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Item 1A. Risk Factors

2024-03-27 compared with 2023-03-15 · 361 added, 416 removed, 1132 unchanged (41% of the section changed)

10 unchanged sentences

of Risk Factors

We have incurred significant

losses since our inception.

We expect to incur losses over the next several years and may never achieve or maintain profitability.

We will need substantial

additional funding.

If we are unable to raise capital when needed, we could be forced to delay, reduce or eliminate our product development

programs or commercialization efforts.

Raising additional capital

may cause dilution to stockholders, restrict operations or require us to relinquish rights to our technologies or product candidates.

Our stockholders may be

subject to substantial dilution by exercises of outstanding options and warrants.

Our operating history to

date may make it difficult to evaluate the success of our business and assess our future viability.

We are early in our development

efforts, which may not be successful.

We cannot be certain that

our product candidates will receive regulatory approval, without which we cannot market any of our product candidates.

in the approval process will harm our business.

Clinical drug development

involves a lengthy and expensive process and uncertain as to outcome.

Delays in any aspect of

our clinical trials could result in increased costs to us and delay or limit our ability to obtain regulatory approval for our product

We may not have or be able

to obtain sufficient quantities of our products to meet our supply and clinical studies obligations and our business, financial condition

and results of operation may be adversely affected.

If we are unable to successfully

commercialize our products our ability to generate revenue will be limited.

If our preclinical and

clinical studies do not produce positive results, if our clinical trials are delayed or if serious side effects are identified during

such studies or trials, we may experience delays, incur additional costs and ultimately be unable to commercialize our product candidates.

If we cannot enroll enough

patients to complete our clinical trials, our business, financial condition and results of operations may be adversely affected.

We may not be able to obtain

or maintain orphan drug designation, Fast Track designation, qualified infection disease designation or breakthrough therapy designation

for any of our product candidates, and even if granted, such designations may not actually lead to a faster development or regulatory

review and would not assure FDA approval of any of our product candidates.

If we are unsuccessful

in identifying and developing additional product candidates, our potential for growth may be impaired.

If we are unable to establish

satisfactory sales and marketing capabilities, we may not successfully commercialize any of our product candidates, even if regulatory

approval is obtained.

If we are unable to file

for approval of MAT2203 under Section 505(b)(2) of the FDCA or if we are required to generate additional data related to safety and

efficacy in order to obtain approval under Section 505(b)(2), we may be unable to meet our anticipated development and commercialization

We face competition from

other biotechnology and pharmaceutical companies.

Even if we obtain marketing

approval for any product candidate, we will be subject to ongoing obligations and continued regulatory review and requirements, which

may result in significant additional expense.

Future legislation, and/or

regulations and policies adopted by the FDA may increase the time and cost required for us to conduct and complete clinical trials.

Changes in health care

law and implementing regulations may have a material adverse effect on us.

Our future growth depends,

in part, on our ability to penetrate foreign markets, where we would be subject to additional regulatory burdens and other risks

and uncertainties.

If we market our product

candidates in a manner that violates healthcare fraud and abuse laws, or if we violate government price reporting laws, we may be

subject to civil or criminal penalties.

We expect that we will

rely on third parties to conduct clinical trials for our product candidates.

We are, and will be, completely

dependent on third parties to manufacture our product candidates, who may not perform as expected.

Unfavorable pricing regulations,

third-party reimbursement practices or healthcare reform initiatives could harm our business.

Outbreaks of communicable

diseases may materially and adversely affect our business, financial condition and results of operations.

We depend on certain technologies

that are licensed to us.

We do not control these technologies and any loss of our rights to them could prevent us from discovering,

developing and commercializing MAT2203.

If we discontinue development

of MAT2203, we could be required to return such technology to the former stockholders of Aquarius and/or Rutgers and we could lose

the rights to our lead product candidate.

It is difficult and costly

to protect our intellectual property rights, and we cannot ensure the protection of these rights.

If we fail to obtain or

maintain patent or trade secret protection for our technologies, third parties could use our proprietary information.

have incurred significant losses since our inception.

We expect to incur losses over the next several years and may never achieve

or maintain profitability.

will need substantial additional funding.

If we are unable to raise capital when needed, we could be forced to delay, reduce or eliminate

our product development programs or commercialization efforts.

additional capital may cause dilution to stockholders, restrict operations or require us to relinquish rights to our technologies

or product candidates.

stockholders may be subject to substantial dilution by exercises of outstanding options and warrants.

operating history to date may make it difficult to evaluate the success of our business and assess our future viability.

are early in our development efforts, which may not be successful.

cannot be certain that our product candidates will receive regulatory approval, without which we will not be able to market any of

our product candidates.

may infringe the intellectual property rights of others, which could increase our costs and delay or prevent our development and

commercialization efforts.

We will need to increase

the size of our organization to grow our business, and we may experience difficulties in managing this growth.

If we are not successful

in attracting and retaining highly qualified personnel, we may not be able to successfully implement our business strategy.

If product liability lawsuits

are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our product candidates.

Our internal computer systems,

or those of our CROs or other contractors or consultants, may fail or suffer security breaches, which could result in a material

disruption of our product development programs.

We may acquire businesses

or products, or form strategic alliances, in the future, and we may not realize the benefits of such acquisitions.

The rights of the holders

of common stock may be impaired by the potential issuance of preferred stock.

We do not intend to pay

dividends on our common stock in the foreseeable future.

An active public trading

market for our common stock may not be sustained.

Our share price has been

and could remain volatile.

If securities or industry

analysts do not publish research or reports about our business, or if they change their recommendations regarding our stock adversely,

our stock price and trading volume could decline.

Upon dissolution of our

Company, you may not recoup all or any portion of your investment.

