Welcome to our dedicated page for bioAffinity Tech SEC filings (Ticker: BIAFW), 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 SEC filings for bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW) provide detailed insight into the company’s biotechnology business, capital structure and diagnostic platform for early lung cancer detection. Registration statements on Form S-1 and Form S-3, along with related amendments, describe offerings of common stock, Series B Convertible Preferred Stock and multiple series of warrants to purchase common stock, including their terms, exercise prices, anti-dilution provisions and resale registration arrangements for selling stockholders.
Through periodic reports and current reports on Form 8-K, bioAffinity discloses operating and financial information related to CyPath® Lung and its subsidiary Precision Pathology Laboratory Services (PPLS). These filings discuss revenue from CyPath® Lung testing and pathology services, research and clinical development expenses, and strategic decisions such as discontinuing certain unprofitable pathology services to focus resources on commercialization of the CyPath® Lung test.
Filings also document corporate actions and listing matters, including a one-for-thirty reverse stock split approved and implemented to address Nasdaq minimum bid price requirements, and subsequent confirmation that the company regained compliance with Nasdaq continued listing standards. Investors reviewing BIAFW often use these documents to understand how changes in capital structure, such as new warrant issuances or amendments to floor prices, affect potential dilution and warrant economics.
bioAffinity’s SEC disclosures further outline its intellectual property position, describing patents that protect the AI-built algorithm and flow cytometry platform used in CyPath® Lung and other diagnostics in development. While the full text of annual reports (Form 10-K) and quarterly reports (Form 10-Q) is not reproduced here, those filings typically provide comprehensive risk factor discussions, management’s analysis of operations and liquidity, and additional detail on the company’s biotechnology programs.
On Stock Titan’s filings page, users can access real-time updates from EDGAR, including 8-K current reports on material events, registration statements related to equity financings and warrants, and periodic reports. AI-powered summaries help explain key elements of complex filings, highlight changes in capital structure, and surface information relevant to BIAFW warrant holders and equity investors, such as reverse stock split terms, warrant adjustments and use of proceeds from offerings.
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. is launching a validation study with Brooke Army Medical Center to test its CyPath® Lung diagnostic on sputum samples collected through tracheal and bronchial suctioning for early lung cancer detection. The study will enroll about 30–50 patients undergoing routine suction procedures, with results expected by mid-year 2026.
CyPath® Lung is a noninvasive test that uses flow cytometry, AI, and a fluorescent porphyrin to identify malignant cell populations in sputum. Prior clinical results showed 92% sensitivity, 87% specificity, and 88% accuracy in high-risk patients with small lung nodules.
The study aims to expand sample collection options beyond at-home sputum collection and leverage bronchoscopy procedures, which are performed roughly 500,000 times annually in the U.S. The company highlights a U.S. bronchoscopy-related market estimated at $700–$920 million and positions this work as a step toward broader use of CyPath® Lung.
bioAffinity Technologies, Inc. reported that a new clinical case study shows how its noninvasive CyPath® Lung test helped guide treatment for a 79-year-old high-risk patient with a suspicious lung nodule found on a low-dose CT scan.
The CyPath Lung result was negative, supporting a choice to monitor with annual CT scans instead of performing an invasive biopsy. A follow-up scan later in 2025 showed the nodule had resolved and no pulmonary nodules were present, reinforcing the conservative approach.
CyPath Lung is designed for early lung cancer detection in high-risk patients using sputum analysis, advanced flow cytometry and AI. Clinical study data cited in the case show 92% sensitivity, 87% specificity and 88% accuracy for detecting lung cancer in small nodules under 2 centimeters.