Form 8-K

8-K — bioAffinity Technologies, Inc.

Accession: 0001493152-26-032263

Filed: 2026-07-07

Period: 2026-07-07

CIK: 0001712762

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

Item: Other Events

Item: Financial Statements and Exhibits

Documents

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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): July 7, 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.

July 7, 2026, bioAffinity Technologies, Inc., a Delaware corporation, issued a press release announcing continued acceleration in commercial

sales for CyPath® Lung, its noninvasive lung cancer diagnostic, with more than 200% growth year-over-year.

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 July 7, 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:

July 7, 2026

BIOAFFINITY

TECHNOLOGIES, INC.

By:

/s/

Maria Zannes

Name:

Maria

Zannes

Title:

President

and Chief Executive Officer

EX-99.1

Filename: ex99-1.htm · Sequence: 2

Exhibit

99.1

bioAffinity

Technologies’ Quarterly CyPath® Lung Sales Double to New Record as Commercial Momentum Continues

CyPath®

Lung sales volume for Q2 2026 grows more than 200% year-over-year and 30% over record-breaking prior quarter

Growth

in Q2 driven by increasing utilization among existing clients and 155% increase in physician offices ordering CyPath® Lung as compared

to Q2 2025

SAN

ANTONIO, Texas – July 7, 2026 – bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company

focused on the need for noninvasive, accurate tests for the detection of early-stage lung cancer and other lung diseases, today announced

continued acceleration in commercial sales for CyPath® Lung, its noninvasive lung cancer diagnostic, with more than 200% growth

year-over-year.

The

number of tests sold in the second quarter of 2026 represents an increase of more than 30% over the first quarter of 2026 and more than

200% compared with the second quarter of 2025.

“We

are at the forefront of a positive change in clinical practice. We believe it is the result of expanding physician familiarity and accumulating

clinical evidence as more patients are evaluated with CyPath® Lung and benefit from CyPath® Lung-guided care,” said Maria

Zannes, President and Chief Executive Officer of bioAffinity Technologies. “The most encouraging trend goes beyond onboarding new

practices — the fact is, physicians who try CyPath® Lung appreciate its benefits and continue to use it. Repeat utilization

suggests the test is becoming part of routine clinical decision-making for patients with indeterminate pulmonary nodules.”

The

Company has now performed nearly 3,000 CyPath® Lung tests since commercial launch, reflecting growing physician adoption across pulmonology

practices, lung nodule clinics, academic and community medical centers, and Veterans Affairs (VA) facilities. bioAffinity Technologies

is executing a commercial strategy focused on increasing utilization of CyPath® Lung among existing clients, expanding its sales

footprint in existing markets, strategically entering new markets, and building lasting relationships with physicians.

“The

number of patients diagnosed with indeterminate pulmonary nodules is expected to grow significantly over the next several years with

expanded lung cancer screening and incidental findings from other procedures,” said Gordon Downie, MD, PhD, Chief Medical Officer

of bioAffinity Technologies. “The challenge is determining which patients require immediate invasive evaluation and which can be

safely monitored. CyPath® Lung is designed to provide clinicians with an objective, noninvasive tool that complements imaging and

helps them make more informed decisions while reducing unnecessary procedures and patient anxiety.”

-1-

published patient case studies, CyPath® Lung has helped detect lung cancer at curative Stage 1A when risk stratification guidelines

and other adjunct tests indicated low risk. Conversely, a negative CyPath® Lung result has spared patients with significant comorbidities

from invasive, often risky procedures. In a recent interview, a CyPath® Lung patient describes the emotional impact of discovering

a pulmonary nodule and explains why she appreciated having a noninvasive testing option. “I was petrified. I was scared to death,”

she recalls. “I was so thankful that CyPath® Lung was something that I could do that was noninvasive…I just want to

shout it from the rafters.”

bioAffinity

Technologies is advancing multiple initiatives that the Company believes will further expand the clinical impact of its proprietary technology

platform. These include a large-scale longitudinal clinical study designed to generate additional validation data for CyPath® Lung,

expansion into oncology by using CyPath® Lung to monitor lung cancer survivors after treatment, and an R&D pipeline that includes

diagnostic tests for asthma and COPD that are designed to help guide personalized treatment with targeted therapies.

“We

are building on the success of CyPath® Lung to develop noninvasive tests designed to ensure asthma and COPD patients

are matched with the most effective treatment for their type of lung disease,” Dr. Downie said. “We continue to develop our

automated flow cytometry platform that supports an expanding number of diagnostic tests that we believe can lead to improved lung health

for millions of people.”

The

Company expects to report its financial results for the second quarter of 2026 in August.

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. 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.

-2-

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, risks related to the regulatory environment

for laboratory developed tests 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

-3-

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