benefit changerelates primarily to new United States tax legislation which was signed into law during 2025 which resulted in the provisionCompany being
eligible for incomecertain taxes
isfederal aand resultstate oftax therefunds Companyrelated nowto recordingprior a full valuation allowance.years.
At
December 31, 2024,2025, we had cash and cash equivalents of $2.9 million and marketable investment securities of $26.8$11.9 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 December 31, 2024,2025, were $32.3
$13.7 million compared to total current
liabilities of $7.3$3.5 million.
Net
cash used in operating activities during the year ended December 31, 20242025 was $29.2$29.1 million, compared to net cash used in operating activities
of $22.1$29.2 million for the year ended December 31, 2023.2024. The increaseslight decrease in cash used in operating activities was primarily due to
lower operating expenses, primarily legal expenses, offset by decreases
in grant revenue, grantnet funding,interest income, and realized gains on investments, and increases in cash-payable operating expenses.
investments.
Net
cash provided by investing activities was $17.1$26.3 million for the year ended December 31, 2024,2025, compared to net cash provided by investing
activities of $15.4$17.1 million during the year ended December 31, 2023.2024. The increase in cash provided by investing activities is primarily
due to interestthe andtiming realized gains related to marketable investment securities, as well asof the redemption of certain investments as they
matured.
Net
cash provided by financing activities was $0.1$11.8 million for the year ended December 31, 2024,2025, compared to $1.4$0.1 million of cash usedprovided
by in
financing activities for the year ended December 31, 2023.2024. The cash provided by financing activities during 20242025 relates to issuances
of common stock,stock comparedunder tothe cashATM usedand inthrough financingregistered activitiesdirect for repurchases of outstanding common shares during 2023.offerings.
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 basedequity-based securities with existing and new investors similar
to those that have provided funding in the past.past Weor havedebt 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.financing.
In September 2025, the Company completed a registered direct offering of 320,634 shares of its common stock to two institutional investors at an offering price of $12.00 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. 333-270628). 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 16 – Registered Direct Offerings to the 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 151,675 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. In October 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. As of December 31, 2025, the Company had sold 31,667 shares of common stock under the Agreement, resulting in net proceeds to the Company of approximately $258,563. There can be no assurance as to the timing or amount of any further sales under the new ATM program. See Note 15 – At the Market Agreement to the consolidated financial statements for additional information regarding this transaction.
In October 2025 the Company completed a second registered direct offering of 400,076 shares of its common stock and 24,167 pre-funded common stock purchase warrants to two institutional investors at offering prices of $16.50 per share and $16.497 per pre-funded warrant, resulting in gross proceeds of approximately $7.0 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. 333-270628). 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 16 – Registered Direct Offerings to the consolidated financial statements for additional information regarding this transaction.
On January 1, 2026, we effected a 1-for-30 reverse stock split. The Reverse Stock Split reduced the number of shares of common stock outstanding from approximately 62.9 million shares to approximately 2.1 million shares. Although this Reverse Stock Split allowed us to regain compliance with Nasdaq’s continued listing requirements, there can be no assurance that we will maintain compliance with all applicable listing standards in the future.
During the fourth quarter of 2025, we identified impairment indicators for our in-process research and development intangible assets, primarily due to a significant and sustained decline in our stock price and market capitalization compared to the assets’ net book value. We remeasured the fair value of these assets and recognized non-cash impairment charges of $18.9 million. This amount is reflected as impairment charges in the consolidated statements of operations and comprehensive loss for 2025. We did not recognize any impairment charges during 2024.
What changed in the latest 10-Q
Risk Factors
Not required under Regulation S-K for “smaller reporting companies.”
No wording changes found in this section.
