What changed in this filing

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Item 5. Market for Registrant’s Common Equity

2021-03-29 compared with 2020-03-09 · 19 added, 303 removed, 19 unchanged (94% of the section changed)

For Registrant’s Common Equity, Related Stockholder Matters And Issuer Purchases Of Equity Securities

Price and Dividend Information

common stock is quoted on the NYSE American under the symbol “MTNB”.

The following table sets forth the high and low

sales price for our common stock for each full quarterly period within the last two fiscal years, as reported by the NYSE American.

February 28, 2020, the closing sale price of our common stock, as reported by the NYSE American, was $1.00 per share and

we had approximately 139 record holders of our common stock.

The number of record holders was determined from the records

of our transfer agent and does not include beneficial owners of common stock whose shares are held in the names of various security

brokers, dealers, and registered clearing agencies.

Fiscal Year 2019

First Quarter

Second Quarter

Third Quarter

Fourth Quarter

Fiscal Year 2020

First Quarter

Second Quarter

Third Quarter

Fourth Quarter

March 12, 2021, the closing sale price of our common stock, as reported by the NYSE American, was $1.20 per share and we had approximately

123 record holders of our common stock.

The number of record holders was determined from the records of our transfer agent and

does not include beneficial owners of common stock whose shares are held in the names of various security brokers, dealers, and

registered clearing agencies.

VStock Transfer, LLC is the transfer agent and registrar for our common stock.

10 unchanged sentences

Financial Data

§229.301 of Regulation S-K, the Company, designated a Smaller Reporting Company as defined in Section §229.10(f)(1)

of Regulation S-K, is not required to provide selected financial data.

Management’s Discussion and Analysis of Financial

Condition and Results of Operations is intended to help the reader understand the results of operations and financial condition

1 unchanged sentence

year ended December 31, 2020.

Management’s

Discussion And Analysis Of Financial Condition And Results Of Operations

following discussion and analysis of our financial condition and results of operations should be read together with our financial

statements and related notes appearing elsewhere in this Annual Report on Form 10-K.

Some of the information contained in this

discussion and analysis or set forth elsewhere in this Annual Report on Form 10-K, including information with respect to our plans

and strategy for our business and financing needs, includes forward-looking statements that involve risks and uncertainties and

should be read together with the “Risk Factors”

section of this Annual Report on Form 10-K for a discussion of important

factors that could cause actual results to differ materially from the results described in or implied by the forward-looking statements

contained in the following discussion and analysis.

Our actual results could differ materially from those anticipated in these

forward-looking statements as a result of various factors, including those discussed below and elsewhere in this Annual Report

and in other reports we file with the Securities and Exchange Commission, particularly those under “Risk Factors.”

Dollars in tabular format are presented in thousands, except per share data, or otherwise indicated.

are a clinical-stage biopharmaceutical company focused on creating value through the development of our lead product candidate,

MAT9001, a highly purified, prescription-only omega-3 free fatty acid formulation specifically designed for the treatment of cardiovascular

and metabolic conditions and (ii) the application of our LNC platform delivery technology to solve complex challenges relating

to the delivery of small molecules, gene therapies, vaccines, proteins and peptides, including MAT2203, our lead product candidate

based on the LNC platform delivery technology.

Based upon MAT9001’s unique mixture of highly purified omega-3 free fatty

acids and our observations of MAT9001’s enhanced bioavailability and potency as compared to Amarin Corporation’s Vascepa®

(icosapent ethyl) in our initial head-to-head PK/PD, clinical study, we believe that the results of our forthcoming targeted clinical

development activities and related clinical investigations may yield an improved therapeutic profile compared to currently-existing

are focused on creating value through 1) the streamlined development of MAT9001 for treating cardiovascular and metabolic conditions;

and 2) the application of our transformative LNC platform delivery technology to overcome current challenges in safely and effectively

delivering small molecules, gene therapies, proteins/peptides, and vaccines.

elements of our strategy include:

advancing the clinical development of MAT9001 for the treatment of SHTG and generating additional clinical data to

further differentiate MAT9001 from Vascepa and other prescription omega-3 drugs in an emerging and rapidly expanding market.

efficacy data for MAT2203 in the EnACT study for the treatment of CM with the non-dilutive financial support from the NIH.

the application of our LNC platform delivery technology through collaborations with sophisticated and well-resourced biotech

and pharmaceutical companies in innovative areas of medicine.

have incurred losses for each period from inception.

Our net loss was approximately $17.4 million and $14.1 million for the fiscal

years ended December 31, 2019 and 2018, respectively.

