bioAffinity Technologies, Inc.

bioAffinity Technologies, Inc. is a biotechnology company focused on developing noninvasive diagnostic laboratory tests for early-stage lung cancer and other lung diseases, utilizing flow cytometry and automated analysis powered by machine learning ¹. The company's core business model revolves around its first commercial diagnostic test, CyPath® Lung, which identifies and analyzes cell populations in sputum to detect malignancy in the lung, including curative Stage 1A lung cancer ². This test is performed and offered by its wholly-owned subsidiary, Precision Pathology Laboratory Services, LLC (PPLS), a CAP-accredited and CLIA-certified commercial laboratory ³. The company also generates revenue from other pathology services, histology service fees, and medical director fees through PPLS ⁴. Revenue streams are primarily transactional, based on services rendered upon completion of the testing process ⁵. The primary customer segments for CyPath® Lung are physicians assessing high-risk patients with indeterminate pulmonary nodules ⁶. The company aims to position CyPath® Lung for scalable growth and improved long-term margin potential ⁷.

The company's product and service lines include CyPath® Lung, which is a noninvasive diagnostic test for early-stage lung cancer. It has demonstrated 92% sensitivity and 87% specificity with 88% accuracy in a clinical trial for patients with small pulmonary nodules less than 20 mm ⁸. This test uses flow cytometry and a proprietary machine learning algorithm to analyze sputum samples, providing a physician's report within minutes that stratifies patients into "Likely Malignancy" or "Unlikely Malignancy" risk groups, along with a numerical probability score ⁹. The strategic role of CyPath® Lung is to increase diagnostic accuracy, potentially leading to increased survival, fewer unnecessary invasive procedures, reduced patient anxiety, and lower medical costs ¹⁰. For the year ended December 31, 2025, CyPath® Lung testing revenue increased approximately 87% to $963,000, compared to $516,000 in 2024, driven by a 99% increase in test results delivered, totaling over 1,200 tests ¹¹.

Beyond CyPath® Lung, bioAffinity Technologies is advancing the development of its flow cytometry+AI platform for companion diagnostic tests targeting asthma and chronic obstructive pulmonary disease (COPD) ¹². These diagnostics are designed to quantify lung inflammation and detect specific receptors in sputum to determine the effectiveness of new and emerging therapies for asthma and COPD, aiming to guide personalized treatment decisions ¹³. Through its wholly-owned subsidiary, OncoSelect® Therapeutics, LLC, the company is also conducting research into novel cancer therapeutic approaches that selectively target cancer cells ¹⁴. This research has led to discoveries demonstrating that inhibiting the expression of two specific cell membrane proteins, CD320 and LRP2, can selectively kill various cancer cell types grown in the laboratory with little or no effect on normal cells ¹⁵. The company is advancing research for the topical treatment of squamous cell skin cancer using this technology and intends to seek strategic partners for future broad-spectrum cancer treatments ¹⁶.

For the fiscal year ended December 31, 2025, total consolidated revenue decreased approximately 34% to $6.2 million, compared to $9.4 million for the year ended December 31, 2024 ¹⁷. This decrease was primarily due to strategic actions to discontinue unprofitable pathology services and reduce costs ¹⁸. Gross profit is not explicitly stated, but direct costs and expenses were $4,226,799 in 2025 ¹⁹. Operating loss for 2025 was approximately $10,572,508, compared to $8,953,445 in 2024 ²⁰. Net loss for the year ended December 31, 2025, was approximately $14.9 million, compared to a net loss of approximately $9.0 million for the year ended December 31, 2024 ²¹. Basic and diluted EPS was $(8.66) for 2025, compared to $(22.50) for 2024 ²². Cash and cash equivalents at December 31, 2025, were approximately $6.4 million ²³. Total current liabilities were $2,906,166 and total liabilities were $3,683,116 as of December 31, 2025 ²⁴. The company had an accumulated deficit of approximately $68.6 million as of December 31, 2025 ²⁵.

