Co-Diagnostics, Inc.

Co-Diagnostics, Inc. (CODX) operates in the molecular diagnostics industry, focusing on developing, manufacturing, and selling reagents for diagnostic tests that detect and analyze nucleic acid molecules (DNA or RNA), primarily for infectious diseases. The company's core technical advance is a proprietary approach to polymerase chain reaction (PCR) test design, known as Co-Primers®, which aims to reduce false positives in PCR amplification. CODX positions itself as a low-cost provider of molecular diagnostics and screening services, leveraging its proprietary platform to avoid patent royalties typically associated with other PCR test systems, thereby enabling significant margins while offering competitive pricing. The company's business model involves generating revenue from product sales of its diagnostic tests and from grants for development activities. Its primary customer segments include clinical laboratories globally, and it is developing products for point-of-care and at-home use. CODX has established a worldwide distribution network covering clinical labs in over 50 countries.

CODX's product and service lines include lab-based PCR diagnostic tests and a developing portable diagnostic device and test system for point-of-care and at-home use. The lab-based tests, designed using Co-Primers® technology, detect infectious diseases such as COVID-19, influenza, tuberculosis, hepatitis B and C, human papillomavirus, malaria, chikungunya, dengue, and the Zika virus. These tests are cleared for use in clinical labs only. In the United States, the Logix Smart® COVID-19 test has Emergency Use Authorization (EUA) from the FDA. Internationally, these tests have received CE marking for sale in the European Community and regulatory clearance in India (through its joint venture CoSara), the United Kingdom, Australia, and Mexico. The company also sells diagnostic equipment from other manufacturers, referred to as the "Co-Dx Box™," in connection with its tests. Beyond infectious diseases, Co-Primers technology is applied to identify genetic traits in plant and animal genomes, and CODX has commercialized three multiplexed Vector Smart® PCR tests for mosquito-borne pathogens, enabling municipalities to target mosquito control efforts.

The Co-Dx™ PCR platform is a portable diagnostic device and test system designed for point-of-care and at-home use. It comprises the Co-Dx™ PCR Pro® instrument, patent-pending diagnostic test cup system, and a mobile application, aiming to provide PCR test results in approximately 30 minutes. This platform is currently subject to U.S. FDA review and is not yet available for sale. An initial 510(k) clearance application for a COVID-19 test on this platform was voluntarily withdrawn in June 2024 due to discussions with the FDA regarding the analytical approach for detecting potential degradation of a test component. Management has since shifted focus to developing and clinically validating a Co-Dx PCR Flu A/B, COVID-19, RSV multiplex test ("ABCR") for this platform, believing it better aligns with current clinical demand for comprehensive upper respiratory infection testing in point-of-care settings. Clinical performance studies for the ABCR test commenced in November 2025. CODX is also developing TB and HPV diagnostic tests for the Co-Dx PCR platform, supported by grants totaling $6.8 million ¹ and $987,000 ² respectively from the Bill & Melinda Gates Foundation.

For the fiscal year ended December 31, 2025, CODX reported total revenue of $622,489 ³, a significant decrease from $3,915,160 ⁴ in the prior year. Product revenue was $418,205 ⁵, down from $770,048 ⁶ in 2024, while grant revenue decreased substantially to $204,284 ⁷ from $3,145,112 ⁸. The company recorded a gross profit of $400,112 ⁹ in 2025, compared to $2,916,036 ¹⁰ in 2024. Operating expenses totaled $50,565,464 ¹¹, an increase from $42,997,346 ¹² in 2024, primarily driven by impairment charges. The net loss for 2025 was $46,895,936 ¹³, a widening from $37,639,008 ¹⁴ in 2024. Basic and diluted EPS were both $(35.25) ¹⁵ for 2025, compared to $(37.22) ¹⁶ for 2024. Cash and cash equivalents stood at $11,884,607 ¹⁷ as of December 31, 2025. The company had no marketable investment securities at year-end 2025, down from $26,811,098 ¹⁸ in 2024. Total current assets were $13,693,465 ¹⁹ and total current liabilities were $3,539,620 ²⁰. Net cash used in operating activities was $29,136,927 ²¹.