Full comparison: every changed paragraph (0)
Management's Discussion & Analysis (MD&A)
New heading “Other Income or Expense”
New heading “The Six Months Ended June 30, 2026 Compared to the Six Months ended June 30, 2025”
New heading “Cost of Revenues”
Largest changes
“The Six Months Ended June 30, 2026 Compared to the Six Months ended June 30, 2025”see in full comparison
“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. …”see in full comparison
“In January 2017, the Company entered into an agreement to manufacture diagnostics tests for seven infectious diseases with a pharmaceutical manufacturing company in India and formed CoSara Diagnostics Pvt. Ltd. as a joint venture. The agreement provided for the construction of a manufacturing plant, the manufacture of the PCR tests using the Company’s primer technology, and the sales and marketing of those tests in India. …”see in full comparison
We have developed a portable diagnostic device and test system designed for point-of-care and at-home use. The system is comprised of oursee in full comparisonourPCR 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,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 duringduringthe review process, the Company voluntarily withdrew the 510(k) submission after discussions regarding the analytical approach forfordetecting potential degradation of a test component over its intended shelf life. While the Company believes that the matter identifiedidentifiedduring 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,and RSV multiplex test (“ABCRABR”). Moving focus to this test allows the Company to incorporate more recent Co-Dx PCR platform developments into the design and test manufacturing process.ManagementThebelieves thatCompanyahasmultiplexcompletedtest targeting influenza A/B, COVID-19,clinical andRSV better aligns with current clinical demand for comprehensive upper respiratory infection testing in point-of-care settings. Accordingly, clinicalanalytical performance studies for the Co-Dx™ABCRPCR Flu A/B and RSV upper respiratory multiplex testareoncurrentlytheunderway.Co-Dx PCR Pro® instrument that the Company included in a submission package for a Dual 510(k) and CLIA Waiver by Application submission to the U.S. Food and Drug Administration in August 2026. There is no guarantee that our Co-Dx PCR platform will receive the necessary regulatory approvals for commercialization, or that, if regulatory approval is received, we will be able to successfully commercialize this platform.
Full comparison: every changed paragraph (31)
We
have developed a portable diagnostic device and test system designed for point-of-care and at-home use. The system is comprised of
our 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,
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
during the review process, the Company voluntarily withdrew the 510(k) submission after discussions regarding the analytical approach for
for detecting potential degradation of a test component over its intended shelf life. While the Company believes that the matter
identified 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,and RSV multiplex test
(“ABCRABR”). Moving focus to this test allows
the Company to incorporate more recent Co-Dx PCR platform developments into
the design and test manufacturing process. ManagementThe believes
thatCompany ahas multiplexcompleted test targeting influenza A/B, COVID-19,clinical and RSV better aligns with current clinical demand for comprehensive upper respiratory
infection testing in point-of-care settings. Accordingly, clinicalanalytical performance studies for the
Co-Dx™ ABCRPCR Flu A/B and RSV upper respiratory multiplex test areon currentlythe underway.Co-Dx PCR Pro® instrument that the Company included in a submission package for a Dual 510(k) and CLIA Waiver by Application submission to the U.S. Food
and Drug Administration in August 2026. There
is no guarantee that our Co-Dx PCR platform will receive the necessary regulatory approvals for
commercialization, or that, if regulatory
approval is received, we will be able to successfully commercialize this
platform.
In January 2017, the Company entered into an agreement to manufacture diagnostics tests for seven infectious diseases with a pharmaceutical manufacturing company in India and formed CoSara Diagnostics Pvt. Ltd. as a joint venture. The agreement provided for the construction of a manufacturing plant, the manufacture of the PCR tests using the Company’s primer technology, and the sales and marketing of those tests in India. The Company also has a services agreement with CoSara under which CoSara provides certain research and development consulting and support services, specifically pertaining to the ongoing development of the Co-Dx PCR platform. During July 2026, CoSara initiated clinical studies for a tuberculosis test on the PCR Pro® instrument.
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.
The
Three Months Ended MarchJune 31,30, 2026 Compared to the Three Months ended MarchJune 31,30, 2025
For
the three months ended MarchJune 31,30, 2026, we generated revenues of $0.1$0.2 million, compared to revenues of $0.1$0.2 million for the three months
ended MarchJune 31,30, 2025.
