Form 8-K

8-K — bioAffinity Technologies, Inc.

Accession: 0001493152-26-021861

Filed: 2026-05-08

Period: 2026-05-08

CIK: 0001712762

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

Item: Results of Operations and Financial Condition

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 8, 2026

BIOAFFINITY

TECHNOLOGIES, INC.

(Exact

name of registrant as specified in its charter)

Delaware

001-41463

46-5211056

(State

or other jurisdiction

of incorporation)

(Commission

File Number)

(I.R.S.

Employer

Identification Number)

3300

Nacogdoches Road, Suite 216

San

Antonio, Texas 78217

(210)

698-5334

(Address

of principal executive offices and Registrant’s telephone number, including area code)

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).

Emerging

growth company ☒

Title

of each class

Trading

Symbol(s)

Name

of each exchange on which registered

Common

Stock, par value $.007 per share

BIAF

The

Nasdaq Stock Market LLC

Tradeable

Warrants to purchase Common Stock

BIAFW

The

Nasdaq Stock Market LLC

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

2.02. Results of Operation and Financial Condition.

May 8, 2026, bioAffinity Technologies, Inc., a Delaware corporation (the “Company”), issued a press release that included

financial information for its first quarter ended March 31, 2026. A copy of the press release is attached as Exhibit 99.1 to this Current

Report on Form 8-K.

The

information in this Item 2.02 and in the press release attached as Exhibit 99.1 to this Current Report on Form 8-K shall not be deemed

to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the

liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information contained in this

Item 2.02 and in the press release attached as Exhibit 99.1 to this Current Report on Form 8-K shall not be incorporated by reference

into any filing with the U.S. Securities and Exchange Commission made by the Company, whether made before or after the date hereof, regardless

of any general incorporation language in such filing.

Item

9.01. Financial Statements and Exhibits.

(d)

Exhibits.

The

following exhibit is furnished with this Current Report on Form 8-K:

Exhibit

Description

99.1

Press Release issued by bioAffinity Technologies, Inc. dated May 8, 2026

104

Cover

Page Interactive Data File (embedded within the Inline 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 8, 2026

BIOAFFINITY

TECHNOLOGIES, INC.

(Registrant)

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

CyPath®

Lung cancer diagnostic unit sales rise 146% year-over-year

Growth

expected to accelerate throughout 2026 as planned commercial initiatives seek to drive increasing awareness of CyPath®

Lung benefits

SAN

ANTONIO, Texas – May 8, 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 reported financial

results for the first quarter ended March 31, 2026.

2026 Highlights

● CyPath®

Lung unit sales increased 146% year-over-year in the first quarter of 2026, reflecting

accelerating physician adoption and expanding clinical use of the Company’s noninvasive

lung cancer diagnostic.

● CyPath®

Lung testing revenue increased approximately 114% to $361,000, compared to $169,000 in

the first quarter of 2025.

● Total

consolidated revenue decreased approximately 27% to $1.4 million, compared to $1.9 million

for the first quarter of 2025, resulting from the discontinuation of certain unprofitable

pathology services in March 2025 to focus on higher margin services, including CyPath®

Lung testing.

● The

number of physician offices and clinics ordering CyPath® Lung increased 69%

from first quarter 2025 to the same period in 2026, reflecting continued productivity

and expansion of the Company’ sales force and focus on additional strategic markets.

The Company expects growth to accelerate throughout 2026, as a result of these commercial

initiatives and increasing awareness of the benefits of CyPath® Lung.

● The

Company launched a large-scale longitudinal clinical trial partially funded by the U.S. Department

of Defense to further validate CyPath® Lung performance and support establishing

the noninvasive test as a standard of care for military and Veterans Administration (VA)

medical centers. The trial is expected to include up to 20 clinical sites, including

multiple Department of Veterans Affairs medical centers and leading U.S. military hospitals.

The John P. Murtha Cancer Center Research Program is providing support and funding for the

study at several federal facilities.

