as of 08-21-2026 3:44pm EST
bioAffinity Technologies Inc develops noninvasive diagnostic laboratory tests to detect early-stage lung cancer and other diseases of the lung using flow cytometry and automated analysis informed by machine learning, a form of artificial intelligence (AI). Its first commercial diagnostic test, CyPath Lung, identifies and analyzes cell populations using flow cytometry, including cancer and cancer-related cells, that indicate a malignancy in the lung. It is developing its flow cytometry platform to address the need to identify patients who can benefit from new and emerging therapies for asthma and chronic obstructive pulmonary disease with noninvasive precision diagnostic tests. The company is organized in two operating segments, Diagnostic Research and Development and Laboratory Services.
| Founded: | 2014 | Country: | United States |
| Employees: | N/A | City: | SAN ANTONIO |
| Market Cap: | 4.5M | IPO Year: | 2022 |
| Target Price: | N/A | AVG Volume (30 days): | 1.8M |
| Analyst Decision: | N/A | Number of Analysts: | N/A |
| Dividend Yield: | N/A | Dividend Payout Frequency: | N/A |
| EPS: | -1.44 | EPS Growth: | -1054.67 |
| 52 Week Low/High: | $0.23 - $13.50 | Next Earning Date: | 05-14-2026 |
| Revenue: | $7,900,000 | Revenue Growth: | 14.49% |
| Revenue Growth (this year): | 20.95% | Revenue Growth (next year): | N/A |
| P/E Ratio: | -0.29 | Index: | N/A |
| Free Cash Flow: | -9389410.0 | FCF Growth: | N/A |
Machine learning model trained on 25+ technical indicators
Disclaimer: This prediction is generated by an AI model and should not be considered as financial advice. Always conduct your own research and consult with financial professionals before making investment decisions.
SEC 8-K filings with transcript text
Aug 7, 2026 · 100% conf.
1D
-9.89%
$0.46
Act: -3.92%
5D
-10.25%
$0.46
20D
-16.04%
$0.43
2 ex99-1.htm
Exhibit 99.1
bioAffinity Technologies Reports Second Quarter 2026 Results and Continued Strong Commercial Momentum for CyPath® Lung
CyPath Lung test volume increased 216% year over year in Q2 2026
Company drives physician adoption of CyPath Lung and advances longitudinal clinical trial
Pipeline expands to include development of precision diagnostics for asthma and COPD and dermally delivered skin cancer therapeutics
SAN ANTONIO, Texas – August 7, 2026 – bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company focused on the need for noninvasive, accurate tests for the detection of early-stage lung cancer and other lung diseases and topically delivered therapeutics for squamous and basal cell skin cancers, today reported financial results and business highlights for the quarter ended June 30, 2026.
Q2 2026 Highlights and Recent Events
●CyPath® Lung diagnostic test volume increased 216% during the second quarter of 2026 compared to the second quarter of 2025.
●CyPath Lung testing revenue for the first six months of 2026 increased 159% to approximately $835,000, compared with approximately $323,000 for the first six months of 2025.
●The Company delivered 1,097 CyPath Lung test reports during the first six months of 2026, compared with 390 during the same period of 2025.
●The number of physician offices and clinics ordering CyPath Lung for their patients increased 122% during the second quarter of 2026 compared to the same period in 2025.
●Existing clients as of June 30, 2025, increased their CyPath Lung orders by 71% year over year during the first six months of 2026.
●The longitudinal clinical trial designed to evaluate the clinical performance of the CyPath Lung test has begun patient enrollment at 11 clinical sites, including nine Department of Veterans Affairs (VA) and military medical centers. Financial support for the trial has been provided by the John P. Murtha Cancer Center Research Program (MCCRP), a research program within the Department of Surgery at the Uniformed Services University of the Health Sciences in Bethesda, Maryland.
●Positive preliminary therapeutic data support the development of topical treatments for squamous and basal cell skin cancers, with self-delivering stabilized siRNAs selectively killing melanoma, squamous and basal carcinoma cells while sparing healthy cutaneous cells.
-1-
●bioAffinity presented positive research results advancing its diagnostic platform designed to identify antibody drug receptors in sputum to match patients with the most appropriate biologic therapies, including receptors for dupilumab, a leading therapy for asthma and chronic obstructive pulmonary disease (COPD), and benralizumab, another asthma therapy.
●The Company published a comprehensive clinical review and white paper authored by Chief Medical Officer Gordon H. Downie, MD, PhD, that presents a practical clinical framework for incorporating CyPath Lung into pulmonary nodule evaluation and cancer surveillance.
●The Company announced a collaboration with Pictor®, Inc., a targeted proteomic platform company, to support development and commercialization of bioAffinity Technologies’ next-generation diagnostic tests designed to provide a more complete picture of lung inflammation in patients with asthma and COPD.
●The Society for Advanced Bronchoscopy (SAB) and National Association of Veterans Research Education Foundations (NAVREF) hosted webinars featuring multi-disciplinary panels of physicians who discussed CyPath Lung’s expanding role in the lung nodule care continuum.
