What changed in this filing

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Item 2. Management’s Discussion and Analysis

2023-08-09 compared with 2023-05-10 · 82 added, 59 removed, 227 unchanged (38% of the section changed)

84 unchanged sentences

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.

have incurred losses for each period from our inception.

For the three months ended March 31, 2023 and 2022, our net loss was $5,513

and $5,978, 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 financing, 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.

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 six month periods ended June 30, 2023 and 2022, our net loss was $11,573 and $11,901, 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.

Operations Overview

the three months ended March 31, 2023, we generated $1,096 in contract research revenue resulting from the research collaborations with

BioNTech SE and Genentech Inc.

and $0 during the three months ended March 3, 2022.

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 and six months ended June 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 during the three and six months ended June 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.

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

months ended March 31, 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.

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,

and six months ended June 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.

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 June 30,

Six months ended June 30,

Direct research and development expenses:

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However, we anticipate that our research and

development expenses during 2023 will be relatively consistent with 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 into the field of nucleic acids.

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 into the field of nucleic acids.

and Administrative Expenses

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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 three months ended March 31, 2023 and 2022, respectively.

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

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

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of Operations

of the three months ended March 31, 2023 to the three months ended March 31, 2022

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

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

Three Months Ended March 31,

Three Months Ended June 30,

Research and development

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Operating Expenses

During the three months ended March 31, 2023 we generated $1,096 from the exclusive research collaborations with BioNTech SE

and Genentech Inc.

and generated no revenue during the same period in 2022.

During the three months ended June 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.

and Development expenses.

Research and Development (R&D) expense for the three months ended March 31, 2023 and 2022 was $3,970

Research and Development (R&D) expense for the three months ended June 30, 2023 and 2022 was $3,559

and $4,127, respectively.

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

trial materials, partially offset by compensation expense due to increased head count in 2023.

trial materials and a decrease in clinical trial consulting costs, partially offset by higher compensation expense due to increased head

count from 2022.

and Administrative expenses.

General and administrative expense for the three months ended March 31, 2023 and 2022 was $2,712

General and administrative expense for the three months ended June 30, 2023 and 2022 was $2,600

and $2,861, respectively.

The general and administrative expense remained relatively consistent between periods.

The decrease in general and administrative expense was primarily due to a decrease in consulting fees between

of the six months ended June 30, 2023 to the six months ended June 30, 2022

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

Six Months Ended June 30,

Research and development

General and administrative

Operating Expenses

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

During the six month periods ended June 30, 2023 and 2022, we generated revenue of $1,096 and $1,063.

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 six month periods ended June 30, 2023 and 2022 was

$7,530 and $9,105, respectively.

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

trial materials and a decrease in clinical trial consulting costs.

and Administrative expenses.

General and administrative expense for the six month periods ended June 30, 2023 and 2022 was $5,443

and $5,605, respectively.

The decrease in general and administrative expense was primarily due to a decrease in consulting fees between

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

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

June 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.

and capital resources

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

As of March 31,

As of June 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 March 31, 2023, we had cash, cash equivalents and marketable debt securities totaling $24,857.

of June 30, 2023, we had cash, cash equivalents and marketable debt securities totaling $22,513.

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

Three Months Ended March 31,

Six Months Ended June 30,

Cash used in operating activities

Cash provided by investing activities

Cash provided by/(used in) investing activities

Cash (used in)/provided by financing activities

Net decrease in cash and cash equivalents and restricted cash

cash used in operating activities was $4,087 and $4,756 for the three months ended March 31, 2023 and 2022, respectively.

of $5,513 and $5,978 for the three months ended March 31, 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.

We expect that there will be an increase in cash used

in operations during the remainder of 2023 and into 2023 due to higher research and development expenses as we continue to move our product

candidates and delivery platform forward in their development cycles.

cash used in investing activities was $3,000 and $2,961 for the three months ended March 31, 2023 and 2022, respectively.

of cash provided by investing activities of $39 was primarily due to the $2,494 decrease in purchases of marketable debt securities and

the $545 decrease in purchases of leasehold improvements and equipment offset the decrease in the proceeds received from maturities of

our marketable debt securities of $3,000.

cash (used in)/provided by financing activities was ($4) and $93 for the three months ended March 31, 2023 and 2022, respectively.

decrease of $97 is primarily due to the decrease in the receipt of proceeds of $99 from the exercise of stock options.

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

cash used in operating activities was $6,280 and $9,887 for the six month periods ended June 30, 2023 and 2022, respectively.

of $11,573 and $11,901 for the six month periods ended June 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.

We expect that there will be a decrease in

cash used in operations during the remainder of 2023 due to lower research and development expenses.

cash provided by/(used in) investing activities was $9,198 and ($831) for the six month periods ended June 30, 2023 and 2022, respectively.

The increase of cash provided by investing activities of $10,029 was primarily due to the $9,481 decrease in purchases of marketable

debt securities, the $398 decrease in purchases of leasehold improvements and equipment, and the $150 increase in maturities of marketable

debt securities.

cash (used in)/provided by financing activities was ($5) and $87 for the six month periods ended June 30, 2023 and 2022, respectively.

The decrease of $92 is primarily due to the decrease in the receipt of proceeds of $99 from the exercise of stock options.

Requirements and Other Liquidity Matters

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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 second half of 2024.

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.

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