Form 8-K

8-K — bioAffinity Technologies, Inc.

Accession: 0001493152-26-036486

Filed: 2026-08-07

Period: 2026-08-07

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): August 7, 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.

August 7, 2026, bioAffinity Technologies, Inc., a Delaware corporation (the “Company”), issued a press release that included

financial information for its second quarter ended June 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 August 7, 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:

August 7, 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 Second Quarter 2026 Results and Continued Strong Commercial Momentum for CyPath® Lung

CyPath

Lung test volume increased 216% year over year in Q2 2026

Company

drives physician adoption of CyPath Lung and advances longitudinal clinical trial

Pipeline

expands to include development of precision diagnostics for asthma and COPD and dermally delivered skin cancer therapeutics

SAN

ANTONIO, Texas – August 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 and topically

delivered therapeutics for squamous and basal cell skin cancers, today reported financial results and business highlights for the quarter

ended June 30, 2026.

2026 Highlights and Recent Events

● CyPath®

Lung diagnostic test volume increased 216% during the second quarter of 2026 compared

to the second quarter of 2025.

● CyPath

Lung testing revenue for the first six months of 2026 increased 159% to approximately $835,000,

compared with approximately $323,000 for the first six months of 2025.

● The

Company delivered 1,097 CyPath Lung test reports during the first six months of 2026, compared

with 390 during the same period of 2025.

● The

number of physician offices and clinics ordering CyPath Lung for their patients increased

122% during the second quarter of 2026 compared to the same period in 2025.

● Existing

clients as of June 30, 2025, increased their CyPath Lung orders by 71% year over year during

the first six months of 2026.

● The

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

test has begun patient enrollment at 11 clinical sites, including nine Department of Veterans

Affairs (VA) and military medical centers. Financial support for the trial has been provided

by the John P. Murtha Cancer Center Research Program

(MCCRP), a research program within the Department of Surgery at the Uniformed Services

University of the Health Sciences in Bethesda, Maryland.

● Positive

preliminary therapeutic data support the development of topical treatments for squamous and

basal cell skin cancers, with self-delivering stabilized siRNAs selectively killing melanoma,

squamous and basal carcinoma cells while sparing healthy cutaneous cells.

-1-

● bioAffinity

presented positive research results advancing its diagnostic platform designed to identify

antibody drug receptors in sputum to match patients with the most appropriate biologic therapies,

including receptors for dupilumab, a leading therapy for asthma and chronic obstructive pulmonary

disease (COPD), and benralizumab, another asthma therapy.

● The

Company published a comprehensive clinical review and white paper authored by Chief Medical

Officer Gordon H. Downie, MD, PhD, that presents a practical clinical framework for incorporating

CyPath Lung into pulmonary nodule evaluation and cancer surveillance.

● The

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

to support development and 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

Society for Advanced Bronchoscopy (SAB) and National Association of Veterans Research Education

Foundations (NAVREF) hosted webinars featuring multi-disciplinary panels of physicians who

discussed CyPath Lung’s expanding role in the lung nodule care continuum.

● bioAffinity

received notification of allowance from the Mexican Institute of Industrial Property for

a patent application protecting the use of defined antibodies and the porphyrin TCPP to label

cell populations in sputum and the use of flow cytometry to determine the presence of lung

cancer cells in sputum.

● In

June 2026, bioAffinity completed a public offering that generated approximately $3.2 million

in gross proceeds to support commercialization activities, clinical development, and general

corporate purposes.

Management

Commentary

“Our

commercial strategy continues to gain significant traction as physicians increasingly recognize the clinical value of CyPath Lung for

evaluating patients at high risk for lung cancer and surveilling lung cancer survivors for recurrence,” said Maria Zannes, President

and Chief Executive Officer of bioAffinity Technologies. “During the second quarter, CyPath Lung test volume surged 216% year-over-year.