●bioAffinity received notification of allowance from the Mexican Institute of Industrial Property for a patent application protecting the use of defined antibodies and the porphyrin TCPP to label cell populations in sputum and the use of flow cytometry to determine the presence of lung cancer cells in sputum.
●In June 2026, bioAffinity completed a public offering that generated approximately $3.2 million in gross proceeds to support commercialization activities, clinical development, and general corporate purposes.
Management Commentary
“Our commercial strategy continues to gain significant traction as physicians increasingly recognize the clinical value of CyPath Lung for evaluating patients at high risk for lung cancer and surveilling lung cancer survivors for recurrence,” said Maria Zannes, President and Chief Executive Officer of bioAffinity Technologies. “During the second quarter, CyPath Lung test volume surged 216% year-over-year. This growth reflects accelerating physician adoption and clinical confidence in our technology. As more clinics integrate CyPath Lung into their standard of care workflows, peer-to-peer education is a powerful driving force behind building broader awareness of the test’s ability to provide objective data that complements traditional imaging and supports faster, more informed clinical decisions.”
Ms. Zannes continued, “Alongside o
May 8, 2026
2 ex99-1.htm
Exhibit 99.1
bioAffinity Technologies Reports First Quarter 2026 Results and Expanding Adoption and Clinical Usage of CyPath® Lung
CyPath® Lung cancer diagnostic unit sales rise 146% year-over-year
Growth expected to accelerate throughout 2026 as planned commercial initiatives seek to drive increasing awareness of CyPath® Lung benefits
SAN ANTONIO, Texas – May 8, 2026 – bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company focused on the need for noninvasive, accurate tests for the detection of early-stage lung cancer and other lung diseases, today reported financial results for the first quarter ended March 31, 2026.
Q1 2026 Highlights
●CyPath® Lung unit sales increased 146% year-over-year in the first quarter of 2026, reflecting accelerating physician adoption and expanding clinical use of the Company’s noninvasive lung cancer diagnostic.
●CyPath® Lung testing revenue increased approximately 114% to $361,000, compared to $169,000 in the first quarter of 2025.
●Total consolidated revenue decreased approximately 27% to $1.4 million, compared to $1.9 million for the first quarter of 2025, resulting from the discontinuation of certain unprofitable pathology services in March 2025 to focus on higher margin services, including CyPath® Lung testing.
●The number of physician offices and clinics ordering CyPath® Lung increased 69% from first quarter 2025 to the same period in 2026, reflecting continued productivity and expansion of the Company’ sales force and focus on additional strategic markets. The Company expects growth to accelerate throughout 2026, as a result of these commercial initiatives and increasing awareness of the benefits of CyPath® Lung.
●The Company launched a large-scale longitudinal clinical trial partially funded by the U.S. Department of Defense to further validate CyPath® Lung performance and support establishing the noninvasive test as a standard of care for military and Veterans Administration (VA) medical centers. The trial is expected to include up to 20 clinical sites, including multiple Department of Veterans Affairs medical centers and leading U.S. military hospitals. The John P. Murtha Cancer Center Research Program is providing support and funding for the study at several federal facilities.
●As part of the Company’s commercial strategy to develop companion tests using its diagnostic platform to more precisely target drugs that treat asthma and COPD, bioAffinity Technologies announced that Brooke Army Medical Center, the military’s largest healthcare institution, was conducting a 40-patient collaborative study. The study will use bioAffinity Technologies’ flow cytometry+AI technology to evaluate whether its proprietary platform can detect biologic drug receptors in sputum, including those for dupilumab and benralizumab, to guide personalized therapy selection and monitor patient response over time. The Company presented findings from its early pipeline development activities at the American Academy of Allergy, Asthma and Immunology (AAAAI) 2026 annual meeting.
●Nationally recognized pulmonary and lung cancer experts joined the Company’s Medical and Scientific Advisory Board (MSAB) to provide independent guidance on strategic priorities, including clinical implementation and broader adoption of CyPath® Lung. David Ost, MD, MPH, University of Texas MD Anderson Cancer Center, Daniel Sterman, MD, New York University Langone Medical Center, and J. Scott Ferguson, MD, University of Wisconsin School of Medicine and Public Health, were named to the Company’s panel of experts.
●The Company released three additional patient case studies in first quarter 2026 in which CyPath® Lung results of “Unlikely Malignancy” helped avoid unnecessary invasive and costly biopsies when other tests suggested the presence of lung cancer in patients at high risk. CyPath® Lung test results were confirmed by follow-up imaging that showed stable or resolved lung nodules.
Management Commentary
“Our first quarter results demonstrate continued momentum for CyPath® Lung in the marketplace. As more and more physicians adopt CyPath® Lung and share their experiences with peers, we see the opportunity to expand our commercial reach and bridge the diagnostic gap between imaging and invasive procedures, especially when dealing with indeterminate nodules in high-risk patients,” said Maria Zannes, President and CEO of bioAffinity Technologies. “We are accelerating our marketing strategy to expand access to CyPath® Lung and educate healthcare practitioners and patients alike about the need for accurate, objective information to better stratify risk and improve patient outcomes. On April 8, we hosted our first webinar featuring a panel of pulmonologists who shared how they use CyPath® Lung in their diverse practices.”
