What changed in this filing

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Item 1A. Risk Factors

2025-03-31 compared with 2024-04-01 · 416 added, 432 removed, 1461 unchanged (37% of the section changed)

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During the years ended December 31, 2024, and December 31, 2023, we generated revenue of approximately

$2.5 million and $5,000, respectively.

During the year ended December 31, 2023, we generated $2.2 million from laboratory patient services

(of which approximately $37,000 related to our first diagnostic test, CyPath ® Lung), and approximately $273,000 from histology

laboratory test, approximately $19,000 from medical director fees, and in connection with CyPath ® Lung tests purchased

by the DOD in the approximate amount of $19,000 for an observational study.

$9.4 million and $2.5 million, respectively.

become and remain profitable, we must succeed in generating additional laboratory revenue in excess of our operating expenses and developing

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of December 31, 2024, we had an accumulated deficit of $53.6 million and $1.1 million cash on hand.

For the year 2023, cash used in

operations was $6.0 million and net loss was $7.9 million.

Despite raising an additional $2.5 million in gross proceeds in March

2024 through the offering of our securities, 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.

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 September 2024.

Our future 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 to curtail or cease operations and be required to realize our

assets and discharge our liabilities other than in the normal course of business which could cause investors to suffer the loss of

all or a substantial portion of their investment.

WithumSmith+Brown, PC, our independent registered public accounting firm for the

fiscal year ended December 31, 2023, has included an explanatory paragraph in its opinion that accompanies our audited consolidated

financial statements as of and for the year ended December 31, 2023, indicating that our current liquidity position raises

substantial doubt about our ability to continue as a going concern.

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.

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.

Without such additional capital, we may be required

to curtail or cease operations and be required to realize our assets and discharge our liabilities other than in the normal course of

business which could cause investors to suffer the loss of all or a substantial portion of their investment.

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.

have a limited operating history, which makes it difficult to evaluate our current business and future prospects.

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and commercial potential which we envision.

Any substantive failure of PPLSlaboratory to meet our expectations could have a material

Any substantive failure of PPLS laboratory to meet our expectations could have a material

negative effect on our results of operations.

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on terms that may not be favorable to us and/or that may reduce the value of our Common Stock.

Related to the Acquisition

combined company may not experience the anticipated strategic benefits of the PPLS acquisition.

we anticipate benefits from the acquisition of PPLS, we may not be able to realize the expected benefits.

Despite due diligence we could

assume previously unidentified or contingent liabilities.

Ownership of a CAP/CLIA laboratory and related services business may not have

the clinical value and commercial potential which we envision.

Any substantive failure of the acquisition to meet our expectations could

have a material negative effect on our results of operations.

There can be no assurance that the anticipated benefits of the acquisition

will materialize or that if they materialize will result in increased stockholder value or revenue stream to the combined company.

may not be able to enforce claims with respect to the representations, warranties, and indemnities that Village Oaks has provided to

us under the Asset Purchase Agreement.

connection with the acquisition, Village Oaks has given certain representations, warranties, and indemnities.

There can be no assurance

we will be able to enforce any claims against Village Oaks’ breaches of such representations, warranties, or indemnities.

Oaks’ liability with respect to breaches of such representations, warranties, and indemnities under the Asset Purchase Agreement

may be limited or the amount and coverage of any insurance obtained with respect to representations and warranties may be limited.

if we ultimately succeed in recovering any amounts, we may temporarily be required to bear these losses ourselves.

are unable to precisely estimate when we will begin to generate significant profit from revenue, if ever, from PPLS’ services,

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Since its acquisition in September 2023, we have generated

$2.5 million 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.

a clinical laboratory is a new business for us, 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.

have never operated a clinical laboratory.

To date, only our Chief Operating Officer, Xavier Reveles, has operated a CAP-accredited,

CLIA-certified clinical laboratory and therefore it may be difficult for investors to analyze our ability to successfully operate a clinical

Our management team may not successfully or efficiently manage our transition to operating a CAP-accredited and CLIA-certified

laboratory subject to significant regulatory oversight and reporting obligations.

However, to ease the transition, Roby Joyce, M.D.,

the Medical Director and Laboratory Director of Village Oaks prior to the acquisition, continues to serve as the Medical Director and

Laboratory Director of PPLS.