Anti-takeover provisions

of our certificate of incorporation, bylaws and Delaware law could make an acquisition of us, which may be beneficial to our stockholders,

more difficult.

Our certificate of incorporation

allows for our board to create new series of preferred stock without further approval by our stockholders, which could adversely

affect the rights of the holders of our common stock

Stockholders’ ability

to obtain a favorable judicial forum for disputes with us or our directors, officers or employees could be limited.

Our ability to use our

net operating loss carryforwards and certain other tax attributes may be limited.

Any delay in the approval process will harm our business.

depend in part on technology owned or licensed to us by third parties, the loss of which would terminate or delay the further development

of our product candidates, injure our reputation, or force us to pay higher royalties.

drug development involves a lengthy and expensive process and uncertain as to outcome.

in any aspect of our clinical trials could result in increased costs to us and delay or limit our ability to obtain regulatory approval

for our product candidates.

may not have or be able to obtain sufficient quantities of our products to meet our supply and clinical studies obligations and our

business, financial condition and results of operation may be adversely affected.

we are unable to successfully commercialize our products our ability to generate revenue will be limited.

our preclinical and clinical studies do not produce positive results, if our clinical trials are delayed or if serious side effects

are identified during such studies or trials, we may experience delays, incur additional costs and ultimately be unable to commercialize

our product candidates.

we cannot enroll enough patients to complete our clinical trials, our business, financial condition and results of operations may

be adversely affected.

may not be able to maintain orphan drug designation or exclusivity for our anti-infective product candidates.

Fast Track designation or grant of priority review status by the FDA may not actually lead to a faster development or regulatory

review or approval process, nor will it assure FDA approval of our product candidates.

Additionally, our product candidates may treat

indications that do not qualify for priority review vouchers.

breakthrough therapy designation granted by the FDA for our product candidates may not lead to a faster development or regulatory

review or approval process, and it does not increase the likelihood that our product candidates will receive marketing approval.

of our product candidates as qualified infectious disease products is not assured and, in any event, even if granted, may not actually

lead to a faster development or regulatory review, and would not assure FDA approval of our product candidates.

may not be able to obtain or maintain orphan drug designation, Fast Track designation, qualified infection disease designation or

breakthrough therapy designation for any of our product candidates, and even if granted, such designations may not actually lead

to a faster development or regulatory review and would not assure FDA approval of any of our product candidates.

we are unsuccessful in identifying and developing additional product candidates, our potential for growth may be impaired.

currently have no sales and marketing organization.

If we are unable to establish satisfactory sales and marketing capabilities,

we may not successfully commercialize any of our product candidates, even if regulatory approval is obtained.

we are unable to file for approval of MAT2203 under Section 505(b)(2) of the FDCA or if we are required to generate additional data

related to safety and efficacy in order to obtain approval under Section 505(b)(2), we may be unable to meet our anticipated development

and commercialization timelines.

face competition from other biotechnology and pharmaceutical companies and our operating results will suffer if we fail to compete

if we obtain marketing approval for any product candidate, we will be subject to ongoing obligations and continued regulatory review,

which may result in significant additional expense.

Additionally, our product candidates could be subject to labeling and other restrictions

and withdrawal from the market, and we may be subject to penalties if we fail to comply with regulatory requirements or if we experience

unanticipated problems with our future products.

legislation, and/or regulations and policies adopted by the FDA may increase the time and cost required for us to conduct and complete

clinical trials.

in health care law and implementing regulations may have a material adverse effect on us.

future growth depends, in part, on our ability to penetrate foreign markets, where we would be subject to additional regulatory burdens

and other risks and uncertainties.

we market our product candidates in a manner that violates healthcare fraud and abuse laws, or if we violate government price reporting

laws, we may be subject to civil or criminal penalties.

have been and expect to be significantly dependent on our collaborative agreements for the development of MAT2203, which exposes

us to the risk of reliance on the performance of third parties.

expect that we will rely on third parties to conduct clinical trials for our product candidates, which exposes us to the risk of

reliance on the performance of third parties.

are, and will be, completely dependent on third parties to manufacture our product candidates, and our commercialization efforts

could be halted, delayed or made less profitable if those third parties fail to obtain manufacturing approval from the FDA or comparable

foreign regulatory authorities, fail to provide us with sufficient quantities of any product candidate or fail to do so at acceptable

quality levels or prices.

pricing regulations, third-party reimbursement practices or healthcare reform initiatives could harm our business.

of communicable diseases may materially and adversely affect our business, financial condition and results of operations.

global conditions, including economic uncertainty, may negatively impact our financial results.

depend on certain technologies that are licensed to us.

We do not control these technologies and any loss of our rights to them could

prevent us from discovering, developing and commercializing product candidates.

is difficult and costly to protect our intellectual property rights, and we cannot ensure the protection of these rights.

we fail to obtain or maintain patent or trade secret protection for our technologies, third parties could use our proprietary information,

which could impair our ability to compete in the market and adversely affect our ability to generate revenues and attain profitability.

product candidates may infringe the intellectual property rights of others, which could increase our costs and delay or prevent our

development and commercialization efforts.

will need to increase the size of our organization to grow our business, and we may experience difficulties in managing this growth.

we are not successful in attracting and retaining highly qualified personnel, we may not be able to successfully implement our business

In addition, the loss of the services of certain key employees would adversely impact our business prospects.

product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization

of our product candidates.

internal computer systems, or those of our CROs or other contractors or consultants, may fail or suffer security breaches, which

could result in a material disruption of our product development programs.

may acquire businesses or products, or form strategic alliances, in the future, and we may not realize the benefits of such acquisitions.

to the terms of our Series A Preferred Stock, we may be obligated to pay significant royalties.

rights of the holders of common stock may be impaired by the potential issuance of preferred stock.

do not intend to pay dividends on our common stock in the foreseeable future.

active public trading market for our common stock may not be sustained.

share price has been and could remain volatile.

securities or industry analysts do not publish research or reports about our business, or if they change their recommendations regarding

our stock adversely, our stock price and trading volume could decline.

could be delisted from the NYSE American, which could seriously harm the liquidity of our stock and our ability to raise capital.

dissolution of our Company, you may not recoup all or any portion of your investment.

certificate of incorporation allows for our board to create new series of preferred stock without further approval by our stockholders,

which could adversely affect the rights of the holders of our common stock.