Year-over-year, total revenue decreased by $3,292,671 ²², or 84% ²³, primarily due to lower grant revenues. Product revenue declined by 46% ²⁴, and grant revenue by 94% ²⁵. Cost of revenue decreased by $776,747 ²⁶, or 78% ²⁷, from $999,124 ²⁸ in 2024 to $222,377 ²⁹ in 2025. Gross profit decreased by $2,515,924 ³⁰, or 86% ³¹. Total operating expenses increased by $7,568,118 ³², or 18% ³³, mainly due to an impairment charge of $18,882,000 ³⁴ related to in-process research and development intangible assets. Sales and marketing expenses decreased by $2,102,208 ³⁵, or 47% ³⁶, to $2,381,131 ³⁷. General and administrative expenses decreased by $7,098,869 ³⁸, or 44% ³⁹, to $9,058,283 ⁴⁰. Research and development expenses decreased by $1,842,347 ⁴¹, or 9% ⁴², to $19,137,242 ⁴³. The net loss widened by $9,256,928 ⁴⁴, or 25% ⁴⁵.

Significant operational developments during the period include the voluntary withdrawal of the 510(k) submission for the Co-Dx PCR COVID-19 Test in June 2024, with a strategic pivot to developing the Co-Dx PCR Flu A/B, COVID-19, RSV multiplex test (ABCR), for which clinical performance studies commenced in November 2025. In October 2025, CODX formed a new joint venture, CoMira Diagnostics, with Arabian Eagle Manufacturing in Saudi Arabia, investing an initial $102,566 ⁴⁶ for a 50% ⁴⁷ ownership interest, to research, develop, manufacture, assemble, distribute, and commercialize Co-Dx technologies in KSA and 18 other MENA countries. The company also completed two registered direct offerings in September and October 2025, raising gross proceeds of approximately $3,847,600 ⁴⁸ and $7.0 million ⁴⁹ respectively. A 1-for-30 reverse stock split was effected on January 1, 2026, reducing outstanding common stock from approximately 62.9 million shares to approximately 2.1 million shares ⁵⁰. Subsequent to year-end, on March 31, 2026, the company approved a workforce reduction impacting approximately 26% ⁵¹ of its employees.

Management explicitly states that the company anticipates continuing to generate operating losses and use cash in operations in the near term. The ability to obtain additional financing in equity capital markets is subject to several factors, including market and economic conditions, company performance, and investor sentiment. There is no assurance that the company will be able to raise a sufficient amount of additional capital to fund operations with acceptable terms, or at all.

A major growth area for CODX is the development and commercialization of its Co-Dx PCR platform, designed for affordable, reliable PCR testing in point-of-care and at-home settings. While the initial 510(k) submission for a COVID-19 test on this platform was withdrawn, management has strategically refocused capital and time towards the development and clinical validation of the Co-Dx PCR Flu A/B, COVID-19, RSV multiplex test (ABCR). Clinical performance studies for the ABCR test commenced in November 2025. This multiplex test is believed to better align with current clinical demand for comprehensive upper respiratory infection testing in point-of-care settings. The company is also developing diagnostics tests for TB and HPV for use with its Co-Dx PCR platform, supported by grants of $6.8 million ⁵² for the TB test and $987,000 ⁵³ for the HPV test from the Bill & Melinda Gates Foundation. These initiatives target significant global health challenges, with the WHO reporting a gap of approximately 2.4 million ⁵⁴ unidentified TB cases in 2024 and high-risk HPVs causing roughly 5% ⁵⁵ of all cancers worldwide.

Another significant growth vector is the newly formed joint venture, CoMira Diagnostics, established in October 2025 with Arabian Eagle Manufacturing in the Kingdom of Saudi Arabia (KSA). CODX invested an initial $102,566 ⁵⁶ for a 50% ⁵⁷ ownership interest. CoMira's mission is to research, develop, manufacture, assemble, distribute, and commercialize Co-Dx technologies and intellectual property, including the upcoming Co-Dx PCR point-of-care platform, within KSA and 18 other countries across the Middle East and North Africa (MENA) region. This venture aligns with Saudi Vision 2030's pillars of technology localization, industrial diversification, and healthcare innovation. Pursuing regulatory clearance with the Saudi Food & Drug Administration (SFDA) is expected to facilitate entry into the broader MENA market.

