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Item 1A. Risk Factors

2022-03-08 compared with 2021-03-29 · 1179 added, 1368 removed, 265 unchanged (91% of the section changed)

investment in our common stock is speculative and involves a high degree of risk, including a risk of loss of your entire investment.

You should carefully consider the risks described below and the other information in this Annual Report before purchasing shares

of our common stock.

You should carefully consider the risks described below and the other information in this Annual Report before purchasing shares of our

common stock.

The risks and uncertainties described below are not the only ones facing us.

Additional risks and uncertainties

may also adversely impair our business operations.

If any of the events described in the risk factors below actually occur, our

business, financial condition or results of operations could suffer significantly.

In such event, the value of our common stock

could decline, and you could lose all or a substantial portion of the money that you pay for our common stock.

Additional risks and uncertainties may also

adversely impair our business operations.

If any of the events described in the risk factors below actually occur, our business, financial

condition or results of operations could suffer significantly.

In such event, the value of our common stock could decline, and you could

lose all or a substantial portion of the money that you pay for our common stock.

of Risk Factors

operations, business and financial results have been and could continue to be adversely impacted by the current public health

pandemic related to COVID-19.

have incurred significant losses since our inception and may never achieve or maintain profitability.

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.

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 the exercise of derivative securities, and by the future issuance of

stock to the former stockholders of Aquarius pursuant to the terms of the merger agreement.

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.

federal income tax reform could materially affect our tax obligations and effective tax rate.

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 candidates.

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.

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

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

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

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

approval for our product candidates.

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

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

for our product candidates.

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

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

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

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

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

to commercialize our product candidates.

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

may be adversely affected.

we are unable to establish sales and marketing capabilities, we may not successfully commercialize any of our product candidates.

we are unable to file for approval of LYPDISO, 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.

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

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

our product candidates.

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

be adversely affected.

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.

will not realize the full potential value of LYPDISO if we are not able to successfully partner for its development.

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.

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.

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.

is designed to be a prescription-only omega-3 fatty acid-based medication.

If approved, it would be subject to competition

from products for which no prescription is required.

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.

are, and will be, completely dependent on third parties to manufacture LYPDISO.

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 we would lose the rights to our lead product candidates.

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

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

our development and commercialization efforts.

may not be able to obtain or maintain orphan drug or fast-track designation or exclusivity, or priority review for any of

our infective product candidates.

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

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

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

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

our business strategy.

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.

are obligated to pay dividends on outstanding shares of our Series B Preferred stock.

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.

A reverse-stock split of our common stock may

not have the intended consequences.

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

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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.

may not be able to maintain an effective system of internal control over financial reporting.

to build our finance infrastructure and improve our accounting systems and controls could impair our ability to comply with

the financial reporting and internal control requirements.

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.

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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’

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

maintain profitability.

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

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

we have not generated any revenues from product sales and have financed our operations through private placements and public offerings

of our equity securities and, to a lesser extent, through funding from the Cystic Fibrosis Foundation, or CFF, and the National

Institutes of Health, or the NIH.

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

development of potential product candidates.

We are still in the early stages of development of our product candidates, 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 we:

To date, we have

not generated any revenues from product sales and have financed our operations through private placements and public offerings of our

equity securities and, to a lesser extent, through funding from the Cystic Fibrosis Foundation, or CFF, and the National Institutes of

Health, or the NIH.

We have devoted substantially all of 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

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 NIH;

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;

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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 company.

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

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

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

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until we are able to obtain marketing approval for, and successfully commercialize, one or more of our product candidates.

will require us to be successful in a range of challenging activities, including completing preclinical testing and clinical trials

of our product candidates, discovering additional product candidates, obtaining regulatory approval for these product candidates,

manufacturing, marketing and selling any products for which we may obtain regulatory approval, satisfying any post-marketing requirements

and obtaining reimbursement for our products from private insurance or government payors.

We are only in the preliminary stages

of most of these activities and have not yet commenced other of these activities.

We may never succeed in these activities and,

even if we do, may never generate revenues that are significant enough to achieve profitability.

of the numerous risks and uncertainties associated with pharmaceutical product development, we are unable to accurately predict

the timing or amount of increased expenses or when, or if, we will be able to achieve profitability.

If we are required by the

Food and Drug Administration, or the FDA, or comparable non-U.S.

regulatory authorities to perform studies in addition to

those currently expected, or if there are any delays in completing our clinical trials or the development of any of our product

candidates, our expenses could increase.

require us to be successful in a range of challenging activities, including completing preclinical testing and clinical trials of our

product candidates, discovering additional product candidates, obtaining regulatory approval for these product candidates, manufacturing,

marketing and selling any products for which we may obtain regulatory approval, satisfying any post-marketing requirements and obtaining

reimbursement for our products from private insurance or government payors.

We are only in the preliminary stages of most of these activities

and have not yet commenced other of these activities.

We may never succeed in these activities and, even if we do, may never generate

revenues that are significant enough to achieve profitability.

of the numerous risks and uncertainties associated with pharmaceutical product development, we are unable to accurately predict the timing

or amount of increased expenses or when, or if, we will be able to achieve profitability.

If we are required by the U.S.

Food and Drug

Administration, or the FDA, or comparable non-U.S.

regulatory authorities to perform studies in addition to those currently expected,

or if there are any delays in completing our clinical trials or the development of any of our product candidates, our expenses could

if we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis.

to become and remain profitable would decrease the value of our company and could impair our ability to raise capital, expand

our business, maintain our research and development efforts, diversify our pipeline of product candidates or even continue our

A decline in the value of our company could also cause you to lose all or part of your investment.

Our failure to

become and remain profitable would decrease the value of our company and could impair our ability to raise capital, expand our business,

maintain our research and development efforts, diversify our pipeline of product candidates or even continue our operations.

in the value of our company could also cause you to lose all or part of your investment.

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.

expect our expenses to increase in connection with our ongoing activities, particularly as we conduct additional preclinical and

clinical studies of our ongoing Phase 2 clinical trial of MAT2203 in CM, our preclinical toxicology program for MAT2501, 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.

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, particularly as we cease to qualify as an “emerging growth company.”

Accordingly, we will need to obtain substantial additional funding in connection with our continuing operations.

If we are unable

to raise capital when needed or on attractive terms, we could be forced to delay, reduce or eliminate our research and development

programs or any future commercialization efforts.

believe that our existing cash, cash equivalents and marketable securities, including restricted cash, of approximately $59.0

million as of December 31, 2020, plus an additional approximately $5.6 million in net proceeds from the sale of our common stock

in January 2021, will enable us to fund our operating expenses and capital expenditure requirements into 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

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:

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.

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;

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;

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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;

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;

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;

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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 that takes years to complete, and we may never generate the necessary data or results required to obtain regulatory approval

and achieve product sales.

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

that takes years to complete, and we may never generate the necessary data or results required to obtain regulatory approval and achieve

product sales.

In addition, our product candidates, if approved, may not achieve commercial success.

Our commercial

revenues, if any, will be derived from sales of products that we do not expect to be commercially available for many years, if

Accordingly, we will need to continue to rely on additional financing to achieve our business objectives.

Adequate additional

financing may not be available to us on acceptable terms, or at all.

In addition, we may seek additional capital due to favorable

market conditions or strategic considerations, even if we believe we have sufficient funds for our current or future operating

Our commercial revenues, if any,

will be derived from sales of products that we do not expect to be commercially available for many years, if at all.

Accordingly, we

will need to continue to rely on additional financing to achieve our business objectives.

Adequate additional financing may not be available

to us on acceptable terms, or at all.

In addition, we may seek additional capital due to favorable market conditions or strategic considerations,

even if we believe we have sufficient funds for our current or future operating plans.

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

or product candidates.

such time, if ever, as we can generate product revenues sufficient to achieve profitability, we expect to finance our cash needs

through a combination of public or private equity offerings, debt financings, government or other third-party funding, collaborations

and licensing arrangements.

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 parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product

candidates or grant licenses on terms that may not be favorable to us.

If we are unable to raise additional funds through equity

or debt financings when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization

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

stockholders may be subject to substantial dilution by exercises of outstanding options and warrants, conversion of preferred

shares and by the future issuance of common stock to the former stockholders of Aquarius pursuant to the terms of the merger agreement.

of December 31, 2020, we had outstanding options to purchase an aggregate of 22,550,715 shares of our common stock at a weighted

average exercise price of $1.26 per share and warrants to purchase an aggregate of 1,327,810 shares of our common stock at a weighted

average exercise price of $0.55 per share.

In addition, as of December 31, 2020, we had 4,361 shares of Series B Preferred Stock

Each share of Series B Preferred Stock may be converted into 2,000 shares of common stock upon the earlier of (i)

the request of the holder (ii) the first FDA approval of one of our product candidates, (iii) June 19, 2021 and (iv) the consent

of the holders of a majority of the Series B then outstanding.

The conversion of preferred shares and the exercise of such outstanding

options and the warrants, will result in dilution of the value of our shares.

In addition, pursuant to the terms of the merger

agreement with Matinas BioPharma Nanotechnologies, Inc.

(f/k/a Aquarius Biotechnologies, Inc.), we will be required to issue up

to an additional 3,000,000 shares of our common stock upon the achievement of certain milestones.

The milestone consideration

consists of (i) 1,500,000 shares issuable upon the dosing of the first patient in a phase III trial sponsored by us for a product

utilizing the LNC platform delivery technology and (ii) 1,500,000 shares issuable upon FDA approval of the first NDA submitted

by us for a product utilizing the LNC platform delivery technology.

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

such time, if ever, as we can generate product revenues sufficient to achieve profitability, we expect to finance our cash needs through

a combination of public or private equity offerings, debt financings, government or other third-party funding, collaborations and licensing

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

parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates

or grant licenses on terms that may not be favorable to us.

If we are unable to raise additional funds through equity or debt financings

when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant

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

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

of December 31, 2021, we had outstanding options to purchase an aggregate of 28,184,291 shares of our common stock at a weighted average

exercise price of $1.21 per share and warrants to purchase an aggregate of 988,000 shares of our common stock at a weighted average exercise

price of $0.56 per share.

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

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

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

We have not yet demonstrated

our ability to successfully obtain regulatory approvals for any of our product candidates, manufacture a commercial scale product,

or arrange for a third party to do so on our behalf, or conduct sales and marketing activities necessary for successful product

commercialization.

Consequently, any predictions you make about our future success or viability may not be as accurate as they

could be if we had a longer operating history.

our ability to successfully obtain regulatory approvals for any of our product candidates, manufacture a commercial scale product, or

arrange for a third party to do so on our behalf, or conduct sales and marketing activities necessary for successful product commercialization.

Consequently, any predictions you make about our future success or viability may not be as accurate as they could be if we had a longer

operating history.

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

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 commercial activities.

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

commercial activities.

We may not be successful in such a transition.

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or annual periods as indications of future operating performance.

federal income tax reform could materially affect our tax obligations and effective tax rate.

December 22, 2017, the Tax Cuts and Jobs Act, or the Tax Act, was signed into law, significantly reforming the tax code.

