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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): March 25, 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
March 25, 2026, bioAffinity Technologies, Inc., a Delaware corporation, issued a press release announcing that it will host a live virtual
physician roundtable featuring pulmonologists who will discuss how they use CyPath® Lung in their clinical practice as part of a
comprehensive approach to lung cancer risk assessment, pulmonary nodule management and surveillance of lung cancer survivors post-treatment.
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 March 25, 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:
March 25, 2026 |
BIOAFFINITY
TECHNOLOGIES, INC. |
| |
|
|
| |
By: |
/s/
Maria Zannes |
| |
Name: |
Maria
Zannes |
| |
Title: |
President
and Chief Executive Officer |
Exhibit 99.1
bioAffinity
Technologies to Host Live Virtual Physician Roundtable on Integrating CyPath® Lung into Pulmonary Practice
Panel
of leading pulmonologists will share real-world patient cases and benefits of clinical use of the noninvasive CyPath® Lung diagnostic
test
First
of “CyPath® Lung in Practice” webinar series focuses on need for greater certainty when diagnosing indeterminate pulmonary
nodules
Healthcare
providers can register here for the April 8, 2026, webinar
SAN
ANTONIO, TX – March 25, 2026 – bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company focused
on noninvasive diagnostics and early cancer detection, today announced it will host the first of a series of live virtual physician roundtables
featuring pulmonologists who will discuss their use of CyPath® Lung in clinical practice as part of a comprehensive approach to lung
cancer risk assessment, pulmonary nodule management and surveillance of lung cancer survivors post-treatment.
During
the webinar, participating physicians will share real-world case studies in which CyPath® Lung helped guide clinical decision-making.
Cases that demonstrate CyPath® Lung’s clinical utility range from identifying lung cancer at Stage 1A when it is curative to
preventing unnecessary invasive, risky and costly procedures when CyPath® Lung resulted in “Unlikely” malignancy.
The
interactive session will provide pulmonologists and other healthcare professionals with practical insights into adding CyPath® Lung
to the diagnostic pathway for patients at high risk for lung cancer. Healthcare professionals interested in learning how CyPath®
Lung can be incorporated into pulmonary practice are encouraged to register.
Webinar
Details
Title:
CyPath® Lung in Practice: A Physician Roundtable Discussion
Format:
Live Zoom webinar. The webinar will be recorded and posted on the CyPath® Lung website.
Date/Time:
Wednesday, April 8, 2026, at 7 p.m. ET/6 p.m. CT.
Registration:
https://bit.ly/4ruhbJO
Moderator:
Gordon H. Downie, MD, PhD
Pulmonologist
and Chief Medical Officer of bioAffinity Technologies with more than 35 years of experience in pulmonary and critical care medicine
and lung cancer diagnostics.
Panelists:
| | ● | Sai
Karan Vamsi Guda, DO |
| | | Interventional pulmonologist with Texas Pulmonary & Critical Care Consultants in Fort Worth specializing in robotic
bronchoscopy, airway stenting, and minimally invasive diagnosis and treatment of lung disease. |
| | | |
| ● | Michael
Nicholson, DO
Pulmonologist and critical care specialist with RWJBarnabas Health Medical Group in
New Jersey with expertise in advanced lung disease and a clinical focus on enhancing noninvasive
malignancy risk stratification in patients with pulmonary nodules. |
| | | |
| ● | Gregory
White, MD
Pulmonologist at CHRISTUS Trinity Clinic specializing in comprehensive pulmonary care,
including advanced bronchoscopy and treatment of lung cancer, asthma, and COPD, with a patient-focused,
personalized approach. |
About
CyPath® Lung
CyPath®
Lung by bioAffinity Technologies is a noninvasive test designed to aid in 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 may 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. LDTs are overseen under the Clinical Laboratory
Improvement Amendments (CLIA), 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, the adoption of CyPath® Lung by physicians and healthcare
providers, the Company’s ability to obtain and maintain regulatory approvals, 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