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What changed in bioAffinity Technologies, Inc.'s 10-K — 2024 vs 2025

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Paragraph-level year-over-year comparison of bioAffinity Technologies, Inc.'s 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.

+342 added−395 removedSource: 10-K (2026-03-16) vs 10-K (2025-03-31)

Top changes in bioAffinity Technologies, Inc.'s 2025 10-K

342 paragraphs added · 395 removed · 231 edited across 7 sections

Item 1. Business

Business — how the company describes what it does

104 edited+75 added−102 removed119 unchanged
Biggest changePremarket Authorization and Notification While most Class I and some Class II devices may be marketed without prior FDA authorization, many Class II and most Class III medical devices can be legally sold within the U.S. only if the FDA has: (1) approved a PMA application prior to marketing, generally applicable to most Class III devices; (2) cleared the device in response to a premarket notification (a “510(k) submission”), generally applicable to some Class I and most II devices; or (3) authorized the device to be marketed through the de novo classification process, generally applicable for novel low- or moderate-risk devices.
Biggest changeNovel low and moderate risk devices, for which substantial equivalence to a legally marketed predicate cannot be demonstrated, can be marketed pursuant to FDA grant of a request for de novo classification. Class III medical devices can be legally sold within the U.S. only if the FDA has approved an application for premarket approval (PMA).
Later, a blinded clinical trial was conducted and results published September 2015 in an article titled “Early Detection of Lung Cancer with Meso-Tetra (4-Carboxyphenyl) Porphyrin-Labeled Sputum” in the Journal of Thoracic Oncology .
Later, a blinded clinical trial was conducted and results published in September 2015 in an article titled “Early Detection of Lung Cancer with Meso-Tetra (4-Carboxyphenyl) Porphyrin-Labeled Sputum” in the Journal of Thoracic Oncology .
As a result of this election, our timeline to comply with new or revised accounting standards will in many cases be delayed as compared to other public companies that are not eligible to take advantage of this election or have not made this election.
As a result of this election, our timeline to comply with new or revised accounting standards will in many cases be delayed compared to other public companies that are not eligible to take advantage of this election or have not made this election.
These provisions include, but are not limited to: ● reduced obligations with respect to financial data, including presenting only two years of audited financial statements and selected financial data, and only two years of related Management’s Discussion and Analysis of Financial Condition and Results of Operations disclosure in our initial registration statement; 21 ● an exemption from the auditor attestation requirement in the assessment of our internal control over financial reporting pursuant to the Sarbanes-Oxley Act of 2002, as amended (“SOX”); ● reduced disclosure about executive compensation arrangements in our periodic reports, registration statements, and proxy statements; and ● exemptions from the requirements to seek non-binding advisory votes on executive compensation or stockholder approval of any golden parachute arrangements.
These provisions include, but are not limited to: ● reduced obligations with respect to financial data, including presenting only two years of audited financial statements and selected financial data, and only two years of related Management’s Discussion and Analysis of Financial Condition and Results of Operations disclosure in our initial registration statement; ● an exemption from the auditor attestation requirement in the assessment of our internal control over financial reporting pursuant to the Sarbanes-Oxley Act of 2002, as amended (“SOX”); ● reduced disclosure about executive compensation arrangements in our periodic reports, registration statements, and proxy statements; and ● exemptions from the requirements to seek non-binding advisory votes on executive compensation or stockholder approval of any golden parachute arrangements.
See “Management’s Discussion and Analysis of Financial Condition and Results of Operations” for a more detailed discussion of the foregoing transactions. 8 Our First Diagnostic Test – CyPath ® Lung Lung cancer remains the most commonly diagnosed cancer and the leading cause of cancer-related deaths worldwide, claiming more than 1.8 million lives with almost 2.5 million new cases reported in 2022 according to a 2024 article in CA: A Cancer Journal for Clinicians .
See “Management’s Discussion and Analysis of Financial Condition and Results of Operations” for a more detailed discussion of the foregoing transactions. 9 Our First Diagnostic Test – CyPath ® Lung Lung cancer remains the most commonly diagnosed cancer and the leading cause of cancer-related deaths worldwide, claiming more than 1.8 million lives with almost 2.5 million new cases reported in 2022, according to a 2024 article in CA: A Cancer Journal for Clinicians .
According to the American Lung Association (“ALA”), screening for individuals at high risk for lung cancer has the potential to improve lung cancer survival rates by finding disease at an earlier stage when it is more likely to be curable. An estimated 19.3 million Americans should have annual screening for lung cancer, according to American Cancer Society recommendations.
The American Lung Association (“ALA”) estimated that screening for individuals at high risk for lung cancer has the potential to improve lung cancer survival rates by finding disease at an earlier stage when it is more likely to be curable. An estimated 19.3 million Americans should have annual screening for lung cancer, according to American Cancer Society recommendations.
Laboratory reagents, supplies, and equipment are commercially available through multiple vendors. Sample processing, labeling, and data collection can be accomplished by a laboratory technician skilled in general laboratory techniques. Data analysis leading to a physician’s report is done by automated analysis software fully integrated into the test.
Laboratory reagents, supplies, and equipment are commercially available through multiple vendors. Sample processing, labeling, and data collection can be accomplished by a laboratory technician skilled in general laboratory techniques. Data analysis leading to a physician’s report is done by using automated analysis software fully integrated into the test.
While the IND is active, progress reports summarizing the results of the clinical trials and nonclinical studies performed since the last progress report, among other information, must be submitted at least annually to the FDA, and written IND safety reports must be submitted to the FDA and investigators for serious and unexpected suspected adverse events, findings from other studies suggesting a significant risk to humans exposed to the same or similar drugs, findings from animal or in vitro testing suggesting a significant risk to humans, and any clinically important increased incidence of a serious suspected adverse reaction compared to that listed in the protocol or investigator brochure. 19 After completion of the required clinical testing, an NDA is prepared and submitted to the FDA.
While the IND is active, progress reports summarizing the results of the clinical trials and nonclinical studies performed since the last progress report, among other information, must be submitted at least annually to the FDA, and written IND safety reports must be submitted to the FDA and investigators for serious and unexpected suspected adverse events, findings from other studies suggesting a significant risk to humans exposed to the same or similar drugs, findings from animal or in vitro testing suggesting a significant risk to humans, and any clinically important increased incidence of a serious suspected adverse reaction compared to that listed in the protocol or investigator brochure. 22 After completion of the required clinical testing, an NDA is prepared and submitted to the FDA.
In fact, for those patients in this indeterminate category who do have cancer, valuable time in diagnosis may be lost. We believe there are many reasons why CyPath ® Lung is a superior test when compared to its competitors.
In fact, for those patients in this indeterminate category who do have cancer, valuable time in diagnosis may be lost. 15 We believe there are many reasons why CyPath ® Lung is a superior test when compared to its competitors.
We will remain an emerging growth company until the earliest of (1) the last day of the fiscal year following the fifth anniversary of the completion of our initial public offering, (2) the last day of the first fiscal year in which our annual gross revenues exceed $1.235 billion, (3) the date on which we have, during the immediately preceding three-year period, issued more than $1.0 billion in non-convertible debt securities and (4) the date on which we are deemed to be a large accelerated filer under the rules of the SEC.
We will remain an emerging growth company until the earliest of (1) the last day of the fiscal year following the fifth anniversary of the completion of our initial public offering, (2) the last day of the first fiscal year in which our annual gross revenues exceed $1.235 billion, (3) the date on which we have, during the immediately preceding three-year period, issued more than $1.0 billion in non-convertible debt securities or (4) the date on which we are deemed to be a large accelerated filer under the rules of the SEC.
Comparison of CyPath ® Lung to Current Standards of Care Diagnostic Test or Procedure Intended Patient Sensitivity Specificity Procedural Risk Source CyPath ® Lung ‌ High risk 82 % 88 % None “Detection of Early-Stage Lung Cancer in Sputum using Automated Flow Cytometry and Machine Learning,” published in Respiratory Research on January 21, 2023 CyPath ® Lung High risk – nodules less than 20 mm 92 % 87 % None “Detection of Early-Stage Lung Cancer in Sputum using Automated Flow Cytometry and Machine Learning,” published in Respiratory Research on January 21, 2023 Low-dose CT screening High risk 94 % 73 % Radiation exposure “Results of initial low dose computed tomographic screening for lung cancer,” published in the New England Journal of Medicine on May 23, 2013 FDG PET imaging Suspicious lung nodules 89 % 75 % Radiation exposure “Accuracy of FDG-PET to diagnose lung cancer in areas with infectious lung disease: a meta-analysis,” published in JAMA in September 2014 Bronchoscopy Suspicious lung nodules – central lesions 88 % 47 % Invasive; risk of collapsed/bleeding lung; infection “A bronchial genomic classifier for the diagnostic evaluation of lung cancer,” published in the New England Journal of Medicine on July 16, 2015 Fine needle biopsy Suspicious lung nodules 90 % 75 % Invasive; risk of collapsed/bleeding lung; infection “Fine-needle aspiration biopsy versus core-needle biopsy in diagnosing lung cancer: a systemic review,” published in Current Oncology in February 2012 Core needle biopsy 21 Suspicious lung nodules 89 % 89 % Invasive; risk of collapsed/bleeding lung; infection “Global patterns and trends in lung cancer incidence: a population-based study,” published in the Journal of Thoracic Oncology on February 16, 2021 11 As seen in the above table, CyPath ® Lung performs similar to current Standard of Care, including more invasive and riskier diagnostic procedures.
Comparison of CyPath ® Lung to Current Standards of Care Diagnostic Test or Procedure Intended Patient Sensitivity Specificity Procedural Risk Source CyPath ® Lung ‌ High risk 82 % 88 % None “Detection of Early-Stage Lung Cancer in Sputum using Automated Flow Cytometry and Machine Learning,” published in Respiratory Research on January 21, 2023 CyPath ® Lung High risk – nodules less than 20 mm 92 % 87 % None “Detection of Early-Stage Lung Cancer in Sputum using Automated Flow Cytometry and Machine Learning,” published in Respiratory Research on January 21, 2023 Low-dose CT screening High risk 94 % 73 % Radiation exposure “Results of initial low dose computed tomographic screening for lung cancer,” published in the New England Journal of Medicine on May 23, 2013 FDG PET imaging Suspicious lung nodules 89 % 75 % Radiation exposure “Accuracy of FDG-PET to diagnose lung cancer in areas with infectious lung disease: a meta-analysis,” published in JAMA in September 2014 Bronchoscopy Suspicious lung nodules – central lesions 88 % 47 % Invasive; risk of collapsed/bleeding lung; infection “A bronchial genomic classifier for the diagnostic evaluation of lung cancer,” published in the New England Journal of Medicine on July 16, 2015 Fine needle biopsy Suspicious lung nodules 90 % 75 % Invasive; risk of collapsed/bleeding lung; infection “Fine-needle aspiration biopsy versus core-needle biopsy in diagnosing lung cancer: a systemic review,” published in Current Oncology in February 2012 Core needle biopsy 21 Suspicious lung nodules 89 % 89 % Invasive; risk of collapsed/bleeding lung; infection “Global patterns and trends in lung cancer incidence: a population-based study,” published in the Journal of Thoracic Oncology on February 16, 2021 13 As seen in the above table, CyPath ® Lung performs favorably compared to current Standards of Care, including more invasive and riskier diagnostic procedures.
Regulatory authorities may withdraw product approvals or request product recalls if a company fails to comply with required regulatory standards, if it encounters problems following initial marketing, or if previously unrecognized problems are subsequently discovered. 20 European Union A medical device or diagnostic test must be CE marked to be sold in the EU.
Regulatory authorities may withdraw product approvals or request product recalls if a company fails to comply with required regulatory standards, if it encounters problems following initial marketing, or if previously unrecognized problems are subsequently discovered. 23 European Union A medical device or diagnostic test must be CE marked to be sold in the EU.
We place significant emphasis on the recruitment, development, and retention of our employees who include award-winning scientists dedicated to advancing scientific discovery from bench to bedside. Of our seven employees engaged in research and development, all of whom are employed full-time, three hold Ph.Ds in biology or medicinal chemistry.
We place significant emphasis on the recruitment, development, and retention of our employees who include award-winning scientists dedicated to advancing scientific discovery from bench to bedside. Of our seven employees engaged in research and development, all of whom are employed full-time, two hold Ph.Ds in biology or medicinal chemistry.
Our business model is to address the need for a noninvasive, cost-effective, high-performing lung cancer diagnostic that meets the need for more diagnostic certainty leading to quicker diagnosis at earlier stage for longer survival and reduced medical costs. The U.S.
Our business model is to address the need for a noninvasive, cost-effective, high-performing lung cancer diagnostic that meets the need for more diagnostic certainty leading to quicker diagnosis at earlier stage for longer survival and reduced medical costs.
A study authored by two pulmonologists and published in 2024 in the peer-reviewed Journal of Health Economics and Outcomes Research reported that adding CyPath ® Lung to the standard of care for Medicare patients with a positive lung cancer screening could have saved an average of $2,773 per patient for total cost savings of $379 million in 2022, while the screening could have saved an average of $6,460 per patient for all patients with a positive lung cancer screening for a total costs savings of $891 million.
A study authored by two pulmonologists and published in 2024 in the peer-reviewed Journal of Health Economics and Outcomes Research reported that adding CyPath ® Lung to the standard of care for Medicare patients with a positive lung cancer screening could have saved an average of $2,773 per patient for total cost savings of $379 million in 2022, while the screening could have saved an average of $6,460 per patient for privately insured patients with a positive lung cancer screening for total cost savings of $891 million.
The therapeutic intellectual property is made up of two families, including one family directed at our siRNA product candidates for the treatment of cancer, and another family directed at our porphyrin conjugates for treating cancer. The term of individual patents depends upon the legal term of the patents in the countries in which they are obtained.
The therapeutic intellectual property patent portfolio is made up of two families, one family directed at our siRNA product candidates for the treatment of cancer, and another family directed at our porphyrin conjugates for treating cancer. The term of individual patents depends upon the legal term of the patents in the countries in which they are obtained.
The Acapella ® Choice Blue has been 510(k)-cleared by the FDA as a positive expiratory pressure device to help mobilize lung secretions in people with certain lung conditions The sputum sample is shipped overnight by the patient to PPLS and processed into a single-cell suspension, then labeled with antibodies that distinguish different cell types and the synthetic porphyrin TCPP that identifies cancer cells and/or cancer-associated cells.
The Acapella ® Choice Blue has been 510(k)-cleared by the Food and Drug Administration (“FDA”) as a positive expiratory pressure device to help mobilize lung secretions in people with certain lung conditions The sputum sample is shipped overnight by the patient to PPLS and processed into a single-cell suspension, then labeled with antibodies that distinguish different cell types and the synthetic porphyrin TCPP that identifies cancer cells and/or cancer-associated cells.
We received aggregate gross proceeds of approximately $1.4 million, before deducting advisory fees and other expenses payable by us.
We received aggregate gross proceeds of approximately $1.4 million, before deducting advisory fees and other expenses payable by it.
Medical Devices The FDCA classifies medical devices into one of three categories based on the risks associated with the device and the level of control necessary to provide reasonable assurance of safety and effectiveness. Class I devices are low risk and are subject only to general regulatory controls. Class II devices are moderate risk.
FDA classifies medical devices into one of three categories—Class I, Class II, and Class III— based on the risks associated with the device and the level of control necessary to provide reasonable assurance of safety and effectiveness. Class I (low risk) devices are subject only to general regulatory controls.
Outside partnerships and collaborations that advance business and scientific research are encouraged, allowing us to multiply workforce efforts without expending significant capital. Implications of Being an Emerging Growth Company and a Smaller Reporting Company We qualify as an “emerging growth company” as defined in the Jumpstart Our Business Startups Act of 2012, or the JOBS Act.
Outside partnerships and collaborations that advance business and scientific research are encouraged, allowing us to multiply workforce efforts without expending significant capital. 24 Implications of Being an Emerging Growth Company and a Smaller Reporting Company We qualify as an “emerging growth company” as defined in the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”).
(A false positive test result indicates that the patient has lung cancer when he or she does not have the disease.) CyPath ® Lung is a test for early-stage lung cancer that is designed to meet the need for greater diagnostic certainty.
(A false positive test result indicates that the patient has lung cancer when he or she does not have the disease.) CyPath ® Lung is a test for early-stage lung cancer proven to detect curative Stage 1A lung cancer that is designed to meet the need for greater diagnostic certainty.
Cancer Epidemiology reports that lung cancer is the leading cause of cancer deaths in the European Union with an estimated 17 to 34 million people at high risk. China reported 1,060,600 new cases of lung cancer in 2022.
Lung cancer is the leading cause of cancer deaths in the European Union with an estimated 17 to 34 million people at high risk, according to Cancer Epidemiology. China reported 1,060,600 cases of lung cancer in 2022.
Our Company has the potential to play a significant role in the global cancer diagnostic market because we hold a strong and expanding IP portfolio for CyPath ® Lung, a noninvasive, cost-effective, and high performing test that has the potential to better patient outcomes.
Our Company has the potential to play a significant role in the global cancer diagnostic market because we hold a strong and expanding IP portfolio for CyPath ® Lung, a noninvasive, cost-effective, and high performing test that has the potential to better patient outcomes. In particular, we believe the market for CyPath ® Lung is poised for significant growth.
We are building on our expertise in using sputum as a sample for flow cytometric analysis to develop tests to detect COPD and asthma, including research to detect the presence of specific therapeutic targets to identify patients who can benefit from specific treatments. We expect to continue research through 2025 with patient studies expected in 2026.
We are building on our expertise in using sputum as a sample for flow cytometric analysis to develop tests to detect COPD and asthma, including research to detect the presence of specific therapeutic targets to identify patients who can benefit from specific treatments. We expect to begin patient studies in 2026.
First, lung sputum is an excellent medium for early lung cancer detection because sputum is in close contact with the tumor and pre-cancerous areas that shed cancer and pre-cancerous cells directly into the sputum, can be obtained noninvasively, and can be transported easily. Moreover, sputum contains immune cell populations in reaction to the presence of a tumor.
First, lung sputum is an excellent medium for early lung cancer detection because (1) sputum is in close contact with the tumor and pre-cancerous areas that shed cancer and pre-cancerous cells directly into the sputum, (2) can be obtained noninvasively, and (3) can be transported easily. Moreover, sputum contains immune cell populations associated with the presence of a tumor.
In consideration of the immediate exercise of the October Warrants and August Warrants by the holders thereof in accordance with the February Inducement Agreement, we issued unregistered common warrants to purchase an aggregate of up to 2,926,166 shares of Common Stock (120% of the number of shares of Common Stock issuable upon exercise of the October Warrants and August Warrants) to such holders.
In consideration of the immediate exercise of the October Warrants and August Warrants by the holders thereof in accordance with the February Inducement Agreement, we issued unregistered common warrants to purchase an aggregate of up to 97,538 shares of Common Stock (120% of the number of shares of Common Stock issuable upon exercise of the October Warrants and August Warrants) to such holders.
Morris, M.D., Brooke Army Medical Center (“BAMC”) pulmonology and critical care physician and Assistant Dean of Research at San Antonio Uniformed Services Health Education Consortium (“SAUSHEC”), and Sheila A. Habib, M.D., Director of the Pulmonary Lung Nodule Clinic and the Lung Cancer Screening Program at the South Texas Veterans Health Care Systems’ Audie L.
Morris, M.D., BAMC pulmonology and critical care physician and Assistant Dean of Research at San Antonio Uniformed Services Health Education Consortium (“SAUSHEC”), and Sheila A. Habib, M.D., Director of the Pulmonary Lung Nodule Clinic and the Lung Cancer Screening Program at the South Texas Veterans Health Care Systems’ Audie L.
A study published in the New England Journal of Medicine titled “Survival of patients with stage I lung cancer detected on CT screening” dated October 26, 2006, reported that the survival rate of individuals with Stage I lung cancer who underwent surgical resection within one month after diagnosis had a ten-year survival rate of 92%, as compared to the overall five-year survival rate in the U.S. of 28.4% as reported by the ALA in its 2024 “State of Lung Cancer” report.
A study published in the New England Journal of Medicine titled “Survival of patients with stage I lung cancer detected on CT screening” dated October 26, 2006, reported that the survival rate of individuals with Stage I lung cancer who underwent surgical resection within one month after diagnosis had a 10-year survival rate of 92%, as compared to the current overall five-year survival rate in the U.S. of 29.7% as reported by the ALA in its 2025 “State of Lung Cancer” report .