Act, among other things, includes changes to U.S.

federal tax rates, imposes significant additional limitations on the deductibility

of interest, limits net operating loss (NOL) deductions, allows for the expensing of capital expenditures, puts into effect the

migration from a “worldwide” system of taxation to a territorial system and modifies or repeals many business deductions

The estimated impact of the Tax Act is based on our management’s current knowledge and assumptions, and recognized

impacts could be materially different from current estimates based on our actual results and our further analysis of the new law.

continue to examine the impact this tax reform legislation may have on our business.

The Tax Act requires complex computations

not previously provided in U.S.

As such, the application of accounting guidance for such items is currently uncertain.

Further, compliance with the Tax Act and the accounting for such provisions require accumulation of information not previously

required or regularly produced.

As additional regulatory guidance is issued by the applicable taxing authorities, as accounting

treatment is clarified, as we perform additional analysis on the application of the law, and as we refine estimates in calculating

the effect, our final analysis, which will be recorded in the period completed, may be different from our current provisional

amounts, which could materially affect our tax obligations and effective tax rate.

Related to Product Development, Regulatory Approval, Manufacturing and Commercialization

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

recently completed a head-to-head crossover study of LYPDISO vs.

Vascepa and announced topline date in February of 2021.

we completed two separate Phase 2 clinical trials of MAT2203.

Because of the early stage of our development efforts, we are still

in the process of determining the overall clinical development path for our current and future product candidates.

the timing and costs of the regulatory paths we will follow, and marketing approvals remain uncertain.

we are still in the clinical stage of our development efforts, and are in the process of determining the overall clinical development

path for our current and future product candidates, the timing and costs of the regulatory paths we will follow.

Our ability to generate

product revenue, which we do not expect will occur for many years, if ever, will depend heavily on the successful development

and eventual commercialization of our early-stage product candidates.

The success of LYPDISO, MAT2203, MAT2501 and any other product

candidates we may develop will depend on many factors, including the following:

product revenue, which we do not expect will occur for many years, if ever, will depend heavily on the successful development and eventual

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:

completion of preclinical studies;

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

cannot be certain that LYPDISO, MAT2203 MAT2501 or any other product candidates that we may develop will receive regulatory approval,

and without regulatory approval we will not be able to market any of our product candidates.

Any delay in the regulatory review

or approval of any of our product candidates will materially or adversely 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.

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.

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

vary substantially based upon the type, complexity and novelty of the products involved.

Furthermore, this approval process is

extremely complex, expensive and uncertain.

We may be unable to submit any new drug application, or an NDA, in the United States

or any marketing approval application in foreign jurisdictions for any of our products.

If we submit an NDA including any amended

NDA or supplemental NDA, to the FDA seeking marketing approval for any of our product candidates, the FDA must decide whether

to accept or reject the submission for filing.

We cannot be certain that any of these submissions will be accepted for filing

and reviewed by the FDA, or that the marketing approval application submissions to any other regulatory authorities will be accepted

for filing and review by those authorities.

We cannot be certain that we will be able to respond to any regulatory requests during

the review period in a timely manner, or at all, without delaying potential regulatory action.

We also cannot be certain that

any of our product candidates will receive favorable recommendations from any FDA advisory committee or foreign regulatory bodies

or be approved for marketing by the FDA or foreign regulatory authorities.

In addition, delays in approvals or rejections of marketing

applications may be based upon many factors, including regulatory requests for additional analyses, reports, data and studies,

regulatory questions regarding data and results, changes in regulatory policy during the period of product development 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.

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.

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

based upon the type, complexity and novelty of the products involved.

Furthermore, this approval process is extremely complex, expensive

and uncertain.

We may be unable to submit any NDA in the United States or any marketing approval application in foreign jurisdictions

for any of our products.

If we submit an NDA including any amended NDA or supplemental NDA, to the FDA seeking marketing approval for

any of our product candidates, the FDA must decide whether to accept or reject the submission for filing.

We cannot be certain that any

of these submissions will be accepted for filing and reviewed by the FDA, or that the marketing approval application submissions to any

other regulatory authorities will be accepted for filing and review by those authorities.

We cannot be certain that we will be able to

respond to any regulatory requests during the review period in a timely manner, or at all, without delaying potential regulatory action.

We also cannot be certain that any of our product candidates will receive favorable recommendations from any FDA advisory committee or

foreign regulatory bodies or be approved for marketing by the FDA or foreign regulatory authorities.

In addition, delays in approvals

or rejections of marketing applications may be based upon many factors, including regulatory requests for additional analyses, reports,

data and studies, regulatory questions regarding data and results, changes in regulatory policy during the period of product development

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.

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

For example, average review times

at the FDA for NDAs have fluctuated over the last ten years, and we cannot predict the review time for any of our submissions

with any regulatory authorities.

Review times can be affected by a variety of factors, including budget and funding levels and

statutory, regulatory and policy changes.

Moreover, in light of widely publicized events concerning the safety risk of certain

drug products, regulatory authorities, members of the U.S.

Government Accountability Office, medical professionals and the general

public have raised concerns about potential drug safety issues.

These events have resulted in the withdrawal of drug products,

revisions to drug labeling that further limit use of the drug products and establishment of REMS measures that may, for instance,

restrict distribution of drug products.

The increased attention to drug safety issues may result in a more cautious approach by

the FDA to clinical trials.

Data from clinical trials may receive greater scrutiny with respect to safety, which may make the

FDA or other regulatory authorities more likely to terminate clinical trials before completion or require longer or additional

clinical trials that may result in substantial additional expense and a delay or failure 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, and the loss of access to this technology would terminate

or delay the further development of our product candidates, injure our reputation or force us to pay higher royalties.

For example, average review times at

the FDA for NDAs have fluctuated in recent years, and we cannot predict the review time for any of our submissions with any regulatory

Review times can be affected by a variety of factors, including budget and funding levels and statutory, regulatory and

policy changes.

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

members of the U.S.

Government Accountability Office, medical professionals and the general public have raised concerns about potential

drug safety issues.

These events have resulted in the withdrawal of drug products, revisions to drug labeling that further limit use

of the drug products and establishment of REMS measures that may, for instance, restrict distribution of drug products.

The increased

attention to drug safety issues may result in a more cautious approach by the FDA to clinical trials.

Data from clinical trials may receive

greater scrutiny with respect to safety, which may make the FDA or other regulatory authorities more likely to terminate clinical trials

before completion or require longer or additional clinical trials that may result in substantial additional expense and a delay or failure

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.

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.

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 product candidate and preclinical development of our MAT2501 product candidate.

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.

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

and additional costs.

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.

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,

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Commercial manufacturing and supply agreements have not been established.

Issues arising from scale-up, environmental controls, public health crises, such as pandemics and epidemics, equipment requirements,

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

if we obtain regulatory approval for our product candidates, if we are unable to successfully commercialize our products, it will

limit our ability to generate revenue and will materially adversely affect our business, financial condition and results of operations.

arising from scale-up, environmental controls, public health crises, such as pandemics and epidemics, equipment requirements, or other

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.

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

of products which lead to revenue and profits.

Pharmaceutical product development is an expensive, high risk, lengthy, complicated,

resource intensive process.

Pharmaceutical product development is an expensive, high risk, lengthy, complicated, resource

intensive process.

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

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

addition, potential products that appear promising at early stages of development may fail for a number of 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 or manufacture, too difficult to administer, or unstable.

Failure to successfully commercialize our products

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

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

potential products that appear promising at early stages of development may fail for a number of 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

or manufacture, too difficult to administer, or unstable.

Failure to successfully commercialize our products will adversely affect our

business, financial condition and results of operations.

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.

obtaining regulatory approval for the sale of our product candidates, we must conduct, generally at our own expense, extensive

preclinical tests to demonstrate the safety of our product candidates in animals, and clinical trials to demonstrate the safety

and efficacy of our product candidates in humans.

Preclinical and clinical testing is expensive, difficult to design and implement

and can take many years to complete.

A failure of one or more of our preclinical studies or clinical trials can occur at any stage

We may experience numerous unforeseen events during, or as a result of, preclinical testing and the clinical trial

process that could delay or prevent 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

obtaining regulatory approval for the sale of our product candidates, we must conduct, generally at our own expense, extensive preclinical

tests to demonstrate the safety of our product candidates in animals, and clinical trials to demonstrate the safety and efficacy of our

product candidates in humans.

Preclinical and clinical testing is expensive, difficult to design and implement and can take many years

A failure of one or more of our preclinical studies or clinical trials can occur at any stage of testing.

We may experience

numerous unforeseen events during, or as a result of, preclinical testing and the clinical trial process that could delay or prevent

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

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;

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;

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;

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

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

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

may have other unexpected characteristics.

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

we currently contemplate, if we are unable to successfully complete our clinical trials or other testing, if the results of these

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

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

contemplate, if we are unable to successfully complete our clinical trials or other testing, if the results of these trials or tests

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 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.

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tests or clinical trials will be initiated as planned, will need to be restructured or will be completed on schedule, if at all.

Significant preclinical or clinical trial delays also could shorten the patent protection period during which we may have the

exclusive right to commercialize our product candidates.

Such delays could allow our competitors to bring products to market before

we do and impair our ability to commercialize our products or product candidates.

we cannot enroll enough patients to complete our clinical trials, such failure may adversely affect our business, financial condition

and results of operations.

preclinical or clinical trial delays also could shorten the patent protection period during which we may have the exclusive right to

commercialize our product candidates.

Such delays could allow our competitors to bring products to market before we do and impair our

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.

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

enrollment is a function of many factors, including:

Patient enrollment

is a function of many factors, including:

identification and recruitment;

7 unchanged sentences

believe our procedures for enrolling patients have been appropriate;

however, delays in patient enrollment would increase costs

and delay ultimate commercialization and sales, if any, of our products.

Such delays could materially adversely affect our business,

financial condition and results of operations.

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

have sought 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.

For a product that obtains orphan drug designation on the basis of a plausible hypothesis that it

is clinically superior to the same drug that is already approved for the same indication, in order to obtain orphan drug exclusivity

upon approval, clinical superiority of such product to this same drug that is already approved for the same orphan indication

must be demonstrated.

The exclusivity period is seven years in the United States and ten years in Europe.

The European exclusivity

period can be reduced to six years if a drug no longer meets the criteria for orphan drug designation or if the drug is sufficiently

profitable so that market exclusivity is no longer justified.

Orphan drug exclusivity may be lost if the FDA or the EMA determines

that the request for designation was materially defective or if the manufacturer 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, or any future application with respect to any other

product candidate, will be granted.

If we are unable to obtain 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 or approval process, nor will it assure FDA approval of our product candidates.

Additionally, our product candidates may

treat indications that do not qualify for priority review vouchers.

have received Fast Track designation for MAT2203 for the treatment of invasive candidiasis, the treatment of aspergillosis, the

prevention of invasive fungal infections due to immunosuppressive therapy and the treatment of cryptococcosis and may seek Fast

Track designation for some of our other product candidates or priority review of applications for approval of our product candidates

for certain indications.

