bioAffinity Technologies develops noninvasive lung diagnostics, led by its CyPath® Lung test run through its Precision Pathology Laboratory Services subsidiary. For the six months ended June 30, 2026, net revenue was $2.86 million, down from $3.12 million a year earlier as the company exited unprofitable pathology services. Within this, CyPath® Lung testing revenue grew sharply to $835,000, up about 159% year over year on roughly 1,100 tests versus about 400 in 2025, reflecting faster physician adoption.
Operating expenses rose to $9.81 million, driven mainly by higher selling, general and administrative costs and ramp-up of a longitudinal CyPath® Lung clinical trial, leading to a net loss of $7.0 million for the first half of 2026 and an accumulated deficit of about $75.6 million. Cash and cash equivalents fell to $2.43 million at June 30, 2026, from $6.45 million at year-end, after $6.43 million of operating cash burn partly offset by $2.50 million of net financing inflows, including a June equity offering with $3.2 million gross proceeds. Management reports cash of $1.0 million as of August 3, 2026 and concludes there is substantial doubt about the company’s ability to continue as a going concern without additional capital. The company also received a Nasdaq notice for its share price remaining below $1, and has requested a hearing to appeal and maintain its listing while the panel reviews the case.
bioAffinity Technologies, Inc. reported net revenue of $1,510,579 for the quarter ended June 30, 2026, up 19% from $1,269,483 a year earlier, primarily from higher sales of its CyPath Lung diagnostic test. Net loss was $3,366,082 versus $4,060,787 in the prior-year quarter.
CyPath Lung test volume rose 216% year over year in Q2, and related testing revenue for the first six months of 2026 grew 159% to approximately $835,000, with 1,097 test reports delivered versus 390 a year earlier. Operating expenses increased to $4,845,443, reflecting higher clinical development and commercialization costs. Cash and cash equivalents were $2,429,719 as of June 30, 2026, after a June public offering that generated about $3.2 million in gross proceeds. The company advanced a longitudinal clinical trial for CyPath Lung and expanded its pipeline in asthma, COPD, and skin cancer therapeutics.
bioAffinity Technologies, Inc. reports it received a Nasdaq Listing Qualifications Staff Determination on July 30, 2026 stating that the bid price of its common stock closed below $1.00 per share for 30 consecutive business days from June 16 through July 29, 2026, violating the Nasdaq Capital Market Minimum Bid Price Requirement under Nasdaq Listing Rule 5550(a)(2).
Because the company effected a 1-for-30 reverse stock split on September 19, 2025, it is not eligible for the usual 180-calendar-day compliance period under Nasdaq Listing Rule 5810(c)(3)(A). bioAffinity intends to submit an appeal to Nasdaq on August 6, 2026, which will stay delisting and suspension pending a Nasdaq Hearings Panel decision, but there is no assurance that any extension will be granted or that continued listing can be maintained.
On July 27, 2026, bioAffinity Technologies, Inc. announced publication of a comprehensive clinical review and white paper by its Chief Medical Officer that presents a practical framework for integrating the CyPath® Lung noninvasive test into pulmonary nodule evaluation and lung cancer surveillance across pulmonology, primary care and oncology settings.
The company notes that in a published clinical trial of high-risk patients CyPath® Lung achieved 92% sensitivity, 87% specificity, 88% accuracy and 99% negative predictive value, and reports 7,783,061 common shares outstanding with an aggregate market value of approximately $5.1 million as of July 24, 2026.
bioAffinity Technologies, Inc. announced a collaboration with Pictor, Inc. to develop and commercialize next-generation diagnostic tests that profile lung inflammation in asthma and COPD by combining bioAffinity’s sputum-based flow cytometry with Pictor’s targeted proteomic platform to analyze immune cell populations and cytokine patterns.
