What changed in this filing

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Item 1A. Risk Factors

2023-03-15 compared with 2022-03-08 · 798 added, 694 removed, 750 unchanged (67% of the section changed)

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of Risk Factors

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 cannot market any of our product

Any delay in the approval process will harm our business.

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

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.

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.

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.

we are unable to file for approval of MAT2203 or MAT2501 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.

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.

are in the process of evaluating potential next steps in the development of LYPIDISO.

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.

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.

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.

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 our product candidates.

we discontinue development of the LNC platform delivery technology, we would be required to return such technology to the former

stockholders of Aquarius and/or Rutgers and we would lose the rights to our lead 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.

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

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.

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.

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.

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

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.

Related to Our Financial Position and Need for Additional Capital

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have incurred significant operating losses in every year since inception and expect to incur net operating losses for the foreseeable

Our net loss was $23.3 million and $22.4 million for the years ended December 31, 2021 and 2020, respectively.

Our net loss was $20,997 thousand and $23,283 thousand for the years ended December 31, 2022 and 2021, respectively.

As of December

31, 2021, we had an accumulated deficit of $131.6 million.

31, 2022, we had an accumulated deficit of $152,631 thousand.

We do not know whether or when we will become profitable.

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Health, or the NIH.

We have devoted substantially all of our financial resources and efforts to the research and development of potential

We have devoted substantially all our financial resources and efforts to the research and development of potential

product candidates.

All of our product candidates are in the development stage, and we have not completed development of any product

All our product candidates are in the development stage, and we have not completed development of any product candidate.

We expect to continue to incur significant expenses and operating losses over the next several years.

Our net losses may fluctuate

significantly from quarter to quarter and year to year.

Net losses and negative cash flows have had, and will continue to have, an adverse

effect on our stockholders’ deficit and working capital.

We anticipate that our expenses will increase substantially if and as

further clinical and preclinical studies of MAT2203 AND MAT2501, our lead LNC product candidates;

the conduct of further clinical studies of MAT2203, even if such studies are primarily 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

Our net losses may fluctuate significantly

from quarter to quarter and year to year.

Net losses and negative cash flows have had, and will continue to have, an adverse effect on

our stockholders’ deficit and working capital.

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.

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 ongoing EnACT clinical trial of MAT2203 in CM, our preclinical toxicology program for MAT2501,

and conduct additional preclinical and clinical trials to further validate and expand our LNC platform delivery technology, 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.

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

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 securities, including restricted cash, of approximately $49.9 million

as of December 31, 2021 will enable us to fund our operating expenses and capital expenditure requirements through 2023.

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

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:

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 delivery technology, including MAT2501,

and any preclinical or clinical work done to further validate our LNC platform delivery technology, 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.

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 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.

regulatory authorities;

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.

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.

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

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arrangements.

We do not have any committed external source of funds other than limited grant funding from the NIH and the CFF.

extent that we raise additional capital through the sale of common stock, convertible securities or other equity securities, your ownership

interest may be materially diluted, and the terms of these securities may include liquidation or other preferences and anti-dilution

protections that could adversely affect your rights as a common stockholder.

Debt financing and preferred equity financing, if available,

would result in increased fixed payment obligations and may involve agreements that include covenants limiting or restricting our ability

to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends, that could adversely

impact our ability to conduct our business.

Securing additional financing could require a substantial amount of time and attention from

our management and may divert a disproportionate amount of their attention away from day-to-day activities, which may adversely affect

our management’s ability to oversee the development of our product candidates.

We do not have any committed external source of funds other than limited grant funding from the NIH.

To the extent that

we raise additional capital through the sale of common stock, convertible securities or other equity securities, your ownership interest

may be materially diluted, and the terms of these securities may include liquidation or other preferences and anti-dilution protections

that could adversely affect your rights as a common stockholder.

Debt financing and preferred equity financing, if available, would result

in increased fixed payment obligations and may involve agreements that include covenants limiting or restricting our ability to take

specific actions, such as incurring additional debt, making capital expenditures, or declaring dividends, that could adversely impact

our ability to conduct our business.

Securing additional financing could require a substantial amount of time and attention from our

management and may divert a disproportionate amount of their attention away from day-to-day activities, which may adversely affect our

management’s ability to oversee the development of our product candidates.

we raise additional funds through collaborations, strategic alliances or marketing, distribution, or licensing arrangements with third

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addition, we may encounter unforeseen expenses, difficulties, complications, delays, and other known and unknown factors.

Even if we obtain

regulatory approval, we will need to transition from a company with a research and development focus to a company capable of supporting

obtain regulatory approval, we will need to transition from a company with a research and development focus to a company capable of supporting

commercial activities.

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commercialization of our product candidates.

The success of MAT2203, MAT2501 and any other product candidates we may develop will depend

on many factors, including the following:

The success of MAT2203 and any other product candidates we may develop will depend on many

factors, including the following:

completion of preclinical studies;

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;

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;

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

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

of the product candidates, if and when 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.

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.

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

to successfully commercialize our product candidates, which would harm our business.

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

to market any of our product candidates.

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

of our product candidates.

Any delay in the approval process will harm our business.

expect to invest most of our capital in the development of our LNC platform delivery technology.

Our ability to generate revenue related

to product sales, which we do not expect will occur for at least the next several years, if ever, will depend on the successful development

and regulatory approval of one or more of our product candidates.

All of our product candidates require regulatory review and approval

prior to commercialization.

Any delays in the regulatory review or approval of our product candidates would delay market launch, increase

our cash requirements and result in additional operating losses.

This failure to obtain regulatory approvals would prevent our product

candidate from being marketed and would have a material and adverse effect on our business.

expect to invest most of our capital in the development of our LNC Platform.

Our ability to generate revenue related to product sales,

which we do not expect will occur for at least the next several years, if ever, will depend on the successful development and regulatory

approval of one or more of our product candidates.

All our product candidates require regulatory review and approval prior to commercialization.

Any delays in the regulatory review or approval of our product candidates would delay market launch, increase our cash requirements and

result in additional operating losses.

This failure to obtain regulatory approvals would prevent our product candidate from being marketed

and would have a material and adverse effect on our business.

process of obtaining FDA and other required regulatory approvals, including foreign approvals, often takes many years and can vary substantially

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and the emergence of new information regarding such product candidates.

obtained from preclinical studies and clinical trials are subject to different interpretations, which could delay, limit or prevent regulatory

review or approval of any of our product candidates.

Furthermore, regulatory attitudes towards the data and results required to demonstrate

safety and efficacy can change over time and can be affected by many factors, such as the emergence of new information, including on

other products, policy changes and agency funding, staffing and leadership.

We do not know whether future changes to the regulatory environment

will be favorable or unfavorable to our business prospects.

obtained from preclinical studies and clinical trials are subject to different interpretations, which could delay, limit, or prevent

regulatory review or approval of any of our product candidates.

Furthermore, regulatory attitudes towards the data and results required

to demonstrate safety and efficacy can change over time and can be affected by many factors, such as the emergence of new information,

including on other products, policy changes and agency funding, staffing and leadership.

We do not know whether future changes to the

regulatory environment will be favorable or unfavorable to our business prospects.

addition, the environment in which our regulatory submissions may be reviewed changes over time.

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policy changes.

Moreover, in light of widely publicized events concerning the safety risk of certain drug products, regulatory authorities,

Moreover, considering widely publicized events concerning the safety risk of certain drug products, regulatory authorities,

members of the U.S.

