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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): February 9, 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
February 9, 2026, bioAffinity Technologies, Inc., a Delaware corporation, issued a press release announcing that David Ost, MD, MPH,
Daniel Sterman, MD, and J. Scott Ferguson, MD, have been appointed to its Medical and Scientific Advisory Board.
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.
Exhibit
Number |
|
Description |
| 99.1 |
|
Press Release issued by bioAffinity Technologies, Inc., dated February 9, 2026 |
| 104 |
|
Cover Page Interactive
Data File (embedded within the 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: February 9, 2026 |
BIOAFFINITY
TECHNOLOGIES, INC. |
| |
|
| |
By: |
/s/ Maria
Zannes |
| |
Name: |
Maria Zannes |
| |
Title: |
President and Chief
Executive Officer |
Exhibit 99.1

bioAffinity
Technologies Appoints Nationally Recognized Pulmonary and Lung Cancer Authorities to its Medical and Scientific Advisory Board
Advisory
Board provides independent guidance on strategic priorities, including growing adoption of the Company’s noninvasive CyPath®
Lung diagnostic test
SAN
ANTONIO, TX – February 9, 2026 – bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company
focused on noninvasive diagnostics and early cancer detection, today announced new appointments to its Medical and Scientific Advisory
Board, welcoming David Ost, MD, MPH, University of Texas MD Anderson Cancer Center, Daniel Sterman, MD, New York University Langone Medical
Center, and J. Scott Ferguson, MD, University of Wisconsin School of Medicine and Public Health, to its panel of recognized leaders in
the field.
The
appointments reflect a planned expansion of the Company’s Medical and Scientific Advisory Board to ensure alignment with bioAffinity’s
current clinical, scientific, and commercial priorities, including the ongoing integration of CyPath® Lung, a noninvasive
diagnostic test for lung cancer, into the standard of care for indeterminate pulmonary nodules.
Drs.
Ost, Sterman and Ferguson join current board members David Hill, MD, Chair of the American Lung Association Board of Directors, Neil
Alexis, PhD, Principal Investigator at the University of North Carolina School of Medicine Center for Environmental Medicine, Asthma
and Lung Biology, Sheila Habib, MD, Director of the Pulmonary Lung Nodule Clinic and the Lung Cancer Screening Program at South Texas
Veterans Health Care Systems, Audie L. Murphy Memorial Veterans Hospital, and Sandeep Bansal, MD, Medical Director of Lung Innovations
Network.
“Our
Medical and Scientific Advisory Board’s extensive experience in real-world pulmonary practice and lung health supports our corporate
and clinical mission to improve outcomes for patients by detecting lung cancer at the earliest stages when it is most treatable and survivable,”
said Gordon Downie, MD, PhD, bioAffinity Technologies Chief Medical Officer. “Lung cancer is still the leading cause of cancer-related
deaths, and our focus remains on patient care, and how our CyPath® Lung diagnostic test can best inform clinicians and change the
course of lung cancer diagnosis and treatment.”
Dr.
Ost, a recognized leader in interventional pulmonology, thoracic oncology and critical care, currently serves as Professor of Medicine
and Chief of Pulmonary, Critical Care, and Sleep Medicine at MD Anderson Cancer Center. His work focuses on improving lung cancer diagnosis,
staging and treatment.
Dr.
Sterman, Professor of Medicine and Chief of the Division of Pulmonary, Critical Care, and Sleep Medicine at NYU Langone Health, is
recognized for his pioneering work in interventional pulmonology. His research is focused on using gene therapy and immunotherapy to
treat lung cancer and mesothelioma and improve and prolong the quality of patients’ lives.
Dr.
Ferguson, Professor of Medicine and Director of Interventional Pulmonology at the University of Wisconsin School of Medicine and
Public Health, specializes in treating complex lung conditions. He is recognized for his advanced diagnostic techniques for lung cancer,
thoracic oncology and therapeutic bronchoscopy.
“These
appointments strengthen our panel of clinical and scientific leaders helping to guide our work as we continue to advance CyPath®
Lung as a vital diagnostic tool to detect lung cancer at an early stage in high-risk patients,” said Maria Zannes, President and
CEO of bioAffinity Technologies. “Drs. Ost, Sterman, and Ferguson are nationally recognized leaders in pulmonary medicine and lung
cancer care. Their advice and counsel will be instrumental as we focus on clinical implementation and broader adoption of our diagnostic
platform.”
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. Clinical study results demonstrated 92% sensitivity, 87% specificity and 88% accuracy in detecting
lung cancer in patients at high risk for the disease who had small indeterminate lung nodules less than 20 millimeters.
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. 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 contributions of Drs. Ost, Sterman and Ferguson to the Company 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.
Contact
bioAffinity
Technologies
Julie
Anne Overton
Director
of Communications
investors@bioaffinitytech.com