CODX US Equity☆

UNITED

STATES

SECURITIES

AND EXCHANGE COMMISSION

Washington,

D.C. 20549.

Form

10-K

(Mark

One)

☒

ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For

the fiscal year ended December 31, 2025

OR

☐

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For

the transition period from_______to_______

Commission

File Number 001-38148

CO-DIAGNOSTICS,

INC.

(Exact

Name of Registrant as Specified in Its Charter)

2401

S. Foothill Drive, Salt Lake City, Utah84109

(Address

of principal executive offices and zip code)

(801)438-1036

(Registrant’s

telephone number including area code)

Securities

registered pursuant to Section 12(b) of the Act:

Title of each class Trading Symbol(s) Name of each exchange on which registered

Common Stock CODX The Nasdaq Capital Market

Securities

registered pursuant to Section 12(g) of the Act: None

Indicate

by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No ☒

Indicate

by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Act. Yes ☐ No ☒

Indicate

by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Exchange Act of 1934

during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject

to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate

by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data

File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding

12 months (or such shorter period that the registrant was required to submit and post such files). Yes ☒ No ☐

Indicate

by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting

company or an emerging growth company. See definitions of “large accelerated filer,” “accelerated filer,” “smaller

reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer ☐ Accelerated filer ☐

Non-accelerated filer ☒ Smaller reporting company ☒

Emerging growth company ☐

If

an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying

with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate

by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness

of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered

public accounting firm that prepared or issued its audit report. ☐

If

securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant

included in the filing reflect the correction of an error to previously issued financial statements. ☐

Indicate

by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation

received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐

Indicate

by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes ☐ No ☒

The

aggregate market value of the voting and non-voting common equity held by non-affiliates computed by reference to the price at which

the common stock was last sold as of the last business day of the registrant’s most recently completed second fiscal quarter was

approximately $10,000,000.

As

of March 29, 2026, there were 3,602,465 shares of common stock, par value $0.001 per share, outstanding.

Table

of Contents

Page

PART I

Item 1. Business. 4

Item 1A. Risk Factors. 13

Item 1B. Unresolved Staff Comments. 23

Item 1C. Cybersecurity 24

Item 2. Properties. 25

Item 3. Legal Proceedings. 25

Item 4. Mine Safety Disclosures. 26

PART II

Item 6. [Reserved.] 28

Item 7A. Quantitative and Qualitative Disclosures About Market Risk. 33

Item 8. Financial Statements and Supplementary Data. 34

Item 9A. Controls and Procedures. 55

Item 9B. Other Information. 56

Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections. 56

PART III

Item 10. Directors, Executive Officers and Corporate Governance. 56

Item 11. Executive Compensation. 61

Item 14. Principal Accountant Fees and Services. 65

PART IV

Item 15. Exhibits and Financial Statement Schedules. 66

PART

I

Forward-Looking

Statements

This

Annual Report on Form 10-K contains “forward-looking statements” that involve risks and uncertainties. All statements other

than statements of historical fact contained in this Annual Report and the documents incorporated by reference herein, including statements

regarding future events, our future financial performance, business strategy, and plans and objectives of management for future operations,

are forward-looking statements. We have attempted to identify forward-looking statements by terminology including “anticipates,”

“believes,” “can,” “continue,” “could,” “estimates,” “expects,”

“intends,” “may,” “plans,” “potential,” “predicts,” “should,”

or “will” or the negative of these terms or other comparable terminology. Although we do not make forward looking statements

unless we believe we have a reasonable basis for doing so, we cannot guarantee their accuracy. These statements are only predictions

and involve known and unknown risks, uncertainties and other factors which may affect our or our industry’s actual results, levels

of activity, performance or achievements expressed or implied by these forward-looking statements. Moreover, we operate in a highly regulated,

very competitive, and rapidly changing environment. New risks emerge from time to time, and it is not possible for us to predict all

risk factors, nor can we address the impact of all factors on our business or the extent to which any factor, or combination of factors,

may cause our actual results to differ materially from those contained in any forward-looking statements.

We

have based these forward-looking statements largely on our current expectations and projections about future events and financial trends

that we believe may affect our financial condition, results of operations, business strategy, short term and long-term business operations,

and financial needs. These forward-looking statements are subject to certain risks and uncertainties that could cause our actual results

to differ materially from those reflected in the forward-looking statements. Factors that could cause or contribute to such differences

include, but are not limited to, those discussed in this Annual Report, and in particular, the risks discussed under “Item 1,

Business,” “Item 1A, Risk Factors,” and “Item 7, Management’s Discussion and Analysis of Financial Condition

and Results of Operations,” and those discussed in other documents we file with the Securities and Exchange Commission (the

“SEC”). In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed in

this Annual Report may not occur as described and actual results could differ materially and adversely from those anticipated or implied

in the forward-looking statement.

