Form 8-K

8-K — bioAffinity Technologies, Inc.

Accession: 0001493152-26-050541

Filed: 2026-11-06

Period: 2026-11-06

CIK: 0001712762

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

Item: Results of Operations and Financial Condition

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): November 6, 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))

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

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

2.02. Results of Operations and Financial Condition.

November 6, 2026, bioAffinity Technologies, Inc., a Delaware corporation (the “Company”), issued a press release that included

financial information for its third quarter ended September 30, 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 November 6, 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:

November 6, 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

News Release

bioAffinity

Technologies Reports Third Quarter 2026 Results and Continued Momentum in CyPath® Lung Commercialization

CyPath®

Lung test unit sales double year to date over 2025, with solid gains in physician utilization and recurring orders; testing revenue increases

79% year-to-date

Company

advances precision medicine pipeline with new asthma and COPD research, collaboration with Pictor and continued development of topical

skin cancer therapeutics

SAN

ANTONIO, Texas – November 6, 2026 – bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company

developing noninvasive healthcare solutions for the early detection and monitoring of lung disease and topically delivered therapeutics

for skin cancer, today reported financial results and business highlights for the third quarter (Q3) ended September 30, 2026.

2026 Highlights and Recent Events

● CyPath®

Lung test unit sales increased 100% through Q3 compared to the first nine months of 2025.

● CyPath

Lung testing revenue for the first nine months of 2026 increased 79% to approximately $1.1

million, compared to the same period in 2025.

● In

July 2026, the Company surpassed the total number of CyPath Lung test reports delivered to

physicians during 2025.

● The

number of ordering physicians increased by 89% in the third quarter of 2026 compared to the

third quarter of 2025, continuing to expand clinical utilization of CyPath Lung. Physicians

already ordering CyPath Lung tests increased their volume by 48% year over year.

● The

Company expanded its government healthcare distribution network and commercial reach through

an agreement with AvMEDICAL, a Service-Disabled Veteran-Owned Small Business and established

distributor of medical-surgical and laboratory products and services to government agencies,

including the Department of Veterans Affairs (VA).

● The

ongoing longitudinal clinical trial designed to evaluate the clinical performance of CyPath

Lung continued to advance. As of September 30, 2026, 11 clinical sites were active, including

nine VA and military medical centers that had begun patient enrollment. The John P. Murtha

Cancer Center Research Program at the Uniformed Services University of the Health Sciences

is providing support and funding for the trial.

-1-

● In

July, the Company published a comprehensive clinical review and white paper authored

by Chief Medical Officer Gordon H. Downie, MD, PhD, presenting a practical framework for

incorporating CyPath Lung into pulmonology and oncology practices. Dr. Downie presented the

framework to physicians in October at the annual meeting of the American College of Chest

Physicians (CHEST 2026).

● The

Company advanced CyPath Lung for potential use in surveillance of lung cancer survivors as

a complement to imaging to monitor patients for cancer recurrence and new primary lung cancers.

● The

Company presented positive research results at CHEST 2026 relating to its development of

noninvasive tests to characterize lung inflammation and investigate biologic drug targets

for asthma and COPD therapies. Further development and validation are underway to determine

whether this approach can identify patients who may benefit from specific biologic therapies

or support monitoring of lung inflammation over time.

● The

Company announced a collaboration with Pictor®, Inc., a targeted proteomic platform

company, to support development and potential commercialization of bioAffinity Technologies’

next-generation diagnostic tests designed to provide a more complete picture of lung inflammation

in patients with asthma and COPD.

● The

Company continued research into potential topically delivered therapeutics for squamous and

basal cell skin cancers. Preliminary research findings have demonstrated that self-delivering,

stabilized small interfering RNAs (siRNAs) selectively kill squamous and basal carcinoma

cells in vitro while sparing noncancerous cutaneous cells.

● In

September, bioAffinity announced the grant of a Hong Kong patent covering CyPath Lung’s

proprietary flow cytometry + AI platform for predicting the likelihood of lung cancer by

characterizing cell populations in sputum. In October, the Company received a Notice of Allowance

from the Japan Patent Office indicating its intention to grant a patent for the method of

predicting the likelihood of lung cancer used by the CyPath Lung test.

● The

Company raised an aggregate of $8.0 million in gross proceeds through a private placement

offering in August 2026 and a registered direct offering and concurrent private placement

in October 2026 for working capital and general corporate purposes, including support

for the ongoing commercialization of CyPath Lung.

