Form 8-K

8-K — bioAffinity Technologies, Inc.

Accession: 0001493152-26-041894

Filed: 2026-09-09

Period: 2026-09-08

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 8, 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 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 check mark 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.

previously disclosed in a Current Report on Form 8-K filed by bioAffinity Technologies, Inc. (the “Company”) on July 30,

2026, the Company received written notice (the “Staff Determination”) from the Listing Qualifications Staff (the “Staff”)

of The Nasdaq Stock Market LLC (“Nasdaq”) notifying the Company that the Staff determined that the bid price of the Company’s

listed securities had closed at less than $1.00 per share over the previous thirty consecutive business days (from June 16, 2026, through

July 29, 2026) and, as a result, the Company was not in compliance with the minimum bid price requirement for continued listing on The

Nasdaq Capital Market set forth in Nasdaq Listing Rule 5550(a)(2) (the “Minimum Bid Price Rule”). The Staff Determination

further provided that normally a company would be afforded a 180-calendar day period to demonstrate compliance with the Minimum Bid Price

Rule. However, pursuant to Nasdaq Listing Rule 5810(c)(3)(A)(iv), the Company was not eligible for any compliance period specified in

Nasdaq Listing Rule 5810(c)(3)(A) due to the fact that the Company had effected a reverse stock split over the prior one-year period.

The Company submitted an appeal to Nasdaq on August 6, 2026, and a hearing before the Nasdaq panel (the “Hearings Panel”)

was scheduled for September 8, 2026.

September 8, 2026, the Company received written notice (the “Written Notice”) from the Staff confirming that the Company

has regained compliance with the Minimum Bid Price Rule and Nasdaq Listing Rule 5560(a) (the “Rights/Warrants Rule”). The

Written Notice further provided that the hearing before the Hearings Panel scheduled to take place on September 8, 2026, had been cancelled

and that the Company’s securities will continue to be listed and traded on The Nasdaq Capital Market.

September 9, 2026, the Company issued a press release announcing that it has regained compliance with the Minimum Bid Price Rule. A copy

of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

of September 8, 2026, there were 1,166,625 outstanding shares of the Company’s common stock and the aggregate market value of the

Company’s common stock was approximately $10.4 million based on the closing price of a share of the Company’s common stock

on that date, as reported by The Nasdaq Capital Market.

Item

9.01 Financial Statements and Exhibits.

(d)

Exhibits.

Exhibit

No.

Description

99.1

Press Release of bioAffinity Technologies, Inc. dated September 9, 2026

104

Cover

Page Interactive Data File (embedded within the Inline 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:

September 9, 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 Regains Compliance with Nasdaq Listing Requirements

BIAF

continues to be listed and traded on Nasdaq

SAN

ANTONIO, TX — September 9, 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 it has received

written notice from The Nasdaq Stock Market LLC stating that the Company has regained compliance with Nasdaq’s applicable listing

requirements.

a result of this determination, bioAffinity Technologies’ common stock and warrants will continue to be listed and traded on the

Nasdaq Capital Market under the symbols BIAF and BIAFW, respectively, subject to the Company’s continued compliance

with all applicable Nasdaq listing requirements.

“We

are pleased to have regained full compliance with Nasdaq’s listing standards,” said Maria Zannes, President and Chief Executive

Officer of bioAffinity Technologies. “Maintaining our Nasdaq listing allows us to remain focused on expanding access to our noninvasive

CyPath® Lung test for lung cancer and continuing development of our broader pipeline of noninvasive healthcare solutions while

building long-term value for shareholders.”

a letter dated September 8, 2026, Nasdaq confirmed that the Company has regained compliance with Listing Rule 5550(a)(2), which requires

a minimum bid price of $1.00 per share (the “Bid Price Rule”), and Listing Rule 5560(a), which establishes listing requirements

applicable to rights and warrants (the “Rights/Warrants Rule”). As a result, the previously scheduled hearing before the

Nasdaq Hearings Panel has been cancelled. The Company is required to maintain ongoing compliance with all applicable Nasdaq listing requirements

to remain listed on the Nasdaq Capital Market.

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.

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 maintain compliance with Nasdaq’s continued listing requirements,

the Company’s ability to obtain additional financing, the Company’s ability to achieve commercial adoption of CyPath Lung,

risks related to regulatory developments, 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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