Form 8-K

8-K — bioAffinity Technologies, Inc.

Accession: 0001493152-26-043052

Filed: 2026-09-17

Period: 2026-09-17

CIK: 0001712762

SIC: 8731 (SERVICES-COMMERCIAL PHYSICAL & BIOLOGICAL RESEARCH)

Item: Other Events

Item: Financial Statements and Exhibits

Documents

8-K — form8-k.htm (Primary)

EX-99.1 (ex99-1.htm)

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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 17, 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 17, 2026, bioAffinity Technologies, Inc., a Delaware corporation (the “Company”), issued a press release announcing

that the Hong Kong Intellectual Property Department has granted a patent for the Company’s proprietary technology for predicting

the likelihood of lung cancer using flow cytometry and fluorescent markers to characterize cell populations in sputum.

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 17, 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 17,

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

bioAffinity

Technologies Announces Grant of Hong Kong Patent for Company’s CyPath® Lung Noninvasive Lung Cancer Diagnostic

Dual

patent protection in Hong Kong and China strengthens CyPath Lung’s positioning to enter Asian market

Asia

accounts for nearly two-thirds of lung cancer cases worldwide

SAN

ANTONIO, Texas – September 17, 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 that the Hong Kong

Intellectual Property Department has granted a patent for the Company’s proprietary platform technology for predicting the likelihood

of lung cancer using flow cytometry and fluorescent markers to characterize cell populations in sputum.

“The

grant of this patent in Hong Kong and the 2025 patent we received from China strengthen the intellectual property protection for our

technology in Asia, a region with a substantial burden of lung cancer,” said Maria Zannes, President and CEO of bioAffinity Technologies.

“With an estimated 1.6 million new lung cancer cases diagnosed annually across Asia,1 the region represents a significant

potential market for noninvasive technologies like CyPath® Lung that support earlier detection and more informed

clinical decision-making that can lead to better patient outcomes.”

Hong

Kong Patent No. HK40048460, titled “System and Method for Determining Lung Health,” covers, as described in the patent claims,

the use of defined antibodies and the porphyrin TCPP to label cell populations in sputum and the use of flow cytometry to determine the

presence of lung cancer cells in the sputum. The patented technology is the scientific foundation underlying CyPath Lung, which remains

the centerpiece of the Company’s commercial efforts, providing physicians with a noninvasive tool to assess the likelihood of malignancy

in lung nodules detected by low-dose CT scans and incidental imaging.

The

Hong Kong patent complements bioAffinity’s expanding global patent estate, which now covers multiple patents and pending applications

in the United States and other international jurisdictions, including Australia, Canada, China, the European Union, Japan, Mexico and

Singapore. Together, these patents safeguard the core technology that powers the CyPath Lung test and other diagnostics in the Company’s

pipeline.

Source: International Agency for Research on Cancer (IARC), World Health Organization, Global Cancer Observatory, GLOBOCAN

2022: Lung Cancer Fact Sheet.

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. These clinical performance data relate to CyPath Lung’s use in the detection

setting and have not been separately validated for post-treatment surveillance. The high NPV may help inform physician decision-making

when evaluating whether further invasive procedures are warranted. 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 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 or other diagnostic products in the United States or internationally; the Company’s

ability to obtain and maintain patent protection and defend its intellectual property rights in the United States and foreign jurisdictions;

uncertainties regarding the enforceability of patents in foreign jurisdictions, including Hong Kong and China; the Company’s ability

to obtain regulatory approvals or clearances required to market its products in international markets; the accuracy of third-party estimates

of market size and lung cancer incidence; the Company’s need for additional capital and its ability to obtain financing on acceptable

terms; 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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