What changed in this filing

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Item 1A. Risk Factors

2026-03-16 compared with 2025-03-31 · 269 added, 369 removed, 1508 unchanged (30% of the section changed)

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guidelines and regulations administered by CMS and CAP;

de novo classification from FDA for our CyPath ® Lung as a Class II in vitro diagnostic

with our partners to develop and commercialize our first diagnostic test, CyPath ® Lung, as a CE-marked test in accordance

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and conduct human clinical studies to support the regulatory approval and marketing of our diagnostic test(s) and therapeutic product(s);

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);

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);

the necessary regulatory approvals to market our diagnostic test(s) and therapeutic product(s);

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was $9.3 million and net loss was $14.9 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.

Our business plan includes

expansion for our commercialization efforts which will require additional funding.

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.

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.

can be no assurance that we will be successful in accomplishing these objectives.

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.

Our business plan

includes expansion for our commercialization efforts which will require additional funding.

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.

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.

is dependent upon the ability to obtain financing and upon future profitable operations from the development of new business opportunities.

There can be no assurance that we will be successful in accomplishing these objectives.

Without such additional capital, we may be required

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testing, and the competitive and regulatory environment in which we will operate.

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.

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.

Even if we do so and are also able to commercialize our diagnostic tests, we may never generate revenue sufficient to become profitable.

Our failure to generate revenue and profit would likely cause our securities to decrease in value or become worthless.

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.

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.

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.

Even if we do so and are also able to commercialize

our diagnostic tests, we may never generate revenue sufficient to become profitable.

Our failure to generate revenue and profit would

likely cause our securities to decrease in value or become worthless.

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.

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 and that revenue generated will

cover necessary operating expenses.

we do not expect to immediately derive substantive profit from revenue from PPLS’ services.

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 and that revenue generated

will cover necessary operating expenses.

In addition, since we have limited experience operating a clinical laboratory, we may not accurately

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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.

In addition, since we have limited experience operating

a clinical laboratory, we may not accurately estimate the expenses we will incur.

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.

$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.

In addition, since we have

limited experience operating a clinical laboratory, we may not accurately estimate the expenses we will incur.

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.

began operating a clinical laboratory in September 2023.

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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.

inherent to the operation of a new business enterprise and cannot assure that we will be able to successfully address these risks.

Related to our Diagnostic Product

we secure FDA clearance for CyPath ® Lung as a Class II in vitro diagnostic, we may encounter physicians who will not

order an LDT.

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 complete our prospective, longitudinal clinical trial, we may encounter physicians who will not order an LDT.

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 experience delays or difficulties in the enrollment of patients in clinical trials, our receipt of necessary regulatory approvals

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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

to participate in these trials as required by some physicians or regulatory authorities outside the U.S., such as the European Medicines

enrollment is affected by many other factors, including:

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such capabilities, we may not be successful in commercializing our diagnostic tests or therapeutic products if and when they are approved.

We are building our sales and marketing organizations and have limited

experience in the sale, marketing, or distribution of our diagnostic

are building our sales and marketing organizations and have limited experience in the sale, marketing, or distribution of our diagnostic

tests and therapeutic products.

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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.

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.”

we are unable to convince physicians of the benefits of our proposed diagnostic tests or therapeutic products, we may incur delays or

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that are more accurate, more convenient, or less expensive than any diagnostic tests or therapeutic products that we may develop.

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.

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.

may be unable to compete in our target marketplaces, which could impair our ability to generate revenues, thus causing a material adverse

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persons could adversely affect our operations and results.

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.

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.

loss of the services of any of our executive officers or other members of our management team could impede the achievement of our research,

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If rapid growth occurs, it may strain our operational, managerial, and financial resources.

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.

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.

do not have, and do not now intend to develop, facilities for the manufacture of the contents of our collection kits needed for clinical

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us should we be sued.

business exposes us to potential product liability and other liability risks that are inherent in the testing, manufacturing, and marketing

of diagnostic tests and therapeutic products.

business exposes us to potential product liability and other liability risks that are inherent in the testing, manufacturing, and

marketing of diagnostic tests and therapeutic products.

Such claims may be asserted against us.

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.

A successful liability

claim, or series of claims, brought against us could have a material adverse effect on our business, financial condition, and results

of operations.

we have obtained product liability insurance covering CyPath ® Lung as a commercialized LDT to be sold by our CAP-accredited, CLIA-certified clinical pathology laboratory PPLS,

in the future we may not be able to obtain or maintain adequate product liability insurance, when needed, on acceptable terms, if at all,

or such insurance may not provide adequate coverage against our potential liabilities.

