bioAffinity Technologies, Inc. 8-K Filings

bioAffinity Technologies, Inc. (BIAF) reports that it has regained compliance with Nasdaq’s listing requirements, including the Minimum Bid Price Rule and the Rights/Warrants Rule, so its common stock and warrants will continue to be listed and traded on the Nasdaq Capital Market.

Nasdaq confirmed compliance in a letter dated September 8, 2026, cancelling a previously scheduled hearing before a Nasdaq Hearings Panel. As of September 8, 2026, the company had 1,166,625 common shares outstanding with an aggregate market value of approximately $10.4 million based on that day’s closing price.

The company also highlights performance of its CyPath® Lung test, which in a published clinical trial of high-risk patients showed 92% sensitivity, 87% specificity, 88% accuracy and 99% negative predictive value for detecting lung cancer in patients with small indeterminate lung nodules less than 20 millimeters.

bioAffinity Technologies, Inc. (BIAF) reported that President and CEO Maria Zannes will present a corporate update and hold one-on-one investor meetings at the H.C. Wainwright 28th Annual Global Investment Conference, being held September 14-16, 2026, and issued a related press release.

The company highlighted recent and upcoming strategic milestones, commercial adoption and momentum for its CyPath® Lung diagnostic test, and development of additional diagnostic and therapeutic applications based on its proprietary technology platform. As of September 2, 2026, there were 600,736 outstanding common shares, with an aggregate market value of approximately $5.9 million based on the Nasdaq Capital Market closing price.

bioAffinity Technologies, Inc. (BIAF) reported that it is advancing the potential use of its noninvasive CyPath® Lung test for surveillance of lung cancer patients after curative-intent treatment. The company highlights a large survivorship population and positions CyPath Lung as a complement to CT imaging in monitoring pulmonary nodules for recurrence or new cancers.

CyPath Lung is a Laboratory Developed Test that analyzes sputum using flow cytometry, artificial intelligence and a fluorescent porphyrin to identify malignant and cancer-related cells. In a published trial in high-risk patients with small indeterminate nodules, CyPath Lung showed 92% sensitivity, 87% specificity, 88% accuracy and 99% negative predictive value for early lung cancer detection, though these performance data have not been separately validated for post-treatment surveillance.

bioAffinity Technologies, Inc. (BIAF) approved and is implementing a 1-for-15 reverse stock split of its common stock. A certificate of amendment was filed in Delaware on August 20, 2026, and the split becomes effective at 4:01 p.m. Eastern Time on August 21, 2026, with trading on a split-adjusted basis on the Nasdaq Capital Market beginning August 24, 2026.

Every 15 issued and outstanding common shares will be combined into one share, with no change to authorized shares or par value. The split is primarily intended to help meet Nasdaq’s minimum bid price requirement. Immediately after effectiveness, approximately 592,373 shares of common stock will be outstanding. Fractional shares will be settled in cash, and equity awards and warrants will be proportionately adjusted. BIAF will keep its ticker, and the common stock will have a new CUSIP 09076W406.

bioAffinity Technologies, Inc. reported that it entered into a distribution agreement with AvMEDICAL, a Service-Disabled Veteran-Owned Small Business that supplies medical and laboratory products to U.S. government agencies. AvMEDICAL’s national sales force will promote bioAffinity’s CyPath® Lung test to federal healthcare customers, including U.S. Department of Veterans Affairs medical centers, using its established procurement channels and indefinite-delivery, indefinite-quantity contracts. The agreement is intended to expand commercial access to CyPath Lung within government healthcare systems and provide an additional pathway for veterans to obtain the test.