If a drug is intended for the treatment of a serious or life-threatening condition and the drug demonstrates

the potential to address unmet medical needs for this condition, the drug sponsor may apply for FDA Fast Track designation.

a product candidate offers major 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.

may withdraw Fast Track designation if it believes that the designation is no longer supported by data from our clinical development

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

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

however, delays in patient enrollment would increase costs and delay

ultimate commercialization and sales, if any, of our products.

Such delays could materially adversely affect our business, financial

condition and results of operations.

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.

For a product

that obtains orphan drug designation on the basis of a plausible hypothesis that it is clinically superior to the same drug that is already

approved for the same indication, in order to obtain orphan drug exclusivity upon approval, clinical superiority of such product to this

same drug that is already approved for the same orphan indication must be demonstrated.

The exclusivity period is seven years in the

United States and ten years in Europe.

The European exclusivity period can be reduced to six years if a drug no longer meets the criteria

for orphan drug designation or if the drug is sufficiently profitable so that market exclusivity is no longer justified.

exclusivity may be lost if the FDA or the EMA determines that the request for designation was materially defective or if the manufacturer

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.

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

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

Additionally, our product candidates may treat indications

that do not qualify for priority review vouchers.

have received Fast Track designation for MAT2203 for the treatment of invasive candidiasis, the treatment of aspergillosis, the prevention

of invasive fungal infections due to immunosuppressive therapy and the treatment of cryptococcosis and may seek Fast Track designation

for some of our other product candidates or priority review of applications for approval of our product candidates for certain indications.

If a drug is intended for the treatment of a serious or life-threatening condition and the drug demonstrates the potential to address

unmet medical needs for this condition, the drug sponsor may apply for FDA Fast Track designation.

If a product candidate offers major

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.

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

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

may seek a breakthrough therapy designation for some of our product candidates.

A breakthrough therapy is defined as a drug that

is intended, alone or in combination with one or more other drugs, to treat a serious or life-threatening disease or condition,

and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one

or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development.

and biologics that have been designated as breakthrough therapies, interaction and communication between the FDA and the sponsor

of the trial can help to identify the most efficient path for clinical development while minimizing the number of patients placed

in ineffective control regimens.

Drugs designated as breakthrough therapies by the FDA may also be eligible for accelerated approval

if the relevant criteria are met.

A breakthrough therapy is defined as a drug that is intended,

alone or in combination with one or more other drugs, to treat a serious or life-threatening disease or condition, and preliminary clinical

evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant

endpoints, such as substantial treatment effects observed early in clinical development.

For drugs and biologics that have been designated

as breakthrough therapies, interaction and communication between the FDA and the sponsor of the trial can help to identify the most efficient

path for clinical development while minimizing the number of patients placed in ineffective control regimens.

Drugs designated as breakthrough

therapies by the FDA may also be eligible for accelerated approval if the relevant criteria are met.

as a breakthrough therapy is within the discretion of the FDA.

Accordingly, even if we believe one of our product candidates meets

the criteria for designation as a breakthrough therapy, the FDA may disagree and instead determine not to make such designation.

In any event, the receipt of a breakthrough therapy designation for a product candidate may not result in a faster development

process, review or approval compared to drugs considered for approval under conventional FDA procedures and does not assure ultimate

approval by the FDA.

In addition, even if one or more of our product candidates qualify as breakthrough therapies, the FDA may

later decide that the products no longer meet the conditions for qualification or decide that the time period for FDA review or

approval will not be shortened.

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

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

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 certain of our 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.

Accordingly, even if we believe one of our product candidates meets the

criteria for designation as a breakthrough therapy, the FDA may disagree and instead determine not to make such designation.

In any event,

the receipt of a breakthrough therapy designation for a product candidate may not result in a faster development process, review or approval

compared to drugs considered for approval under conventional FDA procedures and does not assure ultimate approval by the FDA.

even if one or more of our product candidates qualify as breakthrough therapies, the FDA may later decide that the products no longer

meet the conditions for qualification or decide that the time period for FDA review or approval will not be shortened.

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

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

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.

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

if we receive regulatory approval for LYPDISO, MAT2203, MAT2501 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 LYPDISO, 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 LYPDISO, MAT2203, MAT2501 or such other product candidate will depend on a number of factors, including:

if we receive regulatory approval for MAT2203, MAT2501 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:

demonstration

7 unchanged sentences

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;

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.

LYPDISO, MAT2203, MAT2501 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.

Our efforts to educate the medical community and third-party payors on the benefits of such product

candidate may require significant resources and may never be successful.

MAT2203, MAT2501 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.

efforts to educate the medical community and third-party payors on the benefits of such product candidate may require significant resources

and may never be successful.

addition, even if we obtain regulatory approvals, the timing or scope of any approvals may prohibit or reduce our ability to commercialize

such product candidate successfully.

For example, if the approval process takes too long, we may miss market opportunities and

give other companies the ability to develop competing products or establish market dominance.

Any regulatory approval we ultimately

obtain may be limited or subject to restrictions or post-approval commitments that render such product candidate not commercially

For example, regulatory authorities may approve such product candidate for fewer or more limited indications than we request,

may not approve the price we intend to charge for such product candidate, may grant approval contingent on the performance of

costly post-marketing clinical trials, or may approve such product candidate with a label that does not include the labeling claims

necessary or desirable for the successful commercialization of that indication.

Further, the FDA may place conditions on approvals

including potential requirements or risk management plans and the requirement for a Risk Evaluation and Mitigation Strategy (“REMS”)

to assure the safe use of the drug.

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

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

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.

For example, if the approval process takes too long, we may miss market opportunities and give other

companies the ability to develop competing products or establish market dominance.

Any regulatory approval we ultimately obtain may be

limited or subject to restrictions or post-approval commitments that render such product candidate not commercially viable.

regulatory authorities may approve such product candidate for fewer or more limited indications than we request, may not approve the

price we intend to charge for such product candidate, may grant approval contingent on the performance of costly post-marketing clinical

trials, or may approve such product candidate with a label that does not include the labeling claims necessary or desirable for the successful

commercialization of that indication.

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

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

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.

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

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

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.

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.

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 LYPDISO, MAT2203, MAT2501 or any of our other product candidates.

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.

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

In addition, we will have to compete with established and well-funded pharmaceutical and biotechnology companies to recruit, hire,

train and retain sales and marketing personnel.

Factors that may inhibit our efforts to commercialize LYPDISO, MAT2203, MAT2501

or any of our other product candidates in the United States without strategic partners or licensees include:

we will have to compete with established and well-funded pharmaceutical and biotechnology companies to recruit, hire, train and retain

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;

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

with more extensive product lines;

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

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

do not successfully enter into appropriate collaboration arrangements, we will have difficulty successfully commercializing LYPDISO,

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 partners.

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.

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

we are unable to file for approval of LYPDISO, 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 LYPDISO, 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.

written feedback received from the FDA in 2014 and written and verbal FDA feedback in August 2020, we believe this approach will

create the opportunity for us to leverage existing data developed with certain existing omega-3 fatty acids to create a streamlined

approach to potential approval for LYPDISO for the treatment of SHTG and potentially other indications.

Likewise, we intend to

rely on the history of efficacy of amphotericin B, and although we met with the FDA in the first half of 2019 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

LYPDISO, 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.

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

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

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

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.

Such additional new research and

development activities would be costly and time consuming.

may not be able to realize a shortened development timeline for any of our product candidates, and the FDA may not approve our

NDA based on their review of the submitted data.

If our desired reference-listed drug containing products are withdrawn from the

market by the FDA for any safety reason, we may not be able to reference such products to support a 505(b)(2) NDA for our product

candidates, and we may need to fulfill the more extensive requirements of Section 505(b)(1).

If we are required to generate additional

data to support approval, we may be unable to meet our anticipated development and commercialization timelines, may be unable

to generate the additional data at a reasonable cost, or at all, and may be unable to obtain marketing approval of our lead product

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

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.

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.

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

may not be able to realize a shortened development timeline for any of our product candidates, and the FDA may not approve our NDA based

on their review of the submitted data.

If our desired reference-listed drug containing products are withdrawn from the market by the

FDA for any safety reason, we may not be able to reference such products to support a 505(b)(2) NDA for our product candidates, and we

may need to fulfill the more extensive requirements of Section 505(b)(1).

If we are required to generate additional data to support approval,

we may be unable to meet our anticipated development and commercialization timelines, may be unable to generate the additional data at

a reasonable cost, or at all, and may be unable to obtain marketing approval of our lead product candidates.

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

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

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

and financial, technical and personnel resources than we have.

We face competition from many different sources, including commercial

pharmaceutical and biotechnology enterprises, academic institutions, government agencies and private and public research institutions.

Established competitors may invest heavily to quickly discover and develop novel compounds that could make LYPDISO, 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.

Other competitive factors, including generic competition, which could force us to lower prices or result in reduced sales, particularly

those products that have been marketed by third parties for many years and are well accepted by physicians, patients and payers.

In addition, new products developed by others could emerge as competitors to LYPDISO, MAT2203, MAT2501 or any of our other product

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 LYPDISO, MAT2203, MAT2501 or any other product candidates that we may develop, 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 LYPDISO, 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

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

technical and personnel resources than we have.

We face competition from many different sources, including commercial pharmaceutical

and biotechnology enterprises, academic institutions, government agencies and private and public research institutions.

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.

Other competitive factors, including generic competition,

which could force us to lower prices or result in reduced sales, particularly those products that have been marketed by third parties

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 adverse events and other post-market

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 distribution or use of an approved drug, such as limiting prescribing to certain physicians or medical centers that have

undergone specialized training, limiting treatment to patients who meet certain safe-use criteria or requiring patient testing,

monitoring and/or enrollment in a registry.

respect to sales and marketing activities by us or any future partner, advertising and promotional materials must comply with

FDA rules in addition to other applicable federal, state and local laws in the United States and similar legal requirements in

other countries.

In the United States, the distribution of product samples to physicians must comply with the requirements of

Prescription Drug Marketing Act.

Application holders must obtain FDA approval for product and manufacturing changes,

depending on the nature of the change.

We may also be subject, directly or indirectly through our customers and partners, to various

fraud and abuse laws, including, without limitation, the U.S.

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

distribution or use of an approved drug, such as limiting prescribing to certain physicians or medical centers that have undergone specialized

training, limiting treatment to patients who meet certain safe-use criteria or requiring patient testing, monitoring and/or enrollment

in a registry.

respect to sales and marketing activities by us or any future partner, advertising and promotional materials must comply with FDA rules

in addition to other applicable federal, state and local laws in the United States and similar legal requirements in other countries.

In the United States, the distribution of product samples to physicians must comply with the requirements of the U.S.

Prescription Drug

Marketing Act.

Application holders must obtain FDA approval for product and manufacturing changes, depending on the nature of the change.

We may also be subject, directly or indirectly through our customers and partners, to various fraud and abuse laws, including, without

limitation, the U.S.

Anti-Kickback Statute, U.S.