Furthermore, potential partners with whom we intend

to have collaborative or strategic agreements or our future licensees may not be willing to indemnify us against these types of liabilities

and may not themselves be sufficiently insured or have sufficient liquidity to satisfy any product liability claims.

Claims or losses

in excess of any product liability insurance coverage that we may obtain could have a material adverse effect on our business, financial

condition, and results of operations.

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.

A successful liability claim, or series of claims, brought against us could have a material adverse effect on our

business, financial condition, and results of operations.

we have obtained product liability insurance covering CyPath ® Lung as a commercialized LDT to be sold by our CAP-accredited,

CLIA-certified clinical pathology laboratory PPLS, in the future we may not be able to obtain or maintain adequate product liability

insurance, when needed, on acceptable terms, if at all, or such insurance may not provide adequate coverage against our potential liabilities.

Furthermore, potential partners with whom we intend to have collaborative or strategic agreements or our future licensees may not be

willing to indemnify us against these types of liabilities and may not themselves be sufficiently insured or have sufficient liquidity

to satisfy any product liability claims.

Claims or losses in excess of any product liability insurance coverage that we may obtain could

have a material adverse effect on our business, financial condition, and results of operations.

addition, we may be unable to obtain or to maintain clinical trial liability insurance on acceptable terms, if at all.

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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;

with manufacturing standards we have established;

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.

foreign fraudulent misconduct laws;

or (5) report financial information or data accurately or to disclose unauthorized activities to

business operations and current and future relationships with investigators, healthcare professionals, consultants, third-party payors,

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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.

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

These factors, combined with low business and consumer confidence, could precipitate an economic slowdown and recession.

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resulting in a negative impact on our business, financial condition, and results of operations.

Changes in U.S.

or international social, political, regulatory and economic

conditions or in laws and policies governing trade, manufacturing, development, and investment in the countries where we currently conduct

our business could adversely affect our business, reputation, financial condition, and results of operations.

Changes or proposed changes

or other countries’ trade policies may result in restrictions and economic disincentives on international trade.

government has recently imposed, or is currently considering imposing, tariffs on certain trade partners.

Tariffs, economic sanctions,

and other changes in U.S.

trade policy have in the past and could in the future trigger retaliatory actions by affected countries, and

certain foreign governments have instituted or are considering imposing retaliatory measures on certain U.S.

or international social, political, regulatory and economic conditions or in laws and policies governing trade,

manufacturing, development, and investment in the countries where we currently conduct our business could adversely affect our

business, reputation, financial condition, and results of operations.

Changes or proposed changes in U.S.

or other countries’

trade policies may result in restrictions and economic disincentives on international trade.

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.

Tariffs, economic sanctions, and other changes in U.S.

trade policy have in the past and could in the future trigger retaliatory actions by affected countries, and certain foreign

governments have instituted or are considering imposing retaliatory measures on certain U.S.

Further, any emerging

protectionist or nationalist trends (whether regulatory- or consumer-driven) either in the U.S.

or in other countries could affect the

trade environment.

or in other countries could affect

the trade environment.

Our business, like many other corporations, would be impacted by changes to the trade policies of the U.S.

countries (including governmental action related to tariffs, international trade agreements, or economic sanctions).

Such changes have

the potential to adversely impact the U.S.

economy or certain sectors thereof, the global economy, and our industry, and as a result,

could have a material adverse effect on our business, financial condition, and results of operations.

due to increasing inflation, operating costs for many businesses have increased and, in the future, could impact demand or pricing manufacturing

and foreign countries (including governmental action related to tariffs, international trade agreements, or economic sanctions).

Such changes have the potential to adversely impact the U.S.

economy or certain sectors thereof, the global economy, and our

industry, and as a result, could have a material adverse effect on our business, financial condition, and results of

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.

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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.

Such challenges have caused, and may continue to cause, uncertainty and instability in local

economies and in global financial markets.

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.

Such challenges

have caused, and may continue to cause, uncertainty and instability in local economies and in global financial markets.

are actively monitoring the effects these disruptions and increasing inflation could have on our operations.

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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 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 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.

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 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.

may be unable to effectively maintain equipment or generate revenue when its equipment is not operational.

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coverage it may have.

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 its, and therefore our, financial condition, results of operations, and cash flows.

event of an accident or if PPLS otherwise fails to comply with applicable regulations, it could lose its permits or approvals or be held

liable for damages or penalized with fines.

