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bioAffinityF
Nasdaq / Pharmaceuticals, Biotechnology & Life Sciences
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2026-08-07
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Investor releaseQuarter not tagged2026-08-07

bioAffinity Technologies Reports Second Quarter 2026 Results and Continued Strong Commercial Momentum for CyPath® Lung

Business Wire
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 07, 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 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. bioAffinity presented positive research results advancing its diagnostic platform designed to identify antibody drug receptors in sputum to match patients wit…Read full document

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 07, 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 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. 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 our commercial momentum, we achieved critical milestones across our strategic roadmap. In the second quarter, we expanded physician education initiatives, including scientific presentations, webinars, podcasts and real-world clinical case studies. We continued to make progress in our large-scale longitudinal study that includes VA and military medical centers, expanding our outreach to veterans. By leveraging our expertise in flow cytometry and AI and our work with siRNAs, we are building a robust pipeline of precision diagnostics for the large asthma and COPD markets and even larger therapeutic markets for topically delivered drugs that treat squamous and basal cell skin cancers." Ms. Zannes concluded, "Looking ahead, our priorities for the second half of 2026 are expanding physician adoption, increasing utilization among existing customers, and introducing CyPath Lung to new healthcare systems and specialty practices, including oncology. The positive results we see from research and development of precision diagnostics and a therapeutic for skin cancers are exciting as we advance our pipeline. We believe this balanced approach positions bioAffinity to create lasting value for patients, healthcare providers and shareholders." Second Quarter 2026 Financial Results Revenue for the quarter ended June 30, 2026, was $1.5 million, a 19% increase from the $1.3 million reported for the same period in 2025. The increase is primarily due to an increase in sales of CyPath Lung. Operating expenses for the second quarter of 2026 were $4.8 million, compared with $3.8 million in the second quarter of 2025. Direct costs and expenses for the second quarter of 2026 were $1.1 million, compared to $1 million in the prior-year period, primarily reflecting higher CyPath Lung test volume. Research and development expenses increased 16% year-over-year to $362,000, driven by laboratory supply purchases and costs associated with relocating the research and development lab from the University of Texas at San Antonio to the Precision Pathology Laboratory services campus. Clinical development expenses rose to $476,000 from $129,000 in the second quarter of 2025 due to costs associated with initiating the longitudinal clinical study. Selling, general and administrative expenses were $2.9 million for the second quarter of 2026, up from $2.2 million in the same period last year. The increase was primarily driven by higher employee compensation, reflecting the addition of sales and administrative personnel to support the expanding commercialization of CyPath Lung. Net loss for the quarter ended June 30, 2026, was $3.4 million, compared with a net loss of $4.1 million for the second quarter of 2025. Cash and cash equivalents as of June 30, 2026, were $2.4 million, compared with $6.4 million as of December 31, 2025. About CyPath Lung CyPath Lung by bioAffinity Technologies is a noninvasive test designed to improve the early detection of lung cancer in patients at high risk for the disease. CyPath Lung uses advanced flow cytometry and proprietary artificial intelligence (AI) to identify cell populations in patient sputum that indicate malignancy. CyPath Lung incorporates a fluorescent porphyrin that is preferentially taken up by cancer and cancer-related cells. In a published clinical trial of high-risk patients, CyPath Lung demonstrated 92% sensitivity, 87% specificity, 88% accuracy and 99% negative predictive value (NPV) in detecting lung cancer in patients at high risk for the disease who had small indeterminate lung nodules less than 20 millimeters. The high NPV gives physicians greater confidence that a negative result is truly negative, potentially sparing patients from unnecessary invasive and costly procedures. CyPath Lung is marketed as a Laboratory Developed Test (LDT) and is not intended for use as a sole diagnostic tool and should be considered alongside other clinical findings. About bioAffinity Technologies, Inc. bioAffinity Technologies, Inc. addresses the need for noninvasive diagnosis of early-stage cancer and other diseases of the lung and broad-spectrum cancer treatments. The Company’s first product, CyPath Lung, is a noninvasive test that has shown high sensitivity, specificity and accuracy for the detection of early-stage lung cancer. CyPath Lung is marketed as a Laboratory Developed Test (LDT) by Precision Pathology Laboratory Services, a subsidiary of bioAffinity Technologies. LDTs are overseen under the Clinical Laboratory Improvement Amendments (CLIA), which are administered by the Centers for Medicare & Medicaid Services. For more information, visit www.bioaffinitytech.com. Forward-Looking Statements Certain statements in this press release constitute "forward-looking statements" within the meaning of the federal securities laws. Words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "predict," "forecast," "project," "plan," "intend" or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. These forward-looking statements are subject to various risks and uncertainties, many of which are difficult to predict, that could cause actual results to differ materially from current expectations and assumptions from those set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from current expectations include, among others, the Company's ability to successfully commercialize CyPath Lung and achieve broader market acceptance, the Company's ability to obtain adequate financing to fund operations and development activities, risks related to the results of clinical trials and studies, the Company's ability to obtain and maintain regulatory approvals or clearances, the Company's ability to protect its intellectual property, competition from other companies developing similar products, changes in applicable laws or regulations, the Company's limited operating history and history of operating losses, the Company’s receipt of a delisting determination notice from the Nasdaq Stock Market and the risks and uncertainties associated with the Company’s intent to appeal such determination and the outcome of any such appeal, and the other factors discussed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, and its subsequent filings with the SEC, including subsequent periodic reports on Forms 10-Q and 8-K. Such forward-looking statements are based on facts and conditions as they exist at the time such statements are made and predictions as to future facts and conditions. While the Company believes these forward-looking statements are reasonable, readers of this press release are cautioned not to place undue reliance on any forward-looking statements. The information in this release is provided only as of the date of this release, and the Company does not undertake any obligation to update any forward-looking statement relating to matters discussed in this press release, except as may be required by applicable securities laws. View source version on businesswire.com: https://www.businesswire.com/news/home/20260807553380/en/ Contacts bioAffinity Technologies Julie Anne OvertonDirector of [email protected]

Investor releaseQuarter not tagged2026-07-07

bioAffinity Technologies’ Quarterly CyPath® Lung Sales Double to New Record as Commercial Momentum Continues