This growth reflects accelerating physician adoption and clinical confidence in our technology. As more clinics integrate CyPath Lung

into their standard of care workflows, peer-to-peer education is a powerful driving force behind building broader awareness of the test’s

ability to provide objective data that complements traditional imaging and supports faster, more informed clinical decisions.”

Ms.

Zannes continued, “Alongside our commercial momentum, we achieved critical milestones across our strategic roadmap. In the second

quarter, we expanded physician education initiatives, including scientific presentations, webinars, podcasts and real-world clinical

case studies. We continued to make progress in our large-scale longitudinal study that includes VA and military medical centers, expanding

our outreach to veterans. By leveraging our expertise in flow cytometry and AI and our work with siRNAs, we are building a robust pipeline

of precision diagnostics for the large asthma and COPD markets and even larger therapeutic markets for topically delivered drugs that

treat squamous and basal cell skin cancers.”

-2-

Ms.

Zannes concluded, “Looking ahead, our priorities for the second half of 2026 are expanding physician adoption, increasing utilization

among existing customers, and introducing CyPath Lung to new healthcare systems and specialty practices, including oncology. The positive

results we see from research and development of precision diagnostics and a therapeutic for skin cancers are exciting as we advance our

pipeline. We believe this balanced approach positions bioAffinity to create lasting value for patients, healthcare providers and shareholders.”

Second

Quarter 2026 Financial Results

Revenue

for the quarter ended June 30, 2026, was $1.5 million, a 19% increase from the $1.3 million reported for the same period in 2025. The

increase is primarily due to an increase in sales of CyPath Lung.

Operating

expenses for the second quarter of 2026 were $4.8 million, compared with $3.8 million in the second quarter of 2025.

● Direct

costs and expenses for the second quarter of 2026 were $1.1 million, compared to $1 million

in the prior-year period, primarily reflecting higher CyPath Lung test volume.

● Research

and development expenses increased 16% year-over-year to $362,000, driven by laboratory supply

purchases and costs associated with relocating the research and development lab from the

University of Texas at San Antonio to the Precision Pathology Laboratory services campus.

● Clinical

development expenses rose to $476,000 from $129,000 in the second quarter of 2025 due to

costs associated with initiating the longitudinal clinical study.

● Selling,

general and administrative expenses were $2.9 million for the second quarter of 2026, up

from $2.2 million in the same period last year. The increase was primarily driven by higher

employee compensation, reflecting the addition of sales and administrative personnel to support

the expanding commercialization of CyPath Lung.

Net

loss for the quarter ended June 30, 2026, was $3.4 million, compared with a net loss of $4.1 million for the second quarter of 2025.

Cash

and cash equivalents as of June 30, 2026, were $2.4 million, compared with $6.4 million as of December 31, 2025.

-3-

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 successfully commercialize CyPath Lung and achieve broader market acceptance, the Company’s

ability to obtain adequate financing to fund operations and development activities, risks related to the results of clinical trials and

studies, the Company’s ability to obtain and maintain regulatory approvals or clearances, the Company’s ability to protect

its intellectual property, competition from other companies developing similar products, changes in applicable laws or regulations, the

Company’s limited operating history and history of operating losses, the Company’s receipt of a delisting determination notice

from the Nasdaq Stock Market and the risks and uncertainties associated with the Company’s intent to appeal such determination

and the outcome of any such appeal, 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

-4-

bioAffinity

Technologies, Inc.