False Claims Act, and similar state

laws, which impact, among other things, our proposed sales, marketing, and scientific/educational grant programs.

If we participate

Medicaid Drug Rebate Program, the Federal Supply Schedule of the U.S.

Department of Veterans Affairs, or other government

drug programs, we will be subject to complex laws and regulations regarding reporting and payment obligations.

All of these activities

are also potentially subject to U.S.

federal and state consumer protection and unfair competition laws.

Similar requirements exist

in many of these areas in other countries.

addition, our product labeling, advertising and promotion would be subject to regulatory requirements and continuing regulatory

False Claims Act, and similar state laws, which impact, among other things, our proposed

sales, marketing, and scientific/educational grant programs.

If we participate in the U.S.

Medicaid Drug Rebate Program, the Federal

Supply Schedule of the U.S.

Department of Veterans Affairs, or other government drug programs, we will be subject to complex laws and

regulations regarding reporting and payment obligations.

All of these activities are also potentially subject to U.S.

federal and state

consumer protection and unfair competition laws.

Similar requirements exist in many of these areas in other countries.

addition, our product labeling, advertising and promotion would be subject to regulatory requirements and continuing regulatory review.

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 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 adverse events of unanticipated severity

or frequency, problems with the facility where the product is manufactured, or we or our manufacturers fail to comply with applicable

regulatory requirements, we may be subject to the following administrative or judicial sanctions:

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

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.

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

with the facility where the product is manufactured, or we or our manufacturers fail to comply with applicable regulatory requirements,

we may be subject to the following administrative or judicial sanctions:

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;

2 unchanged sentences

of any ongoing clinical trials;

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

license approvals;

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

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

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

occurrence of any event or penalty described above may inhibit our ability to commercialize LYPDISO, MAT2203, 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.

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.

on the results of our ENANCE-IT study for LYPDISO, and given the significant time and cost associated with cardiovascular outcomes

clinical trials, we have initiated a 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.

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 of LYPDISO, MAT2203, MAT2501 and any other product candidates that we may develop.

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.

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.

has established regulations to govern the drug development and approval process, as have foreign regulatory authorities.

of FDA and other regulatory authorities may change, and additional laws or government regulations may be promulgated that could

prevent, limit, delay but also accelerate regulatory review of our product candidates.

For example, in December 2016, the Cures

Act was signed into law.

of FDA and other regulatory authorities may change, and additional laws or government regulations may be promulgated that could prevent,

limit, delay but also accelerate regulatory review of our product candidates.

For example, in December 2016, the Cures Act was signed

The Cures Act, among other things, is intended to modernize the regulation of drugs and spur innovation.

but all of its provisions have yet to be implemented.

Among other things, the Cures Act provides a new “limited population”

pathway for certain antibacterial and antifungal drugs, or LPAD, but FDA has not issued final guidance regarding the LPAD yet.

Additionally, in August 2017, FDA issued final guidance setting forth its current thinking with respect to development programs

and clinical trial designs for antibacterial drugs to treat serous bacterial diseases in patients with an unmet medical need.

We cannot predict what if any effect the Cures Act or any existing or future guidance from FDA will have on development of our

product candidates.

legislative or regulatory reform measures, including government restrictions on pricing and reimbursement, may have a negative

impact on our business and results of operations.

the United States and some foreign jurisdictions, there have been, and continue to be, several legislative and regulatory changes

and proposed changes regarding the healthcare system that could prevent or delay marketing approval of product candidates, restrict

or regulate post approval activities, and affect our ability to profitably sell any product candidates for which we obtain marketing

policy makers and payors in the United States and elsewhere, there is significant interest in promoting changes in healthcare

systems with the stated goals of containing healthcare costs, improving quality and/or expanding access.

In the United States,

the pharmaceutical industry has been a particular focus of these efforts and has been significantly affected by major legislative

For example, in the United States, the Patient Protection and Affordable Care Act of 2010 (“ACA”) substantially

changed the way health care is financed by both governmental and private insurers and significantly affects the pharmaceutical

Many provisions of the ACA impact the biopharmaceutical industry, including that in order for a biopharmaceutical product

to receive federal reimbursement under the Medicare Part B and Medicaid programs or to be sold directly to U.S.

government agencies,

the manufacturer must extend discounts 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

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.

We cannot predict

what if any effect the Cures Act or any existing or future guidance from FDA will have on development of our product candidates.

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

the United States and some foreign jurisdictions, there have been, and continue to be, several legislative and regulatory changes and

proposed changes regarding the healthcare system that could prevent or delay marketing approval of product candidates, restrict or regulate

post approval activities, and affect our ability to profitably sell any product candidates for which we obtain marketing approval.

policy makers and payors in the United States and elsewhere, there is significant interest in promoting changes in healthcare systems

with the stated goals of containing healthcare costs, improving quality and/or expanding access.

In the United States, the pharmaceutical

industry has been a particular focus of these efforts and has been significantly affected by major legislative initiatives.

in the United States, the Patient Protection and Affordable Care Act of 2010 (“ACA”) substantially changed the way health

care is financed by both governmental and private insurers and significantly affects the pharmaceutical industry.

Many provisions of

the ACA impact the biopharmaceutical industry, including that in order for a biopharmaceutical product to receive federal reimbursement

under the Medicare Part B and Medicaid programs or to be sold directly to U.S.

government agencies, the manufacturer must extend discounts

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

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.

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.

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.

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

will be changed, or what the impact of such changes would be on the marketing approvals, sales, pricing, or reimbursement of our

drug candidates or products, if any, may be.

We expect that these and other healthcare reform measures that may be adopted in

the future, may result in more rigorous coverage criteria and in additional downward pressure on the price that we receive for

any approved drug.

Any reduction in reimbursement from Medicare or other government programs may result in a similar reduction

in payments from private payors.

The implementation of cost containment measures or other healthcare reforms may prevent us from

being able to generate revenue, attain profitability, or commercialize our drugs.

will be changed, or what the impact of such changes would be on the marketing approvals, sales, pricing, or reimbursement of our drug

candidates or products, if any, may be.

We expect that these and other healthcare reform measures that may be adopted in the future,

may result in more rigorous coverage criteria and in additional downward pressure on the price that we receive for any approved drug.

Any reduction in reimbursement from Medicare or other government programs may result in a similar reduction in payments from private

The implementation of cost containment measures or other healthcare reforms may prevent us from being able to generate revenue,

attain profitability, or commercialize our drugs.

addition, FDA regulations and guidance may be revised or reinterpreted by the FDA in ways that may significantly affect our business

and our products.

Any new regulations or guidance, or revisions or reinterpretations of existing regulations or guidance, may

impose additional costs or lengthen FDA review times for our product candidates.

We cannot determine how changes in regulations,

statutes, policies, or interpretations when and if issued, enacted or adopted, may affect our business in the future.

could, among other things, require:

Any new regulations or guidance, or revisions or reinterpretations of existing regulations or guidance, may impose

additional costs or lengthen FDA review times for our product candidates.

We cannot determine how changes in regulations, statutes, policies,

or interpretations when and if issued, enacted or adopted, may affect our business in the future.

Such changes could, among other things,

clinical trials to be conducted prior to obtaining approval;

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recordkeeping.

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

our product candidates.

In addition, delays in receipt of or failure to receive regulatory clearances or approvals for any other

products would harm our business, financial condition, and results of operations.

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

In addition, delays in receipt of or failure to receive regulatory clearances or approvals for any other products would harm

our business, financial condition, and results of operations.

Reimbursement

rates may vary according to the use of the product and the clinical setting in which it is used, may be based on payments allowed

for lower-cost products that are already reimbursed, may be incorporated into existing payments for other products or services,

and may reflect budgetary constraints and/or imperfections in Medicare or Medicaid data used to calculate these rates.

for products may be reduced by mandatory discounts or rebates required by government health care programs.

Such legislation, or

similar regulatory changes or relaxation of laws that restrict imports of products from other countries, could reduce the net

price we receive for any future marketed products.

rates may vary according to the use of the product and the clinical setting in which it is used, may be based on payments allowed for

lower-cost products that are already reimbursed, may be incorporated into existing payments for other products or services, and may reflect

budgetary constraints and/or imperfections in Medicare or Medicaid data used to calculate these rates.

Net prices for products may be

reduced by mandatory discounts or rebates required by government health care programs.

Such legislation, or similar regulatory changes

or relaxation of laws that restrict imports of products from other countries, could reduce the net price we receive for any future marketed

As a result, our future products might not ultimately be considered cost-effective.

We cannot be certain that reimbursement will be available for any of our product candidates.

Also, we cannot be certain that reimbursement

policies will not reduce the demand for, or the price paid for, any future products.

If reimbursement is not available or is available

on a limited basis, we may not be able to successfully commercialize any product candidates that we develop.

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.

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 LYPDISO, MAT2203, MAT2501 or any other product candidates

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

We cannot be certain that reimbursement

will be available for any of our product candidates.

Also, we cannot be certain that reimbursement policies will not reduce the demand

for, or the price paid for, any future products.

If reimbursement is not available or is available on a limited basis, we may not be

able to successfully commercialize any product candidates that we develop.

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.

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;

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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, trade restrictions and changes in tariffs, any of which may adversely affect our results of operations.

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.

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

trade restrictions and changes in tariffs, any of which may adversely affect our results of operations.

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.

enforces laws and regulations which require that the promotion of pharmaceutical products be consistent with the approved prescribing

While physicians may prescribe an approved product for a so-called “off label” use, it is unlawful for

a pharmaceutical company to promote its products in a manner that is inconsistent with its approved label and any company which

engages in such conduct can subject that company to significant liability.

Similarly, industry codes in the EU and other foreign

jurisdictions prohibit companies from engaging in off-label promotion and regulatory agencies in various countries enforce violations

of the code with civil penalties.

While we intend to ensure that our promotional materials are consistent with our label, regulatory

agencies may disagree with our assessment and may issue untitled letters, warning letters or may institute other civil or criminal

enforcement proceedings.

In addition to FDA restrictions on marketing of pharmaceutical products, several other types of state

and federal healthcare fraud and abuse laws have been applied in recent years to restrict certain marketing practices in the pharmaceutical

While physicians may prescribe an approved product for a so-called “off label” use, it is unlawful for a pharmaceutical

company to promote its products in a manner that is inconsistent with its approved label and any company which engages in such conduct

can subject that company to significant liability.

Similarly, industry codes in the EU and other foreign jurisdictions prohibit companies

from engaging in off-label promotion and regulatory agencies in various countries enforce violations of the code with civil penalties.

While we intend to ensure that our promotional materials are consistent with our label, regulatory agencies may disagree with our assessment

and may issue untitled letters, warning letters or may institute other civil or criminal enforcement proceedings.

In addition to FDA

restrictions on marketing of pharmaceutical products, several other types of state and federal healthcare fraud and abuse laws have been

applied in recent years to restrict certain marketing practices in the pharmaceutical industry.

These laws include the U.S.

Anti-Kickback Statute, U.S.

Anti-Kickback

Statute, U.S.

