Form 8-K

8-K — bioAffinity Technologies, Inc.

Accession: 0001493152-26-031327

Filed: 2026-06-30

Period: 2026-06-30

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): June 30, 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.

June 30, 2026, bioAffinity Technologies, Inc., a Delaware corporation (the “Company”), released a newsletter providing an

overview of certain recent developments. A copy of the newsletter is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

Forward-Looking

Statements

Certain

statements in the newsletter 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 Securities and Exchange Commission, 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 the newsletter are cautioned not to place undue reliance on any forward-looking statements. The information in the newsletter are

provided only as of the date of the newsletter, and the Company does not undertake any obligation to update any forward-looking statement

relating to matters discussed in the newsletter, except as may be required by applicable securities laws.

Item

9.01. Financial Statements and Exhibits.

(d) Exhibits.

Exhibit

Number

Description

99.1

Company Newsletter, 1st Edition, 2nd Quarter 2026, released by bioAffinity Technologies, Inc. on June 30, 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:

June 30, 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

Company

Newsletter, 1st Edition

2nd

Quarter 2026

Nasdaq:

BIAF

See

what’s happening at bioAffinity Technologies…

Message

from our CEO

This

is the first of our new Quarterly Newsletter series that will report on the achievements of our team at

bioAffinity Technologies who are bringing to market products that can give people longer, healthier lives. There is much to report. Sales

continue to climb for our noninvasive CyPath® Lung test that offers clarity when diagnosing lung cancer, allowing physicians

to find and treat this deadly cancer at its earliest, curative stage. We are proud to announce our collaboration with Philips on a program

to enhance lung cancer screening for U.S. veterans. Our pipeline of products includes companion diagnostics for the multi-billion-dollar

asthma and COPD market. And we recently announced positive news about our research findings that support our work to develop topical

treatments for the most common of all types of cancer, basal and squamous cell carcinomas. As you will read below, we have achieved a

great deal and have the momentum to achieve much more. Stay tuned.

Sincerely,

Maria

Zannes

President

and CEO

Sales

Accelerate for our Noninvasive CyPath® Lung

CyPath®

Lung unit sales in April increased nearly 300% compared to April 2025. The number of physician offices and clinics ordering CyPath®

Lung increased 69% from first quarter 2025 to the same period in 2026. We saw continued accelerated growth in the second quarter

as more and more physicians learn from their peers and our sales team about CyPath® Lung.

Our

success is a result of solid team execution on key growth strategies including the expansion of ordering physician sites, increasing

peer-to-peer education among pulmonologists, family practices, and oncologists, and integrating CyPath® Lung into the

clinical workflows for lung cancer risk assessment and nodule management.

Partnering

with Philips to Advance Lung Cancer Screening

We’re

partnering with Philips to enhance screening programs for U.S. Veterans at risk for lung diseases, including cancer, using mobile

CT scanning, CyPath® Lung testing and 4DMedical’s advanced imaging software.

learn more, register here for a webinar on July 21 at 6:00 pm ET, hosted by the National Association of Veterans Research and

Education Foundations (NAVREF). The webinar will highlight how Philips, 4DMedical, and bioAffinity Technologies are working together

to detect lung cancer at its earliest stages when it is most treatable, provide diagnostic insight into other lung diseases and

risk-stratify veterans at increased risk for lung disease including cancer, many of whom are eligible under the PACT Act.

Hear,

Watch and Read Why Physicians Use CyPath® Lung and Why Patients Praise It

The

upcoming webinar is one of many you can find on CyPath® Lung Connect that provides easy access to recent webinars and podcasts

where patients and physicians tell their stories about how CyPath® Lung has made a positive impact on their lives and their practices,

respectively. Our podcasts are available on Apple, Spotify, or your favorite podcast channel. And be sure to check out our YouTube channel

@CyPathLungConnect.

You’ll

find particularly moving videos in which a patient tells how CyPath® Lung testing and her patient coach

brought peace of mind after learning she had a pulmonary nodule. Her CyPath® Lung test resulted as unlikely malignancy.

“It was a lifesaver. I want to shout it from the rafters,” she told us, and after watching, you’ll understand why.

Rather

read than watch or listen? Visit CyPathLung.com to review more than a dozen case studies written by physicians demonstrating the

real-world use of CyPath® Lung. Patient outcomes range from detecting lung cancer as early as Stage 1A when other adjuvant tools

failed to find it to sparing patients with significant comorbidities from risky invasive procedures.

Introducing

CyPath® Lung Connect, a platform featuring expert perspectives on lung cancer screening, early diagnosis and emerging

technologies, as well as patient stories about their diagnostic journey.

Recent

Webinars

Navigating

Lower Cancer-Risk Nodules in High-Risk Patients with Noninvasive CyPath® Lung Testing

June

16, 2026

CyPath®

Lung in Practice: A Physician Roundtable

April

8, 2026

Recent

Podcasts

Enhancing

Clinical Confidence: Managing Small Pulmonary Nodules with CyPath® Lung

June

2, 2026

CyPath®

Lung in Clinical Practice: Pulmonologists Roundtable

June

10, 2026

Recent

Patient Videos

Patient’s Journey with CyPath® Lung

June

30, 2026

Working

with Your Patient Coach: A Patient’s View

June

30, 2026

Our

Project Pipeline

Advancing

Research and Development for Companion Diagnostics for Asthma and Chronic Obstructive Pulmonary Disease (COPD)

pilot study with Brooke Army Medical Center (BAMC) is underway to evaluate bioAffinity’s proprietary tests under development that

seek to quantify the type of inflammation in the lung to help determine what drugs might work best for asthma and COPD patients.

The research collaboration with BAMC leverages our proprietary flow cytometry+AI technology to develop precision diagnostics for

common airway diseases that can be treated effectively with new and emerging therapeutics.

Topical

Therapeutics for Skin Cancer

bioAffinity

recently shared preclinical research demonstrating that silencing specific cell surface receptors using our proprietary siRNAs selectively

kills squamous skin cancer cells or impairs their proliferation while leaving normal skin cells unaffected. The findings suggest a potential

topical treatment for common skin cancers - basal cell carcinoma ranks number one, followed by squamous cell carcinoma

at number two. Together, they outpace all other cancers combined.

Get

Caught Up on Our Recent News

Jun

16, 2026

bioAffinity

Technologies Announces Program to Advance Veteran Lung Health: Philips, bioAffinity Technologies and 4DMedical Highlight New Approaches

to Lung Health Screening for U.S. Veterans

Jun

2, 2026

Multidisciplinary

Physician Panel to Share Real-World Benefits of bioAffinity Technologies’ Noninvasive CyPath Lung® Cancer Test in Upcoming

Society for Advanced Bronchoscopy Webinar

May

27, 2026

bioAffinity

Technologies Announces Notification of Mexico Patent Allowance Covering Novel Lung Cancer Detection Methods Using CyPath® Lung Technology

May

12, 2026

bioAffinity

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

May

8, 2026

bioAffinity

Technologies Reports First Quarter 2026 Results and Expanding Adoption and Clinical Usage of CyPath® Lung

Connect

with bioAffinity Technologies

bioaffinitytech.com

cypathlung.com

Want

to change how you receive these emails?

You

can update your preferences or unsubscribe from this list

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