These new obligations and constituents will require significant attention from our senior management and

could divert their attention away from the day-to-day management of our business, which could adversely affect our business, financial

condition, and operating results.

$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.

began operating a clinical laboratory in September 2023.

Previously, only our Chief Operating Officer, Xavier Reveles, had operated a

CAP-accredited, CLIA-certified clinical laboratory and therefore it may be difficult for investors to analyze our ability to successfully

operate a clinical laboratory.

Our ability to generate revenue from the clinical laboratory will depend, in part, on our ability to attract

and maintain customers and on the amount spent by the customers on such services.

If our laboratory fails to attract customers and operate

at sufficient capacity, our margins will suffer, and we may not be able to fund the costs we incur to operate it.

The success of our

clinical laboratory will also depend, in part, on our ability to attract and retain an appropriately skilled and sufficient workforce

to operate the laboratory and our ability to comply with various quality standards and environmental, health and safety laws and regulations.

have insufficient results for investors to use to identify historical trends.

Investors should consider our prospects in light of the

risk, expenses and difficulties we will encounter as an early-stage company with respect to operating a clinical laboratory.

and income potential for the clinical laboratory is unproven and our business model is continually evolving.

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.

Related to our Diagnostic Product

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

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

order an LDT.

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as a Class II in vitro diagnostic.

We intend to launch a pivotal trial later this year in an effort to attain such classification;

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.

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

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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.

do not have a sales or marketing infrastructure and have limited experience in the sale, marketing, or distribution of our diagnostic

We 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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and pharmaceutical companies, LDT laboratories, smaller diagnostic and pharmaceutical companies, and biotechnology companies worldwide.

substantial number of the companies against which we are competing or we may compete against in the future may have significantly greater

substantial number of the companies against which we are competing or may compete against in the future may have significantly greater

financial resources, established presence in the market, and expertise in research and development, manufacturing, preclinical testing,

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persons could adversely affect our operations and results.

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, Vivienne Rebel, M.D., Ph.D., our Chief Science and Medical Officer and Executive Vice President, Xavier

Reveles, MS, CG(ASCP) cm , our Chief Operating Officer, and Michael Dougherty, CPA, MBA, our Chief Financial Officer, as well

as Roby Joyce, M.D., the Medical Director and Laboratory Director of PPLS and the principal of Village Oaks.

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.

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.

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.

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

We had previously been granted a license from Village Oaks

to use its intellectual property, pursuant to a joint development and project agreement, to develop CyPath ® Lung for commercialization.

In connection with the acquisition of PPLS, Village Oaks assigned its rights pursuant to such joint development and project agreement

to PPLS, as well as the intellectual property that is the subject of our license under such agreement.

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 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 our 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.

Therefore, we cannot be certain that the prosecution,

maintenance, and enforcement of these patent rights will be in a manner consistent with the best interests of our business.

our licensor fail to maintain such patents, or if we or our licensor lose rights to those patents or patent applications, the rights

we have licensed may be reduced or eliminated, and our right to develop and commercialize any of our diagnostic 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.

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 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, which could have a material adverse effect

on our operating results and overall financial condition.

addition, intellectual property rights that we in-license in the future may be sublicenses under intellectual property owned by third

parties, in some cases through multiple tiers.

The actions of our licensors may therefore affect our rights to use our sublicensed intellectual

property, even if we are in compliance with all of the obligations under our license agreements.

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.

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.

currently own intellectual property directed to our diagnostic tests, therapeutic product candidates and other proprietary technologies.

Other pharmaceutical companies and academic institutions may also have filed or are planning to file patent applications potentially

relevant to our business.

From time to time, in order to avoid infringing these third-party patents, we may be required to license technology

from additional third parties to further develop or commercialize our diagnostic tests or therapeutic product candidates.

required to obtain licenses to any third-party technology, including any such patents required to manufacture, use, or sell our product

candidates, such licenses may not be available to us on commercially reasonable terms or at all.

The inability to obtain any third-party

license required to develop or commercialize any of our product candidates could cause us to abandon any related efforts, which could

seriously harm our business and operations.

The licensing or acquisition of third-party intellectual property rights is a competitive

area, and several more established companies may pursue strategies to license or acquire third-party intellectual property rights we

may consider attractive or necessary.