Business Wire
CyPath® Lung sales volume for Q2 2026 grows more than 200% year-over-year and 30% over record-breaking prior quarter Growth in Q2 driven by increasing utilization among existing clients and 155% increase in physician offices ordering CyPath® Lung as compared to Q2 2025 SAN ANTONIO, July 07, 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 announced continued acceleration in commercial sales for CyPath® Lung, its noninvasive lung cancer diagnostic, with more than 200% growth year-over-year. The number of tests sold in the second quarter of 2026 represents an increase of more than 30% over the first quarter of 2026 and more than 200% compared with the second quarter of 2025. "We are at the forefront of a positive change in clinical practice. We believe it is the result of expanding physician familiarity and accumulating clinical evidence as more patients are evaluated with CyPath® Lung and benefit from CyPath® Lung-guided care," said Maria Zannes, President and Chief Executive Officer of bioAffinity Technologies. "The most encouraging trend goes beyond onboarding new practices — the fact is, physicians who try CyPath® Lung appreciate its benefits and continue to use it. Repeat utilization suggests the test is becoming part of routine clinical decision-making for patients with indeterminate pulmonary nodules." The Company has now performed nearly 3,000 CyPath® Lung tests since commercial launch, reflecting growing physician adoption across pulmonology practices, lung nodule clinics, academic and community medical centers, and Veterans Affairs (VA) facilities. bioAffinity Technologies is executing a commercial strategy focused on increasing utilization of CyPath® Lung among existing clients, expanding its sales footprint in existing markets, strategically entering new markets, and building lasting relationships with physicians. "The number of patients diagnosed with indeterminate pulmonary nodules is expected to grow significantly over the next several years with expanded lung cancer screening and incidental findings from other procedures," said Gordon Downie, MD, PhD, Chief Medical Officer of bioAffinity Technologies. "The challenge is determining which patients require immediate inva…Read full document

CyPath® Lung sales volume for Q2 2026 grows more than 200% year-over-year and 30% over record-breaking prior quarter Growth in Q2 driven by increasing utilization among existing clients and 155% increase in physician offices ordering CyPath® Lung as compared to Q2 2025 SAN ANTONIO, July 07, 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 announced continued acceleration in commercial sales for CyPath® Lung, its noninvasive lung cancer diagnostic, with more than 200% growth year-over-year. The number of tests sold in the second quarter of 2026 represents an increase of more than 30% over the first quarter of 2026 and more than 200% compared with the second quarter of 2025. "We are at the forefront of a positive change in clinical practice. We believe it is the result of expanding physician familiarity and accumulating clinical evidence as more patients are evaluated with CyPath® Lung and benefit from CyPath® Lung-guided care," said Maria Zannes, President and Chief Executive Officer of bioAffinity Technologies. "The most encouraging trend goes beyond onboarding new practices — the fact is, physicians who try CyPath® Lung appreciate its benefits and continue to use it. Repeat utilization suggests the test is becoming part of routine clinical decision-making for patients with indeterminate pulmonary nodules." The Company has now performed nearly 3,000 CyPath® Lung tests since commercial launch, reflecting growing physician adoption across pulmonology practices, lung nodule clinics, academic and community medical centers, and Veterans Affairs (VA) facilities. bioAffinity Technologies is executing a commercial strategy focused on increasing utilization of CyPath® Lung among existing clients, expanding its sales footprint in existing markets, strategically entering new markets, and building lasting relationships with physicians. "The number of patients diagnosed with indeterminate pulmonary nodules is expected to grow significantly over the next several years with expanded lung cancer screening and incidental findings from other procedures," said Gordon Downie, MD, PhD, Chief Medical Officer of bioAffinity Technologies. "The challenge is determining which patients require immediate invasive evaluation and which can be safely monitored. CyPath® Lung is designed to provide clinicians with an objective, noninvasive tool that complements imaging and helps them make more informed decisions while reducing unnecessary procedures and patient anxiety." In published patient case studies, CyPath® Lung has helped detect lung cancer at curative Stage 1A when risk stratification guidelines and other adjunct tests indicated low risk. Conversely, a negative CyPath® Lung result has spared patients with significant comorbidities from invasive, often risky procedures. In a recent interview, a CyPath® Lung patient describes the emotional impact of discovering a pulmonary nodule and explains why she appreciated having a noninvasive testing option. "I was petrified. I was scared to death," she recalls. "I was so thankful that CyPath® Lung was something that I could do that was noninvasive… I just want to shout it from the rafters." bioAffinity Technologies is advancing multiple initiatives that the Company believes will further expand the clinical impact of its proprietary technology platform. These include a large-scale longitudinal clinical study designed to generate additional validation data for CyPath® Lung, expansion into oncology by using CyPath® Lung to monitor lung cancer survivors after treatment, and an R&D pipeline that includes diagnostic tests for asthma and COPD that are designed to help guide personalized treatment with targeted therapies. "We are building on the success of CyPath® Lung to develop noninvasive tests designed to ensure asthma and COPD patients are matched with the most effective treatment for their type of lung disease," Dr. Downie said. "We continue to develop our automated flow cytometry platform that supports an expanding number of diagnostic tests that we believe can lead to improved lung health for millions of people." The Company expects to report its financial results for the second quarter of 2026 in August. About CyPath® Lung CyPath® Lung by bioAffinity Technologies is a noninvasive test designed to improve the early detection of lung cancer in patients at high risk for the disease. CyPath® Lung uses advanced flow cytometry and proprietary artificial intelligence (AI) to identify cell populations in patient sputum that indicate malignancy. CyPath® Lung incorporates a fluorescent porphyrin that is preferentially taken up by cancer and cancer-related cells. In a published clinical trial of high-risk patients, CyPath® Lung demonstrated 92% sensitivity, 87% specificity, 88% accuracy and 99% negative predictive value (NPV) in detecting lung cancer in patients at high risk for the disease who had small indeterminate lung nodules less than 20 millimeters. The high NPV gives physicians greater confidence that a negative result is truly negative, potentially sparing patients from unnecessary invasive and costly procedures. CyPath® Lung is marketed as a Laboratory Developed Test (LDT) and is not intended for use as a sole diagnostic tool and should be considered alongside other clinical findings. About bioAffinity Technologies, Inc. bioAffinity Technologies, Inc. addresses the need for noninvasive diagnosis of early-stage cancer and other diseases of the lung and broad-spectrum cancer treatments. The Company’s first product, CyPath® Lung, is a noninvasive test that has shown high sensitivity, specificity and accuracy for the detection of early-stage lung cancer. CyPath® Lung is marketed as a Laboratory Developed Test (LDT) by Precision Pathology Laboratory Services, a subsidiary of bioAffinity Technologies. LDTs are overseen under the Clinical Laboratory Improvement Amendments (CLIA), which are administered by the Centers for Medicare & Medicaid Services. For more information, visit www.bioaffinitytech.com. Forward-Looking Statements Certain statements in this press release constitute "forward-looking statements" within the meaning of the federal securities laws. Words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "predict," "forecast," "project," "plan," "intend" or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. These forward-looking statements are subject to various risks and uncertainties, many of which are difficult to predict, that could cause actual results to differ materially from current expectations and assumptions from those set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from current expectations include, among others, the Company’s ability to successfully commercialize CyPath® Lung, risks related to the regulatory environment for laboratory developed tests and the other factors discussed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, and its subsequent filings with the SEC, including subsequent periodic reports on Forms 10-Q and 8-K. Such forward-looking statements are based on facts and conditions as they exist at the time such statements are made and predictions as to future facts and conditions. While the Company believes these forward-looking statements are reasonable, readers of this press release are cautioned not to place undue reliance on any forward-looking statements. The information in this release is provided only as of the date of this release, and the Company does not undertake any obligation to update any forward-looking statement relating to matters discussed in this press release, except as may be required by applicable securities laws. View source version on businesswire.com: https://www.businesswire.com/news/home/20260707410622/en/ Contacts bioAffinity Technologies Julie Anne OvertonDirector of [email protected]

