What changed in this filing

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Item 7. Management’s Discussion and Analysis

2022-03-08 compared with 2021-03-29 · 213 added, 244 removed, 56 unchanged (89% of the section changed)

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 focused on creating value through improving the intracellular delivery of critical therapeutics through our

paradigm-changing lipid nanocrystal (LNC) drug delivery platform and its application to overcome current challenges in safely

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

We are also focused

on creating value through finding a partner to continue the development of LYPDISO, our proprietary, next-generation prescription

omega-3 drug, which we believe is differentiated from all other prescription omega-3 products and positioned to potentially demonstrate

superior cardioprotective effects.

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 focused on redefining the intracellular delivery of nucleic acids and small molecules through our lipid nanocrystal (LNC) drug delivery

platform and its application to overcome current challenges in safely and effectively delivering small molecules, nucleic acids, gene

therapies, proteins/peptides, and vaccines.

elements of our strategy include:

our clinical stage assets based on our LNC platform delivery technology and continuing to expand utilization of this promising

technology into areas of innovative medicine.

efficacy data for MAT2203 in the EnACT study for the treatment of cryptococcal meningitis, which would highlight the safety

and efficacy of this promising drug, while highlighting the ability of our LNC platform technology to deliver potent medicines

across the blood-brain barrier following oral administration.

the development of MAT2501 through extensive preclinical toxicology and efficacy studies in NTM infections and completing

a single ascending dose pharmacokinetic study in healthy volunteers later in 2021, all with the financial support of the Cystic

Fibrosis Foundation.

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

and pharmaceutical companies in areas of innovative medicine.

our clinical stage assets based on our LNC platform delivery technology and continuing to expand utilization of this promising technology

into areas of innovative medicine beyond small molecules, including nucleic acids (e.g.

mRNA, DNA, antisense oligonucleotides (ASOs))

and proteins, both internally and through additional external collaborations and partnerships.

MAT2203 toward NDA filing through the ongoing EnACT study for the treatment of cryptococcal meningitis, which highlights the safety

and efficacy of this promising drug candidate, while also demonstrating the ability of our LNC platform technology to deliver potent

medicines across the blood-brain barrier with oral administration.

the development of MAT2501 through extensive preclinical toxicology and efficacy studies in NTM infections and completing a single

ascending dose (SAD) pharmacokinetic study in healthy volunteers later in 2022, all with the financial support of the CFF.

have incurred losses for each period from inception.

Our net loss was approximately $22.4 million and $17.4 million for the fiscal

years ended December 31, 2020 and 2019, respectively.

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

several years.

Our net loss was approximately $23.3 million and $22.4 million for the fiscal years

ended December 31, 2021 and 2020, 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.

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.

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

the years ended December 31, 2020 and 2019, we generated approximately$0.2 million and $0.1 million, respectively, in contract

research revenues, resulting from a grant with the Cystic Fibrosis Foundation in 2020 and a feasibility study agreement entered

into with Genentech in 2019.

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 candidates.

the years ended December 31, 2021 and 2020, we generated approximately $33 thousand and $158 thousand, respectively, in contract research

revenues, resulting from a grant with the CFF in 2020 and a feasibility study agreement entered into with Genentech in 2019.

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 candidates.

and Development Expenses

and development expenses consist of costs incurred for the development of product candidates LYPDISO, MAT2203, MAT2501 and advancement

of our LNC platform delivery technology, which include:

and development expenses consist of costs incurred for the development of product candidates MAT2203, and MAT2501and advancement of our

LNC platform delivery technology, which include:

cost of conducting pre-clinical work;

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and regulatory operations;

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

or clinical trials;

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

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, 2020 and 2019.

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.

Years Ended December 31,

(in thousands)

Direct research and development expenses:

Manufacturing process development

Preclinical trials

Clinical development

Internal staffing, overhead and other

Total research & development

expenses, including salaries and stock-based compensation expense for those employees involved

in the research and development process;

reimbursement of certain expenses related to the CFF award agreement.