These established companies may have a competitive advantage over us due to their size, capital

resources, and greater clinical development and commercialization capabilities.

In addition, companies that perceive us to be a competitor

may be unwilling to assign or license rights to us.

Even if we are able to obtain a license under such intellectual property rights,

any such license may be non-exclusive, which may allow our competitors access to the same technologies licensed to us.

some of our owned and in-licensed patents or patent applications or future patents may be co-owned with third parties.

If we are unable

to obtain an exclusive license to any such third-party co-owners’ interest in such patents or patent applications, such co-owners

may be able to license their rights to other third parties, including our competitors, and our competitors could market competing diagnostic

tests or therapeutic products and technology.

In addition, we may need the cooperation of any such co-owners of our patents in order

to enforce such patents against third parties, and such cooperation may not be provided to us.

Furthermore, our owned and in-licensed

patents may be subject to a reservation of rights by one or more third parties.

Any of the foregoing could have a material adverse effect

on our competitive position, business, financial conditions, results of operations, and prospects.

will depend on third parties to manufacture our kits, reagents and supplies and help in marketing our diagnostic tests and to design

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of operations.

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

CLIA-certified clinical pathology laboratory (previously Village Oaks and currently 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.

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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are approved for marketing.

competitive position depends on protection of our intellectual property.

and protection of our intellectual property are critical to our business.

If we do not adequately protect our intellectual property,

or if competitors develop technologies incorporating the same or similar technologies that already are in the public domain, those competitors

may be able to develop similar technologies to our own.

Our success depends in part on our ability to obtain patent protection for our

diagnostic tests, therapeutic products, or processes in the U.S.

and other countries, protect trade secrets, and prevent others from

infringing on our proprietary rights.

patent applications in the U.S.

are maintained in secrecy for at least portions of their pendency periods (published on U.S.

patent issuance

or, if earlier, 18 months from earliest filing date for most applications) and since other publication of discoveries in the scientific

or patent literature often lags behind actual discoveries, we cannot be certain that we are or will be the first to make the inventions

to be covered by our patent applications.

The patent position of biopharmaceutical and biotechnology firms generally is highly uncertain

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.

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

claims of any issued patents may not afford meaningful protection for our technologies, tests, or products.

In addition, patents issued

to us or to any future licensors may be challenged and subsequently narrowed, invalidated, or circumvented.

Patent litigation is widespread

in the biotechnology industry and could harm our business.

Litigation might be necessary to protect our patent position or to determine

the scope and validity of third-party proprietary rights, and we may not have the required resources to pursue such litigation or to

protect our patent rights.

we have executed assignment of invention agreements with current scientific and technical employees and in the future will require our

scientific and technical employees and consultants to enter into broad assignment of invention agreements, and require all of our employees,

consultants, and corporate partners with access to proprietary information to enter into confidentiality agreements, these agreements

may not be honored.

tests and therapeutic products we develop could be subject to infringement claims asserted by others.

cannot assure that diagnostic tests and therapeutic products based on our patents or intellectual property that we license from others

will not be challenged by a third-party claiming infringement of its proprietary rights.

If we are not able to successfully defend patents

that may be issued to us, that we may acquire, or that we may license in the future, we may have to pay substantial damages or licensing

fees, possibly including treble damages, for past infringement.

may become involved in lawsuits to protect or enforce our patents or other intellectual property, which could be expensive, time consuming,

and ultimately unsuccessful.

may infringe our issued patents or other intellectual property.

To counter infringement or unauthorized use, we intend to file infringement

claims, which can be expensive and time consuming.

Any claims we assert against perceived infringers could provoke these parties to assert

counterclaims against us alleging that we infringe their intellectual property.

In addition, in a patent infringement proceeding, a court

may decide that a patent of ours is invalid or unenforceable, in whole or in part, construe the patent’s claims narrowly, or refuse

to stop the other party from using the technology at issue on the grounds that our patents do not cover the technology in question.

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.

we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.

addition to seeking patents for some of our technology, we also intend to rely on trade secrets, including unpatented know-how, technology,

and other proprietary information, to maintain our competitive position.

