Company: BIAF
Filing Date: 2025-04-15
Form Type: DRS
Source: 0001641172-25-004915
Chunk: 100

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-04-15
Form: DRS
Chunk 100
---
4 include:

| ● | Consolidated                                                                                                                     
 revenue increased approximately 270% to $9.4 million as compared to $2.5 million for the year ended December 31, 2023, 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.                              |

| 48 |

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 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