Ms. Zannes continued, “Physicians continue to share their case studies in which CyPath® Lung has identified lung cancer as early as Stage 1A w
Mar 13, 2026
2 ex99-1.htm
Exhibit 99.1
bioAffinity Technologies Announces Record 2025 Revenue and Unit Sales for Flagship Lung Cancer Diagnostic CyPath® Lung
Laboratory business streamlined in 2025 to focus on profitable diagnostic testing services including the Company’s high-value CyPath® Lung test
Number of CyPath® Lung tests performed in 2025 increased by 99% compared to 2024
Orders for CyPath® Lung by physicians and clinics rose 67% YoY due to peer-to-peer marketing, positive real-world experiences and growing test awareness
SAN ANTONIO, Texas – March 13, 2026 – bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company focused on the need for noninvasive, accurate tests for the detection of early-stage lung cancer and other lung diseases, today reported financial results for the year ended December 31, 2025.
2025 Highlights
●Record CyPath® Lung Revenue and Unit Sales. Revenue from our noninvasive diagnostic for lung cancer increased 87% over 2024 with the number of tests performed rising 99% year over year, reflecting growing clinical utilization and validating the first phase of our commercialization strategy. The Company’s strategic decision to discontinue unprofitable pathology services and reallocate resources to the commercialization of CyPath® Lung led to a 34% decrease in total revenue and a 9% decrease in operating expenses compared to 2024, respectively.
●Expanded Physician Network. The number of physician offices and clinics ordering CyPath® Lung for their patients increased 67% over 2024. We expect the trend to accelerate in 2026 as we expand our sales force into new markets. Peer-to-peer physician engagement remains a key driver of growth. Compelling patient case studies and key opinion leaders (KOLs) who are sharing their clinical experience are building awareness and clinical adoption of CyPath® Lung.
-1-
●Leadership Appointments. Gordon Downie, MD, PhD, joined bioAffinity Technologies as Chief Medical Officer, bringing more than three decades of experience in pulmonary medicine, clinical research, medical innovation, and interventional pulmonology to the role. Roberto Rios, CPA, and John J. Oppenheimer, MD, were appointed to the Board of Directors in 2025. Mr. Rios has more than four decades of executive leadership experience in corporate finance and governance across industries including biotechnology and medical devices. Dr. Oppenheimer is a recognized leader in the diagnosis and treatment of asthma and COPD and directs clinical research in lung health while also teaching at the University of Medicine and Dentistry of New Jersey-Rutgers.
●Successful Financings. The Company raised approximately $16.9 million in gross proceeds during 2025 from equity transactions to fund CyPath® Lung clinical development, commercialization, and operational expansion.
●CyPath® Lung-Centered Performance. Through targeted operational streamlining and the discontinuation of certain unprofitable pathology services at our laboratory, Precision Pathology Laboratory Services (PPLS), we positioned CyPath® Lung as the core driver of long-term shareholder value. While these actions contributed to lower consolidated revenue in the short term, they improved operating focus and cost structure and are intended to position our noninvasive lung cancer diagnostic for scalable growth and improved long-term margin potential.
●Innovation Pipeline Progress. Research and development continued on diagnostic tests for chronic obstructive pulmonary disease (COPD) and asthma that build on our expertise in using sputum as a sample for flow cytometric analysis. Research is focused on detecting specific receptors in sputum to guide personalized treatment and identify patients likely to benefit from emerging targeted therapies. Asthma and COPD impact approximately 650 million children and adults globally.1 We expect to begin patient studies in 2026.
●Expanded Global Intellectual Property Portfolio. During 2025, we strengthened our intellectual property portfolio supporting CyPath® Lung and our broader flow cytometry platform through multiple patent allowances and acceptances. These included notification of allowance from the U.S. Patent and Trademark Office for our diagnostic algorithm and test method, patent allowances in Canada and China covering flow cytometry-based lung cancer detection methods, and acceptance of patent applications in Australia related to early-stage lung cancer detection and multi-disease lung health assessment. These developments further expand international protection of our diagnostic technology and support our long-term commercialization strategy.
1 https://academic.oup.com/ajrccm/article/212/2/297/8444672?login=false&utm
-2-
Management Commentary
“2025 was a transformational year for bioAffinity Technologies. We took deliberate actions to streamline operations at PPLS and align our resources behind the national expansion of CyPath® Lung,” said Maria Zannes, bioAffin
See how BIAF stacks up against similar companies in the market
Enhance your trading experience with our free tools
The information presented on this page, "BIAF bioAffinity Technologies Inc. - Stocks Price | History | Analysis", including historical data, forecasts, news, insider information, and predictions, is provided for educational purposes only. It should not be considered as financial advice or a recommendation to buy or sell any securities. Decisions regarding investments should be made only after careful consideration and consultation with a qualified financial advisor. We do not endorse or guarantee the accuracy or reliability of the information provided, and we disclaim any liability for financial losses incurred as a result of decisions made based on the information presented.