Investor releaseQuarter not tagged2026-05-14

BIAF Stock Slips Post Q1 Earnings Despite Strength in CyPath Lung

Zacks
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…Read full document

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 operating loss of $1.8 million compared with $2.3 million in the prior-year quarter. bioAffinity Technologies, Inc. price-consensus-eps-surprise-chart | bioAffinity Technologies, Inc. Quote During the quarter, bioAffinity launched a large-scale longitudinal clinical trial partially funded by the U.S. Department of Defense to further validate CyPath Lung and support broader adoption at military and Veterans Administration (VA) medical centers. The study is expected to include up to 20 clinical sites, including VA hospitals and military medical centers. BIAF enrolled its first patient in March 2026. The company is also advancing companion diagnostics using its flow cytometry and AI platform. Brooke Army Medical Center initiated a 40-patient collaborative study evaluating whether bioAffinity’s platform can identify biologic drug receptors in sputum samples to guide asthma and COPD therapy selection and monitor patient response. Early findings from these initiatives were presented at the American Academy of Allergy, Asthma and Immunology 2026 annual meeting. Additionally, bioAffinity expanded its Medical and Scientific Advisory Board with nationally recognized pulmonary and lung cancer experts from MD Anderson Cancer Center, NYU Langone Medical Center and the University of Wisconsin School of Medicine and Public Health. President and CEO Maria Zannes said first-quarter results reflected continued momentum for CyPath Lung as physician adoption expands. Zannes emphasized BIAF’s strategy to broaden commercial reach, strengthen physician engagement and position CyPath Lung as part of the standard of care for evaluating indeterminate lung nodules. Despite growing CyPath Lung demand, bioAffinity continued to face liquidity pressures. Cash and cash equivalents fell to $3.1 million as of March 31, 2026, from $6.4 million as of Dec. 31, 2025. Net cash used in operating activities increased to $3.2 million from $1.6 million a year earlier. Management stated that existing cash resources are expected to support operations only through June 2026 and reiterated that substantial doubt exists regarding BIAF’s ability to continue as a going concern without additional financing. The company disclosed several financing and capital-related developments during and after the quarter. In May 2025, bioAffinity entered into an at-the-market equity sales agreement under which it had raised approximately $1.2 million in gross proceeds through March 31, 2026. The company also converted additional shares of its Series B convertible preferred stock into common shares in May 2026. Separately, bioAffinity signed a new lease agreement in April 2026 for additional research and development laboratory space extending through June 2031. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report bioAffinity Technologies, Inc. (BIAF): Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Investor releaseQuarter not tagged2026-05-08

bioAffinity Technologies Reports First Quarter 2026 Results and Expanding Adoption and Clinical Usage of CyPath® Lung

Business Wire
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…Read full document

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 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 when it is most treatable and conversely in which a negative CyPath® Lung result helped avoid unnecessary invasive procedures. We believe the growing number of case studies and our longitudinal clinical trial, supported by leading military and VA institutions, will lead to broader adoption of CyPath® Lung as part of the standard of care." Ms. Zannes concluded, "We are uniquely positioned to fulfill the need for an accurate, noninvasive diagnostic for lung cancer, particularly when imaging and risk models are inconclusive or turn out to be wrong. The remainder of 2026 will be focused on scaling commercial execution, expanding into new geographic markets, and driving increased utilization of CyPath® Lung through continued physician engagement while also leveraging our flow cytometry and AI platform to advance our pipeline of diagnostics for serious or life-threatening lung diseases." First Quarter 2026 Financial Results Revenue for the quarter ended March 31, 2026, was $1.4 million. Revenue was primarily generated from patient service fees, histology services, and medical director fees. Operating expenses for the first quarter of 2026 were $5.0 million, compared with $4.5 million in the first quarter of 2025. Direct costs and expenses for the first quarter of 2026 were $0.9 million, down 32% from $1.4 million in the prior-year period, primarily due to targeted strategic actions implemented in March 2025. Research and development expenses decreased 5% year-over-year to $350,000, reflecting lower employee compensation and lab supply costs. Clinical development expenses rose to $334,000, driven by higher professional fees supporting the Company’s longitudinal clinical trial strategy. Selling, general and administrative expenses were $3.2 million for the first quarter of 2026, up from $2.5 million in the same period last year. The increase was primarily driven by higher employee compensation related to administrative and sales functions, reflecting the addition of personnel and support services to scale the commercialization of CyPath® Lung. Net loss for the quarter ended March 31, 2026, was $3.6 million, or $(0.81) per share, compared with a net loss of $2.7 million, or $(4.80) per share, for the first quarter of 2025. Cash and cash equivalents as of March 31, 2026, were $3.1 million, compared with $6.4 million as of December 31, 2025. About CyPath® Lung CyPath® Lung by bioAffinity Technologies is a noninvasive test designed to improve the early detection of lung cancer in patients at high risk for the disease. CyPath® Lung uses advanced flow cytometry and proprietary artificial intelligence (AI) to identify cell populations in patient sputum that indicate malignancy. CyPath® Lung incorporates a fluorescent porphyrin that is preferentially taken up by cancer and cancer-related cells. In a clinical trial of high-risk patients, CyPath® Lung demonstrated 92% sensitivity, 87% specificity, 88% accuracy and 99% negative predictive value (NPV) in detecting lung cancer in patients at high risk for the disease who had small indeterminate lung nodules less than 20 millimeters. The high NPV gives physicians greater confidence that a negative result is truly negative, potentially sparing patients from unnecessary invasive and costly procedures. CyPath® Lung is marketed as a Laboratory Developed Test (LDT) and is not intended for use as a sole diagnostic tool and should be considered alongside other clinical findings. About bioAffinity Technologies, Inc. bioAffinity Technologies, Inc. addresses the need for noninvasive diagnosis of early-stage cancer and other diseases of the lung and broad-spectrum cancer treatments. The Company’s first product, CyPath® Lung, is a noninvasive test that has shown high sensitivity, specificity and accuracy for the detection of early-stage lung cancer. CyPath® Lung is marketed as a Laboratory Developed Test (LDT) by Precision Pathology Laboratory Services, a subsidiary of bioAffinity Technologies. LDTs are overseen under the Clinical Laboratory Improvement Amendments (CLIA), administered by the Centers for Medicare & Medicaid Services. For more information, visit www.bioaffinitytech.com. Forward-Looking Statements Certain statements in this press release constitute "forward-looking statements" within the meaning of the federal securities laws. Words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "predict," "forecast," "project," "plan," "intend" or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. These forward-looking statements are subject to various risks and uncertainties, many of which are difficult to predict, that could cause actual results to differ materially from current expectations and assumptions from those set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from current expectations include, among others, the Company's ability to obtain additional financing to fund operations, the Company's limited operating history and history of net losses, the Company's ability to achieve broader market acceptance of CyPath® Lung, the Company's dependence on key personnel, risks related to the regulatory environment for laboratory developed tests, the Company's ability to maintain and protect its intellectual property, and the other factors discussed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, and its subsequent filings with the SEC, including subsequent periodic reports on Forms 10-Q and 8-K. Such forward-looking statements are based on facts and conditions as they exist at the time such statements are made and predictions as to future facts and conditions. While the Company believes these forward-looking statements are reasonable, readers of this press release are cautioned not to place undue reliance on any forward-looking statements. The information in this release is provided only as of the date of this release, and the Company does not undertake any obligation to update any forward-looking statement relating to matters discussed in this press release, except as may be required by applicable securities laws. View source version on businesswire.com: https://www.businesswire.com/news/home/20260508460240/en/ Contacts bioAffinity Technologies Julie Anne Overton Director of Communications [email protected]