Business development is led by our Chief Operating Officer, Xavier Reveles, who has 25 years of experience as a clinical geneticist skilled in the creation and management of CLIA clinical laboratories, coding, and CPT reimbursement valuations. Mr.
Clinical operations are led by our Chief Operating Officer, Xavier Reveles, who has 25 years of experience as a clinical geneticist skilled in the creation and management of CLIA clinical laboratories, coding, and CPT reimbursement valuations. Mr.
We subsequently discovered that the simultaneous knockdown of these two cell-surface receptors, CD320 and LRP2, was deadly to cancer cells or inhibited their growth significantly but left normal cells virtually unharmed. We designed siRNAs to effectively eliminate CD320 and LRP2 protein production to study their role in TCPP uptake into the cell.
We subsequently discovered that the simultaneous knockdown of these two cell-surface receptors, CD320 and LRP2, was deadly to cancer cells or inhibited their growth significantly but left normal cells virtually unharmed. We designed siRNAs to effectively eliminate CD320 and LRP2 protein production.
Following an inspection, the FDA may issue a report, known as a Form 483 notice of observations, listing instances where the manufacturer has failed to comply with applicable regulations and/or procedures. The FDA may also issue a public warning letter.
These inspections may include the manufacturing facilities of subcontractors. Following an inspection, the FDA may issue a report, known as a Form 483 notice of observations, listing instances where the manufacturer has failed to comply with applicable regulations and/or procedures. The FDA may also issue a public warning letter.
Murphy Memorial Veterans Hospital and Assistant Professor at the University of Texas Health Science Center at San Antonio, were first and second authors on the study published in the Journal of Health Economics and Outcomes Research . Economists John E. Schneider, Ph.D., and Maggie L. Do Valle, Master of Public Health, of Avalon Health Economics also contributed to the study.
Murphy Memorial Veterans Hospital and Assistant Professor at the University of Texas Health Science Center at San Antonio, were first and second authors on the study. Economists John E. Schneider, Ph.D., and Maggie L. Do Valle, Master of Public Health, of Avalon Health Economics also were authors on the study.
Microscope slides of sputum samples were labeled with the synthetic fluorescent porphyrin TCPP. The Los Alamos research study of 12 uranium miners included eight men with cancer and four healthy individuals. Researchers were blinded to the sample origin and looked for the presence of highly fluorescent cells indicating uptake of TCPP as an indicator of lung cancer.
The Los Alamos research study of 12 uranium miners included eight men with cancer and four healthy individuals. Researchers were blinded to the sample origin and looked for the presence of highly fluorescent cells indicating uptake of TCPP as an indicator of lung cancer.
The CyPath ® Lung test enables physicians to more confidently identify patients who will likely benefit from timely intervention and more invasive follow-up procedures and those who are likely without lung cancer and should continue routine screening.
The CyPath ® Lung test enables physicians to more confidently identify patients who will likely benefit from timely intervention and more invasive follow-up procedures or those patients who are likely without lung cancer and should continue screening in accordance with guidelines.
The diagnostic family of pending patent applications is directed at diagnosing lung health and includes three pending non-provisional U.S. patent applications and 18 foreign counterpart patent applications in Australia, Canada, China, European Patent Office, Hong Kong, Japan, Mexico, and Singapore filed in 2019 and 2024, one non-provisional U.S. patent application directed to compensation beads for flow cytometry and one International Patent Application filed in 2023 directed to diagnosing lung health.
The diagnostic lung health family of pending patent applications includes three pending non-provisional U.S. patent applications and 21 counterpart patent applications in Australia, Canada, China, European Patent Office, Hong Kong, Japan, Mexico, and Singapore filed in 2019 and 2024, and one non-provisional U.S. patent application directed to compensation beads for flow cytometry.
Our diagnostic patent applications, fall into one of two families: one directed at diagnosing lung health using flow cytometry and the other directed at proprietary compensation beads used in analysis by flow cytometry.
Diagnostic lung health patents have issued in Australia, China and Japan. Our diagnostic lung health patent applications, fall into one of two families: one directed at diagnosing lung health using flow cytometry and the other directed at proprietary compensation beads used in analysis by flow cytometry.
The numerical analysis developed with machine learning captures complex interactions between lung cancer, the microenvironment, and areas of field cancerization that would be impossible for individuals to predict or detect reliably by eye.
Our approach allows the entire sputum sample to be rapidly analyzed. The numerical analysis developed with machine learning captures complex interactions between lung cancer, the microenvironment, and areas of field cancerization that would be impossible for individuals to predict or detect reliably by eye.
As of December 31, 2024, we and our OncoSelect® subsidiary have a patent estate that includes 17 issued U.S. and foreign counterpart patents including two U.S. patents and 15 foreign counterpart patents in Australia, Canada, China, France, Germany, Hong Kong, India, Italy, Mexico, Japan, Spain, Sweden, and the United Kingdom.
As of December 31, 2025, we and our OncoSelect® subsidiary have a patent estate that includes 19 issued U.S. and non-U.S. counterpart patents including three U.S. patents and 16 counterpart patents in Australia, Canada, China, France, Germany, Hong Kong, Italy, Mexico, Japan, Spain, Sweden, and the United Kingdom.
Public and Private Offerings On February 26, 2025, pursuant to the terms of a warrant inducement agreement (the “February Inducement Agreement”), dated February 25, 2025 that we entered into with certain holders of existing warrants, such holders exercised for cash (i) warrants to purchase an aggregate of up to 1,302,082 shares of Common Stock issued on October 21, 2024 (the “October Warrants”), at the reduced exercise price of $0.58 per share, and (ii) warrants to purchase an aggregate of up to 1,136,391 shares of Common Stock issued on August 5, 2024 (the “August Warrants”), at the reduced exercise price of $0.58 per share.
On February 26, 2025, pursuant to the terms of a warrant inducement agreement (the “February Inducement Agreement”), we entered into with certain holders of existing warrants dated February 25, 2025, such holders exercised for cash (i) warrants to purchase an aggregate of up to 43,402 shares of Common Stock issued on August 5, 2024 (the “August Warrants”), at the reduced exercise price of $17.40 per share, and (ii) warrants to purchase an aggregate of up to 37,878 shares of Common Stock issued on October 21, 2024 (the “October Warrants”), at the reduced exercise price of $17.40 per share.
The study protocol and informed consent information for patients in clinical trials must also be submitted to an IRB for approval. The IRB will also monitor the clinical trial until completed.
Imposition of a clinical hold may be full or partial. The study protocol and informed consent information for patients in clinical trials must also be submitted to an IRB for approval. The IRB will also monitor the clinical trial until completed.
CyPath ® Lung uses flow cytometry technology to detect and analyze cell populations in a person’s sputum, or phlegm, to find characteristics indicative of lung cancer, including cancer and/or cancer-related cells that have shed from a lung tumor. The flow cytometer is a well-established instrument used in many commercial laboratories.
CyPath ® Lung uses flow cytometry technology to detect and analyze cell populations in a person’s sputum, or phlegm, to find characteristics indicative of lung cancer, including cancer and/or cancer-related cells that have shed from a lung tumor.
Cancer cells are known to take up certain porphyrins in higher amounts than non-cancer cells, and the high affinity for cancer cells displayed by TCPP makes it an excellent bio-label for cancer, according to an article published in Progress in Clinical and Biological Research in 1984 titled “A comparative study of 28 porphyrins and their abilities to localize in mammary mouse carcinoma: uroporphyrin I superior to hematoporphyrin derivative.” As used in CyPath ® Lung, the proportion of cells with high TCPP fluorescence intensity in a patient’s sputum sample is a significant predictor of lung cancer.
Cancer cells are known to take up certain porphyrins in higher amounts than non-cancer cells, and the high affinity for cancer cells displayed by TCPP makes it an excellent bio-label for cancer, according to an article published in Progress in Clinical and Biological Research in 1984 titled “A comparative study of 28 porphyrins and their abilities to localize in mammary mouse carcinoma: uroporphyrin I superior to hematoporphyrin derivative.” CyPath ® Lung evaluates sputum for the presence of cancer without the opportunity to introduced operator bias.
The study concluded that optimizing the test to provide for analysis of the entire sputum sample would improve results. 10 On January 1, 2024, the Medicare reimbursement code 0406U specific for CyPath ® Lung became effective after multiple regulatory decisions in 2023 leading to approval.
The study concluded that optimizing the test to provide for analysis of the entire sputum sample would improve results. 11 On January 1, 2024, the Medicare reimbursement code 0406U specific for CyPath ® Lung became effective.
With regard to our therapeutic product candidates, we have one issued U.S. patent, five issued foreign patents in Australia, China, Hong Kong, India and Mexico, two pending U.S. applications, and 10 foreign applications pending in Canada, China, European Patent Office, and Hong Kong.
With regard to our therapeutic product candidates, we have two issued U.S. patents, three issued patents in China, Hong Kong, and Mexico, one pending U.S. application, and 7 counterpart applications pending in Canada, China, European Patent Office, and Hong Kong.
We expect to pursue CE marking of CyPath ® Lung for sale in the European Union (“EU”). CyPath ® Lung Business Development Plan We believe in the viability of our business plan based on the circumstances surrounding our business that are known to us as of the date of this Annual Report.
CyPath ® Lung Business Development Plan We believe in the viability of our business plan based on the circumstances surrounding our business that are known to us as of the date of this Annual Report.
However, the timing, strategies, and stages of our business plan may evolve in light of new circumstances that cannot be predicted with certainty at this time. Our business plan envisions four phases of expanding market entry into the U.S., the EU, and worldwide that are timed to maximize our resources and minimize market risk.
However, the timing, strategies, and stages of our business plan may evolve in light of new circumstances that cannot be predicted with certainty at this time. Our business plan envisions three phases of strategic expansion in the U.S. and the European Union (“EU”) and Asia that are timed to maximize our resources and minimize market risk.
Clinical trials, for both significant and nonsignificant risk devices, as well as exempt studies, must be approved by an IRB, an appropriately constituted group that has been formally designated to review and monitor biomedical research involving human subjects and which has the authority to approve, require modifications in, or disapprove research to protect the rights, safety, and welfare of the human research subject.
Clinical trials, for both significant and nonsignificant risk devices, as well as exempt studies, must be approved by an IRB, an appropriately constituted group that has been formally designated to review and monitor biomedical research involving human subjects and which has the authority to approve, require modifications in, or disapprove research to protect the rights, safety, and welfare of the human research subject. 20 Clinical trials that are not conducted in accordance with applicable federal requirements or present an unacceptable risk to participants may be subject to temporary or permanent discontinuation as well as other sanctions.
An NDA supplement for a new indication typically requires clinical data similar to that in the original application, and the FDA uses the same procedures and actions in reviewing NDA supplements as it does in reviewing original NDAs.
An NDA supplement for a new indication typically requires clinical data similar to that in the original application, and the FDA uses the same procedures and actions in reviewing NDA supplements as it does in reviewing original NDAs. Post-Approval Requirements Once an NDA is approved, a product will be subject to certain post-approval requirements.
However, knock-down of CD320 and LRP2 in cancer cell lines derived from diverse tissues (lung, breast, prostate, brain, and skin cancers) inhibited cell growth or killed the cells, in some cases up to 80%.
However, knock-down of CD320 and LRP2 in cancer cell lines derived from diverse tissues (lung, breast, prostate, brain, and skin cancers) inhibited cell growth or killed the cells, in some cases up to 80%. 16 Corporate Information We were incorporated in the State of Delaware on March 26, 2014.
Eight out of 10 (80%) of Stage I tumors were correctly identified. Sensitivity is the percentage of persons with the disease – in this case, lung cancer – who are correctly identified by the test. Specificity is the percentage of persons without lung cancer who are correctly identified by the test.
Sensitivity is the percentage of persons with the disease – in this case, lung cancer – who are correctly identified by the test. Specificity is the percentage of persons without lung cancer who are correctly identified by the test.
For the subset of patients in this trial who had lung nodules 20 mm or smaller or no nodules detected by imaging, this trial resulted in 92% sensitivity, 87% specificity, 99% negative predictive value, and 88% accuracy. In this subset of 132 individuals with small nodules, 119 patients were cancer-free and 13 had confirmed lung cancer.
For the subset of patients in this trial who had lung nodules 20 millimeters or smaller or no nodules detected by imaging, this trial resulted in 92% sensitivity, 87% specificity, 99% negative predictive value, and 88% accuracy.
The FDCA and other federal and state statutes and regulations, govern, among other things, the research, development, testing, manufacture, storage, recordkeeping, approval, labeling, promotion and marketing, distribution, post-approval monitoring and reporting, sampling, and import and export of pharmaceutical products.
Therapeutic Products FDA Approval Process In the U.S., therapeutic products are subject to extensive regulation by the FDA. The FDCA and other federal and state statutes and regulations, govern, among other things, the research, development, testing, manufacture, storage, recordkeeping, approval, labeling, promotion and marketing, distribution, post-approval monitoring and reporting, sampling, and import and export of pharmaceutical products.
In November 2023, we hired a National Sales Director who has more than 15 years of experience in medical sales and marketing, most recently as Executive Account Manager for the respiratory portfolio of Olympus America’s therapeutic solutions division. Our innovative and collaborative culture is in part responsible for our ability to attract and retain highly skilled professionals seeking professional advancement.
Dallas Coleman, Vice President of Sales, brings more than 15 years of experience in medical sales and marketing, including as Executive Account Manager for the respiratory portfolio of Olympus America’s therapeutic solutions division. Our innovative and collaborative culture is in part responsible for our ability to attract and retain highly skilled professionals seeking professional advancement.
The Competition for CyPath ® Lung CyPath ® Lung has not been tested directly against its competitors’ products, but a comparison of the published performance numbers suggests CyPath ® Lung is among the highest performing tests on the market.
The Competition for CyPath ® Lung CyPath ® Lung has not been tested directly against its competitors’ products, but a comparison of the published performance numbers provides evidence that CyPath ® Lung is among the highest performing tests on the market. Furthermore, CyPath ® Lung is noninvasive – not even requiring a needle stick – and cost effective.
Our first diagnostic test, CyPath ® Lung, addresses the need for noninvasive detection of early-stage lung cancer. Lung cancer is the leading cause of cancer-related deaths worldwide. Physicians order CyPath ® Lung to assist in their assessment and care of patients who are at high risk for lung cancer.
Lung cancer is the leading cause of cancer-related deaths worldwide. Physicians order CyPath ® Lung to assist in their assessment of patients who are at high risk for lung cancer.
The recent economic journal article evaluating the significant healthcare cost benefits of using CyPath ® Lung as a standard of care (Morris, et al., 2024) shows that balanced tests, like CyPath ® Lung, can be the most cost effective.
Fifth and as important as any of our test’s benefits, CyPath ® Lung is patient friendly, providing at-home, noninvasive sample collection. The recent economic journal article evaluating the significant healthcare cost benefits of using CyPath ® Lung as a standard of care (Morris, et al., 2024) shows that balanced tests, like CyPath ® Lung, can be the most cost effective.
The FDA may order the temporary or permanent discontinuation of a clinical trial at any time or impose other sanctions if it believes that the clinical trial either is not being conducted in accordance with FDA regulations or presents an unacceptable risk to the clinical trial patients. Imposition of a clinical hold may be full or partial.
Each protocol involving testing on U.S. patients and subsequent protocol amendments must be submitted to the FDA as part of the IND. 21 The FDA may order the temporary or permanent discontinuation of a clinical trial at any time or impose other sanctions if it believes that the clinical trial either is not being conducted in accordance with FDA regulations or presents an unacceptable risk to the clinical trial patients.
We and OncoSelect® own all patents and trademarks in our intellectual property portfolio. One U.S. patent and nine counterpart foreign patents directed at diagnostic applications expire in 2030 and one foreign patent directed at a diagnostic application expires in 2039. One U.S. patent and five counterpart foreign patents directed at therapeutic applications expire in 2037.
We and OncoSelect ® own all patents and trademarks in our intellectual property portfolio. One U.S. patent and nine counterpart non-U.S. patents directed at diagnostic applications expire in 2030, three non-U.S. patents directed at a diagnostic application for lung cancer prediction expires in 2039, and one non-U.S. patent directed to an automated diagnostic lung cancer prediction assay expires in 2042.
We expect to pursue additional research and clinical development in this area with strategic partners that have the resources to advance our discoveries. Our therapeutic platforms originated from our research on how TCPP, the synthetic porphyrin used in CyPath ® Lung, enters cancer cells. We conducted research to better understand the mechanism of TCPP’s selective uptake in cancer cells.
Our therapeutic discoveries originated from our research on how TCPP, the synthetic porphyrin used in CyPath ® Lung, enters cancer cells. We conducted research to better understand the mechanism of TCPP’s selective uptake in cancer cells.
Post-Approval Requirements Once an NDA is approved, a product will be subject to certain post-approval requirements. For instance, the FDA closely regulates the post-approval marketing and promotion of drugs, including standards and regulations for direct-to-consumer advertising, off-label promotion, industry-sponsored scientific and educational activities, and promotional activities involving the internet.
For instance, the FDA closely regulates the post-approval marketing and promotion of drugs, including standards and regulations for direct-to-consumer advertising, off-label promotion, industry-sponsored scientific and educational activities, and promotional activities involving the internet. A drug may be marketed only for the approved indications and in accordance with the provisions of the approved labeling.
However, the New England Journal of Medicine article also reported that LDCT was shown to have a low positive predictive value of less than 4%. This means that for every 100 people who receive a positive result from LDCT screening and are suspected of having lung cancer, only four actually have the disease.
This means that for every 100 people who receive a positive result from LDCT screening and are suspected of having lung cancer, only four actually have the disease.
Balanced tests aim at excluding patients without cancer from unnecessary follow-up diagnostic procedures and detecting patients with early-stage cancer who can proceed to more aggressive procedures to confirm diagnosis.
Balanced tests are designed to achieve high sensitivity and specificity to both exclude patients without cancer from unnecessary follow-up diagnostic procedures and accurately detect patients with early-stage cancer who can proceed to more aggressive procedures to confirm diagnosis.
Those that perform well are most useful to a physician and his or her patient because they provide the most information, allowing a quicker decision on what follow-up path to choose: whether to move forward with more aggressive follow-up procedures (i.e., in the case of CyPath ® Lung, if the test reveals a “likely” or “highly likely” cancer result) or to follow a more conservative approach (i.e., when the CyPath ® Lung test reveals an “unlikely” or “very unlikely” cancer result).
Tests that perform well are most useful to a physician and their patient because they provide the most information, allowing a quicker decision on what follow-up path to choose: whether to move forward with more aggressive follow-up procedures after a CyPath ® Lung results in a “likely malignancy” or to follow a more conservative approach when the CyPath ® Lung test result is “unlikely malignancy”.
In January 2025, we reported the results of the Company’s CyPath ® Lung pilot marketing program using Texas for our beta launch with sales growth Quarter-over-Quarter and more than 600 tests delivered in 2024.
In January 2025, we reported successful results from the Company’s CyPath ® Lung pilot marketing program using Texas for our beta launch with sales growth quarter-over-quarter and more than 600 tests delivered in 2024. Our test marketing approach allowed us to refine future positioning and develop strategic insight for our CyPath ® Lung test before expanding to a larger market.
Item 1. Business Business Overview We develop proprietary noninvasive diagnostics to detect early-stage lung cancer and other diseases of the lung using flow cytometry and automated analysis developed by machine learning, a form of artificial intelligence (“AI”). Our diagnostic tests analyze cell populations, including cancer and cancer-related cells, that are indicative of a specific diseased state.
Item 1. Business Business Overview We develop noninvasive diagnostic laboratory tests to detect early-stage lung cancer and other diseases of the lung using flow cytometry and automated analysis informed by machine learning, a form of artificial intelligence (AI).
The sponsor also must manufacture the investigational device in conformity with the quality controls described in the IDE application and any conditions of IDE approval that the FDA may impose with respect to manufacturing. Postmarket Requirements After a device is placed on the market, numerous general regulatory controls apply.
The sponsor also must manufacture the investigational device in conformity with the quality controls described in the IDE application and any conditions of IDE approval that the FDA may impose with respect to manufacturing. Investigational drugs must be manufactured in accordance with good manufacturing practice (GMP) requirements.
