BIAF

Shares of bioAffinity Technologies, Inc. BIAF have lost 10.9% since the company reported earnings for the quarter ended March 31, 2026, against the S&P 500 Index’s 1.4% gain over the same time frame. Over the past month, the stock plunged 35.5%, underperforming the S&P 500’s 6.8% gain. bioAffinity reported first-quarter 2026 revenues of $1.4 million, down 27.1% year over year from $1.9 million, primarily due to the discontinuation of certain lower-margin pathology services in March 2025. However, CyPath Lung testing revenue climbed 113.6% year over year to $361,000 from $169,000, while CyPath Lung unit sales surged 146%. Net loss widened to $3.6 million, or 81 cents per share, from $2.7 million, or $4.80 per share, in the prior-year quarter. Selling, general and administrative expenses increased 32.2% to $3.2 million from $2.5 million, while clinical development costs jumped 141.4% to $0.3 million from $0.1 million as the company advanced its pivotal clinical trial. Direct costs and expenses declined 32.1% year over year to $0.9 million from $1.4 million due to strategic cost-reduction actions implemented in March 2025. Research and development expenses fell 4.8% to $0.3 million from $0.4 million, reflecting lower compensation and laboratory supply costs. Operating expenses rose 10.9% year over year to $4.9 million from $4.5 million. bioAffinity highlighted continued adoption of CyPath Lung among physicians and clinics during the quarter. The number of physician offices and clinics ordering the test rose 69% year over year, reflecting expansion of the company’s sales force and targeted commercial initiatives. Management said it expects growth to accelerate through the remainder of 2026 as awareness of the noninvasive lung cancer diagnostic increases. BIAF also hosted its first educational webinar on April 8, featuring pulmonologists discussing real-world use cases for CyPath Lung. Management cited multiple patient case studies in which CyPath Lung results categorized as “Unlikely Malignancy” helped avoid unnecessary invasive biopsies for high-risk patients whose imaging initially suggested possible cancer. Segment-wise, laboratory services generated $1.4 million in revenues compared with $1.9 million a year earlier, while diagnostic research and development contributed $1,131 from Department of Defense observational studies. Laboratory services recorded an o...

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, May 08, 2026--(BUSINESS WIRE)--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 la...

CyPath® Lung improves diagnostic clarity in patients with multiple lung nodules In this case study, CyPath® Lung "Unlikely Malignancy" result supported physician’s decision to wait before ordering an invasive lung biopsy In a clinical study, noninvasive CyPath® Lung test demonstrated 92% sensitivity, 87% specificity and 88% accuracy for detecting lung cancer in small nodules less than 20 millimeters SAN ANTONIO, March 17, 2026--(BUSINESS WIRE)--bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company advancing noninvasive diagnostics for lung cancer and other lung diseases, today released a new clinical case study that highlights the benefit of adding CyPath® Lung, a noninvasive test for lung cancer, to the diagnostic pathway for a high-risk patient with multiple pulmonary nodules. The patient is a 71-year-old former 20-pack-year smoker with a history of pneumonia in the right lower lobe. His current medical condition includes obesity and mild restrictive lung disease. Low dose CT scans revealed scattered pulmonary nodules, with one measuring 7 millimeters (mm), a size that has a greater potential for being cancerous and often leads to invasive bronchoscopy or biopsy. "Multiple small nodules in a high-risk patient pose a diagnostic challenge, which can be exacerbated by the patient’s understandable anxiety about a potential cancer," said Daya Nadarajah, MD, the patient’s pulmonologist. "In this case, the patient’s CyPath® Lung result was negative, indicating a low likelihood of malignancy, and together both the patient and I were comfortable in waiting for a follow-up CT scan in three months." The follow-up scan in October 2025 showed the suspicious nodules in the right upper lobe had resolved, indicating benign inflammation, and a small nodule located in the fissure between the upper and lower right lobes remained unchanged. "This is another patient case study that illustrates how CyPath® Lung provides accurate results and greater confidence in pulmonary nodule management, supporting physician decision-making, reducing patient anxiety, and lowering healthcare costs by avoiding expensive, invasive and often risky procedures when they are not necessary," said Gordon Downie, MD, PhD, Chief Medical Officer of bioAffinity Technologies. About CyPath® Lung CyPath® Lung by bioAffinity Technologies is a noninvasive test designed to aid in the ea...

