bioAffinity Technologies, Inc. SEC filings document the public-company record for a biotechnology diagnostics issuer with Nasdaq-listed common stock and tradeable warrants. The filings identify the company as an emerging growth company and smaller reporting company and include disclosures tied to CyPath® Lung, laboratory services, operating performance, and securities registration activity.
Recent filings include Form 8-K reports for financial results, Regulation FD presentation materials, product and clinical-case announcements, and annual meeting voting results. The record also covers governance matters such as director elections and equity incentive plan amendments, along with S-1 registration materials describing securities being registered and related issuer classifications.
bioAffinity Technologies, Inc. (BIAF) approved and is implementing a 1-for-15 reverse stock split of its common stock. A certificate of amendment was filed in Delaware on August 20, 2026, and the split becomes effective at 4:01 p.m. Eastern Time on August 21, 2026, with trading on a split-adjusted basis on the Nasdaq Capital Market beginning August 24, 2026.
Every 15 issued and outstanding common shares will be combined into one share, with no change to authorized shares or par value. The split is primarily intended to help meet Nasdaq’s minimum bid price requirement. Immediately after effectiveness, approximately 592,373 shares of common stock will be outstanding. Fractional shares will be settled in cash, and equity awards and warrants will be proportionately adjusted. BIAF will keep its ticker, and the common stock will have a new CUSIP 09076W406.
bioAffinity Technologies, Inc. reported that it entered into a distribution agreement with AvMEDICAL, a Service-Disabled Veteran-Owned Small Business that supplies medical and laboratory products to U.S. government agencies. AvMEDICAL’s national sales force will promote bioAffinity’s CyPath® Lung test to federal healthcare customers, including U.S. Department of Veterans Affairs medical centers, using its established procurement channels and indefinite-delivery, indefinite-quantity contracts. The agreement is intended to expand commercial access to CyPath Lung within government healthcare systems and provide an additional pathway for veterans to obtain the test.
CyPath Lung is a noninvasive, laboratory-developed test performed by Precision Pathology Laboratory Services, a wholly owned subsidiary of bioAffinity Technologies. In a published clinical trial of high-risk patients with small indeterminate lung nodules under 20 millimeters, CyPath Lung showed 92% sensitivity, 87% specificity, 88% accuracy, and 99% negative predictive value for detecting lung cancer, and is intended for use alongside imaging and other clinical information.
bioAffinity Technologies, Inc. entered into a private placement with an institutional investor involving pre-funded warrants and Series A and B warrants tied to up to 8,462,027 shares each of common stock. Each warrant carries an initial exercise price of $0.4727 per share, while the pre-funded warrants are purchased at $0.4657 and exercisable at $0.007 per share.
The private placement is expected to generate approximately $3.6 million in net proceeds, following estimated fees and expenses, from about $4.0 million in gross proceeds. Warrants are exercisable only after stockholder approval and generally expire five years from issuance, subject to beneficial ownership caps of 4.99% or 9.99% depending on elections. WallachBeth Capital LLC acted as exclusive placement agent and received cash fees and 253,861 placement agent warrants. The company plans to use the proceeds for working capital and general corporate purposes and has agreed to register the resale of underlying shares under a registration rights agreement.
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.