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in obtaining approval or may result in approval for a more limited indication than originally sought.

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.

rely heavily on the LNC platform delivery technology that we have licensed from Rutgers.

The loss of access to this technology could

materially impair our business and future viability, and could result in delays in developing, introducing or maintaining our product

candidates and formulations until equivalent technology, if available, is identified, licensed and integrated.

In addition, any defects

in the technology we license could prevent the implementation or impair the functionality of our product candidates or formulation, delay

new product or formulation introductions or injure our reputation.

If we are required to enter into license agreements with third parties

for replacement technology, we could be subject to higher royalty payments.

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.

rely heavily on the LNC Platform and certain of the patents that we have exclusively licensed from Rutgers.

The loss of access to these

patents could materially impair our business and future viability, and could result in delays in developing, introducing, or maintaining

our product candidates and formulations until equivalent technology, if available, is identified, licensed and integrated.

any defects in the intellectual property that we license could prevent the implementation or impair the functionality of our product

candidates or formulation, delay new product or formulation introductions or injure our reputation.

If we are required to enter into

license agreements with third parties for replacement technology, we could be subject to higher royalty payments.

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.

date, we have only developed limited in-house manufacturing capabilities for the LNC platform delivery technology needed for the clinical

development our MAT2203 and MAT2501 product candidates.

If we do not develop a long-term in-house manufacturing capability for our LNC

platform product candidates sufficient to produce product for continued development and, if regulatory approval is obtained, then commercialization

of these products, we will be dependent on a small number of third-party manufacturers for the manufacture of our product candidates.

We may not have long-term agreements with any of these third parties, and if they are unable or unwilling to perform for any reason,

we may not be able to locate alternative acceptable manufacturers or formulators or enter into favorable agreements with them.

Any inability

to acquire sufficient quantities of our products in a timely manner from these third parties could delay clinical trials and prevent

us from developing our products in a cost-effective manner or on a timely basis.

In addition, manufacturers of our product candidates

are subject to cGMP and similar foreign standards and we would not have control over compliance with these regulations by our manufacturers.

If one of our contract manufacturers fails to maintain compliance, the production of our products could be interrupted, resulting in

delays and additional costs.

In addition, if the facilities of such manufacturers do not pass a pre-approval or post-approval plant inspection,

the FDA will not grant approval and may institute restrictions on the marketing or sale of our products.

date, we have only developed limited in-house manufacturing capabilities for the LNC Platform needed for the clinical development our

MAT2203 product candidates.

We have entered into an agreement with Patheon, a wholly owned subsidiary of ThermoFisher, to prepare for

the commercial manufacture of MAT2203.

If we do not develop a long-term manufacturing capability for our LNC platform product candidates

sufficient to produce product for continued development and, if regulatory approval is obtained, then commercialization of these products,

we will be dependent on a small number of third-party manufacturers for the manufacture of our product candidates.

We may not have long-term

agreements with any of these third parties, and if they are unable or unwilling to perform for any reason, we may not be able to locate

alternative acceptable manufacturers or formulators or enter into favorable agreements with them.

Any inability to acquire enough of

our products in a timely manner from these third parties could delay clinical trials and prevent us from developing our products in a

cost-effective manner or on a timely basis.

In addition, manufacturers of our product candidates are subject to cGMP and similar foreign

standards, and we would not have control over compliance with these regulations by our manufacturers.

If one of our contract manufacturers

fails to maintain compliance, the production of our products could be interrupted, resulting in delays and additional costs.

if the facilities of such manufacturers do not pass a pre-approval or post-approval plant inspection, the FDA will not grant approval

and may institute restrictions on the marketing or sale of our products.

may be reliant on third party manufactures and suppliers to meet the demands of our clinical supplies.

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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 and 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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intensive process.

In order to succeed, among other things, we must be able to:

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.

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.

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

potential products that appear promising at early stages of development may fail for a number of reasons, including the possibility that

potential products that appear promising at early stages of development may fail for several reasons, including the possibility that

the products may require significant additional testing or turn out to be unsafe, ineffective, too difficult or expensive to develop

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

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.

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.

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:

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.

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.

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

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ability to commercialize our products or product candidates.

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

be adversely affected.

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

adversely affected.

completion rate of clinical studies of our products is dependent on, among other factors, the patient enrollment rate.

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identification and recruitment;

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.

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

believe our procedures for enrolling patients have been appropriate;

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

have received orphan drug designation for MAT2203 and MAT2501 in the United States and may seek additional orphan drug designation for

other product candidates.

Regulatory authorities in some jurisdictions, including the United States and Europe, may designate drugs for

relatively small patient populations as orphan drugs.

Under the Orphan Drug Act, the FDA may designate a product as an orphan drug if

it is a drug intended to treat a rare disease or condition, which is generally defined as a patient population of fewer than 200,000

individuals in the United States.

Generally, if a product with an orphan drug designation subsequently receives the first marketing approval

for the indication for which it has such designation, the product is entitled to a period of marketing exclusivity, which precludes the

FDA or the EMA from approving another marketing application for the same indication for that drug during that time period.

have received orphan drug designation for MAT2203 in the United States and may seek additional orphan drug designation for other product

Regulatory authorities in some jurisdictions, including the United States and Europe, may designate drugs for relatively

small patient populations as orphan drugs.

Under the Orphan Drug Act, the FDA may designate a product as an orphan drug if it is a drug

intended to treat a rare disease or condition, which is generally defined as a patient population of fewer than 200,000 individuals in

the United States.

Generally, if a product with an orphan drug designation subsequently receives the first marketing approval for the

indication for which it has such designation, the product is entitled to a period of regulatory or marketing exclusivity, which precludes

the FDA or the EMA from approving another marketing application for the same indication for that drug during that time.

For a product

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is unable to assure sufficient quantity of the drug to meet the needs of patients with the rare disease or condition.

cannot assure you that the application for orphan drug designation of MAT2203, MAT2501, or any future application with respect to any

other product candidate, will be maintained or granted.

If we are unable to maintain orphan drug designation in the United States, we

will not be eligible to obtain the period of market exclusivity that could result from orphan drug designation or be afforded the financial

incentives associated with orphan drug designation.

Even if we obtain orphan drug exclusivity for a product, that exclusivity may not

effectively protect the product from competition because different drugs can be approved for the same condition.

Even after an orphan

drug is approved, the FDA can subsequently approve the same drug for the same condition if the FDA concludes that the later drug is clinically

superior in that it is shown to be safer, more effective or makes a major contribution to patient care.

cannot assure you that the application for orphan drug designation of MAT2203 or any future application with respect to any other product

candidate, will be maintained or granted.

If we are unable to maintain orphan drug designation in the United States, we will not be eligible

to obtain the period of market exclusivity that could result from orphan drug designation or be afforded the financial incentives associated

with orphan drug designation.

Even if we obtain orphan drug exclusivity for a product, that exclusivity may not effectively protect the

product from competition because different drugs can be approved for the same condition.

Even after an orphan drug is approved, the FDA

can subsequently approve the same drug for the same condition if the FDA concludes that the later drug is clinically superior in that

it is shown to be safer, more effective or makes a major contribution to patient care.

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

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advances in treatment, the FDA may designate it eligible for priority review.

The FDA has broad discretion whether or not to grant these

designations, so even if we believe a particular product candidate is eligible for these designations, we cannot assure you that the

FDA would decide to grant them.