CyPath Lung is a noninvasive, laboratory-developed test performed by Precision Pathology Laboratory Services, a wholly owned subsidiary of bioAffinity Technologies. In a published clinical trial of high-risk patients with small indeterminate lung nodules under 20 millimeters, CyPath Lung showed 92% sensitivity, 87% specificity, 88% accuracy, and 99% negative predictive value for detecting lung cancer, and is intended for use alongside imaging and other clinical information.

bioAffinity Technologies, Inc. entered into a private placement with an institutional investor involving pre-funded warrants and Series A and B warrants tied to up to 8,462,027 shares each of common stock. Each warrant carries an initial exercise price of $0.4727 per share, while the pre-funded warrants are purchased at $0.4657 and exercisable at $0.007 per share.

The private placement is expected to generate approximately $3.6 million in net proceeds, following estimated fees and expenses, from about $4.0 million in gross proceeds. Warrants are exercisable only after stockholder approval and generally expire five years from issuance, subject to beneficial ownership caps of 4.99% or 9.99% depending on elections. WallachBeth Capital LLC acted as exclusive placement agent and received cash fees and 253,861 placement agent warrants. The company plans to use the proceeds for working capital and general corporate purposes and has agreed to register the resale of underlying shares under a registration rights agreement.

bioAffinity Technologies, Inc. reported net revenue of $1,510,579 for the quarter ended June 30, 2026, up 19% from $1,269,483 a year earlier, primarily from higher sales of its CyPath Lung diagnostic test. Net loss was $3,366,082 versus $4,060,787 in the prior-year quarter.

CyPath Lung test volume rose 216% year over year in Q2, and related testing revenue for the first six months of 2026 grew 159% to approximately $835,000, with 1,097 test reports delivered versus 390 a year earlier. Operating expenses increased to $4,845,443, reflecting higher clinical development and commercialization costs. Cash and cash equivalents were $2,429,719 as of June 30, 2026, after a June public offering that generated about $3.2 million in gross proceeds. The company advanced a longitudinal clinical trial for CyPath Lung and expanded its pipeline in asthma, COPD, and skin cancer therapeutics.

bioAffinity Technologies, Inc. reports it received a Nasdaq Listing Qualifications Staff Determination on July 30, 2026 stating that the bid price of its common stock closed below $1.00 per share for 30 consecutive business days from June 16 through July 29, 2026, violating the Nasdaq Capital Market Minimum Bid Price Requirement under Nasdaq Listing Rule 5550(a)(2).

Because the company effected a 1-for-30 reverse stock split on September 19, 2025, it is not eligible for the usual 180-calendar-day compliance period under Nasdaq Listing Rule 5810(c)(3)(A). bioAffinity intends to submit an appeal to Nasdaq on August 6, 2026, which will stay delisting and suspension pending a Nasdaq Hearings Panel decision, but there is no assurance that any extension will be granted or that continued listing can be maintained.

On July 27, 2026, bioAffinity Technologies, Inc. announced publication of a comprehensive clinical review and white paper by its Chief Medical Officer that presents a practical framework for integrating the CyPath® Lung noninvasive test into pulmonary nodule evaluation and lung cancer surveillance across pulmonology, primary care and oncology settings.

The company notes that in a published clinical trial of high-risk patients CyPath® Lung achieved 92% sensitivity, 87% specificity, 88% accuracy and 99% negative predictive value, and reports 7,783,061 common shares outstanding with an aggregate market value of approximately $5.1 million as of July 24, 2026.

bioAffinity Technologies, Inc. announced a collaboration with Pictor, Inc. to develop and commercialize next-generation diagnostic tests that profile lung inflammation in asthma and COPD by combining bioAffinity’s sputum-based flow cytometry with Pictor’s targeted proteomic platform to analyze immune cell populations and cytokine patterns.

The partners plan to initially offer these diagnostics as Laboratory Developed Tests under CLIA, with bioAffinity owning intellectual property for tests arising from the collaboration and Pictor retaining and expanding IP around its proteomic platform. Asthma and COPD affect more than 40 million Americans and 650 million people worldwide, and the global therapeutics market was valued at approximately $92 billion in 2024 and is projected to exceed $108 billion in 2026 and $155 billion by 2030, illustrating a large potential addressable market. The company notes forward-looking risks related to product development, regulatory changes for LDTs, intellectual property protection, financing needs and realization of anticipated collaboration benefits.

bioAffinity Technologies, Inc. reported strong commercial momentum for its CyPath® Lung noninvasive lung cancer test, with second-quarter 2026 sales volume growing more than 200% year-over-year. The number of tests sold in Q2 2026 also rose more than 30% compared with the first quarter of 2026.

