What changed in this filing

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Item 1A. Risk Factors

2021-03-29 compared with 2020-03-09 · 728 added, 777 removed, 905 unchanged (62% of the section changed)

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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.

will need substantial additional funding.

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

or eliminate our product development programs or commercialization efforts.

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

or product candidates.

stockholders may be subject to substantial dilution by 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.

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.

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.

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.

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.

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

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

burdens and other risks and uncertainties.

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

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

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

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.

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.

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.

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.

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.

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

share price has been and could remain volatile.

securities or industry analysts do not publish research or reports about our business, or if they change their recommendations

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

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.

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

Anti-takeover

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

to our stockholders, more difficult.

Stockholders’

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

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

Related to Our Financial Position and Need for Additional Capital

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

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 National Institutes of Health, or the NIH.

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

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:

further preclinical and clinical studies of MAT9001, our lead product candidate;

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:

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

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

clinical studies of MAT9001, our lead product candidate, as well as the ongoing Phase 2 clinical trial of MAT2203 in CM, conduct

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

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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.

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

million as of December 31, 2019, plus an additional approximately $46.7 million in net proceeds from a public offering

of our common stock in January 2020, will enable us to fund our operating expenses and capital expenditure requirements into the

second half of 2022.

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

use our capital resources sooner than we currently expect.

Changing circumstances could cause us to consume capital significantly

faster than we currently anticipate, and we may need to spend more money than currently expected because of circumstances beyond

Our 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 MAT9001;

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:

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 cochleate delivery technology platform,

including MAT2501, and any preclinical or clinical work done to further validate our cochleate platform delivery technology,

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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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

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

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

us for a product utilizing the cochleate delivery technology.

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

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could be if we had a longer operating history.

addition, as a young business, we may encounter unforeseen expenses, difficulties, complications, delays and other known and unknown

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.

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.

We may not be successful in such a transition.

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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

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.

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

completed a PK/PD study of MAT9001 head to head vs.

Vascepa in 2015.

We recently completed two separate Phase 2 clinical trials

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.

As a result, the timing and costs of the regulatory paths we will

follow and marketing approvals remain uncertain.

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

The success of MAT9001, MAT2203, and any other product candidates we may develop will depend on many factors, including

the following:

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.

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:

completion of preclinical studies;

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

cannot be certain that MAT9001, MAT2203 or any other product candidates that we may develop will receive regulatory approval,

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.

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

expect to invest most of our capital in the development of MAT9001.

Our ability to generate revenue related to product sales,

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

regulatory approval of one or more of our product candidates.

All of our product candidates require regulatory review and approval

prior to commercialization.

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

increase our cash requirements and result in additional operating losses.

This failure to obtain regulatory approvals would prevent

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

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

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

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

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

The loss of access to this technology

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

drug development involves a lengthy and expensive process with uncertain outcomes that may lead to delayed timelines and increased

cost, and may prevent us from being able to complete clinical trials.

testing is expensive, can take many years to complete, and its outcome is inherently uncertain.

The results of preclinical and

clinical studies of our product candidates may not be predictive of the results of later-stage clinical trials.

For example, the

positive results generated to date in Phase 2 clinical studies for MAT9001 do not ensure that our Phase 3 clinical trials will

demonstrate similar results.

Product candidates in later stages of clinical trials may fail to show the desired safety and efficacy

despite having progressed through preclinical studies and initial clinical trials.

A number of companies in the pharmaceutical

industry have suffered significant setbacks in advanced clinical trials due to lack of efficacy or adverse safety profiles, notwithstanding

promising results in earlier studies, and we cannot be certain that we will not face similar setbacks.

cannot be certain that future clinical trials for MAT9001, MAT2203 or any of our other product candidates, will begin on time,

not need to be redesigned, enroll an adequate number of patients on time or be completed on schedule, if at all, or that any interim

analyses with respect to such trials will be completed on schedule or support continued clinical development of the associated

product candidate.

could also encounter delays if a clinical trial is suspended or terminated by us upon recommendation of the data monitoring committee

for such trial, by the IRBs of the institutions in which such trials are being conducted, or by the FDA or other regulatory authorities.

