Welcome to our dedicated page for bioAffinity Tech SEC filings (Ticker: BIAF), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
The bioAffinity Technologies, Inc. (BIAF) SEC filings page on Stock Titan provides access to the company’s regulatory disclosures filed with the U.S. Securities and Exchange Commission. As a Nasdaq Capital Market issuer, bioAffinity Technologies files current reports, proxy statements, registration statements and financial reports that describe its biotechnology business focused on noninvasive diagnostics and early detection of lung cancer and other lung diseases.
Through its filings, investors can review Form 8-K current reports detailing material events such as College of American Pathologists (CAP) accreditation for its subsidiary Precision Pathology Laboratory Services, notifications of allowance for U.S. and international patents protecting the CyPath® Lung platform, presentations at major medical conferences and capital-raising transactions, including registered direct offerings under an effective Form S-3 shelf registration statement. These 8-Ks also summarize developments related to Nasdaq listing compliance and monitoring.
Definitive proxy statements filed on Schedule 14A outline governance and capital structure proposals, such as warrant exercise and anti-dilution provisions, preferred stock terms, amendments to equity incentive plans and potential non-public offerings under Nasdaq rules. Together with periodic reports, these documents help explain how bioAffinity Technologies manages its equity, financing options and incentive programs while advancing CyPath® Lung and its diagnostic platform.
On Stock Titan, AI-powered tools can assist in reviewing lengthy filings by highlighting key sections related to revenue sources, laboratory operations, patent portfolio, Nasdaq compliance and financing terms. Users can quickly locate disclosures about the marketing of CyPath® Lung as a Laboratory Developed Test through Precision Pathology Laboratory Services, CAP and CLIA credentials, and the scope of the company’s global patent estate. Real-time EDGAR updates ensure that new BIAF filings, including future 10-K annual reports, 10-Q quarterly reports, 8-K current reports and proxy materials, are surfaced promptly, while AI summaries help interpret complex legal and financial language.
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.
bioAffinity Technologies, Inc. furnished an 8-K to share updated investor presentation materials about its operations and performance. Management plans to use these March 2026 presentation materials in future discussions, and they were posted on the company’s website on March 26, 2026.
The presentation is included as Exhibit 99.1 and is provided under Regulation FD, meaning it is furnished rather than filed and is not subject to certain Exchange Act liabilities or automatically incorporated into other securities law filings.
bioAffinity Technologies filed an 8-K to highlight a live virtual physician roundtable on integrating its CyPath® Lung diagnostic test into pulmonary practice. The first “CyPath® Lung in Practice” webinar will be held on April 8, 2026, with pulmonologists presenting real-world cases where the test guided lung cancer risk assessment, nodule management, and post-treatment surveillance.
CyPath® Lung is a noninvasive sputum-based test that uses flow cytometry, AI, and a fluorescent porphyrin to identify cell populations associated with lung cancer in high-risk patients. Clinical study results showed 92% sensitivity, 87% specificity, and 88% accuracy in detecting lung cancer in patients with small indeterminate nodules less than 20 millimeters.
bioAffinity Technologies, Inc. reported a new clinical case study evaluating its noninvasive CyPath® Lung test in a high-risk patient with multiple lung nodules. The company furnished a press release describing how the test result helped guide care and potentially avoid an invasive lung procedure.
The 71‑year‑old former smoker had several pulmonary nodules, including a 7 millimeter nodule that might normally trigger bronchoscopy or biopsy. A CyPath® Lung result indicating unlikely malignancy supported the pulmonologist’s decision to monitor with a follow‑up CT scan instead of immediately ordering an invasive procedure.
The follow‑up scan showed suspicious nodules had resolved, suggesting benign inflammation, while one small nodule remained stable. The press release notes prior clinical study performance for CyPath® Lung, with 92% sensitivity, 87% specificity and 88% accuracy for detecting lung cancer in high‑risk patients with small nodules under 20 millimeters.
bioAffinity Technologies is asking stockholders at its April 30, 2026 annual meeting to approve a broad set of governance and financing proposals. These include electing six directors and ratifying WithumSmith+Brown, PC as auditor for the year ending December 31, 2026.
