Company: BIAF
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001641172-25-001840
Chunk: 2

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1
Chunk 2
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3, primarily as
    a result of the acquisition of PPLS in September 2023.

    ●
    CyPath® Lung testing revenue increased approximately 1,400%
to $0.5 million as compared to $35 thousand for the year ended December 31, 2023, due to an increase in total test results delivered of
more than 600 for the current year.

    ●
    Raised
    approximately $6.9 million in gross proceeds from equity transactions to fund operating activities.

Recent
Developments

FDA
Pivotal Study

In
March 2025, we submitted our pivotal clinical trial protocol “Detection of Early-Stage Lung Cancer in Sputum using Flow
Cytometry and an Automated Analysis Pipeline” to the Sterling Institutional Review Board (“IRB”) for approval
after the Company meet met with the FDA on trial design. In third quarter 2024, the National Association of Veterans Research and
Education Foundation (“NAVREF”) extended a “Call for Interest” to Veterans Administration (“VA”) systems to solicit participation in the
pivotal trial, which resulted in a positive response from 22 VA medical centers. Academic, private, military, and VA centers currently are being qualified as collection sites for the
3,200-patient clinical trial expected to open in the second quarter of 2025.

Case
Studies

In
March 2025, we announced the release of physicians’ case studies showing the benefit to patients and their doctors of using CyPath®
Lung, including one case in which an “Unlikely Lung Cancer” directly prevented a robotic bronchoscopic biopsy or high-risk
percutaneous biopsy in a high-risk patient in response to imaging that showed several new, small non-calcified pulmonary nodules for
a high-risk patient. In a second case study, a positive CyPath® Lung test result led to diagnosis of a recurrence of breast
cancer, and a third case resulted in the diagnosis of a new primary lung cancer after a CyPath® Lung positive test that
prompted a biopsy that otherwise would not have been performed.

Targeted
Strategic Actions

In
March 2025, we announced targeted strategic actions to improve financial
performance and accelerate the commercial growth of CyPath® Lung, taking steps to deliver approximately $4 million in annual
cost savings at our subsidiary PPLS, while increasing resources to expand CyPath® Lung sales in high-potential national markets. Specifically,
cost savings are