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

ended December 31, 2021 and 2020.

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 work.

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 2021, we will be focused

on advancing our lead product candidates, MAT2203, to efficacy data in the treatment of CM, accelerating the preclinical development

of MAT2501 and also expanding application of our LNC platform delivery technology through collaborations with third parties.

have also initiated a process to identify a suitable partner to continue the development of LYPDISO following the announcement

of topline date from the ENHANCE-IT study in February 2021.

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.

Our research and development expenses reflect the reimbursement

of certain MAT2501 program expenses related to the CFF award agreement.

In addition, we will look to strategically expand the use of

our drug platform technology through additional development work.

During 2022, we will be focused on advancing our lead product candidate,

MAT2203, to efficacy data in the treatment of CM, accelerating the development of MAT2501 and also expanding application of our LNC platform

delivery technology through both internal efforts and collaborations with third parties.

We have also initiated a global process to identify

a suitable partner to continue the development of LYPDISO.

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.

We anticipate that our general and administrative expenses will

increase during 2021 due to the increased expenses related to employee compensation and insurance costs.

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

review, consulting and accounting/audit services.

We anticipate that our general and administrative expenses during 2022 will remain

relatively consistent with expenses incurred during 2021.

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 approximately $1.1 million and $1.0 million for the years ended December 31, 2020 and 2019, respectively.

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

Certificate Program was approximately $1.3 million and $1.1 million for the years ended December 31, 2021 and 2020, respectively.

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.

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.

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 LNC product candidates, MAT2203, through clinical development toward

an initial indication for the treatment of CM, accelerating preclinical development of MAT2501 with the assistance of the CFF,

and expanding application of our LNC platform delivery technology through collaborations with third parties.

Our R&D expenses

consist of manufacturing work and the cost of active pharmaceutical ingredients and excipients 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.

We believe 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 most 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.

current R&D efforts are focused on advancing our lead LNC product candidates, MAT2203, through clinical development toward an initial

indication for the treatment of CM, accelerating development of MAT2501 with the assistance of the CFF, and expanding application of

our LNC platform delivery technology through both internal efforts and collaborations with third parties.

Our R&D expenses consist

of manufacturing work and the cost of active pharmaceutical ingredients and excipients 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

We believe 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 most 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.

These expenditures are subject to numerous uncertainties relating to timing and cost to completion.

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.

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 candidates.

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

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following table summarizes our operating expenses for the years ended December 31, 2021 and 2020 (in thousands):

Years Ended December 31,

Research and development

General and administrative

Operating Expenses

Sale of net operating losses (NOLs)

We generated approximately $158.3 thousand and approximately $89.8 thousand for the years ended December 31, 2020 and

2019, respectively.

Amounts earned in 2020 consists of contract research revenue resulting from a grant with the Cystic Fibrosis

Foundation and the feasibility study agreement with Genentech Inc.

The amount earned in 2019 consists of contract research revenue

resulting from a grant with the Cystic Fibrosis Foundation.

and Development expenses.

R&D expense for the year ended December 31, 2020 was approximately $14.4 million, an increase

of approximately $3.2 million over the prior year.

R&D expenses increased mainly due to higher preclinical and clinical development

expenses of approximately $1.8 million, employee compensation of approximately $1.3 million and manufacturing development and

other expenses of approximately $0.1 million.

We expect R&D expenses to increase during 2021 as we move our clinical development

programs forward and continue to invest in our LNC platform delivery technology and our laboratory & manufacturing facility.

Ended December 31,

and development

and administrative

of net operating losses (NOLs)

We generated approximately $33 thousand and approximately $158 thousand for the years ended December 31, 2021 and 2020, respectively.

The amount earned in 2021 consists of contract research revenue resulting from the feasibility study agreement with Genentech, Inc.

earned in 2020 consists of contract research revenue resulting from a grant with the CFF and the feasibility study agreement with Genentech

Research and Development expenses.