We have executed and will continue to seek to protect these

trade secrets, in part, by entering into non-disclosure and confidentiality agreements with parties who have access to them, such as

our employees, corporate collaborators, outside scientific collaborators, contract manufacturers, consultants, advisors, and other third

We also have executed and will continue to seek to enter into confidentiality and invention or patent assignment agreements

with our employees and consultants.

Despite these efforts, any of these parties may breach the agreements and disclose our proprietary

information, including our trade secrets, and we may not be able to obtain adequate remedies for such breaches.

Our trade secrets may

also be obtained by third parties by other means, such as breaches of our physical or computer security systems.

a claim that a party illegally disclosed or misappropriated a trade secret is difficult, expensive, and time consuming, and the outcome

is unpredictable.

In addition, some courts inside and outside the U.S.

are less willing or unwilling to protect trade secrets.

of our trade secrets were to be lawfully obtained or independently developed by a competitor, we would have no right to prevent them,

or those to whom they communicate it, from using that technology or information to compete with us.

If any of our trade secrets were

to be disclosed to or independently developed by a competitor, our competitive position would be harmed.

internal information technology systems, or those of our third-party clinical research organizations or other contractors or consultants,

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of any future claim.

general economic or business conditions may have a negative impact on our business.

concerns over U.S.

healthcare reform legislation 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

general economic or business conditions, including tariff and customs regulations, may have a negative impact on our business.

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.

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.

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.

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

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of these kinds, have in the past and may in the future lead to market-wide liquidity problems.

For example, on March 10, 2023, Silicon

Valley Bank was closed by the California Department of Financial Protection and Innovation, which appointed the Federal Deposit Insurance

Corporation as receiver.

Although we did not have any cash or cash equivalent balances on deposit with Silicon Valley Bank, uncertainty

and liquidity concerns in the broader financial services industry remain, and the failure of Silicon Valley Bank and its potential near-

and long-term effects on the biotechnology industry and its participants, such as our vendors, suppliers, and investors, may also adversely

affect our operations and stock price.

addition, the global macroeconomic environment could be negatively affected by, among other things, a resurgence of COVID-19 or other

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Related to the Operation of a CAP/CLIA Laboratory

operations of PPLS will depend in part upon Roby Joyce, M.D., and his relationship with existing customers and our ability to establish

relationships with these customers.

future success will depend in significant part upon the continued relationships with existing customers, many of whom have developed

professional relationships with Roby Joyce, M.D.

Joyce is the Medical Director and Laboratory Director of PPLS and a member

of our Board of Directors, we cannot assure you 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.

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 the technical knowledge and management and industry expertise of Dr.

Joyce or any of our key

personnel could result in delays in services, loss of customers and sales, and diversion of management resources, which could adversely

affect our operating results.

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 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.

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.

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

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.

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

test volume of CyPath ® Lung grows, PPLS will need to continue to ramp up its testing capacity, implement increases in

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enforced, a court may not hold that our patents are valid, enforceable, and infringed.

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

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.

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

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

Therefore, we cannot be certain that the prosecution,

maintenance, and enforcement of such patent rights dependent on third-party licenses will be in a manner consistent with the best interests

of our business.

If we or our licensor fail to maintain such patents, or if we or our licensor lose rights to those patents or patent

applications, the rights we have licensed may be reduced or eliminated, and our right to develop and commercialize any of our diagnostic

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.

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

that are dependent on third-part license agreements which could have a material adverse effect on our operating results and overall financial

addition, intellectual property rights that we in-license in the future may be sublicenses under intellectual property owned by third

parties, in some cases through multiple tiers.

The actions of our licensors may therefore affect our rights to use our sublicensed intellectual

property, even if we are in compliance with all of the obligations under our license agreements.

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.

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

currently own intellectual property directed to our diagnostic tests, therapeutic product candidates and other proprietary technologies.

Other pharmaceutical companies and academic institutions may also have filed or are planning to file patent applications potentially

relevant to our business.

From time to time, in order to avoid infringing these third-party patents, we may be required to license technology

from additional third parties to further develop or commercialize our diagnostic tests or therapeutic product candidates.

required to obtain licenses to any third-party technology, including any such patents required to manufacture, use, or sell our product

candidates, such licenses may not be available to us on commercially reasonable terms or at all.

The inability to obtain any third-party

license required to develop or commercialize any of our product candidates could cause us to abandon any related efforts, which could

seriously harm our business and operations.

