Co-Diagnostics Inc Stock Price, News & Analysis

Co-Diagnostics (NASDAQ: CODX) reported Q1 2025 financial results with revenue of $0.1 million, down from $0.5 million in Q1 2024 due to lack of grant revenue recognition. The company reduced operating expenses by 18.2% to $8.6 million and reported a net loss of $7.5 million ($0.24 per share), improved from $9.3 million loss in Q1 2024. Cash position stood at $21.5 million as of March 31, 2025. The company remains on track for initiating clinical evaluations of 4 tests in its product pipeline and completing its India manufacturing facility by year-end 2025. These tests include tuberculosis, respiratory multiplex, HPV multiplex, and COVID-19, all designed for use with the Co-Dx PCR Pro platform, which is still pending FDA review.

Co-Diagnostics (NASDAQ: CODX), a molecular diagnostics company known for its patented diagnostic test development platform, has scheduled its first quarter 2025 earnings release for Thursday, May 8, 2025, after market close.

The company will host a conference call and webcast at 4:30 p.m. ET on the same day. Key executives participating include:

• Dwight Egan - Chief Executive Officer
• Brian Brown - Chief Financial Officer
• Andrew Benson - Head of Investor Relations

Investors and analysts can access the event through:

• Webcast: Available on ir.codiagnostics.com (Events & Webcasts page)
• Conference Call: Toll-free (800-715-9871) or Toll (646-307-1963)
• Passcode: 1977478

A recording will be available on the company's website for those unable to attend the live session.

Co-Diagnostics (NASDAQ: CODX) reported its full-year 2024 financial results, showing a decline in revenue to $3.9 million from $6.8 million in 2023. The company's financial performance included:

- Operating expenses of $43.0 million, down 5.2% year-over-year
- Operating loss of $40.1 million
- Net loss of $37.6 million ($1.24 per share)
- Cash position of $29.7 million as of December 31, 2024

Key developments included opening new manufacturing facilities in India and South Salt Lake, and withdrawing their initial FDA 510(k) application for the Co-Dx™ PCR Pro™ Platform to submit an enhanced version. The company plans to commence clinical evaluations for tuberculosis, HPV multiplex, and upper respiratory multiplex tests later in 2025.

Co-Diagnostics (NASDAQ: CODX), a molecular diagnostics company, has scheduled its fourth quarter and full year 2024 earnings release for Thursday, March 27, 2025, after market close. The company will host a conference call and webcast at 4:30 p.m. ET on the same day.

Key executives participating in the call include CEO Dwight Egan, CFO Brian Brown, and Head of Investor Relations Andrew Benson. Investors can access the webcast through the company's investor relations website and join the conference call via domestic (844-481-2661) or international (412-317-0652) lines. A recording will be available on the company's website for those unable to attend the live event.

Co-Diagnostics (CODX) has secured a significant legal victory as the United States District Court for the District of Utah granted complete dismissal of a securities class action lawsuit on March 4, 2025. The lawsuit, filed by Gelt Trading on June 15, 2020, alleged violations of Securities Exchange Act sections regarding the company's May 1, 2020 press release about its Logix Smart® COVID-19 test.

The plaintiff claimed that CODX's statement about '100% sensitivity and 100% specificity' was misleading to investors, suggesting the test was perfectly accurate. However, the Court ruled in favor of CODX, concluding that the plaintiff failed to demonstrate loss causation, as none of the three alleged corrective disclosures effectively 'corrected' the May 1 press release or impacted the stock price.

BakerHostetler, representing CODX, successfully argued that the supposedly contradictory information was already known to the market and reflected in the stock price. This dismissal allows the company to focus on its core mission of expanding global access to high-quality molecular diagnostics.

Co-Diagnostics (CODX) and CoSara Diagnostics announced they will host a symposium titled 'HPV and Cancer: Exploring Advances in Prevention and Care' on March 4, 2025, in Baroda, India, coinciding with International HPV Awareness Day. The event will feature speakers from both companies and cancer experts from across India.

The symposium comes as CODX completes development of its HPV multiplex test on the Co-Dx PCR point-of-care platform, designed to identify 8 high-risk HPV subtypes from cervical swab samples. This development aims to provide affordable HPV screening, particularly in low and middle-income countries, where according to WHO, 94% of the 350,000 cervical cancer deaths in 2022 occurred.

CoSara's Saragene® Human Papillomavirus-High Risk real-time PCR test has already received Indian CDSCO clearance for detecting HPV high-risk genotypes 16 and 18. The National Cancer Institute reports that high-risk HPV subtypes cause approximately 5% of all cancers worldwide, with cervical cancer being the fourth most common cancer in women.

Co-Diagnostics (CODX) has announced the withdrawal of its current 510(k) FDA application for the Co-Dx™ PCR COVID-19 Test on the PCR Pro™, with plans to submit an enhanced version. The withdrawal follows FDA feedback regarding shelf-life stability concerns of a test component.

The company reports positive engagement with the FDA and satisfactory test performance in clinical evaluations. The decision to submit an enhanced version allows Co-Dx to address stability issues and incorporate recent platform developments, potentially improving operational and manufacturing efficiencies.

Moving forward, Co-Dx plans to submit the enhanced COVID-19 test for 510(k) OTC clearance after collecting new clinical evaluation data. The company's pipeline includes future tests for tuberculosis, upper-respiratory multiplex, and HPV. The Co-Dx PCR platform remains under regulatory review and is not yet available for sale.

Co-Diagnostics (CODX) announced its participation at BioUtah's Life Sciences Day on the Hill at the Utah State Capitol Rotunda on January 30, 2025. The event, presented by the Utah Life Sciences Innovation Caucus, the Utah Governor's Office of Economic Opportunity, and BioUtah, features over 25 Utah life sciences companies.

At the event, Co-Dx will showcase its upcoming Co-Dx PCR testing platform for at-home and point-of-care detection of infectious diseases, including COVID-19, influenza, RSV, HPV, and tuberculosis. The platform features cloud-based analysis capabilities for tracking disease outbreaks and is operated through a smartphone interface.

The company notes that the Co-Dx PCR platform, including the Co-Dx PCR Home™, Co-Dx PCR Pro™, mobile app, and associated tests and software, is currently under FDA review and not yet available for sale.

Co-Diagnostics (CODX) announced its participation in Nasdaq's Live from MarketSite broadcast at the Silicon Slopes Summit 2025 on January 14, 2025. CEO Dwight Egan will discuss the upcoming Co-Dx PCR platform and its test pipeline for various diseases, including COVID-19, tuberculosis, HPV, and an upper respiratory multiplex panel.

The company's Co-Dx™ Logix Smart® ABC Test currently detects all known H5N1 strains and is available as a Research Use Only (RUO) assay in the US and as an in vitro diagnostic in CE-marking regions. The company has also completed design work for an H5N1-specific target and is prepared to launch an updated 3-gene version of their mpox test.

Amid a post-holiday COVID-19 surge, the company continues to develop solutions for infectious diseases, including HMPV, H5N1, and mpox. The broadcast will be available on Nasdaq's Live from MarketSite webpage and the company's social media platforms.