Shares of bioAffinity Technologies, Inc. BIAF have lost sharply since the company reported third-quarter 2025 results. The stock has plunged 21.8% since the earnings release compared with the S&P 500 Index’s 2.2% loss during the same period. Over the past month, bioAffinity shares have dipped 48.9%, significantly underperforming the broader market, which slipped 2%. In the third quarter of 2025, bioAffinity generated $1.4 million in total revenues, down 38.5% from $2.4 million a year earlier, reflecting its strategic exit from unprofitable pathology services and renewed emphasis on CyPath Lung commercialization. Despite the top-line decline, the company reported strong momentum in its flagship diagnostic product. CyPath Lung testing revenue rose 122% year over year, supported by higher case volumes and increased physician adoption — including growing usage across Veterans Administration (VA) medical centers. Operating expenses fell 13.5% to $3.7 million from $4.3 million, driven mainly by lower laboratory-related costs. Still, BIAF’s net loss widened to $5.1 million from $2 million a year ago, primarily due to a non-cash expense tied to warrant revaluations. Loss per share narrowed slightly to $4.74 from $4.84. Beyond revenue and operating costs, BIAF reported notable reductions across several expense lines. Direct costs declined 34.6% year over year to $0.9 million from $1.4 million, reflecting March 2025 efficiency initiatives. Selling, general and administrative expenses decreased 6.6%, aided by operational streamlining at Precision Pathology Laboratory Services. Depreciation and amortization expenses dropped 25.1% from the prior year. However, research and development (R&D) spending rose 20.4% and clinical development costs increased 52.9% due to expanded preclinical and clinical work ahead of an upcoming longitudinal study. In addition, bioAffinity highlighted robust operational momentum for CyPath Lung, noting that test volumes for the first nine months of 2025 increased 97% over the prior-year period. The test also reached a record quarterly sales level in the third quarter of 2025, climbing 92% from the preceding quarter. These gains were driven by expanded adoption, particularly within the VA system and in new regional markets. Balance sheet strength improved meaningfully, with cash and equivalents rising to $7.7 million from $1.1 million at year-en...

Company achieves 86% increase in CyPath® Lung testing revenue, strengthens balance sheet SAN ANTONIO, November 14, 2025--(BUSINESS WIRE)--bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company focused on providing noninvasive, accurate detection of early-stage lung cancer and other lung diseases, today reported financial results for the three months ended September 30, 2025. Key Highlights CyPath® Lung revenues increased 86% year over year for the first nine months of 2025, driven by higher test volumes and growing clinical adoption, including the Veterans Administration (VA). Sales of CyPath® Lung reached a record high in the third quarter of 2025, representing a 92% increase over the previous quarter. The increase reflects growing adoption by VA hospitals and market expansion in the mid-Atlantic region. In the first nine months of 2025, the number of CyPath® Lung tests processed increased by 97% over the same period in 2024. Total revenues decreased from $2.4 million to $1.5 million for the three months ended September 30, 2025, as a result of the Company’s strategic decision to discontinue unprofitable pathology services and reallocate resources to the commercialization of CyPath® Lung. Raised approximately $10.4 million in gross proceeds from equity transactions to fund ongoing operations and growth initiatives. Released details of four patient case studies in which CyPath® Lung was the critical factor in clinical decision making, including patients whose lung cancer was detected at Stage 1A. Appointed Roberto Rios, CPA, and John J. Oppenheimer, M.D., to the Board of Directors. Mr. Rios brings executive leadership in corporate finance. Dr. Oppenheimer is a recognized leader in the diagnosis and treatment of asthma and COPD and also serves as an advisor to pharmaceutical companies focused on lung health. Regained full Nasdaq Capital Market compliance for continued listing of the Company’s common stock (BIAF) and warrants (BIAFW), subject to a mandatory panel monitor for a period of one year. Expanded patent portfolio with a new U.S. patent protecting the diagnostic algorithm and test method used to detect lung cancer. Management Commentary "In the third quarter of 2025, our primary focus was on driving the adoption of CyPath® Lung while maintaining fiscal discipline," said Maria Zannes, President and Chief Executive Officer of bioAf...

