Aug 7, 2026, 8:30 AM ETHealthcare

bioAffinity Technologies — Q2 2026 Earnings Summary

BIAFBIOAFFINITY TECHNOLOGIES INC

Financial Performance

Revenue for the quarter ended June 30, 2026, was $1.5 million, a 19% increase from $1.3 million in the same period in 2025.
Net loss for the quarter ended June 30, 2026, was $3.4 million, compared with a net loss of $4.1 million for the second quarter of 2025.
Operating expenses for the second quarter of 2026 were $4.8 million, compared with $3.8 million in the second quarter of 2025.
Direct costs and expenses for the second quarter of 2026 were $1.1 million, compared to $1 million in the prior-year period.
Research and development expenses increased 16% year-over-year to $362,000.
Clinical development expenses rose to $476,000 from $129,000 in the second quarter of 2025.
Selling, general and administrative expenses were $2.9 million for the second quarter of 2026, up from $2.2 million in the same period last year.
Cash and cash equivalents as of June 30, 2026, were $2.4 million, compared with $6.4 million as of December 31, 2025.
Total assets were $7.6 million as of June 30, 2026, down from $11.0 million as of December 31, 2025.
Total liabilities were $3.9 million as of June 30, 2026, up from $3.7 million as of December 31, 2025.
Total stockholders' equity was $3.8 million as of June 30, 2026, down from $7.3 million as of December 31, 2025.
Accumulated deficit was $(75.6) million as of June 30, 2026, compared with $(68.6) million as of December 31, 2025.

Priorities for the second half of 2026 include expanding physician adoption, increasing utilization among existing customers, and introducing CyPath Lung to new healthcare systems and specialty practices, including oncology.
The company aims to build a robust pipeline of precision diagnostics for asthma and COPD markets and therapeutic markets for topically delivered skin cancer drugs.

CyPath Lung diagnostic test volume increased 216% year-over-year in Q2 2026 compared to Q2 2025.
CyPath Lung testing revenue for the first six months of 2026 increased 159% to approximately $835,000, compared with approximately $323,000 for the first six months of 2025.
The company delivered 1,097 CyPath Lung test reports during the first six months of 2026, compared with 390 during the same period of 2025.
The number of physician offices and clinics ordering CyPath Lung increased 122% during the second quarter of 2026 compared to the same period in 2025.
Existing clients as of June 30, 2025, increased their CyPath Lung orders by 71% year-over-year during the first six months of 2026.
The longitudinal clinical trial evaluating CyPath Lung has begun patient enrollment at 11 clinical sites, including nine Department of Veterans Affairs and military medical centers.
Pipeline expansion includes development of precision diagnostics for asthma and COPD and dermally delivered skin cancer therapeutics using self-delivering stabilized siRNAs.
The company announced a collaboration with Pictor®, Inc. to support development of next-generation diagnostic tests for lung inflammation in asthma and COPD patients.
bioAffinity received notification of allowance from the Mexican Institute of Industrial Property for a patent application protecting the use of defined antibodies and porphyrin TCPP to label cell populations in sputum.

CyPath Lung demonstrated 92% sensitivity, 87% specificity, 88% accuracy, and 99% negative predictive value in a published clinical trial of high-risk patients with small indeterminate lung nodules less than 20 millimeters.
The Society for Advanced Bronchoscopy (SAB) and National Association of Veterans Research Education Foundations (NAVREF) hosted webinars discussing CyPath Lung's role in the lung nodule care continuum.
The company published a clinical review and white paper presenting a framework for incorporating CyPath Lung into pulmonary nodule evaluation and cancer surveillance.

Risks include the ability to successfully commercialize CyPath Lung and achieve broader market acceptance.
Risks related to the ability to obtain adequate financing to fund operations and development activities.
Risks related to the results of clinical trials and studies.
Risks related to obtaining and maintaining regulatory approvals or clearances.
Risks related to protecting intellectual property.
Competition from other companies developing similar products.
Changes in applicable laws or regulations.
Limited operating history and history of operating losses.
Receipt of a delisting determination notice from the Nasdaq Stock Market and risks associated with the intent to appeal such determination.

CEO Maria Zannes stated that commercial strategy is gaining significant traction as physicians recognize the clinical value of CyPath Lung for high-risk patients and surveillance of lung cancer survivors.
Zannes noted that growth reflects accelerating physician adoption and clinical confidence, driven by peer-to-peer education and the test's ability to provide objective data.
Management highlighted progress in physician education initiatives, including scientific presentations, webinars, podcasts, and real-world clinical case studies.
Zannes expressed excitement regarding positive results from R&D for precision diagnostics and skin cancer therapeutics, viewing the balanced approach as positioning the company to create lasting value.

In June 2026, bioAffinity completed a public offering that generated approximately $3.2 million in gross proceeds to support commercialization activities, clinical development, and general corporate purposes.
CyPath Lung is marketed as a Laboratory Developed Test (LDT) by Precision Pathology Laboratory Services, a subsidiary of bioAffinity Technologies.
The company presented positive research results advancing a diagnostic platform to identify antibody drug receptors in sputum to match patients with biologic therapies for asthma and COPD.
Positive preliminary therapeutic data support the development of topical treatments for squamous and basal cell skin cancers, with siRNAs selectively killing cancer cells while sparing healthy cutaneous cells.