Growth is being driven by higher utilization among existing clients and a 155% increase in physician offices ordering CyPath® Lung versus Q2 2025. Since commercial launch, the company has performed nearly 3,000 CyPath® Lung tests, reflecting broader adoption across pulmonology practices, lung nodule clinics, academic and community centers, and VA facilities.

The company highlights published clinical data where CyPath® Lung showed 92% sensitivity, 87% specificity, 88% accuracy and 99% negative predictive value in high-risk patients with small indeterminate lung nodules. bioAffinity is also advancing additional initiatives, including a large-scale longitudinal study, use of CyPath® Lung to monitor lung cancer survivors, and development of new tests for asthma and COPD.

bioAffinity Technologies, Inc. filed an 8-K to share a company newsletter outlining commercial and R&D progress. The newsletter highlights that CyPath^® Lung unit sales in April 2026 increased nearly 300% compared to April 2025, while the number of physician offices and clinics ordering the test rose 69% from first quarter 2025 to the same period in 2026.

The company is partnering with Philips and 4DMedical to enhance lung cancer screening for U.S. veterans using mobile CT scanning, CyPath Lung testing and advanced imaging, with a webinar hosted by NAVREF on July 21, 2026. It also discusses a pilot study with Brooke Army Medical Center for asthma and COPD companion diagnostics and preclinical research on proprietary siRNAs as potential topical treatments for common skin cancers.

bioAffinity Technologies, Inc. completed a best efforts public offering of 4,000,000 securities, consisting of 1,040,000 shares of common stock and pre-funded warrants to purchase up to 2,960,000 shares, at $0.80 per share or $0.793 per pre-funded warrant, generating gross proceeds of about $3.2 million before fees.

Each pre-funded warrant is immediately exercisable for one share at an exercise price of $0.007 and remains exercisable until used, subject to a 4.99% (or 9.99% at the holder’s election) beneficial ownership cap. The company agreed to 30-day restrictions on additional equity issuances and at-the-market offerings, broader limits on variable rate transactions for three months, and 30-day lock-ups for executives and directors. After the offering, 6,283,061 shares of common stock are outstanding, and proceeds are earmarked for working capital and general corporate purposes.

bioAffinity Technologies filed an update describing an educational webinar on July 21, 2026, focused on lung health screening and early detection for U.S. veterans at increased risk for lung cancer and other respiratory diseases. The session will cover imaging, noninvasive diagnostics and access to screening and follow-up care.

The webinar is hosted by NAVREF and will feature experts from Philips, bioAffinity Technologies and 4DMedical. Speakers will discuss mobile CT screening, CyPath® Lung testing and advanced functional lung imaging as approaches that may help support earlier detection and clinical decision-making in veteran populations.

The filing also highlights CyPath® Lung, a noninvasive sputum-based test for high-risk patients, which in a published clinical trial showed 92% sensitivity, 87% specificity, 88% accuracy and a 99% negative predictive value for detecting lung cancer in patients with small indeterminate nodules.

bioAffinity Technologies, Inc. filed an 8-K to share a press release about an educational webinar hosted by the Society for Advanced Bronchoscopy on CyPath® Lung’s role in detecting and managing early-stage lung cancer. The live event, titled “Navigating Lower Cancer-Risk Nodules in High-Risk Patients with Noninvasive CyPath® Lung Testing,” is scheduled for Tuesday, June 16, at 7 p.m. ET.

