bioAffinity regains Nasdaq listing compliance
Rhea-AI Filing Summary
bioAffinity Technologies, Inc. (BIAF) reports that it has regained compliance with Nasdaq’s listing requirements, including the Minimum Bid Price Rule and the Rights/Warrants Rule, so its common stock and warrants will continue to be listed and traded on the Nasdaq Capital Market.
Nasdaq confirmed compliance in a letter dated September 8, 2026, cancelling a previously scheduled hearing before a Nasdaq Hearings Panel. As of September 8, 2026, the company had 1,166,625 common shares outstanding with an aggregate market value of approximately $10.4 million based on that day’s closing price.
The company also highlights performance of its CyPath® Lung test, which in a published clinical trial of high-risk patients showed 92% sensitivity, 87% specificity, 88% accuracy and 99% negative predictive value for detecting lung cancer in patients with small indeterminate lung nodules less than 20 millimeters.
Positive
- Regains Nasdaq compliance, avoiding a delisting process and keeping common stock and warrants listed and traded on the Nasdaq Capital Market.
- Clinical data for CyPath Lung show 92% sensitivity, 87% specificity, 88% accuracy and 99% negative predictive value in detecting lung cancer in high-risk patients with small nodules.
Negative
- None.
Filing Explained
The September 9 8-K adds that Nasdaq had found no standard 180-day compliance period available because the company had effected a reverse stock split within the prior year; after the company’s appeal, the scheduled hearing was cancelled, and continued listing remains subject to ongoing compliance.
8-K Event Classification
Key Figures
Key Terms
Minimum Bid Price Rule regulatory
Rights/Warrants Rule regulatory
Nasdaq Capital Market market
Laboratory Developed Test (LDT) medical
Clinical Laboratory Improvement Amendments (CLIA) medical
negative predictive value (NPV) medical
FAQ
What Nasdaq issue did bioAffinity Technologies (BIAF) resolve in this 8-K?
Will BIAF and BIAFW continue trading on the Nasdaq Capital Market?
What are the key CyPath Lung clinical performance metrics mentioned for BIAF?
How is CyPath Lung by bioAffinity Technologies (BIAF) regulated and marketed?
AI-generated analysis. How Rhea-AI works. Not financial advice.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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Item 8.01 Other Events.
As previously disclosed in a Current Report on Form 8-K filed by bioAffinity Technologies, Inc. (the “Company”) on July 30, 2026, the Company received written notice (the “Staff Determination”) from the Listing Qualifications Staff (the “Staff”) of The Nasdaq Stock Market LLC (“Nasdaq”) notifying the Company that the Staff determined that the bid price of the Company’s listed securities had closed at less than $1.00 per share over the previous thirty consecutive business days (from June 16, 2026, through July 29, 2026) and, as a result, the Company was not in compliance with the minimum bid price requirement for continued listing on The Nasdaq Capital Market set forth in Nasdaq Listing Rule 5550(a)(2) (the “Minimum Bid Price Rule”). The Staff Determination further provided that normally a company would be afforded a 180-calendar day period to demonstrate compliance with the Minimum Bid Price Rule. However, pursuant to Nasdaq Listing Rule 5810(c)(3)(A)(iv), the Company was not eligible for any compliance period specified in Nasdaq Listing Rule 5810(c)(3)(A) due to the fact that the Company had effected a reverse stock split over the prior one-year period. The Company submitted an appeal to Nasdaq on August 6, 2026, and a hearing before the Nasdaq panel (the “Hearings Panel”) was scheduled for September 8, 2026.
On September 8, 2026, the Company received written notice (the “Written Notice”) from the Staff confirming that the Company has regained compliance with the Minimum Bid Price Rule and Nasdaq Listing Rule 5560(a) (the “Rights/Warrants Rule”). The Written Notice further provided that the hearing before the Hearings Panel scheduled to take place on September 8, 2026, had been cancelled and that the Company’s securities will continue to be listed and traded on The Nasdaq Capital Market.