The licensing or acquisition of third-party intellectual property rights is a competitive

area, and several more established companies may pursue strategies to license or acquire third-party intellectual property rights we

may consider attractive or necessary.

These established companies may have a competitive advantage over us due to their size, capital

resources, and greater clinical development and commercialization capabilities.

In addition, companies that perceive us to be a competitor

may be unwilling to assign or license rights to us.

Even if we are able to obtain a license under such intellectual property rights,

any such license may be non-exclusive, which may allow our competitors access to the same technologies licensed to us.

some of our owned and in-licensed patents or patent applications or future patents may be co-owned with third parties.

If we are unable

to obtain an exclusive license to any such third-party co-owners’ interest in such patents or patent applications, such co-owners

may be able to license their rights to other third parties, including our competitors, and our competitors could market competing diagnostic

tests or therapeutic products and technology.

In addition, we may need the cooperation of any such co-owners of our patents in order

to enforce such patents against third parties, and such cooperation may not be provided to us.

Furthermore, our owned and in-licensed

patents may be subject to a reservation of rights by one or more third parties.

Any of the foregoing could have a material adverse effect

on our competitive position, business, financial conditions, results of operations, and prospects.

competitive position depends on protection of our intellectual property.

and protection of our intellectual property are critical to our business.

If we do not adequately protect our intellectual property,

or if competitors develop technologies incorporating the same or similar technologies that already are in the public domain, those competitors

may be able to develop similar technologies to our own.

Our success depends in part on our ability to obtain patent protection for our

diagnostic tests, therapeutic products, or processes in the U.S.

and other countries, protect trade secrets, and prevent others from

infringing on our proprietary rights.

patent applications in the U.S.

are maintained in secrecy for at least portions of their pendency periods (published on U.S.

patent issuance

or, if earlier, 18 months from earliest filing date for most applications) and since other publication of discoveries in the scientific

or patent literature often lags behind actual discoveries, we cannot be certain that we are or will be the first to make the inventions

to be covered by our patent applications.

The patent position of biopharmaceutical and biotechnology firms generally is highly uncertain

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.

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

claims of any issued patents may not afford meaningful protection for our technologies, tests, or products.

In addition, patents issued

to us or to any future licensors may be challenged and subsequently narrowed, invalidated, or circumvented.

Patent litigation is widespread

in the biotechnology industry and could harm our business.

Litigation might be necessary to protect our patent position or to determine

the scope and validity of third-party proprietary rights, and we may not have the required resources to pursue such litigation or to

protect our patent rights.

we have executed assignment of invention agreements with current scientific and technical employees and in the future will require our

scientific and technical employees and consultants to enter into broad assignment of invention agreements, and require all of our employees,

consultants, and corporate partners with access to proprietary information to enter into confidentiality agreements, these agreements

may not be honored.

tests and therapeutic products we develop could be subject to infringement claims asserted by others.

cannot assure that diagnostic tests and therapeutic products based on our patents or intellectual property that we license from others

will not be challenged by a third-party claiming infringement of its proprietary rights.

If we are not able to successfully defend patents

that may be issued to us, that we may acquire, or that we may license in the future, we may have to pay substantial damages or licensing

fees, possibly including treble damages, for past infringement.

may become involved in lawsuits to protect or enforce our patents or other intellectual property, which could be expensive, time consuming,

and ultimately unsuccessful.

may infringe our issued patents or other intellectual property.

To counter infringement or unauthorized use, we intend to file infringement

claims, which can be expensive and time consuming.

Any claims we assert against perceived infringers could provoke these parties to assert

counterclaims against us alleging that we infringe their intellectual property.

In addition, in a patent infringement proceeding, a court

may decide that a patent of ours is invalid or unenforceable, in whole or in part, construe the patent’s claims narrowly, or refuse

to stop the other party from using the technology at issue on the grounds that our patents do not cover the technology in question.

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.

we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.

addition to seeking patents for some of our technology, we also intend to rely on trade secrets, including unpatented know-how, technology,

and other proprietary information, to maintain our competitive position.

We have executed and will continue to seek to protect these

trade secrets, in part, by entering into non-disclosure and confidentiality agreements with parties who have access to them, such as

our employees, corporate collaborators, outside scientific collaborators, contract manufacturers, consultants, advisors, and other third

We also have executed and will continue to seek to enter into confidentiality and invention or patent assignment agreements

with our employees and consultants.