Such authorities may suspend or terminate a clinical trial due to a number of factors, including failure to conduct the clinical

trial in accordance with regulatory requirements or our clinical protocols, inspection of the clinical trial operations or trial

site by the FDA or other regulatory authorities resulting in the imposition of a clinical hold, unforeseen safety issues or adverse

side effects, failure to demonstrate a benefit from using a drug, changes in governmental regulations or administrative actions,

or lack of adequate funding to continue the clinical trial.

we experience delays in the completion of, or termination of, any clinical trial of our product candidates, the commercial prospects

of our product candidates may be harmed, and our ability to generate revenue from the sale of any of these product candidates

will be delayed.

In addition, any delays in completing our clinical trials will increase our costs, slow down our product candidate

development and approval processes, and jeopardize our ability to commence product sales and generate revenue.

Any of these occurrences

may significantly harm our business, financial condition and prospects significantly.

in the commencement, enrollment and completion of our clinical trials could result in increased costs to us and delay or limit

our ability to obtain regulatory approval for MAT9001 and our other product candidates.

in the commencement, enrollment and completion of clinical trials could increase our product development costs or limit the regulatory

approval of our product candidates.

The commencement, enrollment and completion of clinical trials can be delayed for a variety

of reasons, including:

to reach agreements on acceptable terms with prospective contract research organizations (CROs) and trial sites, the terms

of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites;

to maintain necessary supplies of study drug and comparator to maintain predicted enrollment rates at clinical trial sites;

objections to commencing a clinical trial;

to identify and maintain a sufficient number of trial sites, many of which may already be engaged in other clinical trial

programs, including some that may be for the same indication as our product candidates;

of clinical trial sites from our clinical trials as a result of changing standards of care or the ineligibility of a site

to participate in our clinical trials;

to obtain institutional review board approval, including that within the NIH, to conduct a clinical trial;

recruiting and enrolling subjects to participate in clinical trials for a variety of reasons, including meeting the enrollment

criteria for our study and competition from other clinical trial programs for the same indication as our product candidates;

to retain subjects in clinical trials due to the treatment protocol, personal issues, side effects from the therapy or lack

in importing and exporting clinical trial materials and study samples.

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

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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 rely exclusively on third party manufacturers for the manufacture of MAT9001.

If we do not develop a long term in-house manufacturing capability for the cochleates needed for our 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.

have long-term agreements with any of these third parties, and if they are unable or unwilling to perform for any reason, we may

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

Any inability

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

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

In addition, manufacturers of our product candidates

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

manufacturers.

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

resulting in delays and additional costs.

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

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

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.

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

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

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

Delays in receipt of materials,

scheduling, release, custom’s control, and regulatory compliance issues may adversely impact our ability to initiate, maintain,

or complete clinical trials that we are sponsoring.

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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;

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

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criteria for the study;

from other companies’

clinical studies for the same patient population;

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

to obtain comparator drug/device.

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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.

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.

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.

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

if we receive regulatory approval for MAT9001, MAT2203 or any other product candidates we may develop, we still may not be able

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

approved for marketing, the commercial success of MAT9001, MAT2203 or any other product candidates we may develop will depend

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

The degree of market acceptance

of MAT9001, MAT2203 or such other product candidate will depend on a number of factors, including:

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:

demonstration

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

effectiveness of our or any future collaborators’

sales and marketing strategies;

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

or warnings contained in FDA approved labeling;

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

MAT9001, MAT2203, or any other product candidates we may develop is approved, but does not achieve an adequate level of acceptance

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

profitability.

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.

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.

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

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Further, the FDA may place conditions on approvals

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

to assure the safe use of the drug.

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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 MAT9001, MAT2203 or any of our other product candidates.

United States until shortly prior to FDA approval of LYPDISO, 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.

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train and retain sales and marketing personnel.

Factors that may inhibit our efforts to commercialize MAT9001, MAT2203 or any

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

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:

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

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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 MAT9001,

MAT2203 or any other product candidates we may develop, which would adversely affect our business, operating results and financial

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

pharmaceutical partners.

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 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.

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 MAT9001 or MAT2203 under Section 505(b)(2) of the FDCA or if we are required to generate

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

anticipated development and commercialization timelines.

current plans for filing the NDAs for MAT9001 and MAT2203 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.

Based upon written

feedback received from the FDA in 2014, 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 MAT9001 for the

treatment of SHTG.

Although our interactions with the FDA have encouraged our efforts to continue to develop MAT9001 for

SHTG, there is no assurance that we will satisfy the FDA’s requirements for approval in this indication.

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.