The press release explains that CyPath® Lung is a noninvasive sputum test using advanced flow cytometry, a fluorescent porphyrin, and proprietary artificial intelligence to analyze the lung microenvironment. In a published clinical trial of high-risk patients with small indeterminate lung nodules less than 20 millimeters, CyPath® Lung showed 92% sensitivity, 87% specificity, 88% accuracy and 99% negative predictive value in detecting lung cancer. The company notes that the test is marketed as a Laboratory Developed Test under CLIA oversight and is intended to be used alongside other clinical findings rather than as a standalone diagnostic.

bioAffinity Technologies, Inc. reported that it received a notification of allowance from the Mexican Institute of Industrial Property for a patent covering methods of predicting the likelihood of lung cancer using flow cytometry. The patent will protect use of specific antibodies, the porphyrin TCPP, and flow cytometry to detect cancer cells in sputum for the company’s CyPath® Lung test.

CyPath® Lung is a noninvasive, at-home sputum-based test for high-risk patients that uses advanced flow cytometry and artificial intelligence. In a published clinical trial of high-risk patients with small indeterminate lung nodules, CyPath® Lung showed 92% sensitivity, 87% specificity, 88% accuracy and 99% negative predictive value in detecting lung cancer.

bioAffinity Technologies reported that unit sales of its CyPath® Lung diagnostic test reached a record monthly level in April 2026 and increased nearly 300% compared with April 2025, based on preliminary unaudited data. Management said this growth exceeds internal projections and reflects accelerating physician adoption and broader clinical use for lung cancer risk assessment and pulmonary nodule management.

CyPath® Lung is a noninvasive sputum-based test that uses flow cytometry and artificial intelligence to detect malignancy in high‑risk patients. In a clinical trial of patients with small indeterminate lung nodules less than 20 millimeters, the test demonstrated 92% sensitivity, 87% specificity, 88% accuracy and a 99% negative predictive value, which can help avoid unnecessary invasive procedures when results are negative.

bioAffinity Technologies reported first quarter 2026 results, with revenue of $1.4 million and a net loss of $3.6 million, or $(0.81) per share. Revenue declined mainly because the company discontinued certain unprofitable pathology services in March 2025 to focus on higher-margin offerings.

Within that strategy, CyPath® Lung performance was strong. CyPath Lung testing revenue rose about 114% to $361,000 and unit sales increased 146% year-over-year, supported by a 69% increase in ordering physician offices and clinics. Direct costs fell 32% to $0.9 million as earlier cost actions took hold.

Operating expenses grew to $5.0 million from $4.5 million, driven by higher selling, general and administrative spending to scale commercialization, while clinical development costs increased to support a large longitudinal trial funded in part by the U.S. Department of Defense. Cash and cash equivalents were $3.1 million as of March 31, 2026, down from $6.4 million at year-end 2025.

bioAffinity Technologies, Inc. reported results of its 2026 Annual Meeting, where stockholders approved several equity and capital structure proposals. They expanded the 2024 Equity Incentive Compensation Plan to reserve 1,000,000 shares, up from 66,666, increasing capacity for stock-based awards. Holders also approved issuances tied to August 2025 warrants and Series B preferred stock, including anti-dilution adjustments that could add hundreds of thousands of shares upon exercise or conversion. Stockholders authorized potential non-public offerings that may trigger a change of control under Nasdaq rules and approved a discretionary 1‑for‑2 to 1‑for‑250 reverse stock split, which the board may implement or abandon. All six director nominees were elected and the independent auditor was ratified.

bioAffinity Technologies, Inc. filed an update describing a new clinical case study using its CyPath® Lung diagnostic test for a high-risk patient with a suspicious 30-millimeter pulmonary nodule. Standard imaging and risk models suggested a high likelihood of lung cancer, but the treating pulmonologist suspected inflammation.

CyPath® Lung, a noninvasive sputum-based test, returned a negative result labeled “Unlikely Malignancy,” prompting additional imaging before proceeding to biopsy. A follow-up CT scan showed the nodule had completely resolved, sparing the 70-year-old patient, who had a 50 pack-year smoking history and emphysema, from a risky and potentially unnecessary invasive procedure.