Anti-takeover

provisions of our certificate of incorporation, bylaws and Delaware law could make an acquisition of us, which may be beneficial

to our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove the current members of our

board and management.

Stockholders’

ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees could be limited.

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

Related to Our Financial Position and Need for Additional Capital

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We anticipate that our expenses will increase substantially if and as we:

conduct further

clinical and preclinical studies of MAT2203, our lead LNC product candidate;

support the conduct of

further clinical studies of MAT2203, even if such studies are partially financed with non-dilutive funding from the NIH;

seek to discover and develop

additional product candidates;

seek regulatory approvals

for any product candidates that successfully complete clinical trials;

require the manufacture

of larger quantities of product candidates for clinical development and potentially commercialization;

maintain, expand and protect

our intellectual property portfolio;

hire additional clinical,

quality control and scientific personnel;

add operational, financial

and management information systems and personnel, including personnel to support our product development and planned future commercialization

efforts and personnel and infrastructure necessary to help us comply with our obligations as a public company.

further clinical and preclinical studies of MAT2203, our lead LNC product candidate;

the conduct of further clinical studies of MAT2203, even if such studies are partially financed with non-dilutive funding from the

to discover and develop additional product candidates;

regulatory approvals for any product candidates that successfully complete clinical trials;

the manufacture of larger quantities of product candidates for clinical development and potentially commercialization;

expand and protect our intellectual property portfolio;

additional clinical, quality control and scientific personnel;

operational, financial and management information systems and personnel, including personnel to support our product development and

planned future commercialization efforts and personnel and infrastructure necessary to help us comply with our obligations as a public

ability to become and remain profitable depends on our ability to generate revenue.

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expect our expenses to increase in connection with our ongoing activities, particularly as we conduct additional clinical studies of

our product candidates, including the potential Phase 3 clinical trials of MAT2203 in CM and IFIs, and conduct additional preclinical

and clinical trials to further validate and expand our LNC Platform, continue research and development, initiate clinical trials and,

if development succeeds, seek regulatory approval of our product candidates.

Our expenses could further increase if we initiate new research

and preclinical development efforts for other product candidates.

In addition, if we obtain regulatory approval for any of our product

candidates, we expect to incur significant commercialization expenses related to product manufacturing, marketing, sales, and distribution.

Furthermore, we expect to incur significant additional costs associated with operating as a public company.

Accordingly, we will need

to obtain substantial additional funding in connection with our continuing operations.

If we are unable to raise capital when needed

or on attractive terms, we could be forced to delay, reduce, or eliminate our research and development programs or any future commercialization

believe that our existing cash, cash equivalents and marketable debt securities, including restricted cash, of $28,763 thousand as of

December 31, 2022 will enable us to fund our operating expenses and capital expenditure requirements into the second quarter of 2024.

We have based this estimate on assumptions that may prove to be wrong in the future, and we could use our capital resources sooner than

we currently expect.

Changing circumstances could cause us to consume capital significantly faster than we currently anticipate, and

we may need to spend more money than currently expected because of circumstances beyond our control.

our product candidates, including the potential Phase 3 clinical trials of MAT2203, and conduct additional preclinical and clinical trials

to further validate and expand our LNC Platform, continue research and development, initiate clinical trials and, if development succeeds,

seek regulatory approval of our product candidates.

Our expenses could further increase if we initiate new research and preclinical development

efforts for other product candidates.

In addition, if we obtain regulatory approval for any of our product candidates, we expect to incur

significant commercialization expenses related to product manufacturing, marketing, sales, and distribution.

Furthermore, we expect to

incur significant additional costs associated with operating as a public company.

Accordingly, we will need to obtain substantial additional

funding in connection with our continuing operations.

If we are unable to raise capital when needed or on attractive terms, we could

be forced to delay, reduce, or eliminate our research and development programs or any future commercialization efforts.

believe that our existing cash, cash equivalents and marketable debt securities, excluding restricted cash, of $13,756 thousand as of

December 31, 2023 will enable us to fund our operating expenses and capital expenditure requirements into the third quarter of 2024,

but not beyond.

We have based this estimate on assumptions that may prove to be wrong in the future, and we could use our capital resources

sooner than we currently expect.

Changing circumstances could cause us to consume capital significantly faster than we currently anticipate,

and we may need to spend more money than currently expected because of circumstances beyond our control.