As reported in an article titled “Detection of Early-Stage Lung Cancer in Sputum using Automated Flow Cytometry and Machine Learning,” published in Respiratory Research on January 21, 2023, we conducted a 150-patient test validation trial of people at high risk for lung cancer including patients with the disease (N=28) and those who were cancer-free (N=122) that resulted in CyPath ® Lung’s overall 88% specificity, meaning the ability to correctly identify a person without cancer, and 82% sensitivity, meaning the ability to correctly identify cancer in a person with the disease.
The results of a clinical trial using CyPath ® Lung, “Detection of Early-Stage Lung Cancer in Sputum using Automated Flow Cytometry and Machine Learning,” published in Respiratory Research on January 21, 2023, reported overall 88% specificity, meaning the ability to correctly identify a person without cancer, and 82% sensitivity, meaning the ability to correctly identify cancer in a person with the disease.
The laws and regulations govern, among other things, the design, manufacture, storage, recordkeeping, approval, labeling, promotion, post-approval monitoring and reporting, distribution, and import and export of medical devices, including IVDs. IVDs are a category of medical device that can be purchased by clinical laboratories and used to perform laboratory testing.
The laws and regulations govern, among other things, the design, manufacture, storage, recordkeeping, approval, labeling, promotion, post-approval monitoring and reporting, distribution, and import and export of medical devices.
The CPT PLA code assigned to CyPath ® Lung is 0406U with the descriptor “Oncology (lung), flow cytometry, sputum, 5 markers (meso-tetra [4- carboxyphenyl] porphyrin [TCPP], CD206, CD66b, CD3, CD19), algorithm reported as likelihood of lung cancer.” We have an agreement with GO2 Partners to produce patient collection kits and to provide warehousing and distribution services for sending out the kits.
The Current Procedural Terminology (“CPT”) Proprietary Laboratory Analysis (“PLA”) code specifically for use with CyPath ® Lung, is 0406U with the descriptor “Oncology (lung), flow cytometry, sputum, 5 markers (meso-tetra [\4- carboxyphenyl porphyrin TCPP, CD206, onveniCD66b, CD3, CD19), algorithm reported as likelihood of lung cancer.” We have an agreement with Cardinal Health for logistical services assisting in the delivery of collection kits and return of patient samples to PPLS.
The FDA also may require postmarket testing, known as Phase 4 testing, REMS, and surveillance to monitor the effects of an approved product, or the FDA may place conditions on an approval that could restrict the distribution or use of the product. In addition, quality control, product manufacture, packaging, and labeling procedures must continue to conform to cGMP after approval.
Adverse event reporting and submission of periodic safety summary reports is required following FDA approval of an NDA. The FDA also may require postmarket testing, known as Phase 4 testing, REMS, and surveillance to monitor the effects of an approved product, or the FDA may place conditions on an approval that could restrict the distribution or use of the product.
Violations of the FDCA relating to inappropriate promotion of medical devices may also lead to investigations alleging violations of federal and state healthcare fraud and abuse and other laws, as well as state consumer protection laws.
Violations of the FDCA relating to inappropriate promotion of medical devices may also lead to investigations alleging violations of federal and state healthcare fraud and abuse and other laws, as well as state consumer protection laws. 19 The FDA enforces its requirements by market surveillance and periodic inspections, both announced and unannounced, to review records, equipment, facilities, laboratories, and processes to confirm regulatory compliance.
Second, our proprietary technology is straightforward. Our CyPath ® Lung platform technology is not a molecular test and does not collect genetic material that requires immediate processing. CyPath ® Lung uses well-established flow cytometry techniques to investigate cells contained in the sputum for characteristics that indicate the likelihood of lung cancer.
Second, our proprietary technology is straightforward. CyPath ® Lung uses well-established flow cytometry techniques to investigate cells contained in the sputum for characteristics that indicate the likelihood of lung cancer, unlike molecular tests which can use labile genetic materials. Sample processing is well established, and laboratory technicians can be easily trained. Reagents used by the test are widely available.
CyPath ® Lung has the potential to increase overall diagnostic accuracy of lung cancer, which could lead to increased survival, fewer unnecessary invasive procedures, reduced patient anxiety, and lower medical costs.
For patients with small pulmonary nodules less than 20 millimeters (mm), CyPath ® Lung has shown 92% sensitivity and 87% specificity with 88% accuracy in a clinical trial, offering the potential to increase the overall diagnostic accuracy of lung cancer testing, which could lead to increased survival, fewer unnecessary invasive procedures, reduced patient anxiety, and lower medical costs.
With regard to our diagnostic patent portfolio, we have one issued U.S. patent and nine foreign counterpart patents in Canada, China, France, Germany, Hong Kong, Italy, Spain, Sweden, and the United Kingdom with another recently awarded diagnostic patent in Japan.
One U.S. patent directed to siRNA therapeutic compounds and method of use for treating cancer expires in 2042, one counterpart non-U.S. patent expires in 2039, and one U.S. patent and two counterpart non-U.S. patents directed to therapeutic porphyrin conjugate compounds and method of use for treating cancer expire in 2037. 17 With regard to our diagnostic patent portfolio, we have one issued U.S. patent and nine counterpart patents in Canada, China, France, Germany, Hong Kong, Italy, Spain, Sweden, and the United Kingdom.
Clinical studies also may be required for de novo classification or a 510(k) premarket notification. Clinical trials may also be conducted or continued to satisfy post-approval requirements for devices with PMAs. For significant risk investigational device studies, the FDA regulations require that human clinical investigations conducted in the U.S. be subject to an approved investigational device exemption (“IDE”).
For significant risk investigational device studies, the FDA regulations require that human clinical investigations conducted in the U.S. be subject to an approved investigational device exemption (“IDE”).
Drug manufacturers and certain of their subcontractors are required to register their establishments with the FDA and certain state agencies. Registration with the FDA subjects entities to periodic unannounced inspections by the FDA, during which the agency inspects a drug product’s manufacturing facilities to assess compliance with cGMP.
Registration with the FDA subjects entities to periodic unannounced inspections by the FDA, during which the agency inspects a drug product’s manufacturing facilities to assess compliance with cGMP. Accordingly, manufacturers must continue to expend time, money, and effort in the areas of production and quality control to maintain compliance with cGMP.
Those “unlikely or very unlikely” to have a malignancy may continue imaging surveillance in accordance with local standard of care. The physician’s report also shows a numerical score between 0.1 to 1.0, with 0.1 to less than 0.5 being a negative result and 0.5 to 1.0 considered positive for lung cancer.
The physician’s report also provides a numerical probability score between 0.1 to 1.0, with 0.1 to less than 0.5 being a negative result and more than 0.5 to 1.0 considered positive for lung cancer.
Therefore, we believe the nasal swab test’s performance may suffer when the classifier is tested on more realistic cohorts with a cancer prevalence lower than 10%.
Similar to LungLB, patients in the study had a high cancer prevalence of 54% as compared to the overall high-risk population that has an estimated lung cancer prevalence of 1.1%. (NLCST) Therefore, we believe the nasal swab test’s performance may suffer when the classifier is tested on more realistic cohorts with a cancer prevalence lower than 10%.
Sample processing is straightforward, and laboratory technicians can be easily trained. Reagents used by the test are widely available. Data acquisition and analysis is fully automated, allowing for non-biased, efficient test results. Third, CyPath ® Lung has shown high specificity and sensitivity that is similar to far more invasive and more expensive procedures currently used to detect lung cancer.
Data acquisition and analysis is fully automated, allowing for non-biased, efficient test results. Third, CyPath ® Lung has demonstrated high specificity and sensitivity that is similar to far more invasive and more expensive procedures currently used to detect lung cancer. Fourth, CyPath ® Lung is cost effective, with a Medicare reimbursement code billable to both government and private insurance carriers.
The CyPath ® Lung technology is based on scientific work originating at Los Alamos National Laboratory in collaboration with St. Mary’s Hospital in Colorado. In the Los Alamos research study, sputum samples from lung cancer patients were differentiated from non-cancer samples with 100% accuracy. This early research was conducted with sputum from 12 uranium miners.
In the Los Alamos research study, sputum samples from lung cancer patients were differentiated from non-cancer samples with 100% accuracy. This early research was conducted with sputum from 12 uranium miners. Microscope slides of sputum samples were labeled with the synthetic fluorescent porphyrin TCPP.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changeMisconduct by these parties could include intentional, reckless, and/or negligent conduct that fails to (1) comply with the regulations of the FDA or foreign health authorities; (2) provide true, complete, and accurate information to the FDA or foreign health authorities; (3) comply with manufacturing standards we have established; (4) comply with healthcare fraud and abuse laws in the U.S. and similar foreign fraudulent misconduct laws; or (5) report financial information or data accurately or to disclose unauthorized activities to us. 30 Our business operations and current and future relationships with investigators, healthcare professionals, consultants, third-party payors, and customers are subject, directly or indirectly, to federal and state healthcare fraud and abuse laws, transparency laws, and other healthcare laws and regulations.
Biggest changeMisconduct by these parties could include intentional, reckless, and/or negligent conduct that fails to (1) comply with the regulations of CMS, the FDA or foreign health authorities; (2) provide true, complete, and accurate information to CMS, the FDA or foreign health authorities; (3) comply with manufacturing standards we have established; (4) comply with healthcare fraud and abuse laws in the U.S. and similar foreign fraudulent misconduct laws; or (5) report financial information or data accurately or to disclose unauthorized activities to us.
In addition, since we have limited experience operating a clinical laboratory, we may not accurately estimate the expenses we will incur. We have a limited operating history operating a clinical laboratory, and the members of our management team have limited experience operating a CAP-accredited, CLIA-certified laboratory, which may limit the ability of investors to make an informed investment decision.
In addition, since we have limited experience operating a clinical laboratory, we may not accurately estimate the expenses we will incur. We have a limited history operating a clinical laboratory, and the members of our management team have limited experience operating a CAP-accredited, CLIA-certified laboratory, which may limit the ability of investors to make an informed investment decision.
Declining general economic or business conditions, including tariff and customs regulations, may have a negative impact on our business. Continuing concerns over the U.S. healthcare system and energy costs, geopolitical issues, the availability and cost of credit and government stimulus programs in the U.S. and other countries have contributed to increased volatility and diminished expectations for the global economy.
Declining general economic or business conditions, including tariff and customs regulations, may have a negative impact on our business. Continuing concerns over the U.S. healthcare system and energy costs, geopolitical issues, and the availability and cost of credit and government stimulus programs in the U.S. and other countries have contributed to increased volatility and diminished expectations for the global economy.
Thus, the Leahy-Smith Act and its implementation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents, all of which could have a material adverse effect on our business, financial condition, results of operations, and prospects.
Thus, the Leahy-Smith Act and its implementation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents, all of which could have a material adverse effect on our business, financial condition, results of operations, and prospects.
The process of implementing and maintaining proper internal controls and complying with Section 404 is expensive and time consuming. We cannot be certain that the measures we will undertake will ensure that we will maintain adequate controls over our financial processes and reporting in the future.
The process of implementing and maintaining proper internal controls and complying with Section 404 is expensive and time consuming. We cannot be certain that the measures we undertake will ensure that we will maintain adequate controls over our financial processes and reporting in the future.
Patent and Trademark Office (“USPTO”) and foreign governmental patent agencies requirement for a number of procedural, documentary, fee payment, and other provisions during the patent process can result in abandonment or lapse of a patent or patent application, and partial or complete loss of patent rights in the relevant jurisdiction; ● it is possible that our pending patent applications will not lead to issued patents; 37 ● issued patents that we own or have exclusively licensed may be revoked, modified, or held invalid or unenforceable, as a result of legal challenges by our competitors; ● our competitors might conduct research and development activities in countries where we do not have patent rights and then use the information learned from such activities to develop competitive tests and products for sale in our major commercial markets; ● we may not develop additional proprietary technologies that are patentable; ● we cannot predict the scope of protection of any patent issuing based on our patent applications, including whether the patent applications that we own or in-license will result in issued patents with claims that are directed to our diagnostic tests and product candidates or uses thereof in the U.S. or foreign countries; ● there may be significant pressure on the U.S. government and international governmental bodies to limit the scope of patent protection both inside and outside the U.S. for disease treatments that prove successful, as a matter of public policy regarding worldwide health concerns; ● countries other than the U.S. may have patent laws less favorable to patentees than those upheld by U.S. courts, allowing foreign competitors a better opportunity to create, develop, and market competing diagnostic tests and product candidates; ● the claims of any patent issuing based on our patent applications may not provide protection against competitors or any competitive advantages, or may be challenged by third parties; and ● if enforced, a court may not hold that our patents are valid, enforceable, and infringed.
Patent and Trademark Office (“USPTO”) and foreign governmental patent agencies requirement for a number of procedural, documentary, fee payment, and other provisions during the patent process can result in abandonment or lapse of a patent or patent application, and partial or complete loss of patent rights in the relevant jurisdiction; ● it is possible that our pending patent applications will not lead to issued patents; 40 ● issued patents that we own or have exclusively licensed may be revoked, modified, or held invalid or unenforceable, as a result of legal challenges by our competitors; ● our competitors might conduct research and development activities in countries where we do not have patent rights and then use the information learned from such activities to develop competitive tests and products for sale in our major commercial markets; ● we may not develop additional proprietary technologies that are patentable; ● we cannot predict the scope of protection of any patent issuing based on our patent applications, including whether the patent applications that we own or in-license will result in issued patents with claims that are directed to our diagnostic tests and product candidates or uses thereof in the U.S. or foreign countries; ● there may be significant pressure on the U.S. government and international governmental bodies to limit the scope of patent protection both inside and outside the U.S. for disease treatments that prove successful, as a matter of public policy regarding worldwide health concerns; ● countries other than the U.S. may have patent laws less favorable to patentees than those upheld by U.S. courts, allowing foreign competitors a better opportunity to create, develop, and market competing diagnostic tests and product candidates; ● the claims of any patent issuing based on our patent applications may not provide protection against competitors or any competitive advantages, or may be challenged by third parties; and ● if enforced, a court may not hold that our patents are valid, enforceable, and infringed.
Among other things, these provisions: ● allow the authorized number of our directors to be changed only by resolution of our Board; ● establish advance notice requirements for stockholder proposals that can be acted on at stockholder meetings and nominations to our Board; ● require that stockholder actions must be effected at a duly called stockholder meeting and prohibit actions by our stockholders by written consent; ● prohibit our stockholders from calling a special meeting of our stockholders; ● provide that the Board is expressly authorized to adopt, amend, alter, or repeal our bylaws; ● establish advance notice requirements for nominations for election to our Board or for proposing matters that can be acted upon by stockholders at annual stockholder meetings; and . ● authorize our Board to issue Preferred Stock without stockholder approval, which could be used to institute a stockholder rights plan, or so-called “poison pill,” that would work to dilute the stock ownership of a potential hostile acquirer, effectively preventing acquisitions that have not been approved by our Board. 49 Any provision in our Charter or A&R Bylaws that has the effect of delaying or deterring a change in control could limit the opportunity for our stockholders to receive a premium for their shares of our Common Stock and could also affect the price that some investors are willing to pay for our Common Stock.
Among other things, these provisions: ● allow the authorized number of our directors to be changed only by resolution of our Board; ● establish advance notice requirements for stockholder proposals that can be acted on at stockholder meetings and nominations to our Board; ● require that stockholder actions must be effected at a duly called stockholder meeting and prohibit actions by our stockholders by written consent; ● prohibit our stockholders from calling a special meeting of our stockholders; ● provide that the Board is expressly authorized to adopt, amend, alter, or repeal our bylaws; ● establish advance notice requirements for nominations for election to our Board or for proposing matters that can be acted upon by stockholders at annual stockholder meetings; and ● authorize our Board to issue Preferred Stock without stockholder approval, which could be used to institute a stockholder rights plan, or so-called “poison pill,” that would work to dilute the stock ownership of a potential hostile acquirer, effectively preventing acquisitions that have not been approved by our Board. 50 Any provision in our Charter or A&R Bylaws that has the effect of delaying or deterring a change in control could limit the opportunity for our stockholders to receive a premium for their shares of our Common Stock and could also affect the price that some investors are willing to pay for our Common Stock.
We may experience numerous unforeseen events during, or as a result of, the testing process that could delay or prevent commercialization of any test or product, including the following: ● the results of pre-clinical studies may be inconclusive, or they may not be indicative of results that will be obtained in human clinical trials; ● safety and efficacy results attained in early human clinical trials may not be indicative of results that are obtained in later clinical trials; ● after reviewing test results, we may abandon projects that we might previously have believed to be promising; ● we or our regulators may suspend or terminate clinical trials because the participating subjects or patients are being exposed to unacceptable health risks; and ● our test or product candidates may not have the desired effects or may include undesirable side effects or other characteristics that preclude regulatory approval or limit their commercial use if approved. 26 Even if our diagnostic tests or therapeutic products receive marketing approval, they may fail to achieve the degree of market acceptance by physicians, patients, third-party payors, and others in the medical community necessary for commercial success.
We may experience numerous unforeseen events during, or as a result of, the testing process that could delay or prevent commercialization of any test or product, including the following: ● the results of pre-clinical studies may be inconclusive, or they may not be indicative of results that will be obtained in human clinical trials; ● safety and efficacy results attained in early human clinical trials may not be indicative of results that are obtained in later clinical trials; ● after reviewing test results, we may abandon projects that we might previously have believed to be promising; ● we or our regulators may suspend or terminate clinical trials because the participating subjects or patients are being exposed to unacceptable health risks; and ● our test or product candidates may not have the desired effects or may include undesirable side effects or other characteristics that preclude regulatory approval or limit their commercial use if approved. 29 Even if our diagnostic tests or therapeutic products receive marketing approval, they may fail to achieve the degree of market acceptance by physicians, patients, third-party payors, and others in the medical community necessary for commercial success.
We have also outsourced elements of our operations to third parties, and as a result we manage a number of third-party contractors who have access to our confidential information. 32 Despite the implementation of security measures, given their size and complexity and the increasing amounts of confidential information that they maintain, our internal information technology systems and those of our third-party clinical research organizations and other contractors and consultants are potentially vulnerable to breakdown or other damage or interruption from service interruptions, system malfunction, natural disasters, terrorism, war, and telecommunication and electrical failures, as well as security breaches from inadvertent or intentional actions by our employees, contractors, consultants, business partners, and/or other third parties, or from cyberattacks by malicious third parties (including the deployment of harmful malware, ransomware, extortion, account takeover attacks, degradation of service attacks, denial-of-service attacks, “phishing,” or social engineering and other means to affect service reliability and threaten the confidentiality, integrity, and availability of information), which may compromise our system infrastructure or lead to data leakage.
