bioAffinity Technologies — Third Quarter 2026 Earnings Summary

Financial Performance:

• Total revenue for Q3 2026 was approximately $1.1 million, a decrease from approximately $1.4 million in Q3 2025.
• Net loss for Q3 2026 was approximately $5.3 million, compared to approximately $5.1 million in Q3 2025.
• Loss from operations increased to approximately $3.5 million in Q3 2026 from approximately $2.3 million in Q3 2025.
• Operating expenses for Q3 2026 were approximately $4.6 million, up from approximately $3.7 million in Q3 2025.
• Direct costs and expenses were approximately $1.1 million in Q3 2026, compared to $942,000 in the prior-year period.
• Research and development expenses increased 18% year-over-year to approximately $389,000 in Q3 2026.
• Clinical development expenses increased 75% to approximately $251,000 in Q3 2026, compared to approximately $143,000 in Q3 2025.
• Selling, general and administrative expenses increased 28% to approximately $2.8 million in Q3 2026, compared to approximately $2.2 million in Q3 2025.
• Cash and cash equivalents were approximately $2.6 million as of September 30, 2026, down from approximately $6.4 million at December 31, 2025.
• Total assets were $7.55 million as of September 30, 2026, compared to $10.96 million at December 31, 2025.
• Total liabilities were $3.64 million as of September 30, 2026, compared to $3.68 million at December 31, 2025.
• Total stockholders' equity was $3.91 million as of September 30, 2026, compared to $7.28 million at December 31, 2025.
• Net loss per common share for Q3 2026 was $5.89, compared to $71.05 in Q3 2025.

Guidance and Future Outlook:

• The Company aims to establish CyPath Lung as a standard of care for evaluating patients at risk for lung cancer.
• Management intends to expand commercial adoption and advance clinical and research programs.
• The Company is pursuing topical therapeutic approaches for squamous and basal cell skin cancers based on findings involving CD320 and LRP2 receptors.
• The Company is advancing its platform to address precision medicine opportunities in asthma and COPD.

Business Segments and Product Lines:

• CyPath Lung test unit sales increased 100% through Q3 2026 compared to the first nine months of 2025.
• CyPath Lung testing revenue for the first nine months of 2026 increased 79% to approximately $1.1 million compared to the same period in 2025.
• The number of ordering physicians increased by 89% in Q3 2026 compared to Q3 2025; existing physicians increased volume by 48% year-over-year.
• The Company surpassed the total number of CyPath Lung test reports delivered to physicians in 2025 in July 2026.
• A longitudinal clinical trial for CyPath Lung is active at 11 sites, including nine VA and military medical centers, with support from the John P. Murtha Cancer Center Research Program.
• The Company announced a collaboration with Pictor, Inc. to develop next-generation diagnostic tests for asthma and COPD.
• Preliminary research on topically delivered therapeutics for squamous and basal cell skin cancers demonstrated that stabilized siRNAs selectively kill carcinoma cells in vitro.
• The Company received a Hong Kong patent grant and a Notice of Allowance from the Japan Patent Office for CyPath Lung technology.
• The Company advanced CyPath Lung for potential use in surveillance of lung cancer survivors to monitor for recurrence and new primary cancers.

Market and Competitive Landscape:

• The Company expanded its government healthcare distribution network through an agreement with AvMEDICAL, a Service-Disabled Veteran-Owned Small Business, to reach the Department of Veterans Affairs.
• The Company published a clinical review and white paper on incorporating CyPath Lung into pulmonology and oncology practices, presented at CHEST 2026.
• The Company presented positive research results at CHEST 2026 regarding noninvasive tests to characterize lung inflammation for asthma and COPD.
• The Company's patent portfolio now includes 22 awarded U.S. and foreign patents and 36 pending applications.

Risks and Challenges:

• Revenue decreased in Q3 2026 primarily due to a decrease in average reimbursement per test and a slight decline in total cases completed at Precision Pathology Laboratory Services (PPLS).
• The decline in PPLS cases was partly due to internal business changes at three research clients, though multiple accounts have since returned.
• The Company faces risks related to the timing, cost, enrollment, and outcome of clinical studies.
• There is a risk that preliminary findings may not translate into safe and effective therapies or commercial products.
• Risks include the need for further validation of new applications, the extent of physician adoption, payer coverage, reimbursement rates, and the ability to obtain and enforce intellectual property rights.

Management Commentary and Tone:

• Maria Zannes, President and CEO, stated that third-quarter results reflect continued momentum in addressing the need for early lung cancer detection.
• Management highlighted that peer-to-peer education and growing clinical experience remain important drivers of adoption.
• Zannes noted that the Company is building a foundation for long-term growth beyond lung cancer into asthma and COPD markets.
• Management emphasized priorities of disciplined execution, expanding commercial adoption, and advancing clinical and research programs.

Other Key Points:

• The Company raised an aggregate of $8.0 million in gross proceeds through a private placement in August 2026 and a registered direct offering in October 2026.
• Subsequent to the quarter-end, the Company completed a financing generating approximately $4.0 million in gross proceeds.
• The Company relocated laboratory facilities in June 2026, contributing to increased R&D costs.
• CyPath Lung demonstrated 92% sensitivity, 87% specificity, 88% accuracy, and 99% negative predictive value in a published clinical trial of high-risk patients.
• CyPath Lung is marketed as a Laboratory Developed Test (LDT) under CLIA regulations.