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bioAffinity to present update at H.C. Wainwright event

bioAffinity Technologies will present a corporate update at the September H.C. Wainwright conference and reports about 600,700 shares outstanding with a $5.9 million market value.

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Form Type
8-K

Rhea-AI Filing Summary

bioAffinity Technologies, Inc. (BIAF) reported that President and CEO Maria Zannes will present a corporate update and hold one-on-one investor meetings at the H.C. Wainwright 28th Annual Global Investment Conference, being held September 14-16, 2026, and issued a related press release.

The company highlighted recent and upcoming strategic milestones, commercial adoption and momentum for its CyPath® Lung diagnostic test, and development of additional diagnostic and therapeutic applications based on its proprietary technology platform. As of September 2, 2026, there were 600,736 outstanding common shares, with an aggregate market value of approximately $5.9 million based on the Nasdaq Capital Market closing price.

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Item 8.01 Other Events Other
Voluntary disclosure of events the company deems important to shareholders but not covered by other items.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, or exhibit attachments filed with this report.
Shares outstanding 600,736 shares Common stock outstanding as of September 2, 2026
Aggregate market value $5.9 million Market value of common stock based on Nasdaq Capital Market closing price on September 2, 2026
Par value per common share $0.007 per share Par value of common stock
Conference dates September 14-16, 2026 H.C. Wainwright 28th Annual Global Investment Conference
Webcast availability date September 11, 2026 Date live and archived webcast of the company’s presentation is available
Laboratory Developed Test (LDT) medical
"CyPath® Lung is marketed as a Laboratory Developed Test (LDT)"
A laboratory developed test (LDT) is a medical diagnostic test that a single clinical laboratory designs, validates and uses in-house rather than buying from a commercial manufacturer. For investors, LDTs matter because they can drive a lab’s revenue and growth more quickly than mass-market products but also carry unique risks around accuracy, reimbursement and changing regulatory rules — think of a local bakery’s custom recipe versus a factory-made packaged product.
Clinical Laboratory Improvement Amendments (CLIA) regulatory
"LDTs are overseen under the Clinical Laboratory Improvement Amendments (CLIA)"
Clinical Laboratory Improvement Amendments (CLIA) are U.S. federal rules that set minimum quality and safety standards for medical laboratories that test human samples, covering test accuracy, staff qualifications, equipment, recordkeeping and routine inspections. For investors, CLIA acts like a regulatory "health inspection" for labs: certification is often required to legally run and sell clinical tests, so it directly affects a lab’s ability to generate revenue, enter markets and avoid regulatory risk.
noninvasive diagnostics medical
"a biotechnology company focused on noninvasive diagnostics for the early detection"
Tests and tools that detect, monitor, or diagnose disease without cutting into the body or inserting instruments past natural openings, typically using blood draws, imaging, breath, urine, saliva, or external sensors. They matter to investors because they can lower patient risk and cost, speed adoption and reimbursement, and affect market size and regulatory pathways—similar to diagnosing a car from its dashboard rather than disassembling the engine.
forward-looking statements regulatory
"Certain statements in this press release constitute “forward-looking statements”"
Forward-looking statements are predictions or plans that companies share about what they expect to happen in the future, like estimating sales or profits. They matter because they help investors understand a company's outlook, but since they are based on guesses and assumptions, they can sometimes be wrong.
Laboratory Developed Test medical
"CyPath® Lung is marketed as a Laboratory Developed Test (LDT)"
A laboratory developed test is a medical diagnostic created, validated and performed within a single clinical laboratory rather than sold as a boxed product to other labs or clinics. For investors, LDTs can offer faster product rollout and niche revenue streams like a custom service, but they also carry regulatory and reimbursement uncertainty and competitive risk—think of them as a handmade tool that can be quickly offered to customers but may face shifting rules or market limits.

FAQ

What event did bioAffinity Technologies (BIAF) announce in this 8-K?
bioAffinity Technologies announced that President and CEO Maria Zannes will present a corporate update and hold one-on-one investor meetings at the H.C. Wainwright 28th Annual Global Investment Conference being held September 14-16, 2026.

How many shares of BIAF common stock were outstanding as of September 2, 2026?
As of September 2, 2026, bioAffinity Technologies had 600,736 outstanding shares of common stock. This share count is disclosed together with the company’s aggregate market value based on the Nasdaq Capital Market closing price on that date.

What was the approximate market value of BIAF’s common stock as of September 2, 2026?
As of September 2, 2026, the aggregate market value of bioAffinity Technologies’ common stock was approximately $5.9 million, calculated using the closing price of the common stock on the Nasdaq Capital Market on that date.

What products and focus areas did bioAffinity Technologies (BIAF) highlight?
bioAffinity Technologies highlighted its first product, CyPath® Lung, a noninvasive test for early-stage lung cancer, and noted commercial adoption, momentum, and advancement of its proprietary technology platform for additional diagnostic and therapeutic applications targeting lung and other cancers.

How is CyPath® Lung from bioAffinity Technologies (BIAF) regulated and marketed?
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.

Where can investors access the bioAffinity Technologies (BIAF) conference presentation?
A live and archived webcast of bioAffinity Technologies’ presentation will be available on September 11 at https://bit.ly/BIAFPresentation. Institutional investors can also register to attend the H.C. Wainwright conference virtually or in person via the conference website.

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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 3, 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

(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))

 

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 ☒

 

If 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.

 

On September 3, 2026, bioAffinity Technologies, Inc., a Delaware corporation (the “Company”), issued a press release announcing that its President and CEO Maria Zannes will present a corporate update and hold one-on-one investor meetings during the H.C. Wainwright 28th Annual Global Investment Conference being held on September 14-16, 2026.

 

A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

 

As of September 2, 2026, there were 600,736 outstanding shares of the Company’s common stock and the aggregate market value of the Company’s common stock was approximately $5.9 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
Number		   Description
99.1   Press Release issued by bioAffinity Technologies, Inc., dated September 3, 2026
104   Cover Page Interactive Data File (embedded within the 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: September 3, 2026 BIOAFFINITY TECHNOLOGIES, INC.
   
  By: /s/ Maria Zannes
  Name: Maria Zannes
  Title: President and Chief Executive Officer

 

-3-

 

 

Exhibit 99.1

 

 

bioAffinity Technologies to Participate in the H.C. Wainwright 28th Annual Global Investment Conference

 

SAN ANTONIO, Texas – September 3, 2026 – bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company focused on noninvasive diagnostics for the early detection of lung cancer and other lung diseases, today announced that President and CEO Maria Zannes will present a corporate update and hold one-on-one investor meetings during the H.C. Wainwright 28th Annual Global Investment Conference being held September 14-16, 2026.

 

Ms. Zannes’ presentation will feature recent and upcoming strategic milestones, commercial adoption and momentum for the Company’s CyPath® Lung diagnostic test, and advancements for the proprietary technology platform to develop additional diagnostic and therapeutic applications.

 

Institutional investors can register here to attend the conference virtually or in-person at the Lotte New York Palace Hotel. Registered investors may request a meeting via the conference website.

 

A live and archived webcast of the bioAffinity presentation will be available on September 11 at https://bit.ly/BIAFPresentation.

 

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, the Company’s limited operating history and history of losses, the Company’s need for additional capital, the impact of competition, the ability to obtain and maintain regulatory approvals, 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

 

 

 

Source: View Original Filing on SEC EDGAR

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