The timelines for filing and review of our NDAs for MAT9001 and MAT2203 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.

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

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development activities would be costly and time consuming.

may not be able to realize a shortened development timeline for MAT9001 for SHTG, and the FDA may not approve our NDA based

on their review of the submitted data.

If omega-3 fatty acids-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 MAT9001, 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 candidate.

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

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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 MAT9001, MAT2203 or

any other product candidates we may develop obsolete or uneconomical.

Any new product that competes with an approved product may

need to demonstrate compelling advantages in efficacy, cost, convenience, tolerability and safety to be commercially successful.

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 MAT9001, MAT2203 or any of our other product candidates.

If we are not able to compete effectively against our current and future competitors, our business will not grow and our financial

condition and operations will suffer.

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 MAT9001, MAT2203 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 MAT9001, MAT2203 or any other product candidates that we may develop, FDA may

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

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

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

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,

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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

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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 MAT9001, MAT2203 or any of our other

product candidates and generate revenue.

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

product liability claims and increase our product liability exposure.

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.

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 MAT9001, MAT2203 and any other product candidates that we may develop.

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

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

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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.

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product candidates.

in health care law and implementing regulations, including government restrictions on pricing and reimbursement, as well as health

care policy and other health care payor cost-containment initiatives, may have a material adverse effect on us.

the United States and some foreign jurisdictions, there have been a number of legislative and regulatory changes and proposed

changes regarding the healthcare system and efforts to control health care costs, including drug prices, that could have a significant

negative impact on our business, including preventing, limiting or delay regulatory approval of our drug candidates and reducing

the sales and profits derived from our products once they are approved.

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 industry.

Many provisions of 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

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 ACA, including the potential for further amendments to the ACA and

legal challenges to or efforts to repeal the ACA.

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.

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.

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

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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.

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:

clinical trials to be conducted prior to obtaining approval;

to manufacturing methods;

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

recordkeeping.

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

our product 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.

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.

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

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we intend to rely on collaborations with third parties.

If we commercialize MAT9001, MAT2203 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;

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:

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

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

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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

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

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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, which exposes

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

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

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

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

The loss of, or failure

to perform by us or our partners under any applicable agreements or arrangements, or our failure to secure additional agreements

for our product candidates, would substantially disrupt or delay our research and development activities, including our in-process

and anticipated clinical trials.

Any such loss would likely increase our expenses and materially harm our business, financial

condition and results of operation.

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.

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

or commercialize MAT9001, MAT2203 or any other product candidates that we may develop and our business could be substantially

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 MAT9001, and MAT2203 and our other product candidates

and can control only certain and very limited aspects of their activities.

Nevertheless, we would be responsible for ensuring

that each of our studies is conducted in accordance with the applicable protocol, legal, regulatory and scientific standards,

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.

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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 MAT2203, MAT9001 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.

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

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As a result of the

foregoing, our financial results and the commercial prospects for MAT9001, MAT2203 and our other product candidates would be harmed,

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

Reimbursement

decisions by third-party payors may have an adverse effect on pricing and market acceptance of MAT9001, MAT2203 or any other product

candidates that we may develop.

If there is not sufficient reimbursement for our future products, it is less likely that such

products will be widely used.

acceptance and sales of MAT9001, MAT2203 or any other product candidates for which we obtain regulatory approval will depend on

reimbursement policies and may be affected by future healthcare reform measures in both the United States and foreign jurisdictions.

Government authorities and third-party payors, such as private health insurers and health maintenance organizations, decide which

products they will cover and establish payment levels.

In addition, government authorities and these third-party payors are increasingly

attempting to contain health care costs by demanding price discounts or rebates and limiting both the types and variety of products

that they will cover and the amounts that they will pay for these products.

In addition, we might need to conduct post-marketing

studies in order to demonstrate the cost-effectiveness of any future products to such payors’

satisfaction.

might require us to commit a significant amount of management time and financial and other resources.

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.

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

We cannot be certain that reimbursement will be available for MAT9001, MAT2203 or any other product candidates that we develop.

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 MAT9001,

MAT2203 or any other product candidates that we develop.

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.

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prescription and are not subject to pharmaceutical manufacturing standards.

As a result, MAT9001, if approved, would be subject

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

to competition from products for which no prescription is required.

approved by the regulatory authorities, MAT9001 will be a prescription-only omega-3 fatty acid-based medication.