False Claims Act and similar state laws.

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

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

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

to induce, or in return for, purchasing, leasing, ordering or arranging for the purchase, lease or order of any healthcare item

or service reimbursable under Medicare, Medicaid or other federally financed healthcare programs.

This statute has been interpreted

broadly to apply to arrangements between pharmaceutical manufacturers on the one hand and prescribers, purchasers and formulary

managers on the other.

Although there are several statutory exemptions and regulatory safe harbors protecting certain common activities

from prosecution, the exemptions and safe harbors are drawn narrowly, and practices that involve remuneration intended to induce

prescribing, purchasing or recommending may be subject to scrutiny if they do not qualify for an exemption or safe harbor.

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.

For example, the ACA, among other things, amends the intent requirement

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.

In addition, the ACA provides that the government may assert that a claim including

items or services resulting from a violation of the U.S.

Anti-Kickback Statute constitutes a false or fraudulent claim for purposes

to induce, or in return for, purchasing, leasing, ordering or arranging for the purchase, lease or order of any healthcare item or service

reimbursable under Medicare, Medicaid or other federally financed healthcare programs.

This statute has been interpreted broadly to apply

to arrangements between pharmaceutical manufacturers on the one hand and prescribers, purchasers and formulary managers on the other.

Although there are several statutory exemptions and regulatory safe harbors protecting certain common activities from prosecution, the

exemptions and safe harbors are drawn narrowly, and practices that involve remuneration intended to induce prescribing, purchasing or

recommending may be subject to scrutiny if they do not qualify for an exemption or safe harbor.

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.

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 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

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

of alleged promotional and marketing activities, such as:

allegedly providing free trips, free goods, sham consulting fees and

grants and other monetary benefits to prescribers;

reporting to pricing services inflated average wholesale prices that were then

used by federal programs to set reimbursement rates;

engaging in off-label promotion that caused claims to be submitted to Medicare

or Medicaid for non-covered, off-label uses;

and submitting inflated best price information to the Medicaid Rebate Program to

reduce liability for Medicaid rebates.

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

promotional and marketing activities, such as:

allegedly providing free trips, free goods, sham consulting fees and grants and other

monetary benefits to prescribers;

reporting to pricing services inflated average wholesale prices that were then used by federal programs

to set reimbursement rates;

engaging in off-label promotion that caused claims to be submitted to Medicare or Medicaid for non-covered,

off-label uses;

and submitting inflated best price information to the Medicaid Rebate Program to reduce liability for Medicaid rebates.

Most states also have statutes or regulations similar to the U.S.

Anti-Kickback Statute

False Claims Act, which apply to items and services reimbursed under Medicaid and other state programs, or, in several

states, apply regardless of the payor.

Sanctions under these federal and state laws may include substantial civil monetary penalties,

exclusion of a manufacturer’s products from 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

Key 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.

expect that we will rely on third parties to conduct clinical trials for our product candidates.

If these third parties do not

successfully carry out their contractual duties or meet expected deadlines, we may not be able to obtain regulatory approval for

or commercialize LYPDISO, MAT2203, MAT2501 or any other product candidates that we may develop, and our business could be substantially

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

We rely heavily on these parties for execution of clinical studies for LYPDISO, 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 would not relieve us of our regulatory responsibilities.

We, the NIH and our CROs would be

required to comply with cGCPs, which are regulations and guidelines enforced by the FDA, the Competent Authorities of the Member

States of the European Economic Area and comparable foreign regulatory authorities for any products in clinical development.

FDA enforces these cGCP regulations through periodic inspections of trial sponsors, principal investigators and trial sites.

we or the NIH or our CROs fail to comply with applicable cGCPs, the clinical data generated in our clinical trials may be deemed

unreliable and the FDA or comparable foreign regulatory authorities may require us to perform additional clinical trials before

approving our marketing applications.

We cannot assure you that, upon inspection, the FDA will determine that any of our clinical

trials comply with cGCPs.

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.

Anti-Kickback Statute and the U.S.

False Claims Act, which apply to

items and services reimbursed under Medicaid and other state programs, or, in several states, apply regardless of the payor.

under these federal and state laws may include substantial civil monetary penalties, exclusion of a manufacturer’s products from

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.

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

on the performance of third parties.

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

would not relieve us of our regulatory responsibilities.

We, the NIH and our CROs would be required to comply with cGCPs, which are regulations

and guidelines enforced by the FDA, the Competent Authorities of the Member States of the European Economic Area and comparable foreign

regulatory authorities for any products in clinical development.

The FDA enforces these cGCP regulations through periodic inspections

of trial sponsors, principal investigators and trial sites.

If we or the NIH or our CROs fail to comply with applicable cGCPs, the clinical

data generated in our clinical trials may be deemed unreliable and the FDA or comparable foreign regulatory authorities may require us

to perform additional clinical trials before approving our marketing applications.

We cannot assure you that, upon inspection, the FDA

will determine that any of our clinical trials comply with cGCPs.

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.

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.

If 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 LYPDISO, 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 LYPDISO, MAT2203, MAT2501 and our other product candidates would

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

is designed to be a prescription-only omega-3 fatty acid-based medication.

Omega-3 fatty acid-based products are also marketed

by other companies as dietary supplements, which, unlike drugs, are not subject to FDA approval and therefore do not require a

prescription and are not subject to pharmaceutical manufacturing standards.

As a result, LYPDISO, if approved, would be subject

to competition from products for which no prescription is required.

approved by the regulatory authorities, LYPDISO will be a prescription-only omega-3 fatty acid-based medication.

Mixtures of omega-3

fatty acids are naturally occurring substances in various foods, including fatty fish.

Omega-3 fatty acids are also marketed as

dietary supplements, which may generally be marketed without a lengthy FDA premarket review and approval process and are not subject

to prescription.

However, unlike prescription drug products, manufacturers of dietary supplements may not make therapeutic claims

for their products;

dietary supplements may be marketed with claims describing how the product affects the structure or function

of the body without premarket approval but may not expressly or implicitly represent that the dietary supplement will diagnose,

cure, mitigate, treat, or prevent disease.

We believe the exact omega-3 fatty acid composition and pharmaceutical-grade purity

of LYPDISO has a superior therapeutic profile to the omega-3 compositions in commercially available dietary supplements.

we cannot be sure that physicians or consumers will view LYPDISO as superior.

To the extent the price of LYPDISO is significantly

higher than the prices of commercially available omega-3 fatty acids marketed by other companies as dietary supplements, physicians

may recommend these commercial alternatives instead of LYPDISO or patients may elect on their own to take commercially available

non-prescription omega-3 fatty acids.

Either of these outcomes may adversely impact our results of operations by limiting product

sales and how we price our product, thereby limiting the revenue we receive from sales of LYPDISO

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

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

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

so at acceptable quality levels or prices.

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.

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

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

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

levels or prices.

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

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 and when MAT2203, or any of our product

candidates are approved for commercialization.

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 MAT22203, or any of our product candidates,

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.

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

to inspections that will be conducted after we submit our NDA to the FDA.

We do not control the manufacturing process of, and

are completely dependent on, our contract manufacturing partners for compliance with cGMPs for manufacture of both active drug

substances and finished drug products.

These cGMP regulations cover all aspects of the manufacturing, testing, quality control

and record keeping relating to our product candidates.

If our contract manufacturers cannot successfully manufacture material

that conforms to our specifications and the strict regulatory requirements of the FDA or others, they will not be able to secure

and/or maintain regulatory approval for their manufacturing facilities.

If the FDA or a comparable foreign regulatory authority

does not approve these facilities for the manufacture of a product candidate or if it withdraws any such approval in the future,

we may need to find alternative manufacturing facilities, which would significantly impact our ability to develop, obtain regulatory

approval for or market such product candidate , if approved.

contract manufacturers will be subject to ongoing periodic unannounced inspections by the FDA and corresponding state and foreign

agencies for compliance with cGMPs and similar regulatory requirements.

We do not have control over our contract manufacturers’

compliance with these regulations and standards.

Failure by any of our contract manufacturers to comply with applicable regulations

could result in sanctions being imposed on us, including fines, injunctions, civil penalties, failure to grant approval to market

any of our product candidates , delays, suspensions or withdrawals of approvals, operating restrictions and criminal prosecutions,

any of which could significantly and adversely affect our business.

In addition, we have no control over the ability of our contract

manufacturers to maintain adequate quality control, quality assurance and qualified personnel.

Failure by our contract manufacturers

to comply with or maintain any of these standards could adversely affect our ability to develop, obtain regulatory approval for

or market any of our product candidates .

for any reason, these third parties are unable or unwilling to perform, we may not be able to terminate our agreements with them,

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

cannot be certain that any such third parties will have the manufacturing capacity to meet future requirements.

If these manufacturers

or any alternate manufacturer of finished drug product experiences any significant difficulties in its respective manufacturing

processes for our API or finished product or should cease doing business with us, we could experience significant interruptions

in product supply or may not be able to create a supply of any product candidate at all.

Were we to encounter manufacturing issues,

our ability to produce a sufficient product supply might be negatively affected.

Our inability to coordinate the efforts of our

third-party manufacturing partners, or the lack of capacity available at our third party manufacturing partners, could impair

our ability to supply any product candidate at required levels.

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.

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

that will be conducted after we submit our NDA to the FDA.

We do not control the manufacturing process of, and are completely dependent

on, our contract manufacturing partners for compliance with cGMPs for manufacture of both active drug substances and finished drug products.

These cGMP regulations cover all aspects of the manufacturing, testing, quality control and record keeping relating to our product candidates.

If our contract manufacturers cannot successfully manufacture material that conforms to our specifications and the strict regulatory

requirements of the FDA or others, they will not be able to secure and/or maintain regulatory approval for their manufacturing facilities.

If the FDA or a comparable foreign regulatory authority does not approve these facilities for the manufacture of a product candidate

or if it withdraws any such approval in the future, we may need to find alternative manufacturing facilities, which would significantly

impact our ability to develop, obtain regulatory approval for or market such product candidate , if approved.

contract manufacturers will be subject to ongoing periodic unannounced inspections by the FDA and corresponding state and foreign agencies

for compliance with cGMPs and similar regulatory requirements.

We do not have control over our contract manufacturers’ compliance

with these regulations and standards.

Failure by any of our contract manufacturers to comply with applicable regulations could result

in sanctions being imposed on us, including fines, injunctions, civil penalties, failure to grant approval to market any of our product

candidates , delays, suspensions or withdrawals of approvals, operating restrictions and criminal prosecutions, any of which could significantly

and adversely affect our business.

In addition, we have no control over the ability of our contract manufacturers to maintain adequate

quality control, quality assurance and qualified personnel.

Failure by our contract manufacturers to comply with or maintain any of these

standards could adversely affect our ability to develop, obtain regulatory approval for or market any of our product candidates .

for any reason, these third parties are unable or unwilling to perform, we may not be able to terminate our agreements with them, and

we may not be able to locate alternative manufacturers or formulators or enter into favorable agreements with them and we cannot be certain

that any such third parties will have the manufacturing capacity to meet future requirements.

