Form 8-K

8-K — bioAffinity Technologies, Inc.

Accession: 0001493152-26-022428

Filed: 2026-05-12

Period: 2026-05-12

CIK: 0001712762

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

Item: Other Events

Item: Financial Statements and Exhibits

Documents

8-K — form8-k.htm (Primary)

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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): May 12, 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))

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 ☒

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.

May 12, 2026, bioAffinity Technologies, Inc., a Delaware corporation, issued a press release announcing that unit sales for its CyPath®

Lung diagnostic test achieved a record high in a single month and increased nearly 300% in April 2026 compared to the same period in

2025, based on preliminary unaudited data.

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 May 12, 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:

May 12, 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 Reports Record Monthly CyPath® Lung Unit Sales and Significant Year-Over-Year Growth in April 2026

CyPath®

Lung unit sales in April increased nearly 300% compared to April 2025

Increasing

unit sales for CyPath® Lung continues first quarter 2026 trend of accelerating adoption and clinical use

Noninvasive

test has potential to transform lung cancer risk assessment and nodule management

SAN

ANTONIO, TX – May 12, 2026 – bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company focused

on noninvasive diagnostics and early cancer detection, today announced that unit sales for its CyPath® Lung diagnostic

test achieved a record high in a single month and increased nearly 300% in April 2026 compared to the same period in 2025, based on preliminary

unaudited data. The strong CyPath® Lung unit sales growth so far this year continues to exceed the Company’s internal

projections and reflects accelerating physician adoption and expanding clinical use by physicians using the Company’s noninvasive

test to aid in diagnosing lung cancer.

“The

growth in CyPath® Lung usage continues to accelerate at a rapid pace as the value of our novel lung cancer diagnostic

is increasingly being recognized,” said Maria Zannes, President and CEO of bioAffinity Technologies. “CyPath®

Lung addresses a significant gap in the diagnostic pathway by supporting lung cancer risk stratification and pulmonary nodule management

as physicians seek more accurate, noninvasive tools to assess cancer risk and detect disease at its earliest, most treatable stage. We

are very pleased with the unit growth that we delivered in April, and we remain focused on expanding adoption of CyPath®

Lung to aid physicians in the early detection of lung cancer and pulmonary nodule management.”

Addressing

a Large and Growing Clinical Need

The

number of patients identified with indeterminate pulmonary nodules continues to rise, driven in part by increases in incidental findings

and screening by low-dose CT for high-risk patients. This expanding patient population poses a diagnostic challenge for physicians who

have to weigh the benefits and risks of “watchful waiting” versus invasive procedures like biopsy.

CyPath®

Lung’s flow cytometry+AI technology provides actionable information to support clinical decision-making by the ordering

physician. The test result is intended to be used in conjunction with other clinical information and is not a standalone diagnostic.

Real-world patient cases have demonstrated the test’s ability to:

● Help

detect lung cancer at Stage 1A, when it is most treatable

● Help

avoid unnecessary invasive, risky, and costly procedures when the test result is negative

Executing

a Focused Commercial Strategy

bioAffinity

Technologies has prioritized CyPath® Lung as its core commercial focus, aligning resources to accelerate adoption and

scale. Growth has been driven by:

● Expansion

of ordering physician sites

● Increased

peer-to-peer education among pulmonologists

● Integration

of CyPath® Lung into clinical workflows for lung cancer risk assessment and nodule management

Positioned

for Continued Expansion

The

company is advancing multiple initiatives to further expand the clinical impact of its proprietary technology platform, including:

● A

large-scale longitudinal clinical study designed to generate additional validation data for

CyPath® Lung

● Broader

use of CyPath® Lung to monitor lung cancer survivors after treatment

● An

R&D pipeline that includes diagnostic tests for asthma and COPD that will help guide

personalized treatment with targeted therapies.

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 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.

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 maintain and grow CyPath® Lung unit volume, the Company’s ability to

achieve or maintain profitability, the Company’s dependence on a single commercial product, risks related to the regulatory environment

for laboratory developed tests, the Company’s ability to obtain adequate reimbursement coverage for CyPath® Lung,

the Company’s ability to successfully execute its commercial strategy and expand its customer base, the outcome of ongoing and

future clinical studies, 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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