8-K: bioAffinity Technologies Regains Nasdaq Listing Compliance

bioAffinity Technologies announced it has regained compliance with Nasdaq's minimum bid price and warrants listing rules, ensuring its continued listing on the Nasdaq Capital Market.

Summary

• bioAffinity Technologies, Inc. received written notice from Nasdaq on September 8, 2026, confirming it has regained compliance with the Minimum Bid Price Rule and the Rights/Warrants Rule.
• This means the company's common stock (BIAF) and warrants (BIAFW) will continue to be listed and traded on The Nasdaq Capital Market.
• A previously scheduled hearing before the Nasdaq Hearings Panel on September 8, 2026, has been cancelled.
• The company had previously been notified of non-compliance due to its bid price closing below $1.00 for thirty consecutive business days from June 16, 2026, to July 29, 2026.
• The company was not eligible for the standard 180-day compliance period due to a reverse stock split within the prior year.
• As of September 8, 2026, there were 1,166,625 outstanding shares of common stock with an aggregate market value of approximately $10.4 million.

Sentiment

Score: 8

Explanation: StockSavvy.ai views this as a positive development, as regaining compliance with Nasdaq listing requirements is crucial for continued trading and investor confidence.

Positives

• Regained compliance with Nasdaq's Minimum Bid Price Rule ($1.00 per share).
• Regained compliance with Nasdaq's Rights/Warrants Rule.
• Secured continued listing and trading of common stock (BIAF) and warrants (BIAFW) on The Nasdaq Capital Market.
• Cancellation of the Nasdaq Hearings Panel hearing.
• The CyPath Lung test demonstrated high performance in a published clinical trial: 92% sensitivity, 87% specificity, 88% accuracy, and 99% negative predictive value (NPV) for detecting lung cancer in high-risk patients.
• The company is focused on expanding access to its CyPath Lung test and developing its pipeline of noninvasive healthcare solutions.

Negatives

• Previously faced delisting risk due to bid price falling below $1.00 for 30 consecutive business days.
• Was not eligible for the standard 180-day compliance period due to a prior reverse stock split.
• The company must maintain ongoing compliance with all applicable Nasdaq listing requirements.

Risks

• The company's ability to maintain compliance with Nasdaq's continued listing requirements.
• The company's ability to obtain additional financing.
• The company's ability to achieve commercial adoption of CyPath Lung.
• Risks related to regulatory developments.
• Other factors discussed in the Company's Annual Report on Form 10-K for the year ended December 31, 2025, and subsequent filings.

Future Outlook

The company must maintain ongoing compliance with all applicable Nasdaq listing requirements. The company is focused on expanding access to its CyPath Lung test and continuing development of its broader pipeline of noninvasive healthcare solutions while building long-term value for shareholders.

Management Comments

• "We are pleased to have regained full compliance with Nasdaqs listing standards," said Maria Zannes, President and Chief Executive Officer of bioAffinity Technologies.
• "Maintaining our Nasdaq listing allows us to remain focused on expanding access to our noninvasive CyPath Lung test for lung cancer and continuing development of our broader pipeline of noninvasive healthcare solutions while building long-term value for shareholders."

Industry Context

StockSavvy.ai notes that maintaining a listing on a major exchange like Nasdaq is critical for biotechnology companies, especially those in the early stages of commercialization, as it provides liquidity, visibility, and access to capital markets. Regaining compliance after a period of non-compliance demonstrates operational resilience and management's ability to address critical listing requirements.

Stakeholder Impact

• Shareholders: Continued listing on Nasdaq provides liquidity and maintains investor confidence, potentially supporting share value.
• Employees: Continued listing provides stability and supports the company's mission and growth objectives.
• Customers: Continued operation and development of CyPath Lung and other solutions benefits patients seeking early disease detection.
• Creditors: Continued listing and operational stability are positive for creditors.

Next Steps

• Maintain ongoing compliance with all applicable Nasdaq listing requirements.
• Continue to focus on expanding access to the CyPath Lung test.
• Continue development of the broader pipeline of noninvasive healthcare solutions.

Key Dates

Recommendation

The filing confirms the company has regained compliance with Nasdaq listing requirements, which is a critical positive development that removes an immediate risk of delisting. However, the company still faces challenges related to financing, commercial adoption of its CyPath Lung test, and ongoing compliance. While the delisting threat has been averted, significant operational and financial hurdles remain, suggesting a 'hold' recommendation pending further progress on commercialization and financial stability.

Keywords

Nasdaq compliance, Minimum Bid Price Rule, CyPath Lung, lung cancer detection, biotechnology, healthcare solutions, warrants, stock listing