Company: BIAF
Filing Date: 2025-11-14
Form Type: 10-Q
Source: 0001493152-25-023405
Chunk: 10

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-11-14
Form: 10-Q
Item: Part I, Item 8
Chunk 10
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, ORGANIZATION, AND BASIS OF PRESENTATION

Description
of Business

bioAffinity
Technologies, Inc., a Delaware corporation (the “Company,” or “bioAffinity Technologies”), addresses the need
for noninvasive diagnosis of lung cancer at early stage and other diseases of the lung. bioAffinity Technologies’ proprietary platform
uses flow cytometry and automated data analysis built by machine learning, a form of artificial intelligence (“AI”), to preferentially
target cancer cell populations and other cell populations indicative of a diseased state. The Company’s first diagnostic test,
CyPath® Lung, is a noninvasive test for early detection of lung cancer, the leading cause of cancer-related deaths. CyPath®
Lung is offered for sale to physicians by the Company’s subsidiary, Precision Pathology Laboratory Services, LLC (“PPLS”).
The Company is developing its flow cytometry platform to address the need to identify patients who can benefit from new and emerging
therapies for asthma and chronic obstructive pulmonary disease (COPD) with noninvasive precision diagnostic tests. Research also is advancing
the Company’s therapeutic discoveries that could in the future result in broad-spectrum cancer treatments, beginning with treatment
delivered topically for squamous cell skin cancer. Commercial operations and product development are conducted in laboratories at PPLS
and laboratory space leased at The University of Texas at San Antonio.

Organization

The
Company was formed on March 26, 2014, as a Delaware corporation with its corporate offices located in San Antonio, Texas. On June 15,
2016, the Company formed a wholly owned subsidiary, OncoSelect® Therapeutics, LLC, as a Delaware limited liability company.
On August 14, 2023, the Company formed a wholly owned subsidiary, PPLS, as a Texas limited liability company, to acquire the assets of
Village Oaks Pathology Services, P.A. (“Village Oaks”), a Texas professional association d/b/a Precision Pathology Services,
including the clinical pathology laboratory it owned.

Basis
of Presentation

The
accompanying unaudited condensed consolidated financial statements have been prepared in accordance with generally accepted accounting
principles in the United States (“GAAP”) and pursuant to the rules and regulations of the SEC for interim financial reporting.
The condensed consolidated financial statements are unaudited and in management’s opinion include all adjustments, including normal
recurring adjustments and accruals, necessary for a fair presentation of the results for