Investor releaseQuarter not tagged2026-03-17

New Case Study: bioAffinity Technologies’ CyPath® Lung Provides Actionable Results and Helps Patient Avoid Costly, Invasive Procedures

Business Wire
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…Read full document

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 early detection of lung cancer in patients at high risk for the disease. CyPath® Lung uses advanced flow cytometry and proprietary artificial intelligence (AI) to identify cell populations in patient sputum that may indicate malignancy. CyPath® Lung incorporates a fluorescent porphyrin that is preferentially taken up by cancer and cancer-related cells. In a clinical study, CyPath® Lung demonstrated 92% sensitivity, 87% specificity and 88% accuracy in detecting lung cancer in patients at high risk for the disease who had small indeterminate lung nodules less than 20 millimeters. About bioAffinity Technologies, Inc. bioAffinity Technologies, Inc. addresses the need for noninvasive diagnosis of early-stage cancer and other diseases of the lung and broad-spectrum cancer treatments. The Company’s first product, CyPath® Lung, is a noninvasive test that has shown high sensitivity, specificity and accuracy for the detection of early-stage lung cancer. CyPath® Lung is marketed as a Laboratory Developed Test (LDT) by Precision Pathology Laboratory Services, a subsidiary of bioAffinity Technologies. LDTs are overseen under the Clinical Laboratory Improvement Amendments (CLIA), administered by the Centers for Medicare & Medicaid Services. For more information, visit www.bioaffinitytech.com. Forward-Looking Statements Certain statements in this press release constitute "forward-looking statements" within the meaning of the federal securities laws. Words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "predict," "forecast," "project," "plan," "intend" or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. These forward-looking statements are subject to various risks and uncertainties, many of which are difficult to predict, that could cause actual results to differ materially from current expectations and assumptions from those set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from current expectations include, among others, the ability of CyPath® Lung to indicate the probability of lung cancer, CyPath® Lung providing confidence in a proposed course of action for high-risk patients, the ability of CyPath® Lung to determine if cancer is present or if the patient is cancer-free, the ability of CyPath® Lung to lower healthcare costs, and the other factors discussed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, and its subsequent filings with the SEC, including subsequent periodic reports on Forms 10-Q and 8-K. Such forward-looking statements are based on facts and conditions as they exist at the time such statements are made and predictions as to future facts and conditions. While the Company believes these forward-looking statements are reasonable, readers of this press release are cautioned not to place undue reliance on any forward-looking statements. The information in this release is provided only as of the date of this release, and the Company does not undertake any obligation to update any forward-looking statement relating to matters discussed in this press release, except as may be required by applicable securities laws. View source version on businesswire.com: https://www.businesswire.com/news/home/20260317808939/en/ Contacts bioAffinity Technologies Julie Anne Overton Director of Communications [email protected]

Investor releaseQuarter not tagged2025-11-20

BIAF Stock Dips After Q3 Earnings Reflect Lower Sales and Wider Loss

Zacks
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…Read full document

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-end 2024, supported by $10.4 million in gross proceeds from equity transactions completed during the quarter. bioAffinity Technologies, Inc. price-consensus-eps-surprise-chart | bioAffinity Technologies, Inc. Quote Management emphasized that third-quarter 2025 efforts centered on advancing CyPath Lung adoption while maintaining cost discipline. CEO Maria Zannes highlighted the value of recently published patient case studies, which showcased the test’s ability to detect malignancy at Stage 1A and in cases where other diagnostic tools were inconclusive or contraindicated. Additionally, marketing initiatives targeting the VA health system continued to yield traction, with further interest emerging in the company’s upcoming longitudinal trial. Leadership also underscored the importance of the newly awarded U.S. patent protecting CyPath Lung’s diagnostic algorithm, strengthening the test’s competitive moat. The quarter’s revenue decline reflects bioAffinity’s pivot away from low-margin pathology services in favor of its higher-value diagnostic platform. The transition has temporarily reduced overall revenue but improved mix quality, as CyPath Lung testing becomes a larger share of total sales. Accelerated spending tied to clinical development and research investments also contributed to the quarterly loss, though these expenditures support BIAF’s broader diagnostic pipeline — including emerging asthma and chronic obstructive pulmonary disease (COPD) companion diagnostics. Non-cash warrant valuation changes further widened the bottom-line loss, but do not reflect core business performance. Meanwhile, bioAffinity’s cost-reduction efforts materially lowered direct expenses, offsetting some of the pressures from increased R&D and clinical development activities. bioAffinity did not issue formal financial guidance, but management outlined strategic objectives for 2025. These include continued expansion of the sales team into national markets, broader engagement with major VA medical centers, increased multi-media marketing and the opening of clinical trial collection sites under a newly approved protocol. bioAffinity also plans ongoing publication of case studies demonstrating clinical impact. On the pipeline front, BIAF is advancing companion diagnostic candidates for asthma and COPD, an estimated $26 billion global market. During the quarter, bioAffinity strengthened its governance and strategic capabilities with the appointments of Roberto Rios, CPA, and John J. Oppenheimer, M.D., to its board of directors. It also regained full Nasdaq Capital Market compliance, subject to a one-year panel monitor. On the intellectual property front, BIAF added another U.S. patent that protects its proprietary algorithm used in CyPath Lung — marking its second consecutive quarter of patent portfolio expansion. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report bioAffinity Technologies, Inc. (BIAF): Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Investor releaseQuarter not tagged2025-11-14

bioAffinity Technologies Reports Third Quarter 2025 Financial Results

Business Wire
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…Read full document