R&D expense for the years ended December 31, 2021 and 2020 was approximately $14.6 million and $14.4 million, respectively.

increase of approximately $0.2 was due to a $1.2 million expense related to the Aquarius Merger Agreement, an increase

of $1.1 million in product development expenses, and an increase of approximately $0.9 million of compensation expense, primarily related

to headcount increases and the exercise of stock options, offset by a $3.0 million decrease in clinical trial expenses, primarily

related to the reimbursement of certain MAT2501 program expenses of approximately $2.2 million and approximately $0.8 million decrease

in other clinical trials expenses due to the completion of the MAT9001 clinical trials in 2020.

and Administrative expenses.

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million, an increase of approximately $0.2 million over prior year.

The increase in general and administrative expense was

primarily due to an increase in employee related expenses of approximately $1.7 million and professional fees of approximately

$0.4 million.

The increase in general and administrative expense was primarily

due to higher compensation expense related to the exercise of stock options and increased insurance expense offset by lower professional

fees & consulting expense.

of net operating losses (NOLs).

The Company recognized approximately $1.1 million and $1.0 million for the years ended

December 31, 2020 and 2019, respectively, in connection with the sale of state net operating losses and state research and development

credits to a third party under the New Jersey Technology Business Tax Certificate Program.

The Company recognized approximately $1.3 million and $1.1 million for the years ended December

31, 2021 and 2020, respectively, in connection with the sale of state net operating losses and state research and development credits

to a third party under the New Jersey Technology Business Tax Certificate Program.

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, 2020, we have raised a total of approximately $150.9 million in gross proceeds and $138.4

million, net, from sales of our equity securities.

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, 2021, we have raised a total of approximately $156.7 million in gross proceeds and $144.0 million,

net, from sales of our equity securities.

of December 31, 2021, we had cash, cash equivalents and marketable securities, excluding restricted cash, totaling $49.6 million.

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July 2, 2020, we entered into an At-The-Market Sales Agreement (the “Sales Agreement”) with BTIG, LLC (“BTIG”),

pursuant to which we may offer and sell, from time to time, through BTIG, as sales agent and/or principal, shares of our common

stock having an aggregate offering price of up to $50,000,000, subject to certain limitations on the amount of common stock that

may be offered and sold by us set forth in the Sales Agreement.

BTIG will be paid a 3% commission on the gross proceeds from each

We may terminate the Sales Agreement at any time;

pursuant to which we may offer and sell, from time to time, through BTIG, as sales agent and/or principal, shares of our common stock

having an aggregate offering price of up to $50,000,000, subject to certain limitations on the amount of common stock that may be offered

and sold by us set forth in the Sales Agreement.

BTIG will be paid a 3% commission on the gross proceeds from each sale.

We may terminate

the Sales Agreement at any time;

BTIG may terminate the Sales Agreement in certain limited circumstances.

As of December 31, 2020, we did not sell any shares of our common stock under the ATM Sales Agreement.

During January 2021, BTIG

sold 3,023,147 shares of the Company’s common stock generating gross proceeds of approximately $5.8 million and net proceeds

of approximately $5.6 million, after deducting BTIG’s commission on gross proceeds.

As of December 31, 2020, we

did not sell any shares of our common stock under the ATM Sales Agreement.

During January 2021, BTIG sold 3,023,147 shares of the Company’s

common stock generating gross proceeds of approximately $5.8 million and net proceeds of approximately $5.6 million, after deducting

BTIG’s commission on gross proceeds.

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

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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 4.1 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.

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.

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

Years Ended December 31

Cash used in operating activities

Cash used in investing activities

Cash provided by financing activities

Net (decrease)/increase in cash and cash equivalents and restricted cash

Ended December 31

used in operating activities

used in investing activities

provided by financing activities

(decrease)/increase in cash and cash equivalents and restricted cash

cash used in operating activities for the year ended December 31, 2021 was approximately $15.2 million, compared to approximately $17.4

million in the prior year.