The case illustrates how CyPath® Lung can support pulmonary nodule management in complex patients. The company notes that this is a single-patient experience and emphasizes prior clinical trial results in high-risk patients with small indeterminate nodules, where CyPath® Lung demonstrated 92% sensitivity, 87% specificity and 88% accuracy for detecting lung cancer.

bioAffinity Technologies, Inc. announced that its noninvasive CyPath® Lung diagnostic test will be featured at the invitation-only “Advances in Early Lung Cancer Detection” symposium at the Cleveland Clinic in Ohio on April 16, 2026. Chief Medical Officer Gordon Downie, MD, PhD, will join a panel on lung nodule management, discussing how the test supports early detection in high-risk patients.

CyPath® Lung is a sputum-based assay that uses flow cytometry and artificial intelligence to analyze the lung microenvironment and identify cancer and cancer-related cells. In patients at high risk with small indeterminate nodules under 20 millimeters, it demonstrated 92% sensitivity, 87% specificity and 88% accuracy, supporting its role as an adjunct to current diagnostic pathways. The test is marketed as a Laboratory Developed Test under CLIA through Precision Pathology Laboratory Services, a bioAffinity subsidiary.

bioAffinity Technologies, Inc. reported that unit sales of its CyPath® Lung diagnostic test in the first quarter of 2026 exceeded internal projections and, based on preliminary unaudited data, grew 146% year over year versus the first quarter of 2025. Management links this surge to accelerating physician adoption and broader clinical use of the noninvasive lung cancer diagnostic.

The company highlights a current and expanding U.S. addressable market of $3.58 billion for pulmonary nodule management and surveillance of lung cancer survivors, and notes prior audited results showing CyPath® Lung revenue rising 87% and test units sold increasing 99% in 2025. CyPath® Lung, a flow cytometry plus AI-based sputum test, previously demonstrated 92% sensitivity, 87% specificity, and 88% accuracy in detecting lung cancer in high‑risk patients.

bioAffinity Technologies, Inc. furnished an 8-K to share updated investor presentation materials about its operations and performance. Management plans to use these March 2026 presentation materials in future discussions, and they were posted on the company’s website on March 26, 2026.

The presentation is included as Exhibit 99.1 and is provided under Regulation FD, meaning it is furnished rather than filed and is not subject to certain Exchange Act liabilities or automatically incorporated into other securities law filings.

bioAffinity Technologies filed an 8-K to highlight a live virtual physician roundtable on integrating its CyPath® Lung diagnostic test into pulmonary practice. The first “CyPath® Lung in Practice” webinar will be held on April 8, 2026, with pulmonologists presenting real-world cases where the test guided lung cancer risk assessment, nodule management, and post-treatment surveillance.

CyPath® Lung is a noninvasive sputum-based test that uses flow cytometry, AI, and a fluorescent porphyrin to identify cell populations associated with lung cancer in high-risk patients. Clinical study results showed 92% sensitivity, 87% specificity, and 88% accuracy in detecting lung cancer in patients with small indeterminate nodules less than 20 millimeters.

bioAffinity Technologies, Inc. reported a new clinical case study evaluating its noninvasive CyPath® Lung test in a high-risk patient with multiple lung nodules. The company furnished a press release describing how the test result helped guide care and potentially avoid an invasive lung procedure.

The 71‑year‑old former smoker had several pulmonary nodules, including a 7 millimeter nodule that might normally trigger bronchoscopy or biopsy. A CyPath® Lung result indicating unlikely malignancy supported the pulmonologist’s decision to monitor with a follow‑up CT scan instead of immediately ordering an invasive procedure.

The follow‑up scan showed suspicious nodules had resolved, suggesting benign inflammation, while one small nodule remained stable. The press release notes prior clinical study performance for CyPath® Lung, with 92% sensitivity, 87% specificity and 88% accuracy for detecting lung cancer in high‑risk patients with small nodules under 20 millimeters.

bioAffinity Technologies reported 2025 results showing rapid growth in its CyPath® Lung lung cancer test but a wider overall loss. Revenue from CyPath® Lung testing rose 87% year over year, with the number of tests up 99% and ordering physician sites up 67%, reflecting stronger clinical adoption.