If these manufacturers or any alternate

manufacturer of finished drug product experiences any significant difficulties in its respective manufacturing processes for our API

or finished product or should cease doing business with us, we could experience significant interruptions in product supply or may not

be able to create a supply of any product candidate at all.

Were we to encounter manufacturing issues, our ability to produce a sufficient

product supply might be negatively affected.

Our inability to coordinate the efforts of our third-party manufacturing partners, or the

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.

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

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we rely on third parties to supply the raw materials needed to manufacture our potential products.

Any reliance on suppliers may

involve several risks, including a potential inability to obtain critical materials and reduced control over production costs,

delivery schedules, 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.

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.

Any reliance on suppliers may involve

several risks, including a potential inability to obtain critical materials and reduced control over production costs, delivery schedules,

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.

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 process.

If we cannot enhance and optimize output, we may not be able to reduce

our costs over time.

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.

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

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

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

markets of many countries.

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

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

or the perception that such an outbreak could occur, and the measures taken by the governments of countries affected could adversely

affect our business, financial condition or results of operations.

For example, an outbreak could significantly disrupt our business

by limiting our ability to travel or ship materials within or outside China and forcing temporary closure of facilities that we

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

of many countries.

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

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

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

condition or results of operations.

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

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

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.

Relating to Our Intellectual Property Rights and Regulatory Exclusivity

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.

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

We do not own the patents that underly

this in-license technology.

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.

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.

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.

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.

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

of our licensed patents or defense or any claims asserting the invalidity of these patents is often subject to the control or

cooperation of our licensors.

Legal action could be initiated against the owners of the intellectual property that we license

and an adverse outcome in such legal action could harm our business because it might prevent such companies or institutions from

continuing to license intellectual property that we may need to operate our business.

In addition, such licensors may resolve

such litigation in a way that benefits them but adversely affects our ability to use the licensed technology for our products.

of our licenses contained in our agreement with Rutgers contain provisions that allow the licensor to terminate the license if

(i) we breach any payment obligation or other material provision under the agreement and fail to cure the breach within a fixed

time following written notice of termination, (ii) we or any of our affiliates, licensees or sub licensees directly or indirectly

challenge the validity, enforceability, or extension of any of the licensed patents or (iii) we declare bankruptcy or dissolve.

Our rights under the licenses are subject to our continued compliance with the terms of the license, including the payment of

royalties due under the license.

Termination of these licenses would prevent us from discovering, developing and commercializing

product candidates based on the LNC platform delivery technology, including our lead anti-infective product candidates, 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 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 we would lose the rights to our lead product candidates.

Enforcement of

our licensed patents or defense or any claims asserting the invalidity of these patents is often subject to the control or cooperation

of our licensors.

Legal action could be initiated against the owners of the intellectual property that we license and an adverse outcome

in such legal action could harm our business because it might prevent such companies or institutions from continuing to license intellectual

property that we may need to operate our business.

In addition, such licensors may resolve such litigation in a way that benefits them

but adversely affects our ability to use the licensed technology for our products.

of our licenses contained in our agreement with Rutgers contain provisions that allow the licensor to terminate the license if (i) we

breach any payment obligation or other material provision under the agreement and fail to cure the breach within a fixed time following

written notice of termination, (ii) we or any of our affiliates, licensees or sub licensees directly or indirectly challenge the validity,

enforceability, or extension of any of the licensed patents or (iii) we declare bankruptcy or dissolve.

Our rights under the licenses

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 Merger Agreement in the event the following conditions are met:

milestone events have occurred on or before the two-year anniversary of the effective time of the Aquarius Merger (the “Transfer

Date”), (ii) during such period 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 (iii) as of the Transfer Date, no unresolved indemnification claims for us and our indemnified parties are pending.

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 to obtain.

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.

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.

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

commercial success will depend, in part, on obtaining and maintaining patent protection for our technologies, products and processes,

successfully defending these patents against third-party challenges and successfully enforcing these patents against third party

The patent positions of pharmaceutical companies can be highly uncertain and involve complex legal, scientific and

factual questions for which important legal principles remain unresolved.

Changes in either the patent laws or in interpretations

of patent laws may diminish the value of our intellectual property.

Accordingly, we cannot predict the breadth of claims that

may be allowable or enforceable in our patents (including patents owned and licensed by us).

We currently own or have rights to

33 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.

degree of future protection for our proprietary rights is uncertain, because legal means afford only limited protection and may

not adequately protect our rights, permit us to gain or keep our competitive advantage, or provide us with any competitive advantage

We cannot be certain that any patent application owned by a third party will not have priority over patent applications

filed by us, or that we will not be involved in interference, opposition or invalidity proceedings before the United States or

foreign patent offices.

also rely on trade secrets to protect technology, especially in cases where we believe patent protection is not appropriate or

successfully defending these patents against third-party challenges and successfully enforcing these patents against third party competitors.

The patent positions of pharmaceutical companies can be highly uncertain and involve complex legal, scientific and factual questions

for which important legal principles remain unresolved.

Changes in either the patent laws or in interpretations of patent laws may diminish

the value of our intellectual property.

Accordingly, we cannot predict the breadth of claims that may be allowable or enforceable in

our patents (including patents owned and licensed by us).

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.

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

protect our rights, permit us to gain or keep our competitive advantage, or provide us with any competitive advantage at all.

be certain that any patent application owned by a third party will not have priority over patent applications filed by us, or that we

will not be involved in interference, opposition or invalidity proceedings before the United States or foreign patent offices.

also rely on trade secrets to protect technology, especially in cases where we believe patent protection is not appropriate or obtainable.

However, trade secrets are difficult to protect.

While we require employees, academic collaborators, consultants and

other contractors to enter into confidentiality agreements, we may not be able to adequately protect our trade secrets or other

proprietary or licensed information.

Typically, research collaborators and scientific advisors have rights to publish data and

information in which we may have rights.

If we cannot maintain the confidentiality of our proprietary technology and other confidential

information, our ability to receive patent protection and our ability to protect valuable information owned by us may be imperiled.

Enforcing a claim that a third-party entity illegally obtained and is using any of our trade secrets is expensive and time consuming,

and the outcome is unpredictable.

In addition, courts are sometimes less willing to protect trade secrets than patents.

our competitors may independently develop equivalent knowledge, methods and know-how.

we fail to obtain or maintain patent protection 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.

While we require employees, academic collaborators, consultants and other contractors

to enter into confidentiality agreements, we may not be able to adequately protect our trade secrets or other proprietary or licensed

Typically, research collaborators and scientific advisors have rights to publish data and information in which we may have

If we cannot maintain the confidentiality of our proprietary technology and other confidential information, our ability to receive

patent protection and our ability to protect valuable information owned by us may be imperiled.

Enforcing a claim that a third-party

entity illegally obtained and is using any of our trade secrets is expensive and time consuming, and the outcome is unpredictable.

addition, courts are sometimes less willing to protect trade secrets than patents.

Moreover, our competitors may independently develop

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.

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

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applications filed by us or our business partners will be approved.

Third parties may also oppose such trademark applications,

or otherwise challenge our use of the trademarks.

In the event that the trademarks we use are successfully challenged, we could

be forced to rebrand our products, which could result in loss of brand recognition, and could require us to devote resources to

advertising and marketing new brands.

Further, we cannot provide assurance that competitors will not infringe the trademarks we

use, or that we will have adequate resources to enforce these trademarks.

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

our development and commercialization efforts.

Third parties may also oppose such trademark applications, or otherwise

challenge our use of the trademarks.

In the event that the trademarks we use are successfully challenged, we could be forced to rebrand

our products, which could result in loss of brand recognition, and could require us to devote resources to advertising and marketing

Further, we cannot provide assurance that competitors will not infringe the trademarks we use, or that we will have adequate

resources to enforce these trademarks.

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

and commercialization efforts.

success depends in part on avoiding infringement of the proprietary technologies of others.

The pharmaceutical industry has been

characterized by frequent litigation regarding patent and other intellectual property rights.

Identification of third-party patent

rights that may be relevant to our proprietary technology is difficult because patent searching is imperfect due to differences

in terminology among patents, incomplete databases and the difficulty in assessing the meaning of patent claims.

Additionally,

because patent applications are maintained in secrecy until the application is published, we may be unaware of third-party patents

that may be infringed by commercialization of LYPDISO, 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 LYPDISO, MAT2203 or MAT2501 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:

The pharmaceutical industry has been characterized

by frequent litigation regarding patent and other intellectual property rights.

Identification of third-party patent rights that may

be relevant to our proprietary technology is difficult because patent searching is imperfect due to differences in terminology among

patents, incomplete databases and the difficulty in assessing the meaning of patent claims.

Additionally, because patent applications

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

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 LYPDISO,

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.

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, LYPDISO, 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 LYPDISO, MAT2203, MAT2501 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 technologies for regulatory approval.

Competitors may seek to oppose our patent applications to delay the approval process

or to challenge our granted patents, for example, by requesting a reexamination of our patent at the United States Patent and

Trademark Office, or the USPTO, or by filing an opposition in a foreign patent office, even if the opposition or challenge has

little or no merit.

Such proceedings are generally highly technical, expensive and time consuming, and there can be no assurance

that such a challenge would not result in the narrowing or complete revocation of any patent of ours that was so challenged.

generic companies have received FDA approval of generic versions of Amarin Corporation’s Vascepa® (icosapent ethyl),

which is made from an omega-3 fatty acid, in the United States.

Any generic market entry of a generic prescription omega-3 fatty

acid product could limit our U.S.

sales, which would have a significant adverse impact on our business and results of operations.

In addition, even if a competitor’s effort to introduce a generic product is ultimately unsuccessful, the perception that

such development is in progress and/or news related to such progress could materially affect the perceived value of our company

and our stock price.

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.

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

technologies for regulatory approval.

Competitors may seek to oppose our patent applications to delay the approval process or to challenge

our granted patents, for example, by requesting a reexamination of our patent at the United States Patent and Trademark Office, or the

USPTO, or by filing an opposition in a foreign patent office, even if the opposition or challenge has little or no merit.

Such proceedings

are generally highly technical, expensive and time consuming, and there can be no assurance that such a challenge would not result in

the narrowing or complete revocation of any patent of ours that was so challenged.

Company-Related Risks

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

currently have only twenty employees as of March 22, 2021.

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 strategy.

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.

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

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

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

business strategy.

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

In addition, the loss of the services of certain key employees, including Jerome D.

Jabbour, our Chief Executive

Officer and President, and James J.

Ferguson, our Chief Medical Officer, would adversely impact our business prospects.

ability to compete in the highly competitive pharmaceutical industry depends in large part upon our ability to attract highly

qualified 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.

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

profiles, and a longer history in the industry than we do.

They also may provide more diverse opportunities and better chances

for career advancement.

Jabbour, our Chief Executive Officer and

President, Theresa Matkovits, our Chief Development Officer, and Dr.