Even if we do receive Fast Track designation or priority review, we may not experience a faster development

process, review or approval compared to conventional FDA procedures.

The FDA may withdraw Fast Track designation if it believes that

the designation is no longer supported by data from our clinical development program.

The FDA has broad discretion whether to grant these designations,

so even if we believe a particular product candidate is eligible for these designations, we cannot assure you that the FDA would decide

to grant them.

Even if we do receive Fast Track designation or priority review, we may not experience a faster development process, review

or approval compared to conventional FDA procedures.

The FDA may withdraw Fast Track designation if it believes that the designation

is no longer supported by data from our clinical development program.

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

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

have received a qualified infectious disease product, or QIDP, designation for MAT2203 and MAT2501 for certain indications and we may

be eligible for designation of future product candidates as QIDPs.

A QIDP is “an antibacterial or antifungal drug intended to treat

serious or life-threatening infections, including those caused by an antibacterial or antifungal resistant pathogen, including novel

or emerging infectious pathogens or certain “qualifying pathogens.” A product designated as a QIDP will be granted priority

review by the FDA and may qualify for “fast track” status.

Upon the approval of an NDA for a drug product designated by the

FDA as a QIDP, the product is granted a period of five years of regulatory exclusivity in addition to any other period of regulatory

exclusivity for which the product is eligible.

The FDA has broad discretion whether or not to grant these designations, so even if we

believe a particular product candidate is eligible for such designation or status, the FDA could decide not to grant it.

Moreover, even

if we do receive such a designation, we may not experience a faster development process, review or approval compared to conventional

FDA procedures and there is no assurance that our product candidate, even if determined to be a QIDP, will be approved by the FDA.

have received a qualified infectious disease product, or QIDP, designation for MAT2203 for certain indications and we may be eligible

for designation of future product candidates as QIDPs.

A QIDP is “an antibacterial or antifungal drug intended to treat serious

or life-threatening infections, including those caused by an antibacterial or antifungal resistant pathogen, including novel or emerging

infectious pathogens or certain “qualifying pathogens.” A product designated as a QIDP will be granted priority review by

the FDA and may qualify for “fast track” status.

Upon the approval of an NDA for a drug product designated by the FDA as

a QIDP, the product is granted a period of five years of regulatory exclusivity in addition to any other period of regulatory exclusivity

for which the product is eligible.

The FDA has broad discretion whether to grant these designations, so even if we believe a particular

product candidate is eligible for such designation or status, the FDA could decide not to grant it.

Moreover, even if we do receive such

a designation, we may not experience a faster development process, review or approval compared to conventional FDA procedures and there

is no assurance that our product candidate, even if determined to be a QIDP, will be approved by the FDA.

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

if we receive regulatory approval for MAT2203, MAT2501 or any other product candidates we may develop, we still may not be able to successfully

if we receive regulatory approval for MAT2203 or any other product candidates we may develop, we still may not be able to successfully

commercialize such products and the revenue that we generate from its sales, if any, may be limited.

approved for marketing, the commercial success of MAT2203, MAT2501 or any other product candidates we may develop will depend upon its

acceptance by the medical community, including physicians, patients and health care payors.

The degree of market acceptance of MAT2203,

MAT2501 or such other product candidate will depend on a number of factors, including:

approved for marketing, the commercial success of MAT2203 or any other product candidates we may develop will depend upon its acceptance

by the medical community, including physicians, patients, and health care payors.

The degree of market acceptance of MAT2203 or such

other product candidate will depend on several factors, including:

demonstration

of clinical safety and efficacy of such product candidate;

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, MAT2501 or any other product candidates we may develop is approved but does not achieve an adequate level of acceptance by physicians,

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.

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

health care payors and patients, we may not generate sufficient revenue and we may not be able to achieve or sustain profitability.

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

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.

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.

currently have no sales and marketing organization.

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present, we have no sales or marketing personnel.

In order to commercialize products that are approved for commercial sales, we must

either develop a sales and marketing infrastructure or collaborate with third parties that have such commercial infrastructure.

elect to develop our own sales and marketing organization, we do not intend to begin to hire sales and marketing personnel until the

time of NDA submission to the FDA at the earliest, and we do not intend to establish our own sales organization in the United States

until shortly prior to FDA approval of MAT2203, MAT2501 or any of our other product candidates.

To commercialize products that are approved for commercial sales, we must either develop

a sales and marketing infrastructure or collaborate with third parties that have such commercial infrastructure.

If we elect to develop

our own sales and marketing organization, we do not intend to begin to hire sales and marketing personnel until the time of NDA submission

to the FDA at the earliest, and we do not intend to establish our own sales organization in the United States until shortly prior to

FDA approval of MAT2203 or any of our other product candidates.

may not be able to establish a direct sales force in a cost-effective manner or realize a positive return on this investment.

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sales and marketing personnel.

Factors that may inhibit our efforts to commercialize MAT2203, MAT2501 or any of our other product candidates

in the United States without strategic partners or licensees include:

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.

Factors that may inhibit our efforts to commercialize MAT2203 or any of our other product candidates in

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.

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

successfully enter into appropriate collaboration arrangements, we will have difficulty successfully commercializing MAT2203, MAT2501

or any other product candidates we may develop, which would adversely affect our business, operating results and financial condition.

Outside the United States, we may commercialize our product candidates by entering into collaboration agreements with pharmaceutical

We may not be able to enter into such agreements on terms acceptable to us or at all.

In addition, even if we enter into such

relationships, we may have limited or no control over the sales, marketing and distribution activities of these third parties.

revenues may depend heavily on the success of the efforts of these third parties

we are unable to file for approval of MAT2203 or MAT2501 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.

current plans for filing the NDAs for MAT2203 and MAT2501 include efforts to minimize the data we will be required to generate in order

to obtain marketing approval for this product candidate and therefore reduce the development time.

We intend to rely on the history of

efficacy of amphotericin B, and although we met with the FDA in 2019 and again in 2021 to discuss our development plans for MAT2203,

there is no assurance we will satisfy FDA’s requirements for approval of MAT2203 under a 505(b)(2) pathway.

We have not yet met

with FDA to discuss the regulatory pathway for MAT2501.

The timelines for filing and review of our NDAs for MAT2203 and MAT2501 are based

on our plan to submit these NDAs under Section 505(b)(2) of the FDCA, which would enable us to rely in part on data in the public domain

or elsewhere.

successfully enter into appropriate collaboration arrangements, we will have difficulty successfully commercializing MAT2203 or any other

product candidates we may develop, which would adversely affect our business, operating results and financial condition.

United States, we may commercialize our product candidates by entering into collaboration agreements with pharmaceutical partners.

may not be able to enter into such agreements on terms acceptable to us or at all.

In addition, even if we enter into such relationships,

we may have limited or no control over the sales, marketing and distribution activities of these third parties.

Our future revenues may

depend heavily on the success of the efforts of these third parties.

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

current plans for filing the NDAs for MAT2203 include efforts to minimize the data we will be required to generate to obtain marketing

approval for this product candidate and therefore reduce the development time.

We intend to rely on the history of efficacy of amphotericin

B, and although we met with the FDA in 2019, 2021 and again in 2022 to discuss our development plans for MAT2203, there is no assurance

we will satisfy FDA’s requirements for approval of MAT2203 under a 505(b)(2) pathway.