Total 2025 revenue was $6.2 million, down from $9.4 million in 2024 after discontinuing unprofitable pathology services. Operating expenses fell 9% to $16.7 million, but the net loss widened to $14.9 million from $9.0 million, mainly due to a non-cash change in warrant fair value and higher commercial and clinical spending.

Cash and cash equivalents increased to $6.5 million as of December 31, 2025, from $1.1 million a year earlier, supported by $16.9 million raised in 2025 financings. The company forecasts CyPath® Lung unit sales growth of more than 100% in 2026 and is running a longitudinal trial targeting up to 2,000 high-risk patients to further validate the test.

bioAffinity Technologies has begun a large, 2,000-patient longitudinal clinical study of CyPath® Lung, its noninvasive sputum-based test for early-stage lung cancer detection in high-risk patients with lung nodules 6 to less than 30 millimeters.

The study will run across up to 20 sites, including numerous VA medical centers and major military hospitals, with patients followed for up to 24 months or until a definitive cancer or no-cancer diagnosis. An earlier trial showed 92% sensitivity, 87% specificity and 88% accuracy in high-risk patients with nodules less than 20 millimeters.

The new trial, supported in part by the John P. Murtha Cancer Center Research Program, uses a research-use version called FlowPath Lung that applies the same flow cytometry and AI technology as the commercially available CyPath® Lung Laboratory Developed Test.

bioAffinity Technologies, Inc. reported that directors Robert Anderson and Roby Joyce have chosen not to stand for re-election when their current terms expire at the company’s 2026 Annual Meeting of Stockholders, currently scheduled for April 30, 2026.

The company stated that the decisions by Mr. Anderson and Mr. Joyce are not due to any disagreements with bioAffinity Technologies regarding its operations, policies, or practices. Both will continue to serve as directors until their terms end at the 2026 Annual Meeting.

bioAffinity Technologies, Inc. reported that it presented a scientific poster titled “Sputum as a Diagnostic Tool for the Treatment of Asthma” at the 2026 American Academy of Allergy, Asthma and Immunology meeting in Philadelphia. The work highlights a noninvasive sputum-based diagnostic approach.

The research describes using bioAffinity’s platform to identify antibody drug receptors in sputum for asthma and COPD therapies, including dupilumab and benralizumab, to help match patients with effective biologic treatments and monitor inflammatory changes. The company notes this platform underpins its commercial CyPath® Lung test, which in clinical studies showed 92% sensitivity, 87% specificity and 88% accuracy for early lung cancer detection.

bioAffinity Technologies, Inc. is launching a validation study with Brooke Army Medical Center to test its CyPath® Lung diagnostic on sputum samples collected through tracheal and bronchial suctioning for early lung cancer detection. The study will enroll about 30–50 patients undergoing routine suction procedures, with results expected by mid-year 2026.

CyPath® Lung is a noninvasive test that uses flow cytometry, AI, and a fluorescent porphyrin to identify malignant cell populations in sputum. Prior clinical results showed 92% sensitivity, 87% specificity, and 88% accuracy in high-risk patients with small lung nodules.

The study aims to expand sample collection options beyond at-home sputum collection and leverage bronchoscopy procedures, which are performed roughly 500,000 times annually in the U.S. The company highlights a U.S. bronchoscopy-related market estimated at $700–$920 million and positions this work as a step toward broader use of CyPath® Lung.

bioAffinity Technologies, Inc. reported that a new clinical case study shows how its noninvasive CyPath® Lung test helped guide treatment for a 79-year-old high-risk patient with a suspicious lung nodule found on a low-dose CT scan.

The CyPath Lung result was negative, supporting a choice to monitor with annual CT scans instead of performing an invasive biopsy. A follow-up scan later in 2025 showed the nodule had resolved and no pulmonary nodules were present, reinforcing the conservative approach.