Comparing year-over-year, consolidated revenue decreased by $3.2 million, or approximately 34%, from $9.4 million in 2024 to $6.2 million in 2025 ²⁶. However, CyPath® Lung testing revenue increased approximately 87% to $963,000 in 2025 from $516,000 in 2024 ²⁷. Direct costs and expenses decreased by approximately $1.8 million, or 29%, from $5,983,475 in 2024 to $4,226,799 in 2025, primarily due to strategic actions to streamline operations ²⁸. Clinical development expenses increased significantly by approximately $384,000, or 119%, from $321,655 in 2024 to $705,744 in 2025, mainly due to increased professional fees for managing the pivotal clinical trial ²⁹. Selling, general and administrative expenses remained consistent at approximately $9.9 million in both 2025 and 2024, despite a $1.0 million increase in costs for sales personnel and services for CyPath® Lung, offset by other cost reductions ³⁰. Depreciation and amortization decreased by approximately $101,000, or 17%, from $605,637 in 2024 to $504,836 in 2025, largely due to the termination of a finance lease ³¹. Net loss increased from $9.0 million in 2024 to $14.9 million in 2025, primarily due to a $5.9 million increase in loss from operations and a $3.8 million fair value adjustment to warrant liability ³².

Significant operational developments during the period include the enrollment of the first patient in the longitudinal clinical trial "Detection of Early-Stage Lung Cancer in Sputum using Flow Cytometry and an Automated Analysis Pipeline" (NCT07168993) in March 2026 ³³. This trial, supported by the John P. Murtha Cancer Center Research Program, aims to enroll up to 2,063 patients at 17 medical centers ³⁴. The company also initiated a collaboration with Brooke Army Medical Center (BAMC) in Q4 2025 to validate CyPath® Lung for analyzing sputum samples obtained by tracheal and bronchial suctioning for early lung cancer detection ³⁵. In Q1 2026, a research collaboration with BAMC began to advance companion diagnostic tests for asthma and COPD ³⁶. Positive research findings for the platform technology's ability to identify antibody drug receptors in sputum for asthma and COPD therapies were presented in March 2026 ³⁷. PPLS maintained its CAP accreditation across all laboratory service lines in January 2026 ³⁸. The company raised approximately $16.9 million in gross proceeds from equity transactions in 2025 to fund operating activities ³⁹.

Management anticipates that the company's cash resources are sufficient to continue operations through June 2026, without additional funding from capital raises, strategic relationships, or grants ⁴⁰. The company expects revenue to increase due to accelerating sales of CyPath® Lung and cost-saving measures recently instituted at PPLS ⁴¹. However, it also expects to continue incurring significant operating losses for the foreseeable future as it advances diagnostic tests through clinical trials ⁴².

A major growth area is the expansion of CyPath® Lung into broader strategic markets, aiming for national coverage in the U.S. and eventual entry into the EU and Asia ⁴³. Phase 2 of the business plan, commencing in 2026, involves increasing the sales force and strategic partners in the Mid-Atlantic region and entering the South Atlantic, Southeast, Northeast, Midwest, West, and federal markets ⁴⁴. This phase also includes the launch of the longitudinal clinical trial, "Detection of Early-Stage Lung Cancer in Sputum using Flow Cytometry and an Automated Analysis Pipeline" (NCT07168993), which will provide additional validation and evidence for CyPath® Lung's ability to detect early-stage lung cancer ⁴⁵. The trial plans to enroll up to 2,063 patients at 17 VA, military, academic, and private medical centers ⁴⁶. The company projects the market for indeterminate pulmonary nodules to increase by 62% from 2.9 million in 2025 to 4.7 million in 2030, representing an estimated market of greater than $4.7 billion for CyPath® Lung ⁴⁷. Additionally, the use of CyPath® Lung for surveillance of cancer survivors represents an estimated market of $870 million over the next ten years, with the number of lung cancer survivors projected to increase by 28% from 680,450 in 2025 to 871,580 in 2035 ⁴⁸.

