bioAffinity Technologies, Inc. Warrant 8-K Filings

bioAffinity Technologies, Inc. (BIAF) announced it will present research at CHEST 2026 on sputum-based tests in development to characterize lung inflammation and detect protein biomarkers, including biologic drug targets associated with asthma and COPD. The research reports detection of multiple targets using cellular and proteomic analysis, with a workflow based on the flow cytometry and AI platform used by the company’s commercially available CyPath Lung diagnostic.

The sputum-based tests are investigational, have not been validated or cleared or approved by the FDA, and are not available for clinical or diagnostic use. The company said further research and validation would be needed before the approach could potentially help identify or monitor patients for specific therapies. References to named drugs identify research targets and are not a claim that the tests guide their use.

bioAffinity Technologies, Inc. (BIAF) closed a registered direct offering, priced at-the-market under Nasdaq rules, and a concurrent private placement on October 9, 2026. The registered sale comprised 116,545 common shares at $6.122 each and pre-funded warrants for up to 536,836 shares at $6.115 each, with a $0.007 exercise price per share. Gross proceeds were approximately $4 million before fees and expenses.

The concurrent private placement included unregistered warrants to purchase up to 980,072 common shares at $6.122 per share, exercisable commencing upon stockholder approval for five years from that date. Exercise is subject to a 4.99% beneficial-ownership limit, waivable up to 9.99% with at least 61 days’ notice. The company agreed to pay placement agent WallachBeth Capital LLC a cash fee equal to 7.5% of gross proceeds, issue warrants to purchase up to 19,602 shares, and pay $70,000 for legal-counsel fees and other out-of-pocket expenses. Net proceeds are intended for working capital, support for expected growing CyPath® Lung sales, and general corporate purposes. BIAF suspended use of the prospectus supplement and related prospectus for its ATM agreement; no sales may occur unless and until a new prospectus supplement is filed, and the agreement remains in effect.

bioAffinity Technologies, Inc. said the Japan Patent Office issued a Notice of Allowance indicating its intention to grant a patent for a method of predicting lung cancer likelihood powered by CyPath Lung. The patent is expected to issue after payment of the applicable issuance fee. If issued, it would be the first Japanese patent for CyPath Lung’s AI-built algorithm and the fifth patent protecting the company’s early lung cancer test in Asia, including China and Hong Kong. CyPath Lung uses flow cytometry and artificial intelligence to assess indeterminate pulmonary nodules in patients at high risk for lung cancer. It is marketed as a Laboratory Developed Test and is not intended for use as a sole diagnostic tool.

bioAffinity Technologies, Inc. (BIAF) reported that sales of its CyPath Lung test increased more than 100% through Q3 2026 compared with 2025. In Q3 2026, ordering physicians increased 89% year over year; physicians who ordered the test through Q3 2025 increased usage, with sales volume up 48% year over year. More than 1,620 tests were delivered through Q3 2026, compared with 775 through Q3 2025.

CyPath Lung is a noninvasive test for assessing lung cancer likelihood in high-risk individuals, with results considered alongside other clinical information. In a published clinical trial of high-risk patients with small indeterminate lung nodules less than 20 millimeters, the test demonstrated 92% sensitivity, 87% specificity, 88% accuracy and 99% negative predictive value. bioAffinity said its distribution agreement with Veteran-Owned AvMEDICAL could broaden access in government healthcare, including the Department of Veterans Affairs.

bioAffinity Technologies, Inc. (BIAF) and federal healthcare distribution partner AvMEDICAL held their first joint exhibition of CyPath Lung under their nationwide distribution agreement, presenting the test to more than 300 physicians, healthcare professionals and VA leaders at the NAVREF Annual Conference in Arlington, Virginia. The agreement is intended to expand government and agency access to CyPath Lung through AvMEDICAL’s procurement channels and government healthcare relationships.

The VA reports approximately 7,700 veterans are diagnosed with lung cancer each year. bioAffinity also presented CyPath Lung at the GO2 for Lung Cancer conference in San Diego; GO2 works with the VA and has a network of more than 700 screening centers of excellence. CyPath Lung analyzes cells in a noninvasive sputum sample using flow cytometry and proprietary AI, and is marketed as a Laboratory Developed Test.

bioAffinity Technologies, Inc. (BIAF) reported that it will present two posters on its noninvasive lung cancer diagnostic, CyPath® Lung, at the 2026 NAVREF Annual Conference, focusing on clinical use and ongoing research in veteran and military populations, together with new distribution partner AvMEDICAL.

One poster discusses complex high-risk cases where CyPath Lung was used alongside imaging and other tests, while a second describes the ongoing 2,000-patient FlowPath™ Lung longitudinal study across 12 VA medical centers and two major military hospitals. The company highlights previously reported CyPath Lung performance in patients with pulmonary nodules of 20 mm or less, including 92% sensitivity, 87% specificity and 99% negative predictive value, and cites an independent economic analysis suggesting its test has the potential to generate substantial per-patient and overall healthcare cost savings in lung cancer screening and diagnosis.

bioAffinity Technologies, Inc. (BIAF) reports that the Hong Kong Intellectual Property Department has granted a patent for its proprietary technology used to predict the likelihood of lung cancer by applying flow cytometry and fluorescent markers to characterize cell populations in sputum. Hong Kong Patent No. HK40048460, titled “System and Method for Determining Lung Health”, covers the use of defined antibodies and the porphyrin TCPP to label sputum cell populations and detect lung cancer cells via flow cytometry. This patent builds on a 2025 patent granted in China and contributes to a broader patent estate that includes multiple patents and pending applications in the United States, Australia, Canada, China, the European Union, Japan, Mexico and Singapore, supporting the CyPath® Lung diagnostic and other pipeline tests. The company highlights CyPath Lung’s noninvasive use in high-risk patients with small indeterminate lung nodules and cites published clinical trial results showing 92% sensitivity, 87% specificity, 88% accuracy and 99% negative predictive value in detecting lung cancer.