● As

part of the Company’s commercial strategy to develop companion tests using its diagnostic

platform to more precisely target drugs that treat asthma and COPD, bioAffinity Technologies

announced that Brooke Army Medical Center, the military’s largest healthcare institution,

was conducting a 40-patient collaborative study. The study will use bioAffinity Technologies’

flow cytometry+AI technology to evaluate whether its proprietary platform can detect biologic

drug receptors in sputum, including those for dupilumab and benralizumab, to guide personalized

therapy selection and monitor patient response over time. The Company presented findings

from its early pipeline development activities at the American Academy of Allergy, Asthma

and Immunology (AAAAI) 2026 annual meeting.

● Nationally

recognized pulmonary and lung cancer experts joined the Company’s Medical and Scientific

Advisory Board (MSAB) to provide independent guidance on strategic priorities, including

clinical implementation and broader adoption of CyPath® Lung. David Ost, MD,

MPH, University of Texas MD Anderson Cancer Center, Daniel Sterman, MD, New York University

Langone Medical Center, and J. Scott Ferguson, MD, University of Wisconsin School of Medicine

and Public Health, were named to the Company’s panel of experts.

● The

Company released three additional patient case studies in first quarter 2026 in which

CyPath® Lung results of “Unlikely Malignancy” helped avoid unnecessary

invasive and costly biopsies when other tests suggested the presence of lung cancer in patients

at high risk. CyPath® Lung test results were confirmed by follow-up imaging

that showed stable or resolved lung nodules.

Management

Commentary

“Our

first quarter results demonstrate continued momentum for CyPath® Lung in the marketplace. As more and more physicians

adopt CyPath® Lung and share their experiences with peers, we see the opportunity to expand our commercial reach and bridge

the diagnostic gap between imaging and invasive procedures, especially when dealing with indeterminate nodules in high-risk patients,”

said Maria Zannes, President and CEO of bioAffinity Technologies. “We are accelerating our marketing strategy to expand access

to CyPath® Lung and educate healthcare practitioners and patients alike about the need for accurate, objective information

to better stratify risk and improve patient outcomes. On April 8, we hosted our first webinar featuring a panel of pulmonologists who

shared how they use CyPath® Lung in their diverse practices.”

Ms.

Zannes continued, “Physicians continue to share their case studies in which CyPath® Lung has identified lung cancer

as early as Stage 1A when it is most treatable and conversely in which a negative CyPath® Lung result helped avoid unnecessary

invasive procedures. We believe the growing number of case studies and our longitudinal clinical trial, supported by leading military

and VA institutions, will lead to broader adoption of CyPath® Lung as part of the standard of care.”

Ms.

Zannes concluded, “We are uniquely positioned to fulfill the need for an accurate, noninvasive diagnostic for lung cancer, particularly

when imaging and risk models are inconclusive or turn out to be wrong. The remainder of 2026 will be focused on scaling commercial execution,

expanding into new geographic markets, and driving increased utilization of CyPath® Lung through continued physician engagement

while also leveraging our flow cytometry and AI platform to advance our pipeline of diagnostics for serious or life-threatening lung

diseases.”

First

Quarter 2026 Financial Results

Revenue

for the quarter ended March 31, 2026, was $1.4 million. Revenue was primarily generated from patient service fees, histology services,

and medical director fees.

Operating

expenses for the first quarter of 2026 were $5.0 million, compared with $4.5 million in the first quarter of 2025.

Direct

costs and expenses for the first quarter of 2026 were $0.9 million, down 32% from $1.4 million in the prior-year period, primarily due

to targeted strategic actions implemented in March 2025. Research and development expenses decreased 5% year-over-year to $350,000, reflecting

lower employee compensation and lab supply costs. Clinical development expenses rose to $334,000, driven by higher professional fees

supporting the Company’s longitudinal clinical trial strategy.

Selling,

general and administrative expenses were $3.2 million for the first quarter of 2026, up from $2.5 million in the same period last year.

The increase was primarily driven by higher employee compensation related to administrative and sales functions, reflecting the addition

of personnel and support services to scale the commercialization of CyPath® Lung.

Net

loss for the quarter ended March 31, 2026, was $3.6 million, or $(0.81) per share, compared with a net loss of $2.7 million, or $(4.80)

per share, for the first quarter of 2025.