Despite these efforts, any of these parties may breach the agreements and disclose our proprietary

information, including our trade secrets, and we may not be able to obtain adequate remedies for such breaches.

Our trade secrets may

also be obtained by third parties by other means, such as breaches of our physical or computer security systems.

a claim that a party illegally disclosed or misappropriated a trade secret is difficult, expensive, and time consuming, and the outcome

is unpredictable.

In addition, some courts inside and outside the U.S.

are less willing or unwilling to protect trade secrets.

of our trade secrets were to be lawfully obtained or independently developed by a competitor, we would have no right to prevent them,

or those to whom they communicate it, from using that technology or information to compete with us.

If any of our trade secrets were

to be disclosed to or independently developed by a competitor, our competitive position would be harmed.

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.

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and the enforcement or defense of our issued patents.

The Leahy-Smith Act includes a number of significant changes to U.S.

The Leahy-Smith Act included a number of significant changes to U.S.

These include provisions that affect the way patent applications are prosecuted, redefine prior art, and provide more efficient and cost-effective

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the terms of all patents covering a diagnostic test or therapeutic product expire, our business may become subject to competition from

competitive medications, including generic medications.

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.

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.

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

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Such a loss of patent protection could have a material adverse impact on our business.

we do not obtain patent term extension in the United States under the Hatch-Waxman Act and in foreign countries under similar legislation,

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

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

September 2023, the FDA announced a proposed rule to ensure the safety and effectiveness of LDTs by amending regulations to explicitly

say that IVDs offered as LDTs fall under the FDCA and phase out its general enforcement discretion approach for most LDTs.

policy makes it clear that the FDA intends to provide greater oversight of LDTs.

The FDA plans to finalize its ruling in April 2024 and

initiate a phased implementation process in which it will require laboratories to register their LDTs and begin the premarket review

process over the next four years.

Any future rulemaking, guidance, or other oversight of LDTs and clinical laboratories that develop

and perform them, if and when finalized, may affect the sales of our products and how customers use our products, and may require us

to change our business model in order to maintain compliance with these laws.

have been numerous legislative proposals to clarify the FDA’s regulatory authority over medical devices.

In 2021, two bills were

reintroduced in the U.S.

the Verifying Accurate, Leading-edge IVCT Development Act of 2020 (the “VALID Act”), which

would have expressly granted the FDA authority to regulate LDTs under a risk-based framework;

and the Verified Innovative Testing in

American Laboratories Act of 2020 (the “VITAL Act”), which would have assigned LDTs to regulation solely under CLIA and would

have directed CMS to update its CLIA regulations.

Neither of these bills were enacted.

The VALID Act was reintroduced in March 2023.

We cannot predict if either of these bills will be enacted in their current (or any other) form and cannot quantify the effect of these

bills on our business.

of legislation directing FDA to regulate LDTs or promulgation of new regulations for LDT oversight by FDA could materially and adversely

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

If FDA premarket review, classification, or approval is required

for CyPath ® Lung before we obtain de novo classification, our phased strategy for market entry would be adversely

Our laboratory licensee, PPLS, could be forced to stop offering CyPath ® Lung as an LDT while we work to obtain

de novo classification.

Our business, results of operations, and financial condition would be negatively affected unless and until

such review were completed and our request for de novo classification were granted.

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,

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(“PMA”) pathway.

We plan to seek de novo classification for the CyPath ® Lung test in the second quarter

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.

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

operation,s and financial condition.

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,

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of accreditation.

Any failure by our laboratory licensee to comply with CLIA/CAP requirements could result in adverse findings on inspection

Any failure by our laboratory licensee to comply with CAP/CLIA requirements could result in adverse findings on inspection

that, if not timely corrected, could result in loss of accreditation and the inability to perform laboratory testing.

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from a clinical and manufacturing perspective.

Approval by the FDA does not ensure approval by regulatory or payor authorities in other

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.

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approvals and may not receive necessary approvals to commercialize our diagnostic tests or therapeutic products in any jurisdiction.