Our future capital requirements,

both short-term and long-term, will depend on many factors, including:

the progress,

timing, costs, and results of our ongoing and planned clinical trials of our product candidates;

the scope, progress, timing,

costs, and results of clinical trials of, and research and preclinical development efforts for, other product candidates, including

MAT2203, any future product candidates based upon our LNC Platform, and any preclinical or clinical work done to further validate

our LNC Platform, generally;

to enter into and the terms and timing of any collaborations, licensing or other arrangements that we may establish;

the number and development

requirements of other product candidates that we pursue;

the costs, timing, and

outcome of regulatory review of our product candidates by the FDA and comparable non-U.S.

progress, timing, costs, and results of our ongoing and planned clinical trials of our product candidates;

scope, progress, timing, costs, and results of clinical trials of, and research and preclinical development efforts for, other product

candidates, including MAT2203, any future product candidates based upon our LNC Platform, and any preclinical or clinical work done

to further validate our LNC Platform, generally;

ability to enter into and the terms and timing of any collaborations, licensing or other arrangements that we may establish;

number and development requirements of other product candidates that we pursue;

costs, timing, and outcome of regulatory review of our product candidates by the FDA and comparable non-U.S.

regulatory authorities;

the costs and timing of

future commercialization activities, including product manufacturing, marketing, sales, and distribution, for any of our product

candidates for which we receive marketing approval;

the revenue, if any, received

from commercial sales of our product candidates for which we receive marketing approval;

our headcount growth and

associated costs as we expand our research and development and establish a commercial infrastructure;

the costs and timing of

preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending any

intellectual property-related claims;

the extent to which we

acquire or in-license other products and technologies;

the costs of operating

as a public company;

the effect of competing

technological and market developments.

costs and timing of future commercialization activities, including product manufacturing, marketing, sales, and distribution, for

any of our product candidates for which we receive marketing approval;

revenue, if any, received from commercial sales of our product candidates for which we receive marketing approval;

headcount growth and associated costs as we expand our research and development and establish a commercial infrastructure;

costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights

and defending any intellectual property-related claims;

extent to which we acquire or in-license other products and technologies;

costs of operating as a public company;

effect of competing technological and market developments.

potential product candidates and conducting preclinical testing and clinical trials is a time-consuming, expensive, and uncertain process

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rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.

stockholders may be subject to substantial dilution by exercises of outstanding options and warrants.

stockholders may be subject to substantial dilution by exercises of outstanding options.

of December 31, 2023, we had outstanding options to purchase an aggregate of 46,707,934 shares of our common stock at a weighted average

exercise price of $1.07 per share and warrants to purchase an aggregate of 238,000 shares of our common stock at a weighted average exercise

price of $0.75 per share.

The exercise of such outstanding options and the warrants will result in dilution of the value of our shares.

operating history to date may make it difficult to evaluate the success of our business to date and to assess our future viability.

exercise price of $0.83 per share.

The exercise of such outstanding options will result in dilution of the value of our shares.

operating history to date may make it difficult to evaluate the success of our business and to assess our future viability.

commenced active operations in 2013 and our product candidates are in early stages of clinical development.

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completion of preclinical studies;

successful enrollment in,

and completion of, clinical trials:

demonstrating safety and

receipt of marketing approvals

from applicable regulatory authorities;

establishing clinical and

commercial manufacturing capabilities or making arrangements with third-party manufacturers;

enrollment in, and completion of, clinical trials:

demonstrating

safety and efficacy;

of marketing approvals from applicable regulatory authorities;

clinical and commercial manufacturing capabilities or making arrangements with third-party manufacturers;

and maintaining patent and trade secret protection and non-patent exclusivity for our product candidates and technologies;

launching commercial sales

of the product candidates, if approved, whether alone or selectively in collaboration with others;

acceptance of the product

candidates, if approved, by patients, the medical community and third-party payers;

effectively competing with

other therapies;

a continued acceptable

safety profile of the products following approval;

enforcing and defending

intellectual property rights and claims.

commercial sales of the product candidates, if approved, whether alone or selectively in collaboration with others;

of the product candidates, if approved, by patients, the medical community and third-party payers;

competing with other therapies;

continued acceptable safety profile of the products following approval;

and defending intellectual property rights and claims.

we do not accomplish one or more of these goals in a timely manner, or at all, we could experience significant delays or an inability

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factors, may have an adverse impact on our ability to manufacture our product candidates.

we are unable to successfully commercialize our products our ability to generate revenue and will be limited.

we are unable to successfully commercialize our products our ability to generate revenue will be limited.

if we obtain regulatory approval for our product candidates, our long-term viability and growth depend on the successful commercialization

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To succeed, among other things, we must be able to:

identify potential

drug product candidates;

design and conduct appropriate

laboratory, preclinical and other research;

submit for and receive

regulatory approval to perform clinical studies;

design and conduct appropriate

preclinical and clinical studies according to good laboratory and good clinical practices;

select and recruit clinical

investigators;

select and recruit subjects

for our studies;

collect, analyze, and correctly

interpret the data from our studies;

submit for and receive

regulatory approvals for marketing;

manufacture the drug product

candidates according to cGMP.

potential drug product candidates;

and conduct appropriate laboratory, preclinical and other research;

for and receive regulatory approval to perform clinical studies;

and conduct appropriate preclinical and clinical studies according to good laboratory and good clinical practices;

and recruit clinical investigators;

and recruit subjects for our studies;

analyze, and correctly interpret the data from our studies;

for and receive regulatory approvals for marketing;

the drug product candidates according to cGMP.

development program with respect to any given product will take many years and thus delay our ability to generate profits.