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. 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. 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.

bioAffinity Technologies, Inc. filed a current report to share a corporate update. On September 9, 2025, the company issued a press release announcing the release of a new case study involving its CyPath® Lung test. The case study describes how CyPath® Lung identified cancer in a patient who had an incidental finding of ground glass nodules. The press release is included with the report as an exhibit, making the information part of the company’s official disclosures.

bioAffinity Technologies, Inc. furnished an investor presentation under a Regulation FD disclosure. The company plans to use these presentation materials to discuss its operations and performance, including at the H.C. Wainwright 27th Annual Global Investment Conference held from September 8–10, 2025. The presentation is attached as Exhibit 99.1 to the report and is provided for informational purposes only. It is expressly stated as being "furnished" rather than "filed," which means it is not subject to certain liability provisions of the Exchange Act and is not automatically incorporated into other securities law filings.

bioAffinity Technologies, Inc. filed an update describing media coverage of its CyPath® Lung diagnostic test. On September 3, 2025, the company issued a press release noting that U.S. Medicine Magazine featured CyPath® Lung in its pulmonary issue. The article highlights the test’s potential to improve lung cancer detection while lowering costs for the U.S. Department of Veterans Affairs.

The press release is included in this report as an exhibit, providing additional detail on how CyPath® Lung is being positioned in the clinical community.

bioAffinity Technologies, Inc. entered into amendments to two series of outstanding warrants. Effective as of August 12, 2025, the Company and the warrant holders agreed to raise the Floor Price in both the May 2025 Warrants and the August 2025 Warrants from $0.10 to $0.15 per share. This change reduced the total number of shares issuable upon exercise of the May 2025 Warrants from 53,377,497 to 35,584,997, meaning fewer shares can be issued if those warrants are fully exercised. The August 2025 Warrants remain subject to shareholder approval, and the detailed amendment terms are provided in the attached warrant amendment exhibits.

bioAffinity Technologies reported changes to its board of directors and board committees. On August 12, 2025, the company appointed Roberto Rios, CPA, and John J. Oppenheimer, M.D., as directors, each serving until the 2026 annual meeting of stockholders. Their annual compensation will match that of other non-employee directors, and the company states there are no related party transactions requiring disclosure.

On the same date, director Gary Rubin resigned from the board and from the Nominating and Corporate Governance Committee, with the company noting his resignation did not arise from any disagreement over operations, policies, or practices. The board named Mr. Rios as Chair of the Audit Committee and a member of the Compensation Committee, and Dr. Oppenheimer to the Nominating and Corporate Governance Committee. It also appointed Jamie Platt to the Audit Committee and as Chair of the Nominating and Corporate Governance Committee, and Robert Anderson to the Compensation Committee. On August 18, 2025, the company issued a press release announcing the new director appointments.

bioAffinity Technologies, Inc. reported a series of financing and capital structure moves. The company completed a private placement of 990 shares of Series B Convertible Preferred Stock with a stated value of $1,000 per share, initially convertible into 4,304,343 shares of common stock at $0.23 per share, and issued warrants to purchase up to 6,714,780 common shares at $0.352 per share, for expected gross proceeds of approximately $1.2 million before fees. It also entered a warrant inducement agreement leading to cash exercise of earlier warrants at $0.23 per share, providing $253,000 of gross proceeds and issuing new warrants for up to 1,430,000 shares at $0.352 per share, exercisable after stockholder approval and lasting five years.

The company increased authorized common shares from 100,000,000 to 350,000,000 and amended May 2025 warrants so they are expected to be reclassified, increasing stockholders’ equity by approximately $2.8 million. Anti-dilution adjustments reduced the May 2025 warrant exercise price to $0.23 per share and increased the number of shares issuable upon exercise by approximately 8 million. The Series B Preferred Stock includes non-voting status (except as required by law), conversion limits at 4.99% beneficial ownership, and compliance provisions tied to 19.99% exchange rules and a $0.10 floor price for future anti-dilution adjustments.

bioAffinity Technologies, Inc. disclosed that Nasdaq notified the company it failed to maintain the $1.00 minimum bid price for the period December 23, 2024 through February 6, 2025 and did not regain compliance by the 180-day cure deadline. The Listing Qualifications Staff also determined the company is ineligible for a second compliance period because its reported stockholders' equity of $1,439,404 as of March 31, 2025 is below Nasdaq's $2,500,000 minimum for continued listing.

The company was told its securities will be scheduled for delisting and suspended at the opening of business on August 18, 2025 unless it requests an appeal by August 14, 2025. bioAffinity intends to file an appeal to stay the suspension and will present its plan to regain compliance; hearings are typically scheduled ~30-45 days after a hearing request and the Panel typically issues a decision within ~30 days after the hearing. The filing also notes a press release announcing increased commercial sales of CyPath® Lung.