Important

factors that could cause actual results to differ materially from those in the forward-looking statements include, without limitation:

● our ability to obtain regulatory approval to market and sell our products;

● the results of clinical evaluations of our product candidates;

● market acceptance of any products that may be approved for commercialization;

● our ability to protect our intellectual property rights;

● the impact of any infringement actions or other litigation brought against us;

● competition from other providers and products;

● changes in government regulation;

Should

one or more of these risks or uncertainties materialize, or should the underlying assumptions prove incorrect, actual results may differ

significantly from those anticipated, believed, estimated, expected, intended or planned.

Given

these risks and uncertainties, readers are cautioned not to place undue reliance on any forward-looking statements. Forward-looking statements

contained in this Annual Report speak only as of the date of this Annual Report. We undertake no obligation to update any forward-looking

statements as a result of new information, events or circumstances or other factors arising or coming to our attention after the date

hereof.

As

used in this Annual Report, the terms “we”, “us”, “our”, “Company”, “CODX”

and “Co-Diagnostics” means Co-Diagnostics, Inc., a Utah corporation and its consolidated subsidiaries (the “Company”),

unless otherwise indicated.

ITEM

1: BUSINESS

Overview

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 molecular tools for detection

of infectious diseases. Our diagnostics systems enable dependable, low-cost, molecular testing for organisms and genetic diseases by

automating or simplifying historically complex procedures in both the development and administration of tests. CODX’s technical

advance involves a novel, proprietary approach to polymerase chain reaction (“PCR”) test design of primer and probe structure

(“Co-Primers®”) that dramatically reduces one of the key vexing issues of PCR amplification: the exponential growth of

primer-dimer amplification (false positives) which adversely interferes with identification of the target DNA/RNA. Using our proprietary

test design system and reagents, we have designed and obtained regulatory approval to sell PCR diagnostic tests for the detection of

COVID-19, influenza, tuberculosis, hepatitis B and C, human papillomavirus, malaria, chikungunya, dengue, and the Zika virus. These initial

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

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

PCR instrument that we refer to as the Co-DxTM 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-DxTM PCR platform”

which has been designed to bring affordable, reliable polymerase chain reaction (“PCR”) testing to patients in point-of-care

and at-home settings. The Co-Dx PCR platform is subject to U.S. Food and Drug Administration (“FDA”) review and is not available

for sale at the time of this filing. In June 2024, we completed our first FDA application for 510(k) clearance for the Co-Dx PCR Pro instrument, the Co-Dx PCR COVID-19 Test, and the Co-Dx PCR mobile app for over-the-counter (OTC) use. Following engagement

with the FDA during the review process, the Company voluntarily withdrew the 510(k) submission after discussions regarding the analytical

approach for detecting potential degradation of a test component over its intended shelf life. While the Company believes that the matter

identified during the review process could have been addressed through additional development and clinical validation activities, management

determined that the capital and time required to resubmit the COVID-19 test for 510(k) clearance would be more effectively deployed toward

development and clinical validation of the Co-Dx PCR Flu A/B, COVID-19, RSV multiplex test (“ABCR”). Moving focus to this

test allows the Company to incorporate more recent Co-Dx PCR platform developments into the design and test manufacturing process. Management

believes that a multiplex test targeting influenza A/B, COVID-19, and RSV better aligns with current clinical demand for comprehensive

upper respiratory infection testing in point-of-care settings. Accordingly, clinical performance studies for the ABCR test are currently

underway. 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.

Technology

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 (“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.

In

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

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

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

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 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 user’s needs.

Using

our proprietary test design system and reagents, we have designed and obtained regulatory clearance in the European Community and in

India (along with our joint venture, CoSara) to sell PCR diagnostic tests for the detection of COVID-19, influenza, tuberculosis, hepatitis

B and C, human papillomavirus, malaria, chikungunya, dengue, and the Zika virus. In the United States, we obtained Emergency Use Authorization

(“EUA”) for our Logix Smart® COVID-19 detection test from the FDA, and we sell that test to qualified labs. 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 BoxTM”.

In

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

describes any type of genetic trait, which creates several significant applications. We, in conjunction with our customers, have designed

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.