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

In the event of an accident or if PPLS otherwise fails to comply with applicable regulations, it could lose its permits or approvals

or be held liable for damages or penalized with fines.

PPLS is unable to successfully scale its operations to support demand for CyPath ® Lung, its business could suffer.

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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.

errors can occur with claims submission, third-party transmission, or in the processing of the claim by the payor.

These errors can occur with claims submission, third-party transmission, or in the processing of the claim by the payor.

Claim adjudication

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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.

and the consistency and comparability of our results of operations.

relies on a third-party billing provider and an in-house billing function to transmit claims to payors, and any delay in transmitting

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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.

from payors, or possibly denial of claims for lack of timely submission, which would have an adverse effect on our revenue and business.

Related to Intellectual Property Rights

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we could lose rights that are important to our business.

We may in the future require licenses to third-party technology and materials.

Such licenses may not be available

in the future or may not be available on commercially reasonable terms, or at all, which could have a material adverse effect on our business

and financial condition.

We may in the future rely on third parties from whom we license proprietary technology to file and prosecute

patent applications and maintain patents and otherwise protect the intellectual property we license from them.

We may have limited control

over these activities or any other intellectual property that may be related to future in-licensed intellectual property.

we cannot be certain that such activities by these licensors will be conducted in compliance with applicable laws and regulations or will

result in valid and enforceable patents and other intellectual property rights.

We may have limited control over the manner in which our

licensors initiate an infringement proceeding against a third-party infringer of the intellectual property rights or defend certain of

the intellectual property that may be licensed to us.

It is possible that the licensors’ infringement proceeding or defense activities

may be less vigorous than if we conduct them ourselves.

Even if we acquire the right to control the prosecution, maintenance, and enforcement

of the licensed and sublicensed intellectual property relating to our diagnostic tests or therapeutic product candidates, we may require

may in the future require licenses to third-party technology and materials.

Such licenses may not be available in the future or may not

be available on commercially reasonable terms, or at all, which could have a material adverse effect on our business and financial condition.

We may in the future rely on third parties from whom we license proprietary technology to file and prosecute patent applications and

maintain patents and otherwise protect the intellectual property we license from them.

We may have limited control over these activities

or any other intellectual property that may be related to future in-licensed intellectual property.

For example, we cannot be certain

that such activities by these licensors will be conducted in compliance with applicable laws and regulations or will result in valid

and enforceable patents and other intellectual property rights.

We may have limited control over the manner in which our licensors initiate

an infringement proceeding against a third-party infringer of the intellectual property rights or defend certain of the intellectual

property that may be licensed to us.

It is possible that the licensors’ infringement proceeding or defense activities may be less

vigorous than if we conduct them ourselves.

Even if we acquire the right to control the prosecution, maintenance, and enforcement of

the licensed and sublicensed intellectual property relating to our diagnostic tests or therapeutic product candidates, we may require

the cooperation of our licensors and any upstream licensor, which may not be forthcoming.

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tests or therapeutic product candidates that are the subject of such licensed rights could be adversely affected.

In addition to the foregoing,

the risks associated with patent rights that we license from third parties will also apply to patent rights we may own in the future.

Further, if we fail to comply with our diligence, development and commercialization timelines, milestone payments, royalties, insurance,

and other obligations under our license agreements, we may lose our patent rights with respect to such agreement, which would affect our

patent rights worldwide.

Our inability to secure any future license agreements necessary for development of our products would reduce or eliminate

our rights under these agreements on which we rely that include license provisions and may result in our having to negotiate new or reinstated

agreements with less favorable terms or cause us to lose our rights under these agreements, including our rights to important intellectual

property or technology.

In addition to the

foregoing, the risks associated with patent rights that we license from third parties will also apply to patent rights we may own in

Further, if we fail to comply with our diligence, development and commercialization timelines, milestone payments, royalties,

insurance, and other obligations under our license agreements, we may lose our patent rights with respect to such agreement, which would

affect our patent rights worldwide.

inability to secure any future license agreements necessary for development of our products would reduce or eliminate our rights under

these agreements on which we rely that include license provisions and may result in our having to negotiate new or reinstated agreements

with less favorable terms or cause us to lose our rights under these agreements, including our rights to important intellectual property

or technology.

Any of the foregoing could prevent us from commercializing our other diagnostic tests or therapeutic product candidates

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and involves complex legal and factual questions.

Patent and Trademark Office has not established a consistent policy regarding

the breadth of claims that it will allow in biotechnology patents.