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our ability to obtain regulatory approval or commercialize our product candidates, including:

our preclinical

tests or clinical trials may produce negative or inconclusive results, and we may decide, or regulators may require us, to conduct

additional preclinical testing or clinical trials or we may abandon projects that we expect to be promising;

regulators or institutional

review boards may not authorize us to commence a clinical trial or conduct a clinical trial at a prospective trial site;

conditions imposed on us

by the FDA or any non-U.S.

regulatory authority regarding the scope or design of our clinical trials may require us to resubmit our

clinical trial protocols to institutional review boards for re-inspection due to changes in the regulatory environment;

the number of patients

required for our clinical trials may be larger than we anticipate, or participants may drop out of our clinical trials at a higher

rate than we anticipate;

our third-party contractors

or clinical investigators may fail to comply with regulatory requirements or fail to meet their contractual obligations to us in

a timely manner;

we might have

to suspend or terminate one or more of our clinical trials if we, the regulators or the institutional review boards determine that

the participants are being exposed to unacceptable health risks;

regulators or institutional

review boards may require that we hold, suspend or terminate clinical research for various reasons, including noncompliance with

regulatory requirements;

the cost of our clinical

trials may be greater than we anticipate;

the supply or quality of

our product candidates or other materials necessary to conduct our clinical trials may be insufficient or inadequate or we may not

be able to reach agreements on acceptable terms with prospective clinical research organizations;

the effects of our product

candidates may not be the desired effects or may include undesirable side effects or the product candidates may have other unexpected

characteristics.

preclinical tests or clinical trials may produce negative or inconclusive results, and we may decide, or regulators may require us,

to conduct additional preclinical testing or clinical trials or we may abandon projects that we expect to be promising;

or institutional review boards may not authorize us to commence a clinical trial or conduct a clinical trial at a prospective trial

imposed on us by the FDA or any non-U.S.

regulatory authority regarding the scope or design of our clinical trials may require us

to resubmit our clinical trial protocols to institutional review boards for re-inspection due to changes in the regulatory environment;

number of patients required for our clinical trials may be larger than we anticipate, or participants may drop out of our clinical

trials at a higher rate than we anticipate;

third-party contractors or clinical investigators may fail to comply with regulatory requirements or fail to meet their contractual

obligations to us in a timely manner;

might have to suspend or terminate one or more of our clinical trials if we, the regulators or the institutional review boards determine

that the participants are being exposed to unacceptable health risks;

or institutional review boards may require that we hold, suspend or terminate clinical research for various reasons, including noncompliance

with regulatory requirements;

cost of our clinical trials may be greater than we anticipate;

supply or quality of our product candidates or other materials necessary to conduct our clinical trials may be insufficient or inadequate

or we may not be able to reach agreements on acceptable terms with prospective clinical research organizations;

effects of our product candidates may not be the desired effects or may include undesirable side effects or the product candidates

may have other unexpected characteristics.

addition, if we are required to conduct additional clinical trials or other testing of our product candidates beyond those that we currently

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are not positive or are only modestly positive or if there are safety concerns, we may:

in obtaining, or may not be able to obtain, marketing approval for one or more of our product candidates;

obtain approval for indications

that are not as broad as intended or entirely different than those indications for which we sought approval;

have the product removed

from the market after obtaining marketing approval.

delayed in obtaining, or may not be able to obtain, marketing approval for one or more of our product candidates;

approval for indications that are not as broad as intended or entirely different than those indications for which we sought approval;

the product removed from the market after obtaining marketing approval.

product development costs will also increase if we experience delays in testing or approvals.

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identification and recruitment;

regulatory approvals to

initiate study sites;

patient population size;

the nature of the protocol

to be used in the trial;

patient proximity to clinical

eligibility criteria for

competition from other

companies’ clinical studies for the same patient population;

ability to obtain comparator

approvals to initiate study sites;

population size;

nature of the protocol to be used in the trial;

proximity to clinical sites;

criteria for the study;

from other companies’ clinical studies for the same patient population;

to obtain comparator drug/device.

believe our procedures for enrolling patients have been appropriate;

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of clinical safety and efficacy of such product candidate;

relative convenience and

ease of administration;

the prevalence and severity

of any adverse effects;

the willingness

of physicians to prescribe such product candidates and of the target patient population to try new therapies;

pricing and cost-effectiveness;

the inclusion or omission

of such product candidate in applicable treatment guidelines;

the effectiveness of our

or any future collaborators’ sales and marketing strategies;

limitations or warnings

contained in FDA approved labeling;

our ability to obtain and

maintain sufficient third-party coverage or reimbursement from government health care programs, including Medicare and Medicaid,

private health insurers and other third-party payors;

the willingness of patients

to pay out-of-pocket in the absence of third-party coverage or reimbursement.

convenience and ease of administration;

prevalence and severity of any adverse effects;

willingness of physicians to prescribe such product candidates and of the target patient population to try new therapies;

and cost-effectiveness;

inclusion or omission of such product candidate in applicable treatment guidelines;

effectiveness of our or any future collaborators’ sales and marketing strategies;

or warnings contained in FDA approved labeling;

ability to obtain and maintain sufficient third-party coverage or reimbursement from government health care programs, including Medicare

and Medicaid, private health insurers and other third-party payors;

willingness of patients to pay out-of-pocket in the absence of third-party coverage or reimbursement.

MAT2203 or any other product candidates we may develop is approved but does not achieve an adequate level of acceptance by physicians,

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Further, the FDA may place conditions on approvals including potential requirements or risk management

plans and the requirement for a Risk Evaluation and Mitigation Strategy (REMS) to assure the safe use of the drug.

If the FDA concludes

a REMS is needed, the sponsor of the NDA must submit a proposed REMS;

plans and the requirement for a REMS to assure the safe use of the drug.

If the FDA concludes a REMS is needed, the sponsor of the NDA

must submit a proposed REMS;

the FDA will not approve the NDA without an approved REMS, if required.

A REMS could include medication guides, physician communication plans, or elements to assure safe use, such as restricted distribution

methods, patient registries and other risk minimization tools.

Any of these limitations on approval or marketing could restrict the commercial

promotion, distribution, prescription or dispensing of such product candidate.

Moreover, product approvals may be withdrawn for non-compliance

with regulatory standards or if problems occur following the initial marketing of the product.