SAN ANTONIO, October 07, 2025--(BUSINESS WIRE)--bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company advancing noninvasive diagnostics for lung cancer and other lung diseases, today announced sales of its CyPath® Lung diagnostic test for lung cancer reached a new high in the third quarter of 2025, representing a 95% increase over the previous quarter. The increase reflects growing adoption by Veterans’ hospitals and market expansion in the mid-Atlantic region. In the first nine months of 2025, sales of CyPath® Lung rose 97% over the same period in 2024. "The continued acceleration in CyPath® Lung adoption underscores the growing physician confidence in our test to detect lung cancer at its earliest, most treatable stages," said Maria Zannes, President and CEO of bioAffinity Technologies. "Physicians are equally impressed by CyPath® Lung’s ability to save patients from unnecessary invasive procedures when the nodule is benign." "Our strong quarter-over-quarter growth demonstrates that CyPath® Lung is gaining traction in the marketplace, and we are encouraged by the test’s increasing integration into clinical practice," Zannes said. "Performance metrics showed similar improvements in the third quarter, including a 77% increase in the number of new patients using CyPath® Lung and greater patient compliance for at-home sample collection and return." Published patient case studies demonstrate the clinical impact of CyPath® Lung, including: Detecting Stage 1A lung cancer in patients after other diagnostics suggested a low probability of cancer. Sparing patients from invasive procedures when the CyPath® Lung result was negative. Detecting lung cancer earlier in difficult-to-diagnose ground-glass nodules. "As we expand our marketing and sales efforts, we are immensely proud of the real-world impact CyPath® Lung is having on patients and their families," said Gordon Downie, MD, PhD, Chief Medical Officer of bioAffinity Technologies. "Every early cancer detected means a life that may be saved, and every unnecessary invasive procedure avoided means a patient spared from risk, anxiety and cost. This is why more physicians are adding CyPath® Lung as an essential tool in the diagnostic pathway." About CyPath® Lung CyPath® Lung uses proprietary advanced flow cytometry and artificial intelligence (AI) to identify cell populations in patient sputum t...

Shares of bioAffinity Technologies, Inc. BIAF have dipped sharply since its second-quarter 2025 earnings release. The stock has lost 11% since the company reported results for the quarter ended June 30, 2025, compared with a 1.1% decline in the S&P 500 Index over the same period. Over the past month, bioAffinity shares have plunged 27.4%, while the S&P 500 gained 1.5%. For the second quarter of 2025, bioAffinity reported revenues of $1.3 million, a 47.1% decline from $2.4 million in the prior-year quarter, primarily due to its decision to discontinue unprofitable pathology services and focus resources on its flagship CyPath Lung diagnostic test. However, CyPath Lung itself posted encouraging momentum, with testing revenue rising 62.3% year over year in the first half of 2025 to $323,000 from $199,000, reflecting growing physician adoption. Operating expenses in second-quarter 2025 decreased 15.6% to $3.8 million from $4.5 million a year earlier, driven by a reduction in direct costs and a decline in research and development spending. Despite these cost improvements, BIAF’s net loss widened to $4.1 million, or $0.17 per share, from a loss of $2.1 million, or $0.19 per share, in the second quarter of 2024. The deeper loss was primarily attributable to $1.5 million in non-cash expenses linked to warrant remeasurement and costs from a May 2025 public offering. BIAF highlighted meaningful improvements in cost efficiency. Direct costs fell 27.8% year over year, reflecting savings from initiatives rolled out in March 2025. Research and development spending decreased 22.6% to $0.3 million from $0.4 million, but clinical development expenses surged 151.2% to $129,279 from $51,462, as bioAffinity ramped up professional fees tied to advancing CyPath Lung toward pivotal trials. Selling, general and administrative expenses were trimmed 10.4% to $2.2 million from $2.5 million, largely through efficiencies gained after integrating Precision Pathology Laboratory Services. Depreciation and amortization also declined 25% year over year. On the balance sheet, cash and equivalents stood at $0.8 million as of June 30, 2025, versus $1.1 million at year-end 2024. To shore up liquidity, BIAF completed a $3.25 million public offering in May. Still, the accumulated deficit widened to $60.4 million, and the total stockholders’ deficit was $2.1 million. bioAffinity Technologies, Inc. p...