Hui Liu, our Chief Technology Officer, would adversely impact our

business prospects.

ability to compete in the highly competitive pharmaceutical industry depends in large part upon our ability to attract highly qualified

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.

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

and a longer history in the industry than we do.

They also may provide more diverse opportunities and better chances for career advancement.

Some of these characteristics may be more appealing to high-quality candidates than what we have to offer.

If we are unable to continue to attract and retain high-quality personnel, the rate and success at which we can develop and commercialize

product candidates would be limited.

If we are unable to continue

to attract and retain high-quality personnel, the rate and success at which we can develop and commercialize product candidates would

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

of our product candidates.

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

candidates and will face an even greater risk if we commercialize LYPDISO, MAT2203, MAT2501 or any other future product.

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

LYPDISO, MAT2203 or MAT2501.

Even successful defense would require significant financial and management resources.

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

demand for LYPDISO, MAT2203, MAT2501 or any future products that we may develop;

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.

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;

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decline in our stock price.

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

liability claims could prevent or inhibit the commercialization of products we develop.

We have obtained product liability insurance

covering our clinical trials in the amount of greater than or equal to $5 million in the aggregate.

Although we will maintain

such insurance, any claim that may be brought against us could result in a court judgment or settlement in an amount that is not

covered, in whole or in part, by our insurance or that is in excess of the limits of our insurance coverage.

Our insurance policies

also have various exclusions, and we may be subject to a product liability claim for which we have no coverage.

We may have to

pay any amounts awarded by a court or negotiated in a settlement that exceed our coverage limitations or that are not covered

by our insurance, and we may not have, or be able to obtain, sufficient capital to pay such amounts.

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.

the implementation of security measures, our internal computer systems and those of our CROs and other contractors and consultants

are vulnerable to damage or disruption from computer viruses, software bugs, unauthorized access, natural disasters, terrorism,

war, and telecommunication, equipment and electrical failures.

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 data.

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.

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

claims could prevent or inhibit the commercialization of products we develop.

We have obtained product liability insurance covering our

clinical trials in the amount of greater than or equal to $5 million in the aggregate.

Although we will maintain such insurance, any

claim that may be brought against us could result in a court judgment or settlement in an amount that is not covered, in whole or in

part, by our insurance or that is in excess of the limits of our insurance coverage.

Our insurance policies also have various exclusions,

and we may be subject to a product liability claim for which we have no coverage.

We may have to pay any amounts awarded by a court or

negotiated in a settlement that exceed our coverage limitations or that are not covered by our insurance, and we may not have, or be

able to obtain, sufficient capital to pay such amounts.

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.

the implementation of security measures, our internal computer systems and those of our CROs and other contractors and consultants are

vulnerable to damage or disruption from computer viruses, software bugs, unauthorized access, natural disasters, terrorism, war, and

telecommunication, equipment and electrical failures.

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

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

take measures to protect the privacy and security of certain information gathered and used in our business.

For example, HIPAA and its

implementing regulations impose, among other requirements, certain regulatory and contractual requirements regarding the privacy and

security of personal health information.

In the European Union the General Data Protection Regulation, or GDPR, is even more restrictive

with respect to all personal information, including information masked by a coding system.

In addition to HIPAA and GDPR, numerous other

federal and state laws, including, without limitation, state security breach notification laws, state health information privacy laws

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.

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

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.

related to our Securities

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for our Series A Preferred Stock, we are required to pay royalties of up to $35 million per year.

If and when we obtain FDA or

EMA approval of MAT2203 and/or MAT2501, which we do not expect to occur before 2023, if ever, and/or if we generate sales of such

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

the holders of our Series A Preferred Stock, subject to certain vesting requirements, in aggregate, a royalty equal to (i) 4.5%

of Net Sales (as defined in the Certificate of Designations), subject in all cases to a cap of $25 million per calendar year,

and (ii) 7.5% of Licensing Proceeds (as defined in the Certificate of Designations), subject in all cases to a cap of $10 million

per calendar year.

The Royalty Payment Rights will expire when the patents covering the applicable product expire, which is currently

expected to be in 2033.

are obligated to pay dividends on outstanding shares of our preferred stock.

of our Series B Preferred Stock will be entitled to receive dividends equaling a number of shares of common stock equal to 20%

of the shares of common stock underlying the Series B Preferred then held by such holder on June 19, 2021.

payment of such dividends will result in additional dilution to our holders of our common stock.

If and when we obtain FDA or EMA approval

of MAT2203 and/or MAT2501, which we do not expect to occur before 2024, if ever, and/or if we generate sales of such products, or we

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

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

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

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

The Royalty Payment Rights

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

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

articles of incorporation give our board of directors the ability to designate and issue preferred stock in one or more series.

As a result, the board of directors may, without stockholder approval, issue new series of preferred stock with voting, dividend,

conversion, liquidation or other rights which could adversely affect the relative voting power and equity interest of the holders

of common stock.

Additional issuances of preferred stock, which could be issued with the right to more than one vote per share,

could have the effect of discouraging, delaying or preventing a change of control of us.

The possible impact on takeover attempts

could adversely affect the price of our common stock.

Although we have no present intention to designate any new series, or issue

any shares, of preferred stock, we may do so in the future.

reverse-stock split of our common stock may not have the intended consequences.

January 26, 2021, our shareholders approved an amendment to our Certificate of Incorporation to effect a reverse stock split at

a ratio in the range of 1-for-2 to 1-for-15, to be determined at the discretion of the Board.

We believe that the reverse stock

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

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

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

and exchange-traded funds.

we cannot assure you that the reverse stock split, if implemented, will result in any anticipated benefits, including an increase

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

Moreover, a reverse-stock split may have the effect of decreasing our overall market value.

There can be no assurance that

the reverse stock split will result in a per share price that will attract institutional investors or investment funds or that

such share price will satisfy the investing guidelines of institutional investors or investment funds or improve the trading liquidity

of our common stock.

Further, because implementation of the reverse stock split would not change the total number of shares

of our common stock authorized for issuance, the number of shares of our common stock available for issuance following the implementation

of the reverse stock split would increase to the extent the reverse stock split reduces the number of outstanding shares of our

common stock.

Such available shares may be used for future corporate purposes, including future acquisitions, investment opportunities,

the establishment of collaboration or other strategic agreements, capital raising transactions involving equity or convertible

debt securities, future at the market offerings of common stock, or issuance under current or future employee equity plans, and

the issuance of equity securities in connection with such transactions may result in potentially significant dilution of our current

stockholders’ ownership interests in us.

result, the board of directors may, without stockholder approval, issue new series of preferred stock with voting, dividend, conversion,

liquidation or other rights which could adversely affect the relative voting power and equity interest of the holders of common stock.

Additional issuances of preferred stock, which could be issued with the right to more than one vote per share, could have the effect

of discouraging, delaying or preventing a change of control of us.

The possible impact on takeover attempts could adversely affect the

price of our common stock.

Although we have no present intention to designate any new series, or issue any shares, of preferred stock,

we may do so in the future.

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

Board of Directors will determine, in its sole discretion, our dividend policy after considering our financial condition, results

of operations and capital requirements, as well as other factors.

No dividends may be declared or paid on our common stock, unless

a dividend, payable in the same consideration or manner, is simultaneously declared or paid, as the case may be, on the shares

of Series B Preferred Stock.

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.

Board of Directors will determine, in its sole discretion, our dividend policy after considering our financial condition, results of

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.

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

A lack of an active market may impair your ability to

sell shares of our common stock at the time you wish to sell them or at a price that you consider reasonable.

The lack of an active

market may also reduce the price of shares of our common stock.

An inactive market may also impair our ability to raise capital

by selling shares of capital stock and may impair our ability to acquire other companies or technologies by using our common stock

as consideration.

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

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

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

of our common stock at the time you wish to sell them or at a price that you consider reasonable.

The lack of an active market may also

reduce the price of shares of our common stock.

An inactive market may also impair our ability to raise capital by selling shares of

capital stock and may impair our ability to acquire other companies or technologies by using our common stock as consideration.

share price has been and could remain volatile.

market price of our common stock has historically experienced and may continue to experience significant volatility.

in developing our product candidates, the impact of government regulations on our products and industry, the potential sale of

a large volume of our common stock by stockholders, our quarterly operating results, changes in general conditions in the economy

or the financial markets and other developments affecting us or our competitors could cause the market price of our common stock

to fluctuate substantially with significant market losses.

If our stockholders sell a substantial number of shares of common stock,

especially if those sales are made during a short period of time, those sales could adversely affect the market price of our common

stock and could impair our ability to raise capital.

In addition, in recent years, the stock market has experienced significant

price and volume fluctuations.

This volatility has affected the market prices of securities issued by many companies for reasons

unrelated to their operating performance and may adversely affect the price of our common stock.

In addition, we could be subject

to a securities class action litigation as a result of volatility in the price of our stock, which could result in substantial

costs and diversion of management’s attention and resources and could harm our stock price, business, prospects, results

of operations and financial condition.

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.

trading market for our common stock will be influenced by the research and reports that industry or securities analysts publish

about us or our business.

Our progress in

developing our product candidates, the impact of government regulations on our products and industry, the potential sale of a large volume

of our common stock by stockholders, our quarterly operating results, changes in general conditions in the economy or the financial markets

and other developments affecting us or our competitors could cause the market price of our common stock to fluctuate substantially with

significant market losses.

If our stockholders sell a substantial number of shares of common stock, especially if those sales are made

during a short period of time, those sales could adversely affect the market price of our common stock and could impair our ability to

raise capital.

In addition, in recent years, the stock market has experienced significant price and volume fluctuations.

This volatility

has affected the market prices of securities issued by many companies for reasons unrelated to their operating performance and may adversely

affect the price of our common stock.

In addition, we could be subject to a securities class action litigation as a result of volatility

in the price of our stock, which could result in substantial costs and diversion of management’s attention and resources and could

harm our stock price, business, prospects, results of operations and financial condition.

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.

trading market for our common stock will be influenced by the research and reports that industry or securities analysts publish about

us or our business.

Our research coverage by industry and financial analysts is currently limited.

Even if our analyst coverage

increases, if one or more of the analysts who cover us downgrade our stock, our stock price would likely decline.

If one or more

of these analysts cease coverage of our company or fail to regularly publish reports on us, we could lose visibility in the financial

markets, which in turn could cause our stock price or trading volume to decline.

we are unable to maintain an effective system of internal control over financial reporting, the reliability of our financial reporting,

investor confidence in us and the value of our common stock could be adversely affected.

a public company, we are required to maintain internal control over financial reporting and to report any material weaknesses

in such internal controls.

Section 404 of SOX, or Section 404, requires that we evaluate and determine the effectiveness of our

internal controls over financial reporting and provide a management report on internal control over financial reporting.

weakness is a deficiency, or combination of deficiencies, in internal control over financial reporting such that there is a reasonable

possibility that a material misstatement of annual or interim financial statements will not be prevented or detected and corrected

on a timely basis.

assessed the effectiveness of our internal control over financial reporting based on criteria established in “Internal Control—Integrated

Framework (2013)” issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO).