Any of the foregoing scenarios could materially

harm the commercial success of such product candidate.

A REMS could include medication

guides, physician communication plans, or elements to assure safe use, such as restricted distribution methods, patient registries and

other risk minimization tools.

Any of these limitations on approval or marketing could restrict the commercial promotion, distribution,

prescription or dispensing of such product candidate.

Moreover, product approvals may be withdrawn for non-compliance with regulatory

standards or if problems occur following the initial marketing of the product.

Any of the foregoing scenarios could materially harm the

commercial success of such product candidate.

currently have no sales and marketing organization.

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the United States without strategic partners or licensees include:

our inability

to recruit and retain adequate numbers of effective sales and marketing personnel;

the inability of sales

personnel to obtain access to or persuade adequate numbers of physicians to prescribe our future products;

the lack of complementary

products to be offered by sales personnel, which may put us at a competitive disadvantage relative to companies with more extensive

product lines;

unforeseen costs and expenses

associated with creating an independent sales and marketing organization.

inability to recruit and retain adequate numbers of effective sales and marketing personnel;

inability of sales personnel to obtain access to or persuade adequate numbers of physicians to prescribe our future products;

lack of complementary products to be offered by sales personnel, which may put us at a competitive disadvantage relative to companies

with more extensive product lines;

costs and expenses associated with creating an independent sales and marketing organization.

we are not successful in recruiting sales and marketing personnel or in building a sales and marketing infrastructure, or if we do not

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on the marketing or manufacturing of the product, withdrawal of the product from the market, or voluntary or mandatory product recalls;

issuance of warning letters

or untitled letters;

clinical holds;

injunctions or the imposition

of civil or criminal penalties or monetary fines;

suspension or withdrawal

of regulatory approval;

suspension of any ongoing

clinical trials;

refusal to approve pending

applications or supplements to approved applications filed by us, or suspension or revocation of product license approvals;

suspension or imposition

of restrictions on operations, including costly new manufacturing requirements;

product seizure or detention

or refusal to permit the import or export of product.

of warning letters or untitled letters;

or the imposition of civil or criminal penalties or monetary fines;

or withdrawal of regulatory approval;

of any ongoing clinical trials;

to approve pending applications or supplements to approved applications filed by us, or suspension or revocation of product license

or imposition of restrictions on operations, including costly new manufacturing requirements;

seizure or detention or refusal to permit the import or export of product.

occurrence of any event or penalty described above may inhibit our ability to commercialize MAT2203 or any of our other product candidates

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Additionally,

the Inflation Reduction Act of 2022, which took in 2023, includes policies that are designed to have a direct impact on drug prices and

reduce drug spending by the federal government.

the Inflation Reduction Act of 2022, which took effect in 2023, includes policies that are designed to have a direct impact on drug prices

and reduce drug spending by the federal government.

This legislation contains substantial drug pricing reforms, including the establishment

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clinical trials to be conducted prior to obtaining approval;

changes to manufacturing

recalls, replacements,

or discontinuance of one or more of our products;

additional recordkeeping.

to manufacturing methods;

replacements, or discontinuance of one or more of our products;

recordkeeping.

changes would likely require substantial time and impose significant costs or could reduce the potential commercial value of our product

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markets, we would be subject to additional risks and uncertainties, including:

our customers’

ability to obtain reimbursement for our product candidates in foreign markets;

our inability to directly

control commercial activities because we are relying on third parties;

the burden of complying

with complex and changing foreign regulatory, tax, accounting and legal requirements;

different medical practices

and customs in foreign countries affecting acceptance in the marketplace;

import or export licensing

requirements;

longer accounts receivable

collection times;

longer lead times for shipping;

language barriers

for technical training;

reduced protection of intellectual

property rights in some foreign countries;

foreign currency exchange

rate fluctuations;

the interpretation of contractual

provisions governed by foreign laws in the event of a contract dispute.

customers’ ability to obtain reimbursement for our product candidates in foreign markets;

inability to directly control commercial activities because we are relying on third parties;

burden of complying with complex and changing foreign regulatory, tax, accounting and legal requirements;

medical practices and customs in foreign countries affecting acceptance in the marketplace;

or export licensing requirements;

accounts receivable collection times;

lead times for shipping;

barriers for technical training;

protection of intellectual property rights in some foreign countries;

currency exchange rate fluctuations;

interpretation of contractual provisions governed by foreign laws in the event of a contract dispute.

sales of our product candidates could also be adversely affected by the imposition of governmental controls, political and economic instability,

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face risks related to health epidemics or outbreaks of communicable diseases.

The outbreak of communicable diseases, such as COVID-19,

have resulted in a widespread health crisis that has adversely affected general commercial activity and the economies and financial markets

of many countries.

Since some of our business partners are outside of the U.S., in China and other Asian countries, including manufacturing

operations for our active pharmaceutical ingredient, an outbreak of communicable diseases in Asia or elsewhere, or the perception that

such an outbreak could occur, and the measures taken by the governments of countries affected could adversely affect our business, financial

condition or results of operations.

For example, an outbreak could significantly disrupt our business by limiting our ability to travel

or ship materials within or outside China and forcing temporary closure of facilities that we rely upon.

Since some of our business partners are outside of the

U.S., in China and other Asian countries, including manufacturing operations for our active pharmaceutical ingredient, an outbreak of

communicable diseases in Asia or elsewhere, or the perception that such an outbreak could occur, and the measures taken by the governments

of countries affected could adversely affect our business, financial condition or results of operations.

For example, an outbreak could

significantly disrupt our business by limiting our ability to travel or ship materials within or outside China and forcing temporary

closure of facilities that we rely upon.

global conditions, including economic uncertainty, may negatively impact our financial results.

