bioAffinity Technologies (BIAF) Registration filing summary

Company overview and business model

• Develops noninvasive diagnostic tests for early-stage lung cancer and other lung diseases using flow cytometry and AI-driven analysis.

• First commercial product, CyPath® Lung, aids in early lung cancer detection with high sensitivity and specificity.

• Expanding diagnostic pipeline to asthma and COPD, aiming to guide therapy selection and reduce trial-and-error in treatment.

• Owns a CAP-accredited, CLIA-certified laboratory and conducts research through subsidiaries.

• Recently entered a distribution agreement to expand CyPath® Lung's reach in government healthcare markets.

Financial performance and metrics

• Reported net loss of $14.9 million for 2025 and $9.0 million for 2024.

• Net loss per share (post-reverse split) was $(129.96) for 2025 and $(335.50) for 2024.

• Weighted average shares outstanding (post-split) were 114,729 in 2025 and 26,944 in 2024.

• Recent quarters continue to show significant net losses.

Use of proceeds and capital allocation

• Will not receive proceeds from stockholder sales; may receive up to $5.7 million if all warrants are exercised for cash.

• Net proceeds from August 2026 private placement (~$3.5 million) intended for working capital and general corporate purposes.