The USPTO has not established a consistent policy regarding the breadth of claims that

it will allow in biotechnology patents.

patent applications we file, including applications that will follow the filing of provisional patents, may not issue as patents or the

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in patent law in the U.S.

and other jurisdictions could diminish the value of patents in general, thereby impairing our ability

to protect our diagnostic tests and therapeutic product candidates.

and other jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect

our diagnostic tests and therapeutic product candidates.

is the case with other biopharmaceutical companies, our success is heavily dependent on intellectual property, particularly patents.

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competitive diagnostics or therapeutics.

Given the amount of time required

for the development, testing, and regulatory review and approval of new diagnostic test or therapeutic product candidates, patents protecting

such candidates may expire before or shortly after such candidates are commercialized.

As a result, our owned and licensed patent portfolio

may not provide us with sufficient rights to exclude others from commercializing diagnostic tests and therapeutic products similar or

identical to ours.

Given the amount of time required for the development, testing, and regulatory review and approval

of new diagnostic test or therapeutic product candidates, patents protecting such candidates may expire before or shortly after such

candidates are commercialized.

As a result, our owned and licensed patent portfolio may not provide us with sufficient rights to exclude

others from commercializing diagnostic tests and therapeutic products similar or identical to ours.

patents covering our product candidates could be found invalid or unenforceable if challenged in court or the USPTO.

we or a licensee initiate legal proceedings against a third party to enforce a patent covering one of our diagnostic tests or therapeutic

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,

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we do not obtain patent term extension in the U.S.

under the Hatch-Waxman Act and in foreign countries under similar legislation,

thereby potentially extending the term of marketing exclusivity for our diagnostic tests or therapeutic product candidates, our business

may be harmed.

under the Hatch-Waxman Act and in foreign countries under similar legislation, thereby

potentially extending the term of marketing exclusivity for our diagnostic tests or therapeutic product candidates, our business may

the U.S., a patent that covers an FDA-approved drug or biologic may be eligible for a term extension designed to restore the period of

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Related to Government Regulations

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.

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

This means that even though the FDA believes it can impose regulatory requirements on LDTs, such as requirements to obtain premarket

approval, de novo classification, or clearance of LDTs, it has generally chosen not to enforce those requirements.

on occasion, sent warning letters to laboratories offering LDTs that the agency believed were not eligible for enforcement discretion

because of how they were developed, validated, performed, or marketed and consequent risks to the public.

May 6, 2024, FDA promulgated a final rule phasing out over four years its enforcement discretion over LDTs.

The agency states it will

expect compliance with premarket review and quality system requirements for LDTs marketed after May 6, 2024.

The FDA states that the

agency will generally not enforce premarket review requirements for LDTs that were marketed before May 6, 2024, if they are not modified

in certain ways.

In particular, the rule states that the LDT is exempt if marketed before May 6, 2024, and is not modified in a way that

changes its indications for use;

does not alter its operating principle;

does not include significantly different technology;

LDT does not adversely change its performance or safety specifications.

The Company has no expectation or intention to modify CyPath ®

Lung in any manner that will change its indications for use, alter its operating principal or include different technology, or

change its performance or safety specifications.

we do intend to conduct clinical trials in order to receive de novo classification from the FDA as a Class II in vitro diagnostic,

there can be no assurance that the trial will have favorable results or that it will generate the results necessary to obtain such clearance.

by or failure of the FDA to grant our request for de novo classification, or failure on our part to comply with applicable requirements,

would adversely affect our business, results of operations, and financial condition.

FDCA requires that medical devices introduced to the U.S.

market, unless exempted by regulation, be authorized by the FDA pursuant to

either the premarket notification pathway, known as 510(k) clearance, the de novo classification pathway, or the premarket approval

(“PMA”) pathway.

We plan to seek de novo classification for the CyPath ® Lung test in fiscal year

The FDA may not agree that CyPath ® Lung meets the criteria for de novo classification, in which case we would

be required to submit a PMA to obtain marketing authorization, which would require manufacturing information and a pre-approval inspection

of the manufacturing facilities and could require review by an FDA advisory panel comprised of experts outside the FDA.

or failure of the FDA to grant our de novo request or PMA could adversely affect our consolidated revenues, results of operations,

and financial condition.

Additionally,

obtaining FDA marketing authorization, approval, or de novo classification for diagnostics can be expensive, time consuming and

uncertain, and for higher-risk devices can take several years and require detailed and comprehensive scientific and clinical data.

addition, medical devices are subject to ongoing FDA obligations and continued regulatory oversight and review.