Co-Dx

PCR Platform

We

believe the benefits of affordable, high-quality diagnostics should be available to everyone. High-quality point-of-care polymerase chain

reaction (“PCR”) testing plays a crucial role in healthcare. It enables rapid diagnosis of infectious diseases, such as COVID-19,

influenza or tuberculosis, facilitating timely treatment and containment measures. By delivering results on-site, it eliminates the need

for sample transportation, reducing the risk that the sample is transported incorrectly or lost, reducing turnaround time to results,

and allowing for immediate decision-making. Gold-standard PCR testing at the point of care ensures reliable detection of pathogens, minimizing

incorrect results. In short, high-quality PCR testing at home and at the point of care enhances patient care, public health response,

and helps control the spread of infectious diseases. That is why we have developed the Co-Dx PCR platform utilizing our Co-Primers®

real-time PCR technology for at-home and point-of-care testing. Because we believe that testing for upper respiratory and other infectious

diseases will continue to be a consideration for public health worldwide, we initiated the Co-Dx PCR platform to facilitate frequent,

affordable, reliable PCR testing to patients in point-of-care and at-home settings, including schools, businesses, pharmacies and the

hospitality industry. Our Co-Dx PCR Pro platform is comprised of a compact, relatively

low-cost testing device, the Co-Dx PCR Pro instrument, together with diagnostic test cups that work with the instrument,

and an intuitive mobile application that is easy to use by professionals and non-professionals, all of which can provide PCR test results

in around 30 minutes. As user test results are analyzed and anonymized in the cloud, we believe this data may be useful for governmental

health agencies and the World Health Organization to determine where outbreaks of infectious diseases may be occurring and to enable

them to act more quickly and efficiently to slow-down or perhaps even prevent further spread.

The

6 1⁄2” x 4 1/2” x 6”, 2 lbs. Co-Dx PCR Pro instrument operates via a smartphone app with simple-to-follow instructions

that includes videos to walk users through every step, from sample swab collection to the straightforward instrument operation. Results

are processed in the cloud and delivered back to the user’s smartphone or tablet in about 30 minutes using software designed from

the ground-up for this specific use. The PCR tests themselves (contained in the simple but unique, innovative test collection cups) are

powered by patented Co-Dx Co-Primers PCR technology.

The initial diagnostic test designed for use on this platform, an at-home

and point-of-care COVID-19 PCR test, was ultimately facilitated by our development of a saliva or nasal swab-based PCR test that does

not require RNA/DNA extraction (standard in laboratory-based PCR testing). The final result was believed to be approximately equivalent

to those processed by a high-complexity clinical laboratory. Our COVID-19 PCR platform test had the advantages of increased speed over

clinical laboratories, with results in around 30 minutes compared to hours or even days, and ease of handling thanks to lyophilization

(or freeze-drying) of our testing reagents to allow for storage at room temperatures. In December 2023, we submitted our proprietary Co-Dx

PCR COVID-19 test cups, together with the Co-Dx PCR Pro instrument and mobile application, all designed for use in point-of-care and at-home

settings, for review by the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA). In June 2024, we completed

our first FDA application for 510(k) clearance for the Co-Dx PCR Pro instrument, the Co-Dx PCR COVID-19 Test, and the Co-Dx PCR mobile

app for over-the-counter (OTC) use. Following engagement with the FDA during the review process, the Company voluntarily withdrew the

510(k) submission after discussions regarding the analytical approach for detecting potential degradation of a test component over its

intended shelf life. While the Company believes that the matter identified during the review process could have been addressed through

additional development and clinical validation activities, management determined that the capital and time required to resubmit the COVID-19

test for 510(k) clearance would be more effectively deployed toward development and clinical validation of the Co-Dx PCR Flu A/B, COVID-19,

RSV multiplex test (“ABCR”). Moving focus to this test allows the Company to incorporate more recent Co-Dx PCR platform developments

into the design and test manufacturing process. Management believes that a multiplex test targeting influenza A/B, COVID-19, and RSV better

aligns with current clinical demand for comprehensive upper respiratory infection testing in point-of-care settings. Accordingly, we announced

on November 17, 2025 that the clinical performance studies for the ABCR test were 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.

In

July 2023 we were awarded $1.2 million in funding from the National Institutes of Health (NIH) as part of the Rapid Acceleration of Diagnostics

(RADx®) Tech program for development of our upper respiratory panel diagnostic test for use on the Company’s Co-Dx

PCR platform. We have utilized the funds from the RADx Tech award to complete development of our flu A/B, COVID-19, and RSV multiplex

test, in preparation for the clinical performance testing on the Co-Dx PCR Pro instrument, which began in November 2025. The NIH launched

the RADx initiative on April 29, 2020, with the goal of speeding innovation in the development, commercialization, and implementation

of technologies for COVID-19 testing, leveraging the existing NIH Point-of-Care Technology Research Network. The RADx Tech program is

managed by the National Institute of Biomedical Imaging and Bioengineering (NIBIB), to support the accelerated development of tests and

provide regulatory guidance during the COVID-19 pandemic and beyond.