The timeline for filing and review of our

NDA for MAT2203 is based on our plan to submit the NDA under Section 505(b)(2) of the FDCA, which would enable us to rely in part on

data in the public domain or elsewhere.

We have not yet filed an NDA under Section 505(b)(2) for any product candidate.

Depending on the data that may be required

by the FDA for approval, some of the data may be related to products already approved by the FDA.

If the data relied upon is related

to products already approved by the FDA and covered by third-party patents, we would be required to certify that we do not infringe the

listed patents or that such patents are invalid or unenforceable.

As a result of the certification, the third-party would have 45 days

from notification of our certification to initiate an action against us.

the event that an action is brought in response to such a certification, the approval of our NDA could be subject to a stay of up to

30 months or more while we defend against such a suit.

Approval of our product candidates under Section 505(b)(2) may therefore be delayed

until patent exclusivity expires or until we successfully challenge the applicability of those patents to our product candidates.

Alternatively,

we may elect to generate sufficient additional clinical data so that we no longer rely on data which triggers a potential stay of the

approval of our product candidates.

Even if no exclusivity periods apply to our applications under Section 505(b)(2), the FDA has broad

discretion to require us to generate additional data on the safety and efficacy of our product candidates to supplement third-party data

on which we may be permitted to rely.

In either event, we could be required, before obtaining marketing approval for any of our product

candidates, to conduct substantial new research and development activities beyond those we currently plan to engage in order to obtain

approval of our product candidates.

the data that may be required by the FDA for approval, some of the data may be related to products already approved by the FDA.

data relied upon is related to products already approved by the FDA and covered by third-party patents, we would be required to certify

that we do not infringe the listed patents or that such patents are invalid or unenforceable.

As a result of the certification, the third-party

would have 45 days from notification of our certification to initiate an action against us.

an action is brought in response to such a certification, the approval of our NDA could be subject to a stay of up to 30 months or more

while we defend against such a suit.

Approval of our product candidates under Section 505(b)(2) may therefore be delayed until patent

exclusivity expires or until we successfully challenge the applicability of those patents to our product candidates.

Alternatively, we

may elect to generate sufficient additional clinical data so that we no longer rely on data which triggers a potential stay of the approval

of our product candidates.

Even if no exclusivity periods apply to our applications under Section 505(b)(2), the FDA has broad discretion

to require us to generate additional data on the safety and efficacy of our product candidates to supplement third-party data on which

we may be permitted to rely.

In either event, we could be required, before obtaining marketing approval for any of our product candidates,

to conduct substantial new research and development activities beyond those we currently plan to engage to obtain approval of our product

Such additional new research and development activities would be costly and time consuming.

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biotechnology and pharmaceutical industries are intensely competitive and subject to rapid and significant technological change.

competitors in a number of jurisdictions, many of which have substantially greater name recognition, commercial infrastructures and financial,

competitors in several jurisdictions, many of which have substantially greater name recognition, commercial infrastructures and financial,

technical and personnel resources than we have.

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Established competitors

may invest heavily to quickly discover and develop novel compounds that could make MAT2203, MAT2501 or any other product candidates we

may develop obsolete or uneconomical.

Any new product that competes with an approved product may need to demonstrate compelling advantages

in efficacy, cost, convenience, tolerability and safety to be commercially successful.

may invest heavily to quickly discover and develop novel compounds that could make MAT2203 or any other product candidates we may develop

obsolete or uneconomical.

Any new product that competes with an approved product may need to demonstrate compelling advantages in efficacy,

cost, convenience, tolerability, and safety to be commercially successful.

Other competitive factors, including generic competition,

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for many years and are well accepted by physicians, patients, and payers.

In addition, new products developed by others could emerge as

competitors to MAT2203, MAT2501 or any of our other product candidates.

If we are not able to compete effectively against our current

and future competitors, our business will not grow, and our financial condition and operations will suffer.

although we believe that our proprietary LNC platform delivery technology, experience and knowledge in our areas of focus provide us

with competitive advantages, potential competitors for MAT2203 could reduce our commercial opportunities.

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.

if we obtain United States regulatory approval of MAT2203, MAT2501 or any other product candidates that we may develop, FDA may

still impose significant restrictions on its indicated uses or marketing or the conditions of approval or impose ongoing

requirements for potentially costly and time-consuming post-approval studies, and post-market surveillance to monitor safety and

Our future products will also be subject to ongoing regulatory requirements governing the manufacturing, labeling,

packaging, storage, distribution, safety surveillance, advertising, promotion, recordkeeping and reporting of AEs and other

post-market information.

These requirements include registration with FDA, as well as continued compliance with current Good

Clinical Practices regulations, or cGCPs, for any clinical trials that we conduct post-approval.

In addition, manufacturers of drug

products and their facilities are subject to continuous review and periodic inspections by the FDA and other regulatory authorities

for compliance with current good manufacturing practices, cGMP, requirements relating to quality control, quality assurance and

corresponding maintenance of records and documents.

In addition, new products developed by others could emerge

as competitors to MAT2203 or any of our other product candidates.

If we are not able to compete effectively against our current and future

competitors, our business will not grow, and our financial condition and operations will suffer.

although we believe that our proprietary LNC Platform, experience, and knowledge in our areas of focus provide us with competitive advantages,

potential competitors for MAT2203 could reduce our commercial opportunities.

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.

if we obtain United States regulatory approval of MAT2203 or any other product candidates that we may develop, FDA may still impose significant

restrictions on its indicated uses or marketing or the conditions of approval or impose ongoing requirements for potentially costly and

time-consuming post-approval studies, and post-market surveillance to monitor safety and efficacy.

Our future products will also be subject

to ongoing regulatory requirements governing the manufacturing, labeling, packaging, storage, distribution, safety surveillance, advertising,

promotion, recordkeeping and reporting of AEs and other post-market information.

These requirements include registration with FDA, as

well as continued compliance with current Good Clinical Practices regulations, or cGCPs, for any clinical trials that we conduct post-approval.

In addition, manufacturers of drug products and their facilities are subject to continuous review and periodic inspections by the FDA

and other regulatory authorities for compliance with current good manufacturing practices, cGMP, requirements relating to quality control,

quality assurance and corresponding maintenance of records and documents.

has the authority to require a REMS, as part of an NDA or after approval, which may impose further requirements or restrictions on the

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FDA strictly regulates the promotional claims that may be made about prescription products.

In particular, a product may not be promoted

for uses that are not approved by FDA as reflected in the product’s approved labeling.

If we receive marketing approval for our

product candidates, physicians may nevertheless legally prescribe our products to their patients in a manner that is inconsistent with

the approved label.

If we are found to have promoted such off-label uses, we may become subject to significant liability and government

FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses, and a company that

is found to have improperly promoted off-label uses may be subject to significant sanctions, including revocation of its marketing approval.

The federal government has levied large civil and criminal fines against companies for alleged improper promotion and has enjoined several

companies from engaging in off-label promotion.

FDA has also requested that companies enter into consent decrees of permanent injunctions

under which specified promotional conduct is changed or curtailed.

A product may not be promoted for uses that

are not approved by FDA as reflected in the product’s approved labeling.

If we receive marketing approval for our product candidates,

physicians may nevertheless legally prescribe our products to their patients in a manner that is inconsistent with the approved label.

If we are found to have promoted such off-label uses, we may become subject to significant liability and government fines.

FDA and other

agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses, and a company that is found to have improperly

promoted off-label uses may be subject to significant sanctions, including revocation of its marketing approval.