The increase of approximately $3.3 million for the period was primarily due to an increase in

net loss, approximately $5.1 million, offset by the increase in non-cash stock-based compensation expense of approximately $1.6

We expect that there will be an increase in cash used in operations during 2021 due to higher research and development

expenses as we continue to move our product candidates and LNC platform delivery technology forward in their development cycles.

The decrease of approximately $2.2 million for the period was primarily due to a decrease of approximately

$2.0 million of working capital adjustments due to the timing of receipts and payments in the ordinary course of business and approximately

$0.9 million of net non-cash items offset by approximately $0.8 million of an increase in net loss in the current period.

that there will be an increase in cash used in operations during 2022 due to higher research and development expenses as we continue

to move our product candidates and LNC platform delivery technology forward in their development cycles.

Approximately

$40.7 million and approximately $6.0 million of cash was used in investing activities for the years ended December 31, 2020 and

2019, respectively.

The increase of $34.7 million was primarily due to the net increase in purchases and maturities of our marketable

securities of approximately $40.7 million during 2020 compared to the purchase of our marketable securities of approximately $5.6

million in December 2019 and the decrease of approximately $0.4 million in purchases of leasehold improvements and equipment.

$16.8 million of cash was provided by and approximately $40.7 million of cash was used in investing activities for the years ended December

31, 2021 and 2020, respectively.

The increase of $57.5 million was primarily due to the approximately $8.8 million increase in proceeds

received from maturities of our marketable securities and the decrease of approximately $48.9 million in purchases of marketable securities

as compared to the prior year partially offset by $0.2 million in purchases of equipment and leasehold improvements for the year ended

December 31, 2021.

cash provided by financing activities was approximately $7.0 million and approximately $48.0 million for the years ended December 31,

2021 and 2020, respectively.

The increase of $18.1 million in cash provided by financing activities is primarily due to the

approximately $46.7 million of net proceeds from the January 2020 public offering of common stock compared to the approximately

$30.1 million of net proceeds from the March 2019 public offering of common stock, as well as an increase of approximately $0.8

million from the exercising of certain warrants and approximately $0.6 million from the exercising of stock options during 2020.

The decrease of $41.0 million in cash provided by financing activities is primarily due to the Company raising

approximately $5.6 million of net proceeds from the January 2021 ATM sales of our common stock compared to the approximately $46.7

million of net proceeds that was raised from the January 2020 public offering of common stock.

Other financing activities included

a decrease of approximately $0.8 million from the exercising of warrants offset by an increase of approximately $0.8 million from the

exercising of stock options.

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 MAT2203, our lead product candidate, even is such studies are primarily financed

with non-dilutive funding from NIH;

the conduct of further preclinical studies of MAT2501, even if such studies are primarily financed with non-dilutive funding

from the CFF;

We anticipate that our expenses

will increase substantially if and as we:

further preclinical and clinical studies of MAT2203, our lead product candidate, even is such studies are primarily financed with

non-dilutive funding from NIH;

the conduct of further preclinical and clinical studies of MAT2501, even if such studies are primarily financed with non-dilutive

funding from the CFF;

to discover and develop additional product candidates;

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additional clinical, quality control and scientific personnel;

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

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

as a public company.

expect that our existing cash, cash equivalents and marketable securities, coupled with the approximately $5.6 million of net

proceeds generated from the recently completed sales of common stock, will be sufficient to fund our operating expenses and capital

expenditures requirements into 2024.

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 CFF

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

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.

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

expect that our existing cash, cash equivalents and marketable securities will be sufficient to fund our operating expenses and capital

expenditures requirements through 2023.

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 CFF and 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

2 unchanged sentences

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.

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

ACCOUNTING PRONOUNCEMENTS

1 unchanged sentence

for a discussion of recent accounting pronouncements.

And Qualitative Disclosures About Market Risk

Not applicable.

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 7. Management’s Discussion and Analysis