Operationally, the company is undergoing a workforce reduction, approved on March 31, 2026, impacting approximately 26% ⁵⁸ of its employees across multiple functions. This action is part of an ongoing effort to align the cost structure with current business conditions and strategic priorities. The company expects this reduction to be substantially completed by April 15, 2026, and anticipates a reduction in operating expenses beginning in the second quarter of 2026. Management continues to evaluate its cost structure and may take additional actions as deemed appropriate to support its long-term strategic objectives.

Regarding capital allocation, CODX's cash and cash equivalents were $11,884,607 ⁵⁹ at December 31, 2025. The company completed a registered direct offering in September 2025, selling 320,634 ⁶⁰ shares of common stock at $12.00 ⁶¹ per share, generating gross proceeds of approximately $3,847,600 ⁶². Another registered direct offering in October 2025 involved selling 400,076 ⁶³ shares of common stock at $16.50 ⁶⁴ per share and 24,167 ⁶⁵ pre-funded warrants at $16.497 ⁶⁶ per warrant, yielding gross proceeds of approximately $7.0 million ⁶⁷. The net proceeds from these offerings are intended for working capital and general corporate purposes. Additionally, the company entered into a new at-the-market (ATM) equity offering program with Maxim Group LLC in October 2025, allowing for the sale of common stock with an aggregate offering price of up to $10.0 million ⁶⁸. As of December 31, 2025, 31,667 ⁶⁹ shares had been sold under this new ATM, resulting in net proceeds of approximately $258,563 ⁷⁰. Subsequent to year-end, an additional 1,507,434 ⁷¹ shares were sold under the ATM, generating net proceeds of $4,334,671 ⁷². The company does not expect to pay cash dividends on its common stock in the foreseeable future, intending to use all available funds to finance future development and business expansion.

The company faces substantial risks, including its limited commercial history and recurring operating losses, with an accumulated deficit of $80.4 million ⁷³ as of December 31, 2025, raising substantial doubt about its ability to continue as a going concern. Future success is highly dependent on obtaining regulatory approval for its Co-Dx PCR platform and related diagnostic tests, which is not guaranteed, and the ability to successfully commercialize these products in a highly competitive molecular diagnostics market dominated by larger companies. Dependence on a limited number of third-party suppliers for key raw materials without supply agreements poses risks to manufacturing and product development. The company is subject to evolving and stringent data protection, privacy, and information security laws globally, with non-compliance potentially leading to significant fines, litigation, and reputational harm. Intellectual property protection is critical, and challenges to patents or infringement claims could be costly and divert management attention. The company is currently involved in legal proceedings, including a securities class action lawsuit and civil actions claiming breach of contract, with potential for material adverse effects on financial condition if outcomes are unfavorable. The price of its common stock is subject to wide fluctuations due to various factors, including regulatory approvals, financing efforts, and competition. Furthermore, the company is subject to a Discretionary Panel Monitor by Nasdaq through March 9, 2027, meaning if its closing bid price falls below $1.00 ⁷⁴ per share for 30 consecutive business days during this period, Nasdaq may issue a delisting determination without an additional compliance period.

Management's message to shareholders conveys a focus on strategic development and cost alignment amidst challenging financial conditions. They explicitly state that the company will continue to generate operating losses and use cash in operations in the near term, and that substantial doubt exists about the company's ability to continue as a going concern for the next 12 months from the financial statements' issuance date. Key strategic priorities emphasized include the continued development and regulatory approval of the Co-Dx PCR platform, particularly the Co-Dx PCR Flu A/B, COVID-19, RSV multiplex test (ABCR), following the voluntary withdrawal of the initial COVID-19 test submission. Management believes the ABCR test better aligns with current clinical demand. Another priority is expanding the company's global footprint and technology commercialization through strategic partnerships, as evidenced by the formation of the CoMira Diagnostics joint venture in the KSA/MENA region. Finally, management is actively managing its cost structure, as demonstrated by the workforce reduction initiated on March 31, 2026, impacting approximately 26% ⁷⁵ of employees, with an expectation of reduced operating expenses starting in the second quarter of 2026.