Co-Diagnostics Reports Full Year 2025 Financial Results

Original from: PR Newswire

Co-Diagnostics, Inc. (NASDAQ: CODX) ("Co-Diagnostics," "Co-Dx," or "the Company"), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, today announced its financial results for the full year ended December 31, 2025.

Full Year 2025 Financial Results:

- Revenue of $0.6 million, compared to $3.9 million in 2024, primarily due to lower grant revenue

- Operating expenses of $50.6 million, compared to $43.0 million in 2024, driven by a non-cash impairment charge of $18.9 million from revaluation of intangible assets

- Operating loss of $50.2 million, compared to $40.1 million in 2024

- Net loss of $46.9 million, or $35.25 per share, compared to net loss of $37.6 million, or $37.22 per share in 2024, primarily due to intangible asset impairment charges and lower grant revenue, partially offset by decreases in operating expenses and a benefit from income taxes

- Adjusted EBITDA loss of $28.0 million, compared to a loss of $33.5 million in 2024

- Cash, cash equivalents, and marketable investment securities totaled $11.9 million as of December 31, 2025, compared to $29.7 million as of December 31, 2024

Full Year 2025 Business Highlights:

- Closed $3.8 million offering of 9.62 million shares of common stock at an offering price of $0.40 per share on a pre-reverse split basis

- Closed $7.0 million offering of 12.7 million shares of common stock at an offering price of $0.55 per share on a pre-reverse split basis

- Continued advancement of CoSara Diagnostics joint venture in India, including regulatory progress and manufacturing readiness for PCR Pro® instrument*

- Signed definitive agreement with Arabian Eagle to establish CoMira Diagnostics joint venture in Saudi Arabia; currently progressing on execution and finalizing lease for manufacturing facility

- Initiated and advanced clinical evaluations of upper respiratory multiplex test

- Further progressed development across pipeline programs, including tuberculosis (TB) and HPV tests

- Expanded the AI business unit, integrating machine learning capabilities into the Co-Dx™ Primer Ai™ platform

- Strengthened the intellectual property portfolio with a new international patent granted in Australia

- Engaged Maxim Group to pursue SPAC transaction for CoSara Diagnostics

- Received recognition from Utah Governor's Office and BioUtah for the formation of CoMira Diagnostics

Recent Developments:

- Received CDSCO license to manufacture and sell the CoSara PCR Pro® instrument in India, representing a key regulatory milestone and enabling commercialization readiness

- Signed an agreement to expand CoSara Diagnostics' commercial and distribution territory across South Asia to include Bangladesh, Pakistan, Nepal, and Sri Lanka, increasing the regional addressable market to approximately $13 billion

- Initiated shipments of PCR Pro® instruments and tuberculosis (TB) test* materials to India to support upcoming clinical performance studies, with the instrument and test kits being aligned with new WHO guidance on TB testing

- Strengthened the intellectual property portfolio with a new international patent granted in Japan

"Over the past year, we made meaningful progress across multiple initiatives that have positioned the Company for its next phase of growth, including advancing our clinical pipeline, expanding our global footprint, and preparing for commercialization of the platform in 2026," said Dwight Egan, Chief Executive Officer of Co-Diagnostics. "Importantly, we have remained focused on execution and continued to build momentum across the business. Our strategy is centered on four key pillars: advancing CoSara and our broader opportunity in India, executing on our CoMira joint venture in the Middle East and Northern Africa, progressing our clinical programs toward key regulatory milestones, and expanding our AI-driven capabilities. Together, these initiatives support our scalable, globally deployable diagnostics platform and reinforce our focus on long-term value creation."

Mr. Egan continued, "Based on dramatically reduced rates of COVID prevalence in our clinical study locations, we are currently planning on an initial FDA 510(k) submission for our upper respiratory test focused on flu A, flu B, and RSV. As we move forward, we remain committed to disciplined performance as we advance toward commercialization, and we anticipate that this modified approach will allow us to accelerate regulatory and commercialization timelines while retaining the flexibility to incorporate COVID into the test at a later stage if conditions change.

"We believe the progress we've made in our clinical studies and on all other initiatives are creating a clear path to unlock the full potential of our platform as we enter the next phase of execution in 2026."

Source: Co-Diagnostics Reports Full Year 2025 Financial Results