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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 Russian invasion of the Ukraine, the withdrawal of the United Kingdom from the European

Union, 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, which may adversely affect our business.

in the geopolitical environment and 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, which may adversely affect our business.

Relating to Our Intellectual Property Rights and Regulatory Exclusivity

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We do not control these technologies and any loss of our rights to them could

prevent us from discovering, developing and commercializing our product candidates.

prevent us from discovering, developing and commercializing product candidates.

rely upon our LNC Platform and certain of the patents which are exclusively licensed to us by Rutgers.

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product candidates.

we discontinue development of the LNC Platform, we could be required to return such technology to the former stockholders of Aquarius

and/or Rutgers and we could lose the rights to our lead product candidates.

certain circumstances, we will be required to transfer Aquarius’ LNC Platform back to the former shareholders of Aquarius.

This transfer would be required under the Aquarius Merger Agreement pursuant to which we acquired the rights to the LNC Platform in

the event the following conditions are met:

(i) we shall have discontinued efforts to develop or commercialize the LNC Platform (as

conclusively demonstrated by our omission of the LNC Platform in at least two consecutive royalty, progress and payment reports

delivered to Rutgers pursuant to the license agreement entered into between Aquarius and Rutgers) and (ii) as of the Transfer Date,

no unresolved indemnification claims for us and our indemnified parties are pending.

If the foregoing conditions are met, we would

transfer the LNC Platform to the stockholder representative or to a newly formed entity as directed by the stockholder

representative (in either case for the benefit of the former Aquarius stockholders) following receipt of any necessary third-party

consents required for the transfer, which we shall use its commercially reasonable efforts to obtain.

If we are required to transfer

the LNC Platform back to the former shareholders of Aquarius, we would lose our rights to our lead product candidates, which would

have a material and adverse effect on our business.

is difficult and costly to protect our intellectual property rights, and we cannot ensure the protection of these rights.

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infringement asserted by third parties against us would be time-consuming and may:

result in costly

divert the time and attention

of our technical personnel and management;

prevent us from commercializing

a product until the asserted patent expires or is held finally invalid or not infringed in a court of law;

require us to cease or

modify our use of the technology and/or develop non-infringing technology;

require us to enter into

royalty or licensing agreements.

in costly litigation;

the time and attention of our technical personnel and management;

us from commercializing a product until the asserted patent expires or is held finally invalid or not infringed in a court of law;

us to cease or modify our use of the technology and/or develop non-infringing technology;

us to enter into royalty or licensing agreements.

no third party has asserted a claim of infringement against us, others may hold proprietary rights that could prevent MAT2203 from being

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Regardless of the merits or eventual outcome, liability claims may result in:

decreased demand

for MAT2203 or any future products that we may develop;

injury to our reputation;

withdrawal of clinical

trial participants;

costs to defend the related

a diversion of management’s

time and our resources;

substantial monetary awards

to trial participants or patients;

product recalls, withdrawals

or labeling, marketing, or promotional restrictions;

loss of revenue;

the inability to commercialize

our product candidates;

a decline in our stock

demand for MAT2203 or any future products that we may develop;

to our reputation;

of clinical trial participants;

to defend the related litigation;

diversion of management’s time and our resources;

monetary awards to trial participants or patients;

recalls, withdrawals or labeling, marketing, or promotional restrictions;

inability to commercialize our product candidates;

decline in our stock price.

inability to obtain and retain sufficient product liability insurance at an acceptable cost to protect against potential product liability

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of MAT2203 and/or MAT2501, which we do not expect to occur before 2027, if ever, and/or if we generate sales of such products, or we

receive any proceeds from the licensing or other disposition of MAT2203 or MAT2501, we are required to pay to the holders of our Series

A Preferred Stock, subject to certain vesting requirements, in aggregate, a royalty equal to (i) 4.5% of Net Sales (as defined in the

Certificate of Designations), subject in all cases to a cap of $25 million per calendar year, and (ii) 7.5% of Licensing Proceeds (as

defined in the Certificate of Designations), subject in all cases to a cap of $10 million per calendar year.

The Royalty Payment Rights

will expire when the patents covering the applicable product expire, which is currently expected to be in 2033.

receive any proceeds from the licensing or other disposition of MAT2203 or MAT2501, we are required to pay to certain former holders

of our Series A Preferred Stock, in aggregate, a royalty equal to (i) 4.5% of Net Sales (as defined in the Certificate of Designations),

subject in all cases to a cap of $25 million per calendar year, and (ii) 7.5% of Licensing Proceeds (as defined in the Certificate of

Designations), subject in all cases to a cap of $10 million per calendar year.

The Royalty Payment Rights will expire when the patents

covering the applicable product expire, which is currently expected to be in 2033.

rights of the holders of common stock may be impaired by the potential issuance of preferred stock.

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active public trading market for our common stock may not be sustained.

our common stock is listed on the NYSE American, the market for our shares has demonstrated varying levels of trading activity, and

we cannot assure you that an active trading market will be sustained.

our common stock is listed on the NYSE American, the market for our shares has demonstrated varying levels of trading activity, and we

cannot assure you that an active trading market will be sustained.

A lack of an active market may impair your ability to sell shares

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turn could cause our stock price or trading volume to decline.

could be delisted from the NYSE American, which could seriously harm the liquidity of our stock and our ability to raise capital.

had in the past, and may have in the future, difficulty satisfying NYSE American listing requirements for our common stock.

unable to regain or maintain such compliance, we may cease to be eligible to trade on Nasdaq.

In such event:

may have to pursue trading on a less recognized or accepted market, such as the OTC Bulletin Board or the “pink sheets.”

of our common stock could be less liquid and marketable, thereby reducing the ability of stockholders to purchase or sell our shares

as quickly and as inexpensively as they have done historically.