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 bioAffinity Technologies. "The strong increase in CyPath® Lung testing revenue reflects growing confidence among physicians who are recognizing our test’s ability to detect early-stage lung cancer when it is most treatable. The continued publication of case studies in which patients have benefited from Stage 1A lung cancer detection and others have been spared unnecessary and costly biopsies is particularly impactful. "Our marketing program to the VA is showing results in terms of both sales and interest in participating in our upcoming longitudinal study. Our work with the VA is especially meaningful since we know veterans are at higher risk for lung cancer due to environmental and occupational exposures during their service. Now VA clinicians have access to a powerful tool to detect lung cancer early when treatment can save lives. "We raised approximately $10.4 million in gross proceeds from equity transactions in the third quarter to fund ongoing operations. We are also seeing the results of our targeted strategic actions announced in March to streamline laboratory operations and reduce costs by discontinuing certain unprofitable pathology services at our wholly owned laboratory. This has allowed us to focus additional resources on our flagship diagnostic, CyPath® Lung. "We expanded our intellectual property portfolio for the second quarter in a row with an important U.S. patent that protects our proprietary algorithm which results in CyPath® Lung’s superior test performance of 92% sensitivity and 87% specificity for patients with small pulmonary nodules. "And we were delighted to welcome two new members to our board. Mr. Rios’ business and financial expertise combined with Dr. Oppenheimer’s clinical and strategic leadership will be invaluable as we increase sales of CyPath® Lung, develop companion diagnostics for asthma and COPD, and continue to build shareholder value," Ms. Zannes said. Financial Results For the quarter ended September 30, 2025, bioAffinity reported total revenue of $1.5 million, compared to $2.4 million for the same period in 2024. The decrease was primarily attributable to the Company’s strategic decision to discontinue unprofitable pathology services and reallocate resources to the commercialization of CyPath® Lung. CyPath® Lung testing revenue for the quarter ended September 30, 2025, increased approximately 122% year over year, reflecting growth in physician adoption and an increase in total test results delivered. Operating expenses for the third quarter of 2025 were $3.7 million, down 16% from $4.3 million in the third quarter of 2024. The decrease was primarily due to lower direct costs related to laboratory operations, partially offset by increased research and development expenses and clinical development spending in advance of the Company’s longitudinal study. Direct costs and expenses were $0.9 million, a 38% decrease from the prior-year period, driven by cost-saving initiatives implemented in March 2025. Research and development expenses increased 20% year-over-year to $330,000, primarily due to expenditures for lab supplies, preclinical studies and compensation costs. Clinical development expenses increased to $143,000, up from $94,000 in Q3 2024, due to higher professional fees. Selling, general and administrative expenses decreased 7% to $2.2 million, primarily due to strategic actions to reduce costs and streamline operations at Precision Pathology Services Laboratory (PPLS). Depreciation and amortization expense declined 25% year-over-year to $113,000. Net loss for the three months ended September 30, 2025, was $5.1 million, or $4.74 per share, compared with a net loss of $2.0 million, or $4.84 per share, for the third quarter of 2024. The increase in net loss was primarily driven by expense recorded for the change in fair value of warrants issued by the company. Cash and cash equivalents as of September 30, 2025, were $7.7 million, compared with $1.1 million as of December 31, 2024. bioAffinity Technologies raised aggregate gross proceeds of $10.4 million from equity transactions in the third quarter. About CyPath® Lung CyPath® Lung uses proprietary advanced flow cytometry and artificial intelligence (AI) to identify cell populations in patient sputum that indicate malignancy. Automated data analysis helps determine if cancer is present or if the patient is cancer-free. CyPath® Lung incorporates a fluorescent porphyrin that is preferentially taken up by cancer and cancer-related cells. Clinical study results demonstrated that CyPath® Lung had 92% sensitivity, 87% specificity and 88% accuracy in detecting lung cancer in patients at high risk for the disease who had small lung nodules less than 20 millimeters. Diagnosing and treating early-stage lung cancer can improve outcomes and increase patient survival. For more information, visit www.cypathlung.com. About bioAffinity Technologies, Inc. bioAffinity Technologies, Inc. addresses the need for noninvasive diagnosis of early-stage cancer and other diseases of the lung and broad-spectrum cancer treatments. The Company’s first product, CyPath® Lung, is a noninvasive test that has shown high sensitivity, specificity and accuracy for the detection of early-stage lung cancer. CyPath® Lung is marketed as a Laboratory Developed Test (LDT) by Precision Pathology Laboratory Services, a subsidiary of bioAffinity Technologies. For more information, visit www.bioaffinitytech.com. Forward-Looking Statements Certain statements in this press release constitute "forward-looking statements" within the meaning of the federal securities laws. Words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "predict," "forecast," "project," "plan," "intend" or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. These forward-looking statements are subject to various risks and uncertainties, many of which are difficult to predict, that could cause actual results to differ materially from current expectations and assumptions from those set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from current expectations include, among others, clinical adoption of CyPath® Lung; strategic actions reducing costs while expanding sales focus on high-margin diagnostics like CyPath® Lung; international patents expanding CyPath® Lung’s global commercialization potential; the targeted actions accelerating the commercial growth of CyPath® Lung; patient case studies continuing to underscore the diagnostic power of CyPath® Lung in real-world settings; expanding access to CyPath® Lung for patients at risk of lung cancer; and advancing new diagnostics for diseases like COPD and asthma; and the other factors discussed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, and its subsequent filings with the SEC, including subsequent periodic reports on Forms 10-Q and 8-K. Such forward-looking statements are based on facts and conditions as they exist at the time such statements are made and predictions as to future facts and conditions. While the Company believes these forward-looking statements are reasonable, readers of this press release are cautioned not to place undue reliance on any forward-looking statements. The information in this release is provided only as of the date of this release, and the Company does not undertake any obligation to update any forward-looking statement relating to matters discussed in this press release, except as may be required by applicable securities laws. View source version on businesswire.com: https://www.businesswire.com/news/home/20251114274995/en/ Contacts bioAffinity Technologies Julie Anne Overton Director of Communications [email protected]