Condensed

Consolidated Balance Sheets

June 30, 2026

December 31, 2025

(unaudited)

ASSETS

Current assets:

Cash and cash equivalents

$ 2,429,719

$ 6,449,782

Accounts and other receivables, net

894,823

541,962

Inventory

82,378

53,548

Prepaid expenses and other current assets

458,360

519,916

Total current assets

3,865,280

7,565,208

Non-current assets:

Property and equipment, net

313,708

265,593

Operating lease right-of-use asset, net

769,270

334,289

Finance lease right-of-use asset, net

562,187

661,575

Goodwill

1,404,486

Intangible assets, net

687,639

716,806

Other assets

16,709

12,815

Total assets

$ 7,619,279

$ 10,960,772

LIABILITIES AND STOCKHOLDERS’ EQUITY

Current liabilities:

Accounts payable

$ 969,845

$ 761,901

Accrued expenses

1,414,492

1,717,989

Unearned revenue

31,140

42,405

Operating lease liability, current portion

163,276

139,220

Finance lease liability, current portion

79,592

139,490

Notes payable, current portion

22,561

105,161

Total current liabilities

2,680,906

2,906,166

Non-current liabilities:

Operating lease liability, net of current portion

637,643

202,878

Finance lease liability, net of current portion

495,468

532,759

Notes payable, net of current portion

36,465

41,313

Total liabilities

3,850,482

3,683,116

Commitments and contingencies

Stockholders’ equity:

Preferred Stock, par value $0.001 per share; 20,000,000 shares authorized; 450 shares and 700 shares issued and outstanding at June 30, 2026, and December 31, 2025, respectively

Common Stock, par value $0.007 per share; 350,000,000 shares authorized; 6,783,061 and 4,498,675 issued and outstanding at June 30, 2026, and December 31, 2025, respectively

47,454

31,461

Additional paid-in capital

79,272,098

75,800,258

Accumulated deficit

(75,550,756 )

(68,554,064 )

Total stockholders’ equity

3,768,797

7,277,656

Total liabilities and stockholders’ equity

$ 7,619,279

$ 10,960,772

-5-

bioAffinity

Technologies, Inc.

Unaudited

Condensed Consolidated Statements of Operations

Three Months Ended

June 30,

Six Months Ended

June 30,

2026

2025

2026

2025

Net revenue

$ 1,510,579

$ 1,269,483

$ 2,862,106

$ 3,123,080

Operating expenses:

Direct costs and expenses

1,087,837

1,016,602

2,016,473

2,384,462

Research and development

361,575

311,372

711,282

678,758

Clinical development

475,885

129,279

809,925

267,632

Selling, general and administrative

2,858,590

2,214,561

6,100,192

4,667,110

Depreciation and amortization

61,556

113,229

176,074

267,817

Total operating expenses

4,845,443

3,785,043

9,813,946

8,265,779

Loss from operations

(3,334,864 )

(2,515,560 )

(6,951,840 )

(5,142,699 )

Other income (expense):

Interest income

3,358

2,025

13,384

2,567

Interest expense

(11,688 )

(10,460 )

(26,410 )

(25,945 )

Other income

4,738

38,053

3,372

38,055

Other expense

(27,626 )

(483,043 )

(35,198 )

(492,685 )

Change in fair value of warrants issued

—

(1,062,818 )

—

(1,062,818 )

Total other income (expense), net

(31,218 )

(1,516,243 )

(44,852 )

(1,540,826 )

Net loss before provision for income tax expense

(3,366,082 )

(4,031,803 )

(6,996,692 )

(6,683,525 )

Income tax expense

—

28,984

—

37,679

Net loss

$ (3,366,082 )

$ (4,060,787 )

$ (6,996,692 )

$ (6,721,204 )

Net loss per common share, basic and diluted

$ (0.64 )

$ (5.07 )

$ (1.44 )

$ (10.01 )

Weighted average common shares outstanding

5,226,753

800,637

4,860,753

671,529

-6-

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

+ References

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

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 14d

-Subsection 2b

+ Details

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dei_PreCommencementTenderOffer

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- Definition

Title of a 12(b) registered security.

+ References

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

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b

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- Definition

Name of the Exchange on which a security is registered.

+ References

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

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection d1-1

+ Details

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dei_SecurityExchangeName

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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 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

+ Details

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- Definition

Trading symbol of an instrument as listed on an exchange.

+ References

No definition available.

+ Details

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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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