Welcome to our dedicated page for bioAffinity Technologies 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.
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 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.
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.