bioAffinity Technologies, Inc. is conducting a primary offering of 2,631,579 shares of common stock, together with pre-funded and placement agent warrants and the shares issuable upon their exercise. The assumed price is $1.52 per share, implying estimated net proceeds of about $3.4 million for working capital and general corporate purposes.
The company focuses on noninvasive lung diagnostics, led by its CyPath® Lung test, which showed 92% sensitivity, 87% specificity, and 88% accuracy for small pulmonary nodules in a clinical trial. CyPath® Lung unit sales grew 146% year over year in first-quarter 2026, and a new multicenter clinical trial began enrolling in March 2026.
bioAffinity reported $1.4 million in revenue for the quarter ended March 31, 2026, and $6.2 million and $9.4 million in 2025 and 2024, respectively, but had an accumulated deficit of $72.2 million and $3.1 million in cash. Its auditor raised substantial doubt about its ability to continue as a going concern, and management indicates existing cash supports operations only through June 2026 without additional financing.
bioAffinity Technologies, Inc. filed an 8-K to share a press release about an educational webinar hosted by the Society for Advanced Bronchoscopy on CyPath® Lung’s role in detecting and managing early-stage lung cancer. The live event, titled “Navigating Lower Cancer-Risk Nodules in High-Risk Patients with Noninvasive CyPath® Lung Testing,” is scheduled for Tuesday, June 16, at 7 p.m. ET.
The press release explains that CyPath® Lung is a noninvasive sputum test using advanced flow cytometry, a fluorescent porphyrin, and proprietary artificial intelligence to analyze the lung microenvironment. In a published clinical trial of high-risk patients with small indeterminate lung nodules less than 20 millimeters, CyPath® Lung showed 92% sensitivity, 87% specificity, 88% accuracy and 99% negative predictive value in detecting lung cancer. The company notes that the test is marketed as a Laboratory Developed Test under CLIA oversight and is intended to be used alongside other clinical findings rather than as a standalone diagnostic.
bioAffinity Technologies, Inc. reported that it received a notification of allowance from the Mexican Institute of Industrial Property for a patent covering methods of predicting the likelihood of lung cancer using flow cytometry. The patent will protect use of specific antibodies, the porphyrin TCPP, and flow cytometry to detect cancer cells in sputum for the company’s CyPath® Lung test.
CyPath® Lung is a noninvasive, at-home sputum-based test for high-risk patients that uses advanced flow cytometry and artificial intelligence. In a published clinical trial of high-risk patients with small indeterminate lung nodules, CyPath® Lung showed 92% sensitivity, 87% specificity, 88% accuracy and 99% negative predictive value in detecting lung cancer.
bioAffinity Technologies reported that unit sales of its CyPath® Lung diagnostic test reached a record monthly level in April 2026 and increased nearly 300% compared with April 2025, based on preliminary unaudited data. Management said this growth exceeds internal projections and reflects accelerating physician adoption and broader clinical use for lung cancer risk assessment and pulmonary nodule management.
CyPath® Lung is a noninvasive sputum-based test that uses flow cytometry and artificial intelligence to detect malignancy in high‑risk patients. In a clinical trial of patients with small indeterminate lung nodules less than 20 millimeters, the test demonstrated 92% sensitivity, 87% specificity, 88% accuracy and a 99% negative predictive value, which can help avoid unnecessary invasive procedures when results are negative.
bioAffinity Technologies reported first quarter 2026 results, with revenue of $1.4 million and a net loss of $3.6 million, or $(0.81) per share. Revenue declined mainly because the company discontinued certain unprofitable pathology services in March 2025 to focus on higher-margin offerings.
Within that strategy, CyPath® Lung performance was strong. CyPath Lung testing revenue rose about 114% to $361,000 and unit sales increased 146% year-over-year, supported by a 69% increase in ordering physician offices and clinics. Direct costs fell 32% to $0.9 million as earlier cost actions took hold.