Investor releaseQuarter not tagged2025-10-07

bioAffinity Technologies Reports Record Growth in CyPath® Lung Test Volume for Third Quarter 2025

Business Wire
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…Read full document

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 that indicate malignancy. Automated data analysis helps determine if cancer is present or if the patient is cancer-free. CyPath® Lung incorporates a fluorescent porphyrin that is preferentially taken up by cancer and cancer-related cells. Clinical study results demonstrated that CyPath® Lung had 92% sensitivity, 87% specificity and 88% accuracy in detecting lung cancer in patients at high risk for the disease who had small lung nodules less than 20 millimeters. Diagnosing and treating early-stage lung cancer can improve outcomes and increase patient survival. For more information, visit www.cypathlung.com. About bioAffinity Technologies, Inc. bioAffinity Technologies, Inc. addresses the need for noninvasive diagnosis of early-stage cancer and other diseases of the lung and broad-spectrum cancer treatments. The Company’s first product, CyPath® Lung, is a noninvasive test that has shown high sensitivity, specificity and accuracy for the detection of early-stage lung cancer. CyPath® Lung is marketed as a Laboratory Developed Test (LDT) by Precision Pathology Laboratory Services, a subsidiary of bioAffinity Technologies. For more information, visit www.bioaffinitytech.com. Forward-Looking Statements Certain statements in this press release constitute "forward-looking statements" within the meaning of the federal securities laws. Words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "predict," "forecast," "project," "plan," "intend" or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. These forward-looking statements are subject to various risks and uncertainties, many of which are difficult to predict, that could cause actual results to differ materially from current expectations and assumptions from those set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from current expectations include, among others, the Company’s ability to continue sales growth in 2025 and beyond, and the other factors discussed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, and its subsequent filings with the SEC, including subsequent periodic reports on Forms 10-Q and 8-K. Such forward-looking statements are based on facts and conditions as they exist at the time such statements are made and predictions as to future facts and conditions. While the Company believes these forward-looking statements are reasonable, readers of this press release are cautioned not to place undue reliance on any forward-looking statements. The information in this release is provided only as of the date of this release, and the Company does not undertake any obligation to update any forward-looking statement relating to matters discussed in this press release, except as may be required by applicable securities laws. View source version on businesswire.com: https://www.businesswire.com/news/home/20251007557170/en/ Contacts bioAffinity Technologies Julie Anne Overton Director of Communications [email protected]

Investor releaseQuarter not tagged2025-08-22

BIAF Stock Down Following Q2 Earnings Despite CyPath Lung Growth

Zacks
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…Read full document

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. price-consensus-eps-surprise-chart | bioAffinity Technologies, Inc. Quote CEO Maria Zannes emphasized that second-quarter results reflect the acceleration of the CyPath Lung commercialization strategy. Zannes noted growing physician adoption supported by real-world case studies showing the test’s ability to detect early-stage lung cancers that other diagnostics missed. bioAffinity’s pilot marketing program in Texas—home to about 6% of U.S. pulmonologists—has been particularly successful, encouraging expansion into the Mid-Atlantic region and the Veterans Administration healthcare system. Zannes also pointed to steps taken to strengthen financial footing, including the price increase for CyPath Lung to $2,900, which aligns with private payer reimbursement, and the logistics partnership with Cardinal Health OptiFreight to improve national sample delivery reliability. She highlighted the addition of Dr. Gordon Downie as chief medical officer and the expansion of the intellectual property portfolio through new patents in the United States, China, Canada and Australia. The year-over-year revenue decline was largely due to the strategic exit from lower-margin pathology services to concentrate on high-margin diagnostics. At the same time, CyPath Lung gained traction with back-to-back record sales in June and July. Rising clinical development costs underscore management’s focus on long-term growth by advancing pivotal trials. However, the larger net loss reflects external financing costs, specifically warrant-related charges from the May public offering. While no formal numerical guidance was provided, management reaffirmed its focus on expanding access to CyPath Lung and driving operational efficiency. Zannes underscored the goal of broadening distribution into new regions and health systems, while also advancing the company’s next-generation diagnostic and therapeutic platforms, including siRNA-based therapies showcased at the 2025 RNA Therapeutics Conference. Beyond financial results, bioAffinity bolstered its leadership and strategic assets during the quarter. Dr. Downie’s appointment adds seasoned pulmonology expertise. The company also secured several new international patents, broadening global protection for its diagnostics and therapeutics. This includes a newly issued U.S. patent that covers a broad-spectrum cancer therapy targeting CD320 and LRP2 receptors. Additionally, Zannes was named to the American Lung Association in Texas Leadership Board, reinforcing bioAffinity’s advocacy role in lung health. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report bioAffinity Technologies, Inc. (BIAF): Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Investor releaseQuarter not tagged2025-08-14

bioAffinity Technologies Reports Second Quarter 2025 Results

Business Wire
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…Read full document

