Company: BIAF
Filing Date: 2025-05-02
Form Type: S-1
Source: 0001641172-25-008170
Chunk: 207

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-05-02
Form: S-1
Chunk 207
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 activities         |     |                 | (6,586,133 | ) |     |      | (5,011,347 | ) |
| Total operating loss         |     |                 | (8,953,445 | ) |     |      | (7,973,228 | ) |
| Non-operating                
 income (expense), net        |     |                 |    (74,736 | ) |     |      |     57,210 |   |
| Net loss before income taxes |     |                 | (9,028,181 | ) |     |      | (7,916,018 | ) |
| Income                       
 tax expense                  |     |                 |    (11,650 | ) |     |      |    (20,993 | ) |
| Net loss                     |     | $               | (9,039,831 | ) |     | $    | (7,937,011 | ) |

Research and Development

Research and development costs are charged to expense as incurred. The Company’s research and development expenses consist primarily of expenditures for laboratory operations, preclinical studies, compensation, and consulting costs.

Accrued Research and Development Costs

The Company records accrued liabilities for estimated costs of research and development activities conducted by service providers, which include preclinical studies. The Company records the estimated costs of research and development activities based upon the estimated amount of services provided but not yet invoiced and includes these costs in accrued expenses in the accompanying consolidated balance sheets and within research and development expense in the accompanying consolidated statements of operations.

The Company accrues for these costs based on factors such as estimates of the work completed and in accordance with agreements established with service providers. The Company makes significant judgments and estimates in determining the accrued expenses balance in each reporting period. As actual costs become known, the Company adjusts its accrued liabilities. The Company has not experienced any material differences between accrued costs and actual costs incurred since its inception.

Regulatory Matters

Regulations imposed by federal, state, and local authorities in the U.S. are a significant factor in providing medical care. In the U.S., drugs, biological products, and medical devices are regulated by the federal Food, Drug and Cosmetic Act, which is administered by the FDA and CMS. The Company has not yet obtained marketing authorization from the FDA but is able to market its CyPath ®Lung test as a laboratory developed test sold by Precision Pathology Laboratory Services, a CAP-accredited, CLIA-certified clinical pathology laboratory and wholly owned subsidiary.

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