Operating expenses grew to $5.0 million from $4.5 million, driven by higher selling, general and administrative spending to scale commercialization, while clinical development costs increased to support a large longitudinal trial funded in part by the U.S. Department of Defense. Cash and cash equivalents were $3.1 million as of March 31, 2026, down from $6.4 million at year-end 2025.
bioAffinity Technologies, Inc. has filed a resale registration for up to 497,483 shares of common stock on behalf of existing investors. The shares consist of 365,603 warrant shares and 131,880 shares issuable upon conversion of Series B preferred stock after anti-dilution adjustments. The company will not sell shares in this offering and will receive no proceeds from stockholder resales, other than any cash paid if warrants are exercised. As of December 31, 2025, 4,498,675 common shares were outstanding, rising to 4,996,155 shares if all registered warrant and conversion shares are issued. bioAffinity develops noninvasive lung cancer diagnostics, including its CyPath® Lung test, which showed 92% sensitivity and 87% specificity in a clinical trial and recently posted 146% unit sales growth year over year in the first quarter of 2026.
bioAffinity Technologies, Inc. reported results of its 2026 Annual Meeting, where stockholders approved several equity and capital structure proposals. They expanded the 2024 Equity Incentive Compensation Plan to reserve 1,000,000 shares, up from 66,666, increasing capacity for stock-based awards. Holders also approved issuances tied to August 2025 warrants and Series B preferred stock, including anti-dilution adjustments that could add hundreds of thousands of shares upon exercise or conversion. Stockholders authorized potential non-public offerings that may trigger a change of control under Nasdaq rules and approved a discretionary 1‑for‑2 to 1‑for‑250 reverse stock split, which the board may implement or abandon. All six director nominees were elected and the independent auditor was ratified.
bioAffinity Technologies, Inc. filed an update describing a new clinical case study using its CyPath® Lung diagnostic test for a high-risk patient with a suspicious 30-millimeter pulmonary nodule. Standard imaging and risk models suggested a high likelihood of lung cancer, but the treating pulmonologist suspected inflammation.
CyPath® Lung, a noninvasive sputum-based test, returned a negative result labeled “Unlikely Malignancy,” prompting additional imaging before proceeding to biopsy. A follow-up CT scan showed the nodule had completely resolved, sparing the 70-year-old patient, who had a 50 pack-year smoking history and emphysema, from a risky and potentially unnecessary invasive procedure.
The case illustrates how CyPath® Lung can support pulmonary nodule management in complex patients. The company notes that this is a single-patient experience and emphasizes prior clinical trial results in high-risk patients with small indeterminate nodules, where CyPath® Lung demonstrated 92% sensitivity, 87% specificity and 88% accuracy for detecting lung cancer.
bioAffinity Technologies, Inc. announced that its noninvasive CyPath® Lung diagnostic test will be featured at the invitation-only “Advances in Early Lung Cancer Detection” symposium at the Cleveland Clinic in Ohio on April 16, 2026. Chief Medical Officer Gordon Downie, MD, PhD, will join a panel on lung nodule management, discussing how the test supports early detection in high-risk patients.
CyPath® Lung is a sputum-based assay that uses flow cytometry and artificial intelligence to analyze the lung microenvironment and identify cancer and cancer-related cells. In patients at high risk with small indeterminate nodules under 20 millimeters, it demonstrated 92% sensitivity, 87% specificity and 88% accuracy, supporting its role as an adjunct to current diagnostic pathways. The test is marketed as a Laboratory Developed Test under CLIA through Precision Pathology Laboratory Services, a bioAffinity subsidiary.
bioAffinity Technologies, Inc. reported that unit sales of its CyPath® Lung diagnostic test in the first quarter of 2026 exceeded internal projections and, based on preliminary unaudited data, grew 146% year over year versus the first quarter of 2025. Management links this surge to accelerating physician adoption and broader clinical use of the noninvasive lung cancer diagnostic.
The company highlights a current and expanding U.S. addressable market of $3.58 billion for pulmonary nodule management and surveillance of lung cancer survivors, and notes prior audited results showing CyPath® Lung revenue rising 87% and test units sold increasing 99% in 2025. CyPath® Lung, a flow cytometry plus AI-based sputum test, previously demonstrated 92% sensitivity, 87% specificity, and 88% accuracy in detecting lung cancer in high‑risk patients.