What changed in this filing

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Item 2. Management’s Discussion and Analysis

2024-05-09 compared with 2023-11-08 · 95 added, 125 removed, 184 unchanged (54% of the section changed)

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assumptions, estimates, intentions and future performance, and involve known and unknown risks, uncertainties and other factors, which

may be beyond our control, including risks and uncertainties related to the impact of COVID-19, and which may cause our actual results,

performance or achievements to be materially different from future results, performance or achievements expressed or implied by such

forward-looking statements.

All statements other than statements of historical fact are statements that could be forward-looking statements.

You can identify these forward-looking statements through our use of words such as “may,” “can,” “anticipate,”

“assume,” “should,” “indicate,” “would,” “believe,” “contemplate,”

“expect,” “seek,” “estimate,” “continue,” “plan,” “point to,”

“project,” “predict,” “could,” “intend,” “target,” “potential”

and other similar words and expressions of the future.

may be beyond our control, and which may cause our actual results, performance or achievements to be materially different from future

results, performance or achievements expressed or implied by such forward-looking statements.

All statements other than statements of

historical fact are statements that could be forward-looking statements.

You can identify these forward-looking statements through our

use of words such as “may,” “can,” “anticipate,” “assume,” “should,” “indicate,”

“would,” “believe,” “contemplate,” “expect,” “seek,” “estimate,”

“continue,” “plan,” “point to,” “project,” “predict,” “could,”

“intend,” “target,” “potential” and other similar words and expressions of the future.

are a number of important factors that could cause the actual results to differ materially from those expressed in any forward-looking

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dependence on product candidates which are still in an early development stage;

reliance on our proprietary lipid nanocrystal (LNC) platform delivery technology, which is licensed to us by Rutgers University;

reliance on our proprietary lipid nanocrystal (LNC) platform delivery technology, and certain related patents which are exclusively

licensed to us by Rutgers University;

ability to manufacture GMP batches of our product candidates which are required for preclinical and clinical trials and, subsequently,

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and projections relating to our competitors or our industry;

operations, business and financial results may be adversely impacted by COVID-19;

operations, business and financial results could be adversely impacted by global instability caused by armed conflicts, pandemics

and geo-political uncertainty;

factors listed under the heading “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2023,

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are a clinical-stage biopharmaceutical company focused on delivering groundbreaking therapies using our lipid nanocrystal (LNC) platform

delivery technology (LNC Platform) to maximize global clinical impact and patient access.

The Company is developing an internal portfolio

of products and strives to be the partner of choice for leading pharmaceutical companies seeking to develop novel formulations that capitalize

on the unique characteristics of the LNC Platform to facilitate, enhance and optimize the delivery of complex nucleic acids.

internal pipeline consists of MAT2203 (oral amphotericin B), a highly potent antifungal drug which we have successfully made oral, safe,

and well-tolerated for patients.

We also have internal discovery programs ongoing in the formulation and delivery of small oligonucleotides,

namely antisense oligonucleotides (ASOs) and silencing or short interfering RNAs (siRNAs).

We are also intent on expanding the application

of our LNC Platform through collaborations with well-respected pharmaceutical companies whose molecules and compounds benefit from the

unique capabilities of our delivery technology, which can provide oral bioavailability and facilitate non-toxic and efficient intracellular

delivery of nucleic acids, particularly in the fields of mRNA and DNA.

delivery technology (LNC Platform).

We are seeking to develop an internal pipeline of products utilizing the LNC Platform to successfully

encapsulate small molecules and small oligonucleotides and facilitate targeted and extrahepatic delivery to desired cell tissues without

elements of our strategy include:

our LNC Platform and expanding the utilization of this promising technology into areas of innovative medicine beyond small molecules,

including nucleic acids (e.g., mRNA, DNA, ASOs) and proteins.

MAT2203 for an NDA filing for various indications for the treatment of serious IFIs, including cryptococcal meningitis.

We are seeking

non-dilutive funds from prospective third-party pharmaceutical partners and various governmental sources of capital, such as the

Biomedical Advanced Research and Development Authority (BARDA) and the NIH to continue the development of MAT2203 into Phase 3.

are also seeking the input and guidance of the FDA for an additional Phase 3 study of various IFIs.

an external pipeline of collaborations focused on our LNC Platform with leading pharmaceutical companies like Genentech and National

Resilience to provide delivery solutions for their complex nucleic acid drug products.

the nine month periods ended September 30, 2023 and 2022, our net loss was $17,628 and $17,363, respectively.

We have incurred losses

for each period from our inception and expect to incur additional losses for the foreseeable future.

We believe the cash, cash equivalents

and marketable debt securities on hand are sufficient to fund planned operations into the third quarter of 2024, but not beyond.

seek to fund our operations through public or private equity offerings, debt financing, government or other third-party funding, collaborations

and licensing arrangements.

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

As a result, substantial

doubt exists about our ability to continue as a going concern.

MAT2203 into the ORALTO trial for the treatment of invasive aspergillosis in patients with limited treatment options by securing

a development and/or commercial partner.