We expect to incur significant expenses and operating losses over the next

several years.

Accordingly, we will need additional financing to support our continuing operations.

We will seek to fund our operations

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

arrangements.

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

Our failure to raise capital

as and when needed would impact our going concern and would have a negative impact on our financial condition and our ability

to pursue our business strategy and continue as a going concern.

We will need to generate significant revenues to achieve profitability,

and we may never do so.

Operations Overview

each of the years ended December 31, 2019 and 2018, we generated approximately $0.1 million in contract research revenues, resulting

from a grant with the Cystic Fibroses Foundation.

Our ability to generate product revenue, which we do not expect to occur for

many years, if ever, will depend heavily on the successful development and eventual commercialization of our early-stage product

The Company has adopted ASC 606 as of January 1, 2018.

For the year ended December 31, 2018, there were no changes

to our opening balances upon the adoption of ASC 606 and the amounts which would have been reported under the standards in effect

prior to adoption.

and Development Expenses

and development expenses consist of costs incurred for the development of product candidates MAT9001 and MAT2203 and advancement

of our LNC platform delivery technology, which include:

cost of conducting pre-clinical work;

cost of acquiring, developing and manufacturing pre-clinical and human clinical trial materials;

for consultants and contractors associated with Chemistry and Manufacturing Controls (CMC), pre-clinical and clinical activities

and regulatory operations;

incurred under agreements with contract research organizations, or CROs, including the NIH, that conduct our pre-clinical

or clinical trials;

employee-related

expenses, including salaries and stock-based compensation expense for those employees involved in the research and development

table below summarizes our direct research and development expenses for our product candidates and development platform for the

years ended December 31, 2019 and 2018.

Our direct research and development expenses consist principally of external costs, such

as fees paid to contractors, consultants, analytical laboratories and CROs and/or the NIH, in connection with our development

We typically use our employee and infrastructure resources for manufacturing clinical trial materials, conducting product

analysis, study protocol development and overseeing outside vendors.

Included in “Internal Staffing, Overhead and Other”

below is the cost of laboratory space, supplies, research and development (R&D) employee costs (including stock option expenses),

travel and medical education.

Ended December 31,

research and development expenses:

Manufacturing

process development

staffing, overhead and other

research & development

and development activities are central to our business model.

We expect our research and development expenses to increase because

product candidates in later stages of clinical development generally have higher development costs than those in earlier stages

of clinical development, primarily due to the increased size and duration of later-stage human trials.

In addition, we will look

to strategically expand the use of our drug platform technology through additional development work.

During 2020, we will be focused

on advancing our lead product candidate, MAT9001 through clinical development toward an initial indication for the treatment of

SHTG, expanding application of our LNC platform delivery technology through collaborations with third parties, and driving

MAT2203 to efficacy data in the treatment of CM.

and Administrative Expenses

and administrative expenses consist principally of salaries and related costs for personnel in executive and finance functions.

Other general and administrative expenses include facility costs, insurance, investor relations expenses, professional fees for

legal, patent review, consulting and accounting/audit services.

anticipate that our general and administrative expenses will increase during 2020 due to the increased expenses related to our

status as a publicly traded company, including expenses in support of compliance with the requirements of Section 404 of the Sarbanes

Oxley Act as well as investor relations, protection of our intellectual property and insurance costs.

of Net Operating Losses (NOLs)

obtained from selling unused net operating losses (NOLs) and unused research tax credits under the New Jersey Technology Business

Tax Certificate Program was $1.0 million for the year ended December 31, 2019.

We did not recognize income from the sale of NOLs

for the year ended December 31, 2018.

income, net is largely comprised of interest income (expense) and franchise taxes.

of Critical Accounting Policies and Accounting Estimates

critical accounting policy is one that is both important to the portrayal of our financial condition and results of operation

and requires management’s most difficult, subjective or complex judgments, often as a result of the need to make estimates

about the effect of matters that are inherently uncertain.

a description of our significant accounting policies, refer to “Note 3 –

Summary of Significant Accounting Policies .”

Of these policies, the following are considered critical to an understanding of our Consolidated Financial Statements as they

require the application of the most difficult, subjective and complex judgments;

(i) Stock-based compensation, (ii) Fair value

measurements, (iii) Research and development costs, (iv) Goodwill and other intangible assets, and (v) Basic and diluted net

loss per common share.

Operating Trends

current R&D efforts are focused on advancing our lead product candidate, MAT9001 through clinical development toward

an initial indication for the treatment of SHTG, expanding application of our LNC platform delivery technology through

collaborations with third parties, and driving MAT2203 to efficacy data in the treatment of CM.