We have also outsourced elements of our operations to third parties, and as a result we manage a number of third-party contractors who have access to our confidential information. 35 Despite the implementation of security measures, given their size and complexity and the increasing amounts of confidential information that they maintain, our internal information technology systems and those of our third-party clinical research organizations and other contractors and consultants are potentially vulnerable to breakdown or other damage or interruption from service interruptions, system malfunction, natural disasters, terrorism, war, and telecommunication and electrical failures, as well as security breaches from inadvertent or intentional actions by our employees, contractors, consultants, business partners, and/or other third parties, or from cyberattacks by malicious third parties (including the deployment of harmful malware, ransomware, extortion, account takeover attacks, degradation of service attacks, denial-of-service attacks, “phishing,” or social engineering and other means to affect service reliability and threaten the confidentiality, integrity, and availability of information), which may compromise our system infrastructure or lead to data leakage.
If claims are not submitted to payors on a timely basis or are erroneously submitted, or if PPLS is required to switch to a different provider to handle claim submissions, it may experience delays in its ability to process these claims and receipt of payments from payors, or possibly denial of claims for lack of timely submission, which would have an adverse effect on its, and therefore our, revenue and business.
If claims are not submitted to payors on a timely basis or are erroneously submitted, or if PPLS is required to switch to a different provider to handle claim submissions, it may experience delays in its ability to process these claims and receipt of payments from payors, or possibly denial of claims for lack of timely submission, which would have an adverse effect on our revenue and business.
We may be unable to compete in our target marketplaces, which could impair our ability to generate revenues, thus causing a material adverse impact on our results of operations. Our success depends upon our ability to retain key executives and to attract, retain, and motivate qualified personnel, and the loss of these persons could adversely affect our operations and results.
We may be unable to compete in our target marketplaces, which could impair our ability to generate revenues, thus causing a material adverse impact on our results of operations. 31 Our success depends upon our ability to retain key executives and to attract, retain, and motivate qualified personnel, and the loss of these persons could adversely affect our operations and results.
PPLS may also face increased risk in its collection efforts, including potential write-offs of doubtful accounts and long collection cycles, which could adversely affect its business, results of operations, and financial condition. 36 Several factors make the billing process complex, including: ● the reimbursement rates of payors; ● compliance with complex federal and state regulations related to billing Medicare; ● risk of government audits related to billing Medicare; ● disputes among payors as to which party is responsible for payment; ● differences in coverage and in information and billing requirements among payors, including the need for prior authorization and/or advanced notification; ● the effect of patient co-payments or co-insurance; ● changes to billing codes and/or coverage policies that apply to PPLS’ assays; ● incorrect or missing billing information; and ● the resources required to manage the billing and claims appeals process.
PPLS may also face increased risk in its collection efforts, including potential write-offs of doubtful accounts and long collection cycles, which could adversely affect its business, results of operations, and financial condition. 39 Several factors make the billing process complex, including: ● the reimbursement rates of payors; ● compliance with complex federal and state regulations related to billing Medicare; ● risk of government audits related to billing Medicare; ● disputes among payors as to which party is responsible for payment; ● differences in coverage and in information and billing requirements among payors, including the need for prior authorization and/or advanced notification; ● the effect of patient co-payments or co-insurance; ● changes to billing codes and/or coverage policies that apply to PPLS’ assays; ● incorrect or missing billing information; and ● the resources required to manage the billing and claims appeals process.
Our competitors also may obtain FDA or other regulatory approval for their diagnostic tests or therapeutic products more rapidly than we may obtain approval for ours, which could result in our competitors establishing a stronger market position. In addition, our ability to compete may be affected in many cases by insurers or other third-party payors.
Our competitors also may obtain regulatory approval for their diagnostic tests or therapeutic products more rapidly than we may obtain approval for ours, which could result in our competitors establishing a stronger market position. In addition, our ability to compete may be affected in many cases by insurers or other third-party payors.
The failure of our laboratory to obtain state licenses or permits, where required, could interfere with our strategy for a national rollout of CyPath ® Lung. ICU Medical is providing the Acapella ® Choice Blue device to assist patients in expelling sputum out of the lungs into a collection cup noninvasively.
The failure of our laboratory to obtain state licenses or permits, where required, could interfere with our strategy for a national rollout of CyPath ® Lung. ICU Medical is providing the Acapella tm Choice Blue device to assist patients in expelling sputum out of the lungs into a collection cup noninvasively.
We may not be able to maintain certification of CyPath ® Lung as an LDT in accordance with CAP/CLIA guidance and regulations, or obtain approval of our diagnostic tests in development by the CMS, the FDA, European Medicines Agency, or Chinese National Medical Products Administration.
We may not be able to maintain certification of CyPath ® Lung as an LDT in accordance with CAP/CLIA guidance and regulations, or obtain approval of our diagnostic tests in development by the CMS, European Medicines Agency, or Chinese National Medical Products Administration.
If we are required to conduct additional clinical trials or other testing beyond those that we currently contemplate, if we are unable to successfully complete clinical trials or other testing, if the results of these trials or tests are not positive or are only modestly positive, or if there are safety concerns, we may: ● be delayed in obtaining marketing approval; ● not obtain marketing approval at all, which would seriously impair our viability; 25 ● obtain marketing approval in some countries and not in others; ● obtain approval for indications or patient populations that are not as broad as we intend or desire; ● obtain approval with labeling that includes significant use or distribution restrictions or safety warnings; ● be subject to additional post-marketing testing requirements; or ● have the diagnostic test or therapeutic product removed from the market after obtaining marketing approval.
If we are required to conduct additional clinical trials or other testing beyond those that we currently contemplate, if we are unable to successfully complete clinical trials or other testing, if the results of these trials or tests are not positive or are only modestly positive, or if there are safety concerns, we may: ● be delayed in obtaining marketing approval; ● not obtain marketing approval at all, which would seriously impair our viability; 28 ● obtain marketing approval in some countries and not in others; ● obtain approval for indications or patient populations that are not as broad as we intend or desire; ● obtain approval with labeling that includes significant use or distribution restrictions or safety warnings; ● be subject to additional post-marketing testing requirements; or ● have the diagnostic test or therapeutic product removed from the market after obtaining marketing approval.
Should our licensors or any of the upstream licensors fail to comply with their obligations under the agreements pursuant to which they obtain the rights that are sublicensed to us, or should such agreements be terminated or amended, our ability to develop and commercialize our diagnostic tests or therapeutic product candidates may be materially harmed. 38 In the future, we may need to obtain additional licenses of third-party technology that may not be available to us or are available only on commercially unreasonable terms, which may cause us to operate our business in a more costly or otherwise adverse manner that was not anticipated We currently own intellectual property directed to our diagnostic tests, therapeutic product candidates and other proprietary technologies.
Should our licensors or any of the upstream licensors fail to comply with their obligations under the agreements pursuant to which they obtain the rights that are sublicensed to us, or should such agreements be terminated or amended, our ability to develop and commercialize our diagnostic tests or therapeutic product candidates may be materially harmed. 41 In the future, we may need to obtain additional licenses of third-party technology that may not be available to us or are available only on commercially unreasonable terms, which may cause us to operate our business in a more costly or otherwise adverse manner that was not anticipated We currently own intellectual property directed to our diagnostic tests, therapeutic product candidates and other proprietary technologies.
The market price of our Common Stock could be subject to wide fluctuations in response to quarterly variations in our revenues and operating expenses, announcements of new products or services by us, significant sales of our Common Stock, including “short” sales, the operating and stock price performance of other companies that investors may deem comparable to us, and news reports relating to trends in our markets or general economic conditions. 48 An investment in our Company may involve tax implications, and you are encouraged to consult your own advisors as neither we nor any related party is offering any tax assurances or guidance regarding our Company or your investment.
The market price of our Common Stock could be subject to wide fluctuations in response to quarterly variations in our revenues and operating expenses, announcements of new products or services by us, significant sales of our Common Stock, including “short” sales, the operating and stock price performance of other companies that investors may deem comparable to us, and news reports relating to trends in our markets or general economic conditions. 49 An investment in our Company may involve tax implications, and you are encouraged to consult your own advisors as neither we nor any related party is offering any tax assurances or guidance regarding our Company or your investment.
In addition, using diagnostic tests and therapeutic products that may be developed with potential collaborators in our clinical trials and the subsequent sale of these tests and products by bioAffinity or our potential collaborators may cause us to bear a portion of or all product liability risks.
In addition, using diagnostic tests and therapeutic products that may be developed with potential collaborators in our clinical trials and the subsequent sale of these tests and products by bioAffinity Technologies or our potential collaborators may cause us to bear a portion of or all product liability risks.
While we do not believe that any of the patents owned or licensed by us will be found invalid based on this decision, we cannot predict how future decisions by the courts, Congress or the USPTO may impact the value of our patents. 40 Obtaining and maintaining patent protection depends on compliance with various procedural, document submissions, fee payment, and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
While we do not believe that any of the patents owned or licensed by us will be found invalid based on this decision, we cannot predict how future decisions by the courts, Congress or the USPTO may impact the value of our patents. 43 Obtaining and maintaining patent protection depends on compliance with various procedural, document submissions, fee payment, and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
These billing complexities and the related uncertainty in obtaining payment for its assays could negatively affect its revenue and cash flow, its ability to achieve profitability, and the consistency and comparability of its, and therefore our, results of operations.
These billing complexities and the related uncertainty in obtaining payment for its assays could negatively affect its revenue and cash flow, its ability to achieve profitability, and the consistency and comparability of our results of operations.
In addition, while we anticipate generating continued revenue from PPLS, our CAP-accredited, CLIA-certified clinical pathology laboratory, we do not expect to immediately derive profit from revenue from PPLS’ services.
In addition, while we anticipate generating continued revenue from PPLS, our CAP-accredited, CLIA-certified clinical pathology laboratory, we do not expect to immediately derive substantive profit from revenue from PPLS’ services.
Further, due to increasing inflation, operating costs for many businesses have increased and, in the future, could impact demand or pricing manufacturing of our drug candidates or services providers.
Further, due to inflation, operating costs for many businesses have increased and, in the future, could impact demand or pricing manufacturing of our drug candidates or services providers.
These diagnostic tests and products may compete with our diagnostic tests and therapeutic product candidates, and our or our licensors’ patents or other intellectual property rights may not be effective or sufficient to prevent them from competing. 41 The laws of some jurisdictions do not protect intellectual property rights to the same extent as the laws or regulations in the U.S. and Europe, and many companies have encountered significant difficulties in protecting and defending proprietary rights in such jurisdictions.
These diagnostic tests and products may compete with our diagnostic tests and therapeutic product candidates, and our or our licensors’ patents or other intellectual property rights may not be effective or sufficient to prevent them from competing. 44 The laws of some jurisdictions do not protect intellectual property rights to the same extent as the laws or regulations in the U.S. and Europe, and many companies have encountered significant difficulties in protecting and defending proprietary rights in such jurisdictions.
There can be no assurance that the anticipated benefits of PPLS will materialize or that if they materialize will result in increased stockholder value or revenue stream to the combined company. 23 We will require additional financing to implement our business plan, which may not be available on favorable terms or at all, and we may have to accept financing terms that would place restrictions on us.
There can be no assurance that the anticipated benefits of PPLS will materialize or that if they materialize will result in increased stockholder value or revenue stream to the combined company. 26 We will require additional financing to implement our business plan, which may not be available on favorable terms or at all, and we may have to accept financing terms that would place restrictions on us.
In addition, if PPLS is unable to continue to obtain expedited delivery services on commercially reasonable terms, its operating results may be adversely affected. 34 Security breaches, loss of data, and other disruptions could compromise sensitive information related to PPLS’ business or prevent it from accessing critical information and expose it to liability, which could adversely affect its business and reputation.
In addition, if PPLS is unable to continue to obtain expedited delivery services on commercially reasonable terms, its operating results may be adversely affected. 37 Security breaches, loss of data, and other disruptions could compromise sensitive information related to PPLS’ business or prevent it from accessing critical information and expose it to liability, which could adversely affect its business and reputation.
Acquisitions of, or investments in, competing diagnostic, pharmaceutical, or biotechnology companies by large corporations could increase such competitors’ financial, marketing, manufacturing, and other resources. 31 The market for our proposed tests and products is competitive and rapidly changing, and new diagnostic technologies which may be developed by others could impair our ability to maintain and grow our business and remain competitive.
Acquisitions of, or investments in, competing diagnostic, pharmaceutical, or biotechnology companies by large corporations could increase such competitors’ financial, marketing, manufacturing, and other resources. 34 The market for our proposed tests and products is competitive and rapidly changing, and new diagnostic technologies which may be developed by others could impair our ability to maintain and grow our business and remain competitive.
WithumSmith+Brown, PC, our independent registered public accounting firm for the fiscal year ended December 31, 2024, has included an explanatory paragraph in its opinion that accompanies our audited consolidated financial statements as of and for the year ended December 31, 2024, indicating that our current liquidity position raises substantial doubt about our ability to continue as a going concern.
WithumSmith+Brown, PC, our independent registered public accounting firm for the fiscal year ended December 31, 2025, has included an explanatory paragraph in its opinion that accompanies our audited consolidated financial statements as of and for the year ended December 31, 2025, indicating that our current liquidity position raises substantial doubt about our ability to continue as a going concern.
Complying with these various laws could cause us to incur substantial costs or require PPLS to change its business practices and compliance procedures in a manner adverse to our business. 35 If PPLS uses hazardous chemicals in a manner that causes injury, PPLS could be liable for damages. PPLS’ activities currently require the controlled use of potentially harmful chemicals.
Complying with these various laws could cause us to incur substantial costs or require PPLS to change its business practices and compliance procedures in a manner adverse to our business. 38 If PPLS uses hazardous chemicals in a manner that causes injury, PPLS could be liable for damages. PPLS’ activities currently require the controlled use of potentially harmful chemicals.
If the FDA were to conclude that we are required to obtain premarket authorization for the software, our ability to offer CyPath ® Lung as an LDT could be delayed or prevented, which would adversely affect our business. 43 The third-party licensors of our future therapeutic products, when ready, may be unable to obtain regulatory approval.
If the FDA were to conclude that we are required to obtain premarket authorization for the software, our ability to offer CyPath ® Lung as an LDT could be delayed or prevented, which would adversely affect our business. 45 The third-party licensors of our future therapeutic products, when ready, may be unable to obtain regulatory approval.
An adverse result in any litigation proceeding could put one or more of our patents at risk of being invalidated or interpreted narrowly, which could adversely affect us. 39 If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
An adverse result in any litigation proceeding could put one or more of our patents at risk of being invalidated or interpreted narrowly, which could adversely affect us. 42 If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
Since its acquisition in September 2023, we have generated $2.5 million in 2023 and $9.4 million in 2024 in revenue from PPLS. Once we begin to generate such profit, there is no guarantee that it will be sufficient to realize the expected financial benefits of the acquisition.
Since its acquisition in September 2023, we have generated $2.5 million in 2023, $9.4 million in 2024, and $6.2 million in 2025 in revenue from PPLS. Once we begin to generate such profit, there is no guarantee that it will be sufficient to realize the expected financial benefits of the acquisition.
Our dependence on independent parties and clinical sites involves risks, including reduced control over the timing and other aspects of our clinical trials. 29 We are exposed to product liability and pre-clinical and clinical liability risks which could place a substantial financial burden upon us should we be sued.
Our dependence on independent parties and clinical sites involves risks, including reduced control over the timing and other aspects of our clinical trials. 32 We are exposed to product liability and pre-clinical and clinical liability risks which could place a substantial financial burden upon us should we be sued.
PPLS uses standard industry billing codes, known as Current Procedural Terminology (“CPT”) codes, to bill for its diagnostic assays. These codes can change over time. When codes change, there is a risk of an error being made in the claim adjudication process.
PPLS uses standard industry billing codes, known as Current Procedural Terminology (“CPT”) codes, to bill for its diagnostic assays and services. These codes can change over time. When codes change, there is a risk of an error being made in the claim adjudication process.
There may be differences between actual and projected results, and actual results may be materially different from those contained in the projections. 47 Our stock price has fluctuated in the past, has recently been volatile, and may be volatile in the future, and as a result, investors in our Common Stock could incur substantial losses.
There may be differences between actual and projected results, and actual results may be materially different from those contained in the projections. 48 Our stock price has fluctuated in the past, has recently been volatile, and may be volatile in the future, and as a result, investors in our Common Stock could incur substantial losses.
If we or a licensee initiate legal proceedings against a third party to enforce a patent covering one of our diagnostic tests or therapeutic product candidates, the defendant could counterclaim that the patent covering our diagnostic tests or therapeutic product candidate, as applicable, is invalid and/or unenforceable.
If we or a licensee initiates legal proceedings against a third party to enforce a patent covering one of our diagnostic tests or therapeutic product candidates, the defendant could counterclaim that the patent covering our diagnostic tests or therapeutic product candidate, as applicable, is invalid and/or unenforceable.
The impact of changes to healthcare law and guidance, as well as other changes in the healthcare industry, and changes in healthcare spending is currently unknown and may adversely affect our business model. Our revenue prospects could be affected by changes in healthcare spending and policy in the U.S. and abroad.
The impact of changes to healthcare law and guidance, as well as other changes in the healthcare industry, and changes in healthcare spending are currently unknown and may adversely affect our business model. Our revenue prospects could be affected by changes in healthcare spending and policy in the U.S. and abroad.
Any return on investment may be limited to the value of our Common Stock. We do not anticipate paying cash dividends on our Common Stock in the foreseeable future.
We do not expect to pay dividends in the foreseeable future. Any return on investment may be limited to the value of our Common Stock. We do not anticipate paying cash dividends on our Common Stock in the foreseeable future.
To become profitable, we must develop our diagnostic tests and therapeutic products, which will depend in large part on our ability to: ● Develop, enhance, and protect our diagnostic tests and therapeutic products; ● Raise sufficient funding to support our diagnostic tests and therapeutic product development program(s); ● Complete pre-clinical testing; ● Work with our partners to expand commercialization of our first diagnostic test, CyPath ® Lung, as an LDT under the CAP/CLIA guidelines and regulations administered by CMS and CAP; ● Obtain de novo classification from FDA for our CyPath ® Lung as a Class II in vitro diagnostic 22 ● Work with our partners to develop and commercialize our first diagnostic test, CyPath ® Lung, as a CE-marked test in accordance with the IVDR of the EU; ● Synthesize, test, and attract licensing partners for drug conjugates, siRNAs, and other therapeutics (and methods for their use) developed by the Company; ● Develop and conduct human clinical studies to support the regulatory approval and marketing of our diagnostic test(s) and therapeutic product(s); ● Develop and manufacture the test(s) and product(s) to FDA standards, appropriate EU standards, and appropriate standards required for the commercialization of our tests and products in countries in which we seek to sell our diagnostic test(s) and therapeutic product(s); ● Obtain the necessary regulatory approvals to market our diagnostic test(s) and therapeutic product(s); ● Secure the necessary personnel and infrastructure to support the development, commercialization, and marketing of our diagnostic test(s) and therapeutic product(s); and ● Develop strategic relationships to support development, manufacturing, and marketing of our diagnostic test(s) and therapeutic product(s).
