What changed in this filing

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Item 1. Financial Statements

2023-08-09 compared with 2023-05-10 · 146 added, 117 removed, 331 unchanged (44% of the section changed)

3 unchanged sentences

thousands, except for share data)

March 31, 2023

June 30, 2023

December 31, 2022

26 unchanged sentences

Stockholders’ equity:

Common stock par value $ 0.0001 per share, 500,000,000 shares authorized at March 31, 2023 and December 31, 2022;

217,264,526 issued and outstanding as of March 31, 2023 and December 31, 2022

Common stock par value $ 0.0001 per share, 500,000,000 shares authorized at June 30, 2023 and December 31, 2022;

217,264,526 issued and outstanding as of June 30, 2023 and December 31, 2022

Additional paid-in capital

7 unchanged sentences

thousands, except share and per share data)

Months Ended March 31,

Three Months Ended

Six Months Ended

Contract Revenue

4 unchanged sentences

Loss from operations

Sale of New Jersey net operating loss & tax credits

Sale of New Jersey net operating losses & tax credits

Other income, net

Net loss per share – basic and diluted

Net loss per share -

Weighted average common shares outstanding:

Basic and diluted

Weighted average common

shares outstanding - basic

Other comprehensive gain/(loss), net of tax

6 unchanged sentences

thousands, except for share data)

(Loss)/Income

Accumulated Other

1 unchanged sentence

Stockholders’

(Loss)/Income

Balance, December 31, 2022

2 unchanged sentences

Other comprehensive income

Balance, June 30, 2023

$ ( 164,204 )

Accumulated Other

Comprehensive

Stockholders’

(Loss)/Income

Balance, March 31, 2023

$ ( 158,144 )

Stock-based compensation

Other comprehensive income

Balance, June 30, 2023

$ ( 164,204 )

4 unchanged sentences

$ ( 131,634 )

Stock-based compensation

2 unchanged sentences

Other comprehensive loss

Balance, June 30, 2022

$ ( 143,535 )

Accumulated Other

Comprehensive

Stockholders’

Balance, March 31, 2022

1 unchanged sentence

$ ( 137,612 )

Stock-based compensation

Other comprehensive loss

Balance, June 30, 2022

$ ( 143,535 )

accompanying notes are an integral part of these condensed consolidated financial statements

1 unchanged sentence

Consolidated Statements of Cash Flow

Three Months Ended March 31,

Six Months Ended June 30,

Cash flows from operating activities:

16 unchanged sentences

Purchases of leasehold improvements and equipment

Net cash provided by investing activities

Net cash provided by/(used in) investing activities

Cash flows from financing activities:

1 unchanged sentence

Payments of finance lease liability – principal

Net cash provided by financing activities

Net decrease in cash, cash equivalents and restricted cash

Net cash (used in)/provided by financing activities

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

Cash, cash equivalents and restricted cash at beginning of period

17 unchanged sentences

and developing novel pharmaceutical products.

2 – Liquidity and Plan of Operations

2 – Liquidity, Plan of Operations and Going Concern

Company has experienced net losses and negative cash flows from operations each period since its inception.

Through March 31, 2023, the

Through June 30, 2023, the

Company had an accumulated deficit of $ 164,204 .

The Company’s net loss was $ 5,513 for the three months ended March 31, 2023.

The Company’s net loss was $ 11,573 for the six months ended June 30, 2023.

Company has been engaged in developing its lipid nanocrystal (“LNC”) platform delivery technology and a pipeline of associated

14 unchanged sentences

future, and that these losses will be increasing.

of March 31, 2023, the Company had cash and cash equivalents of $ 5,739 , marketable debt securities of $ 19,118 and restricted cash of

The Company believes the cash and cash equivalents and marketable debt securities on hand are sufficient to fund planned operations

into the second half of 2024.

of June 30, 2023, the Company had cash and cash equivalents of $ 9,743 , marketable debt securities of $ 12,770 and restricted cash of $ 250 .