This initial indication is designed to be a gateway indication to establish the pharmacodynamic

bridge necessary to expand the use of MAT2203 into other indications to treat deadly invasive fungal infections (e.g., mucormycosis,

candidiasis and the endemic mycoses) through limited additional clinical work under a 505(b)(2) pathway, thereby making MAT2203 a

pipeline in a product.

the utilization of our LNC Platform with other small molecules and small oligonucleotides into inflammation and oncology in order

to develop an internal pipeline of differentiated drug candidates.

Oral, extrahepatic and non-toxic intracellular delivery of these

molecules would represent a significant advancement.

an external pipeline of collaborations focused on our LNC Platform with leading pharmaceutical companies to provide delivery solutions

for their complex small molecules and small oligonucleotides, including ASOs and siRNAs.

the three month periods ended March 31, 2024 and 2023, our net loss was $5,824 and $5,513, respectively.

We have incurred losses for

each period from our inception and expect to incur additional losses for the foreseeable future.

We do not believe the cash, cash equivalents

and marketable debt securities on hand are sufficient to fund planned operations beyond the next twelve months from the filing date of

these financial statements.

We seek to fund our operations through public or private equity offerings, debt financing, government or

other third-party funding, collaborations and licensing arrangements.

These financing alternatives may not be available to us on acceptable

terms, or at all.

As a result, substantial doubt exists about our ability to continue as a going concern.

Operations Overview

the three and nine months ended September 30, 2023, we generated $0 and $1,096, respectively, in contract research revenue resulting

from the research collaborations with BioNTech SE and Genentech Inc., and $1,063 and $2,125 during the three and nine months ended September

30, 2022, respectively, from the research collaboration with BioNTech SE.

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 three months ended March 31, 2024 and 2023, we generated $0 and $1,096, respectively, in contract research revenue resulting from

the research collaborations with BioNTech SE and Genentech Inc.

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

and Development Expenses

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

and nine months ended September 30, 2023 and 2022.

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-based compensation), travel and medical

Three months ended September 30,

Nine months ended September 30,

months ended March 31, 2024 and 2023.

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.

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-based compensation), travel and medical education.

Three Months Ended March 31,

Direct research and development expenses:

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However, we anticipate that our research and

development expenses during 2023 will be lower than expenses incurred in 2022 as we pause the development of MAT2501 to focus our existing

resources on MAT2203 and advancement of our LNC platform delivery technology.

development expenses during 2024 will be lower compared with expenses incurred during 2023 until such time as we are able to secure additional

funding to support initiation of our ORALTO trial for MAT2203 and advancement of our LNC platform delivery technology.

and Administrative Expenses

and administrative expense for the three and nine months ended September 30, 2023 were $2,839 and $8,151, respectively, and for the three

and nine months ended September 30, 2022 were $2,818 and $8,424, respectively.

General 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 during 2023 will remain relatively consistent with expenses incurred during

of Net Operating Losses (NOLs) & Tax Credits

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

Tax Certificate Transfer Program was $0 and $1,734 for the nine month periods ended September 30, 2023 and 2022, respectively.

and administrative expense for the three months ended March 31, 2024 and 2023 were $2,456 and $2,712, respectively.

General 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

We anticipate that our general and administrative expenses during 2024 will decrease slightly compared to expenses incurred

income, net is largely comprised of interest income/(expense) and dividends.

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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, and (iv) Goodwill and other intangible assets.

(i) Research and development

costs, and (ii) Goodwill and other intangible assets.

Accounting Pronouncements

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of Operations

of the three months ended September 30, 2023 to the three months ended September 30, 2022

of the three months ended March 31, 2024 to the three months ended March 31, 2023

following tables summarize our revenues and operating expenses for the periods presented:

Three Months Ended September 30,

Three Months Ended March 31,

Research and development

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Operating Expenses

During the three months ended September 30, 2023 and 2022, we generated revenue of $0 and $1,063.

The amount earned during the

prior year resulted from the exclusive research collaborations with BioNTech SE.

During the three months ended March 31, 2024 and 2023, we generated revenue of $0 and $1,096.

The amount earned during the prior

year resulted from the exclusive research collaborations with BioNTech SE and Genentech Inc.

and Development expenses.

Research and Development (R&D) expense for the three months ended September 30, 2023 and 2022 was

Research and Development (R&D) expense for the three months ended March 31, 2024 and 2023 was $3,446

and $3,970, respectively.

The decrease in R&D expense was primarily attributable to the decrease in manufacturing costs of

clinical trial materials, in clinical trial consulting costs and in headcount costs.

and Administrative expenses.

General and administrative expense for the three months ended September 30, 2023 and 2022 was relatively

consistent at $2,839 and $2,818, respectively, as higher legal fees were offset by lower stock based compensation, insurance premiums

and consulting costs.

of the nine months ended September 30, 2023 to the nine months ended September 30, 2022

following tables summarize our revenues and operating expenses for the periods presented:

Nine Months Ended September 30,

Research and development

General and administrative

Operating Expenses

Sale of New Jersey net operating losses (NOLs) and tax credits

During the nine month periods ended September 30, 2023 and 2022, we generated revenue of $1,096 and $2,125.