On September 9, 2026, the Company issued a press release announcing that it has regained compliance with the Minimum Bid Price Rule. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
As of September 8, 2026, there were 1,166,625 outstanding shares of the Company’s common stock and the aggregate market value of the Company’s common stock was approximately $10.4 million based on the closing price of a share of the Company’s common stock on that date, as reported by The Nasdaq Capital Market.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
| Exhibit No. | Description | |
| 99.1 | Press Release of bioAffinity Technologies, Inc. dated September 9, 2026 | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this Current Report on Form 8-K to be signed on its behalf by the undersigned hereunto duly authorized.
| Date: September 9, 2026 | BIOAFFINITY TECHNOLOGIES, INC. | |
| By: | /s/ Maria Zannes | |
| Name: | Maria Zannes | |
| Title: | President and Chief Executive Officer | |
Exhibit 99.1
bioAffinity Technologies Regains Compliance with Nasdaq Listing Requirements
BIAF continues to be listed and traded on Nasdaq
SAN ANTONIO, TX — September 9, 2026 — bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company developing noninvasive healthcare solutions for the early detection and monitoring of lung disease, today announced that it has received written notice from The Nasdaq Stock Market LLC stating that the Company has regained compliance with Nasdaq’s applicable listing requirements.
As a result of this determination, bioAffinity Technologies’ common stock and warrants will continue to be listed and traded on the Nasdaq Capital Market under the symbols BIAF and BIAFW, respectively, subject to the Company’s continued compliance with all applicable Nasdaq listing requirements.
“We are pleased to have regained full compliance with Nasdaq’s 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.”
In a letter dated September 8, 2026, Nasdaq confirmed that the Company has regained compliance with Listing Rule 5550(a)(2), which requires a minimum bid price of $1.00 per share (the “Bid Price Rule”), and Listing Rule 5560(a), which establishes listing requirements applicable to rights and warrants (the “Rights/Warrants Rule”). As a result, the previously scheduled hearing before the Nasdaq Hearings Panel has been cancelled. The Company is required to maintain ongoing compliance with all applicable Nasdaq listing requirements to remain listed on the Nasdaq Capital Market.
About CyPath Lung
CyPath Lung by bioAffinity Technologies is a noninvasive test designed to improve the early detection of lung cancer in patients at high risk for the disease. CyPath Lung uses advanced flow cytometry and proprietary artificial intelligence (AI) to identify cell populations in patient sputum that indicate malignancy. CyPath Lung incorporates a fluorescent porphyrin that is preferentially taken up by cancer and cancer-related cells. In a published clinical trial of high-risk patients, CyPath Lung demonstrated 92% sensitivity, 87% specificity, 88% accuracy and 99% negative predictive value (NPV) in detecting lung cancer in patients at high risk for the disease who had small indeterminate lung nodules less than 20 millimeters. The high NPV gives physicians greater confidence that a negative result is truly negative, potentially sparing patients from unnecessary invasive and costly procedures. CyPath Lung is marketed as a Laboratory Developed Test (LDT) and is not intended for use as a sole diagnostic tool and should be considered alongside other clinical findings.
About bioAffinity Technologies, Inc.
bioAffinity Technologies, Inc. addresses the need for noninvasive diagnosis of early-stage cancer and other diseases of the lung and broad-spectrum cancer treatments. The Company’s first product, CyPath Lung, is a noninvasive test that has shown high sensitivity, specificity and accuracy for the detection of early-stage lung cancer. CyPath Lung is marketed as a Laboratory Developed Test (LDT) by Precision Pathology Laboratory Services, a subsidiary of bioAffinity Technologies. LDTs are overseen under the Clinical Laboratory Improvement Amendments (CLIA), which are administered by the Centers for Medicare & Medicaid Services. For more information, visit www.bioaffinitytech.com.
Forward-Looking Statements
Certain statements in this press release constitute “forward-looking statements” within the meaning of the federal securities laws. Words such as “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “predict,” “forecast,” “project,” “plan,” “intend” or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. These forward-looking statements are subject to various risks and uncertainties, many of which are difficult to predict, that could cause actual results to differ materially from current expectations and assumptions from those set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from current expectations include, among others, 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, and other factors discussed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, and its subsequent filings with the SEC, including subsequent periodic reports on Forms 10-Q and 8-K. Such forward-looking statements are based on facts and conditions as they exist at the time such statements are made and predictions as to future facts and conditions. While the Company believes these forward-looking statements are reasonable, readers of this press release are cautioned not to place undue reliance on any forward-looking statements. The information in this release is provided only as of the date of this release, and the Company does not undertake any obligation to update any forward-looking statement relating to matters discussed in this press release, except as may be required by applicable securities laws.
Contact
bioAffinity Technologies
Julie Anne Overton
Director of Communications
investors@bioaffinitytech.com