We

are also developing diagnostics tests for TB and HPV for use with our Co-Dx PCR platform. We have been awarded two grants totaling $6.8

million for the TB test and one grant totaling $987,000 for the HPV test by the Bill & Melinda Gates Foundation to support the development

and manufacture of these tests for our Co-Dx PCR platform. In 2014, all United Nations Member States and the World Health Organization

(WHO) committed to ending the global TB epidemic by 2030, before the COVID-19 pandemic slowed, stalled or reversed progress of global

TB targets. The WHO reported a worldwide gap of roughly 2.4 million unidentified cases between the reported number of newly diagnosed

TB cases in 2024 and the estimated number of incident cases, highlighting the need for a dramatic increase of affordable, high-quality,

point-of-care TB diagnostics to enable rapid treatment decisions to be made for a disease that has a mortality rate of about 50% if left

untreated. The National Cancer Institute estimates that high-risk HPVs cause roughly 5% of all cancers worldwide, including cervical

cancer, the fourth most common cancer in women and which led to an estimated 350,000 cervical cancer deaths in 2022 according to the

WHO. About 94% of these deaths are in low- and middle-income countries, and all of which the WHO believes can be dramatically reduced

by access to diagnostics, vaccinations, and cancer screenings.

Infectious

Disease Product Offering

Using

our proprietary test design system and patented Co-Primers, we and CoSara Diagnostics Pvt Ltd (“CoSara”), our joint

venture for development and manufacturing in India, design and sell PCR diagnostic tests for detection of diseases and pathogens

such as COVID-19, influenza, tuberculosis, hepatitis B and C, malaria, dengue, human papillomavirus, chikungunya, and Zika virus,

all of which tests have been designed and verified in our laboratories. The Co-Dx Logix Smart® Mycobacteria Tuberculosis (MTB)

test and Logix Smart Zika test received CE marking in 2018, and for the Logix Smart Zika, dengue and chikungunya (ZDC) multiplex

test received CE marking in 2019, qualifying the tests to be sold throughout the European community and in most countries in Central

and South America (subject to local registration requirements). In December 2019, CoSara received a license from the Central Drugs

Standard Control Organization (“CDSCO”) to manufacture and sell tuberculosis, hepatitis B, hepatitis C, human

papillomavirus 16/18 and malaria tests in India. In February 2020, we received CE marking for our Logix Smart COVID-19 test followed

by an EUA by the FDA in April 2020. Also, in April 2020, our COVID-19 test was approved for manufacture and sale in India by the

CDSCO and in Mexico by the INDRE, Mexico’s equivalent to the United States Center for Disease Control. In August 2020, we

received approval from the Australian Department of Health Therapeutic Goods Division to sell our COVID-19 test in

Australia.

As

explained above, our Logix Smart COVID-19 test was designed, developed, submitted for regulatory clearance and ready to be used as an

in vitro diagnostic (“IVD”) in countries that accept CE marking for regulatory clearance in a period of just over 30 days. This

is a real-world example of how CODX technology can be used in an evolving epidemic or pandemic to get diagnostic tools in the hands of

medical professionals in a timely manner. It can be similarly used to design a test for mutated strains of SARS-CoV-2 or other viruses

should they not be detectable using currently available tests.

Caribbean

and Central and South America

We

began selling PCR diagnostic tests to entities located in South and Central America and the Caribbean in 2018. In some of those countries,

there are limited regulatory hurdles, which allowed us to begin offering our tests immediately with CE markings. We have applied for

and received registrations for our tests in many of those countries that require registration, and our distributors in those countries

have provided us with in-country assistance in completing such registrations.

We

first offered our Zika test in this region because of the demand for such a test at that time, followed by tests for tuberculosis, and

our triplex test for Zika, chikungunya, and dengue. Sales of those tests have been modest, but with the granting of CE marking and EUA

for our Logix Smart COVID-19, we experienced an increase in sales in this region.

India

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 joint sales and marketing of those tests in India. We have

received a license for the plant in Ranoli, India to manufacture approved tests and it is being used for testing and manufacturing of

our products for the Indian market.

The CDSCO has issued clearances for 15 laboratory-based PCR tests to be sold by CoSara as IVDs, and the Company’s joint venture

manufactures and sells 14 of those tests under the SaraGene brand. The Company manages a reagent rental program in India with thermocyclers

purchased from a third-party manufacturer, the Co-Dx Box. The placement of thermocyclers in India has facilitated the sale of the SaraGene

PCR tests in India. The WHO 2025 Global Tuberculosis Report indicates that India was the country with the highest number of cases of

tuberculosis in the world in 2024, with 25% of an estimated global incidence of approximately 10.7 million cases.