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

Mixtures of omega-3

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

of MAT9001 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 MAT9001 as superior.

To the extent the price of MAT9001 is significantly

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 MAT9001 or patients may elect on their own to take commercially available

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 MAT9001

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

is increasing pressure on biotechnology companies to reduce healthcare costs.

In the U.S., these pressures come from a variety

of sources, such as managed care groups, institutional, government purchasers and government leaders.

For example, President Trump

has indicated support for possible new measures related to drug pricing.

Increased purchasing power of entities that negotiate

on behalf of federal healthcare programs and private sector beneficiaries could increase pricing pressures in the future.

pressures may also increase the risk of litigation or investigation by the government regarding pricing calculations.

The biotechnology

industry will likely face greater regulation and political and legal action in the future.

regulations that govern marketing approvals, pricing and reimbursement for new therapeutic products vary widely from country to

Some countries require approval of the sale price of a product before it can be marketed.

In many countries, the pricing

review period begins after marketing or product licensing approval is granted.

In some foreign markets, prescription pharmaceutical

pricing remains subject to continuing governmental control even after initial approval is granted.

As a result, we might obtain

regulatory approval for a product in a particular country, but then be subject to price regulations that delay our commercial

launch of the product and negatively impact the revenue we are able to generate from the sale of the product in that country.

pricing limitations may hinder our ability to recoup our investment in one or more product candidates, even if our product candidates

obtain regulatory approval.

Adverse pricing limitations prior to approval will also adversely affect us by reducing our commercial

Our ability to commercialize any products successfully also will depend in part on the extent to which reimbursement

for these products and related treatments becomes available from government health administration authorities, private health

insurers and other organizations.

authorities and third-party payors, such as private health insurers and health maintenance organizations, decide which medications

they will pay for and establish reimbursement levels.

primary trend in the U.S.

healthcare industry and elsewhere is cost containment.

Government authorities and these third-party

payors have attempted to control costs by limiting coverage and the amount of reimbursement for particular medications.

Increasingly,

third-party payors are requiring that companies provide them with predetermined discounts from list prices and are challenging

the prices charged for medical products.

We cannot be sure that coverage and reimbursement will be available for any product that

we commercialize and, if reimbursement is available, what the level of reimbursement will be.

Reimbursement may impact the demand

for, or the price of, any product for which we obtain marketing approval.

Obtaining reimbursement for our products may be particularly

difficult because of the higher prices often associated with products administered under the supervision of a physician.

If reimbursement

is not available or is available only to limited levels, we may not be able to successfully commercialize any product candidate

that we successfully develop.

may be significant delays in obtaining reimbursement for approved products, and coverage may be more limited than the purposes

for which the product is approved by the FDA or regulatory authorities in other countries.

Moreover, eligibility for reimbursement

does not imply that any product will be paid for in all cases or at a rate that covers our costs, including research, development,

manufacture, sale and distribution.

Interim payments for new products, if applicable, may also not be sufficient to cover our

costs and may not be made permanent.

Payment 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 and may be incorporated into

existing payments for other services.

Net prices for products may be reduced by mandatory discounts or rebates required by government

healthcare programs or private payors and by any future relaxation of laws that presently restrict imports of products from countries

where they may be sold at lower prices than in the United States.

Third-party payors often rely upon Medicare coverage policy

and payment limitations in setting their own reimbursement policies.

Our inability to promptly obtain coverage and profitable

payment rates from both government funded and private payors for new products that we develop could have a material adverse effect

on our operating results, our ability to raise capital needed to commercialize products and our overall financial condition.

are, and will be, completely dependent on third parties to manufacture MAT9001, and our commercialization of MAT9001 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 MAT9001 or fail to do so at acceptable quality

levels or prices.

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.

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

or API, in MAT9001 for use in our clinical trials or for commercial product, if any.

In addition, we do not have the capability

to encapsulate MAT9001 as a finished drug product for commercial distribution.

As a result, we will rely on contract manufacturers

throughout the development process and then if and when MAT9001 is 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 MAT9001 on favorable terms to us, or at all.

facilities used by our contract manufacturers to manufacture MAT9001 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

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 MAT9001 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 MAT9001, if approved.

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.

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,

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.

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

MAT9001, 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 , 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,

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

processes for our API or finished MAT9001 product or should cease doing business with us, we could experience significant interruptions

in the supply of MAT9001 or may not be able to create a supply of MAT9001 at all.