To become profitable, we must develop our diagnostic tests and therapeutic products, which will depend in large part on our ability to: ● Develop, enhance, and protect our diagnostic tests and therapeutic products; ● Raise sufficient funding to support our diagnostic tests and therapeutic product development program(s); ● Complete pre-clinical testing; ● Work with our partners to expand commercialization of our first diagnostic test, CyPath ® Lung, as an LDT under the CAP/CLIA guidelines and regulations administered by CMS and CAP; 25 ● Work with our partners to develop and commercialize our first diagnostic test, CyPath ® Lung, as a CE-marked test in accordance with the IVDR of the EU; ● Synthesize, test, and attract licensing partners for drug conjugates, siRNAs, and other therapeutics (and methods for their use) developed by the Company; ● Develop and conduct human clinical studies to support the regulatory approval and marketing of our diagnostic test(s) and therapeutic product(s); ● Develop and manufacture therapeutic product(s) to FDA standards, EU standards, and appropriate standards required for the commercialization of our tests and products in countries in which we seek to sell our diagnostic test(s) and therapeutic product(s); ● Obtain the necessary regulatory approvals to market our diagnostic test(s) and therapeutic product(s); ● Secure the necessary personnel and infrastructure to support the development, commercialization, and marketing of our diagnostic test(s) and therapeutic product(s); and ● Develop strategic relationships to support development, manufacturing, and marketing of our diagnostic test(s) and therapeutic product(s).
Clearance by the FDA does not ensure approval by regulatory or payor authorities in other countries or jurisdictions, and approval by one regulatory or payor authority outside the U.S. does not ensure approval by regulatory authorities in other countries or jurisdictions or by the FDA.
Authorization by the FDA does not ensure approval by regulatory or payor authorities in other countries or jurisdictions, and approval by one regulatory or payor authority outside the U.S. does not ensure approval by regulatory authorities in other countries or jurisdictions or by the FDA.
If we are unable to obtain approval of any of our diagnostic tests or therapeutic product candidates by regulatory or payor authorities in the EU, Asia, or elsewhere, or if we fail to comply with the regulatory requirements in foreign jurisdictions, the commercial prospects of that diagnostic test or therapeutic product candidate may be significantly diminished, and our target market will be reduced and our ability to realize the full market potential of our diagnostic tests or therapeutic product candidates will be harmed. 44 Even if we obtain FDA clearance of any of our diagnostic tests or therapeutic product candidates, we may never obtain approval or commercialize such products outside of the United States, which would limit our ability to realize their full market potential.
If we are unable to obtain approval of any of our diagnostic tests or therapeutic product candidates by regulatory or payor authorities in the EU, Asia, or elsewhere, or if we fail to comply with the regulatory requirements in foreign jurisdictions, the commercial prospects of that diagnostic test or therapeutic product candidate may be significantly diminished, and our target market will be reduced and our ability to realize the full market potential of our diagnostic tests or therapeutic product candidates will be harmed. 46 Even if we obtain FDA approval of any of our therapeutic product candidates and obtain CMS validation for our diagnostic tests, we may never obtain approval or commercialize such products outside of the United States, which would limit our ability to realize their full market potential.
We may not be able to initiate or continue clinical trials if we are unable to locate and enroll a sufficient number of eligible patients to participate in these trials as required by the FDA or similar regulatory authorities outside the U.S., such as the European Medicines Agency.
We may not be able to initiate or continue clinical trials if we are unable to locate and enroll a sufficient number of eligible patients to participate in these trials as required by some physicians or regulatory authorities outside the U.S., such as the European Medicines Agency.
Without funding from the proceeds of a capital raise or strategic relationship or grant, management anticipates that our cash resources are sufficient to continue operations through April 2025. Our future is dependent upon the ability to obtain financing and upon future profitable operations from the development of new business opportunities.
Without funding from the proceeds of a capital raise or strategic relationship or grant, management anticipates that our cash resources are sufficient to continue operations through June 2026. Our future is dependent upon the ability to obtain financing and upon future profitable operations from the development of new business opportunities.
Actual events involving reduced or limited liquidity, defaults, non-performance, or other adverse developments that affect financial institutions or other companies in the financial services industry or the financial services industry generally, or concerns or rumors about any events of these kinds, have in the past and may in the future lead to market-wide liquidity problems. 33 In addition, the global macroeconomic environment could be negatively affected by, among other things, a resurgence of COVID-19 or other pandemics or epidemics, instability in global economic markets, increased U.S. trade tariffs and trade disputes with other countries, instability in the global credit markets, supply chain weaknesses, instability in the geopolitical environment as a result of the withdrawal of the United Kingdom from the European Union, the Russian invasion of Ukraine, the war in the Middle East and other political tensions, and foreign governmental debt concerns.
Actual events involving reduced or limited liquidity, defaults, non-performance, or other adverse developments that affect financial institutions or other companies in the financial services industry or the financial services industry generally, or concerns or rumors about any events of these kinds, have in the past and may in the future lead to market-wide liquidity problems. 36 In addition, the global macroeconomic environment could be negatively affected by, among other things, a resurgence of COVID-19 or other pandemics or epidemics, instability in global economic markets, increased U.S. trade tariffs and trade disputes with other countries, instability in the global credit markets, supply chain weaknesses, instability in the geopolitical environment as a result of the Russian invasion of Ukraine, conflict in the Middle East and other political tensions, and foreign governmental debt concerns.
A decline in the value of our Company could also cause you to lose all or part of your investment. We must raise additional capital to fund our operations in order to continue as a going concern. As of December 31, 2024, we had an accumulated deficit of $53.6 million and $1.1 million cash on hand.
A decline in the value of our Company could also cause you to lose all or part of your investment. We must raise additional capital to fund our operations in order to continue as a going concern. As of December 31, 2025, we had an accumulated deficit of $68.6 million and $6.4 million cash on hand.
The patent position of biopharmaceutical and biotechnology firms generally is highly uncertain and involves complex legal and factual questions. The U.S. Patent and Trademark Office has not established a consistent policy regarding the breadth of claims that it will allow in biotechnology patents.
The patent position of biopharmaceutical and biotechnology firms generally is highly uncertain and involves complex legal and factual questions. The USPTO has not established a consistent policy regarding the breadth of claims that it will allow in biotechnology patents.
Prior to 2022, we had not generated any revenue. During the years ended December 31, 2024, and December 31, 2023, we generated revenue of approximately $9.4 million and $2.5 million, respectively.
Prior to 2022, we had not generated any revenue. During the years ended December 31, 2025, and December 31, 2024, we generated revenue of approximately $6.2 million and $9.4 million, respectively.
We are highly dependent on the principal members of our management, scientific, and clinical teams, including Maria Zannes, J.D., our President and Chief Executive Officer, Xavier Reveles, MS, CG(ASCP) cm , our Chief Operating Officer, and Michael Edwards, our Chief Financial Officer, as well as Roby Joyce, M.D., the Medical Director of PPLS.
We are highly dependent on the principal members of our management, scientific, and clinical teams, including Maria Zannes, J.D., our President and Chief Executive Officer, Xavier Reveles, MS, CG(ASCP) cm , our Chief Operating Officer, and J. Michael Edwards, our Chief Financial Officer.
Consequently, our directors will not be personally liable to us or our stockholders for monetary damages for any breach of fiduciary duties as directors, except liability for: ● any breach of the director’s duty of loyalty to us or our stockholders; 50 ● any act or omission not in good faith or that involves intentional misconduct or a knowing violation of law; ● unlawful payments of dividends or unlawful stock repurchases or redemptions as provided in Section 174 of the DGCL; or ● any transaction from which the director derived an improper personal benefit.
Consequently, our directors will not be personally liable to us or our stockholders for monetary damages for any breach of fiduciary duties as directors, except liability for: ● any breach of the director’s duty of loyalty to us or our stockholders; ● any act or omission not in good faith or that involves intentional misconduct or a knowing violation of law; ● unlawful payments of dividends or unlawful stock repurchases or redemptions as provided in Section 174 of the DGCL; or ● any transaction from which the director derived an improper personal benefit. 51 Our Charter and our A&R Bylaws require us to indemnify our directors and officers and allow us to indemnify other employees and agents to the fullest extent permitted by the DGCL.
Without clearance of CyPath ® Lung by the FDA, some physicians may not order the test. 24 If we experience delays or difficulties in the enrollment of patients in clinical trials, our receipt of necessary regulatory approvals could be delayed or prevented.
Without results of a larger clinical trial of CyPath ® Lung, some physicians may not order the test. 27 If we experience delays or difficulties in the enrollment of patients in clinical trials, our receipt of necessary regulatory approvals could be delayed or prevented.
Any reduction in reimbursement from Medicare or other government programs may result in a similar reduction in payments from private payors, which may adversely affect our future profitability. Risks Related to Ownership of Our Common Stock and Warrants Our failure to meet the continued listing requirements of The Nasdaq Capital Market could result in a de-listing of our Common Stock.
Any reduction in reimbursement from Medicare or other government programs may result in a similar reduction in payments from private payors, which may adversely affect our future profitability. Risks Related to Ownership of Our Common Stock and Warrants We are currently listed on The Nasdaq Capital Market (“Nasdaq”).
Also, the trend toward managed healthcare in the U.S. and the concurrent growth of organizations such as HMOs, which could control or significantly influence the purchase of healthcare services, diagnostics, and drugs, as well as legislative proposals to reform healthcare or reduce government insurance programs, may all result in lower prices for or rejection of our tests or products.
Also, the trend toward managed healthcare in the U.S. and the concurrent growth of organizations such as HMOs, which could control or significantly influence the purchase of healthcare services, diagnostics, and drugs, as well as legislative proposals to reform healthcare or reduce government insurance programs, may all result in lower prices for or rejection of our tests or products. 33 Our employees, independent contractors, consultants, commercial partners, and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
Risks Related to the Operation of a CAP/CLIA Laboratory The operations of PPLS will depend in part upon prior relationships with existing customers and our ability to continue such relationships with these customers.
Risks Related to the Operation of a CAP/CLIA Laboratory The operations of PPLS will depend in part upon prior relationships with existing customers and our ability to continue such relationships with these customers. PPLS’ future success will depend in part upon the continued relationships with existing customers, many of whom have developed professional relationships with our pathologists and vice versa.
PPLS also generates revenue related to the use of CyPath ® Lung tests for a DOD observational study titled “Detection of Abnormal Respiratory Cell Populations in Lung Cancer Screening Patients Using the CyPath ® Lung Assay,” and when performed for DOD research and development on using bronchoalveolar lavage fluid as a biological sample to assess cardiopulmonary function and exercise performance in military personnel post COVID-19 infection. 27 If we are unable to convince physicians of the benefits of our proposed diagnostic tests or therapeutic products, we may incur delays or additional expense in our attempt to establish market acceptance.
PPLS also generates revenue related to the use of CyPath ® Lung tests for a military observational study titled “Detection of Abnormal Respiratory Cell Populations in Lung Cancer Screening Patients Using the CyPath ® Lung Assay.” 30 If we are unable to convince physicians of the benefits of our proposed diagnostic tests or therapeutic products, we may incur delays or additional expense in our attempt to establish market acceptance.
Changes or proposed changes in U.S. or other countries’ trade policies may result in restrictions and economic disincentives on international trade. The U.S. government has recently imposed, or is currently considering imposing, tariffs on certain trade partners.
Changes or proposed changes in U.S. or other countries’ trade policies may result in restrictions and economic disincentives on international trade. The U.S. government has recently imposed, or is currently considering imposing, tariffs on certain trade partners. The impact of these tariffs is uncertain given recent court decisions; however, uncertainty can lead to greater instability.
Some types of SaMD are subject to premarket authorization requirements.
Some types of SaMD are subject to medical device requirements, including in some cases premarket authorization requirements.
If we are unable to do so, our business and financial condition would be materially harmed.
If we are unable to do so, our business and financial condition would be materially harmed. If rapid growth occurs, it may strain our operational, managerial, and financial resources.
To date, we have generated revenue from a limited market launch of CyPath ® Lung in Texas. There can be no assurance that we will be able to successfully expand our commercialization efforts or that we will obtain the necessary regulatory approvals that will allow us to expand our marketing efforts.
There can be no assurance that we will be able to successfully expand our commercialization efforts or that we will obtain the necessary regulatory approvals that will allow us to expand our marketing efforts.
If we are unable to comply, or have not fully complied, with such laws, we could face substantial penalties. Healthcare providers and others play a primary role in the recommendation, ordering, and prescription of any diagnostic tests or therapeutic products for which we obtain marketing approval.
Healthcare providers and others play a primary role in the recommendation, ordering, and prescription of any diagnostic tests or therapeutic products for which we obtain marketing approval.
PPLS may be unable to effectively maintain equipment or generate revenue when its equipment is not operational. Timely, effective service is essential to maintaining the reputation and high use rates of our CAP/CLIA laboratory, PPLS.
Timely, effective service is essential to maintaining the reputation and high use rates of our CAP/CLIA laboratory, PPLS.
Additionally, PPLS is subject to, on an ongoing basis, federal, state, and local laws and regulations governing the use, storage, handling, and disposal of these materials and specified waste products.
Additionally, PPLS is subject to, on an ongoing basis, federal, state, and local laws and regulations governing the use, storage, handling, and disposal of these materials and specified waste products. The cost of compliance with these laws and regulations may become significant and could have a material adverse effect on our financial condition, results of operations, and cash flows.
If we do not pay dividends, our Common Stock may be less valuable because a return on your investment will occur only if our stock price appreciates. Our Common Stock market price may never exceed the exercise price of our outstanding warrants.
If we do not pay dividends, our Common Stock may be less valuable because a return on your investment will occur only if our stock price appreciates. 47 Holders of warrants have no rights as stockholders other than as set forth in the warrants until such holders exercise their warrants and acquire our shares of Common Stock.
Despite raising an additional $1.4 million in gross proceeds in February 2025 through a private placement offering, we may need to raise further capital through the sale of additional equity or debt securities or other debt instruments, strategic relationships or grants, or other arrangements to support our future operations.
For the year 2025, cash used in operations was $9.3 million and net loss was $14.9 million. We may need to raise further capital through the sale of additional equity or debt securities or other debt instruments, strategic relationships or grants, or other arrangements to support our future operations.
We are subject to the risks inherent to the operation of a new business enterprise and cannot assure you that we will be able to successfully address these risks.
We are subject to the risks inherent to the operation of a new business enterprise and cannot assure that we will be able to successfully address these risks. Risks Related to our Diagnostic Product Until we complete our prospective, longitudinal clinical trial, we may encounter physicians who will not order an LDT.
The failure to take any of these actions will constitute a default under the warrant inducement agreement. The financial and operational projections that we may make from time to time are subject to inherent risks.
The financial and operational projections that we may make from time to time are subject to inherent risks.
Joyce, and we do not have “key person” life insurance policies for any of our other officers or advisors. The loss of employees who have established business relationships with our clients could result in delays in services, loss of customers and sales, and diversion of management resources, which could adversely affect our operating results.
The loss of employees who have established business relationships with our clients could result in delays in services, loss of customers and sales, and diversion of management resources, which could adversely affect our operating results. PPLS may be unable to effectively maintain equipment or generate revenue when its equipment is not operational.
The FDA considers an LDT to be a test that is developed, validated, and performed within a single laboratory. The FDA has historically asserted its authority to regulate LDTs as medical devices under the FDCA, but it has generally exercised enforcement discretion with regard to LDTs.
The FDA historically asserted its authority to regulate LDTs as medical devices under the FDCA, but for many years generally exercised enforcement discretion with regard to most LDTs.
If rapid growth occurs, it may strain our operational, managerial, and financial resources. 28 We will depend on third parties to manufacture our kits, reagents and supplies and help in marketing our diagnostic tests and to design trial protocols, arrange for and monitor the clinical trials, and collect and analyze data.
We will depend on third parties to manufacture our kits, reagents, and supplies, and to support certain commercialization and clinical development activities, including marketing support for our diagnostic tests, the design of clinical trials, the arrangement and oversight of clinical trials, and the collection and analysis of data.
Risks Related to Government Regulations CyPath ® Lung is currently being offered as an LDT by PPLS. Should the FDA disagree that CyPath ® Lung is an LDT, or if the FDA’s regulatory approach to LDTs should change in the future, our commercialization strategy may be adversely affected, which would negatively affect our results of operations and financial condition.
While a federal district court decision concluded FDA does not have jurisdiction to regulate LDTs, FDA could in the future determine that CyPath ® Lung is not an LDT, or Congress could enact legislation granting FDA authority to regulate LDTs, which could adversely affect our commercialization strategy and negatively affect our results of operations and financial condition.
Removed
For the year 2024, cash used in operations was $7.1 million and net loss was $9.0 million.
Added
To date, we have generated revenue from anatomical laboratory services offered by PPLS and the marketing of CyPath ® Lung in Texas and the recent expansion into the Mid-Atlantic region and Veterans Administration.
Removed
Risks Related to our Diagnostic Product Until we secure FDA clearance for CyPath ® Lung as a Class II in vitro diagnostic, we may encounter physicians who will not order an LDT.
Added
Physicians may require a prospective longitudinal clinical trial to confirm the performance of our CyPath ® Lung test. We launched our longitudinal trial in March 2026; however, there can be no assurance that the trial will have favorable results.
Removed
In order to market our CyPath ® Lung as an IVD medical device, we must receive de novo classification from the FDA as a Class II in vitro diagnostic.
Added
Our business operations and current and future relationships with investigators, healthcare professionals, consultants, third-party payors, and customers are subject, directly or indirectly, to federal and state healthcare fraud and abuse laws, transparency laws, and other healthcare laws and regulations. If we are unable to comply, or have not fully complied, with such laws, we could face substantial penalties.
Removed
Subject to obtaining necessary financing, we intend to launch a pivotal trial later this year in an effort to attain such classification; however, there can be no assurance that the trial will have favorable results or that it will generate the results necessary to obtain such classification.
Added
Risks Related to Government Regulations PPLS currently offers CyPath ® Lung as an LDT by PPLS.
Removed
Until such time as we receive de novo classification, which we may never receive, our marketing efforts are limited to the marketing and sale of CyPath ® Lung as an LDT.
Added
FDA’s approach changed on May 6, 2024, when FDA promulgated a final rule phasing out its enforcement discretion over LDTs, and stating that compliance with premarket review and quality system requirements would be expected for many LDTs marketed after that date. On March 31, 2025, a federal district court vacated the FDA final rule, thereby cancelling the rulemaking’s associated requirements.
Removed
Our employees, independent contractors, consultants, commercial partners, and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