CoSara

received authorization to manufacture and sell COVID-19 tests in India. Those tests in India are branded as SaraGene COVID-19 tests and

are sold exclusively by CoSara. The Indian government places restrictions on the price that could be charged for COVID-19 tests which

limited the revenue in India more than we experienced in other parts of the world. At the time of this report, CoSara has received CDSCO

clearance for RT-PCR tests for Mycobacterium tuberculosis, malaria, hepatitis B, hepatitis C (including viral load tests for both hepatitis

B and C), human papillomavirus (HPV), a test for high-risk HPV, two COVID-19 assays, chikungunya, dengue, a dengue/chikungunya duplex

test, an influenza A/influenza B/COVID-19 (“ABC”) multiplex test, and in 2024 CDSCO cleared the manufacture and sale of the

SARAPLEXTM Influenza Multiplex (IFM) Test Kit to clinical laboratories as an in vitro diagnostic for the detection and differentiation

of Influenza A and Influenza B. Additionally, in 2026, CoSara received a license from CDSCO to manufacture the CoSara PCR Pro®real-time PCR point-of-care instrument for sale or distribution.

Europe

Molecular

diagnostics, such as our tests, are governed in Europe by the framework for IVDs, which encompasses diagnostic products such as reagents,

instruments and systems intended for use in diagnosis of disease. The regulatory system for some IVDs historically allowed for a self-certification

procedure, placing heavy responsibility on manufacturers. Non self-certified products were subject to the same standards as self-certified

products but were also subject to audit and review by a notified body prior to receiving approval to receiving CE marking. A CE-marking

is a manufacturer’s declaration that a product meets the requirements of the applicable European Commission (EC) directive. Examples

of current obligations include having in place a qualitative manufacturing process, user instructions that are clear and fit for purpose,

and ensuring that the ‘physical’ features of devices and diagnostics do not pose any danger. If a product fulfils these and

other related control requirements, it may bear a CE marking, as an indication that the product is compliant with EU legislation and

sold in the European Union. We have received CE markings for six of our tests including for COVID-19, COVID-19 (2 gene test), ABC (a

triplex test for Flu A, Flu B and COVID-19), a DS (Direct Saliva, extraction-free) COVID-19 test, tuberculosis, Zika, and our Zika, dengue,

chikungunya triplex tests. In May 2022, the In Vitro Diagnostic Regulation (IVDR), a new regulation that significantly revised the requirements

for CE marking of IVDs, became effective. To avoid potential shortages of essential healthcare products, the EC extended the transition

deadlines in 2024. Co-Dx is actively pursuing CE-IVD compliance under IVDR through the Annex IX route to conformity. For manufacturers

actively pursuing IVDR compliance, European regulators have allowed a grace period until 2029 for Class B devices to harmonize their

devices and Quality Management Systems (QMS) with the new regulation.

Co-Diagnostics

PCR tests are manufactured under an ISO 13485:2016 certified quality management system, relating to the design and manufacture of our

medical device products. The ISO certification indicates that we meet the standards required to pursue CE-marking for certain of our

products, subject to the requirements in the updated directive mentioned above.

KSA/MENA

Region

In

October 2025, we entered into a definitive 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 upcoming Co-DxTM PCR point-of-care platform, within KSA and 18 other countries throughout the Middle East and North

Africa (“MENA”). CoMira’s mission aligns with the key pillars of Saudi Vision 2030, supporting technology localization,

industrial diversification, and healthcare innovation, as the new venture engages in research, development, manufacturing, assembly,

distribution, and commercialization of Co-Dx products. CoMira believes that initially pursuing regulatory clearance with the

Saudi Food & Drug Administration (“SFDA”) will also directly facilitate entry into many of the other 18 MENA countries

included in the agreement, consisting of: Bahrain, Iraq, Jordan, Kuwait, Lebanon, Oman, Palestine, Qatar, Syria, Turkey, United Arab

Emirates (UAE), Yemen, Algeria, Egypt, Libya, Morocco, Sudan and Tunisia

Arabian Eagle was the Company’s primary distributor in the Middle East and was instrumental in KSA being one of the largest international

markets for the Company’s Logix Smart® tests. Similar to the Company’s partnership in India with CoSara, Co-Dx will provide

CoMira an exclusive license to use, manufacture, and commercialize the licensed IP, which will include the upcoming Co-Dx PCR platform

as well as the Company’s existing suite of lab-based PCR diagnostic products. We believe that our cutting-edge PCR technology,

along with the scope and mission of CoMira, addresses the key demand drivers for growth published by KSA while reinforcing our resolve

to close the accessibility gap between high-quality PCR diagnostics and those who need them.

