Form 8-K

8-K — bioAffinity Technologies, Inc.

Accession: 0001493152-26-046755

Filed: 2026-10-13

Period: 2026-10-13

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): October 13, 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.

October 13, 2026, bioAffinity Technologies, Inc., a Delaware corporation (the “Company”), issued a press release announcing

that it will present new data at CHEST 2026, the annual meeting of the American College of Chest Physicians, on the Company’s sputum-based

tests in development to characterize lung inflammation and detect multiple protein biomarkers of lung inflammation, including biologic

drug targets of therapeutics used to treat asthma and chronic obstructive pulmonary disease (COPD). These sputum-based tests are investigational,

have not been validated, are not cleared or approved by the U.S. Food and Drug Administration, and are not currently available for clinical

or diagnostic use..

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 October 13, 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:

October 13, 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 Research Data in Development of Its New Test Measuring Asthma and COPD-Related Lung Inflammation and

Drug-Related Receptors at CHEST 2026

Findings

report on ability to measure cellular and soluble inflammatory protein biomarkers in sputum, including biologic drug targets

Company

advances research and development in diagnostic tests for major lung diseases building on CyPath® Lung + AI foundation

Global

asthma therapeutics market projected to reach $47.6 billion by 2034

SAN

ANTONIO, Texas – October 13, 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 will present new

data at CHEST 2026, the annual meeting of the American College of Chest Physicians, on the Company’s sputum-based tests

in development to characterize lung inflammation and detect multiple protein biomarkers of lung inflammation, including biologic drug

targets of therapeutics used to treat asthma and chronic obstructive pulmonary disease (COPD).

providing a more complete picture of a patient’s inflammatory profile, this research approach may, with further development and

validation, help inform identification of patients who could benefit from specific biologic therapies and support monitoring of lung

inflammation over time, consistent with a precision medicine approach.

bioAffinity

Technologies will present a poster, titled “Sputum as a Diagnostic Tool for the Measurement of Lung Inflammation in Asthma,”

that describes a workflow based on the proprietary flow cytometry + AI platform used by the Company’s commercially available noninvasive

CyPath® Lung diagnostic for lung cancer.

The

poster reports research on measuring key cytokines and cell-surface receptors involved in lung inflammation, including targets of approved

and emerging biologic therapies for asthma and COPD. Data show that the test in development can detect multiple targets in sputum using

a combination of cellular and proteomic analysis. Data are specifically provided for soluble and cellular biologic drug targets that

play different roles in driving inflammation:

● TSLP:

an epithelial alarmin that is an early trigger of inflammation. It is targeted by tezepelumab

(Tezspire) and related drugs.

-1-

● CRLF2:

a cell-surface receptor for TSLP targeted by the investigational therapeutic verkitug.

● IL4-Rα

(CD124): a receptor subunit present in IL-4 and IL-13 receptors involved in Th2 asthma inflammation

and some forms of COPD. It is targeted by dupilumab (Dupixent).

● IL-5:

a cytokine that promotes the growth and activity of eosinophils, immune cells involved in

eosinophilic asthma and some COPD. It is targeted by mepolizumab (Nucala).

References

to these and other branded therapeutics identify biological pathways and drug targets studied in the research and do not constitute a

claim that the Company’s test in development can be used to select, guide, monitor or otherwise inform the use of any named therapy.

The test described is investigational and not yet available for clinical or diagnostic use.

According

to the Asthma and Allergy Foundation of America1, an estimated 28 million Americans have asthma, including 5 million children,

or seven out of 100 people under the age of 18. In 2020, asthma accounted for nearly 100,000 discharges from hospital inpatient care

and almost 1 million emergency department visits. The global asthma therapeutics market is estimated at approximately $29.7 billion in

2025, projected to reach $47.6 billion by 2034.2 The market includes a growing range of biologic therapies that target specific

pathways involved in inflammation.

“Lung

inflammation in asthma is complex and heterogeneous, and clinicians need better tools to characterize what is happening in the lung and

understand differences among patients,” said Gordon Downie, MD, PhD, bioAffinity Technologies Chief Medical Officer. “We

believe this research represents an important step toward a better understanding of distinct types of lung inflammation and targeted

treatment specific to each patient.”

Dr.

Downie will lead a discussion at CHEST 2026 on the clinical use of CyPath Lung and the development of sputum-based tests to characterize

lung inflammation in patients with asthma and COPD. The discussion will take place in Learning Theater 4 at 12:30 p.m. on October 21.

the study, sputum samples were collected from people with asthma, smokers without asthma, smokers with COPD, a smoker with both COPD

and asthma, and healthy individuals. Immune cell populations were analyzed by flow cytometry and inflammatory proteins (cytokines) were

measured by an enzyme-linked immunosorbent assay (ELISA). The combined data were analyzed using machine learning.

measuring the inflammatory markers in sputum, the Company’s ongoing research aims to improve understanding of different patterns

of lung inflammation, with the goal of ultimately helping identify and monitor patients who may be most likely to benefit from specific

treatments, subject to further research and validation.

Asthma and Allergy Foundation of America, Asthma Fact and Figures

Fortune Business Insights, Asthma Therapeutics Market Size, Share & Industry Analysis, September 2026

-2-

“Our

research shows the potential to measure cellular and protein features directly from sputum, including selected targets associated with

specific biologic drugs,” said William Bauta, PhD, bioAffinity Technologies Chief Science Officer. “We believe this test

could provide a more detailed picture of lung inflammation and, with further study, help doctors discern among treatment options and

track inflammatory changes in the lung over time.”

CHEST

2026 Presentation Details

Title:

Sputum as a Diagnostic Tool for the Measurement of Lung Inflammation in Asthma

Poster: 3071

Session: Original Investigation / Allergy-Airway

Date: October 20, 2026

Time: 1:45–2:30 p.m.

Location: Phoenix Convention Center, Phoenix, AZ

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 novel 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 may help inform physician decision-making when evaluating whether further

invasive procedures are warranted. CyPath Lung is marketed as a Laboratory Developed Test (LDT), is not intended for use as a sole diagnostic

tool, and should be considered alongside other clinical findings. For more information, visit www.cypathlung.com.

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

the Company’s research and development of sputum-based tests to characterize lung inflammation and detect protein biomarkers, including

biologic drug targets, for asthma and COPD; the potential clinical utility, benefits, or future availability of such tests, including

their potential to help identify or monitor patients who may benefit from specific biologic therapies or to support a precision medicine

approach; the Company’s plans and expectations regarding ongoing research, development, and validation of its sputum-based tests;

expectations regarding the content and conclusions of the poster presentation and discussion at CHEST 2026; projections of the global

asthma therapeutics market size, including the estimate that the market will reach $47.6 billion by 2034; 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

-3-

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