9 edited+1 added−0 removed3 unchanged
Biggest changeThese cybersecurity partners, including consultants and other third-party service providers , are a key part of bioAffinity’s cybersecurity risk management strategy and infrastructure and provide services including maintenance of an IT assets inventory, periodic vulnerability scanning, identity access management controls including restricted access to privileged accounts, network integrity safeguarded by web-based software, including endpoint protection, endpoint detection and response, and remote monitoring management on all devices, industry-standard encryption protocols, critical data backups, infrastructure maintenance, incident response, cybersecurity strategy, and cyber risk advisory, assessment and remediation. bioAffinity’s management team, in conjunction with third-party IT and cybersecurity service providers, is responsible for oversight and administration of the cyber risk management program and informing senior management and other relevant stakeholders regarding the prevention, detection, mitigation, and remediation of cybersecurity incidents.
Biggest changeThese cybersecurity partners, including consultants and other third-party service providers , are a key part of our cybersecurity risk management strategy and infrastructure and provide services including maintenance of an IT assets inventory, periodic vulnerability scanning, identity access management controls including restricted access to privileged accounts, network integrity safeguarded by web-based software, including endpoint protection, endpoint detection and response, and remote monitoring management on all devices, industry-standard encryption protocols, critical data backups, infrastructure maintenance, incident response, cybersecurity strategy, and cyber risk advisory, assessment and remediation.
Our management team has prior experience selecting, deploying, and overseeing cybersecurity technologies, initiatives, and processes and relies on threat intelligence as well as other information obtained from governmental, public, or private sources. The Audit Committee of the Board of Directors oversees bioAffinity cybersecurity risk exposures and the steps taken by management to monitor and mitigate cybersecurity risks .
Our management team has prior experience selecting, deploying, and overseeing cybersecurity technologies, initiatives, and processes and relies on threat intelligence as well as other information obtained from governmental, public, or private sources. The Audit Committee of the Board of Directors oversees our cybersecurity risk exposures and the steps taken by management to monitor and mitigate cybersecurity risks .
“Risk Factors – Our internal information technology systems, or those of our third-party clinical research organizations or other contractors or consultants, may fail or suffer security breaches, loss or leakage of data, and other disruptions, which could result in a material disruption of our diagnostic tests’ or therapeutic product candidates’ development programs, compromise sensitive information related to our business, or prevent us from accessing critical information, potentially exposing us to liability or otherwise adversely affecting our business.” 52
“Risk Factors – Our internal information technology systems, or those of our third-party clinical research organizations or other contractors or consultants, may fail or suffer security breaches, loss or leakage of data, and other disruptions, which could result in a material disruption of our diagnostic tests’ or therapeutic product candidates’ development programs, compromise sensitive information related to our business, or prevent us from accessing critical information, potentially exposing us to liability or otherwise adversely affecting our business.” 53
Item 1C. Cybersecurity We maintain a cyber risk management program designed to identify, assess, manage, mitigate, and respond to cybersecurity threats. The underlying processes and controls of the bioAffinity cyber risk management program incorporate recognized best practices and standards for cybersecurity and information technology, including the National Institute of Standards and Technology (“NIST”) Cybersecurity Framework (“CSF”).
Item 1C. Cybersecurity We maintain a cyber risk management program designed to identify, assess, manage, mitigate, and respond to cybersecurity threats. The underlying processes and controls of our cyber risk management program incorporate recognized best practices and standards for cybersecurity and information technology, including the National Institute of Standards and Technology (“NIST”) Cybersecurity Framework (“CSF”).
Further, there is increasing regulation regarding responses to cybersecurity incidents, including reporting to regulators, investors, and additional stakeholders, which could subject the Company to additional liability and reputational harm. In response to such risks, the Company has implemented initiatives such as implementation of the cybersecurity risk assessment process and development of an incident response plan.
Further, there is increasing regulation regarding responses to cybersecurity incidents, including reporting to regulators, investors, and additional stakeholders, which could subject us to additional liability and reputational harm. In response to such risks, we have implemented initiatives such as implementation of the cybersecurity risk assessment process and development of an incident response plan.
The Company proactively seeks to detect and investigate unauthorized attempts and attacks against our IT assets, data, and services, and to prevent their occurrence and recurrence where practicable through changes or updates to internal processes and tools and changes or updates to service delivery; however, potential vulnerabilities to known or unknown threats will remain.
We proactively seek to detect and investigate unauthorized attempts and attacks against our IT assets, data, and services, and to prevent their occurrence and recurrence where practicable through changes or updates to internal processes and tools and changes or updates to service delivery; however, potential vulnerabilities to known or unknown threats will remain.
In addition, bioAffinity maintains policies over areas, such as information security, access on/offboarding, and access and account management, to help govern the processes put in place by management designed to protect bioAffinity IT assets, data, and services from threats and vulnerabilities. bioAffinity partners with industry-recognized cybersecurity providers leveraging third-party technology and expertise.
In addition, we maintain policies over areas, such as information security, access on/offboarding, and access and account management, to help govern the processes put in place by management designed to protect our IT assets, data, and services from threats and vulnerabilities. We partner with industry-recognized cybersecurity providers leveraging third-party technology and expertise.
In addition, cybersecurity risks are reviewed by our Board of Directors at least annually, as part of the Company’s corporate risk oversight processes. bioAffinity faces risks from cybersecurity threats that could have a material adverse effect on its business, financial condition, results of operations, cash flows, or reputation. bioAffinity acknowledges that the risk of cyber incident is prevalent in the current threat landscape and that a future cyber incident may occur in the normal course of its business.
We face risks from cybersecurity threats that could have a material adverse effect on its business, financial condition, results of operations, cash flows, or reputation. We acknowledge that the risk of cyber incident is prevalent in the current threat landscape and that a future cyber incident may occur in the normal course of our business.
This includes updates on bioAffinity processes to prevent, detect, and mitigate cybersecurity incidents.
This includes updates on our processes to prevent, detect, and mitigate cybersecurity incidents. In addition, cybersecurity risks are reviewed by our Board of Directors at least annually, as part of the Company’s corporate risk oversight processes.
Added
Our management team, in conjunction with third-party IT and cybersecurity service providers, is responsible for oversight and administration of the cyber risk management program and informing senior management and other relevant stakeholders regarding the prevention, detection, mitigation, and remediation of cybersecurity incidents.