If our stock is traded as a “penny stock,” transactions

in our stock would be more difficult and cumbersome.

may be unable to access capital on favorable terms or at all, as companies trading on alternative markets may be viewed as less attractive

investments with higher associated risks, such that existing or prospective institutional investors may be less interested in, or

prohibited from, investing in our common stock.

This may also cause the market price of our common stock to decline.

A reverse-stock split

of our common stock may not have the intended consequences.

On November 1, 2023, our

shareholders approved an amendment to our Certificate of Incorporation to effect a reverse stock split at a ratio in the range of 1-for-2

to 1-for-50, to be determined at the discretion of the Board, and to reduce the total number of authorized shares of common stock from

500,000,000 to 250,000,000, which we refer to as the reverse stock split and authorized share reduction, respectively.

We believe that

the reverse stock split may result in an increase to the market price of our common stock, enhance the appeal of our common stock to the

financial community, improve the trading liquidity of our common stock, make it possible for us to “up-list” our common stock

to a higher tier stock exchange, and make us eligible for inclusion on certain biotechnology and pharmaceutical trading indices and exchange-traded

However, we cannot assure

you that the reverse stock split, if implemented, will result in any anticipated benefits, including an increase of the market price of

our common stock in proportion to the reduction in the number of shares of our common stock outstanding.

Moreover, a reverse-stock split

may have the effect of decreasing our overall market value.

There can be no assurance that the reverse stock split will result in a per

share price that will attract institutional investors or investment funds or that such share price will satisfy the investing guidelines

of institutional investors or investment funds or improve the trading liquidity of our common stock.

Moreover, the number of shares of our common stock

available for issuance following the implementation of the reverse stock split would increase to the extent the reverse stock split reduces

the number of outstanding shares of our common stock relative to the number of authorized shares.

Such available shares may be used for

future corporate purposes, including future acquisitions, investment opportunities, the establishment of collaboration or other strategic

agreements, capital raising transactions involving equity or convertible debt securities, future at the market offerings of common stock,

or issuance under current or future employee equity plans, and the issuance of equity securities in connection with such transactions

may result in potentially significant dilution of our current stockholders’ ownership interests in us.

dissolution of our company, you may not recoup all or any portion of your investment.

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These provisions, among other things:

that special meetings of stockholders may be called only by the board of directors, President, or our Chairman of the Board of Directors,

or at the request in writing by stockholders of record owning at least fifty (50%) percent of the issued and outstanding voting shares

of common stock;

they do not include a provision

for cumulative voting in the election of directors.

Under cumulative voting, a minority stockholder holding a sufficient number of

shares may be able to ensure the election of one or more directors.

The absence of cumulative voting may have the effect of limiting

the ability of minority stockholders to effect changes in our board of directors;

they allow us to issue,

without stockholder approval, up to 10,000,000 shares of preferred stock (all of which remain available for issuance) that could

adversely affect the rights and powers of the holders of our common stock.

provide that special meetings of stockholders may be called only by the board of directors, President, or our Chairman of the Board

of Directors, or at the request in writing by stockholders of record owning at least fifty (50%) percent of the issued and outstanding

voting shares of common stock;

do not include a provision for cumulative voting in the election of directors.

Under cumulative voting, a minority stockholder holding

a sufficient number of shares may be able to ensure the election of one or more directors.

The absence of cumulative voting may have

the effect of limiting the ability of minority stockholders to effect changes in our board of directors;

allow us to issue, without stockholder approval, up to 10,000,000 shares of preferred stock (all of which remain available for issuance)

that could adversely affect the rights and powers of the holders of our common stock.

addition, we are governed by the provisions of Section 203 of the Delaware General Corporation Law, or DGCL, which may, unless certain

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income for losses arising in taxable years beginning after December 31, 2017.

Cybersecurity

Risk Management and Strategy

like other companies in our industry, face several cybersecurity risks in connection with our business.

Our business strategy, results

of operations, and financial condition have not, to date, been affected by risks from cybersecurity threats.

During the reporting period,

we have not experienced any material cyber incidents, nor have we experienced a series of immaterial incidents, which would require disclosure.

the ordinary course of our business, we use, store and process data including data of our employees, trial participants, partners, clients,

We have implemented a cybersecurity risk management program that is designed to identify, assess, and mitigate risks from

cybersecurity threats to this data and our systems.

Our cybersecurity risk management program incorporates several components, including

information security program assessments, continuous monitoring of cyber risks and threats using automated tools, written incident response

and disaster recovery policies and procedures, and employee training.

Under the direction of our Chief Financial Officer, our cyber risk

management program is led by a third-party IT consultant with more than 30 years of technology engineering experience and several advanced

We also deploy endpoint detection software and device management in conjunction with other reputable cybersecurity software.

Additionally, we require multifactor authentication across all systems.

periodically engage third parties to conduct risk assessments and other vulnerability analyses.

Lastly, our program includes cybersecurity

training for all employees.

The semi-annual training focuses on cyber threat awareness, including phishing.

Related to Cybersecurity Risks

the ultimate direction of our chief executive officer (“CEO”), the Board of Directors is updated on our cybersecurity risk

management program, including any critical cybersecurity risks, ongoing cybersecurity initiatives and strategies, and applicable regulatory

requirements and industry standards, on an as-needed basis.

The CEO also notifies the Board of any cybersecurity incidents (suspected

or actual) and provides updates on the incidents as well as cybersecurity risk mitigation activities as appropriate.

administrative offices consist of approximately 8,900 square feet of office space in Bedminster, NJ that we occupy under a lease that

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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