Co-Diagnostics, Inc. reported a significant decline in financial performance for the fiscal year ending December 31, 2025, with total revenue falling to $622,489, an 84% decrease from $3.9 million in 2024. This decline was primarily attributed to a substantial drop in grant revenue, which plummeted by 94% to $204,284, compared to $3.1 million in the previous year. Product revenue also decreased by 46%, from $770,048 in 2024 to $418,205 in 2025. The company's gross profit similarly fell to $400,112, down 86% from $2.9 million in the prior year.
Operating expenses increased by 18% to $50.6 million, driven largely by an impairment charge of $18.9 million related to in-process research and development intangible assets. This charge was a significant factor in the company's net loss, which widened to $46.9 million from $37.6 million in 2024. The company also recorded an income tax benefit of $1.6 million in 2025, compared to a tax expense of $57,368 in the previous year, reflecting changes in tax legislation that allowed for certain federal and state tax refunds.
In terms of strategic developments, Co-Diagnostics has focused on advancing its Co-Dx PCR platform, which is designed for point-of-care and at-home testing. The company withdrew its 510(k) submission for the Co-Dx PCR COVID-19 test after discussions with the FDA regarding the analytical approach for detecting potential degradation of a test component. Management has redirected efforts towards developing a multiplex test for influenza A/B, COVID-19, and RSV, which aligns with current clinical demand for comprehensive upper respiratory infection testing. Clinical performance studies for this multiplex test are currently underway.
Operationally, Co-Diagnostics has seen a reduction in its workforce, with 115 employees reported as of December 31, 2025, down from previous years. The company has also expanded its geographic reach, entering into a joint venture with Arabian Eagle Manufacturing to develop and commercialize its technologies in the Middle East and North Africa. This partnership is expected to enhance the company's market presence in these regions, which are critical for its growth strategy.
Looking ahead, Co-Diagnostics faces challenges in securing additional financing to support its operations and product development. The company has indicated that it may need to raise further capital through equity or debt financing, which could be dilutive to existing shareholders. The ongoing uncertainty regarding its ability to continue as a going concern remains a significant risk, as highlighted in its financial statements. The company’s management is actively pursuing strategies to improve liquidity and capitalize on market opportunities, but the path to profitability remains uncertain.
About Co-Diagnostics, Inc.
Co-Diagnostics, Inc. develops and manufactures molecular diagnostic tests using proprietary PCR technology to detect infectious diseases and genetic traits. Its core products include PCR-based diagnostic kits for COVID-19, influenza, tuberculosis, HPV, and other pathogens, sold globally to clinical labs and health agencies. The company emphasizes affordable, rapid, and accurate testing solutions, with a focus on innovative platform development for point-of-care and at-home use.
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