Item 2. Properties

Properties — owned and leased real estate

1 edited+1 added−0 removed4 unchanged
Biggest changeThe license agreement has a one-year term that we can extend by requesting a term extension from UTSA. Since 2016, UTSA has granted each of our annual requests for a license extension. PPLS leases a premises in San Antonio, Texas, used in connection with operation of the CAP-accredited, CLIA-certified clinical pathology laboratory.
Biggest changeThe license agreement has a one-year term that we can extend by requesting a term extension from UTSA. Since 2016, UTSA has granted each of our annual requests for a license extension.
Added
UTSA provided notice in January 2026 that our lease would not be renewed, and as a result we will relocate our research operations from UTSA to privately owned laboratory space. PPLS leases a premises in San Antonio, Texas, used in connection with operation of the CAP-accredited, CLIA-certified clinical pathology laboratory.

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

4 edited+0 added−0 removed4 unchanged
Biggest changePlan category Number of securities to be issued upon exercise of outstanding options, warrants, and rights Weighted-average exercise price of outstanding options, warrants, and rights Number of securities remaining available for future issuance under equity compensation plans (excluding securities reflected in column (a)) (a) (b) (c) Equity compensation plans approved by security holders 2024 Equity Incentive Plan 519,792 $ 2.00 1,480,208 2014 Equity Incentive Plan 380,132 $ 5.78 — Equity compensation plans not approved by security holders — — — Total 899,924 $ 3.59 1,480,208 Item 6. [Reserved.]
Biggest changePlan category Number of securities to be issued upon exercise of outstanding options, warrants, and rights Weighted-average exercise price of outstanding options, warrants, and rights Number of securities remaining available for future issuance under equity compensation plans (excluding securities reflected in column (a)) (a) (b) (c) Equity compensation plans approved by security holders 2024 Equity Incentive Plan 2,179 $ 36.46 41,800 2014 Equity Incentive Plan 11,247 $ 179.99 — Equity compensation plans not approved by security holders — — — Total 13,413 $ 156.67 41,800 Item 6. [Reserved.]
Unregistered Sales of Equity Securities We did not sell any equity securities during the quarter ended December 31, 2024, in transactions that were not registered under the Securities Act other than as previously disclosed in our filings with the SEC.
Unregistered Sales of Equity Securities We did not sell any equity securities during the quarter ended December 31, 2025, in transactions that were not registered under the Securities Act other than as previously disclosed in our filings with the SEC.
Securities Authorized for Issuance Under Equity Compensation Plans The following table presents information as of December 31, 2024, with respect to shares of our Common Stock that may be issued under our equity incentive plans.
Securities Authorized for Issuance Under Equity Compensation Plans The following table presents information as of December 31, 2025, with respect to shares of our Common Stock that may be issued under our equity incentive plans.
Holders of Record As of March 17, 2025, there were approximately 92 holders of record of shares of our Common Stock. This number does not reflect the beneficial holders of our Common Stock who hold shares in street name through brokerage accounts or other nominees. Dividends We have never declared or paid any cash dividends on our capital stock.
Holders of Record As of March 1, 2026, there were approximately 88 holders of record of shares of our Common Stock. This number does not reflect the beneficial holders of our Common Stock who hold shares in street name through brokerage accounts or other nominees. Dividends We have never declared or paid any cash dividends on our capital stock.

Item 6. [Reserved]

Selected Financial Data — reserved (removed by SEC in 2021)

11 edited+1 added−3 removed15 unchanged
Biggest changeRisks Related to Our Diagnostic Tests ● If our tests do not perform as expected, our operating results, reputation, and business will suffer. ● We may experience difficulties that delay or prevent our development, introduction, or marketing of enhanced or new tests. ● If clinical testing of a particular diagnostic test or therapeutic product candidate does not yield successful results, we will be unable to commercialize that test or product candidate. ● Even if our diagnostic tests or therapeutic products receive marketing approval, we may not be successful in commercializing them or they may fail to achieve market acceptance. ● We are currently dependent upon PPLS to offer and perform CyPath ® Lung. ● If we are unable to convince physicians of the benefits of our proposed diagnostic tests or therapeutic products, we may incur delays or additional expense in our attempt to establish market acceptance. ● We face substantial competition. ● Our success depends upon our ability to retain key executives and attract and retain qualified personnel. ● Our lack of operating experience may make it difficult to manage our growth. ● We will depend on third parties to manufacture and market our diagnostic tests and to design trial protocols and monitor clinical trials. ● We are exposed to product liability and pre-clinical and clinical liability risks. ● Our failure to comply with privacy and security regulations could result in liability or reputational harm. ● Our ability to obtain adequate reimbursement for our diagnostic tests may impact our revenues. ● Our employees, consultants, partners, and vendors may engage in misconduct or other improper activities. ● Failure to comply with healthcare laws and regulations could result in substantial penalties. ● We face intense competition in the biotechnology and pharmaceutical industries. ● The market for our proposed tests and products is competitive and rapidly changing. ● Healthcare cost containment initiatives and the growth of managed care may limit our returns. ● Disruption of internal information technology systems will adversely affect our business. ● Declining general economic or business conditions may have a negative impact on our business. ● Global climate change and related regulations could negatively affect our business. 5 Risks Related to the Operation of a CAP/CLIA Laboratory ● PPLS’s operations depend upon the relationship of certain of our pathologists with existing customers. ● PPLS may be unable to maintain equipment or generate revenue when its equipment is not operational. ● If our sole laboratory facility becomes damaged or inoperable, loses its accreditation, or is required to vacate the facility, PPLS’ ability to sell its products or provide diagnostic assays and pursue its research and development efforts may be jeopardized. ● PPLS relies on commercial courier delivery services to transport sputum samples for CyPath ® Lung, the disruption of which could harm its business. ● Security breaches, data loss, and other disruptions could compromise sensitive information of PPLS’ business. ● If PPLS uses hazardous chemicals in a manner that causes injury, PPLS could be liable for damages. ● If PPLS is unable to successfully scale its operations to support demand its business could suffer. ● PPLS must dedicate substantial time and resources to its complex billing process to be paid. ● Delays of third-party billing and collection providers and an in-house billing function to transmit claims to payors could have an adverse effect on PPLS.
Biggest changeRisks Related to Development and Commercialization of Our Diagnostic Tests ● Delays or difficulties in the enrollment of patients in our clinical trials could delay greater adoption by physicians of our commercial test. ● Clinical trials are expensive, time-consuming, and may not be successful. ● If our tests do not perform as expected, our operating results, reputation, and business will suffer. ● We may experience difficulties that delay or prevent our development, introduction, or marketing of enhanced or new tests. ● If clinical testing of a particular diagnostic test or therapeutic product candidate does not yield successful results, we will be unable to commercialize that test or product candidate. ● Even if our diagnostic tests or therapeutic products receive marketing approval, we may not be successful in commercializing them or they may fail to achieve market acceptance. ● We are currently dependent upon our subsidiary, PPLS, to offer and perform CyPath ® Lung. ● If we are unable to convince physicians of the benefits of our proposed diagnostic tests or therapeutic products, we may incur delays or additional expense in our attempt to establish market acceptance. ● Our ability to obtain adequate reimbursement for our diagnostic tests may impact our revenues. ● Our employees, consultants, partners, and vendors may engage in misconduct or other improper activities. ● Failure to comply with healthcare laws and regulations could result in substantial penalties. ● We face intense competition in the biotechnology and pharmaceutical industries. ● The market for our proposed tests and products is competitive and rapidly changing. ● Healthcare cost containment initiatives and the growth of managed care may limit our returns. ● Disruption of internal information technology systems will adversely affect our business. ● Global climate change and related regulations could negatively affect our business. 5 Risks Related to the Operation of Our Commercial Laboratory Accredited by the College of American Pathologists (“CAP”) and the U.S.
The factors that may affect our expectations regarding our operations include, among others, the following: ● our projected financial position and estimated cash burn rate; ● our estimates regarding expenses, future revenues, and capital requirements; ● the success, cost, and timing of our clinical trials; ● our ability to obtain funding for our operations necessary to complete further development and commercialization of our diagnostic tests or therapeutic product candidates; ● our dependence on third parties in the conduct of our clinical trials; ● our ability to obtain the necessary regulatory approvals to market and commercialize our diagnostic tests or therapeutic product candidates; ● the potential that the results of our pre-clinical and clinical trials indicate our current diagnostic tests or any future diagnostic tests or therapeutic product candidates we may seek to develop are unsafe or ineffective; ● the results of market research conducted by us or others; ● our ability to obtain and maintain intellectual property protection for our diagnostic and therapeutic inventions or future diagnostic and therapeutic inventions to expand our product offerings; ● our ability to protect our intellectual property (“IP”) rights and the potential for us to incur substantial costs from lawsuits to enforce or protect our IP rights; ● the possibility that a third party may claim we or our third-party licensors have infringed, misappropriated, or otherwise violated their IP rights and that we may incur substantial costs and be required to devote substantial time defending against such claims; ● our reliance on third parties; ● the success of competing therapies, diagnostic tests, and therapeutic products that are or will become available; ● our ability to expand our organization to accommodate potential growth and to retain and attract key personnel; ● our potential to incur substantial costs resulting from product liability lawsuits against us and the potential for such lawsuits to cause us to limit the commercialization of our diagnostic tests and therapeutic product candidates; 3 ● market acceptance of our diagnostic tests and therapeutic product candidates, the size and growth of the potential markets for our current diagnostic tests and therapeutic product candidates, and any future diagnostic tests and therapeutic product candidates we may seek to develop, and our ability to serve those markets; ● the successful development of our commercialization capabilities, including sales and marketing capabilities; ● compliance with government regulations, including environmental, health, and safety regulations and liabilities thereunder; ● the impact of a health epidemic on our business, our clinical trials, our research programs, healthcare systems, or the global economy as a whole; ● general instability of economic and political conditions in the United States (“U.S.”), including inflationary pressures, increased interest rates, economic slowdown or recession, and escalating geopolitical tensions; ● our anticipated uses of net proceeds from our financings; ● the increased expenses associated with being a public company; and ● other factors discussed elsewhere in this Annual Report.
The factors that may affect our expectations regarding our operations include, among others, the following: ● our projected financial position and estimated cash burn rate; ● our estimates regarding expenses, future revenues, and capital requirements; ● the success, cost, and timing of our clinical trials; ● our ability to obtain funding for our operations necessary to complete further development and commercialization of our diagnostic tests or therapeutic product candidates; ● our dependence on third parties in the conduct of our clinical trials; ● our ability to obtain the necessary regulatory approvals to market and commercialize our diagnostic tests or therapeutic product candidates; ● the potential that the results of our pre-clinical and clinical trials indicate our current diagnostic tests or any future diagnostic tests or therapeutic product candidates we may seek to develop are unsafe or ineffective; ● the results of market research conducted by us or others; ● our ability to obtain and maintain intellectual property (“IP”) protection for our diagnostic and therapeutic inventions or future diagnostic and therapeutic inventions to expand our product offerings; ● our ability to protect our IP rights and the potential for us to incur substantial costs from lawsuits to enforce or protect our IP rights; ● the possibility that a third party may claim we or our third-party licensors have infringed, misappropriated, or otherwise violated their IP rights and that we may incur substantial costs and be required to devote substantial time defending against such claims; ● our reliance on third parties; ● the success of competing diagnostic tests and therapeutic products that are or will become available; ● our ability to expand our organization to accommodate potential growth and to retain and attract key personnel; ● our potential to incur substantial costs resulting from product liability lawsuits against us and the potential for such lawsuits to cause us to limit the commercialization of our diagnostic tests and therapeutic product candidates; 3 ● market acceptance of our diagnostic tests and therapeutic product candidates, the size and growth of the potential markets for our current diagnostic tests and therapeutic product candidates, and any future diagnostic tests and therapeutic product candidates we may seek to develop, and our ability to serve those markets; ● the successful development of our commercialization capabilities, including sales and marketing capabilities; ● compliance with government regulations, including environmental, health, and safety regulations and liabilities thereunder; ● the impact of a health epidemic on our business, our clinical trials, our research programs, healthcare systems, or the global economy as a whole; ● general instability of economic and political conditions in the United States (“U.S.”), including inflationary pressures, increased interest rates, economic slowdown or recession, and escalating geopolitical tensions; ● our anticipated uses of net proceeds from our financings; ● the increased expenses associated with being a public company; and ● other factors discussed elsewhere in this Annual Report.
Risks Related to Intellectual Property Rights ● If we fail to comply with our obligations imposed by any intellectual property licenses with third parties that we may need in the future, we could lose rights that are important to our business. ● In the future, we may need to obtain additional licenses of third-party technology that may not be available to us or are available only on commercially unreasonable terms. ● Our competitive position depends on protection of our intellectual property. ● Diagnostic tests and therapeutic products we develop could be subject to infringement claims. ● We may become involved in lawsuits to protect or enforce our intellectual property. ● If we are unable to protect our trade secrets, our business and competitive position could be harmed. ● Changes in patent law could impair our ability to protect our tests and product candidates. ● Our patent protection could be reduced or eliminated for non-compliance with requirements imposed by governmental patent agencies. ● Patent terms may be inadequate to protect our diagnostic tests or therapeutic product candidates. ● Issued patents could be found invalid or unenforceable. ● If we do not obtain patent term extension, our business may be harmed. ● We enjoy only limited geographical protection with respect to certain patents. ● If our trademarks and trade names are not adequately protected, we may not be able to build name recognition.
Risks Related to Intellectual Property Rights ● If we fail to comply with our obligations imposed by any IP licenses with third parties that we may need in the future, we could lose rights that are important to our business. ● In the future, we may need to obtain additional licenses of third-party technology that may not be available to us or are available only on commercially unreasonable terms. ● Our competitive position depends on protection of our IP. ● Diagnostic tests and therapeutic products we develop could be subject to infringement claims. ● We may become involved in lawsuits to protect or enforce our IP. ● If we are unable to protect our trade secrets, our business and competitive position could be harmed. ● Changes in patent law could impair our ability to protect our tests and product candidates. ● Our patent protection could be reduced or eliminated for non-compliance with requirements imposed by governmental patent agencies. ● Patent terms may be inadequate to protect our diagnostic tests or therapeutic product candidates. ● Issued patents could be found invalid or unenforceable. ● If we do not obtain patent term extension, our business may be harmed. ● We enjoy only limited geographical protection with respect to certain patents. ● If our trademarks and trade names are not adequately protected, we may not be able to build name recognition.
Many of the foregoing risks and uncertainties, as well as risks and uncertainties that are currently unknown to us, are or may be exacerbated by factors such as the ongoing conflict between Ukraine and Russia, escalating tensions between China and Taiwan, the war in the Middle East, increasing economic uncertainty and inflationary pressures, and any consequent worsening of the global business and economic environment.
Many of the foregoing risks and uncertainties, as well as risks and uncertainties that are currently unknown to us, are or may be exacerbated by factors such as the ongoing conflict between Ukraine and Russia, escalating tensions between China and Taiwan, conflict in the Middle East, increasing economic uncertainty and inflationary pressures, and any consequent worsening of the global business and economic environment.
Other Information 62 Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 62 PART III Item 10. Directors, Executive Officers and Corporate Governance 63 Item 11. Executive Compensation 63 Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 63 Item 13. Certain Relationships and Related Transactions, and Director Independence 63 Item 14.
Other Information 63 Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 63 PART III Item 10. Directors, Executive Officers and Corporate Governance 64 Item 11. Executive Compensation 64 Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 64 Item 13. Certain Relationships and Related Transactions, and Director Independence 64 Item 14.
Exhibit and Financial Statement Schedules 64 Signatures 70 2 Throughout this Annual Report on Form 10-K (the “Annual Report”), the terms “bioAffinity,” “bioAffinity Technologies,” “we,” “us,” “our” or “Company” refer to bioAffinity Technologies, Inc., a Delaware corporation, and its wholly owned subsidiaries, OncoSelect ® Therapeutics, LLC, a Delaware limited liability company, and Precision Pathology Laboratory Services, LLC, a Texas limited liability company.
Exhibit and Financial Statement Schedules 65 Signatures 71 2 Throughout this Annual Report on Form 10-K (the “Annual Report”), the terms “bioAffinity,” “bioAffinity Technologies,” “we,” “us,” “our” or “Company” refer to bioAffinity Technologies, Inc., a Delaware corporation, and its wholly owned subsidiaries, OncoSelect ® Therapeutics, LLC, a Delaware limited liability company, and Precision Pathology Laboratory Services, LLC, a Texas limited liability company.
Item 6. [Reserved] 54 Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations 54 Item 7A. Quantitative and Qualitative Disclosures About Market Risk 61 Item 8. Financial Statements and Supplementary Data 61 Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure 61 Item 9A. Controls and Procedures 62 Item 9B.
Item 6. [Reserved] 55 Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations 55 Item 7A. Quantitative and Qualitative Disclosures About Market Risk 62 Item 8. Financial Statements and Supplementary Data 62 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 62 Item 9A. Controls and Procedures 63 Item 9B.
Unless the context requires otherwise, references to “we,” “us,” “our,” and “bioAffinity,” refer to bioAffinity Technologies, Inc. and its subsidiaries. 4 Summary of Risk Factors Risks Related to Our Financial Position ● Our business plan relies upon our ability to obtain additional sources of capital and financing. ● We must raise additional capital to fund our operations in order to continue as a going concern. ● Our limited operating history makes it difficult to evaluate our business and future prospects. ● We are unable to precisely estimate when we will begin to generate significant profit from Precision Pathology Laboratory Services (PPLS). ● We have limited experience operating a laboratory.
Unless the context requires otherwise, references to “we,” “us,” “our,” and “bioAffinity,” refer to bioAffinity Technologies, Inc. and its subsidiaries. 4 Summary of Risk Factors Risks Related to Our Financial Position ● Our business plan relies upon our ability to obtain additional sources of capital and financing. ● We must raise additional capital to fund our operations in order to continue as a going concern. ● We are unable to precisely estimate when we will begin to generate significant profit from Precision Pathology Laboratory Services (“PPLS”).
Principal Accountant Fees and Services 63 PART IV Item 15.
Principal Accountant Fees and Services 64 PART IV Item 15.
Risks Related to Government Regulations ● Should the FDA’s regulatory approach to LDTs change, our strategy may be adversely affected. ● Delay by or failure of the FDA to grant our request for de novo classification or our failure to comply with applicable requirements would adversely affect our business. ● Failure to comply with laws pertaining to LDTs or in vitro devices (“IVDs”) could adversely affect our business. ● Third-party licensors of our future therapeutic products may be unable to obtain regulatory approval. ● Failure to obtain regulatory approval in foreign jurisdictions would prevent our product candidates from being marketed in those jurisdictions that deny approval. ● We may never obtain approval or commercialize such products outside of the U.S., which would limit our ability to realize their full market potential. ● The impact of changes to healthcare policy and future healthcare reform legislation is unknown.
Risks Related to Government Regulations ● Failure to comply with applicable laws pertaining to our commercial test could adversely affect our business . ● Third-party licensors of our future therapeutic products may be unable to obtain regulatory approval. ● Failure to obtain regulatory approval in foreign jurisdictions would prevent our product candidates from being marketed in those jurisdictions. ● We may never obtain approval of or commercialize such products outside of the U.S., which would limit our ability to realize their full market potential. ● The impact of changes to healthcare policy and future healthcare reform legislation is unknown.
Any return on investment may be limited to the value of our Common Stock. ● Our Common Stock market price may never exceed the exercise price of our outstanding warrants. ● Holders of our warrants have no rights as stockholders until they exercise their warrants. ● The provisions of our outstanding warrants could limit a warrant holder’s ability to choose the judicial forum for disputes. ● Our failure to file timely registration statement pursuant to the terms of a warrant inducement agreement will result in a breach thereof. ● The financial and operational projections that we may make from time to time are subject to inherent risks. ● Our stock price has fluctuated in the past, has recently been volatile, and may be volatile in the future. ● Our Common Stock has often been thinly traded. ● An investment in our Company may involve tax implications. ● Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited. ● Our Certificate of Incorporation permits “blank check” Preferred Stock, which can be designated by our Board without stockholder approval. ● Provisions in our corporate charter documents and under Delaware law could make an acquisition of the Company more difficult. ● Certain provisions in our Charter and Amended and Restated (“A&R”) Bylaws could make a merger, tender offer, or proxy contest difficult. ● Certain provisions of Delaware’s General Corporation Law (“DGCL”) may have anti-takeover effects that could delay, defer, or discourage another party from acquiring control of us. ● Our Charter designates Delaware state or federal courts as the exclusive forum for disputes. ● Certain provisions in our Charter and A&R Bylaws may discourage stockholders from bringing a lawsuit against our directors and officers. ● Our management collectively owns a substantial percentage of our Common Stock. ● If analysts do not publish research or publish inaccurate or unfavorable research about our business, our stock price and trading volume could decline. ● Any inability to report and file our financial results accurately and timely could harm our business. 6 PART I
Risks Related to Ownership of Our Common Stock and Warrants ● Our Common Stock market price may never exceed the exercise price of our outstanding warrants. ● Holders of our warrants have no rights as stockholders until they exercise their warrants. ● The provisions of our outstanding warrants could limit a warrant holder’s ability to choose the judicial forum for disputes. ● An investment in our Company may involve tax implications. ● Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited. ● Our Certificate of Incorporation permits “blank check” Preferred Stock, which can be designated by our Board without stockholder approval. ● Provisions in our corporate charter documents and under Delaware law could make an acquisition of the Company more difficult. ● Certain provisions in our Charter and Amended and Restated (“A&R”) Bylaws could make a merger, tender offer, or proxy contest difficult. 6 PART I
Removed
Risks Related to our Diagnostic Product ● Until we secure U.S.
Added
Centers for Medicare and Medicaid (“CMS”) in Accordance with the Clinical Laboratory Improvements Amendments of 1988 (“CLIA”). ● PPLS’s operations depend upon the relationship of certain of our pathologists with existing customers. ● PPLS may be unable to maintain equipment or generate revenue when its equipment is not operational. ● If our sole laboratory facility becomes damaged or inoperable, loses its accreditation, or is required to vacate the facility, PPLS’ ability to sell its products or provide diagnostic assays and commercialization of tests in the research and development stage may be jeopardized. ● PPLS relies on commercial courier delivery services to transport sputum samples for CyPath ® Lung, the disruption of which could harm its business. ● Security breaches, data loss, and other disruptions could compromise sensitive information of PPLS’ business. ● If PPLS uses hazardous chemicals in a manner that causes injury, PPLS could be liable for damages. ● If PPLS is unable to successfully scale its operations to support demand, its business could suffer. ● PPLS must dedicate substantial time and resources to its complex billing process to be paid. ● Delays of third-party billing and collection providers and delays associated with an in-house billing function to transmit claims to payors could have an adverse effect on PPLS.
Removed
Food and Drug Administration (“FDA”) clearance for CyPath ® Lung as an in vitro diagnostic, the FDA could impose greater regulatory burdens on laboratory developed tests (“LDTs”). ● Delays or difficulties in the enrollment of patients could delay or prevent regulatory approvals. ● Clinical trials are expensive, time-consuming, and may not be successful.
Removed
Risks Related to Ownership of Our Common Stock and Warrants ● Our failure to meet the continued listing requirements of The Nasdaq Capital Market could result in a de-listing of our Common Stock. ● We do not expect to pay dividends in the foreseeable future.