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® Lung commercialization strategy, with testing revenue up 62% for the first half of the year," Maria Zannes, President and Chief Executive Officer of bioAffinity Technologies said. "This growth is driven by increasing clinical adoption of our noninvasive lung cancer diagnostic and supported by physician-authored case studies showing that CyPath® Lung has identified early-stage cancers that other tests missed. These real-world results are validating our test’s unique value in guiding clinical decisions and improving patient outcomes. "The success of our pilot marketing program in Texas, which has approximately 6% of the total number of U.S. pulmonologists, has demonstrated that our approach to the medical community is sound and effective. We are prepared to meet increased demand as we implement our strategy to enter additional key markets, including our expansion in the Mid-Atlantic region and the Veterans Administration healthcare system. "During the quarter, we took important steps to strengthen our financial foundation, including a successful $3.25 million public offering and a strategic price adjustment for CyPath® Lung to better reflect its value and align with reimbursement from private payers. At the same time, our partnership with Cardinal Health OptiFreight® Logistics has enhanced our national sample delivery capabilities to meet growing demand. "We are also proud to have expanded our leadership team with the appointment of Dr. Gordon Downie as Chief Medical Officer. His expertise in pulmonary medicine and lung cancer screening is already shaping our clinical direction, including advancement toward pivotal trials. "Our intellectual property portfolio continues to grow with newly granted patents in the U.S., China, Canada, and Australia—strengthening both our diagnostic and therapeutic platforms on a global scale. We also presented breakthrough research at the 2025 RNA Therapeutics Conference, showcasing our siRNA-based approach to selectively kill cancer cells while sparing healthy tissue, a strategy with broad potential across multiple tumor types. "Looking ahead, we remain focused on expanding access to CyPath® Lung, delivering operational efficiency, and advancing the next generation of diagnostics and therapeutics," Zannes added. "Every test we deliver is a step toward earlier cancer detection, better patient care, and stronger value for our shareholders." Second Quarter 2025 Financial Results Revenue for the quarter ended June 30, 2025, was $1.3 million, compared with $2.4 million for the second quarter of 2024. The decrease was primarily attributable to the Company’s strategic decision to discontinue unprofitable pathology services and reallocate resources toward the commercialization of CyPath® Lung. CyPath® Lung testing revenue for the six months ended June 30, 2025, increased approximately 62% year-over-year to $323,000, reflecting growth in physician adoption and an increase in total test results delivered. Operating expenses for the second quarter of 2025 were $3.8 million, down 16% from $4.5 million in the second quarter of 2024. The decrease was primarily due to lower direct costs related to laboratory operations and reduced research and development expenses, partially offset by increased clinical development spending in support of the Company’s pivotal trial strategy. Direct costs and expenses were $1.0 million, a 28% decrease from the prior-year period, driven by cost-saving initiatives implemented in March 2025. Research and development expenses decreased 23% year-over-year to $311,000, reflecting lower compensation and lab supply costs. Clinical development expenses increased to $129,000, up from $51,000 in Q2 2024, due to higher professional fees. Selling, general and administrative expenses decreased 10% to $2.2 million, largely reflecting efficiencies following the integration of PPLS and adjustments to staffing and support functions. Depreciation and amortization expense declined 25% year-over-year to $113,000. Net loss for the quarter ended June 30, 2025, was $4.1 million, or $0.17 per share, compared with a net loss of $2.1 million, or $0.19 per share, for the second quarter of 2024. The increase in net loss was primarily driven by a $1.5 million increase in non-cash expenses related to warrant remeasurement and offering costs associated with the Company’s May 2025 public offering. Cash and cash equivalents as of June 30, 2025, were $0.8 million, compared with $1.1 million as of December 31, 2024. bioAffinity Technologies raised aggregate gross proceeds of $3.25 million through a public offering in May 2025. About bioAffinity Technologies, Inc. bioAffinity Technologies, Inc. addresses the need for noninvasive diagnosis of early-stage cancer and diseases of the lung and broad-spectrum cancer treatments. The Company’s first product, CyPath® Lung, is a noninvasive test that has shown high sensitivity, specificity and accuracy for the detection of early-stage lung cancer. CyPath® Lung is marketed as a Laboratory Developed Test (LDT) by Precision Pathology Laboratory Services, a subsidiary of bioAffinity Technologies. For more information, visit www.bioaffinitytech.com. Forward-Looking Statements Certain statements in this press release constitute "forward-looking statements" within the meaning of the federal securities laws. Words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "predict," "forecast," "project," "plan," "intend" or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. These forward-looking statements are based upon current estimates and assumptions and include statements regarding strategic actions reducing costs while expanding sales focus on high-margin diagnostics like CyPath® Lung; international patents expanding CyPath® Lung’s global commercialization potential; the targeted actions accelerating the commercial growth of CyPath® Lung; patient case studies continuing to underscore the diagnostic power of CyPath® Lung in real-world settings; expanding access to CyPath® Lung for patients at risk of lung cancer; and advancing new diagnostics for diseases like COPD and asthma. These forward-looking statements are subject to various risks and uncertainties, many of which are difficult to predict that could cause actual results to differ materially from current expectations and assumptions from those set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from current expectations include, among others, strategic actions reducing costs while expanding sales focus on high-margin diagnostics like CyPath® Lung; international patents expanding CyPath® Lung’s global commercialization potential; the targeted actions accelerating the commercial growth of CyPath® Lung; patient case studies continuing to underscore the diagnostic power of CyPath® Lung in real-world settings; expanding access to CyPath® Lung for patients at risk of lung cancer; advancing new diagnostics for diseases like COPD and asthma; and the other factors discussed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, and its subsequent filings with the SEC, including subsequent periodic reports on Forms 10-Q and 8-K. Such forward-looking statements are based on facts and conditions as they exist at the time such statements are made and predictions as to future facts and conditions. While the Company believes these forward-looking statements are reasonable, readers of this press release are cautioned not to place undue reliance on any forward-looking statements. The information in this release is provided only as of the date of this release, and the Company does not undertake any obligation to update any forward-looking statement relating to matters discussed in this press release, except as may be required by applicable securities laws. View source version on businesswire.com: https://www.businesswire.com/news/home/20250814042365/en/ Contacts bioAffinity Technologies Julie Anne Overton Director of Communications [email protected] Investor Relations Dave Gentry RedChip Companies Inc. 1-800-RED-CHIP (733-2447) Or 407-491-4498 [email protected]

Investor releaseQuarter not tagged2025-07-29

Case Study: CyPath® Lung Detects Stage 1A Lung Cancer in High-Risk Patient With Inconclusive Imaging and Low-Risk Serum Test Results

Business Wire
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…Read full document