The partners plan to initially offer these diagnostics as Laboratory Developed Tests under CLIA, with bioAffinity owning intellectual property for tests arising from the collaboration and Pictor retaining and expanding IP around its proteomic platform. Asthma and COPD affect more than 40 million Americans and 650 million people worldwide, and the global therapeutics market was valued at approximately $92 billion in 2024 and is projected to exceed $108 billion in 2026 and $155 billion by 2030, illustrating a large potential addressable market. The company notes forward-looking risks related to product development, regulatory changes for LDTs, intellectual property protection, financing needs and realization of anticipated collaboration benefits.
bioAffinity Technologies, Inc. reported strong commercial momentum for its CyPath® Lung noninvasive lung cancer test, with second-quarter 2026 sales volume growing more than 200% year-over-year. The number of tests sold in Q2 2026 also rose more than 30% compared with the first quarter of 2026.
Growth is being driven by higher utilization among existing clients and a 155% increase in physician offices ordering CyPath® Lung versus Q2 2025. Since commercial launch, the company has performed nearly 3,000 CyPath® Lung tests, reflecting broader adoption across pulmonology practices, lung nodule clinics, academic and community centers, and VA facilities.
The company highlights published clinical data where CyPath® Lung showed 92% sensitivity, 87% specificity, 88% accuracy and 99% negative predictive value in high-risk patients with small indeterminate lung nodules. bioAffinity is also advancing additional initiatives, including a large-scale longitudinal study, use of CyPath® Lung to monitor lung cancer survivors, and development of new tests for asthma and COPD.
bioAffinity Technologies, Inc. filed an 8-K to share a company newsletter outlining commercial and R&D progress. The newsletter highlights that CyPath® Lung unit sales in April 2026 increased nearly 300% compared to April 2025, while the number of physician offices and clinics ordering the test rose 69% from first quarter 2025 to the same period in 2026.
The company is partnering with Philips and 4DMedical to enhance lung cancer screening for U.S. veterans using mobile CT scanning, CyPath Lung testing and advanced imaging, with a webinar hosted by NAVREF on July 21, 2026. It also discusses a pilot study with Brooke Army Medical Center for asthma and COPD companion diagnostics and preclinical research on proprietary siRNAs as potential topical treatments for common skin cancers.
bioAffinity Technologies, Inc. completed a best efforts public offering of 4,000,000 securities, consisting of 1,040,000 shares of common stock and pre-funded warrants to purchase up to 2,960,000 shares, at $0.80 per share or $0.793 per pre-funded warrant, generating gross proceeds of about $3.2 million before fees.
Each pre-funded warrant is immediately exercisable for one share at an exercise price of $0.007 and remains exercisable until used, subject to a 4.99% (or 9.99% at the holder’s election) beneficial ownership cap. The company agreed to 30-day restrictions on additional equity issuances and at-the-market offerings, broader limits on variable rate transactions for three months, and 30-day lock-ups for executives and directors. After the offering, 6,283,061 shares of common stock are outstanding, and proceeds are earmarked for working capital and general corporate purposes.
bioAffinity Technologies filed Amendment No. 1 to its Registration Statement on Form S-1. The amendment is narrowly focused and is being used to add specific deal-related documents as exhibits, rather than to change the overall terms of the planned offering.
The company is filing the form of Placement Agency Agreement with WallachBeth Capital LLC, along with the form of Pre-Funded Warrant and the form of Placement Agent Warrant, as new exhibits. The rest of the S-1 remains unchanged and is incorporated by reference. The amendment also restates standard undertakings on indemnification of directors and officers and includes updated signature pages from the company’s chief executive officer, chief financial officer, and directors.
bioAffinity Technologies filed an update describing an educational webinar on July 21, 2026, focused on lung health screening and early detection for U.S. veterans at increased risk for lung cancer and other respiratory diseases. The session will cover imaging, noninvasive diagnostics and access to screening and follow-up care.
The webinar is hosted by NAVREF and will feature experts from Philips, bioAffinity Technologies and 4DMedical. Speakers will discuss mobile CT screening, CyPath® Lung testing and advanced functional lung imaging as approaches that may help support earlier detection and clinical decision-making in veteran populations.
The filing also highlights CyPath® Lung, a noninvasive sputum-based test for high-risk patients, which in a published clinical trial showed 92% sensitivity, 87% specificity, 88% accuracy and a 99% negative predictive value for detecting lung cancer in patients with small indeterminate nodules.