Based on this assessment,

management has concluded as of December 31, 2020, our internal control over financial reporting was not effective, as management

identified a deficiency in internal control over financial reporting that was determined to be a material weakness, and the auditor’s

report included an adverse opinion.

did not maintain an effective control environment over the internal control activities to ensure the processing of and reporting

of transactions are complete, accurate and timely.

Specifically, we have not designed and implemented a sufficient level of formal

financial reporting and operating policies and procedures that define how transactions should be initiated, processed, recorded

and reported, including presentation and disclosure in the consolidated financial statements.

our steps are insufficient to successfully remediate the material weakness and otherwise establish and maintain an effective system

of internal control over financial reporting, the reliability of our financial reporting, investor confidence in us and the value

of our common stock could be materially and adversely affected.

Effective internal control over financial reporting is necessary

for us to provide reliable and timely financial reports and, together with adequate disclosure controls and procedures, are designed

to reasonably detect and prevent fraud.

Any failure to implement required new or improved controls, or difficulties encountered

in their implementation could cause us to fail to meet our reporting obligations.

Undetected material weaknesses in our internal

control over financial reporting could lead to financial statement restatements and require us to incur the expense of remediation.

we do not expect that disclosure controls or internal control over financial reporting will prevent all errors and all fraud.

A control system, no matter how well designed and operated, can provide only reasonable, not absolute, assurance that the control

system’s objectives will be met.

Further, the design of a control system must reflect the fact that there are resource constraints

and the benefits of controls must be considered relative to their costs.

Because of the inherent limitations in all control systems,

no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, have been detected.

Failure of our control systems to prevent error or fraud could materially adversely impact us.

to build our finance infrastructure and improve our accounting systems and controls could impair our ability to comply with the

financial reporting and internal control requirements for publicly traded companies.

a public company, we operate in an increasingly demanding regulatory environment, which requires us to comply with applicable

provisions of the Sarbanes-Oxley Act, and the related rules and regulations of the SEC, expanded disclosure requirements, accelerated

reporting requirements and more complex accounting rules.

Company responsibilities required by the Sarbanes-Oxley Act include

establishing corporate oversight and adequate internal control over financial reporting and disclosure controls and procedures.

Effective internal controls are necessary for us to produce reliable financial reports and are important to help prevent financial

rely on consultants to perform certain of our accounting and financial reporting functions.

We will need to hire additional finance

personnel and build our financial infrastructure as we comply with public company reporting requirements, including complying

with the applicable requirements of Section 404 of the Sarbanes-Oxley Act.

We may be unable to do so on a timely basis.

Even if our analyst coverage increases,

if one or more of the analysts who cover us downgrade our stock, our stock price would likely decline.

If one or more of these analysts

cease coverage of our company or fail to regularly publish reports on us, we could lose visibility in the financial markets, which in

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

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

the event of a liquidation, dissolution or winding-up of our company, whether voluntary or involuntary, the proceeds and/or assets

of our company remaining after giving effect to such transaction, and the payment of all of our debts and liabilities will be

distributed first to the holders of our preferred stock and thereafter to the stockholders of common stock (including the holders

of our preferred stock on an “as converted” basis) on a pro rata basis.

There can be no assurance that we will have

available assets to pay to the holders of common stock, or any amounts, upon such a liquidation, dissolution or winding-up of

In this event, you could lose some or all of your investment.

the event of a liquidation, dissolution or winding-up of our company, whether voluntary or involuntary, the proceeds and/or assets of

our company remaining after giving effect to such transaction, and the payment of all of our debts and liabilities will be distributed

first to the holders of our preferred stock and thereafter to the stockholders of common stock (including the holders of our preferred

stock on an “as converted” basis) on a pro rata basis.

There can be no assurance that we will have available assets to pay

to the holders of common stock, or any amounts, upon such a liquidation, dissolution or winding-up of our Company.

In this event, you

could lose some or all of your investment.

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

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

We anticipate

that our board of directors will have the authority to issue up to 8,392,000 additional shares of our preferred stock without

further stockholder approval.

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.

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.

Anti-takeover

provisions of our certificate of incorporation, our 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

or other change of control that stockholders may consider favorable, including transactions in which you might otherwise receive

a premium for your Shares.

Furthermore, these provisions could prevent or frustrate attempts by our stockholders to replace or

remove members of our board of directors.

These provisions also could limit the price that investors might be willing to pay in

the future for our common stock, thereby depressing the market price of our common stock.

Stockholders who wish to participate

in these transactions may not have the opportunity to do so.

or other change of control that stockholders may consider favorable, including transactions in which you might otherwise receive a premium

for your Shares.

Furthermore, these provisions could prevent or frustrate attempts by our stockholders to replace or remove members of

our board of directors.

These provisions also could limit the price that investors might be willing to pay in the future for our common

stock, thereby depressing the market price of our common stock.

Stockholders who wish to participate in these transactions may not have

the opportunity to do so.

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;

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 (of which up to 8,392,000 shares

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 criteria are met, prohibit large stockholders, in particular those owning 15% or more of the voting rights on our common

stock, from merging or combining with us for a prescribed period of time.

certificate of incorporation provides that the Court of Chancery of the State of Delaware and, to the extent enforceable, the

federal district courts of the United States of America will be the exclusive forums for substantially all disputes between us

and our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with

us or our directors, officers or employees.

Under cumulative voting, a minority stockholder holding

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

The absence of cumulative voting may have

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

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

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

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

criteria are met, prohibit large stockholders, in particular those owning 15% or more of the voting rights on our common stock, from

merging or combining with us for a prescribed period of time.

Stockholders’

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

certificate of incorporation provides that the Court of Chancery of the State of Delaware is the exclusive forum for (i) any derivative

action or proceeding brought on our behalf, (ii) any action asserting a claim for breach of a fiduciary duty owed by any of our

directors, officers or other employees to us or our stockholders, (iii) any action asserting a claim arising pursuant to any provision

of the Delaware General Corporation Law, our certificate of incorporation or our bylaws or (iv) any action asserting a claim governed

by the internal affairs doctrine.

Our certificate of incorporation further provides that the federal district courts of the United

States of America will be the exclusive forum for resolving any complaint asserting a cause of action arising under the Securities

Act, subject to and contingent upon a final adjudication in the State of Delaware of the enforceability of such exclusive forum

These exclusive forum provisions may limit a stockholder’s ability to bring a claim in a judicial forum that

it finds favorable for disputes with us or our directors, officers or other employees, which may discourage such lawsuits against

us and our directors, officers and other employees.

For example, stockholders who do bring a claim in the Court of Chancery could

face additional litigation costs in pursuing any such claim, particularly if they do not reside in or near the State of Delaware.

The Court of Chancery and federal district courts may also reach different judgments or results than would other courts, including

courts where a stockholder considering an action may be located or would otherwise choose to bring the action, and such judgments

or results may be more favorable to us than to our stockholders.

Some companies that adopted a similar federal district court

forum selection provision are currently subject to a suit in the Chancery Court of Delaware by stockholders who assert that the

provision is not enforceable.

If a court were to find either choice of forum provision contained in our certificate of incorporation

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

jurisdictions, which could adversely affect our business and financial condition.

For example, the Court of Chancery of the State

of Delaware recently determined that the exclusive forum provision of federal district courts of the United States of America

for resolving any complaint asserting a cause of action arising under the Securities Act is not enforceable.

As a result of this

decision, we do not currently intend to enforce the federal forum selection provision in our certificate of incorporation, unless

action or proceeding brought on our behalf, (ii) any action asserting a claim for breach of a fiduciary duty owed by any of our directors,

officers or other employees to us or our stockholders, (iii) any action asserting a claim arising pursuant to any provision of the Delaware

General Corporation Law, our certificate of incorporation or our bylaws or (iv) any action asserting a claim governed by the internal

affairs doctrine.

Our certificate of incorporation further provides that the federal district courts of the United States of America

will be the exclusive forum for resolving any complaint asserting a cause of action arising under the Securities Act, subject to and

contingent upon a final adjudication in the State of Delaware of the enforceability of such exclusive forum provision.

These exclusive

forum provisions may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes with

us or our directors, officers or other employees, which may discourage such lawsuits against us and our directors, officers and other

For example, stockholders who do bring a claim in the Court of Chancery could face additional litigation costs in pursuing

any such claim, particularly if they do not reside in or near the State of Delaware.

The Court of Chancery and federal district courts

may also reach different judgments or results than would other courts, including courts where a stockholder considering an action may

be located or would otherwise choose to bring the action, and such judgments or results may be more favorable to us than to our stockholders.

Some companies that adopted a similar federal district court forum selection provision are currently subject to a suit in the Chancery

Court of Delaware by stockholders who assert that the provision is not enforceable.

If a court were to find either choice of forum provision

contained in our certificate of incorporation to be inapplicable or unenforceable in an action, we may incur additional costs associated

with resolving such action in other jurisdictions, which could adversely affect our business and financial condition.

For example, the

Court of Chancery of the State of Delaware recently determined that the exclusive forum provision of federal district courts of the United

States of America for resolving any complaint asserting a cause of action arising under the Securities Act is not enforceable.

of this decision, we do not currently intend to enforce the federal forum selection provision in our certificate of incorporation, unless

the decision is reversed on appeal.

5 unchanged sentences

federal tax credits may be limited under Sections 382 of the Internal Revenue Code of 1986, as amended.

The limitations

apply if an “ownership change,” as defined by Section 382 and Section 383, occurs.

Generally, an ownership change

occurs if the percentage of the value of the stock that is owned by one or more direct or indirect “five percent shareholders”

increases by more than 50 percentage points over their lowest ownership percentage at any time during the applicable testing period

(typically three years).

In addition, future changes in our stock ownership, which may be outside of our control, may trigger

an “ownership change” and, consequently, Section 382 and Section 383 limitations.

As a result, if we earn net taxable

income, our ability to use our pre-change net operating loss carryforwards and other tax attributes to offset U.S.

federal taxable

income may be subject to limitations, which could potentially result in increased future tax liability to us.

In addition, the

Tax Act, among other things, imposes significant additional limitations on the deductibility of interest and limits net operating

loss (NOL) deductions to 80% of net taxable income for losses arising in taxable years beginning after December 31, 2017.

Staff comments

The limitations apply

if an “ownership change,” as defined by Section 382 and Section 383, occurs.

Generally, an ownership change occurs if the

percentage of the value of the stock that is owned by one or more direct or indirect “five percent shareholders” increases

by more than 50 percentage points over their lowest ownership percentage at any time during the applicable testing period (typically

three years).

In addition, future changes in our stock ownership, which may be outside of our control, may trigger an “ownership

change” and, consequently, Section 382 and Section 383 limitations.

As a result, if we earn net taxable income, our ability to

use our pre-change net operating loss carryforwards and other tax attributes to offset U.S.

federal taxable income may be subject to

limitations, which could potentially result in increased future tax liability to us.

In addition, the Tax Act, among other things, imposes

significant additional limitations on the deductibility of interest and limits net operating loss (NOL) deductions to 80% of net taxable

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

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.

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