Ongoing compliance with

FDA regulations increases the cost of conducting our business and subjects us to heightened regulation by the FDA and penalties for failure

to comply with these requirements.

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.

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.

March 31, 2025, a federal district court vacated the FDA final rule, thereby cancelling the rulemaking’s associated requirements.

The court held that laboratory developed tests do not meet the definition of a medical device under the Federal Food, Drug, and Cosmetic

(“FD&C”) Act and the FDA therefore lacks jurisdiction to regulate them.

The court directed FDA to rescind the final rule,

which occurred on September 19, 2025.

FDA has not indicated how it will interpret the court ruling or whether it will seek a different

regulatory approach with respect to LDTs or components thereof.

believe that CyPath ® Lung is an LDT within the scope of the district court decision and that it is not subject to regulation

Should FDA take the position that CyPath ® Lung, or a component thereof, is not an LDT, or should the Company change

the way CyPath ® Lung is offered in the future such that it is no longer an LDT, or should Congress in the future enact

legislation granting FDA authority to regulate LDTs, CyPath ® Lung could become subject to regulation by FDA and face new

regulatory burdens including but not limited to premarket authorization requirements

by our laboratory to comply with applicable laws pertaining to LDTs or IVDs could adversely affect our business, results of operations,

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of CyPath ® Lung.

Medical is providing the Acapella ® Choice Blue device to assist patients in expelling sputum out of the lungs into a collection

cup noninvasively.

This device is 510(k) cleared as a positive expiratory pressure device to help mobilize lung secretions in people

with certain lung conditions.

The device does not have a cleared indication for use as a specimen collection device.

Promotion of the

device by us or our partners for use of the device for specimen collection could cause the FDA to consider the device to be adulterated

or misbranded in violation of the FDCA and to require a 510(k) clearance for a specimen collection indication as a condition of distributing

Any disruption to our ability to distribute the Acapella ® Choice Blue could interfere with our ability to

collect adequate patient samples necessary for CyPath ® Lung.

Medical is providing the Acapella tm Choice Blue device to assist patients in expelling sputum out of the lungs into a

collection cup noninvasively.

This device is 510(k) cleared as a positive expiratory pressure device to help mobilize lung

secretions in people with certain lung conditions.

The device does not have a cleared indication for use as a specimen collection

Promotion of the device by us or our partners for use of the device for specimen collection could cause the FDA to consider

the device to be adulterated or misbranded in violation of the FDCA and to require a 510(k) clearance for a specimen collection

indication as a condition of distributing the device.

Any disruption to our ability to distribute the Acapella ®

Choice Blue could interfere with our ability to collect adequate patient samples necessary for CyPath ®

Lung also relies on a proprietary algorithm to develop and validate software integrated into the test procedure that generates

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software are subject to FDA regulation as a medical device (specifically, software as a medical device or “SaMD”) .

types of SaMD are subject to premarket authorization requirements.

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.

types of SaMD are subject to medical device requirements, including in some cases premarket authorization requirements.

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.

third-party licensors of our future therapeutic products, when ready, may be unable to obtain regulatory approval.

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from a clinical and manufacturing perspective.

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.

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

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candidates will be harmed.

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 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

order to market any diagnostic test or therapeutic product outside of the U.S., we must establish and comply with numerous and varying

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our ability to realize the full market potential of our diagnostic tests or therapeutic products will be harmed.

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.

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.

revenue prospects could be affected by changes in healthcare spending and policy in the U.S.

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Related to Ownership of Our Common Stock and Warrants

failure to meet the continued listing requirements of The Nasdaq Capital Market could result in a de-listing of our Common Stock.

shares of our Common Stock are listed for trading on The Nasdaq Capital Market under the symbol “BIAF” and our Tradeable

Warrants are listed under the symbol “BIAFW.” On February 7, 2025, we received written notice from the Listing Qualifications

Department of The Nasdaq Stock Market LLC (“Nasdaq”) notifying us that for the preceding 30 consecutive business days (December

23, 2024, through February 6, 2025), our Common Stock did not maintain a minimum closing bid price of $1.00 (“Minimum Bid Price

Requirement”) per share as required by Nasdaq Listing Rule 5550(a)(2).

The notice has no immediate effect on the listing or trading

of our Common Stock, and the Common Stock will continue to trade on The Nasdaq Capital Market under the symbol “BIAF.” In

accordance with Nasdaq Listing Rule 5810(c)(3)(A), we have a compliance period of 180 calendar days, or until August 6, 2025, to regain

compliance with Nasdaq Listing Rule 5550(a)(2).

