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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): June 2, 2026

 

bioAffinity Technologies, Inc.

(Exact name of registrant as specified in its charter)

 

Delaware   001-41463   46-5211056

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(I.R.S. Employer

Identification Number)

 

3300 Nacogdoches Road, Suite 216

San Antonio, 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 communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
   
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
   
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
   
Pre-commencement 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 of each class   Trading Symbols   Name of each exchange on which registered

Common Stock, par value $0.007 per share

 

 

 

BIAF

 

 

The Nasdaq Stock Market LLC

(Nasdaq Capital Market)

         
Warrants to purchase Common Stock   BIAFW  

The Nasdaq Stock Market LLC

(Nasdaq 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.

 

 

 

 

 

 

Item 8.01. Other Events.

 

On June 2, 2026, bioAffinity Technologies, Inc., a Delaware corporation, issued a press release announcing that the Society for Advanced Bronchoscopy (SAB) will host a webinar on CyPath® Lung’s expanding role in pulmonary, oncology and surgical practices in the detection and management of early-stage lung cancer.

 

A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

 

Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits.

 

Exhibit

Number

  Description
99.1   Press Release issued by bioAffinity Technologies, Inc., dated June 2, 2026
104   Cover 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: June 2, 2026 BIOAFFINITY TECHNOLOGIES, INC.
   
  By: /s/ Maria Zannes
  Name: Maria Zannes
  Title: President and Chief Executive Officer

 

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Exhibit 99.1

 

 

 

Multidisciplinary Physician Panel to Share Real-World Benefits of bioAffinity Technologies’ Noninvasive CyPath Lung Cancer Test in Upcoming Society for Advanced Bronchoscopy Webinar

 

Interventional pulmonologist, medical oncologist and thoracic surgeon will discuss how CyPath® Lung results have made a critical difference in their practices

 

CyPath® Lung has demonstrated the ability to aid in the detection of early-stage lung cancer and support surveillance of cancer survivors for recurrence

 

SAN ANTONIO, Texas – June 2, 2026 – bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company advancing noninvasive diagnostics for lung cancer and other lung diseases, today announced the Society for Advanced Bronchoscopy (SAB) will host a webinar on CyPath® Lung’s expanding role in pulmonary, oncology and surgical practices for the detection and management of early-stage lung cancer.

 

The live webinar, “Navigating Lower Cancer-Risk Nodules in High-Risk Patients with Noninvasive CyPath® Lung Testing,” will take place Tuesday, June 16, at 7 p.m. ET. Clinicians, pulmonologists, oncologists, thoracic surgeons, healthcare professionals and the public are invited to register here (https://bit.ly/3PaFPSR) for the complimentary education event.

 

“We are seeing a significant increase in patients with indeterminate lung nodules as a result of expanded lung cancer screening and imaging for other conditions. When we consider not only prior smoking history but also an aging population, environmental and occupational exposures, and a better understanding of genetic predispositions, we recognize the real clinical challenges of managing this condition, of distinguishing between malignant and benign nodules,” said Gordon Downie, MD, PhD, Chief Medical Officer of bioAffinity Technologies.

 

“Advanced navigational bronchoscopy serves as an accurate tool to diagnose lung cancer without major surgery, particularly in nodules greater than a centimeter. For smaller nodules, CyPath® Lung complements bronchoscopy by helping to risk stratify and identify patients who should move forward with more invasive follow-up,” Dr. Downie said.

 

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Moderated by pulmonologist Robert Sussman, MD, former Medical Director of the Atlantic Health System Pulmonary Clinical Research Center, the webinar will feature:

 

Vijay K. Gunuganti, MD – Medical oncologist and hematologist at Texas Oncology
Reginald Carl Baptiste, MD – Thoracic and cardiovascular surgeon at Christus St. Michael Health System
 Sai Karan Vamsi Guda, DO – Director of Interventional Pulmonary at Texas Pulmonary and Critical Care Consultants, P.A.

 

The panel will discuss how CyPath® Lung, a noninvasive test that uses automated flow cytometry and artificial intelligence to analyze the lung microenvironment, is being incorporated into their practice to help:

 

aid in the detection of lung cancer at its earliest and most treatable stages
support surgical and treatment decision-making
lower overall healthcare costs by reducing unnecessary invasive procedures
support surveillance of cancer patients after they complete treatment.

 

“We are honored to collaborate with the Society for Advanced Bronchoscopy to provide clinicians with an opportunity to discuss innovative tools like CyPath® Lung that support earlier intervention leading to better patient outcomes,” said Maria Zannes, President and CEO of bioAffinity Technologies.

 

About the Society for Advanced Bronchoscopy

 

The Society for Advanced Bronchoscopy (SAB) is a national organization dedicated to advancing the field of bronchoscopy through innovation, collaboration and education. Founded to improve patient outcomes, SAB fosters excellence in interpretive skills, technical knowledge, research, and training for advanced bronchoscopic techniques. The society unites a multidisciplinary community – including physicians, advanced practice providers, respiratory therapists, and technologists – to push the boundaries of minimally invasive lung diagnostics and interventions, ultimately transforming the standard of care and enhancing the diagnosis and treatment of respiratory diseases worldwide.

 

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.

 

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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 successfully commercialize CyPath® Lung, risks related to the regulatory environment for laboratory developed tests, the Company’s ability to obtain and maintain adequate reimbursement for its products, and the 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

[email protected]

 

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