Our R&D expenses consist

of manufacturing work and the cost of drug ingredients used in such work, fees paid to consultants for work related to clinical

trial design and regulatory activities, fees paid to providers for conducting various clinical studies as well as for the analysis

of the results of such studies, and for other medical research addressing the potential efficacy and safety of our drugs.

that significant investment in product development is a competitive necessity, and we plan to continue these investments in order

to be in a position to realize the potential of our product candidates and proprietary technologies.

expect that all of our R&D expenses in the near-term future will be incurred in support of our current and future preclinical

and clinical development programs rather than technology development.

These expenditures are subject to numerous uncertainties

relating to timing and cost to completion.

We test compounds in numerous preclinical studies for safety, toxicology and efficacy.

At the appropriate time, subject to the approval of regulatory authorities, we expect to conduct early-stage clinical trials for

each drug candidate.

We anticipate funding these trials ourselves, and possibly with the assistance of federal grants, contracts

or other agreements.

As we obtain results from trials, we may elect to discontinue or delay clinical trials for certain products

in order to focus our resources on more promising products.

Completion of clinical trials may take several years, and the length

of time generally varies substantially according to the type, complexity, novelty and intended use of a product candidate.

commencement and completion of clinical trials for our products may be delayed by many factors, including lack of efficacy during

clinical trials, unforeseen safety issues, slower than expected participant recruitment, lack of funding or government delays.

In addition, we may encounter regulatory delays or rejections as a result of many factors, including results that do not support

the intended safety or efficacy of our product candidates, perceived defects in the design of clinical trials and changes in regulatory

policy during the period of product development.

As a result of these risks and uncertainties, we are unable to accurately estimate

the specific timing and costs of our clinical development programs or the timing of material cash inflows, if any, from our product

Our business, financial condition and results of operations may be materially adversely affected by any delays in,

or termination of, our clinical trials or a determination by the FDA that the results of our trials are inadequate to justify

regulatory approval, insofar as cash in-flows from the relevant drug or program would be delayed or would not occur.

of Operations

Ended December 31, 2019 and 2018

following table summarizes our operating expenses for the years ended December 31, 2019 and 2018 (in thousands):

Ended December 31,

and development

and administrative

and Development expenses.

R&D expense for the year ended December 31, 2019 was approximately $11.2 million,

an increase of approximately $4.4 million over the prior year.

R&D expenses increased mainly due to higher preclinical and

clinical development expenses of approximately $2.2 million, employee compensation of approximately $1.6 million

and manufacturing development of approximately $0.6 million.

We expect R&D expenses to increase during 2020 as we move

our clinical development programs forward and continue to invest in our laboratory & manufacturing facility.

and Administrative expenses.

General and administrative expense for the year ended December 31, 2019 was approximately

$7.8 million, a decrease of approximately $0.2 million over prior year.

The decrease in general and administrative expense was

primarily due to a decrease in employee related expenses.

and capital resources

have funded our operations since inception primarily through private placements of our preferred stock and our common stock and

common stock warrants.

As of December 31, 2019, we have raised a total of approximately $100.1 million in gross proceeds and $90.9

million, net, from sales of our equity securities.

of December 31, 2019, we had cash, cash equivalents and marketable securities, excluding restricted cash, totaling $27.8

Common Stock Offering

January 14, 2020, the Company closed an underwritten public offering of its common stock.

The offering resulted in the sale of

approximately 32.3 million shares to the public at a price of $1.55 per share.

The Company generated net proceeds of approximately

$46.7 million.

The Company granted the underwriters a 30-day option (the “option”) to purchase up to approximately

4.8 million additional shares of common stock subject to the same terms and conditions.

No additional shares of the

Company’s common stock were sold pursuant to this option.

Common Stock Offering

March 19, 2019, the Company closed an underwritten public offering of its common stock.

The offering resulted in the sale of approximately

27.3 million shares to the public at a price of $1.10 per share.

The Company generated net proceeds of approximately

$27.8 million.

The Company granted the underwriters a 30-day option (the “option”) to purchase up to

approximately 4.1 million additional shares of common stock subject to the same terms and conditions.

If the underwriters

exercise the option in full, additional net proceeds of approximately $4.2 million will be generated.

On March 28, 2019, approximately

2.2 million additional shares were sold pursuant to the option at a price of $1.10 per share, resulting in net proceeds to

the Company of approximately $2.3 million .

