Company: BIAF
Filing Date: 2025-04-11
Form Type: S-1
Source: 0001641172-25-003892
Chunk: 109

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-04-11
Form: S-1
Chunk 109
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 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.                                                                                                                              |

| 51 |

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 met with the FDA on trial design. In the 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 CyPathLung, 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 a result of labor cost reductions, operational efficiency enhancements, and discontinuing
certain pathology services with suboptimal profit margins to focus on high-margin services such as CyPath Lung and by
discontinuing certain pathology services with suboptimal profit margins.

Continuation of Department of Defense Research