Company: BIAF
Filing Date: 2025-05-05
Form Type: S-1/A
Source: 0001641172-25-008629
Chunk: 102

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-05-05
Form: S-1/A
Chunk 102
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 less than 30 minutes, allowing for cost-effective, large-scale commercialization.

We conducted a 150-patient test validation trial of people at high risk for lung cancer including patients with the disease (N=28) and those who were cancer-free (N=122) that resulted in CyPath ®Lung’s overall 88% specificity, meaning the ability to correctly identify a person without cancer, and 82% sensitivity, meaning the ability to correctly identify cancer in a person with the disease. CyPath ®Lung correctly detected 80% of Stage I lung cancers. The test detected multiple lung cancer types including non-small cell, small cell, adenocarcinoma, squamous, and large cell cancers. For the subset of patients in this trial who had lung nodules 20 millimeters (“mm”) or smaller, this trial resulted in 92% sensitivity, 87% specificity, 99% negative predictive value, and 88% accuracy. In this subset of 132 individuals with small nodules, 119 patients were cancer-free and 13 had confirmed lung cancer. The detection of small lung nodules in people who have early-stage cancer can increase lung cancer survival.

Current Year Financial Highlights

Key financial results for the year ended December 31, 2024 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.                              |

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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