Form 8-K
8-K — bioAffinity Technologies, Inc.
Accession: 0001493152-26-026773
Filed: 2026-06-02
Period: 2026-06-02
CIK: 0001712762
SIC: 8731 (SERVICES-COMMERCIAL PHYSICAL & BIOLOGICAL RESEARCH)
Item: Other Events
Item: Financial Statements and Exhibits
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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)
-2-
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
-3-
EX-99.1
EX-99.1
Filename: ex99-1.htm · Sequence: 2
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.
-1-
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.
-2-
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
investors@bioaffinitytech.com
-3-
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