Compliance may be achieved without further action if the closing bid price of our Common

Stock is at or above $1.00 for a minimum of ten consecutive business days at any time during the 180-day compliance period, in which

case Nasdaq will notify us if it determines we are in compliance and the matter will be closed;

however, Nasdaq may require the closing

bid price to equal or to exceed the $1.00 minimum bid price requirement for more than 10 consecutive business days before determining

that a company complies.

however, we do not achieve compliance with the Minimum Bid Price Requirement by August 6, 2025, we may be eligible for additional time

In order to be eligible for such additional time, we will be required to meet the continued listing requirements for market

value of publicly held shares and all other initial listing standards for The Nasdaq Capital Market, with the exception of the Minimum

Bid Price Requirement, and must notify Nasdaq in writing of our intention to cure the deficiency during the second compliance period.

We intend to actively monitor the bid price of our Common Stock and will consider available options to regain compliance with the Nasdaq

listing requirements.

we fail to satisfy the continued listing requirements of The Nasdaq Capital Market, such as the corporate governance requirements, the

stockholder’s equity requirement, or the minimum closing bid price requirement, The Nasdaq Capital Market may take steps to de-list

our Common Stock or Tradeable Warrants.

Such a de-listing or even notification of failure to comply with such requirements would likely

have a negative effect on the price of our Common Stock and Tradeable Warrants and would impair the ability to sell or purchase our

Common Stock when you wish to do so.

In the event of a de-listing, we would take actions to restore our compliance with The Nasdaq Capital

Market’s listing requirements, but we can provide no assurance that any such action taken by us would allow our Common Stock to

become listed again, stabilize the market price, improve the liquidity of our Common Stock, prevent our Common Stock from dropping below

The Nasdaq Capital Market minimum bid price requirement, or prevent future non-compliance with The Nasdaq Capital Market’s listing

requirements.

National Securities Markets Improvement Act of 1996, which is a federal statute, prevents or preempts the states from regulating the

sale of certain securities, which are referred to as “covered securities.” Because our Common Stock is listed on The Nasdaq

Capital Market, it is a covered security.

Although the states are preempted from regulating the sale of covered securities, the federal

statute does allow the states to investigate companies if there is a suspicion of fraud, and, if there is a finding of fraudulent activity,

then the states can regulate or bar the sale of covered securities in a particular case.

Further, if we were to be delisted from The

Nasdaq Capital Market, our Common Stock would cease to be recognized as a covered security and we would be subject to regulation in each

state in which we offer our securities.

are currently listed on The Nasdaq Capital Market (“Nasdaq”).

If we are unable to maintain listing of our securities on Nasdaq

or any stock exchange, our stock price could be adversely affected and the liquidity of our stock and our ability to obtain financing

could be impaired and it may be more difficult for our stockholders to sell their securities.

our Common Stock is currently listed on Nasdaq and we are in compliance with the exchange’s minimum listing requirement, we may

not be able to continue to meet Nasdaq’s minimum listing requirements or those of any other national exchange.

The Listing Rules

of Nasdaq require listing issuers to comply with certain standards in order to remain listed on its exchange.

If, for any reason, we

should fail to maintain compliance with these listing standards and Nasdaq should delist our securities from trading on its exchange

and we are unable to obtain listing on another national securities exchange, a reduction in some or all of the following may occur, each

of which could have a material adverse effect on our stockholders:

liquidity of our Common Stock;

market price of our Common Stock;

ability to obtain financing for the continuation of our operations;

number of investors that will consider investing in our Common Stock;

number of market makers in our Common Stock;

availability of information concerning the trading prices and volume of our Common Stock;

number of broker-dealers willing to execute trades in shares of our Common Stock.

do not expect to pay dividends in the foreseeable future.

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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.

Tradeable Warrant and Non-Tradeable Warrant that we issued in our initial public offering has an exercise price of $3.0625.

outstanding warrants have exercise prices ranging from $1.50 to $7.35.

In the event our Common Stock price does not exceed

the exercise price of the warrants during the period when they are exercisable, the warrants may not have any value.

of warrants have no rights as stockholders other than as set forth in the warrants until such holders exercise their warrants and acquire

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of members of the Company as a stockholder.

The warrant certificates governing our warrants designate the state and

federal courts of the State of New York sitting in the City of New York, Borough of Manhattan, as the exclusive forum for actions and

proceedings with respect to all matters arising out of the warrants, which could limit a warrant holder’s ability to choose the

judicial forum for disputes arising out of the warrants.