The federal government

has levied large civil and criminal fines against companies for alleged improper promotion and has enjoined several companies from engaging

in off-label promotion.

FDA has also requested that companies enter into consent decrees of permanent injunctions under which specified

promotional conduct is changed or curtailed.

we or a regulatory agency discovers previously unknown problems with a product, such as AEs of unanticipated severity or frequency, problems

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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;

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 commercializeMAT2203, MAT2501 or any of our other product

candidates and generate revenue.

Adverse regulatory action, whether pre- or post-approval, can also potentially lead to product liability

claims and increase our product liability exposure.

are in the process of evaluating potential next steps in the development of LYPDISO.

have initiated a global process to identify a partner to advance development of LYPDISO and have allocated resources away from a Phase

3 program for LYPDISO.

However, there is no guarantee that we will identify a suitable partner for LYPDISO or that we will be able to

enter into a partnering agreement on favorable terms.

In the event that we do not identify a suitable partner, enter into a partnering

agreement on favorable terms, or if a potential partner fails to satisfy its obligations to develop and commercialize LIPDOSO, we may

never realize the full or any value from LYPDISO.

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.

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

and generate revenue.

Adverse regulatory action, whether pre- or post-approval, can also potentially lead to product liability claims

and increase our product liability exposure.

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

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to entities eligible to participate in the drug pricing program under the Public Health Services Act, or PHS.

Since its enactment, there

have been judicial and Congressional challenges and amendments to certain aspects of ACA.

There is continued uncertainty about the implementation

of the ACA, including the potential for further amendments to the ACA and legal challenges to or efforts to repeal the ACA.

Additionally,

there has been heightened governmental scrutiny in the United States of pharmaceutical pricing practices in light of the rising cost

of prescription drugs and biologics.

Such scrutiny has resulted in several recent congressional inquiries and proposed and enacted federal

and state legislation designed to, among other things, bring more transparency to product pricing, review the relationship between pricing

and manufacturer patient programs, and reform government program reimbursement methodologies for products.

At the federal level, the

now-departed Trump administration proposed numerous prescription drug cost control measures.

Similarly, the new Biden administration

has made lowering prescription drug prices one of its priorities.

The Biden administration has not yet proposed any specific plans, but

we expect that these will be forthcoming in the near term.

At the state level, legislatures are increasingly passing legislation and

implementing regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement

constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some

cases, designed to encourage importation from other countries and bulk purchasing.

Other examples of proposed changes include, but are

not limited to, expanding post-approval requirements, changing the Orphan Drug Act, and restricting sales and promotional activities

for pharmaceutical products.

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.

This legislation contains substantial drug pricing reforms, including the establishment

of a drug price negotiation program within the U.S.

Department of Health and Human Services that would require manufacturers to charge

a negotiated “maximum fair price” for certain selected drugs covered by Medicare or pay an excise tax for noncompliance,

the establishment of rebate payment requirements on manufacturers of certain drugs payable under Medicare Parts B and D to penalize price

increases that outpace inflation, and requires manufacturers to provide discounts on Part D drugs.

administrative, and private payor efforts to control drug costs span a range of proposals, including drug price negotiation, Medicare

Part D redesign, drug price inflation rebates, international mechanisms, generic drug promotion and anticompetitive behavior, manufacturer

reporting, and reforms that could impact therapies utilizing the accelerated approval pathway.

We cannot predict the ultimate content,

timing or effect of any changes to the ACA, the Inflation Reduction Act, or other federal and state healthcare policy reform efforts

including those aimed at drug pricing.

There is no assurance that federal or state health care reform will not adversely affect our future

business and financial results, and we cannot predict how future federal or state legislative, judicial or administrative changes relating

to healthcare policy will affect our business.

cannot be sure whether additional legislative changes will be enacted, or whether government regulations, guidance or interpretations

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clinical trials to be conducted prior to obtaining approval;

to manufacturing methods;

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

recordkeeping.

changes to manufacturing

recalls, replacements,

or discontinuance of one or more of our products;

additional 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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and other risks and uncertainties.

future profitability will depend, in part, on our ability to commercialize our product candidates in foreign markets for which we

intend to rely on collaborations with third parties.

If we commercialize MAT2203, MAT2501 or any other product candidates that we

may develop in foreign markets, we would be subject to additional risks and uncertainties, including:

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.

future profitability will depend, in part, on our ability to commercialize our product candidates in foreign markets for which we intend

to rely on collaborations with third parties.

If we commercialize MAT2203 or any other product candidates that we may develop in foreign

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.

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

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Because of the breadth of these laws and the narrowness of the safe harbors, it

is possible that some of our business activities could be

is possible that some of our business activities could be subject to challenge under one or more of these laws.

Anti-Kickback Statute prohibits, among other things, knowingly and willfully offering, paying, soliciting, or receiving remuneration

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Our practices may not, in all cases,

meet all of the criteria for safe harbor protection from anti-kickback liability.

Moreover, recent health care reform legislation has

strengthened these laws.

meet all the criteria for safe harbor protection from anti-kickback liability.

Moreover, recent health care reform legislation has strengthened

For example, the ACA, among other things, amends the intent requirement of the U.S.

Anti-Kickback Statute and

criminal health care fraud statutes;

a person or entity no longer needs to have actual knowledge of this statute or specific intent to

In addition, the ACA provides that the government may assert that a claim including items or services resulting from a violation

Anti-Kickback Statute and criminal health

care fraud statutes;

a person or entity no longer needs to have actual knowledge of this statute or specific intent to violate it.

addition, the ACA provides that the government may assert that a claim including items or services resulting from a violation of the

Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the U.S.

False Claims Act.

Federal false claims

laws prohibit any person from knowingly presenting, or causing to be presented, a false claim for payment to the federal government or

knowingly making, or causing to be made, a false statement to get a false claim paid.

Federal false claims laws

prohibit any person from knowingly presenting, or causing to be presented, a false claim for payment to the federal government or knowingly

making, or causing to be made, a false statement to get a false claim paid.

the past few years, several pharmaceutical and other healthcare companies have been prosecuted under these laws for a variety of alleged

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reimbursement under government programs, substantial criminal fines and imprisonment.

have been and expect to be significantly dependent on our collaborative agreements for the development of MAT2203 and MAT2501, which

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

conducting our research and development activities for MAT2203 and MAT2501, we currently rely, and expect to continue to rely, on collaborative

agreements with universities, governmental agencies and not-for-profit organizations for both strategic and financial resources.

among these agreements is our collaboration agreements with the NIH for the development of MAT2203 and our award agreement with the CFF

for the development of MAT2501.

The loss of, or failure to perform by us or our partners under any applicable agreements or arrangements,

or our failure to secure additional agreements for our product candidates, would substantially disrupt or delay our research and development

activities, including our in-process and anticipated clinical trials.

Any such loss would likely increase our expenses and materially

harm our business, financial condition and results of operation.

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.

conducting our research and development activities for MAT2203, we currently rely, and expect to continue to rely, on collaborative agreements

with universities, governmental agencies, and not-for-profit organizations for both strategic and financial resources.

Key among these

agreements is our collaboration agreements with the NIH for the development of MAT2203.

The loss of, or failure to perform by us or our

partners under any applicable agreements or arrangements, or our failure to secure additional agreements for our product candidates,

would substantially disrupt or delay our research and development activities, including our in-process and anticipated clinical trials.