Another significant growth vector is the development of companion diagnostic tests for asthma and COPD, leveraging the company's flow cytometry platform and automated AI analysis ⁴⁹. These tests are designed to identify patients who would benefit from specific biologic therapies by detecting the type and severity of lung inflammation and specific therapeutic targets in sputum ⁵⁰. The diagnostics market for COPD alone was valued at $5.6 billion in 2023 and is expected to reach $8.2 billion by 2029 ⁵¹. The company expects to begin patient studies for these asthma and COPD diagnostics in 2026 ⁵². Furthermore, the company intends to seek strategic partners to develop its therapeutic discoveries, which could lead to broad-spectrum cancer treatments in the future, starting with topical treatment for squamous cell skin cancer ⁵³.

Operationally, the company plans to relocate its research operations from The University of Texas at San Antonio (UTSA) to privately owned laboratory space in the second quarter of 2026, following notice from UTSA that its lease would not be renewed ⁵⁴. The company's targeted strategic actions in March 2025 to discontinue unprofitable pathology services and reduce costs through operational efficiency are intended to improve operating focus and cost structure, positioning the lung cancer diagnostic for scalable growth and improved long-term margin potential ⁵⁵. The company will continue to execute strategic marketing and promotional collaborations to accelerate growth, including leveraging existing relationships with physicians and patients and expanding its sales team ⁵⁶.

Regarding capital allocation, the company raised approximately $16.9 million in gross proceeds from equity transactions in 2025 to fund operating activities ⁵⁷. It anticipates raising additional cash through private or public sales of equity or debt securities, collaborative arrangements, or a combination thereof to fund future operations and product development ⁵⁸. The company does not anticipate paying cash dividends on its Common Stock in the foreseeable future, intending to retain all available funds and future earnings to fund business development and expansion ⁵⁹.

The company faces substantial doubt about its ability to continue as a going concern, with an accumulated deficit of $68.6 million and cash on hand of $6.4 million as of December 31, 2025, and cash used in operations of $9.3 million for 2025 ⁶⁰. Without additional funding, cash resources are anticipated to be sufficient only through June 2026 ⁶¹. There is a risk that the company may not be able to obtain additional capital or financing on favorable terms, or at all, which could force it to curtail or abandon its business plan ⁶². Clinical trials are expensive, time-consuming, and may not be successful, with potential delays in patient enrollment or negative results hindering regulatory approvals and commercialization ⁶³. The company is dependent on its subsidiary PPLS to offer CyPath® Lung, and any failure of the laboratory to perform as expected, maintain accreditation, or scale operations could harm the business ⁶⁴. Cybersecurity threats pose a risk of system failures, data breaches, or loss of sensitive information, potentially leading to liability and reputational damage, despite existing risk management programs ⁶⁵. Changes in healthcare laws, regulations, and reimbursement policies, including those related to LDTs, could adversely affect market acceptance and revenue generation ⁶⁶. The biotechnology and pharmaceutical industries are intensely competitive, with larger, more resourced competitors potentially developing superior or less expensive diagnostic tests or therapeutic products ⁶⁷.

Management's overall tone emphasizes strategic actions taken to streamline operations and position the company for future growth, despite a short-term decrease in consolidated revenue. The company is focused on driving sales growth for CyPath® Lung and advancing its pipeline of diagnostic and therapeutic candidates. Management explicitly states that consolidated revenue decreased approximately 34% to $6.2 million in 2025 compared to $9.4 million in 2024, but highlights an 87% increase in CyPath® Lung testing revenue to $963,000 ⁶⁸. They acknowledge the need to raise additional capital to fund operations, noting that current cash resources are sufficient to continue operations through June 2026 without further funding ⁶⁹. The three strategic priorities emphasized for the period ahead are: expanding the commercialization of CyPath® Lung in the U.S. and internationally, advancing the development of companion diagnostic tests for asthma and COPD, and seeking strategic partners for its novel cancer therapeutic discoveries ⁷⁰.