The amount earned

during the current year consists of contract research revenue resulting from the research collaboration with BioNTech SE and Genentech

Inc., while the amount earned during the prior year resulted from the research collaboration with BioNTech SE.

and Development expenses.

Research and Development (R&D) expense for the nine month periods ended September 30, 2023 and

2022 was $10,824 and $12,811, respectively.

The decrease in R&D expense was primarily attributable to decreases in manufacturing

costs of clinical trial materials and in clinical trial consulting costs, partially offset by an increase in headcount costs.

The decrease in R&D expense was primarily attributable to the decrease in clinical trial consulting costs

and in headcount costs.

and Administrative expenses.

General and administrative expense for the nine month periods ended September 30, 2023 and 2022

General and Administrative (G&A) expense for the three months ended March 31, 2024 and 2023

was $2,456 and $2,712, respectively.

The decrease in general and administrative expense between periods was primarily due to decreases

in consulting fees, insurance premiums and stock based compensation expense, partially offset by increases in legal fees and headcount

of New Jersey net operating losses (NOLs) & tax credits.

The Company recognized $0 and $1,734 for the nine month periods

ended September 30, 2023 and 2022, respectively, in connection with the sale of state net operating losses and research and development

tax credits to third parties under the New Jersey Technology Business Tax Certificate Transfer Program.

The decrease in G&A expense was primarily attributable to lower stock based compensation expense

and decreased insurance premiums.

and capital resources

have funded our operations since inception through private placements and public offerings of our equity securities.

As of September

30, 2023, we have raised a total of $156.7 million in gross proceeds and $143.9 million, net, from sales of our equity securities.

of September 30, 2023, we had cash, cash equivalents and marketable debt securities totaling $18,216.

have funded our operations since inception primarily through private placements and public offerings of our equity securities.

March 31, 2024, we have raised a total of $156,907 in gross proceeds and $144,195, net, from sales of our equity securities.

of March 31, 2024, we had cash, cash equivalents and marketable debt securities totaling $8,110.

Registered Direct Offering

April 5, 2024, the Company closed a registered direct offering of 33,333,334 shares of its common stock and warrants to purchase up to

an aggregate of 33,333,334 additional shares of common stock, at a combined purchase price of $0.30 per share and accompanying warrant.

The Company generated gross proceeds of approximately $10,000 and net proceeds of approximately $9,250, after deducting underwriting

discounts and commissions and other offering expenses.

following table sets forth the primary sources and uses of cash, cash equivalents and restricted cash for each of the periods set forth

Nine Months Ended September 30,

Three Months Ended March 31,

Cash used in operating activities

Cash provided by investing activities

Cash (used in)/provided by financing activities

Cash provided by/(used in) financing activities

Net decrease in cash and cash equivalents and restricted cash

cash used in operating activities was $10,699 and $14,857 for the nine month periods ended September 30, 2023 and 2022, respectively.

Net losses of $17,628 and $17,363 for the nine month periods ended September 30, 2023 and 2022, respectively, were partially offset by

working capital adjustments due to the timing of receipts and payments in the ordinary course of business.

cash provided by investing activities was $10,282 and 4,919 for the nine month periods ended September 30, 2023 and 2022, respectively.

The increase of cash provided by investing activities of $5,363 was primarily due to the $9,481 decrease in purchases of marketable debt

securities, the $632 decrease in purchases of leasehold improvements and equipment, offset by the $4,750 decrease in maturities of marketable

debt securities.

cash (used in)/provided by financing activities was ($6) and $84 for the nine month periods ended September 30, 2023 and 2022, respectively.

The decrease of $90 is primarily due to the decrease in the receipt of proceeds of $99 from the exercise of stock options.

cash used in operating activities was $5,769 and $4,087 for the three month periods ended March 31, 2024 and 2023, respectively.

losses of $5,824 and $5,513 for the three month periods ended March 31, 2024 and 2023, respectively, were partially offset by working

capital adjustments due to the timing of receipts and payments in the ordinary course of business and adjustments for non-cash stock

based compensation expense.

cash provided by investing activities was $2,000 and $3,000 for the three month periods ended March 31, 2024 and 2023, respectively.

The decrease of cash provided by investing activities was due to a $1,000 decrease in maturities of marketable debt securities.

cash provided by/(used in) financing activities was $53 and ($4) for the three month periods ended March 31, 2024 and 2023, respectively.

The increase in cash provided by financing activities is primarily due to the proceeds from the sale of our common stock under the ATM

with BTIG, LLC.

Requirements and Other Liquidity Matters

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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 debt securities will be sufficient to fund our operating expenses and

capital expenditures requirements into the third quarter of 2024, but not beyond.

As a result, substantial doubt exists about the Company’s

ability to continue as a going concern.

do not expect that our existing cash, cash equivalents and marketable debt securities will be sufficient to fund our operating expenses

and capital expenditure requirements beyond the next twelve months from the filing date of these financial statements.

As a result, substantial

doubt exists about the Company’s ability to continue as a going concern.

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

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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-Q

Item 2. Management’s Discussion and Analysis