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

33 edited+21 added−18 removed38 unchanged
Biggest changeCurrent Year Financial Highlights Key financial results for the year ended December 31, 2024 include: ● Consolidated revenue increased approximately 270% to $9.4 million as compared to $2.5 million for the year ended December 31, 2023, primarily as a result of the acquisition of PPLS in September 2023. ● CyPath ® Lung testing revenue increased approximately 1,400% to $0.5 million as compared to $35 thousand for the year ended December 31, 2023, due to an increase in total test results delivered of more than 600 for the current year. ● Raised approximately $6.9 million in gross proceeds from equity transactions to fund operating activities.
Biggest changeWhile these actions contributed to lower consolidated revenue in the short term, they improved operating focus and cost structure and are intended to position our noninvasive lung cancer diagnostic for scalable growth and improved long-term margin potential. ● CyPath ® Lung testing revenue increased approximately 87% to $963,000 as compared to $516,000 for the year ended December 31, 2024, due to a 99% increase in total test results delivered of more than 600 for the current year. ● Raised approximately $16.9 million in gross proceeds from equity transactions to fund operating activities. 56 Recent Financial Developments Public and Private Offerings All share and per-share amounts in the accompanying footnotes have been retroactively adjusted to reflect our 1-for-30 reverse stock split, which occurred on September 18, 2025.
Factors that could cause such differences are discussed in the “Cautionary Note Regarding Forward-Looking Statements” section of this Annual Report and in the “Risk Factors” in this Annual Report. 54 Our MD&A is organized as follows: ● Company Overview – Discussion of our business plan and strategy to provide context for the remainder of the MD&A. ● Results of Operations – Analysis of our financial results comparing the year ended December 31, 2024, to the year ended December 31, 2023. ● Liquidity and Capital Resources – Analysis of changes in our cash flows and discussion of our financial condition and potential sources of liquidity. ● Critical Accounting Estimates – Accounting estimates are those estimates made in accordance with U.S. generally accepted accounting principles (“GAAP”) that we believe are important to understanding the assumptions and judgments incorporated in our reported financial results and forecasts.
Factors that could cause such differences are discussed in the “Cautionary Note Regarding Forward-Looking Statements” section of this Annual Report and in the “Risk Factors” in this Annual Report. 55 Our MD&A is organized as follows: ● Company Overview – Discussion of our business plan and strategy to provide context for the remainder of the MD&A. ● Results of Operations – Analysis of our financial results comparing the year ended December 31, 2025, to the year ended December 31, 2024. ● Liquidity and Capital Resources – Analysis of changes in our cash flows and discussion of our financial condition and potential sources of liquidity. ● Critical Accounting Estimates – Accounting estimates are those estimates made in accordance with U.S. generally accepted accounting principles (“GAAP”) that we believe are important to understanding the assumptions and judgments incorporated in our reported financial results and forecasts.
This quantitative assessment required that the estimated fair value of PPLS’ net assets, including Goodwill, be calculated and compared to the carrying amount. If that estimated fair value is in excess of the carrying amount, no impairment is recognized. We performed this assessment as of December 31, 2024.
This quantitative assessment required that the estimated fair value of PPLS’ net assets, including Goodwill, be calculated and compared to the carrying amount. If that estimated fair value is in excess of the carrying amount, no impairment is recognized. We performed this assessment as of December 31, 2025.
The process for estimating revenues and the ultimate collection of accounts receivable involves significant judgment and estimation. 60 Patient Fee Receivables and Considerations for Credit Losses We follow accounting considerations of CECL - Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments.
The process for estimating revenues and the ultimate collection of accounts receivable involves significant judgment and estimation. 61 Patient Fee Receivables and Considerations for Credit Losses We follow accounting considerations of CECL - Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments.
Results of Operations Year Ended December 31, 2024 Compared to the Year Ended December 31, 2023 Our results of operations have varied significantly from year to year and quarter to quarter and may vary significantly in the future.
Results of Operations Year Ended December 31, 2025 Compared to the Year Ended December 31, 2024 Our results of operations have varied significantly from year to year and quarter to quarter and may vary significantly in the future.
We received aggregate gross proceeds of approximately $1.4 million, before deducting advisory fees and other expenses payable by us.
We received aggregate gross proceeds of approximately $1.4 million, before deducting advisory fees and other expenses payable by it.
We received aggregate gross proceeds of approximately $1.4 million, before deducting advisory fees and other expenses payable by us.
We received aggregate gross proceeds of approximately $1.4 million, before deducting advisory fees and other expenses payable by it.
Based on our current expected level of operating expenditures and the cash on hand of approximately $390 thousand at the time of this filing, management concludes that there is substantial doubt about our ability to continue as a going concern for a period of at least twelve (12) months subsequent to the issuance of the accompanying consolidated financial statements.
Based on our current expected level of operating expenditures and the cash on hand of approximately $4.0 million at the time of this filing, management concludes that there is substantial doubt about our ability to continue as a going concern for a period of at least twelve (12) months subsequent to the issuance of the accompanying consolidated financial statements.
In consideration of the immediate exercise of the October Warrants and August Warrants by the holders thereof in accordance with the February Inducement Agreement, we issued unregistered common warrants to purchase an aggregate of up to 2,926,166 shares of Common Stock (120% of the number of shares of Common Stock issuable upon exercise of the October Warrants and August Warrants) to such holders.
In consideration of the immediate exercise of the October Warrants and August Warrants by the holders thereof in accordance with the February Inducement Agreement, we issued unregistered common warrants to purchase an aggregate of up to 97,538 shares of Common Stock (120% of the number of shares of Common Stock issuable upon exercise of the October Warrants and August Warrants) to such holders.
As a result, since our inception in 2014, we have funded our operations principally through private sales of our equity or debt securities. We have never been profitable, and as of December 31, 2024, we had a working capital deficit of $0.4 million and an accumulated deficit of approximately $53.6 million.
As a result, since our inception in 2014, we have funded our operations principally through private sales of our equity or debt securities. We have never been profitable, and as of December 31, 2025, we had working capital surplus of $4.7 million and an accumulated deficit of approximately $68.6 million.
Our diagnostic test, CyPath ® Lung, addresses the need for noninvasive detection of early-stage lung cancer. Lung cancer is the leading cause of cancer-related deaths worldwide. Physicians order CyPath ® Lung to assist in their assessment of patients who are at high risk for lung cancer.
CyPath ® Lung, our first commercial diagnostic test, addresses the need for noninvasive detection of early-stage lung cancer by detecting lung cancer as early as curative Stage 1A. Lung cancer is the leading cause of cancer-related deaths worldwide. Physicians order CyPath ® Lung to assist in their assessment of patients who are at high risk for lung cancer.
During 2024 and 2023, we had net losses of $9.0 million and $7.9 million, respectively, and we expect to incur substantial additional losses in future periods. We have an accumulated deficit of approximately $53.6 million as of December 31, 2024.
During 2025 and 2024, we had net losses of $14.9 million and $9.0 million, respectively, and we expect to incur substantial additional losses in future periods. We have an accumulated deficit of approximately $68.6 million as of December 31, 2025.
The direct offering resulted in gross proceeds of $2.5 million. We have incurred losses since our inception in 2014 as a result of significant expenditures for operations and research and development and, prior to April 2022, the lack of any approved diagnostic test or therapeutic products to generate revenue.
We have incurred losses since our inception in 2014 as a result of significant expenditures for operations and research and development and, prior to April 2022, the lack of any approved diagnostic test or therapeutic products to generate revenue.
Net loss for the year ended December 31, 2024 was approximately $9.0 million, compared to a net loss of approximately $7.9 million for the year ended December 31, 2023, resulting from the operational activities described below. Revenue Post-acquisition, additional revenue streams have been generated starting September 19, 2023.
Net loss for the year ended December 31, 2025 was approximately $14.9 million, compared to a net loss of approximately $9.0 million for the year ended December 31, 2024, resulting from the operational activities described below. Revenue Since acquisition of the clinical pathology laboratory on September 19, 2023, additional revenue streams have been consolidated.
If we are unable to improve our liquidity position, we may not be able to continue as a going concern. Our ability to continue as a going concern is dependent upon our ability to generate revenue and raise capital from financing transactions. There can be no assurance that we will be successful in accomplishing these objectives.
If we are unable to improve our liquidity position, we may not be able to continue as a going concern. Our ability to continue as a going concern is dependent upon our ability to generate revenue and raise capital from financing transactions.
The increase in operating expenses is the result of the following factors. Direct Costs and Expenses Our direct costs and expenses are primarily direct labor for pathology services, laboratory supplies and reagents, laboratory equipment and allocated shared facilities. Direct costs and expenses totaled approximately $6.0 million and $1.7 million during 2024 and 2023, respectively.
The decrease in operating expenses is the result of the following factors. Direct Costs and Expenses Our direct costs and expenses are primarily direct labor for pathology services, laboratory supplies and reagents, laboratory equipment, and allocated shared facilities. Direct costs and expenses totaled $4.2 million and $6.0 million during the years ended December 31, 2025 and 2024, respectively.
Without funding from the proceeds of a capital raise or strategic relationship or grant, management anticipates that our cash resources are sufficient to continue operations through April 2025. Cash and cash equivalents were approximately $1.1 million as of December 31, 2024, which does not take into account the gross proceeds of $1.4 million that we received in February 2025.
Without funding from the proceeds of a capital raise or strategic relationship or grant, management anticipates that our cash resources are sufficient to continue operations through June 2026. Cash and cash equivalents were approximately $6.4 million as of December 31, 2025.
We intend to seek strategic partners to develop our therapeutic discoveries which could result in broad-spectrum cancer treatments in the future. Research and optimization of our platform technologies are conducted in laboratories at our wholly owned subsidiary, PPLS and leased laboratory space at The University of Texas at San Antonio.
We intend to seek strategic partners to develop our therapeutic discoveries which could result in broad-spectrum cancer treatments in the future. Research and development of our diagnostic tests in the pipeline and advancement of our therapeutic discoveries have been conducted at leased laboratory space at The University of Texas at San Antonio.
Research and development expenses remained consistent year-over-year, totaling $1.5 million for the years ended December 31, 2024 and 2023. Clinical Development Clinical development expenses totaled $321,655 and $256,661 for the years ended December 31, 2024 and 2023, respectively.
Research and development expenses remained consistent year-over-year, totaling $1.4 million and $1.5 million for the years ended December 31, 2025 and 2024, respectively. Clinical Development Clinical development expenses totaled approximately $706,000 and $322,000 for the years ended December 31, 2025 and 2024, respectively.
Cash Flows The following information reflects cash flows for the years presented: Year Ended December 31, 2024 2023 Cash and cash equivalents at beginning of year $ 2,821,570 $ 11,413,749 Net cash used in operating activities (7,264,795 ) (6,037,806 ) Net cash used in investing activities (79,083 ) (2,209,399 ) Net cash provided by (used in) financing activities 5,627,599 (344,984 ) Cash and cash equivalents at end of year $ 1,105,291 $ 2,821,570 Net Cash Used in Operating Activities Net cash used in operating activities was approximately $7.3 million and $6.0 million for the years ended December 31, 2024 and 2023, respectively.
There can be no assurance that we will be successful in accomplishing these objectives. 60 Cash Flows The following information reflects cash flows for the years presented: Year Ended December 31, 2025 2024 Cash and cash equivalents at beginning of year $ 1,105,291 $ 2,821,570 Net cash used in operating activities (9,328,842 ) (7,264,795 ) Net cash used in investing activities (60,568 ) (79,083 ) Net cash provided by financing activities 14,733,901 5,627,599 ) Cash and cash equivalents at end of year $ 6,449,782 $ 1,105,291 Net Cash Used in Operating Activities Net cash used in operating activities was approximately $9.3 million and $7.3 million for the years ended December 31, 2025 and 2024, respectively.
In consideration of the immediate exercise of the March Warrants by the holders thereof in accordance with the August Inducement Agreement, we issued unregistered common warrants to purchase an aggregate of up to 1,302,082 shares of Common Stock (120% of the number of shares of Common Stock issuable upon exercise of the March Warrants) to such holders.
In consideration of the immediate exercise of the October Warrants and August Warrants by the holders thereof in accordance with the February Inducement Agreement, we issued unregistered common warrants to purchase an aggregate of up to 97,538 shares of Common Stock (120% of the number of shares of Common Stock issuable upon exercise of the October Warrants and August Warrants) to such holders. 57 Financial To date, we have devoted a substantial portion of our efforts and financial resources to the development of our diagnostic test, CyPath ® Lung.
Recent Financings February 2025 Warrant Inducement On February 26, 2025, pursuant to the terms of the February Inducement Agreement certain holders of existing warrants exercised for cash (i) October Warrants to purchase an aggregate of up to 1,302,082 shares of Common Stock, at the reduced exercise price of $0.58 per share, and (ii) August Warrants to purchase an aggregate of up to 1,136,391 shares of Common Stock, at the reduced exercise price of $0.58 per share.
On February 26, 2025, pursuant to the terms of a warrant inducement agreement (the “February Inducement Agreement”), we entered into with certain holders of existing warrants dated February 25, 2025, such holders exercised for cash (i) warrants to purchase an aggregate of up to 43,402 shares of Common Stock issued on August 5, 2024 (the “August Warrants”), at the reduced exercise price of $17.40 per share, and (ii) warrants to purchase an aggregate of up to 37,878 shares of Common Stock issued on October 21, 2024 (the “October Warrants”), at the reduced exercise price of $17.40 per share.
We received aggregate gross proceeds from the offerings of approximately $450,000, before deducting fees payable to the placement agent and other estimated offering expenses.
The gross proceeds to us from the offering were approximately $1.8 million before deducting placement agent fees and other offering expenses payable by us.
Year Ended December 31, 2024 2023 Patient service fees 1 $ 8,175,670 $ 2,199,558 Histology service fees 1,103,751 272,660 Medical director fees 66,576 19,324 Department of Defense observational studies 8,654 19,442 Other revenues 7,371 21,515 Total net revenue $ 9,362,022 $ 2,532,499 1 Patient services fees includes direct billing for CyPath® Lung diagnostic test of approximately $516,000 and $35,000 for the years ended December 31, 2024 and 2023, respectively. 57 Operating Expenses Year Ended Change in 2024 December 31, Versus 2023 2024 2023 $ % Operating expenses: Direct costs and expenses $ 5,983,475 $ 1,740,884 $ 4,242,591 244 % Research and development 1,461,227 1,467,936 (6,709 ) 0 % Clinical development 321,655 256,661 64,994 25 % Selling, general and administrative 9,943,473 6,790,654 3,152,819 46 % Depreciation and amortization 605,637 249,592 356,045 143 % Total operating expenses $ 18,315,467 $ 10,505,727 $ 7,809,740 74 % Operating expenses totaled $18.3 million and $10.5 million for the years ended December 31, 2024 and 2023, respectively.
Year Ended December 31, 2025 2024 Patient service fees 1 $ 4,917,342 $ 8,175,670 Histology service fees 1,116,912 1,103,751 Medical director fees 68,268 66,576 Department of Defense observational studies 577 8,654 Other revenues 4,860 7,371 Total net revenue $ 6,161,959 $ 9,362,022 1 Patient services fees includes direct billing for CyPath ® Lung diagnostic test of approximately $963,000 and $516,000 for the years ended December 31, 2025 and 2024, respectively. 58 Operating Expenses Year Ended Change in 2025 December 31, Versus 2024 2025 2024 $ % Operating expenses: Direct costs and expenses $ 4,226,799 $ 5,983,475 $ (1,756,676 ) (29 )% Research and development 1,383,359 1,461,227 (77,868 ) (5 )% Clinical development 705,744 321,655 384,089 119 % Selling, general and administrative 9,913,729 9,943,473 (29,744 ) 0 % Depreciation and amortization 504,836 605,637 (101,801 ) (17 )% Total operating expenses $ 16,734,467 $ 18,315,467 $ (1,581,800 ) (9 )% Operating expenses totaled $16.7 million and $18.3 million for the years ended December 31, 2025 and 2024, respectively.
Public and Private Offerings On February 26, 2025, pursuant to the terms of the February Inducement Agreement certain holders of existing warrants exercised for cash (i) October Warrants to purchase an aggregate of up to 1,302,082 shares of Common Stock, at the reduced exercise price of $0.58 per share, and (ii) August Warrants to purchase an aggregate of up to 1,136,391 shares of Common Stock, at the reduced exercise price of $0.58 per share.
On February 26, 2025, pursuant to the terms of a warrant inducement agreement (the “February Inducement Agreement”), we entered into with certain holders of existing warrants dated February 25, 2025, such holders exercised for cash (i) warrants to purchase an aggregate of up to 43,402 shares of Common Stock issued on August 5, 2024 (the “August Warrants”), at the reduced exercise price of $17.40 per share, and (ii) warrants to purchase an aggregate of up to 37,878 shares of Common Stock issued on October 21, 2024 (the “October Warrants”), at the reduced exercise price of $17.40 per share.
Net Cash Provided by Financing Activities During the year ended December 31, 2024, net cash provided by financing activities was $5.5 million as compared to net cash used in financing activities of $0.3 million during 2023, representing an increase of approximately $5.9 million.
Net Cash Provided by Financing Activities Cash provided in financing activities was approximately $14.7 million compared to cash provided by financing activities of approximately $5.6 million for the years ended December 31, 2025 and 2024, respectively.
Additionally, the increase was due to the expansion of sales efforts for CyPath ® Lung. 59 Net Cash Used in Investing Activities We used approximately $79,000 in investing activities for the year ended December 31, 2024, compared to $2.2 million used for the year ended December 31, 2023.
Net Cash Used in Investing Activities We used approximately $61,000 for the year ended December 31, 2025, in investing activities related primarily to purchase of computer and lab equipment, compared to approximately $79,000 used in investing activities for the year ended December 31, 2024.
The increase of approximately $4.3 million, or 244%, was primarily attributable to the laboratory operations of PPLS being owned for the full fiscal year 2024, compared to approximately 3.5 months in fiscal year 2023. Research and Development Our research and development expenses consist primarily of expenditures for lab operations, preclinical studies, compensation, and consulting costs.
The decrease of approximately $1.8 million for 2025 compared to 2024 was primarily attributable to the targeted strategic actions which occurred in March 2025, aimed at streamlining operations and reducing costs related to our lab operations. Research and Development Our research and development expenses consist primarily of expenditures for lab operations, preclinical studies, compensation, and consulting costs.
The increase of $64,994, or 25% was primarily attributable to an increase in compensation costs and benefits as we added clinic development personnel. Selling, General and Administrative Our selling, general and administrative expenses consist primarily of expenditures related to employee compensation, legal, accounting and tax, other professional services, and general operating expenses.
Selling, General and Administrative Our selling, general and administrative expenses consist primarily of expenditures related to employee compensation, selling and marketing costs, legal, accounting and tax, and other professional services, and general operating expenses. Selling, general and administrative expenses totaled approximately $9.9 million and $9.9 million for each year ended December 31, 2025 and 2024, respectively.
October 2024 Registered Direct Offering and Concurrent Private Placement On October 21, 2024, we issued to certain institutional investors (i) in a registered direct offering, 2,048,294 shares of our Common Stock, and (ii) in a concurrent private placement, common warrants to purchase an aggregate of 2,662,782 shares of Common Stock, with an exercise price of $1.50, pursuant to a securities purchase agreement, dated October 18, 2024, that we entered into with such institutional investors, and received aggregate gross proceeds from the offerings of approximately $2.7 million, before deducting placement agent fees and other offering expenses.
In October 2025, we entered into definitive agreements for the purchase and sale of 720,000 shares of Common Stock, at a purchase price of $2.50 per share in a registered direct offering priced at-the-market under Nasdaq rules. The gross proceeds from the offering were approximately $1.8 million before deducting placement agent fees and other offering expenses payable by us.
The current year amount related to approximately $18,000 interest earned from money market account offset by interest paid in financing lease for laboratory equipment. 58 Liquidity and Capital Resources To date, we have funded our operations primarily through our IPO, exercise of warrants, and the sale of our equity and debt securities, resulting in gross proceeds of approximately $42.7 million.
The increase in total other expenses of approximately $4.2 million is mostly attributable to the remeasurement of warrant liability and offering costs related to the May public offering, which was further reclassified as equity after the completion of certain events which prevented equity classification. 59 Liquidity and Capital Resources To date, we have funded our operations primarily through our IPO, exercise of warrants, and the sale of our equity and debt securities, resulting in gross proceeds of approximately $58.2 million.
Other Income (Expense) Year Ended Change in 2024 December 31, Versus 2023 2024 2023 $ % Interest (expense) income, net $ (74,865 ) $ 85,006 $ 159,871 (188 )% Other income (expense), net 129 (27,796 ) (27,925 ) (100 )% Total other (expense) income $ (74,736 ) $ 57,210 $ 131,946 231 % Other net income (expense) totaled $129 and $(27,796) for the years ended December 31, 2024 and 2023, respectively, an increase of approximately $28,000, or 100%.
Other Income (Expense) Year Ended Change in 2025 December 31, Versus 2024 2025 2024 $ % Interest (expense) income, net $ (20,987 ) $ (74,865 ) $ 53,878 72 % Other (expense) income, net (461,939 ) 129 (462,068 ) (358,192 )% Gain (loss) on remeasurement of warrant liabilities (3,810,278 ) — (3,810,278 ) (100 )% Total other (expense) income $ (4,293,204 ) $ (74,736 ) $ (4,218,468 ) 5,644 % Other Income (Expense) Total other income (expense), net totaled ($4.3 million) and approximately $(75,000) for the years ended December 31, 2025 and 2024, respectively.
We received aggregate gross proceeds of approximately $1.3 million, before deducting advisory fees and other expenses payable by us.
On May 7, 2025, the Company completed a public offering of securities for gross proceeds to the Company of $3.25 million, before deducting agent fees and other estimated expenses payable by the company.
Removed
Recent Financial Developments Targeted Strategic Actions In March 2025, we announced targeted strategic actions to improve financial performance and accelerate the commercial growth of CyPath® Lung, taking steps to deliver approximately $4 million in annual cost savings at our subsidiary PPLS, while increasing resources to expand CyPath® Lung sales in high-potential national markets.
Added
We plan to move our research and development efforts to privately owned laboratory space in the second quarter 2026.
Removed
Specifically, cost savings are a result of labor cost reductions, operational efficiency enhancements, and discontinuing certain pathology services with suboptimal profit margins to focus on high-margin services such as CyPath ® Lung and by discontinuing certain pathology services with suboptimal profit margins.
Added
Current Year Financial Highlights Key financial results for the year ended December 31, 2025, include: ● Primarily as a result of the Company’s targeted strategic actions to discontinue unprofitable pathology services, reduce costs through operational efficiency, and drive sales growth for CyPath ® Lung, consolidated revenue decreased approximately 34% to $6.2 million as compared to $9.4 million for the year ended December 31, 2024.
Removed
In consideration of the immediate exercise of the October Warrants and August Warrants by the holders thereof in accordance with the February Inducement Agreement, we issued unregistered common warrants (the “February Warrants”) to purchase an aggregate of up to 2,926,166 shares of Common Stock (120% of the number of shares of Common Stock issuable upon exercise of the October Warrants and August Warrants) to such holders. 55 We agreed in the February Inducement Agreement to file a registration statement to register the resale of the shares of Common Stock (the “February Warrant Shares”) issuable upon exercise of the February Warrants (the “Resale Registration Statement”) as soon as practicable (and in any event within 45 calendar days following the date of the Inducement Agreement), and to use commercially reasonable efforts to have the Resale Registration Statement declared effective by the SEC and to keep such registration statement effective at all times until the Holders no longer own any February Warrants or February Warrant Shares.
Added
On September 29, 2025, we consummated a best efforts public offering of an aggregate of (i) 1,047,694 shares of Common Stock and (ii) pre-funded warrants to purchase up to 874,067 shares of Common Stock in lieu of shares of Common Stock. Each share was sold at a public offering price of $2.50.
Removed
On October 21, 2024, we issued to certain institutional investors (i) in a registered direct offering, 2,048,294 shares of our Common Stock, and (ii) in a concurrent private placement (the “October Private Placement”), common warrants to purchase an aggregate of 2,662,782 shares of Common Stock, with an exercise price of $1.50, pursuant to a securities purchase agreement, dated October 18, 2024, that we entered into with such institutional investors, and received aggregate gross proceeds from the offerings of approximately $2.7 million, before deducting placement agent fees and other offering expenses.
Added
Each pre-funded warrant was sold at a public offering price of $2.493. The total gross proceeds for the transaction were approximately $4.8 million.
Removed
The common warrants issued in the October Private Placement became exercisable on December 20, 2024, the date that our stockholders approved the issuance of the shares of Common Stock issuable upon exercise of such warrants, and expire on December 19, 2029. 56 Financial To date, we have devoted a substantial portion of our efforts and financial resources to the development of our diagnostic test, CyPath ® Lung.
Added
On August 13, 2025, we entered into a securities purchase agreement with certain institutional and accredited investors, pursuant to which we agreed to issue and sell in a private placement (i) 990 shares of our newly designated Series B Convertible Preferred Stock, with a par value $0.001 per share and stated value of $1,000 per share, for gross proceeds to us of $990,000, which were initially convertible into 143,476 shares of our Common Stock at an initial conversion price of $6.90 per share and (ii) warrants to purchase up to 223,824 shares of our Common Stock at an exercise price of $10.56 per share of Common Stock.
Removed
Pre-acquisition, bioAffinity Technologies’ revenue was generated in three ways: (1) royalties from our diagnostic test, CyPath ® Lung, (2) clinical flow cytometry services provided to Village Oaks related to CyPath ® Lung test, and (3) CyPath ® Lung tests purchased by the U.S.
Added
The offering consisted of 338,541 shares of our Common Stock, of which 79,044 were pre-funded warrants, together with warrants to purchase up to 507,812 shares of Common Stock, at a combined offering price for each share of common stock (or pre-funded warrant) and accompanying warrant of $9.60 per share.
Removed
Department of Defense (“DOD”) for an observational study, “Detection of Abnormal Respiratory Cell Populations in Lung Cancer Screening Patients Using the CyPath ® Lung Assay (NCT05870592),” and research and development on using bronchoalveolar lavage fluid as a biological sample to assess cardiopulmonary function and exercise performance in military personnel post-COVID-19 infection.
Added
The warrants have an exercise price of $10.56 per share and have certain provisions that allow for additional shares to be issued in the event of a reverse split of the Company’s common stock. Additionally, the warrants include an anti-dilution adjustment which is subject to stockholder approval.
Removed
The royalty income from CyPath ® Lung and clinical flow cytometry services income, beginning September 19, 2023, are related party income, and therefore, eliminated from consolidated net revenues. See net revenue summarized in the table below.
Added
The Company recognizes as revenue the amount that reflects the consideration to which it expects to be entitled in exchange for goods sold or services rendered primarily upon completion of the testing process (when results are reported) or when services have been rendered.
Removed
Selling, general and administrative expenses totaled approximately $9.9 million and $6.8 million for the years ended December 31, 2024 and 2023, respectively. The increase of approximately $3.1 million, or 46% was primarily attributable to the laboratory operations of PPLS being owned for the full fiscal year 2024, compared to approximately 3.5 months in fiscal year 2023.
Added
The increase of approximately $384,000, or 119%, for the year ended December 31, 2025, compared to the same period in 2024 was primarily attributable to an increase in professional fees in 2025 related to managing our clinical strategy for our pivotal clinical trial.
Removed
Additionally, the increase was due to the expansion of sales efforts for CyPath ® Lung, partially offset by a reduction in legal and professional fees.
Added
Our selling, general and administrative costs stayed level despite an increase of approximately $1.0 million in costs related to the addition of personnel and services to support sales of our diagnostic test, CyPath ® Lung, offset by decreases in expenses from targeted strategic actions aimed at streamlining operations and reducing costs in our lab operations.
Removed
The net other expense for the year ended December 31, 2023 related to the loss on the disposal of an asset and other non-operating costs. The net other income for the year ended December 31, 2024 related to approximately a $9,000 gain on a sale of an asset and offset by property taxes.
Added
Depreciation and Amortization Depreciation and amortization expenses totaled approximately $505,000 and $606,000 for the years ended December 31, 2025 and 2024, respectively.
Removed
Interest income (expense) We had net interest (expense) income of approximately $(74,865) and $85,006 for the years ended December 31, 2024 and 2023, respectively. The prior year amount related to approximately $120,000 interest earned from money market account partially offset by interest paid in financing lease for laboratory equipment.
Added
The decrease of approximately $101,000, or 17%, for the year ended December 31, 2025, compared to the same period in 2024 was primarily attributable to the termination of a financing lease in April 2025 due to the Company’s targeted strategic actions announced in March 2025.
Removed
August 2024 Warrant Inducement, Registered Director Offering and Concurrent Private Placement On August 5, 2024, pursuant to the terms of the August Inducement Agreement, certain holders of existing warrants, exercised for cash March Warrants to purchase an aggregate of up to 1,041,667 shares of Common Stock, at the reduced exercise price of $1.25 per share.
Added
Recent Financings In October 2025, we entered into definitive agreements for the purchase and sale of 720,000 shares of Common Stock, at a purchase price of $2.50 per share in a registered direct offering priced at-the-market under Nasdaq rules.
Removed
On August 5, 2024, we also issued to an institutional investor (i) in a registered direct offering, 360,000 shares of Common Stock, and (ii) in a concurrent private placement, warrants to purchase an aggregate of 450,000 shares of Common Stock, with an exercise price of $1.50.
Added
On September 29, 2025, we consummated a best efforts public offering of an aggregate of (i) 1,047,694 shares of Common Stock and (ii) pre-funded warrants to purchase up to 874,067 shares of Common Stock in lieu of shares of Common Stock. Each share was sold at a public offering price of $2.50.
Removed
March 2024 Registered Direct Offering and Concurrent Private Placement On March 8, 2024, we issued to certain investors, pursuant to a Securities Purchase Agreement (1) 1,600,000 shares of Common Stock in a registered direct offering, and (2) warrants to purchase an aggregate of 1,600,000 shares of Common Stock with an exercise price of $1.64, in a concurrent private placement.
Added
Each pre-funded warrant was sold at a public offering price of $2.493. The total gross proceeds for the transaction were approximately $4.8 million.
Removed
The increase of approximately $1.3 million in cash used by operations was primarily attributable to the laboratory operations of PPLS being owned for the full fiscal year 2024, compared to approximately 3.5 months in fiscal year 2023.
Added
On August 13, 2025, we entered into a securities purchase agreement with certain institutional and accredited investors, pursuant to which we agreed to issue and sell in a private placement (i) 990 shares of our newly designated Series B Convertible Preferred Stock, with a par value $0.001 per share and stated value of $1,000 per share, for gross proceeds to us of $990,000, which were initially convertible into 143,476 shares of our Common Stock at an initial conversion price of $6.90 per share and (ii) warrants to purchase up to 223,824 shares of our Common Stock at an exercise price of $10.56 per share of Common Stock.
Removed
The significant decrease of $1.4 million in cash used in investing activities was primarily due to equipment purchases in the current year, and the investing activities in the prior year related to the acquisition of PPLS.
Added
On May 7, 2025, the Company completed a public offering of securities for gross proceeds to the Company of $3.25 million, before deducting agent fees and other estimated expenses payable by the company.
Removed
During the year ended December 31, 2024, net cash provided by financing activities was primarily due to net proceeds of approximately $5.8 million from issuance of Common Stock and, option and warrant exercises, partially offset by financing payments.
Added
The offering consisted of 338,541 shares of our Common Stock, of which 79,044 were pre-funded warrants, together with warrants to purchase up to 507,812 shares of Common Stock, at a combined offering price for each share of common stock (or pre-funded warrant) and accompanying warrant of $9.60 per share.
Added
The warrants have an exercise price of $10.56 per share and have certain provisions that allow for additional shares to be issued in the event of a reverse split of the Company’s common stock. Additionally, the warrants include an anti-dilution adjustment which is subject to stockholder approval.
Added
The increase of approximately $2.0 million in cash used by operations during the years ended December 31, 2025, compared to the same period in 2024 was primarily attributable to an increase of $5.9 million in our loss from operations, a decrease in accounts payable and accrued expenses by $0.5 million offset by a decrease in accounts receivable by $0.9 million compared to the prior year, decrease in stock compensation by $0.3 million, decrease in depreciation and amortization by $0.1 million, and a fair value adjustment to the warrant liability by $3.8 million related to the May 2025 warrant agreement.
Added
The change in proceeds from prior year was primarily related to net proceeds from the equity transactions of $15.1 million offset by payments for loans and finance leases of $0.4 million, compared to the prior year of equity transactions of $5.8 million offset by payments for loans and finance leases of approximately $0.2 million.

Other BIAF 10-K year-over-year comparisons