Series B Preferred Stock Offering

June 19, 2018, the Company entered into a placement agency agreement with ThinkEquity, a Division of Fordham Financial Management,

Inc., as placement agent , relating to the offering, issuance and sale of up to 8,000 shares of the Company’s Series B Convertible

Preferred Stock, par value $0.0001 per share with a stated value of $1,000 per share which are convertible into an aggregate of

up to 16,000,000 shares of the Company’s common stock, par value $0.0001 per share at an initial conversion price of $0.50

per share of Common Stock and an additional up to 7,200,000 shares of Common Stock issuable upon payment of dividends under the

Series B Preferred Stock .

The offering closed on June 21, 2018 raising a gross amount of $8 million with a net raise of $7.1

million after deducting issuance costs.

Controlled Equity Offering

entered into a Controlled Equity Offering SM Sales Agreement (the “Equity Sales Agreement”) with Cantor

Fitzgerald & Co.

(“Cantor”), pursuant to which, subject to certain limited restrictions and daily sales limits,

we may sell shares of common stock having an offering price of up to $30 million.

Through December 31, 2019, we raised a net of

approximately $10.4 million through this agreement.

On February 19, 2020, we provided notice

of termination of the Equity Sales Agreement which was effective on February 29, 2020.

The Company is not subject to any termination

penalties related to the termination of the Equity Sales Agreement.

following table sets forth the primary sources and uses of cash for each of the period set forth below (in thousands):

Ended December 31

used in operating activities

used in investing activities

provided by financing activities

increase in cash and cash equivalents and restricted cash

cash used in operating activities for the year ended December 31, 2019 was approximately $14.1 million, compared to approximately

$10.3 million in the prior year.

The increase of approximately $3.8 million for the period was primarily due to increased research

and development expenses, approximately $4.4 million, primarily related to clinical trials for the advancement of the Company’s

lead product candidates MAT9001 and MAT2203, and approximately $0.1 in other items, offset by changes in operating assets and

liabilities of approximately $0.7 million.

Approximately

$6.0 million and approximately $0.5 million of cash was used in investing activities for the years ended December

31, 2019 and 2018, respectively.

The increase of $5.5 million is primarily due to the purchase marketable securities in

No marketable securities were purchased in 2018.

cash provided by financing activities was approximately $29.9 million and approximately $15.9 million for the year

ended December 31, 2019 and 2018, respectively.

The increase of $14.0 million in cash provided by financing activities

is primarily due to the approximately $30.1 million of net proceeds from the March 2019 public offering of common

stock primarily offset by the approximately $16.3 million of net proceeds in 2018 which was due to the issuance

of Series B Preferred Stock in June and sales of our common stock through the Controlled Equity Offering SM .

Requirements and Other Liquidity Matters

expect to continue to incur significant expenses and increasing operating losses for the foreseeable future.

We anticipate that

our expenses will increase substantially if and as we:

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

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

from the NIH;

to discover and develop additional product candidates;

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

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

expand and protect our intellectual property portfolio;

additional clinical, quality control and scientific personnel;

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

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

as a public company.

expect that our existing cash, cash equivalents and marketable securities, coupled with the approximately $46.7

million of net proceeds generated from the recently completed underwritten public offering of common stock, will be sufficient

to fund our operating expenses and capital expenditures requirements into the second half of 2022.

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

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

and licensing arrangements.

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

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

the ownership interest of our stockholders may be materially diluted, and the terms of these securities may include liquidation

or other preferences that adversely affect your rights of our common stockholders.

Debt financing and preferred equity financing,

if available, would result in increased fixed payment obligations and may involve agreements that include covenants limiting or

restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring

dividends, that could adversely impact our ability to conduct our business.

Securing additional financing could require a substantial

amount of time and attention from our management and may divert a disproportionate amount of their attention away from day-to-day

activities, which may adversely affect our management’s ability to oversee the development of our product candidates.

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

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

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

If we are unable to raise additional funds through equity

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

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

Obligations and Commitments

to Note 9 –

“Commitments”

in the accompanying notes to the consolidated financial statements for a discussion

of the Company’s contractual obligations and commitments.

Sheet Arrangements

did not have during the periods presented, and we do not currently have, any off-balance sheet arrangements, as defined under

SEC rules, such as relationships with unconsolidated entities or financial partnerships, which are often referred to as structured

finance or special purpose entities, established for the purpose of facilitating financing transactions that are not required

to be reflected on our balance sheets.

ACCOUNTING PRONOUNCEMENTS

to Note 3 - “

Significant Accounting Policies ,”

in the accompanying notes to the consolidated financial statements

for a discussion of recent accounting pronouncements.

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 5. Market for Registrant’s Common Equity