The warrant certificates governing our warrants provide that all legal

proceedings concerning the interpretations, enforcement, and defense of the transactions contemplated by the warrant certificate (whether

brought against a party to the warrant certificate or their respective affiliates, directors, officers, shareholders, partners, members,

employees, or agents) shall be commenced exclusively in the state and federal courts sitting in the City of New York.

The warrant certificates

further provide that we and the warrant holders irrevocably submit to the exclusive jurisdiction of the state and federal courts sitting

in the City of New York, Borough of Manhattan, for the adjudication of any dispute under the warrant certificate or in connection with

it or with any transaction contemplated by it or discussed in it.

Furthermore, we and the warrant holders irrevocably waive, and agree

not to assert in any suit, action, or proceeding, any claim that we or they are not personally subject to the jurisdiction of any such

court, that such suit, action, or proceeding is improper or is an inconvenient venue for such proceeding.

With respect to any complaint

asserting a cause of action arising under the Securities Act or the rules and regulations promulgated thereunder, we note, however, that

there is uncertainty as to whether a court would enforce this provision and that investors cannot waive compliance with the federal securities

laws and the rules and regulations thereunder.

Section 22 of the Securities Act creates concurrent jurisdiction for state and federal

courts over all suits brought to enforce any duty or liability created by the Securities Act or the rules and regulations thereunder.

Section 27 of the Exchange Act creates exclusive federal jurisdiction over all suits brought to enforce any duty or liability created

by the Exchange Act or the rules and regulations thereunder.

As a result, the exclusive forum provision in the warrant certificates expressly

does not apply to suits brought to enforce any duty or liability created by the Exchange Act.

Any person or entity purchasing or otherwise acquiring or holding or owning

(or continuing to hold or own) any interest in any of our warrants shall be deemed to have notice of and consented to the foregoing provisions.

Although we believe this exclusive forum provision benefits us by providing increased consistency in the application of the governing

law in the types of lawsuits to which it applies, the exclusive forum provision may limit a warrant holder’s ability to bring a

claim in a judicial forum of its choosing for disputes with us or any of our directors, officers, other employees, stockholders, or others

which may discourage lawsuits with respect to such claims.

Our warrant holders will not be deemed to have waived our compliance with the

federal securities laws and the rules and regulations thereunder as a result of this exclusive forum provision.

Further, in the event

a court finds the exclusive forum provision contained in our warrant certificates to be unenforceable or inapplicable in an action, we

may incur additional costs associated with resolving such action in other jurisdictions, which could harm our results of operations.

failure to file a registration statement to register the shares of Common Stock issuable upon exercise of the warrants that we issued

in February 2025 will result in a breach of the terms of the warrant inducement agreement.

to the terms of the warrant inducement agreement that we entered into with certain investors in February 2025, we are obligated to file

a registration statement to register the shares of Common Stock issuable upon exercise of the new warrants within 45 days of the date

of such agreement and to use commercially reasonable efforts to keep the registration statement effective at all times while the investors

own any warrants or shares of Common Stock issuable upon exercise of the warrants.

The failure to take any of these actions will constitute

a default under the warrant inducement agreement.

warrant certificates governing our warrants designate the state and federal courts of the State of New York sitting in the City of New

York, Borough of Manhattan, as the exclusive forum for actions and proceedings with respect to all matters arising out of the warrants,

which could limit a warrant holder’s ability to choose the judicial forum for disputes arising out of the warrants.

warrant certificates governing our warrants provide that all legal proceedings concerning the interpretations, enforcement, and defense

of the transactions contemplated by the warrant certificate (whether brought against a party to the warrant certificate or their respective

affiliates, directors, officers, shareholders, partners, members, employees, or agents) shall be commenced exclusively in the state and

federal courts sitting in the City of New York.

The warrant certificates further provide that we and the warrant holders irrevocably

submit to the exclusive jurisdiction of the state and federal courts sitting in the City of New York, Borough of Manhattan, for the adjudication

of any dispute under the warrant certificate or in connection with it or with any transaction contemplated by it or discussed in it.

Furthermore, we and the warrant holders irrevocably waive, and agree not to assert in any suit, action, or proceeding, any claim that

we or they are not personally subject to the jurisdiction of any such court, that such suit, action, or proceeding is improper or is

an inconvenient venue for such proceeding.