United

States

Section

801(e) of the Federal Food, Drug, and Cosmetic Act, as amended (the “FDA Act”) covers certain medical devices that have not

yet received an approved Premarket Approval in the United States by the FDA, such as our products. We have not commenced any premarket

approval of 510(k) submission steps with the FDA for any of our Logix Smart PCR tests. Section 801(e) of the FDA Act applies to medical

devices that are acceptable to the importing country and that are manufactured under the FDA’s Good Manufacturing Practices, and

grants Co-Diagnostics permission to export all of our IVD products. We have received EUA clearance for our Logix Smart COVID-19 test,

which allows sales to qualified labs in the United States and facilitates the registration for sale in other countries as well. We intend

to pursue all appropriate FDA review pathways for products under development, including traditional premarket review pathways.

Under

our EUA, we continue to sell our Logix Smart COVID-19 test to overseas customers and to CLIA certified laboratories in the United States.

The CLIA labs are able to use our test, or to further validate our COVID-19 tests (or other tests) as Laboratory Developed Tests (LDTs),

which refers to a diagnostic test that has been validated for use in the CLIA lab. LDTs may be used by the lab only in that laboratory.

CLIA laboratories develop the performance characteristics, perform the analytical validation for their LDTs and obtain licenses to offer

them as diagnostic services. We are currently marketing our Logix Smart COVID-19 test to CLIA laboratories throughout the US.

Market

Opportunity

The

market opportunity for our tests changed radically with the emergence of the COVID-19 pandemic. Because we were able to respond rapidly

and produce a quality product, we have been able to build a worldwide distribution network that

has allowed us to export products throughout the world. We anticipate that our network of distributors that we have built over

the past six years will serve us well in sales and distribution of other diagnostic tests and our forthcoming PCR diagnostic platform.

The

molecular diagnostics market is a fast-growing portion of the in vitro (test tube-based, controlled environment) diagnostics market.

There are several advantages of PCR tests over other forms of diagnostic testing. These advantages include higher specificity and sensitivity,

the ability to perform multiplex tests and the ability to test for drug resistance or for individual genes.

Mosquito

Vector Control Services

In

response to market demand, in June 2019 we introduced our first Vector Smart® PCR tests to be used exclusively for mosquito-borne

pathogens in mosquito populations. Municipalities in the US and many other countries in the world are concerned about the infections

carried by mosquitos, which infect the human population. To prevent outbreaks of potentially harmful viruses such as Zika or West Nile

from infecting the public, many municipalities conduct mitigation operations to eliminate the mosquito populations carrying the diseases.

Because it is too expensive and potentially harmful to the environment to treat all mosquito breeding areas, municipalities may identify

and focus their efforts on particular areas with mosquitos that are carrying these harmful viruses. To know where the host mosquitos

with harmful viruses are located, traps are set, mosquitos collected and then tested. There are over 3,000 mosquito abatement districts

throughout the United States and almost all of them conduct testing to help make the spraying more effective.

Our

first vector related test was the Vector Smart NAM-w triplex test for West Nile, western equine encephalitis and St. Louis encephalitis.

We began shipping the tests in June 2019. We added a second test that tests mosquitos for Zika, chikungunya and dengue in a triplex test.

Finally, in November 2019, we completed the Vector Smart NAM-e test for West Nile, eastern equine encephalitis and St. Louis encephalitis,

specifically for use in the eastern United States. As a result, mosquito abatement districts can test for three target viruses in one

test as compared to performing three different tests using other market available tests. Our products also allow municipalities to obtain

test results in-house in a matter of hours, instead of the days or weeks they might otherwise have to wait for a central lab to process

the mosquito tests.

We

have sold our Vector Smart test products and/or related lab equipment to testing districts in different sections of the country and are

marketing our products through trade shows, electronic and regular mail solicitations.

Competitive

Advantages of Co-Diagnostics

We

believe that we have the following competitive advantages:

Intellectual

Property

Much

of our future success and value depends on our proprietary technology, and therefore, our patent and intellectual property strategy is

of critical importance. Currently, our flagship Co-Primers technology is covered by two U.S. patents titled “Cooperative primers,

probes, and applications thereof” as well as by granted and pending foreign counterparts. We have another three U.S. patents directed

to our earlier work in primer and assay designs. For more recent works, we have filed international and U.S. patent applications directed

to “Methods and Compositions for Next Generation Sequencing (NGS) Library Preparation,” “Allele-Specific Design of

Cooperative Primers for Improved Nucleic Acid Variant Genotyping,” “Methods and Compositions Related to Cooperative Primers

and Reverse Transcription,” and “Systems, Methods, and Apparatus for Automated Self-Contained Biological Analysis”

which is the basis of the Co-Dx at-home and point-of-care PCR platform. In December 2025 we announced the first patent received for this

platform, granted by Australia (Patent No. AU2022270084A1). This was followed by the announcement in March 2026 that the Japan Patent

Office had granted Patent No. 7797537, titled “Systems, Methods, and Apparatus for Automated Self-Contained Biological Analysis,”

which includes 34 claims covering the fundamental systems, methods, and apparatus of the Co-Dx PCR Pro®instrument and proprietary

test cups designed for use with the system. We intend to continue building our patent portfolio as development continues and resources

are available.