Cash

and cash equivalents as of March 31, 2026, were $3.1 million, compared with $6.4 million as of December 31, 2025.

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 obtain additional financing to fund operations, the Company’s limited operating history

and history of net losses, the Company’s ability to achieve broader market acceptance of CyPath® Lung, the Company’s

dependence on key personnel, risks related to the regulatory environment for laboratory developed tests, the Company’s ability

to maintain and protect its intellectual property, 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

bioAffinity

Technologies, Inc.

Consolidated

Balance Sheets

March 31, 2026

December 31, 2025

(unaudited)

ASSETS

Current assets:

Cash and cash equivalents

$ 3,098,366

$ 6,449,782

Accounts and other receivables, net

685,235

541,962

Inventory

77,887

53,548

Prepaid expenses and other current assets

479,913

519,916

Total current assets

4,341,401

7,565,208

Non-current assets:

Property and equipment, net

246,849

265,593

Operating lease right-of-use asset, net

651,430

334,289

Finance lease right-of-use asset, net

586,048

661,575

Goodwill

1,404,486

Intangible assets, net

702,222

716,806

Other assets

12,816

12,815

Total assets

$ 7,945,252

$ 10,960,772

LIABILITIES AND STOCKHOLDERS’ EQUITY

Current liabilities:

Accounts payable

$ 836,211

$ 761,901

Accrued expenses

2,033,924

1,717,989

Unearned revenue

31,140

42,405

Operating lease liability, current portion

142,303

139,220

Finance lease liability, current portion

80,241

139,490

Notes payable, current portion

61,141

105,161

Total current liabilities

3,184,960

2,906,166

Non-current liabilities

Operating lease liability, net of current portion

545,157

202,878

Finance lease liability, net of current portion

514,834

532,759

Notes payable, net of current portion

38,915

41,313

Total liabilities

4,283,866

3,683,116

Commitments and contingencies (See Note 11)

Stockholders’ equity:

Preferred stock, par value $0.001 per share; 20,000,000 shares authorized; 700 shares issued or outstanding at March 31, 2026, and December 31, 2025, respectively

Common stock, par value $0.007 per share; 350,000,000 shares authorized; 4,498,675 shares issued and outstanding as of March 31, 2026, and December 31, 2025

31,464

31,461

Additional paid-in capital

75,814,595

75,800,258

Accumulated deficit

(72,184,674 )

(68,554,064 )

Total stockholders’ equity

3,661,386

7,277,656

Total liabilities, and stockholders’ equity

$ 7,945,252

$ 10,960,772

bioAffinity

Technologies, Inc.

Unaudited

Consolidated Statements of Operations

Three Months Ended

March 31,

2026

2025

Net Revenue

$ 1,351,527

$ 1,853,597

Operating expenses:

Direct costs and expenses

928,636

1,367,860

Research and development

349,707

367,386

Clinical development

334,040

138,353

Selling, general and administrative

3,241,602

2,452,549

Depreciation and amortization

114,518

154,588

Total operating expenses

4,968,503

4,480,736

Loss from operations

(3,616,976 )

(2,627,139 )

Other income (expense):

Interest income

10,026

542

Interest expense

(14,722 )

(15,485 )

Other income

—

Other expense

(8,938 )

(9,642 )

Total other expense

(13,634 )

(24,583 )

Net loss before provision for income taxes

(3,630,610 )

(2,651,722 )

Income tax expense

—

(8,695 )

Net loss

$ (3,630,610 )

$ (2,660,417 )

Net loss per common share, basic and diluted

$ (0.81 )

$ (4.80 )

Weighted average common shares outstanding, basic and diluted

4,494,752

541,841

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v3.26.1

Cover

May 08, 2026

Document Type

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BIOAFFINITY

TECHNOLOGIES, INC.

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Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 14a

-Subsection 12

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- Definition

Trading symbol of an instrument as listed on an exchange.

+ References

No definition available.

+ Details

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dei_TradingSymbol

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Balance Type:

Period Type:

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- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Securities Act

-Number 230

-Section 425

+ Details

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- Details

Name:

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