bioAffinity Technologies — Third Quarter 2026 Earnings Summary

Financial Performance

• Total revenue for the quarter ended September 30, 2026, was approximately $1.1 million, a decrease from approximately $1.4 million in the same period of 2025.
• Net loss for the quarter ended September 30, 2026, was approximately $5.3 million, compared to approximately $5.1 million in the third quarter of 2025.
• Operating expenses for the third quarter of 2026 were approximately $4.6 million, an increase from approximately $3.7 million in the prior-year quarter.
• 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 the prior-year period.
• 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 $7,553,671 as of September 30, 2026, compared to $10,960,772 at December 31, 2025.
• Total liabilities were $3,639,110 as of September 30, 2026, compared to $3,683,116 at December 31, 2025.
• Stockholders' equity decreased to $3,914,561 as of September 30, 2026, from $7,277,656 at December 31, 2025.
• Accumulated deficit increased to $(80,827,779) as of September 30, 2026, from $(68,554,064) at December 31, 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 is advancing the platform to address precision medicine opportunities in asthma and COPD, targeting the multi-billion-dollar therapeutic markets.
• The Company is pursuing topical therapeutic approaches for squamous and basal cell skin cancers based on promising findings involving CD320 and LRP2 receptors.
• Future development includes validation of new applications for CyPath Lung in surveillance of lung cancer survivors to monitor for recurrence and new primary cancers.

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, with existing physicians increasing 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 evaluating CyPath Lung performance is active at 11 sites, including nine VA and military medical centers.
• The Company announced a collaboration with Pictor, Inc. to support development of next-generation diagnostic tests for asthma and COPD.
• Preliminary research demonstrated that self-delivering, stabilized siRNAs selectively kill squamous and basal 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's lung cancer prediction technology.
• The Company has a total of 22 awarded U.S. and foreign patents and 36 pending applications.

Market and Competitive Landscape

• The Company expanded its government healthcare distribution network through an agreement with AvMEDICAL, a distributor serving government agencies including the Department of Veterans Affairs.
• The Company is targeting the multi-billion-dollar asthma and COPD therapeutic markets with precision diagnostics designed to match patients to treatments like Tezspire, Dupixent, and Nucala.
• The Company is addressing the substantial burden of lung cancer in the VA healthcare market.

Risks and Challenges

• Revenue decreased due to a decline in average reimbursement per test and a slight decline in total cases completed at Precision Pathology Laboratory Services (PPLS).
• Internal business changes at three PPLS research clients caused a decline in cases, though multiple accounts have since returned.
• Risks include the ability to expand commercial adoption, timing and outcomes of clinical studies, translation of preliminary findings into safe and effective therapies, 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 results reflect continued momentum in early lung cancer detection driven by new physician orders and increased use by existing customers.
• Management emphasized that peer-to-peer education and growing clinical experience are important drivers of adoption.
• The tone is focused on disciplined execution, expanding commercial adoption, and advancing clinical and research programs.
• Management views the AvMEDICAL agreement as a key step to expand reach into government healthcare markets.

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 published a clinical review and white paper by Chief Medical Officer Gordon H. Downie, MD, PhD, presented at the CHEST 2026 annual meeting.
• 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) by Precision Pathology Laboratory Services, a subsidiary of bioAffinity Technologies.