Any such loss would likely increase our expenses and materially harm our business, financial condition, and results of operation.

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

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expect to enter into agreements with third-party CROs, or governmental entities like the NIH, to conduct and manage our clinical programs.

We rely heavily on these parties for execution of clinical studies for MAT2203, MAT2501 and our other product candidates and can control

only certain and very limited aspects of their activities.

Nevertheless, we would be responsible for ensuring that each of our studies

is conducted in accordance with the applicable protocol, legal, regulatory and scientific standards, and our reliance on the NIH or CROs

We rely heavily on these parties for execution of clinical studies for MAT2203 and our other product candidates and can control only

certain and very limited aspects of their activities.

Nevertheless, we would be responsible for ensuring that each of our studies is

conducted in accordance with the applicable protocol, legal, regulatory, and scientific standards, and our reliance on the NIH or CROs

would not relieve us of our regulatory responsibilities.

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In addition, our clinical trials must be conducted with products produced

under cGMP regulations and will require a large number of test subjects.

Our failure or the failure of the NIH or our CROs to comply

with these regulations may require us to repeat clinical trials, which would delay the regulatory approval process and could also subject

us to enforcement action up to and including civil and criminal penalties.

under cGMP regulations and will require many test subjects.

Our failure or the failure of the NIH or our CROs to comply with these regulations

may require us to repeat clinical trials, which would delay the regulatory approval process and could also subject us to enforcement

action up to and including civil and criminal penalties.

a result, many important aspects of our drug development programs would be outside of our direct control.

In addition, the NIH or

the CROs may not perform all of their obligations under their arrangements with us or in compliance with regulatory requirements.

NIH or the CROs do not perform clinical trials in a satisfactory manner, breach their obligations to us or fail to comply with

regulatory requirements, the development and commercialization of MAT2203, MAT2501 or any other product candidates that we may

develop may be delayed or our development program may be materially and irreversibly harmed.

We cannot control the amount and timing

of resources these CROs would devote to our program or our product candidates.

If we are unable to rely on the clinical data

collected by our CROs, we could be required to repeat, extend the duration of, or increase the size of our clinical trials, which

could significantly delay commercialization and require significantly greater expenditures.

If any of our relationships with these

third-party CROs terminate, we may not be able to enter into arrangements with alternative CROs.

As a result of the foregoing, our

financial results and the commercial prospects for MAT2203, MAT2501 and our other product candidates would be harmed, our costs

could increase and our ability to generate revenue could be delayed.

In addition, the NIH or the

CROs may not perform all their obligations under their arrangements with us or in compliance with regulatory requirements.

the CROs do not perform clinical trials in a satisfactory manner, breach their obligations to us or fail to comply with regulatory requirements,

the development and commercialization of MAT2203 or any other product candidates that we may develop may be delayed or our development

program may be materially and irreversibly harmed.

We cannot control the amount and timing of resources these CROs would devote to our

program or our product candidates.

If we are unable to rely on the clinical data collected by our CROs, we could be required to repeat,

extend the duration of, or increase the size of our clinical trials, which could significantly delay commercialization and require significantly

greater expenditures.

If any of our relationships with these third-party CROs terminate, we may not be able to enter into arrangements

with alternative CROs.

As a result of the foregoing, our financial results, and the commercial prospects for MAT2203 and our other product

candidates would be harmed, our costs could increase and our ability to generate revenue could be delayed.

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

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do not currently have, nor do we plan to acquire, the capability or infrastructure to manufacture the active pharmaceutical ingredient,

or API, in MAT2203, MAT2501, or any of our product candidates, for use in our clinical trials or for commercial product, if any.

result, we will rely on contract manufacturers throughout the development process and then if and when MAT2203, MAT2501, or any of our

product candidates are approved for commercialization.

We have not entered into any agreement with any contract manufacturers for commercial

supply and may not be able to engage a contract manufacturer for commercial supply of MAT2203, MAT2501, or any of our product candidates,

on favorable terms to us, or at all.

or API, in MAT2203, or any of our product candidates, for use in our clinical trials or for commercial product, if any.

we will rely on contract manufacturers throughout the development process and then if MAT2203, or any of our product candidates are approved

for commercialization.

We have not entered into any agreement with any contract manufacturers for commercial supply and may not be able

to engage a contract manufacturer for commercial supply of MAT2203, or any of our product candidates, on favorable terms to us, or at

facilities used by our contract manufacturers to manufacture any of our product candidates must be approved by the FDA pursuant to inspections

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lack of capacity available at our third-party manufacturing partners, could impair our ability to supply any product candidate at required

Because of the significant regulatory requirements that we would need to satisfy in order to qualify a new bulk or finished product

manufacturer, if we face these or other difficulties with our current manufacturing partners, we could experience significant interruptions

in product supply if we decided to transfer manufacturing to one or more alternative manufacturers in an effort to deal with the difficulties.

Because of the significant regulatory requirements that we would need to satisfy to qualify a new bulk or finished product manufacturer,

if we face these or other difficulties with our current manufacturing partners, we could experience significant interruptions in product

supply if we decided to transfer manufacturing to one or more alternative manufacturers in an effort to deal with the difficulties.

manufacturing problem or the loss of a contract manufacturer could be disruptive to our operations and result in lost sales.

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reliability, and quality.

Any unanticipated disruption to a future contract manufacturer caused by problems at suppliers could delay shipment

of our product candidates, increase our cost of goods sold and result in lost sales.

Any unanticipated disruption to a future contract manufacturer caused by problems at suppliers could delay

shipment of our product candidates, increase our cost of goods sold and result in lost sales.

cannot guarantee that our manufacturing and supply partners will be able to reduce the costs of commercial scale manufacturing of any

product candidate over time.

If the commercial-scale manufacturing costs of LYPDISO are higher than expected, these costs may significantly

impact our operating results.

In order to reduce costs, we may need to develop and implement process improvements.

However, in order

to do so, we will need, from time to time, to notify or make submissions with regulatory authorities, and the improvements may be subject

to approval by such regulatory authorities.

We cannot be sure that we will receive these necessary approvals or that these approvals

will be granted in a timely fashion.

We also cannot guarantee that we will be able to enhance and optimize output in our commercial manufacturing

If we cannot enhance and optimize output, we may not be able to reduce our costs over time.

If commercial-scale manufacturing costs are higher than expected, these costs may significantly impact our

operating results.

To reduce costs, we may need to develop and implement process improvements.

However, to do so, we will need, from

time to time, to notify or make submissions with regulatory authorities, and the improvements may be subject to approval by such regulatory

We cannot be sure that we will receive these necessary approvals or that these approvals will be granted in a timely fashion.

We also cannot guarantee that we will be able to enhance and optimize output in our commercial manufacturing process.

If we cannot enhance

and optimize output, we may not be able to reduce our costs over time.

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

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

Adverse global conditions, including economic

uncertainty, may negatively impact our financial results.

Global conditions, dislocations in the financial

markets, or inflation could adversely impact our business.

In addition, the global macroeconomic environment has been and may continue

to be negatively affected by, among other things, instability in global economic markets, increased U.S.

trade tariffs and trade disputes

with other countries, instability in the global credit markets, supply chain weaknesses, instability in the geopolitical environment

as a result of the Russian invasion of 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.

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

conditions, dislocations in the financial markets, or inflation could adversely impact our business.

In addition, the global macroeconomic

environment has been and may continue to be negatively affected by, among other things, instability in global economic markets, increased

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.

