8-K
bioAffinity Technologies, Inc. (BIAF)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): July 23, 2025
bioAffinityTechnologies, Inc.
(Exact name of registrant as specified in its charter)
| Delaware | 001-41463 | 46-5211056 |
|---|---|---|
| (State<br> or other jurisdiction<br><br> <br>of<br> incorporation) | (Commission<br><br> <br>File<br> Number) | (I.R.S.<br> Employer<br><br> <br>Identification<br> Number) |
3300Nacogdoches Road, Suite 216
SanAntonio, Texas 78217
(Address of principal executive offices, including zip code)
(210)698-5334
(Registrant’s telephone number, including area code)
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
| ☐ | Written<br> communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|---|---|
| ☐ | Soliciting<br> material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ | Pre-commencement<br> communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ | Pre-commencement<br> communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e- 4(c)) |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
| Title<br> of each class | Trading<br> Symbols | Name<br> of each exchange on which registered |
|---|---|---|
| Common<br> Stock, par value $0.007 per share | BIAF | The<br> Nasdaq Stock Market LLC<br><br> <br>(Nasdaq<br> Capital Market) |
| Warrants<br> to purchase Common Stock | BIAFW | The<br> Nasdaq Stock Market LLC<br><br> <br>(Nasdaq<br> Capital Market) |
Indicate by check mark whether the registrant is an emerging growth company as defined in in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by checkmark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item8.01. Other Events.
On July 23, 2025, bioAffinity Technologies, Inc., a Delaware corporation, (the “Company”) issued a press release announcing the release of a new case study in which CyPath® Lung identified a Stage 1A neuroendocrine tumor in the lung after PET scan, bronchoscopies and a serum tumor marker test suggested it was non-cancerous inflammation.
A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
Item9.01. Financial Statements and Exhibits.
| (d) | Exhibits. |
|---|---|
| Exhibit<br><br> <br>Number | Description |
| --- | --- |
| 99.1 | Press Release issued by bioAffinity Technologies, Inc., dated July 23, 2025 |
| 104 | Cover<br> Page Interactive Data File (embedded within the XBRL document) |
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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:<br> July 23, 2025 | BIOAFFINITY TECHNOLOGIES, INC. | |
|---|---|---|
| By: | /s/ Maria Zannes | |
| Name: | Maria<br> Zannes | |
| Title: | President<br> and Chief Executive Officer |
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Exhibit99.1
CaseStudy: CyPath® Lung Detects Neuroendocrine Tumor Missed by Other Diagnostic Tools
bioAffinityTechnologies’ noninvasive sputum test flagged difficult-to-diagnose cancer at earliest Stage 1A
SANANTONIO, TX – July 23, 2025 – bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company addressing the need for noninvasive, accurate tests for the detection of early-stage cancer, today released a compelling new case study in which CyPath^®^ Lung identified a Stage 1A neuroendocrine tumor in the patient’s lung after PET scan, bronchoscopies and a serum tumor marker test suggested it was non-cancerous inflammation.
“We believe that this patient’s experience demonstrates the high added value that CyPath^®^ Lung brings to the diagnostic pathway. Multiple procedures and diagnostic tools were inconclusive, failing to identify the 13mm lung nodule as cancer,” said Gordon Downie, MD, PhD, bioAffinity Technologies’ Chief Medical Officer. “So when her CyPath^®^ Lung test returned a ‘likely cancer’ result, it clarified appropriate next steps. The end result was surgical removal of a Stage 1A neuroendocrine tumor, a cancer type that can be difficult to detect by imaging and bronchoscopy alone, early enough for potentially life-saving treatment.”
The female patient, an 80-year-old former smoker, had less than a 15-pack-year history and quit smoking in 1999. She had stable pulmonary function until a COVID-19 infection left her with asthma symptoms, including wheezing, coughing and shortness of breath, which responded to inhalers. A low dose CT in October 2023 revealed a 13mm nodule in the right lower lobe, but a PET scan showed low metabolic activity and risk models placed the likelihood of malignancy around 16%.
Initial diagnostic workups – including bronchoscopy and serum markers – indicated inflammation or infection without malignancy, and the patient was placed on a surveillance plan with antibiotics and asthma management. Follow-up LDCT scans in January and July 2024 were stable.
In early 2025, a new upper respiratory infection prompted repeat imaging, which showed that the nodule was growing. A second bronchoscopy again returned no evidence of malignancy. Her physician ordered CyPath^®^ Lung for further risk assessment. The CyPath^®^ Lung test, reported on March 4, 2025, returned a high score of 0.72, indicating the likelihood of cancer.
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Based on the CyPath^®^ Lung result, the patient was referred for robotic wedge resection in June 2025, and pathology confirmed a Stage 1A neuroendocrine tumor.
“We believe that this case underscores CyPath^®^ Lung’s growing importance as an essential adjunct to low-dose CT scans for patients with indeterminate pulmonary nodules when imaging and traditional tools leave questions unanswered,” bioAffinity Technologies President and CEO Maria Zannes said.
AboutCyPath^®^ Lung
CyPath^®^ Lung uses proprietary advanced flow cytometry and artificial intelligence (AI) to identify cell populations in patient sputum that indicate malignancy. Automated data analysis helps determine if cancer is present or if the patient is cancer-free. CyPath^®^ Lung incorporates a fluorescent porphyrin that is preferentially taken up by cancer and cancer-related cells. Clinical study results demonstrated that CyPath^®^ Lung had 92% sensitivity, 87% specificity and 88% accuracy in detecting lung cancer in patients at high risk for the disease who had small lung nodules less than 20 millimeters. Diagnosing and treating early-stage lung cancer can improve outcomes and increase patient survival. For more information, visit www.cypathlung.com.
AboutbioAffinity 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. For more information, visit www.bioaffinitytech.com.
Forward-LookingStatements
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 based upon current estimates and assumptions and include statements regarding the ability of CyPath^®^ Lung to indicate a high probability of lung cancer, the benefits of adding CyPath^®^ Lung to the standard of care for evaluating indeterminate lung nodules, and CyPath^®^ Lung providing clarity when imaging and risk models are inconclusive and when other adjuvant diagnostics are contraindicated. 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 ability of CyPath^®^ Lung to indicate a high probability of lung cancer, the benefits of adding CyPath^®^ Lung to the standard of care for evaluating indeterminate lung nodules, and CyPath^®^ Lung providing clarity when imaging and risk models are inconclusive and when other adjuvant diagnostics are contraindicated, and the other factors discussed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, 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.
Contacts
bioAffinityTechnologies
Julie Anne Overton
Director of Communications
jao@bioaffinitytech.com
InvestorRelations
Dave Gentry
RedChip Companies Inc.
1-800-RED-CHIP (733-2447) or 407-491-4498
BIAF@redchip.com
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