CyPath Lung is designed for early lung cancer detection in high-risk patients using sputum analysis, advanced flow cytometry and AI. Clinical study data cited in the case show 92% sensitivity, 87% specificity and 88% accuracy for detecting lung cancer in small nodules under 2 centimeters.

bioAffinity Technologies reported a new clinical case study using its CyPath® Lung diagnostic test in a high-risk 59-year-old smoker with multiple small pulmonary nodules classified as Lung-RADS 3, a category considered probably benign. A negative CyPath Lung result supported continued six-month CT surveillance rather than more invasive procedures.

The company highlights prior clinical results where CyPath Lung showed 92% sensitivity, 87% specificity and 88% accuracy for detecting lung cancer in high-risk patients with nodules under 20 millimeters. The test is a noninvasive, sputum-based Laboratory Developed Test marketed through Precision Pathology Laboratory Services.

bioAffinity Technologies, Inc. filed a current report to furnish updated presentation materials about the company’s operations and performance. Management intends to use these February 2026 presentation slides in meetings, and the materials were posted to the company’s website on February 10, 2026.

The materials are furnished under Regulation FD as Exhibit 99.1 and are expressly not deemed “filed” for liability purposes under the Securities Exchange Act of 1934 or incorporated by reference into other Securities Act or Exchange Act filings.

bioAffinity Technologies filed an 8-K reporting that it has expanded its Medical and Scientific Advisory Board by appointing three nationally recognized pulmonary and lung cancer specialists: Dr. David Ost of MD Anderson Cancer Center, Dr. Daniel Sterman of NYU Langone Health, and Dr. J. Scott Ferguson of the University of Wisconsin School of Medicine and Public Health.

The company develops CyPath® Lung, a noninvasive diagnostic test for early detection of lung cancer in high-risk patients with small indeterminate pulmonary nodules. In clinical studies, CyPath® Lung showed 92% sensitivity, 87% specificity and 88% accuracy in detecting lung cancer, supporting its role as an added tool to inform clinicians and potentially improve early-stage diagnosis.

bioAffinity Technologies, Inc. has scheduled its 2026 Annual Meeting of Stockholders for April 30, 2026 at its principal executive offices in San Antonio, Texas. The company plans to include at this meeting the proposals from a prior Special Meeting that was convened on December 19, 2025 but adjourned without business because a quorum of common stockholders was not present.

Stockholders who wish to bring business before the 2026 Annual Meeting or nominate directors must deliver written notice to the company’s principal executive offices by February 14, 2026, in accordance with the detailed requirements of the company’s Amended and Restated Bylaws.

bioAffinity Technologies, Inc. reported that its wholly owned laboratory subsidiary, Precision Pathology Laboratory Services, has successfully maintained its accreditation from the College of American Pathologists. The continued accreditation follows an on-site inspection, indicating the lab met the standards reviewed during that visit.

The company disclosed this development in connection with a press release, which is included as an exhibit to the report.

bioAffinity Technologies, Inc. reported that it will present a scientific poster titled “CyPath® Lung in Practice: From Uncertainty to Clarity and Confidence” at the American Cancer Society National Lung Cancer Roundtable on December 8, 2025. The poster highlights three clinical cases in which CyPath® Lung, a noninvasive sputum-based flow cytometry test, successfully identified Stage 1A lung cancer in patients whose presentations were atypical and diagnostically challenging. The company announced this upcoming presentation in a press release dated December 3, 2025, and has filed both the press release and the poster as exhibits.

bioAffinity Technologies, Inc. (BIAF) filed an 8-K reporting that it furnished a press release containing financial information for the quarter ended September 30, 2025. The company stated the press release is provided under Item 2.02 and is furnished, not filed, and will not be incorporated by reference into other SEC filings.