CyPath® Lung revenues up 62% year-over-year in first six months of 2025 SAN ANTONIO, August 14, 2025--(BUSINESS WIRE)--bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company focused on providing noninvasive, accurate detection of early-stage lung cancer and other lung diseases, today reported financial results for the three months ended June 30, 2025. Key Highlights Increased CyPath® Lung revenues 62% year-over-year for the six-month period ended June 30, 2025. Completed CyPath® Lung tests in July represented a 72% increase over the previous monthly average for the first six months of 2025, including back-to-back record monthly sales in June and July. Released real-world case studies demonstrating the diagnostic utility of CyPath® Lung, including successful detection of Stage 1A lung cancers for multiple patients who had previous tests and imaging that incorrectly deemed the risk of cancer as low. Increased the list price of CyPath® Lung to $2,900, aligning with private payer reimbursement strategies and enhancing per-test profitability. Expanded logistics capabilities through partnership with Cardinal Health™ OptiFreight® Logistics, improving sample tracking, cost efficiency, and national delivery reliability in support of CyPath® Lung’s commercial growth. Completed a $3.25 million public offering in May 2025 providing working capital. Appointed Dr. Gordon Downie, MD, PhD, as Chief Medical Officer, bringing more than 30 years of clinical leadership in pulmonology and interventional lung care to support bioAffinity’s diagnostic and clinical strategy. Announced patent grants in the U.S., China, Canada, and Australia, expanding the Company’s global intellectual property portfolio for both diagnostics and therapeutics, including a newly issued U.S. patent for a broad-spectrum cancer therapy targeting CD320 and LRP2 receptors. Presented novel siRNA-based cancer therapy research at the 2025 RNA Therapeutics Conference, showcasing the potential of a new therapeutic approach to selectively kill cancer cells without harming healthy tissue. bioAffinity President and CEO Maria Zannes appointed to the American Lung Association in Texas Leadership Board, reinforcing the Company’s advocacy and leadership in lung health and early cancer detection. Management Commentary "Our second quarter results reflect the continued acceleration of our CyPath® Lun...

