Form 8-K

8-K — bioAffinity Technologies, Inc.

Accession: 0001493152-26-043654

Filed: 2026-09-22

Period: 2026-09-22

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): September 22, 2026

bioAffinity

Technologies, Inc.

(Exact

name of registrant as specified in its charter)

Delaware

001-41463

46-5211056

(State

or other jurisdiction

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))

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 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 ☒

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.

September 22, 2026, bioAffinity Technologies, Inc., a Delaware corporation, issued a press release announcing that it is presenting two

posters highlighting its noninvasive lung cancer diagnostic, CyPath® Lung, in clinical practice and ongoing research evaluating the

technology in veteran and military populations at the 2026 NAVREF Annual Conference, September 27-30, 2026, in Arlington, Virginia.

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 September 22, 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:

September 22, 2026

BIOAFFINITY

TECHNOLOGIES, INC.

By:

/s/

Maria Zannes

Name:

Maria

Zannes

Title:

President

and Chief Executive Officer

-3-

EX-99.1

Filename: ex99-1.htm · Sequence: 2

Exhibit 99.1

News Release

bioAffinity

Technologies to Present Positive Clinical and Veteran-Focused Data on CyPath® Lung at NAVREF 2026 Annual Conference

Presentations

demonstrate beneficial role for CyPath Lung in veteran lung cancer care

NAVREF

2026 focuses on innovative research to improve healthcare for veterans

SAN

ANTONIO, Texas – September 22, 2026 – bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company

developing noninvasive healthcare solutions for the early detection and monitoring of lung disease, today announced it is presenting

two posters highlighting its noninvasive lung cancer diagnostic, CyPath® Lung, in clinical practice and ongoing research evaluating

the technology in veteran and military populations at the 2026 NAVREF Annual Conference, September 27-30, 2026, in Arlington,

Virginia.

The

National Association of Veterans’ Research and Education Foundations (NAVREF) Annual Conference brings together leaders from the

Department of Veterans Affairs (VA), VA-affiliated research organizations, academia and industry working to improve healthcare and quality

of life for veterans. bioAffinity Technologies is a member of NAVREF’s Industry Partner Consortium.

Representatives

from bioAffinity Technologies and its new distribution partner, AvMEDICAL, will be available during the conference to discuss

the potential healthcare benefits and commercial momentum of CyPath Lung. The NAVREF conference marks the first time that bioAffinity

Technologies and AvMEDICAL will jointly engage with the federal healthcare market.

Lung

cancer remains one of the most significant cancer challenges facing veterans. According to the VA, approximately 7,700 veterans are diagnosed

with lung cancer each year. “The VA has made substantial progress in expanding lung cancer screening for veterans, which means

a significant increase in the number of lung nodules that require careful evaluation,” said Maria Zannes, President and CEO of

bioAffinity Technologies. “At the NAVREF conference we will share how CyPath Lung may benefit veterans by providing real-time information

about lung nodules discovered by imaging.”

Poster

#1: CyPath Lung in Practice

The

first poster, “CyPath® Lung in Practice: From Uncertainty to Clarity and Confidence,” presents three clinical cases that

involved atypical presentations and complex diagnostic considerations in high-risk patients with indeterminate pulmonary nodules.

CyPath

Lung was used in conjunction with standard clinical evaluation, including low-dose CT, PET imaging, risk modeling and blood-based testing.

The poster describes how incorporating CyPath Lung’s noninvasive flow cytometry + AI diagnostic into the clinical evaluation accelerated

diagnosis, helped guide difficult clinical discussions and prevented unnecessary invasive procedures.

Poster

#2: Longitudinal Study on Detection of Early-Stage Lung Cancer in Sputum

The

second poster, “BA-004: Detection of Early-Stage Lung Cancer in Sputum using Flow Cytometry and an Automated Analysis Pipeline,”

describes the ongoing FlowPath™ Lung study, a 2,000-patient longitudinal study designed to

evaluate the clinical performance of the CyPath Lung flow cytometry test in veteran and military populations. The FlowPath Lung

test is identical to the commercially available CyPath Lung test. The FlowPath Lung name is used exclusively for this research study.

The

FlowPath Lung clinical study is currently enrolling patients. Veterans and military personnel from 12 VA medical centers and two of the

nation’s largest military hospitals will participate in the clinical study. The John P. Murtha Cancer Center Research

Program (MCCRP), a research program within the Department of Surgery at the Uniformed Services University of the Health Sciences

in Bethesda, Maryland, is providing support and partial funding for the study.

The

poster highlights CyPath Lung’s at-home sputum collection, which eliminates the need for patients to travel to a VA medical facility

for specimen collection. It also presents CyPath Lung’s previously reported performance in patients with pulmonary nodules

of 20 mm or less, including 92% sensitivity, 87% specificity and 99% negative predictive value. These results may not be indicative of

performance in broader populations or different clinical settings. The poster summarizes the findings of an economic analysis published

in 2024 by pulmonologists at Audie L. Murphy VA Medical Center and Brooke Army Medical Center who concluded that utilization of the

bioAffinity’s test “has the potential to result in thousands of dollars per person and hundreds of millions of dollars overall

in savings to health care associated with screening and diagnosis of lung cancer.”

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. 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.

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 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. Forward-looking statements in this press release include, but are not limited to, statements regarding

the potential healthcare cost savings associated with screening and diagnosis of lung cancer using the Company’s technology. Any

projections of cost savings or economic benefits are based on third-party analyses using assumptions that may not reflect actual clinical

outcomes, reimbursement rates, utilization patterns, or healthcare system dynamics, and actual savings, if any, may differ materially

from those projected. Important factors that could cause actual results to differ materially from current expectations include, among

others, the Company’s ability to maintain regulatory approvals, the Company’s ability to achieve and maintain profitability,

the outcome of ongoing and future clinical studies, uncertainties regarding the actual economic impact of the Company’s diagnostic

technology in clinical practice, changes in healthcare reimbursement policies and payor coverage decisions, risks related to competition

and technological changes in the biotechnology and diagnostics industries, the Company’s need for additional financing, risks related

to government contracts and the federal procurement process, and 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

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