bioAffinity Technologies, Inc.

What they do

bioAffinity develops noninvasive diagnostic laboratory tests that analyze sputum using flow cytometry plus automated, machine-learning-informed analysis. Its first commercial test, CyPath Lung, is intended to help physicians assess high-risk patients and identify those likely to need invasive follow-up versus continued screening; in a clinical trial of nodules under 20 mm it showed 92% sensitivity, 87% specificity and 88% accuracy. Testing is performed by wholly owned subsidiary PPLS, a CAP-accredited, CLIA-certified anatomic and clinical pathology laboratory that has operated more than 18 years and was acquired from Village Oaks Pathology Services. The company also runs early-stage programs in asthma/COPD diagnostics and, through OncoSelect Therapeutics, cancer therapeutics including topically delivered stabilized siRNAs for squamous and basal cell skin cancers.

Revenue drivers

• CyPath Lung diagnostic testing — Test revenue is billed through PPLS, with 2025 CyPath Lung revenue of approximately $963,000 (up 87% from $516,000 in 2024) and $835,000 in the first half of 2026 (up 159% from $323,000). This is the company's growth product but remains a small share of total revenue.
• Pathology laboratory services — The balance of consolidated revenue comes from PPLS laboratory services, which the company deliberately reduced by discontinuing unprofitable pathology services, driving total 2025 revenue down about 34% to $6.2 million from $9.4 million in 2024.
• Equity financing rather than operations — The company funds itself mainly through stock sales, raising approximately $16.9 million gross in equity transactions during 2025 and an additional approximately $3.2 million gross from a June 2026 public offering.
• Asthma/COPD and therapeutics pipeline — Pipeline diagnostics for lung inflammation and siRNA-based skin cancer therapeutics are under development and not yet described as generating revenue; the company intends to seek strategic partners.

Recent performance

For the second quarter of 2026, CyPath Lung test volume rose 216% year over year, and the number of physician offices and clinics ordering the test increased 122%. First-half 2026 CyPath Lung revenue was approximately $835,000, up 159%, on 1,097 test reports delivered versus 390 in the first half of 2025. Total quarterly revenue was $1.5 million in the June 2026 quarter, versus $1.4 million in each of the March 2026 and September 2025 quarters and $1.6 million in December 2025. Full-year 2025 net loss widened to $14.9 million from $9.0 million in 2024, and operating cash use increased to $9.3 million from $7.3 million. At June 30, 2026, total assets were $7.6 million, total liabilities $3.9 million, equity $3.8 million, and cash and equivalents $2.4 million.

Strategy

Management's stated approach is to discontinue unprofitable pathology services, cut costs, and concentrate on growing CyPath Lung volume through physician adoption. It is supporting that push with a longitudinal clinical trial now enrolling at 11 sites, including nine VA and military medical centers, funded with support from the John P. Murtha Cancer Center Research Program. The company is also expanding its platform into asthma and COPD diagnostics, including a collaboration with Pictor, Inc. on next-generation tests, and is advancing dermal siRNA therapeutics for squamous and basal cell skin cancers toward partnering and in vivo studies. Research operations are being moved from University of Texas at San Antonio leased space, after notice in January 2026 that the lease would not be renewed, to privately owned laboratory space, with the 10-K citing the second quarter of 2026. Financing continues through public equity offerings, including approximately $3.2 million gross raised in June 2026.

Risks

• Going-concern and capital dependence — The 10-K states that if capital raised plus revenue is insufficient for its needs, the company may be required to cease operations; it used $9.3 million of cash in operations in 2025 and held $2.4 million of cash at June 30, 2026.
• Concentrated revenue in a small, early product — CyPath Lung generated only about $963,000 in 2025 revenue, while total consolidated revenue fell 34% to $6.2 million as unprofitable pathology services were discontinued.
• Persistent losses and dilution — Net loss widened to $14.9 million in 2025 from $9.0 million in 2024, with diluted EPS of -$8.66, and the company has repeatedly funded itself by issuing equity, including a 1-for-30 reverse stock split on September 18, 2025.
• Unproven pipeline and trial execution — Asthma/COPD diagnostics and siRNA skin cancer therapeutics remain in early development and require clinical testing, regulatory clearance and partners, and the CyPath Lung longitudinal trial is dependent on external research funding and enrolled sites.

Outlook

Management points to accelerating physician adoption of CyPath Lung, citing 216% year-over-year volume growth in Q2 2026 and a 71% increase in orders from existing clients, as evidence the test is entering standard nodule evaluation and survivor surveillance. It says it will continue enrolling the longitudinal trial at 11 sites and developing asthma/COPD diagnostics with Pictor, while seeking partners for its skin cancer therapeutics. The company also notes it must keep raising capital to fund these activities, having completed a June 2026 offering of approximately $3.2 million gross.