Were we to encounter manufacturing issues, our

ability to produce a sufficient supply of MAT9001 might be negatively affected.

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 MAT9001 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 the supply of MAT9001 if we decided to transfer the manufacture of

MAT9001 to one or more alternative manufacturers in an effort to deal with the difficulties.

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.

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

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Any unanticipated disruption to a future contract manufacturer caused by problems

at suppliers could delay shipment of MAT9001, increase our cost of goods sold and result in lost sales.

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 MAT9001 over time.

If the commercial-scale manufacturing costs of MAT9001 are higher than expected, these costs may significantly

impact our operating results.

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.

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

of communicable diseases in various parts of China and other countries may materially and adversely affect our business, financial

condition and results of operations.

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

For example, there have been recent outbreaks

in several countries, including China, of a highly transmissible and pathogenic coronavirus.

The outbreak of such communicable

diseases could result in a widespread health crisis that could adversely affect general commercial activity and the economies

and financial markets of many countries.

Since some of our business partners are in China and other Asian countries, including

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.

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

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

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

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

markets of many countries.

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

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

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We do not own the patents that underly

this 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.

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

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.

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

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

product candidates based on the cochleate delivery technology, including our lead anti-infective product candidate, MAT2203.

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 cochleate delivery technology, including our lead

anti-infective product candidate.

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

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.

certain circumstances, we will be required to transfer Aquarius’

cochleate delivery technology back to the former shareholders

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 cochleate delivery technology

(as conclusively demonstrated by our omission of the cochleate 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.

If the foregoing

conditions are met, we would transfer the cochleate 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 cochleate 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.

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.

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

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We currently own or have rights to

22 issued patents relating to our cochleate delivery technology, as well as pending patent applications for our cochleate 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.

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

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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 MAT9001, MAT2203 or any future product candidate.

There may be certain issued patents

and patent applications claiming subject matter that we may be required to license in order to research, develop or commercialize

MAT9001 or MAT2203 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:

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:

in costly litigation;

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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 MAT9001

or MAT2203 from being marketed.

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

relating to MAT9001 or MAT2203 or our processes could subject us to potential liability for damages and require us to obtain a

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

We cannot predict

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

commercially acceptable terms, if at all.

In addition, we cannot be sure that we could redesign, MAT9001, MAT2203, or any future

product candidates or processes to avoid infringement, if necessary.

Accordingly, an adverse determination in a judicial or administrative

proceeding, or the failure to obtain necessary licenses, could prevent us from developing and commercializing MAT9001, MAT2203

or a future product candidate, which could harm our business, financial condition and operating results.

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

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

generic companies are seeking 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.

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.

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.

may be subject to claims that we have wrongfully hired an employee from a competitor or that we or our employees have wrongfully

used or disclosed alleged confidential information or trade secrets of their former employers.

is commonplace in our industry, we employ individuals who were previously employed at or retained by other pharmaceutical companies,

including our competitors or potential competitors.

Although no claims against us are currently pending, we may be subject in

the future to claims that our employees or prospective employees are subject to a continuing obligation to their former employers

(such as non-competition or non-solicitation obligations) or claims that our employees or we have inadvertently or otherwise used

or disclosed trade secrets or other proprietary information of their former employers.

Litigation may be necessary to defend against

these claims.

Even if we are successful in defending against these claims, litigation could result in substantial costs and be

a distraction to management.

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 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.

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.

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 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”

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.

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.

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-one employees.

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.

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

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of our product candidates.

face a potential risk of product liability as a result of the clinical testing of MAT9001, MAT2203, MAT2501 or any future product

candidates and will face an even greater risk if we commercialize MAT9001, MAT2203 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.

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

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ourselves against product liability claims, we may incur substantial liabilities or be required to limit commercialization of

MAT9001 or MAT2203.

LYPDISO, 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 MAT9001, MAT2203 or any future products that we may develop;

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

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

to our reputation;

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to defend the related litigation;

diversion of management’s time and our resources;

monetary awards to trial participants or patients;

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related to our Securities

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

to the terms of the Certificate of Designations of Preferences, Rights and Limitations (the “Certificate of Designations”)

for our outstanding Series A Preferred Stock, we may be 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 2021, 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.

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

to the terms of the Certificate of Designations of Preferences, Rights and Limitations (the “Certificate of Designations”)

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 payable as follows:

(i) a number of shares of common stock

equal to 15% of the shares of common stock underlying the Series B Preferred then held by such holder on June 19, 2020 and (ii)

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.