Exhibits include 99.1 (the press release dated November 14, 2025) and 104 (Cover Page Interactive Data File). The company’s securities listed are Common Stock (BIAF) and Tradeable Warrants (BIAFW) on The Nasdaq Stock Market LLC.

bioAffinity Technologies (BIAF) filed an 8‑K announcing month‑over‑month growth in CyPath® Lung test volume. The company disclosed the update under Item 8.01 (Other Events) and furnished a detailed press release as Exhibit 99.1. The filing identifies the company’s listed securities on the Nasdaq Capital Market under symbols BIAF (common stock) and BIAFW (warrants). The report date is November 5, 2025.

bioAffinity Technologies reported that the Australian Patent Office has accepted its patent application AU 2019253111, titled “System and Method for Determining Lung Health.” The patent covers methods that combine flow cytometry with fluorescent probes and molecular tags that attach to specific cell types to detect cellular and molecular signatures of multiple lung diseases. The company issued a press release, attached as Exhibit 99.1.

bioAffinity Technologies reported it will present new research at CHEST 2025, the annual meeting of the American College of Chest Physicians. The company’s project manager for product development, Rossella Titone, PhD, will present the poster titled “The Effect of Sputum Storage and Shipping Temperature on Flow Cytometric Outcomes of Sputum-Based Diagnostic Tests.”

The presentation is scheduled for October 22, 2025 at 10:20 a.m. at poster board #4324. The company attached its press release and the full poster as Exhibits 99.1 and 99.2, which are incorporated by reference.

bioAffinity Technologies (BIAF) reported a regulatory milestone. The company received a notification of allowance from the U.S. Patent and Trademark Office for a patent titled “Detection of Early-Stage Lung Cancer in Sputum using Automated Flow Cytometry and Machine Learning.” The patent covers a system and method for predicting the likelihood of lung cancer by analyzing patient sputum samples.

The company disclosed the news in a Form 8-K under Item 8.01 and attached a related press release as Exhibit 99.1. A notification of allowance indicates the USPTO intends to grant the patent following completion of administrative steps.

bioAffinity Technologies announced it has regained compliance with Nasdaq listing standards. A Nasdaq Hearings Panel found the company in compliance with Listing Rule 5550(a)(2) (the Minimum Bid Price Rule) and 5550(b)(1) (the Minimum Stockholders’ Equity Rule).

The company will be under a mandatory panel monitor for one year. If, during that period, it falls out of compliance with the Minimum Stockholders’ Equity Rule, it will not be granted additional time to regain compliance, though it may request a new hearing before any delisting. The company issued a press release on October 15, 2025, noting the compliance status.

bioAffinity Technologies entered into a securities purchase agreement with institutional investors for a registered direct offering of 720,000 shares of common stock. The transaction closed on October 9, 2025, providing the company with approximately $1.8 million in gross proceeds before placement fees and expenses.

WallachBeth Capital, LLC acted as exclusive placement agent and will receive a cash fee of 8.0% of the gross proceeds plus up to $75,000 of expense reimbursement. The company agreed that, until November 14, 2025, it will not issue most additional equity, and it will not enter into variable rate transactions for six months after the closing date, with the restriction on at-the-market offerings and equity lines ending on November 14, 2025. Officers and directors also signed 60‑day lock-up agreements limiting sales of company securities.

bioAffinity Technologies, Inc. reported that sales of its CyPath® Lung diagnostic test for lung cancer reached a new high in the third quarter of 2025. The company disclosed this business update through a press release, which is furnished as an exhibit to this report.

The filing does not include detailed financial figures, but highlights growing adoption of the CyPath® Lung test as a notable operating milestone for the period.

bioAffinity Technologies, Inc. filed a Current Report on Form 8-K disclosing a corporate action: the company announced a Reverse Stock Split and furnished a related press release dated September 17, 2025. The filing also includes a Certificate of Amendment to the Certificate of Incorporation as Exhibit 3.1, and the press release is furnished as Exhibit 99.1. The 8-K indicates these documents are part of the company's report of a material event but does not provide the split ratio or detail any effects on shares outstanding, shareholder approvals, or listing status within the disclosed text.