Management

Commentary

“Our

third-quarter results reflect CyPath Lung’s continued momentum in addressing the critical need for early lung cancer detection,

driven by both new physicians ordering the test and increased use by existing customers. We believe this growth reflects increasing physician

engagement and recognition of the role CyPath Lung can play in managing care for patients at risk for lung cancer. We are also advancing

its potential use in surveillance following curative-intent treatment, where CyPath Lung could complement imaging in monitoring for recurrence

and new cancers,” said Maria Zannes, President of CEO of bioAffinity Technologies. “Peer-to-peer education and growing clinical

experience with the test remain important drivers of adoption, while our longitudinal study is designed to generate robust, real-world

data across multiple sites to further evaluate how CyPath Lung may support risk assessment and clinical decision-making. Together, these

efforts advance our objective of establishing CyPath Lung as a standard of care for evaluating patients at risk for lung cancer.

-2-

“We

continue to build the foundation for long-term growth. Beyond lung cancer, we are advancing our platform to take advantage of precision

medicine opportunities in asthma and COPD, where sputum-based analysis may help characterize lung inflammation and help physicians better

match individual patients to available treatments, including Tezspire, Dupixent and Nucala. The tests we are developing are designed

to meet a critical need for precision diagnostics in the multi-billion-dollar asthma and COPD therapeutic markets.

“Our

patent portfolio now includes 22 awarded U.S. and foreign patents and 36 pending applications. The recent Hong Kong patent and the Japanese

patent allowance, once awarded, are important additions to our patent portfolio. Our distribution agreement with AvMEDICAL is intended

to expand our reach into government healthcare markets, including the VA, where the substantial burden of lung cancer underscores the

need for more effective ways to evaluate pulmonary nodules and improve patient outcomes.

Ms.

Zannes concluded, “Our priorities remain disciplined execution, expanding commercial adoption and advancing our clinical and research

programs. We are also pursuing topical therapeutic approaches for squamous and basal cell skin cancers based on promising findings involving

the CD320 and LRP2 receptors. We believe our expertise in flow cytometry, automated data analysis and siRNA technology provides a foundation

for developing differentiated products across these markets. Together, these programs demonstrate our commitment to translating scientific

innovation into meaningful new opportunities for patients and the Company.”

Third

Quarter 2026 Financial Results

Total

revenue for the quarter ended September 30, 2026, was approximately $1.1 million, compared with approximately $1.4 million for the same

period in 2025. The decrease is due primarily to a decrease in average reimbursement per CyPath Lung test and a slight decline in total

cases completed at Precision Pathology Laboratory Services (PPLS) compared to the same period in 2025, in part due to internal business

changes at three PPLS research clients. Multiple accounts previously serviced under these clients have since returned to PPLS. The Company

is working to restore additional accounts and improve reimbursement levels.

Net

loss for the quarter ended September 30, 2026, was approximately $5.3 million, compared with approximately $5.1 million for the third

quarter of 2025. The increase in net loss is primarily due to the increase in loss from operations of approximately $3.5 million from

approximately $2.3 million in the prior-year quarter, partially offset by a $1.2 million loss from the change in fair value of warrants,

compared with a $2.7 million loss in the prior-year quarter.

Cash

and cash equivalents were approximately $2.6 million as of September 30, 2026, compared with approximately $6.4 million at December 31,

2025. Subsequent to quarter-end, the Company completed a financing that generated approximately $4.0 million in gross proceeds.

Operating

expenses for the third quarter of 2026 were approximately $4.6 million, compared with approximately $3.7 million in the third quarter

of 2025.

● Direct

costs and expenses were approximately $1.1 million, compared with $942,000 in the prior-year

period. The increase primarily reflected additional personnel to process CyPath Lung commercial

tests and tests associated with the longitudinal clinical study.

● Research

and development expenses increased 18% year over year to approximately $389,000, primarily

due to laboratory supplies and costs associated with relocating laboratory facilities in

June 2026.

-3-

● Clinical

development expenses increased 75% to approximately $251,000, compared with approximately

$143,000 in the third quarter of 2025. The increase primarily reflected the initiation of

clinical trial sites and patient enrollment in the longitudinal clinical study.

● Selling,

general and administrative expenses increased 28% to approximately $2.8 million, compared

with approximately $2.2 million in the prior-year period. The increase primarily reflected

additional sales and marketing personnel and support services to expand commercialization

of CyPath Lung.

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 analyzes the lung microenvironment by using advanced flow cytometry and proprietary artificial intelligence

(AI) to identify cell populations in patient sputum that indicate malignancy. The test incorporates a novel 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. For more information, visit www.cypathlung.com.

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” and similar expressions may identify forward-looking statements, although not all forward-looking

statements contain these words. Actual results could differ materially from those expressed or implied because of risks and uncertainties,

including the Company’s ability to expand the commercial adoption of CyPath Lung and capitalize on government healthcare market

opportunities; the timing, cost, enrollment and outcome of clinical studies; the possibility that preliminary, in vitro or study-specific

findings will not be replicated or translate into safe and effective therapies or commercial products for asthma, COPD or skin cancer;

the need for further validation of new applications, including surveillance; the extent and timing of physician adoption, repeat utilization

and customer retention; payer coverage, reimbursement rates and collections; and the Company’s ability to obtain, maintain and

enforce intellectual property rights. Additional risks are discussed in the Company’s Annual Report on Form 10-K for the year ended

December 31, 2025, and subsequent SEC filings, including its reports on Forms 10-Q and 8-K. Forward-looking statements reflect expectations

and assumptions only as of the date of this release. Readers should not place undue reliance on them. The Company undertakes no obligation

to update these statements, except as required by applicable law.