Relating to Our Intellectual Property Rights and Regulatory Exclusivity

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

rely exclusively upon our LNC platform delivery technology which is licensed to us by Rutgers.

We do not own some of the patents that

underly this in-license technology.

Our rights to use the technology we license are subject to the negotiation of, continuation of and

compliance with the terms of our license agreement with Rutgers.

Pursuant to the terms of our license agreement with Rutgers, we control

the prosecution, maintenance, or filing of the patents to which we hold licenses, as well as the enforcement of these patents against

third parties.

However, some of our patents and patent applications were either acquired from another company who acquired those patents

and patent applications from yet another company or are licensed from a third party.

Thus, these patents and patent applications were

not written by us or our attorneys, and we did not have control over the drafting and prosecution of certain of these patents.

patent owners and our licensors might not have given the same attention to the drafting and prosecution of these patents and applications

as we would have if we had been the owners of the patents and applications and had control over the drafting and prosecution.

be certain that drafting and/or prosecution of the licensed patents and patent applications by the licensors have been or will be conducted

in compliance with applicable laws and regulations or will result in valid and enforceable patents and other intellectual property rights.

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

We do not exclusively own some

of the patents that underly the LNC Platform.

Our rights to use upon the patents we exclusively license are subject to the negotiation

of, continuation of and compliance with the terms of our license agreement with Rutgers.

Pursuant to the terms of our license agreement

with Rutgers, we control the prosecution, maintenance, or filing of the patents to which we hold licenses, as well as the enforcement

of these patents against third parties.

However, some of our patents and patent applications were either acquired from another company

who acquired those patents and patent applications from yet another company or are licensed from a third party.

Thus, these patents and

patent applications were not written by us or our attorneys, and we did not have control over the drafting and prosecution of certain

of these patents.

The former patent owners and our licensors might not have given the same attention to the drafting and prosecution

of these patents and applications as we would have if we had been the owners of the patents and applications and had control over the

drafting and prosecution.

We cannot be certain that drafting and/or prosecution of the licensed patents and patent applications by the

licensors have been or will be conducted in compliance with applicable laws and regulations or will result in valid and enforceable patents

and other intellectual property rights.

rights to use the technology we license are subject to the validity of the owner’s intellectual property rights.

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are subject to our continued compliance with the terms of the license, including the payment of royalties due under the license.

of these licenses may prevent us from discovering, developing and commercializing product candidates based on the LNC platform delivery

technology, including our lead anti-infective product candidates, MAT2203 and MAT2501.

Determining the scope of the license and related

royalty obligations can be difficult and can lead to disputes between us and the licensor.

An unfavorable resolution of such a dispute

could lead to an increase in the royalties payable pursuant to the license.

If a licensor believed we were not paying the royalties

due under the license or were otherwise not in compliance with the terms of the license, the licensor might attempt to revoke the license.

If such an attempt were successful, we might be barred from discovering, developing and commercializing product candidates based on the

LNC platform delivery technology, including our lead anti-infective product candidates.

we discontinue development of the LNC platform delivery technology, we would be required to return such technology to the former stockholders

of Aquarius and/or Rutgers and we would lose the rights to our lead product candidates.

certain circumstances, we will be required to transfer Aquarius’ LNC platform delivery technology back to the former shareholders

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

the LNC platform delivery technology in the event the following conditions are met:

(i) we shall have discontinued efforts to develop

or commercialize the LNC platform delivery technology (as conclusively demonstrated by our omission of the LNC platform delivery technology

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

If the foregoing conditions are met, we would transfer the LNC platform delivery technology 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

If we are required to transfer the LNC platform delivery technology 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.

of these licenses may prevent us from discovering, developing, and commercializing product candidates based on the LNC Platform, including

our lead anti-infective product candidate MAT2203.

Determining the scope of the license and related royalty obligations can be difficult

and can lead to disputes between us and the licensor.

An unfavorable resolution of such a dispute could lead to an increase in the royalties

payable pursuant to the license.

If a licensor believed we were not paying the royalties due under the license or were otherwise not

in compliance with the terms of the license, the licensor might attempt to revoke the license.

If such an attempt were successful, we

might be barred from discovering, developing and commercializing product candidates based on the LNC Platform, including our lead anti-infective

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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We currently own or have rights to 30 issued patents relating to our LNC Platform,

delivery technology, as well as pending patent applications for our LNC platform delivery technology that may never be approved by the

United States or foreign patent offices.

Furthermore, any patents which may eventually be issued from existing patent applications for

any of our technologies, may be challenged, invalidated or circumvented by third parties and might not protect us against competitors

with similar products or technologies.

as well as pending patent applications for our LNC Platform that may never be approved by the United States or foreign patent offices.

Furthermore, any patents which may eventually be issued from existing patent applications for any of our technologies, may be challenged,

invalidated, or circumvented by third parties and might not protect us against competitors with similar products or technologies.

degree of future protection for our proprietary rights is uncertain because legal means afford only limited protection and may not adequately

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equivalent knowledge, methods and know-how.

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.

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.

may also develop trademarks to distinguish our products from the products of our competitors.

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are maintained in secrecy until the application is published, we may be unaware of third-party patents that may be infringed by commercialization

of MAT2203, MAT2501 or any future product candidate.

There may be certain issued patents and patent applications claiming subject matter

that we may be required to license in order to research, develop or commercialize MAT220, MAT2501 or any future product candidate and

we do not know if such patents and patent applications would be available to license on commercially reasonable terms, or at all.

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

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 or MAT2501

from being marketed.

Any patent-related legal action against us claiming damages and seeking to enjoin commercial activities relating

to LYPDISO, MAT2203, MAT2501 or our processes could subject us to potential liability for damages and require us to obtain a license

to continue to manufacture or market our current product candidates or any future product candidates.

We cannot predict whether we would

prevail in any such actions or that any license required under any of these patents would be made available on commercially acceptable

terms, if at all.

In addition, we cannot be sure that we could redesign, MAT2203, MAT2501or any future product candidates or processes

to avoid infringement, if necessary.

Accordingly, an adverse determination in a judicial or administrative proceeding, or the failure

to obtain necessary licenses, could prevent us from developing and commercializing MAT2203, MAT2501 or a future product candidate, which

could harm our business, financial condition and operating results.

of MAT2203 or any future product candidate.

There may be certain issued patents and patent applications claiming subject matter that

we may be required to license in order to research, develop or commercialize MAT2203 or any future product candidate and we do not know

if such patents and patent applications would be available to license on commercially reasonable terms, or at all.

Any claims of patent

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.

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

Any patent-related legal action against us claiming damages and seeking to enjoin commercial activities relating to MAT2203

or our processes could subject us to potential liability for damages and require us to obtain a license to continue to manufacture or

market our current product candidates or any future product candidates.

We cannot predict whether we would prevail in any such actions

or that any license required under any of these patents would be made available on commercially acceptable terms, if at all.

we cannot be sure that we could redesign, MAT2203 or any future product candidates or processes to avoid infringement, if necessary.

Accordingly, an adverse determination in a judicial or administrative proceeding, or the failure to obtain necessary licenses, could

prevent us from developing and commercializing MAT2203 or a future product candidate, which could harm our business, financial condition,

and operating results.

anticipate that competitors may from time to time oppose our efforts to obtain patent protection for new technologies or to submit patented

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

We have 31 employees as of February 25, 2022.

