BIAF

MKT CAP $28.9MP/E —DIV YIELD —FCF YIELD -39.99%REV TTM $5.9M −23.2%NET INCOME −$15.2MNET CASH —52W 3.51 – 71.10SEC XBRL · TTM TO Invalid Date

How BIAF rewrote its risk factors

10-K ITEM 1A · FY2024 → FY2025

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New in FY2025

During the years ended December 31, 2025, and December 31, 2024, we generated revenue of approximately $6.2 million and $9.4 million, respectively.
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; ● 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).
As of December 31, 2025, we had an accumulated deficit of $68.6 million and $6.4 million cash on hand.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Without results of a larger clinical trial of CyPath ® Lung, some physicians may not order the test.
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.
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.” 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 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.
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.
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.
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.
Misconduct 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.
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.
The impact of these tariffs is uncertain given recent court decisions; however, uncertainty can lead to greater instability.
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.
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.
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.
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.
PPLS uses standard industry billing codes, known as Current Procedural Terminology (“CPT”) codes, to bill for its diagnostic assays and services.
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.
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.
The USPTO has not established a consistent policy regarding the breadth of claims that it will allow in biotechnology patents.
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.
Risks Related to Government Regulations PPLS currently offers CyPath ® Lung as an LDT by PPLS.
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.
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.
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.

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Gone since FY2024

During the years ended December 31, 2024, and December 31, 2023, we generated revenue of approximately $9.4 million and $2.5 million, respectively.
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 ● 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).
As of December 31, 2024, we had an accumulated deficit of $53.6 million and $1.1 million cash on hand.
For the year 2024, cash used in operations was $7.1 million and net loss was $9.0 million.
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.
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.
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.
To date, we have generated revenue from a limited market launch of CyPath ® Lung in Texas.
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.
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.
Since its acquisition in September 2023, we have generated $2.5 million in 2023 and $9.4 million in 2024 in revenue from PPLS.
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.
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.
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.
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.
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.
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.
Without clearance of CyPath ® Lung by the FDA, some physicians may not order the test.
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.
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.
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 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.
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 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.
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.
Misconduct 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.
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.
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.
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.
PPLS’ future success will depend in part upon the continued relationships with existing customers, many of whom have developed professional relationships with pathologists who have established relationships with our customers.
In particular, Roby Joyce, M.D. who is the Medical Director of PPLS and a member of our Board of Directors, has a long-term relationship with certain PPLS clients.
We cannot be assured that we will be able to retain his services.
Although we have entered into a three-year employment agreement with him, there can be no assurance that the agreement will not be terminated prior to its expiration.
We do not have an insurance policy on the life of Dr.
Joyce, and we do not have “key person” life insurance policies for any of our other officers or advisors.
The cost of compliance with these laws and regulations may become significant and could have a material adverse effect on its, and therefore our, financial condition, results of operations, and cash flows.
PPLS uses standard industry billing codes, known as Current Procedural Terminology (“CPT”) codes, to bill for its diagnostic assays.
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.
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.
Patent and Trademark Office has not established a consistent policy regarding the breadth of claims that it will allow in biotechnology patents.

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Sentence-level comparison of Item 1A in the two most recent 10-Ks (FY2024 ↗, FY2025 ↗). A reworded sentence counts as one dropped and one added, so heavy edits read as low “kept”. Headings and page furniture are stripped; nothing is summarised by a model.

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