The Company believes the cash and cash equivalents and marketable debt securities on hand are sufficient to fund planned operations 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

ability of the Company to continue as a going concern is dependent upon control over its operating expenses, anticipated proceeds from

future sales of common stock through the At-The-Market Sales Agreement (“ATM”) with BTIG, LLC.

and securing additional financing.

While the Company believes in the viability of this strategy and believes the actions presently being taken by the Company provide the

opportunity for it to continue as a going concern, there can be no assurance the Company will be successful in its implementation.

particular, utilization of the ATM may not be viable due to market conditions and new financing may not be available on acceptable terms,

These consolidated financial statements do not include any adjustments related to the recoverability and classification of

asset amounts or the amounts and classification of liabilities that might be necessary if the Company is unable to continue as a going

3 – Summary of Significant Accounting Policies

20 unchanged sentences

Restricted cash

at both March 31, 2023 and December 31, 2022 of $ 250 represents funds the Company is required to set aside as collateral, primarily for

at both June 30, 2023 and December 31, 2022 of $ 250 represents funds the Company is required to set aside as collateral, primarily for

one of the Company’s operating leases and other purposes.

following table provides a reconciliation of cash, cash equivalents and restricted cash reported in the Condensed Consolidated Balance

Sheets to the total of the amounts in the Condensed Consolidated Statements of Cash Flows as of March 31, 2023, December 31, 2022, March

Sheets to the total of the amounts in the Condensed Consolidated Statements of Cash Flows as of June 30, 2023, December 31, 2022, June

30, 2022 and December 31, 2021:

of Cash, Cash Equivalents and Restricted Cash

Schedule of Cash, Cash Equivalents and Restricted Cash

Cash and cash equivalents

9 unchanged sentences

Realized gains and losses from our marketable debt securities are recorded in other income, net.

For the three months ended March 31, 2023, the Company recorded unrealized gains of $ 229 .

For the three months ended March 31, 2022,

the Company recorded unrealized losses of $ 484 .

As of March 31, 2023 and December 31, 2022, the Company had net accumulated unrealized

losses of $ 595 and $ 824 , respectively.

following tables summarize the Company’s marketable debt securities as of March 31, 2023:

of Marketable Securities

Amortized Cost

Unrealized Gain

Unrealized (Loss)

For the three and six months ended June 30, 2023, the Company recorded unrealized gains of $ 81 and $ 310 , respectively.

For the three

and six months ended June 30, 2022, the Company recorded unrealized losses of $ 125 and $ 609 , respectively.

As of June 30, 2023 and December

31, 2022, the Company had net accumulated unrealized losses of $ 514 and $ 824 , respectively.

following tables summarize the Company’s marketable debt securities as of June 30, 2023:

Schedule of Marketable Securities

Treasury Bonds

Government Notes

Corporate Debt Securities

Total marketable debt securities

of debt securities classified as available-for-sale were as follows at March 31, 2023:

of Maturities of Debt Securities Available-for-sale

of debt securities classified as available-for-sale were as follows at June 30, 2023:

Schedule of Maturities of Debt Securities Available-for-sale

Due within one year

1 unchanged sentence

following tables summarize the Company’s marketable debt securities as of December 31, 2022:

Amortized Cost

Unrealized Gain

Unrealized (Loss)

Treasury Bonds

Government Notes

Corporate Debt Securities

Total marketable debt securities

Debt Securities

marketable debt securities

of debt securities classified as available-for-sale were as follows at December 31, 2022:

Due within one year

Due after one year through five years

within one year

after one year through five years

5 - Fair Value Measurements

11 unchanged sentences

whose inputs are directly or indirectly observable or whose significant value drivers are observable.

3 – Valuations derived from valuation techniques in which one or more significant inputs to the valuation model are

unobservable and for which assumptions are used based on management estimates.

3 – Valuations derived from valuation techniques in which one or more significant inputs to the valuation model are unobservable

and for which assumptions are used based on management estimates.

Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent

3 unchanged sentences

summary of the assets and liabilities carried at fair value in accordance with the hierarchy defined above is as follows:

of Fair Value Measurement of Assets and Liabilities

Schedule of Fair Value Measurement of Assets and Liabilities

Fair Value Hierarchy

March 31, 2023

June 30, 2023

Marketable Debt Securities:

1 unchanged sentence

Government Notes

Corporate Debt Securities

Fair Value Hierarchy

11 unchanged sentences

6 – Leasehold Improvements and Equipment

improvements and equipment, summarized by major category, consist of the following as of March 31, 2023 and December 31, 2022:

of Leasehold Improvements and Equipment

March 31, 2023

improvements and equipment, summarized by major category, consist of the following as of June 30, 2023 and December 31, 2022:

Schedule of Leasehold Improvements and Equipment

June 30, 2023

December 31, 2022

3 unchanged sentences

Leasehold improvements and equipment, net

and amortization expense for the three months ended March 31, 2023 and 2022 was $ 93 and $ 69 , respectively.

and amortization expense for the three and six months ended June 30, 2023 was $ 97 and $ 190 , respectively, and the three and six months

ended June 30, 2022 was $ 86 and $ 155 , respectively.

During the six month periods ended June 30, 2023 and 2022, the Company purchased

equipment of $ 202 and $ 600 , respectively.

7 – Accrued Expenses and Other Liabilities

Expenses, summarized by major category, as of March 31, 2023 and December 31, 2022 consist of the following:

of Accrued Expenses

March 31, 2023

Expenses, summarized by major category, as of June 30, 2023 and December 31, 2022 consist of the following:

Schedule of Accrued Expenses

June 30, 2023

December 31, 2022

5 unchanged sentences

December 31, 2022, the balance included $ 688 related to an exclusive research collaboration with BioNTech SE (the “BioNTech

Agreement”) and $ 33 was related to a feasibility study agreement with Genentech, Inc.

Agreement”) and $ 33 related to a feasibility study agreement with Genentech, Inc.

(the “Genentech Agreement”).

(See Note 9 – Revenue Recognition, Collaboration Agreements and Other).

December 31, 2022, the balances of $ 88 was related to an award agreement with the Cystic Fibrosis Foundation (the “CFF Agreement).

December 31, 2022, the balances of $ 88 related to an award agreement with the Cystic Fibrosis Foundation (the “CFF Agreement).

(See Note 9 – Revenue Recognition, Collaboration Agreements and Other).

11 unchanged sentences

lease obligations

Company incurred lease expense for its operating leases of $ 226 for each of the three months ended March 31, 2023 and 2022.

incurred amortization expense on its operating lease right-of-use assets of $ 132 and $ 136 for the three months ended March 31, 2023 and

2022, respectively.

Company incurred interest expense on its finance leases of $ 1 for each of the three months ended March 31, 2023 and 2022.

incurred amortization expense on its finance lease right-of-use assets of $ 4 and $ 6 for the three months ended March 31, 2023 and 2022,

respectively.

Company incurred lease expense for its operating leases of $ 226 for each for the three month periods ended June 30, 2023 and 2022, respectively,

and $ 452 for each of the six month periods ended June 30, 2023 and 2022, respectively.

The Company incurred amortization expense on its

operating lease right-of-use assets of $ 135 and $ 268 for the three and six months ended June 30, 2023, respectively, and $ 139 and $ 275

for the three and six months ended June 30, 2022, respectively.

Company incurred interest expense on its finance leases of $ 1 and $ 2 for the three and six months ended June 30, 2023, respectively,

and $ 0 and $ 1 for the three and six months ended June 30, 2022, respectively.

The Company incurred amortization expense on its finance

lease right-of-use assets of $ 1 and $ 5 for the three and six months ended June 30, 2023, respectively, and $ 6 and $ 12 for the three and

six months ended June 30, 2022, respectively.

following table presents information about the amount and timing of liabilities arising from the Company’s operating leases and

finance leases as of March 31, 2023:

of Maturity of Operating and Finance Liabilities

finance leases as of June 30, 2023:

Schedule of Maturity of Operating and Finance Liabilities

Maturity of Lease Liabilities

19 unchanged sentences

Research Collaboration

April 8, 2022, the Company entered into the BioNTech Agreement to evaluate the combination of mRNA formats utilizing the

Company’s proprietary LNC platform delivery technology.