Regulatory authorities in jurisdictions outside of the U.S, have requirements for approval of diagnostic tests or therapeutic product

Regulatory authorities in jurisdictions outside of the U.S.

have requirements for approval of diagnostic tests or therapeutic product

candidates with which we must comply prior to marketing in those jurisdictions.

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candidates will be harmed.

if we obtain FDA approval of any of our diagnostic tests or therapeutic product candidates, we may never obtain approval or commercialize

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.

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

impact of recent healthcare reform legislation, other changes in the healthcare industry, and in healthcare spending is currently unknown

and may adversely affect our business model.

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.

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.

do not expect to pay dividends in the foreseeable future.

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your investment will occur only if our stock price appreciates.

Warrants may never have a market price that exceeds the exercise price.

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.

Warrant that we issued in March 2024 has an exercise price equal to $1.64.

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.

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.

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.

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 March 2024, or to timely hold a stockholders’ meeting to obtain stockholder approval of the issuance of shares of Common Stock

upon the exercise of the Warrants that we issued in March 2024, will result in a breach of the terms of the Securities Purchase Agreement.

to the terms of the Securities Purchase Agreement that we entered into with certain purchasers in March 2024, we are obligated to file

a registration statement to register the shares of Common Stock issuable upon exercise of the Warrants within 30 days of the date of

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

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.

We are also obligated to hold a stockholders’

meeting 90 days after the closing date and, if approval is not obtained at the shareholders meeting, every three months thereafter seeking

approval of the exercise of the Warrants issued to the Purchasers .

The failure to take any of these actions will constitute a

default under the Securities Purchase Agreement.

The failure to take any of these actions will constitute

a default under the warrant inducement agreement.

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, 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.

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.” If 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 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 Warrants and would impair your

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.

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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party is offering any tax assurances or guidance regarding our Company or your investment.

formation of our Company, as well as an investment in our Company generally, involves complex federal, state, and local income tax considerations.

Neither the Internal Revenue Service nor any state or local taxing authority has reviewed the transactions described herein and may take

different positions than the ones contemplated by management.

You are strongly urged to consult your own tax and other advisors prior

to investing, as neither we nor any of our officers, directors, or related parties can offer tax or similar advice, nor are any such

persons making any representations and warranties regarding such matters.

investment in our Company generally, involves complex federal, state, and local income tax considerations.

Neither the Internal Revenue

Service nor any state or local taxing authority has reviewed the transactions described herein and may take different positions than

the ones contemplated by management.

You are strongly urged to consult your own tax and other advisors prior to investing, as neither

we nor any of our officers, directors, or related parties can offer tax or similar advice, nor are any such persons making any representations

and warranties regarding such matters.

ability to use our net operating loss carryforwards and certain other tax attributes may be limited.

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our stockholders from calling a special meeting of our stockholders;

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.

because we are incorporated in Delaware, we are governed by the provisions of Section 203 of the Delaware General Corporation Law (the

“DGCL”), which prohibits a person who owns 15% or more of our outstanding voting stock from merging or combining with us

for a period of three years after the date of the transaction in which the person acquired 15% or more of our outstanding voting stock,

unless the merger or combination is approved in a prescribed manner.

These provisions could discourage potential acquisition proposals

and could delay or prevent a change in control transaction.

They could also have the effect of discouraging others from making tender

offers for our Common Stock, including transactions that may be in your best interests.

These provisions may also prevent changes in

our management or limit the price that investors are willing to pay for our stock.

provisions in our Charter and A&R Bylaws could make a merger, tender offer, or proxy contest difficult, thereby depressing the trading

price of our Common Stock.

Charter and A&R Bylaws contain provisions that could depress the trading price of our Common Stock by acting to discourage, delay,

or prevent a change of control of our Company or changes in our management that the stockholders of our Company may deem advantageous.

These provisions include the following:

the Board to establish the number of directors and fill any vacancies and newly created directorships;

the issuance of “blank check” preferred stock that our Board could use to implement a stockholder rights plan;

stockholders from calling special meetings of stockholders;

stockholder action by written consent, which requires all stockholder actions to be taken at a meeting of our stockholders;

that the Board is expressly authorized to adopt, amend, alter, or repeal our bylaws;

the forum for certain litigation against us to Delaware;

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;

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.

provision in our Charter or A&R Bylaws that has the effect of delaying or deterring a change in control could limit the opportunity

125 unchanged sentences

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