bioAffinity Technologies’ noninvasive sputum test catches rare cancer in time for curative surgery SAN ANTONIO, July 29, 2025--(BUSINESS WIRE)--bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company focused on noninvasive diagnostics and early cancer detection, today shared another compelling patient case study in which its flagship test, CyPath® Lung, detected pulmonary mucinous adenocarcinoma in a high-risk individual whose previous tests and follow-up scans had suggested a low probability of cancer that could have led to diagnosis at a later, less treatable stage. "CyPath® Lung gave us the diagnostic clarity we needed to intervene before this cancer progressed further," said Gordon Downie, MD, PhD, bioAffinity Technologies’ Chief Medical Officer. "This patient had low PET uptake, low serum marker risk, and gaps in imaging. CyPath® Lung helped identify a relatively rare cancer that may have otherwise gone untreated." "Once again, CyPath® Lung has demonstrated that it can detect lung cancer at Stage 1A when traditional diagnostic tests indicated a low probability of cancer. For high-risk patients with inconclusive imaging or limited diagnostic options, we believe that our noninvasive test can offer a vital path forward. Every early diagnosis is a life potentially saved, and that’s the promise CyPath® Lung seeks to deliver on every day," said Maria Zannes, President and CEO of bioAffinity Technologies. The female patient, now 62 years old with a history of heavy smoking and COPD, initially presented in 2022 with a suspicious left upper lobe ground-glass opacity (GGO), a hazy gray area on the CT scan that indicates increased density in the airways. The initial PET scan in 2022 showed low uptake of the radioactive tracer, which is consistent with a benign outcome, and a blood-based risk test reported a reduced malignancy risk of 11%. Serial LDCTs appeared stable through 2023, but a July 2024 scan revealed a transition to a more solid nodule, raising clinical concern. When the patient opted against surveillance CT scans and a follow-up PET scan, her physician ordered the CyPath® Lung test in March 2025. The test result of 0.56 – classified as "likely malignancy" – prompted her care team to recommend surgical consultation. The patient subsequently underwent wedge resection of the upper left lung in June 2025. Final pathology confirmed Stag...

CyPath® Lung sales up 276% year-over-year SAN ANTONIO, May 15, 2025--(BUSINESS WIRE)--bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company focused on the need for accurate, noninvasive tests for the detection of early-stage lung cancer and other lung diseases, today reported financial results for the three months ended March 31, 2025. Key Highlights Generated revenue of $1.9 million in the first quarter of 2025. CyPath® Lung sales up 276% year-over-year in the first quarter of 2025. Reported strong results from the Texas beta launch of CyPath® Lung, with first-quarter test sales building on the momentum of more than 600 tests delivered in 2024. Announced strategic actions expected to reduce annual costs by approximately $3.8 million while expanding sales focus on high-margin diagnostics like CyPath® Lung. Released multiple patient case studies highlighting CyPath® Lung’s impact in real-world clinical settings, including early detection of second primary lung cancer and avoidance of unnecessary invasive procedures. Received acceptance of a new patent application from the Australian Patent Office, strengthening international IP protection for CyPath® Lung and expanding global commercialization potential. Subsequent to the end of the first quarter, announced improvements to CyPath® Lung processing that increased data acquisition throughput by 50% and reduced unit cost by more than 25%, enhancing efficiency without compromising test performance. Management Commentary "We began 2025 with strong momentum, delivering 276% year-over-year growth in CyPath® Lung sales and expanding our commercial footprint across the U.S.," said Maria Zannes, President and Chief Executive Officer of bioAffinity Technologies. "Our first-quarter results reflect both the growing demand for our noninvasive lung cancer diagnostic and the successful execution of our strategy to focus on high-value services and operational efficiency. "During the quarter, we took decisive actions to streamline operations at our subsidiary lab by reducing labor costs, implementing operational efficiencies and discontinuing certain pathology services with suboptimal profit margins. These targeted actions will reduce costs approximately $3.8 million annually and accelerate the commercial growth of CyPath® Lung. These changes are already translating into margin improvements and enhanced...

Revenue: US$9.36m (up 270% from FY 2023). Net loss: US$9.04m (loss widened by 14% from FY 2023). US$0.75 loss per share. AI is about to change healthcare. These 20 stocks are working on everything from early diagnostics to drug discovery. The best part - they are all under $10bn in marketcap - there is still time to get in early. All figures shown in the chart above are for the trailing 12 month (TTM) period Revenue missed analyst estimates by 2.2%. Earnings per share (EPS) exceeded analyst estimates by 8.5%. Looking ahead, revenue is expected to decline by 14% p.a. on average during the next 2 years, while revenues in the Biotechs industry in the US are expected to grow by 19%. Performance of the American Biotechs industry. The company's shares are up 278% from a week ago. Before we wrap up, we've discovered 6 warning signs for bioAffinity Technologies (5 are significant!) that you should be aware of. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) simplywallst.com.This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.