We

also protect some of our technology and know-how as trade secrets and, where appropriate, we use and register trademarks to protect and

strengthen our products and proprietary brands. All trademarks, trade/product names, graphics and logos of Co-Diagnostics contained herein

are trademarks of Co-Diagnostics or its subsidiary, as applicable, in the U.S. and/or other countries. Solely for convenience, we may

refer to trademarks in this Annual Report on Form 10-K without the TM or ® symbols, but such references are not intended

to indicate, in any way, that we will not assert, to the fullest extent permitted by law, our rights to our trademarks.

Major

Customers

The

Company had certain customers which were each responsible for generating 10% or more of revenue for the years ended December 31, 2025

and 2024, respectively. One customer accounted for approximately 31% of product revenue for the year ended December 31, 2024. One granting

agency accounted for 100% of grant revenue for the year ended December 31, 2025, and two granting agencies accounted for approximately

95% of grant revenue for the year ended December 31, 2024. These customers and granting agencies may not account for the same percentage

of product revenue or grant revenue in future periods. If

we were to sell nothing to those customers in the future, it would have a material adverse effect on our financial condition unless we

were able to replace those customers with others.

Competition

The

molecular diagnostics industry is extremely competitive. There are many firms that provide some or all of the products we provide and

provide many diagnostic tests that we have yet to develop. Many of these competitors are larger than us and have significantly greater

financial resources. Many of our competitors have a competitive advantage in the diagnostic testing industry because they also have other

lines of business in the diagnostics, pharmaceutical, or biotech industries from which they derive revenues and for which they are well

known and respected in the medical profession. Many of these competitors already have an established customer base with industry standard

technology, which we must overcome to be successful. In the diagnostic testing and POCT industries, we compete with such companies as

BioMerieux, Siemens, Qiagen, Roche Diagnostics and Cepheid and with such pharmaceutical companies as Abbott Laboratories, Becton Dickinson

and Johnson and Johnson. We also compete with companies from Asia in certain markets who are willing to sell their tests for much less

than we sell our tests, which creates competitive price pressure on us in certain regions, particularly Asia and Latin America.

We

expect competition to continue to increase as other established and emerging companies enter the market, as customer requirements evolve,

and as new products, services and technologies are introduced. Some of our existing or new competitors may have strong relationships

with current and potential customers, including governmental authorities, and, as a result, may be able to respond more quickly to new

or changing regulatory requirements, new or emerging technologies, and changes in customer requirements.

Government

Regulation

In

the United States, we are regulated by the FDA and our products must be approved, cleared, or authorized by the FDA before we are allowed

to sell our tests in the United States as in vitro diagnostics. The FDA granted us an EUA to manufacture and sell our Logix Smart

COVID-19 test to CLIA labs in the United States. The Company operates under an ISO 13485:2016 certified quality management system, relating

to the design and manufacture of our medical device products. Being ISO certified greatly facilitates our applications for regulatory

clearance, including CE marking, which allows us to sell any tests in most countries in Europe, South America and Asia, depending on

the country and following that country’s registration process. We currently have CE markings issued for our Logix Smart COVID-19

test, tuberculosis test, Zika virus test, a Zika, dengue, and chikungunya multiplex test, a triplex “ABC” test that identifies

and distinguishes between Flu A, Flu B and Covid-19, our SARS-CoV-2 2-gene multiplex test, and our DS (Direct Saliva, extraction-free)

COVID-19 test. In addition, our Logix Smart COVID-19 has received the required license to manufacture and sell in India from India’s

CDSCO, and The National Epidemiology Institute in Mexico evaluated our Logix Smart COVID-19 and ABC tests and approved them for sale

in Mexico. We have also received clearance to sell our Logix Smart COVID-19 test in Australia.

Employees

As

of December 31, 2025, we had 115 full-time and part-time employees at our executive offices and lab facilities in Salt Lake City, Utah.

We have engaged independent contractors to promote the use of our products and develop outlets for products and employ the services of

independent sales representatives on an “as needed” basis.

We

consider our people and the way we work to support each other and serve our customers to be critical to our success. The key human capital

measures and objectives that we focus on in managing our business are maintaining a strong and collaborative company culture, increasing

our diversity, inclusion and belonging, offering fair and competitive compensation and benefits, investing in people and organizational

development, protecting and enriching employee health and wellness, and sustaining a culture of respectful and effective communications.