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.

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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.

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

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

common stock was listed on the NYSE American under the symbol “MTNB”

on March 2, 2017.

Prior to March 2, 2017, our

common stock was available for quotation on the OTCQB under the symbol “MTNB.”

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.

1, 2017 through February 28, 2020, the market price of our common stock has fluctuated from a high of $3.99 per share in the first

quarter of 2017 to a low of $0.35 per share in the third quarter of 2018.

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

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

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.

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

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

the current level of trading may not be sustained in the future.

The lack of an active market for our common stock may impair

investors’

ability to sell their shares at the time they wish to sell them or at a price that they consider reasonable,

may reduce the fair market value of their shares and may impair our ability to raise capital to continue to fund operations by

selling shares and may impair our ability to acquire additional intellectual property assets by using our shares as consideration.

do not anticipate paying dividends on our common stock and, accordingly, stockholders must rely on stock appreciation for any

return on their investment.

have never declared or paid cash dividends on our common stock and do not expect to do so in the foreseeable future.

The declaration

of dividends is subject to the discretion of our board of directors and limitations under applicable law, and will depend on various

factors, including our operating results, financial condition, future prospects and any other factors deemed relevant by our board

of directors.

You should not rely on an investment in our company if you require dividend income from your investment in our company.

The success of your investment will likely depend entirely upon any future appreciation of the market price of our common stock,

which is uncertain and unpredictable.

There is no guarantee that our common stock will appreciate in value.

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

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markets, which in turn could cause our stock price or trading volume to decline.

are no longer an “emerging growth company”

and are therefore subject to the auditor attestation requirement

in the assessment of our internal controls over financial reporting and certain other increased disclosure and governance requirements.

of January 1, 2020, we lost our status as an “emerging

growth company”

as defined in the Jumpstart Our Business Startups Act of 2012.

As a result, we are no longer

able to take advantage of certain exemptions from various reporting requirements.

Therefore, we are now subject to certain

requirements that apply to other public companies that did not previously apply to us, due to our previous

status as an emerging growth company.

These requirements include:

with the auditor attestation requirement in the assessment of our internal controls over financial reporting pursuant to Section

404 of the Sarbanes-Oxley Act;

with any new rules that may be adopted by the Public Company Accounting Oversight Board;

with any new or revised financial accounting standards applicable to public companies without an extended transition period;

disclosure regarding executive compensation required of larger public companies;

with the requirement of holding a nonbinding advisory vote on executive compensation and obtaining shareholder approval of

any golden parachute payments not previously approved.

to comply with these requirements could subject us to enforcement actions by the SEC, divert management’s attention, damage

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

In particular, if our independent

registered public accounting firm is not able to render the required attestation, it could result in a loss of investor confidence

in the accuracy, reliability, and completeness of our financial reports.

We expect that the loss of “emerging growth company”

status and compliance with these additional requirements will require management to expend additional time while also condensing

the time frame available to comply with certain requirements, which may further increase our legal and financial compliance costs.

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.

have identified a material weakness in our internal control over financial reporting.

If we are not able to remediate

this material weakness and otherwise 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

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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).

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.

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

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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

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.

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.

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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.

of our preferred stock on an “as converted” basis) on a pro rata basis.

There can be no assurance that we will have

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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

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.

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 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 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 the decision is reversed on appeal.

However, if the decision is reviewed on appeal

and ultimately overturned by the Delaware Supreme Court, we would enforce the federal district court exclusive forum provision.

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

the decision is reversed on appeal.

However, if the decision is reviewed on appeal and ultimately overturned by the Delaware Supreme

Court, we would enforce the federal district court exclusive forum provision.

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

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The limitations

apply if an “ownership change,”

as defined by Section 382 and Section 383, occurs.

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

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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.

an “ownership change” and, consequently, Section 382 and Section 383 limitations.

As a result, if we earn net taxable

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income may be subject to limitations, which could potentially result in increased future tax liability to us.

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,

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

administrative offices consist of approximately 5,900 square feet of office space in Bedminster, NJ that we occupy under a lease

that expires in May 2021.

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

are not currently a party to any legal proceedings, and we are not aware of any claims or actions pending or threatened against

In the future, we might from time to time become involved in litigation relating to claims arising from our ordinary course

Safety Disclosures

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