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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. 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 is offering 1,040,000 shares of common stock at $0.80 per share and registering up to 2,960,000 pre-funded warrants exercisable at $0.007 to prevent purchasers exceeding 4.99% (or 9.99% by election) ownership. The prospectus states estimated net proceeds of approximately $2.6 million and a Placement Agent fee of 7.5%.
The offering includes Placement Agent Warrants equal to 3.0% of shares sold at an exercise price of $0.88. Shares outstanding were 4,743,061 as of June 16, 2026, and would be 8,743,061 assuming full exercise of pre-funded warrants sold hereunder.
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.