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bioAffinity Technologies, Inc.

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Business Summary

bioAffinity Technologies, Inc. is a Delaware corporation focused on developing noninvasive diagnostic laboratory tests for early-stage lung cancer and other lung diseases, utilizing flow cytometry and automated analysis informed by machine learning (AI). The company's core business model revolves around its first commercial diagnostic test, CyPath® Lung, which identifies and analyzes cell populations in sputum to indicate lung malignancy. 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 . The company also generates revenue from histology service fees and medical director fees through PPLS . CyPath® Lung is designed to provide greater diagnostic certainty for patients with indeterminate pulmonary nodules, aiming to improve the positive predictive value of low-dose computed tomography (LDCT) screening, reduce unnecessary invasive procedures, and lower healthcare costs .

The company's product and service lines include CyPath® Lung, which is a noninvasive test for early-stage lung cancer, demonstrating 92% sensitivity and 87% specificity with 88% accuracy for patients with small pulmonary nodules less than 20 mm in a clinical trial . This test uses a synthetic porphyrin, meso-tetra (4-carboxyphenyl) porphyrin (TCPP), to label cancer cells and an AI-driven algorithm for automated analysis, providing a physician's report within minutes . The market for CyPath® Lung is projected to grow significantly, with the total number of indeterminate pulmonary nodules detected by lung cancer screening and incidentally expected 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 . Additionally, CyPath® Lung's use for surveillance of cancer survivors represents an estimated market of $870 million over the next ten years .

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) . These diagnostics are designed to quantify lung inflammation and detect specific receptors in sputum to guide the effectiveness of new and emerging therapies for these conditions . The diagnostics market for COPD alone was valued at $5.6 billion in 2023 and is expected to reach $8.2 billion by 2029 . Through its wholly-owned subsidiary, OncoSelect® Therapeutics, LLC, the company is also conducting research on novel cancer therapeutic approaches that selectively target cancer cells, specifically advancing research for topical treatment of squamous cell skin cancer . This therapeutic research originated from understanding TCPP's selective uptake in cancer cells, identifying CD320 and LRP2 receptors, whose simultaneous knockdown was found to be deadly to various cancer cell lines while leaving normal cells unharmed .

For the fiscal year ended December 31, 2025, consolidated revenue decreased approximately 34% to $6.2 million, compared to $9.4 million for the year ended December 31, 2024 . This decrease was attributed to targeted strategic actions to discontinue unprofitable pathology services and reduce costs . Despite the overall revenue decline, CyPath® Lung testing revenue increased approximately 87% to $963,000, up from $516,000 in 2024, driven by a 99% increase in test results delivered, totaling more than 1,200 for the current year . The company reported a net loss of approximately $14.9 million for the year ended December 31, 2025, compared to a net loss of approximately $9.0 million for the year ended December 31, 2024 . Cash and cash equivalents stood at approximately $6.4 million as of December 31, 2025 . Net cash used in operating activities was approximately $9.3 million for 2025, an increase from $7.3 million in 2024 . The accumulated deficit as of December 31, 2025, was approximately $68.6 million .

During the reported period, the company raised approximately $16.9 million in gross proceeds from equity transactions to fund operating activities . Significant operational developments include the enrollment of the first patient in a longitudinal clinical study for "Detection of Early-Stage Lung Cancer in Sputum using Flow Cytometry and an Automated Analysis Pipeline" (NCT07168993) in March 2026, with support and funding from the John P. Murtha Cancer Center Research Program . This trial aims to enroll up to 2,063 patients at 17 medical centers . 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 . In Q1 2026, a research collaboration with BAMC began to advance companion diagnostic tests for asthma and COPD . 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 . PPLS maintained its accreditation across all laboratory service lines from the College of American Pathologists (CAP) in January 2026 .

Business Outlook

The company's business plan includes strategic expansion in the U.S., European Union (EU), and Asia, timed to maximize resources and minimize market risk . Following a successful pilot marketing program in Texas in 2024, which saw CyPath® Lung test revenue increase by approximately 87% to $963,000 due to a 99% increase in test results delivered , the company expanded its sales team in the second half of 2025 to enter the Mid-Atlantic market .

In 2026, the company plans to enter Phase 2 of its business plan, which involves expansion into broader strategic markets to achieve national coverage in the U.S. This includes increasing its sales force and strategic partners in the Mid-Atlantic region and entering the South Atlantic, Southeast, Northeast, Midwest, West, and federal markets . A key component of Phase 2 is the launch of a 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 further evidence of CyPath® Lung's ability to detect early-stage lung cancer . This trial is approved to enroll up to 2,063 patients at 17 VA, military, academic, and private medical centers .

