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.

• Flagship product CyPath® Lung offers high sensitivity and specificity for lung cancer detection from sputum samples.

• Commercial operations are conducted through a CAP-accredited, CLIA-certified subsidiary laboratory, PPLS.

• Pipeline includes companion diagnostics for asthma and COPD, and research into novel cancer therapeutics.

• Business plan targets phased expansion in the U.S., EU, and Asia, aiming for national coverage and eventual standard-of-care adoption.

Financial performance and metrics

• CyPath® Lung unit sales grew 146% in Q1 2026 vs. Q1 2025; Q1 2026 revenue for CyPath® Lung increased 114% to $361,000.

• Consolidated revenue for Q1 2026 was $1.4 million, down 36% from Q1 2025.

• 2025 and 2024 annual revenues were $6.2 million and $9.4 million, respectively.

• As of March 31, 2026, accumulated deficit was $72.2 million with $3.1 million cash on hand.

• Company must raise additional capital to continue as a going concern beyond June 2026.

Use of proceeds and capital allocation

• Estimated net proceeds of $3.4 million from the offering, after fees and expenses.

• Proceeds intended for working capital and general corporate purposes; management has broad discretion over use.

• Proceeds not immediately used will be invested in short-term securities.