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 Stage 1A invasive mucinous adenocarcinoma, a lung cancer subtype that is frequently missed by standard imaging and often presents with subtle radiographic changes. The patient successfully quit smoking in March 2025. About CyPath® Lung CyPath® Lung uses proprietary advanced flow cytometry and artificial intelligence (AI) to identify cell populations in patient sputum that indicate malignancy. Automated data analysis helps determine if cancer is present or if the patient is cancer-free. CyPath® Lung incorporates a fluorescent porphyrin that is preferentially taken up by cancer and cancer-related cells. Clinical study results demonstrated that CyPath® Lung had 92% sensitivity, 87% specificity and 88% accuracy in detecting lung cancer in patients at high risk for the disease who had small lung nodules less than 20 millimeters. Diagnosing and treating early-stage lung cancer can improve outcomes and increase patient survival. For more information, visit www.cypathlung.com. About bioAffinity Technologies, Inc. bioAffinity Technologies, Inc. addresses the need for noninvasive diagnosis of early-stage cancer and other diseases of the lung and broad-spectrum cancer treatments. The Company’s first product, CyPath® Lung, is a noninvasive test that has shown high sensitivity, specificity and accuracy for the detection of early-stage lung cancer. CyPath® Lung is marketed as a Laboratory Developed Test (LDT) by Precision Pathology Laboratory Services, a subsidiary of bioAffinity Technologies. For more information, visit www.bioaffinitytech.com. Forward-Looking Statements Certain statements in this press release constitute "forward-looking statements" within the meaning of the federal securities laws. Words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "predict," "forecast," "project," "plan," "intend" or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. These forward-looking statements are based upon current estimates and assumptions and include statements regarding the ability of CyPath® Lung to indicate a high probability of lung cancer, the benefits of adding CyPath® Lung to the standard of care for evaluating indeterminate lung nodules, and CyPath® Lung providing clarity when imaging and risk models are inconclusive and when other adjuvant diagnostics are contraindicated. These forward-looking statements are subject to various risks and uncertainties, many of which are difficult to predict, that could cause actual results to differ materially from current expectations and assumptions from those set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from current expectations include, among others, the ability of CyPath® Lung to indicate a high probability of lung cancer, the benefits of adding CyPath® Lung to the standard of care for evaluating indeterminate lung nodules, and CyPath® Lung providing clarity when imaging and risk models are inconclusive and when other adjuvant diagnostics are contraindicated, and the other factors discussed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, and its subsequent filings with the SEC, including subsequent periodic reports on Forms 10-Q and 8-K. Such forward-looking statements are based on facts and conditions as they exist at the time such statements are made and predictions as to future facts and conditions. While the Company believes these forward-looking statements are reasonable, readers of this press release are cautioned not to place undue reliance on any forward-looking statements. The information in this release is provided only as of the date of this release, and the Company does not undertake any obligation to update any forward-looking statement relating to matters discussed in this press release, except as may be required by applicable securities laws. View source version on businesswire.com: https://www.businesswire.com/news/home/20250729544866/en/ Contacts bioAffinity Technologies Julie Anne Overton Director of Communications [email protected] Investor Relations Dave Gentry RedChip Companies Inc. 1-800-RED-CHIP (733-2447) or 407-491-4498 [email protected]

Investor releaseQuarter not tagged2025-05-15

bioAffinity Technologies Reports First Quarter 2025 Results

Business Wire
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…Read full document

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 resource allocation in support of our commercialization goals. "In parallel, patient case studies continue to underscore the diagnostic power of CyPath® Lung in real-world settings — from avoiding unnecessary invasive procedures to identifying secondary or recurrent cancers. As we move forward, we’re encouraged by the clinical and economic validation that supports our growth, including recent operational enhancements that have increased our test throughput by 50% and lowered per-test cost by over 25%. "We remain committed to expanding access to CyPath® Lung for patients at risk of lung cancer and advancing new diagnostics for diseases like COPD and asthma," Zannes added. "With every test delivered, we’re improving outcomes for patients and delivering value to our shareholders." First Quarter 2025 Financial Results Revenue for the quarter ended March 31, 2025, was $1.9 million. Revenue was primarily generated from patient service fees, histology services, and medical director fees. Operating expenses for the first quarter of 2025 were $4.5 million, compared with $4.4 million in the first quarter of 2024. Direct costs and expenses for the first quarter of 2025 were $1.4 million, down 13% from $1.6 million in the prior-year period, primarily due to targeted strategic actions implemented in March 2025. Research and development expenses decreased 7% year-over-year to $367,000, reflecting lower employee compensation and lab supply costs. Clinical development expenses rose to $138,000, driven by higher professional fees supporting the Company’s pivotal clinical trial strategy. Selling, general and administrative expenses were $2.5 million for the first quarter of 2025, up from $2.2 million in the same period last year. The increase was primarily driven by higher employee compensation related to administrative and sales functions, reflecting the addition of personnel and support services to scale the commercialization of CyPath® Lung. Net loss for the quarter ended March 31, 2025, was $2.7 million, or $0.16 per share, compared with a net loss of $2.0 million, or $0.20 per share, for the first quarter of 2024. Cash and cash equivalents as of March 31, 2025, were $0.4 million, compared with $1.1 million as of December 31, 2024. Subsequent to the end of 2024, bioAffinity Technologies raised gross proceeds of $1.4 million through the inducement of warrant exercises in February 2025 and $3.3 million in a public offering in May 2025. About bioAffinity Technologies, Inc. bioAffinity Technologies, Inc. addresses the need for noninvasive diagnosis of early-stage cancer and diseases of the lung and broad-spectrum cancer treatments. The Company’s first product, CyPath® Lung, is a noninvasive test that has shown high sensitivity, specificity and accuracy for the detection of early-stage lung cancer. CyPath® Lung is marketed as a Laboratory Developed Test (LDT) by Precision Pathology Laboratory Services, a subsidiary of bioAffinity Technologies. For more information, visit www.bioaffinitytech.com. Forward-Looking Statements Certain statements in this press release constitute "forward-looking statements" within the meaning of the federal securities laws. Words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "predict," "forecast," "project," "plan," "intend" or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. These forward-looking statements are based upon current estimates and assumptions and include statements regarding announced strategic actions reducing annual costs by approximately $3.8 million while expanding sales focus on high-margin diagnostics like CyPath® Lung; international patents expanding CyPath® Lung’s global commercialization potential; the targeted actions accelerating the commercial growth of CyPath® Lung; patient case studies continuing to underscore the diagnostic power of CyPath® Lung in real-world settings; and expanding access to CyPath® Lung for patients at risk of lung cancer and advancing new diagnostics for diseases like COPD and asthma. These forward-looking statements are subject to various risks and uncertainties, many of which are difficult to predict that could cause actual results to differ materially from current expectations and assumptions from those set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from current expectations include, among others, the Company’s ability to reduce costs while expanding sales of high-margin diagnostics; the Company’s ability to accelerate the commercial growth of CyPath® Lung; the Company’s ability to advance new diagnostics for diseases like COPD and asthma; and the other factors discussed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, and its subsequent filings with the SEC, including subsequent periodic reports on Forms 10-Q and 8-K. Such forward-looking statements are based on facts and conditions as they exist at the time such statements are made and predictions as to future facts and conditions. While the Company believes these forward-looking statements are reasonable, readers of this press release are cautioned not to place undue reliance on any forward-looking statements. The information in this release is provided only as of the date of this release, and the Company does not undertake any obligation to update any forward-looking statement relating to matters discussed in this press release, except as may be required by applicable securities laws.   View source version on businesswire.com: https://www.businesswire.com/news/home/20250515648695/en/ Contacts bioAffinity Technologies Julie Anne OvertonDirector of [email protected] Investor Relations Dave GentryRedChip Companies Inc.1-800-RED-CHIP (733-2447)Or [email protected]

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