BIAFW Overview

Sales Growth of CyPath® Lung: bioAffinity Technologies reported a 111% increase in test volume for its noninvasive lung cancer diagnostic test, CyPath® Lung, in October 2025 compared to the monthly average for the first nine months of the year, indicating strong adoption by physicians.

Clinical Value Recognition: The increase in test volume reflects growing recognition among clinicians of the test's clinical value in early lung cancer detection, particularly for patients with indeterminate pulmonary nodules.

Consistent Growth Trends: Throughout 2025, CyPath® Lung has shown consistent month-over-month and quarter-over-quarter sales growth, with a 95% increase in third-quarter sales compared to the previous quarter.

Technology and Accuracy: CyPath® Lung utilizes advanced flow cytometry and AI for detecting malignancy in sputum samples, achieving 92% sensitivity and 88% accuracy in clinical studies, which underscores its potential to improve early-stage lung cancer diagnosis and patient outcomes.

Stock Offering Announcement: bioAffinity Technologies, Inc. has completed a registered direct offering of 720,000 shares of common stock at $2.50 per share, with proceeds intended for working capital and to support sales growth of its noninvasive lung cancer test, CyPath® Lung.

Company Overview: bioAffinity Technologies focuses on noninvasive cancer diagnostics, with its primary product, CyPath® Lung, demonstrating high sensitivity and accuracy for early-stage lung cancer detection, marketed through its subsidiary, Precision Pathology Laboratory Services.

Stock Offering Announcement: bioAffinity Technologies, Inc. has announced a registered direct offering of 720,000 shares of common stock at $2.50 per share, expected to close around October 9, 2025, with gross proceeds estimated at $1.8 million.

Use of Proceeds: The company plans to use the net proceeds for working capital, supporting sales growth of its noninvasive lung cancer test, CyPath® Lung, and for general corporate purposes.

Public Offering Announcement: bioAffinity Technologies, Inc. has successfully closed a public offering of securities, raising $4.8 million through the sale of 1,921,761 shares of Common Stock at a price of $2.50 per share.

Product Focus: The company specializes in noninvasive tests for early-stage cancer detection, with its first product, CyPath® Lung, demonstrating high sensitivity and accuracy for detecting early-stage lung cancer.

Noninvasive Lung Cancer Detection: bioAffinity Technologies has released case studies demonstrating that its noninvasive diagnostic test, CyPath® Lung, successfully detected Stage 1A lung cancer and helped avoid unnecessary invasive procedures for patients with indeterminate lung nodules.

Clinical Impact and Technology: The test utilizes advanced flow cytometry and AI to analyze sputum samples, achieving high sensitivity and specificity in identifying lung cancer, thereby enhancing clinical decision-making and potentially improving patient outcomes.

New Board Appointments: bioAffinity Technologies has appointed Roberto Rios, CPA, and John J. Oppenheimer, M.D., to its Board of Directors to enhance commercial growth and clinical strategies.

Expertise Contributions: Mr. Rios brings extensive financial leadership experience from various industries, while Dr. Oppenheimer offers significant clinical expertise in asthma and COPD, which will aid in advancing the company's diagnostics and therapeutics.

CyPath® Lung Overview: The company’s product, CyPath® Lung, is a noninvasive test for early-stage lung cancer detection, demonstrating high sensitivity and accuracy in clinical studies.

Board Changes: Gary Rubin has stepped down from the Board for personal reasons, with no disagreements reported, and the company expresses gratitude for his contributions over the past seven years.