Organizational

History and Corporate Information

We

were incorporated as Co-Diagnostics, Inc., in Utah on April 18, 2013. Our principal executive office is located at 2401 S. Foothill Drive,

Salt Lake City, Utah 84109. Our telephone number is (801) 438-1036. Our web address is www.codiagnostics.com. The contents of

our website are not incorporated by reference in this Annual Report.

ITEM

1A. RISK FACTORS

Risks

Related to Our Business and Industry

We

have limited commercial history upon which to base our prospects and are not certain that we will achieve profitability in the future.

We

have a limited operating history. We began operations in April 2013. Our accumulated deficit was $80.4 million and $33.5 million

as of December 31, 2025 and 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

approval of clearance to commercialize such 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

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

the PCR Pro instrument and related diagnostic tests, demand for infectious disease diagnostics and upon our ability to develop and market

other commercially accepted diagnostic tests for our PCR platform.

Our

future success will depend, in part, on our development of our Co-Dx PCR platform and securing regulatory approval for the platform including

the PCR Pro instrument and related diagnostic tests, our ability to develop and sell sufficient quantities of other diagnostics tests,

and our ability to successfully and profitably market our Co-Dx PCR platform. Attracting new customers and distribution networks requires

substantial time and expense. Any failure to obtain regulatory approval for our product candidates and to increase sales of our diagnostic

tests in sufficient quantities to achieve profitability in a timely manner would adversely affect our operating results. Many factors

could affect the market acceptance and commercial success of any of our diagnostic tests and devices, including:

● the breadth of our test menu relative to competitors;

● the extent and success of our marketing and sales efforts; and

The

diagnostic market is highly competitive, and we may not be able to compete effectively against the larger, well-established companies

that dominate this market or emerging and small innovative companies that may seek to obtain or increase their share of the market.

The

markets for diagnostic products are intensely competitive, and many of our competitors are much larger and have substantially more financial

and human resources than we do. Many have long histories and strong reputations within the industry, and a relatively small number of

companies dominate these markets.

These

companies enjoy significant competitive advantages over us, including:

● products that are supported by long-term clinical data;

● greater financial and other resources for product research and development;

● established manufacturing operations and contract manufacturing relationships;

● significantly greater name recognition and widely recognized trademarks; and

● established relationships with healthcare providers and payers.

Our

products and any product candidates that we may introduce into the market may not enable us to overcome the competitive advantages of

these large and dominant companies. In addition, even if we successfully introduce additional product candidates into the market, emerging

and small innovative companies may seek to increase their market share and they may eventually possess competitive advantages, which

could adversely impact our business. Our competitors may also employ pricing strategies that could adversely affect the pricing of our

products.

We

depend on a limited number of third-party suppliers for key raw materials used in the manufacturing of our products, and the loss of

these third-party suppliers or their inability to supply us with adequate raw materials could harm our business.

We

rely on a limited number of third-party suppliers for the raw materials required for the production of our diagnostic products and product

candidates. Our dependence on a limited number of third-party suppliers involves several risks, including limited control over pricing,

availability, quality, and delivery schedules for raw materials. We have no supply agreements in place with any of our suppliers and

cannot be certain that our current suppliers will continue to provide us with the quantities of raw materials that we require or that

satisfy our anticipated specifications and quality requirements. Any supply interruption in limited or single sourced raw materials could

materially harm our ability to manufacture our products until a new source of supply, if any, could be identified and qualified. We may

be unable to find a sufficient alternative supply channel within a reasonable time or on commercially reasonable terms. Any performance

failure on the part of our suppliers could delay the production of our products and product candidates and delay the development and

commercialization of our product candidates, including limiting supplies necessary for commercial sale, clinical trials and regulatory

approvals, which could have a material adverse effect on our business.

In

order to be successful, we must expand our available product lines by commercializing new product candidates, but we may not be able

to do so in a timely fashion and at expected costs, or at all.

Although

we are currently manufacturing diagnostic kits for commercialization, in order to be successful, we will need to expand our product lines

to include other diagnostic products. To succeed in our commercialization efforts, we must effectively continue product development and

testing, find new strategic partners, obtain regulatory clearances and approvals, and enhance our sales and marketing capabilities. Because

of these uncertainties, there is no assurance that we will succeed in bringing any of our current or future product candidates to market.

If we fail in bringing our product candidates to market, or experience delays in doing so, we will not generate revenues as planned and

will need to curtail operations or seek additional financing earlier than otherwise anticipated.

We

are dependent on our senior management team, scientific team, and external advisors, and the loss of any of them could harm our business,

including by adversely affecting our ability to effectuate our business strategy.

The