bioAffinity enrolls first patient in pivotal lung cancer trial; revenue falls 34% on pathology exit

Filed March 16, 2026 · Period ending December 31, 2025 · Compared to 10-K Mar 31, 2025 · ~2 min read

Key Changes

• high

  Pivotal clinical trial for CyPath Lung enrolled first patient in March 2026 at military/VA sites, advancing toward regulatory validation. Trial targets 2,063 high-risk patients with indeterminate nodules, down from originally planned 3,200.

  Business: pivotal clinical trial enrollment verify on EDGAR →
• high

  Revenue declined 34% to $6.2M as company exited unprofitable pathology services in March 2025 restructuring. CyPath Lung revenue grew 87% to $963K on 99% volume increase, but remains small fraction of total revenue.

  MD&A: consolidated revenue decline verify on EDGAR →
• high

  Company raised $16.9M in equity during 2025 (vs $6.9M in 2024) through multiple offerings. Going-concern runway extended to June 2026; accumulated deficit widened from $53.6M to $68.6M on $14.9M net loss.

  MD&A: equity capital raised verify on EDGAR →