The proxy also seeks approval for issuing up to 271,500 shares upon exercise of August 2025 warrants and related anti-dilution adjustments that could increase warrant and Series B preferred share issuances. The Board requests authorization for non‑public offerings, potential change of control under Nasdaq rules, a 1‑for‑2 to 1‑for‑250 reverse stock split at the Board’s discretion, and an adjournment option.
In addition, the company proposes amending its 2024 Equity Incentive Plan to raise the share reserve from 66,666 to 1,000,000 shares, citing the need to attract and retain key employees and directors while aligning compensation with stockholder interests.
bioAffinity Technologies, Inc. files its annual report describing a lung cancer diagnostics and therapeutics business built around its CyPath® Lung test and flow cytometry + AI platform.
For the year ended December 31, 2025, consolidated revenue fell about 34% to $6.2 million from $9.4 million as the Company discontinued unprofitable pathology services and focused operations. CyPath® Lung testing revenue grew about 87% to $963,000, driven by a 99% increase to more than 1,200 test results.
The Company emphasizes that its business plan depends on securing additional capital and explicitly notes it must raise more funds to continue as a going concern. In 2025 it raised roughly $16.9 million in gross proceeds through multiple public, private and warrant-related equity transactions. As of June 30, 2025, non‑affiliate equity market value was approximately $22.6 million, and shares outstanding were 4,498,675 as of March 13, 2026.
bioAffinity highlights progress on a large longitudinal lung cancer trial, new military collaborations, early asthma/COPD companion diagnostic research, and an oncology therapeutic platform, supported by a portfolio of 19 issued patents and numerous pending applications worldwide.
bioAffinity Technologies reported 2025 results showing rapid growth in its CyPath® Lung lung cancer test but a wider overall loss. Revenue from CyPath® Lung testing rose 87% year over year, with the number of tests up 99% and ordering physician sites up 67%, reflecting stronger clinical adoption.
Total 2025 revenue was $6.2 million, down from $9.4 million in 2024 after discontinuing unprofitable pathology services. Operating expenses fell 9% to $16.7 million, but the net loss widened to $14.9 million from $9.0 million, mainly due to a non-cash change in warrant fair value and higher commercial and clinical spending.
Cash and cash equivalents increased to $6.5 million as of December 31, 2025, from $1.1 million a year earlier, supported by $16.9 million raised in 2025 financings. The company forecasts CyPath® Lung unit sales growth of more than 100% in 2026 and is running a longitudinal trial targeting up to 2,000 high-risk patients to further validate the test.
bioAffinity Technologies has begun a large, 2,000-patient longitudinal clinical study of CyPath® Lung, its noninvasive sputum-based test for early-stage lung cancer detection in high-risk patients with lung nodules 6 to less than 30 millimeters.
The study will run across up to 20 sites, including numerous VA medical centers and major military hospitals, with patients followed for up to 24 months or until a definitive cancer or no-cancer diagnosis. An earlier trial showed 92% sensitivity, 87% specificity and 88% accuracy in high-risk patients with nodules less than 20 millimeters.
The new trial, supported in part by the John P. Murtha Cancer Center Research Program, uses a research-use version called FlowPath Lung that applies the same flow cytometry and AI technology as the commercially available CyPath® Lung Laboratory Developed Test.
bioAffinity Technologies, Inc. reported that directors Robert Anderson and Roby Joyce have chosen not to stand for re-election when their current terms expire at the company’s 2026 Annual Meeting of Stockholders, currently scheduled for April 30, 2026.
The company stated that the decisions by Mr. Anderson and Mr. Joyce are not due to any disagreements with bioAffinity Technologies regarding its operations, policies, or practices. Both will continue to serve as directors until their terms end at the 2026 Annual Meeting.