Company: BIAF
Filing Date: 2025-10-09
Form Type: 424B5
Source: 0001493152-25-017591
Chunk: 55

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-10-09
Form: 424B5
Chunk 55
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 our revenue could decline.

If PPLS becomes damaged or inoperable, loses its accreditation or is required to vacate the facility, PPLS’ ability to sell its products or provide diagnostic assays may be jeopardized.

Our only CLIA-certified, CAP-accredited, and state-licensed laboratory is PPLS. Its facilities and equipment could be harmed or rendered inoperable by natural or man-made disasters, including fire, earthquake, flooding and power outages, which may render it difficult or impossible for it to provide pathology services or perform our diagnostic assays for some period of time. The inability to of PPLS to perform its services for its customers if its facility is inoperable for even a short period of time, may result in the loss of customers or harm to its reputation or relationships with its customers, and it may be unable to regain those customers or repair its reputation in the future. Furthermore, PPLS facilities and the equipment it uses to perform its services could be costly and time-consuming to repair or replace.

Further, if PPLS’ current or future CLIA-certified, CAP-accredited, and state-licensed laboratory becomes inoperable or unqualified in any way it may not be able to license or transfer its technology to another facility with the necessary qualifications, including state licensure and CLIA certification, under the scope of which its current assays and its planned future assays could be performed. Even if PPLS finds a facility with such qualifications to perform its assays, it may not be available to PPLS on commercially reasonable terms.

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PPLS relies on commercial delivery services to transport sputum samples to PPLS for processing the CyPath ®Lung test in a timely and cost-efficient manner and if these delivery services are disrupted, its business will be harmed.

PPLS’ business depends on its ability to quickly and reliably deliver test results to its customers. Sputum samples are received overnight within the United States through commercial delivery services for analysis at the clinical pathology laboratory located in San Antonio, Texas. Disruptions in delivery service, whether due to bad weather, natural disaster, terrorist acts or threats or for other reasons could adversely affect specimen integrity and its ability to process samples in a timely manner and to service its customers, and ultimately its reputation and its business. In addition, if PPLS is unable to continue to obtain such expedited delivery services at commercially reasonable prices, its operating results may be adversely affected.

Security breaches, loss of data and other