We
recorded cost of revenues of approximately $0.2$0.05 million for the three months ended MarchJune 31,30, 2026, compared to approximately $22,000$0.03
million for the three months ended MarchJune 31,30, 2025. Included within cost of revenues is a decrease of approximately $0.2$0.03 million for
the three
months ended MarchJune 31,30, 2026, and a decrease of approximately $41,000$0.1 million for the three months ended MarchJune 31,30, 2025, related
to reserves against
certain raw materials and finished goods inventories.
Total
operating expenses for the three months ended MarchJune 31,30, 2026 were $9.2
$6.3 million, compared to total operating expenses of $8.6$8.2 million for
the three months ended MarchJune 31,30, 2025. The increasedecrease in operating expenses was primarily due to expenses related to clinical trials for
the Co-Dx PCR platform and increaseddecreased legal expense and professional services
expense, as well as decreased personnel and stock-based compensation expense, partially offset by decreasedincreased stock-basedexpense compensationrelated to clinical
expense.trials for the Co-Dx PCR platform.
Sales
and marketing expenses for the three months ended MarchJune 31,30, 2026 were $0.5 million, compared to $0.7$0.6 million for the three months ended
MarchJune 31,30, 2025. The decrease was primarily a result of decreased stock-based compensation expense and decreasedconsulting tradeshow and travel
expense.
General
and administrative expenses for the three months ended MarchJune 31,30, 2026 were $2.5$1.5 million, compared to $2.8$2.6 million for the three months
ended MarchJune 31,30, 2025. The decrease resulted primarily from decreased personnelstock-based relatedcompensation expense and stock-based compensation expense,
partially offset by increaseddecreased legal and professional
services expense.
Research
and development expenses for the three months ended MarchJune 31,30, 2026 were $5.9$4.2 million, compared to $4.9$4.7 million for the three months ended
MarchJune 31,30, 2025. The increasedecrease 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, partially offset
by decreased personnel related expense.platform.
Other Income or Expense
Other expense for the three months ended June 30, 2026 was $0.1 million, compared to other income of $0.3 million for the three months ended June 30, 2025. The decrease was primarily a result of decreased realized gains from investments in marketable securities, as well as changes in the fair value of contingent consideration liabilities.
Net Loss
Net loss for the three months ended June 30, 2026 was $6.3 million, compared to $7.7 million for the three months ended June 30, 2025. The smaller net loss was primarily the result of lower operating expenses, partially offset by decreased other income, including changes in the fair value of contingent consideration liabilities and decreased realized gains on investments.
The Six Months Ended June 30, 2026 Compared to the Six Months ended June 30, 2025
Revenues
For the six months ended June 30, 2026, we generated revenues of $0.3 million, compared to revenues of $0.2 million for the six months ended June 30, 2025.
Cost of Revenues
We recorded cost of revenues of approximately $0.2 million for the six months ended June 30, 2026, compared to approximately $0.1 million for the six months ended June 30, 2025. Included within cost of revenues is a decrease of approximately $0.2 million for the six months ended June 30, 2026, and a decrease of approximately $0.1 million for the six months ended June 30, 2025, related to reserves against certain raw materials and finished goods inventories.
Expenses
Total operating expenses for the six months ended June 30, 2026 were $15.5 million, compared to total operating expenses of $16.8 million for the six months ended June 30, 2025. The decrease in operating expenses was primarily due to decreased legal and professional services expense, as well as decreased personnel and stock-based compensation expense, partially offset by increased expense related to clinical trials for the Co-Dx PCR platform.
Sales and marketing expenses for the six months ended June 30, 2026 were $0.9 million, compared to $1.3 million for the six months ended June 30, 2025. The decrease was primarily a result of decreases in stock-based compensation expense, tradeshow and travel expense, and consulting expense.
General and administrative expenses for the six months ended June 30, 2026 were $4.0 million, compared to $5.4 million for the six months ended June 30, 2025. The decrease resulted primarily from decreased personnel related expense and stock-based compensation expense, as well as decreased legal and professional services expense.
