Company: BIAF
Filing Date: 2025-05-15
Form Type: 10-Q
Source: 0001641172-25-010787
Chunk: 14

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-05-15
Form: 10-Q
Item: Part I, Item 7
Chunk 14
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 in our 2024 Form 10-K.

Risks Related to Our Financial
Position

Our business plan relies
upon our ability to obtain additional sources of capital and financing. If the amount of capital we are able to raise from financing activities,
together with our revenues from operations, is not sufficient to satisfy our capital needs, we may be required to cease operations.

Prior to 2022, we had not
generated any revenue. During the three months ended March 31, 2025, we generated revenue of approximately $1.9 million, and $9.4 million
during the year ended December 31, 2024.

To become and remain profitable,
we must succeed in generating additional laboratory revenue and developing and commercializing our diagnostic tests and therapeutic products
that we expect will generate significant income in the planned timeframe. This will require us to be successful in a range of challenging
activities, including completing preclinical testing and clinical trials of our diagnostic and therapeutic technologies, obtaining regulatory
approval for our diagnostic and therapeutic technologies, manufacturing, marketing, and selling any diagnostic tests and therapeutic products
for which we may obtain regulatory approval, and establishing and managing our collaborations at various phases of each diagnostic test
and therapeutic product candidate’s development. We are in the preliminary phases of these activities. We may never succeed in these
activities and, even if we do, may never generate sufficient income to achieve profitability.

To become profitable, we
must develop our diagnostic tests and therapeutic products, which will depend in large part on our ability to:

    ●
    Develop, enhance, and protect our diagnostic tests and therapeutic products;

    ●
    Raise sufficient funding to support our diagnostic tests and therapeutic product development program(s);

    ●
    Complete pre-clinical testing;

24

    ●
    Work with our partners to expand commercialization of our first diagnostic test, CyPath® Lung, as an LDT under the CAP/CLIA guidelines and regulations administered by CMS and CAP;

    ●
    Obtain de novo classification from FDA for our CyPath® Lung as a Class II in vitro diagnostic;

    ●
    Work with our partners to develop and commercialize our first diagnostic test, CyPath® Lung, as a CE-marked test in accordance with the In Vitro Diagnostic Regulation (“IVDR”) of the European Union (“EU”);

    ●
    Synthesize, test, and attract licensing partners for drug conjugates, siRNAs, and other therapeutics (and methods for their use) developed