With respect to any complaint asserting a cause of action arising under the Securities Act

or the rules and regulations promulgated thereunder, we note, however, that there is uncertainty as to whether a court would enforce

this provision and that investors cannot waive compliance with the federal securities laws and the rules and regulations thereunder.

Section 22 of the Securities Act creates concurrent jurisdiction for state and federal courts over all suits brought to enforce any duty

or liability created by the Securities Act or the rules and regulations thereunder.

Section 27 of the Exchange Act creates exclusive

federal jurisdiction over all suits brought to enforce any duty or liability created by the Exchange Act or the rules and regulations

As a result, the exclusive forum provision in the warrant certificates expressly does not apply to suits brought to enforce

any duty or liability created by the Exchange Act.

person or entity purchasing or otherwise acquiring or holding or owning (or continuing to hold or own) any interest in any of our warrants

shall be deemed to have notice of and consented to the foregoing provisions.

Although we believe this exclusive forum provision benefits

us by providing increased consistency in the application of the governing law in the types of lawsuits to which it applies, the exclusive

forum provision may limit a warrant holder’s ability to bring a claim in a judicial forum of its choosing for disputes with us

or any of our directors, officers, other employees, stockholders, or others which may discourage lawsuits with respect to such claims.

Our warrant holders will not be deemed to have waived our compliance with the federal securities laws and the rules and regulations thereunder

as a result of this exclusive forum provision.

Further, in the event a court finds the exclusive forum provision contained in our warrant

certificates to be unenforceable or inapplicable in an action, we may incur additional costs associated with resolving such action in

other jurisdictions, which could harm our results of operations.

financial and operational projections that we may make from time to time are subject to inherent risks.

projections that we provide herein or our management may provide from time to time (including, but not limited to, those relating to

potential peak sales amounts, clinical and regulatory timelines, production and supply matters, commercial launch dates, and other

financial or operational matters) reflect numerous assumptions made by management, including assumptions with respect to our

specific as well as general business, regulatory issues, economic, market, and financial conditions and other matters, all of which are

difficult to predict and many of which are beyond our control.

Accordingly, there is a risk that the assumptions made in preparing

the projections, or the projections themselves, will prove inaccurate.

There may be differences between actual and projected

results, and actual results may be materially different from those contained in the projections.

potential peak sales amounts, clinical and regulatory timelines, production and supply matters, commercial launch dates, and other financial

or operational matters) reflect numerous assumptions made by management, including assumptions with respect to our specific as well as

general business, regulatory issues, economic, market, and financial conditions and other matters, all of which are difficult to predict

and many of which are beyond our control.

Accordingly, there is a risk that the assumptions made in preparing the projections, or the

projections themselves, will prove inaccurate.

There may be differences between actual and projected results, and actual results may

be materially different from those contained in the projections.

stock price has fluctuated in the past, has recently been volatile, and may be volatile in the future, and as a result, investors in

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settlement and damage awards against directors and officers as required by these indemnification provisions.

management collectively owns a substantial percentage of our Common Stock.

on the provisions for determining beneficial ownership in accordance with Rule 13d-3 and Item 403 of Regulation S-K under the Exchange

Act, immediately after this Offering, our officers and directors will own or exercise control of approximately 24% of the voting power

of our outstanding Common Stock.

As a result, investors may be prevented from affecting matters involving our Company, including:

composition of our Board and, through it, any determination with respect to our business direction and policies, including the appointment

and removal of officers;

determinations with respect to mergers or other business combinations;

acquisition or disposition of assets;

corporate financing activities.

this concentration of voting power could have the effect of delaying, deterring, or preventing a change of control or other business

combination that might otherwise be beneficial to our stockholders.

This significant concentration of share ownership may also adversely

affect the trading price for our Common Stock because investors may perceive disadvantages in owning stock in a company that is controlled

by a small number of stockholders.

securities or industry analysts do not publish research or publish inaccurate or unfavorable research about our business, our stock price

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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.

Furthermore, if we are able to rapidly

grow our business, the internal controls that we will need may become more complex, and significantly more resources will be required

to ensure our internal controls remain effective.

Failure to implement required controls or difficulties encountered in their implementation

could harm our operating results or cause us to fail to meet our reporting obligations.

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.

Furthermore, if we are able to rapidly grow

our business, the internal controls that we will need may become more complex, and significantly more resources will be required to ensure

our internal controls remain effective.

Failure to implement required controls or difficulties encountered in their implementation could

harm our operating results or cause us to fail to meet our reporting obligations.

If we or our auditors discover a material weakness

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1A. Risk Factors