Research and development expenses for the six months ended June 30, 2026 were $10.1 million, compared to $9.6 million for the six months ended June 30, 2025. The increase was primarily a result of expenses related to clinical trials for the Co-Dx PCR platform, partially offset by decreased personnel related expense.
Other
income for the threesix months ended MarchJune 31,30, 2026 was $0.1 million,nominal, compared
to other income of $1.0$1.4 million for the threesix months ended MarchJune 31,30, 2025.
The decrease was primarily a result of changes in the fair value of contingent consideration liabilities, as well as decreased realized
realized gains from investments in marketable securities.
Net
loss for the threesix months ended MarchJune 31,30, 2026 was $9.1$15.4 million, compared to $7.5$15.3 million for the threesix months ended March
31,June 30, 2025. The
larger net loss was primarily the result of higher operating expenses and decreased other income, including changes in
the fair value of contingent consideration liabilities
and decreased realized gains on investments.investments, partially offset by lower operating expenses.
At
MarchJune 31,30, 2026, we had cash and cash equivalents of $8.2$3.6 million. Additionally, our total current assets at MarchJune 31,30, 2026, were $9.8$5.2 million
million compared to total current liabilities of $4.3$2.9 million.
Net
cash used in operating activities during the threesix months ended MarchJune 31,30, 2026 was $7.8$15.0 million, compared to $8.7$17.0 million for the threesix
months ended MarchJune 31,30, 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.
Net
cash used in investing activities was $0.1$0.3 million for the threesix months ended MarchJune 31,30, 2026, compared to cash provided by investing activities
activities of $7.4$24.4 million during the threesix months ended MarchJune 31,30, 2025. The decrease in cash provided by investing activities is primarily
due to
higher proceeds from redemption less purchasesredemptions of investments during the prior year.
Net
cash provided by financing activities was $4.3$7.1 million for the threesix months ended MarchJune 31,30, 2026, compared to $0.4$0.8 million for the threesix months
months ended MarchJune 31,30, 2025. The cash provided by financing activities during 2026 relates to issuances of common stock under the ATM.ATM and proceeds
related to a private placement transaction.
CODX insider buying and selling (Form 4)
Since 2026-04-11, insiders reported open-market purchases in 0 Form 4 filings and open-market sales in 0 filings. Totals add up every open-market (code P and S) line in those filings, using the prices reported in the filings. Awards, option exercises, tax withholding and gifts are listed below but not counted.
| Trade date | Insider | Transaction | Shares | Price | Value |
|---|---|---|---|---|---|
| 2026-05-23 | Egan Dwight H |
Disposition to issuer | 1,633 | $5.07 | $8.3K |
| 2026-05-23 | Egan Dwight H |
Grant/award | 4,584 | — | — |
| 2026-05-23 | Brown Brian Lee |
Disposition to issuer | 1,350 | $5.07 | $6.8K |
| 2026-05-23 | Brown Brian Lee |
Grant/award | 3,750 | — | — |
| 2026-05-23 | Abbott Richard David |
Grant/award | 1,890 | — | — |
| 2026-05-23 | Abbott Richard David |
Disposition to issuer | 680 | $5.07 | $3.4K |
| 2026-05-23 | Murphy Edward L. |
Grant/award | 1,695 | — | — |
| 2026-05-23 | Serbin Richard S |
Grant/award | 1,695 | — | — |
| 2026-05-23 | Durenard Eugene |
Grant/award | 1,695 | — | — |
| 2026-05-23 | Nelson James B |
Grant/award | 1,695 | — | — |
Well-known investors holding CODX (13F)
| Investor | Quarter | Shares | Reported value | % of their 13F | Change vs prior quarter |
|---|---|---|---|---|---|
| Millennium Management (Israel Englander) | 2026-06-30 | 31,995 | $99.2K | 0.0% | New position |
| Renaissance Technologies | 2026-06-30 | 12,500 | $38.8K | 0.0% | New position |