As our development and commercialization plans and strategies develop, we will

need to expand the size of our employee base for managerial, development, operational, sales, marketing, financial and other resources.

Future growth would impose significant added responsibilities on members of management, including the need to identify, recruit, maintain,

motivate and integrate additional employees.

In addition, our management may have to divert a disproportionate amount of its attention

away from our day-to-day activities and devote a substantial amount of time to managing these growth activities.

Our future financial

performance and our ability to commercialize our product candidates and our ability to compete effectively will depend, in part, on our

ability to effectively manage any future growth.

have 34 employees as of March 3, 2023.

As our development and commercialization plans and strategies develop, we will need to expand

the size of our employee base for managerial, development, operational, sales, marketing, financial and other resources.

Future growth

would impose significant added responsibilities on members of management, including the need to identify, recruit, maintain, motivate,

and integrate additional employees.

In addition, our management may have to divert a disproportionate amount of its attention away from

our day-to-day activities and devote a substantial amount of time to managing these growth activities.

Our future financial performance

and our ability to commercialize our product candidates and our ability to compete effectively will depend, in part, on our ability to

effectively manage any future growth.

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

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managerial, scientific, and medical personnel.

In order to induce valuable employees to remain with us, we intend to provide employees

with stock options that vest over time.

The value to employees of stock options that vest over time will be significantly affected by

movements in our stock price that we will not be able to control and may at any time be insufficient to counteract more lucrative offers

from other companies.

To induce valuable employees to remain with us, we intend to provide employees with stock

options that vest over time.

The value to employees of stock options that vest over time will be significantly affected by movements

in our stock price that we will not be able to control and may at any time be insufficient to counteract more lucrative offers from other

pharmaceutical companies with which we compete for qualified personnel have greater financial and other resources, different risk profiles,

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of our product candidates.

face a potential risk of product liability as a result of the clinical testing of MAT2203, MAT2501 or any future product candidates and

will face an even greater risk if we commercializeMAT2203, MAT2501 or any other future product.

For example, we may be sued if any product

we develop or any material that we use in our products allegedly causes injury or is found to be otherwise unsuitable during product

testing, manufacturing, marketing or sale.

Any such product liability claims may include allegations of defects in manufacturing, defects

in design, a failure to warn of dangers inherent in the product, negligence, strict liability and a breach of warranties.

also be asserted under state consumer protection acts.

If we cannot successfully defend ourselves against product liability claims, we

may incur substantial liabilities or be required to limit commercialization of MAT2203 or MAT2501.

Even successful defense would require

significant financial and management resources.

face a potential risk of product liability because of the clinical testing of MAT2203 or any future product candidates and will face

an even greater risk if we commercializeMAT2203 or any other future product.

For example, we may be sued if any product we develop or

any material that we use in our products allegedly causes injury or is found to be otherwise unsuitable during product testing, manufacturing,

marketing, or sale.

Any such product liability claims may include allegations of defects in manufacturing, defects in design, a failure

to warn of dangers inherent in the product, negligence, strict liability, and a breach of warranties.

Claims could also be asserted under

state consumer protection acts.

If we cannot successfully defend ourselves against product liability claims, we may incur substantial

liabilities or be required to limit commercialization of MAT2203.

Even successful defense would require significant financial and management

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

demand for MAT2203, MAT2501 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.

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

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

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While we have not, to our knowledge, experienced any significant system failure,

accident or security breach to date, if such an event were to occur and cause interruptions in our operations, it could result in a material

disruption of our programs.

For example, the loss of clinical trial data from completed or ongoing clinical trials for any of our product

candidates could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the

accident, or security breach to date, if such an event were to occur and cause interruptions in our operations, it could result in a

material disruption of our programs.

For example, the loss of clinical trial data from completed or ongoing clinical trials for any of

our product candidates could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce

Moreover, our information security systems and those of our CROs are also subject to laws and regulations requiring that we

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and federal and state consumer protection laws, govern the collection, use, disclosure, and storage of personal information.

extent that any disruption or security breach results in a loss of or damage to our data or applications, or inappropriate disclosure

or theft of confidential or proprietary information, we could incur liability, the further development of our product candidates could

be delayed, our competitive position could be compromised, or our business reputation could be harmed.

To the extent

that any disruption or security breach results in a loss of or damage to our data or applications, or inappropriate disclosure or theft

of confidential or proprietary information, we could incur liability, the further development of our product candidates could be delayed,

our competitive position could be compromised, or our business reputation could be harmed.

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

may acquire additional businesses or products, form strategic alliances or create joint ventures with third parties that we believe will

complement or augment our existing business.

If we acquire businesses with promising markets or technologies, we may not be able to realize

the benefit of acquiring such businesses if we are unable to successfully integrate them with our existing operations and company culture.

We may encounter numerous difficulties in developing, manufacturing and marketing any new products resulting from a strategic alliance

or acquisition that delay or prevent us from realizing their expected benefits or enhancing our business.

We cannot assure you that,

following any such acquisition, we will achieve the expected synergies to justify the transaction.

may acquire additional businesses or products, form strategic alliances, or create joint ventures with third parties that we believe

will complement or augment our existing business.

If we acquire businesses with promising markets or technologies, we may not be able

to realize the benefit of acquiring such businesses if we are unable to successfully integrate them with our existing operations and

company culture.

We may encounter numerous difficulties in developing, manufacturing and marketing any new products resulting from a

strategic alliance or acquisition that delay or prevent us from realizing their expected benefits or enhancing our business.

assure you that, following any such acquisition, we will achieve the expected synergies to justify the transaction.

related to our Securities

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operations and capital requirements, as well as other factors.

We do not anticipate paying cash dividends on our common stock in the foreseeable future and you should not invest in us with

the anticipation of receiving dividend income.

We do not anticipate paying cash dividends on our common stock in the

foreseeable future and you should not invest in us with the anticipation of receiving dividend income.

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

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

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.

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board of directors has the authority to fix and determine the relative rights and preferences of preferred stock.

directors has the authority to issue up to 10,000,000 additional shares of our preferred stock without further stockholder

As a result, our board of directors could authorize the issuance of a series of preferred stock that would grant to holders

the preferred right to our assets upon liquidation, the right to receive dividend payments before dividends are distributed to the holders

of common stock and the right to the redemption of the shares, together with a premium, prior to the redemption of our common stock.

In addition, our board of directors could authorize the issuance of a series of preferred stock that has greater voting power than our

common stock or that is convertible into our common stock, which could decrease the relative voting power of our common stock or result

in dilution to our existing stockholders.

Our board of directors

has the authority to issue up to 10,000,000 additional shares of our preferred stock without further stockholder approval.

our board of directors could authorize the issuance of a series of preferred stock that would grant to holders the preferred right to

our assets upon liquidation, the right to receive dividend payments before dividends are distributed to the holders of common stock and

the right to the redemption of the shares, together with a premium, prior to the redemption of our common stock.

In addition, our board

of directors could authorize the issuance of a series of preferred stock that has greater voting power than our common stock or that

is convertible into our common stock, which could decrease the relative voting power of our common stock or result in dilution to our

existing stockholders.

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.

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.

provisions of our amended and restated certificate of incorporation and bylaws could discourage, delay, or prevent a merger, acquisition

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These provisions, among other things:

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.

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.

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

expires in August 2028.

expires in June 2029.

We also lease laboratory space approximating 14,000 square feet in Bridgewater, NJ, that expires in July 2027.

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