Under the terms of the BioNTech Agreement, the Company received an

exclusivity fee in the amount of $ 2,750 ,

and BioNTech SE funded certain of the Company’s research expenses that were incurred under the agreement.

The term of the

agreement began on the effective date and ends on the later of 12-months after the effective date or the conclusion of the Research Program, unless terminated earlier pursuant to the terms of the agreement.

April 8, 2022, the Company entered into the BioNTech Agreement to evaluate the combination of mRNA formats utilizing the Company’s

proprietary LNC platform delivery technology.

Under the terms of the BioNTech Agreement, the Company received an exclusivity fee in the

amount of $ 2,750 , and BioNTech SE funded certain of the Company’s research expenses that were incurred under the agreement.

term of the agreement began on the effective date and expired on April 8, 2023.

$ 2,750 license fee was recorded as deferred revenue and was recognized over the term of the contract performance obligation period, which

2 unchanged sentences

was earned on a monthly basis during the term of the contract.

the three months ended March 31, 2023, $ 688 of the contract research revenue was recognized from the license fee and $ 375 was earned

from the monthly clinical research services performed by the Company.

As of March 31, 2023, the Company recognized all of contract research

revenue from the BioNTech Agreement.

the first quarter of 2023, $ 688

of the contract research revenue was recognized from the license fee and $ 375

was earned from the monthly clinical research services performed by the Company.

As of March 31, 2023, the Company had recognized

all of contract research revenue from the BioNTech Agreement.

Fibrosis Foundation Therapeutics Development Award

4 unchanged sentences

of $ 321 , which was received in the fourth quarter of 2021.

of March 31, 2023, the Company has received approximately $ 3.6 million of the $ 4.5 million Award, including the Amendment’s additional

milestone payment, and a related deferred liability balance of $ 0 and $ 88 is included in accrued expenses at March 31, 2023 and December

of June 30, 2023, the Company has received approximately $ 3.6 million of the $ 4.5 million Award, including the Amendment’s additional

milestone payment, and a related deferred liability balance of $ 0 and $ 88 is included in accrued expenses at June 30, 2023 and December

31, 2022, respectively.

12 unchanged sentences

three molecules.

During the three months ended March 31, 2023, the Company completed its obligations related to the remaining molecule.

During the six months ended June 30, 2023, the Company completed its obligations related to the remaining molecule.

10 – Income Taxes

of net operating losses (NOLs) & tax credits

Company recognized $ 0 and $ 1,734 for the three months ended March 30, 2023 and 2022, respectively, in connection with the sale of certain

state net operating losses (“NOLs”) and research and development tax credits to a third party under the New Jersey Technology

Business Tax Certificate Transfer Program.

Company recognized $ 0 and $ 1,734 for the six month periods ended June 30, 2023 and 2022, respectively, in connection with the sale of

certain state net operating losses (“NOLs”) and research and development tax credits to a third party under the New Jersey

Technology Business Tax Certificate Transfer Program.

11 – Stockholders’ Equity

9 unchanged sentences

closing price of the Company’s common stock of $ 0.728 on the date of issuance.

the three months ended March 31, 2023, the Company did not sell any shares of its common stock under its At-The-Market Sales Agreement

with BTIG, LLC.

warrants issued by the Company are exercisable immediately upon issuance and have a five-year term.

The warrants may be exercised at

any time in whole or in part upon payment of the applicable exercise price until expiration.

No fractional shares will be issued upon

the exercise of the warrants.

The exercise price and the number of shares purchasable upon the exercise of the warrants are subject to

adjustment upon the occurrence of certain events, which include stock dividends, stock splits, combinations and reclassifications of

the Company’s capital stock or other similar changes to the equity structure of the Company.

The warrants do not have a redemption

They may be exercised on a cashless basis at the holder’s option.

The warrants are classified as equity instruments.

of March 31, 2023, the Company had outstanding warrants to purchase an aggregate of 238,000 shares of common stock at the exercise price

of $ 0.75 per share, all of which are fully vested and with an expiration date of June 21, 2023 .