Phase 3 of the business plan anticipates achieving a national sales footprint, which will serve as a foundation for securing strategic partners in the EU and Asia to support market entry into those regions . The company also aims to establish CyPath® Lung as a Standard of Care for the federal and VA healthcare systems, which is expected to propel its adoption as a Standard of Care for the entire U.S. healthcare system . The company will continue to execute strategic marketing and promotional collaborations to accelerate growth, including leveraging existing relationships with physicians and patients .

The company expects revenue to increase due to accelerating sales of CyPath® Lung and cost-saving measures recently instituted at PPLS . Research and development efforts for diagnostic tests in the pipeline and therapeutic discoveries will be moved to privately owned laboratory space in the second quarter of 2026, following notice from UTSA that the current lease would not be renewed . The company intends to seek strategic partners for its therapeutic discoveries related to selective broad-spectrum cancer treatments through pre-clinical and clinical development .

Risk Factors

The company faces substantial financial risks, including the need to raise additional capital to fund operations and continue as a going concern, given an accumulated deficit of $68.6 million and cash on hand of $6.4 million as of December 31, 2025, with current cash resources anticipated to last only through June 2026 . There is no assurance of generating significant profit from PPLS services, and the company has a limited operating history in clinical laboratory management . Development and commercialization of diagnostic tests and therapeutic products are subject to risks such as delays or difficulties in patient enrollment for clinical trials, the high cost and time-consuming nature of trials, and the possibility that tests may not perform as expected or achieve market acceptance . The company is dependent on its subsidiary PPLS for CyPath® Lung revenue and relies on third parties for manufacturing kits, reagents, supplies, and clinical development activities, exposing it to supply chain and operational control risks . Product liability and pre-clinical/clinical liability risks are inherent, and insurance may not provide adequate coverage . Compliance with evolving U.S. and international privacy and security regulations, including HIPAA and EU GDPR, is critical, with potential for significant liability and reputational harm from non-compliance or data breaches . Reimbursement from third-party payors and governmental agencies for CyPath® Lung and other products is uncertain and could limit market acceptance and revenues . The company operates in a highly competitive biotechnology and pharmaceutical industry, facing competitors with greater resources and established market presence . Cybersecurity threats pose a risk of business disruption, data loss, and liability, despite existing risk management programs . Economic conditions, including inflation and geopolitical instability, could negatively impact business operations, costs, and demand . Regulatory changes, particularly regarding FDA oversight of Laboratory Developed Tests (LDTs) like CyPath® Lung, could impose new burdens and affect commercialization strategy .

Management Priorities

Management's overall tone emphasizes a strategic pivot towards profitability through focused operational efficiency and growth of its flagship diagnostic product. The company has undertaken "targeted strategic actions to discontinue unprofitable pathology services, reduce costs through operational efficiency, and drive sales growth for CyPath® Lung" . While these actions led to a short-term decrease in consolidated revenue to $6.2 million in 2025 from $9.4 million in 2024, they are intended to improve operating focus and cost structure, positioning the lung cancer diagnostic for scalable growth and improved long-term margin potential . Management explicitly states that CyPath® Lung testing revenue increased approximately 87% to $963,000 in 2025, compared to $516,000 in 2024, driven by a 99% increase in test results delivered . The company anticipates that its cash resources are sufficient to continue operations through June 2026, but acknowledges the need to raise further capital through equity or debt securities, strategic relationships, or grants . Key strategic priorities include expanding CyPath® Lung's market presence nationally in the U.S. in 2026, launching a longitudinal clinical trial to provide additional validation for CyPath® Lung, and seeking strategic partners for its therapeutic discoveries . Management also highlights the intention to establish CyPath® Lung as a Standard of Care for federal and VA healthcare systems, which is expected to drive broader adoption across the U.S. healthcare system .