Contact

bioAffinity

Technologies

Julie

Anne Overton

Director

of Communications

investors@bioaffinitytech.com

-4-

bioAffinity

Technologies, Inc.

Condensed

Consolidated Balance Sheets

September 30,

2026

December 31,

2025

(unaudited)

ASSETS

Current assets:

Cash and cash equivalents

$ 2,550,034

$ 6,449,782

Accounts and other receivables, net

742,144

541,962

Inventory

108,754

53,548

Prepaid expenses and other current assets

427,230

519,916

Total current assets

3,828,162

7,565,208

Non-current assets:

Property and equipment, net

362,359

265,593

Operating lease right-of-use asset, net

730,572

334,289

Finance lease right-of-use asset, net

538,326

661,575

Goodwill

1,404,486

Intangible assets, net

673,056

716,806

Other assets

16,710

12,815

Total assets

$ 7,553,671

$ 10,960,772

LIABILITIES AND STOCKHOLDERS’ EQUITY

Current liabilities:

Accounts payable

$ 949,018

$ 761,901

Accrued expenses

1,143,227

1,717,989

Unearned revenue

48,874

42,405

Operating lease liability, current portion

168,534

139,220

Finance lease liability, current portion

78,926

139,490

Notes payable, current portion

144,715

105,161

Total current liabilities

2,533,294

2,906,166

Non-current liabilities:

Operating lease liability, net of current portion

596,086

202,878

Finance lease liability, net of current portion

475,772

532,759

Notes payable, net of current portion

33,958

41,313

Total liabilities

3,639,110

3,683,116

Stockholders’ equity:

Preferred Stock, par value $0.001 per share; 20,000,000 shares authorized; 150 shares and 700 shares issued and outstanding at September 30, 2026, and December 31, 2025, respectively

Common Stock, par value $0.007 per share; 350,000,000 shares authorized; 1,166,625 and 299,826 issued and outstanding at September 30, 2026, and December 31, 2025, respectively

8,166

2,097

Additional paid-in capital

84,734,173

75,829,622

Accumulated deficit

(80,827,779 )

(68,554,064 )

Total stockholders’ equity

3,914,561

7,277,656

Total liabilities and stockholders’ equity

$ 7,553,671

$ 10,960,772

-5-

bioAffinity

Technologies, Inc.

Unaudited

Condensed Consolidated Statements of Operations

Three Months Ended

September 30,

Nine Months Ended

September 30,

2026

2025

2026

2025

Net revenue

$ 1,070,280

$ 1,446,066

$ 3,932,386

$ 4,569,146

Operating expenses:

Direct costs and expenses

1,114,176

942,211

3,130,649

3,326,673

Research and development

389,122

330,589

1,100,404

1,009,347

Clinical development

251,043

143,311

1,060,968

410,943

Selling, general and administrative

2,759,769

2,209,441

8,859,961

6,876,551

Depreciation and amortization

66,842

113,360

242,916

381,177

Total operating expenses

4,580,952

3,738,912

14,394,898

12,004,691

Loss from operations

(3,510,672 )

(2,292,846 )

(10,462,512 )

(7,435,545 )

Other income (expense):

Interest income

4,734

1,088

18,118

3,655

Interest expense

(10,713 )

(5,358 )

(37,123 )

(31,303 )

Other income

3,144

513

6,516

38,568

Other expense

(13,072 )

(3,839 )

(48,270 )

(16,828 )

Offering costs allocated to warrant liability

(532,209 )

—

(532,209 )

(479,696 )

Loss on warrant liabilities

(1,218,235 )

(2,747,460 )

(1,218,235 )

(3,810,278 )

Total other income (expense), net

(1,766,351 )

(2,755,056 )

(1,811,203 )

(4,295,882 )

Net loss before provision for income tax expense

(5,277,023 )

(5,047,902 )

(12,273,715 )

(11,731,427 )

Income tax expense

—

3,182

—

40,861

Net loss

$ (5,277,023 )

$ (5,051,084 )

$ (12,273,715 )

$ (11,772,288 )

Net loss per common share, basic and diluted

$ (5.89 )

$ (71.05 )

$ (23.72 )

$ (219.47 )

Weighted average common shares outstanding

896,271

71,090

517,490

53,640

-6-

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Local phone number for entity.

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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 pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act.

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

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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 pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act.

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Name of the Exchange on which a security is registered.

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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.

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Trading symbol of an instrument as listed on an exchange.

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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 written communications pursuant to Rule 425 under the Securities Act.

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