The following table summarizes the changes

in warrants outstanding during 2022 and for the three months ended March 31, 2023:

of Shareholder Equity Warrants Outstanding

the six months ended June 30, 2023, the Company did not sell any shares of its common stock under its At-The-Market Sales Agreement with

of June 30, 2023, the Company did not have any outstanding warrants to purchase shares of the Company’s common stock.

The following

table summarizes the changes in warrants outstanding during 2022 and for the six months ended June 30, 2023:

Summary of Shareholder Equity Warrants Outstanding

Outstanding at December 31, 2021

Outstanding at December 31, 2022

Outstanding at March 31, 2023

Outstanding at June 30, 2023

and diluted net loss per common share

the three months ended March 31, 2023 and 2022, diluted loss per common share is the same as basic loss per common share because, as

the Company incurred a net loss during each period presented, the potentially dilutive securities from the assumed exercise of all outstanding

stock options and warrants, would have an anti-dilutive effect.

The following outstanding shares of potentially dilutive securities were

excluded from the computation of diluted net loss per share because including them would have been anti-dilutive as of March 31, 2023

of Anti-dilutive Securities Excluded from Computation of Earning Per Share

As of March 31,

the three and six months ended June 30, 2023 and 2022, diluted loss per common share is the same as basic loss per common share because,

as the Company incurred a net loss during each period presented, the potentially dilutive securities from the assumed exercise of all

outstanding stock options and warrants, would have an anti-dilutive effect.

The following outstanding shares of potentially dilutive

securities were excluded from the computation of diluted net loss per share because including them would have been anti-dilutive as of

June 30, 2023 and 2022:

Schedule of Anti-dilutive Securities Excluded from Computation of Earning Per Share

As of June 30,

Stock options

12 – Accumulated Other Comprehensive Loss

following table summarizes the changes in accumulated other comprehensive loss by component during the three months ended March 31, 2023

of Components of Accumulated Other Comprehensive (Loss) Income

Net Unrealized Gain/(Losses) on Available-for-Sale Securities

Accumulated Other Comprehensive

following table summarizes the changes in accumulated other comprehensive loss by component during the three months ended June 30, 2023

Schedule of Components of Accumulated Other Comprehensive (Loss) Income

Net Unrealized

Gain/(Loss) on

Available-for-Sale

Comprehensive

Balance, December 31, 2022

Net unrealized gain on securities available-for-sale

Balance, March 31, 2023

Balance, June 30, 2023

Balance, December 31, 2021

Net unrealized loss on securities available-for-sale

Balance, March 31, 2022

Balance, June 30, 2022

components of accumulated other comprehensive income are net of tax.

3 unchanged sentences

There were no significant

modifications to the Plan during the three months ended March 31, 2023 and 2022.

following table contains information about the Company’s stock plan at March 31, 2023:

of Equtiy Compensation Plan by Arrangements

modifications to the Plan during the six month periods ended June 30, 2023 and 2022.

following table contains information about the Company’s stock plan at June 30, 2023:

Schedule of Equtiy Compensation Plan by Arrangements

2013 Equity Compensation Plan

3 unchanged sentences

operations as follows:

of Recognized Stock Based Compensation

Three Months Ended March 31,

Schedule of Recognized Stock Based Compensation

Three Months Ended

Six Months Ended

Research and Development

General and Administrative

of March 31, 2023, total compensation costs related to unvested awards not yet recognized was $ 8,690 and the weighted-average periods

of June 30, 2023, total compensation costs related to unvested awards not yet recognized was $ 7,437 and the weighted-average periods

over which the awards are expected to be recognized was 2.3 years.

following table summarizes the activity for Company’ stock options for the three months ended March 31, 2023:

of Stock Option Activity

at December 31, 2022

at March 31, 2023

following table summarizes the activity for Company’ stock options for the six months ended June 30, 2023:

Schedule of Stock Option Activity

Stock Options

Outstanding at December 31, 2022

Outstanding at June 30, 2023

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 1. Financial Statements