View Source Annual Report on SEC.gov ↗

References

  1. [1] Item 1, Business Overview
  2. [2] Item 7, MD&A — Revenue
  3. [3] Item 1, Business Overview
  4. [4] Item 1, Our First Diagnostic Test – CyPath® Lung
  5. [5] Item 1, Our First Diagnostic Test – CyPath® Lung
  6. [6] Item 1, The Cancer Diagnostics Market and CyPath® Lung
  7. [7] Item 1, The Cancer Diagnostics Market and CyPath® Lung
  8. [8] Item 1, Building on our Flow Cytometry Platform to Develop Asthma and COPD Companion Diagnostics
  9. [9] Item 1, Building on our Flow Cytometry Platform to Develop Asthma and COPD Companion Diagnostics
  10. [10] Item 1, Building on our Flow Cytometry Platform to Develop Asthma and COPD Companion Diagnostics
  11. [11] Item 1, OncoSelect® Therapeutics Research
  12. [12] Item 1, OncoSelect® Therapeutics Research
  13. [13] Item 7, MD&A — Current Year Financial Highlights
  14. [14] Item 7, MD&A — Current Year Financial Highlights
  15. [15] Item 7, MD&A — Current Year Financial Highlights
  16. [16] Item 7, MD&A — Results of Operations
  17. [17] Item 7, MD&A — Liquidity and Capital Resources
  18. [18] Item 7, MD&A — Net Cash Used in Operating Activities
  19. [19] Item 7, MD&A — Liquidity and Capital Resources
  20. [20] Item 7, MD&A — Current Year Financial Highlights
  21. [21] Item 1, Recent Developments — The Start of Our Longitudinal Clinical Study
  22. [22] Item 1, Recent Developments — The Start of Our Longitudinal Clinical Study
  23. [23] Item 1, Recent Developments — Continuation of Research Studies with the Military
  24. [24] Item 1, Recent Developments — Continuation of Research Studies with the Military
  25. [25] Item 1, Recent Developments — Positive Research Findings Advance Company’s Pipeline Tests for Asthma
  26. [26] Item 1, Recent Developments — PPLS Continues to Meet Highest Standards for Laboratory Operations
  27. [27] Item 1, CyPath® Lung Business Development Plan
  28. [28] Item 7, MD&A — Current Year Financial Highlights
  29. [29] Item 1, CyPath® Lung Business Development Plan
  30. [30] Item 1, CyPath® Lung Business Development Plan
  31. [31] Item 1, CyPath® Lung Business Development Plan
  32. [32] Item 1, Recent Developments — The Start of Our Longitudinal Clinical Study
  33. [33] Item 1, CyPath® Lung Business Development Plan
  34. [34] Item 1, CyPath® Lung Business Development Plan
  35. [35] Item 1, CyPath® Lung Business Development Plan
  36. [36] Item 7, MD&A — Financial
  37. [37] Item 7, MD&A — Company Overview
  38. [38] Item 7, MD&A — Financial
  39. [39] Item 1A, Risk Factors — Risks Related to Our Financial Position
  40. [40] Item 1A, Risk Factors — Risks Related to Our Financial Position
  41. [41] Item 1A, Risk Factors — Risks Related to Development and Commercialization of Our Diagnostic Tests
  42. [42] Item 1A, Risk Factors — We will depend on third parties to manufacture our kits, reagents, and supplies, and to support certain commercialization and clinical development activities, including marketing support for our diagnostic tests, the design of clinical trials, the arrangement and oversight of clinical trials, and the collection and analysis of data.
  43. [43] Item 1A, Risk Factors — We are exposed to product liability and pre-clinical and clinical liability risks which could place a substantial financial burden upon us should we be sued.
  44. [44] Item 1A, Risk Factors — Our collection, use, and disclosure of personal information, including health and employee information, is subject to U.S. state and federal privacy and security regulations, and our failure to comply with those regulations or to adequately secure the information we hold could result in significant liability or reputational harm.
  45. [45] Item 1A, Risk Factors — If we are unable to obtain adequate reimbursement from third-party payors or governmental agencies for CyPath® Lung or other diagnostic tests or therapeutic products under development or if new restrictive legislation is adopted, market acceptance of our tests or products may be limited, and we may not achieve expected revenues.
  46. [46] Item 1A, Risk Factors — We face intense competition in the biotechnology and pharmaceutical industries.
  47. [47] Item 1A, Risk Factors — Our internal information technology systems, or those of our third-party clinical research organizations or other contractors or consultants, may fail or suffer security breaches, loss or leakage of data, and other disruptions, which could result in a material disruption of our diagnostic tests’ or therapeutic product candidates’ development programs, compromise sensitive information related to our business, or prevent us from accessing critical information, potentially exposing us to liability or otherwise adversely affecting our business.
  48. [48] Item 1A, Risk Factors — Declining general economic or business conditions, including tariff and customs regulations, may have a negative impact on our business.
  49. [49] Item 1A, Risk Factors — PPLS currently offers CyPath® Lung as an LDT by PPLS. While a federal district court decision concluded FDA does not have jurisdiction to regulate LDTs, FDA could in the future determine that CyPath® Lung is not an LDT, or Congress could enact legislation granting FDA authority to regulate LDTs, which could adversely affect our commercialization strategy and negatively affect our results of operations and financial condition.
  50. [50] Item 7, MD&A — Current Year Financial Highlights
  51. [51] Item 7, MD&A — Current Year Financial Highlights
  52. [52] Item 7, MD&A — Current Year Financial Highlights
  53. [53] Item 7, MD&A — Liquidity and Capital Resources
  54. [54] Item 1, CyPath® Lung Business Development Plan
  55. [55] Item 1, CyPath® Lung Business Development Plan

Analysis on 5/20/2026