What changed in this filing

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Item 1. Financial Statements

2024-05-09 compared with 2023-11-08 · 89 added, 177 removed, 311 unchanged (46% of the section changed)

3 unchanged sentences

thousands, except for share data)

September 30, 2023

March 31, 2024

December 31, 2023

26 unchanged sentences

Stockholders’ equity:

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

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

Common stock par value $ 0.0001 per share, 500,000,000 shares authorized at March 31, 2024 and December 31, 2023;

217,482,830 and 217,264,526 issued and outstanding as of March 31, 2024 and December 31, 2023, respectively

Additional paid-in capital

6 unchanged sentences

Consolidated Statements of Operations and Comprehensive Loss

thousands, except share and per share data)

Three Months Ended

September 30,

Nine Months Ended

September 30,

thousands, except for share and per share data)

Three Months Ended March 31,

Contract revenue

4 unchanged sentences

Loss from operations

Sale of New Jersey net operating losses & tax credits

Other income, net

2 unchanged sentences

Basic and diluted

Other comprehensive gain/(loss), net of tax

Unrealized gain/(loss) on securities available-for-sale

Other comprehensive gain/(loss), net of tax

Other comprehensive gain, net of tax

Unrealized gain on securities available-for-sale

Other comprehensive gain, net of tax

Comprehensive loss

3 unchanged sentences

thousands, except for share data)

(Loss)/Income

Accumulated Other

5 unchanged sentences

Stock-based compensation

Issuance of common stock in public offering, net of stock issuance cost ($ 2 )

Other comprehensive income

Balance, September 30, 2023

Balance, March 31, 2024

$ ( 181,397 )

3 unchanged sentences

(Loss)/Income

Balance, June 30, 2023

$ ( 164,204 )

Stock-based compensation

Other comprehensive income

Balance, September 30, 2023

$ ( 170,259 )

Accumulated Other

Comprehensive

Stockholders’

Balance, December 31, 2022

$ ( 152,631 )

Stock-based compensation

Issuance of common stock in exchange for Options

Issuance of common stock pursuant to license agreement amendment

Other comprehensive loss

Balance, September 30, 2022

$ ( 152,631 )

Accumulated Other

Comprehensive

Stockholders’

Balance, June 30, 2022

$ ( 143,535 )

Stock-based compensation

Other comprehensive loss

Other comprehensive income (loss)

Balance, September 30, 2022

Other comprehensive income

Balance, March 31, 2023

$ ( 158,144 )

3 unchanged sentences

Consolidated Statements of Cash Flow

Nine Months Ended September 30,

Three Months Ended March 31,

Cash flows from operating activities:

5 unchanged sentences

Amortization of bond discount

Stock issued pursuant to license agreement amendment

Changes in operating assets and liabilities:

5 unchanged sentences

Cash flows from investing activities:

Purchase of marketable debt securities

Proceeds from maturities of marketable debt securities

Purchases of leasehold improvements and equipment

Net cash provided by investing activities

Cash flows from financing activities:

Proceeds from exercise of options

Net proceeds from public offering of common stock

Payments of finance lease liability – principal

Net cash (used in)/provided by financing activities

Net cash provided by/(used in) financing activities

Net decrease in cash, cash equivalents and restricted cash

2 unchanged sentences

Supplemental non-cash financing and investing activities:

Unrealized gain/(loss) on marketable debt securities

Right of use asset in exchange from liabilities from operating lease

Unrealized gain on marketable debt securities

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

15 unchanged sentences

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

Through September 30, 2023,

the Company had an accumulated deficit of $ 170,259 .

The Company’s net loss was $ 17,628 for the nine months ended September 30,

Through March 31, 2024, the

Company had an accumulated deficit of $ 181,397 .

The Company’s net loss was $ 5,824 for the three months ended March 31, 2024.

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 September 30, 2023, the Company had cash and cash equivalents of $ 6,407 , marketable debt securities of $ 11,809 and restricted cash

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 concern.

of March 31, 2024, the Company had cash and cash equivalents of $ 1,071 , marketable debt securities of $ 7,039 and restricted cash of $ 250 .

In addition, on April 5, 2024, the Company completed a registered direct offering of its common stock, raising $ 9,250 , net of fees and

expenses (see Note 13).

The Company does not believe the cash and 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.

As a result, substantial

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

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.

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

and securing additional financing.

21 unchanged sentences

debt securities.

Cash and cash equivalents consisted of cash in bank checking and savings accounts, money market funds and short-term

Cash and cash equivalents consist of cash in bank checking and savings accounts, money market funds and short-term U.S.

treasury bonds that mature within three months of settlement date.

2 unchanged sentences

Restricted cash

at both September 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.

at both March 31, 2024 and December 31, 2023 of $ 250 represents funds the Company is required to set aside as collateral, primarily for

one of the Company’s operating leases.

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 September 30, 2023, December 31, 2022,

September 30, 2022 and December 31, 2021:

Sheets to the total of the amounts in the Condensed Consolidated Statements of Cash Flows as of March 31, 2024, December 31, 2023, March

31, 2023 and December 31, 2022:

Schedule of Cash, Cash Equivalents and Restricted Cash

September 30,

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 and nine months ended September 30, 2023, the Company recorded unrealized gains of $ 155 and $ 465 , respectively.

three and nine months ended September 30, 2022, the Company recorded unrealized losses of $ 181 and $ 790 , respectively.

As of September

30, 2023 and December 31, 2022, the Company had net accumulated unrealized losses of $ 359 and $ 824 , respectively.

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

Schedule of Marketable Securities

The Company did not incur any realized gains and losses during the three months ended March 31, 2024 and 2023.

For the three months ended

March 31, 2024 and 2023, the Company recorded unrealized gains of $ 87 and $ 229 , respectively.

As of March 31, 2024 and December 31, 2023,

the Company had net accumulated unrealized losses of $ 134 and $ 221 , respectively.

following tables summarize the Company’s marketable debt securities as of March 31, 2024:

of Marketable Debt Securities

Amortized Cost

1 unchanged sentence

Unrealized (Loss)

Treasury Bonds

Government Notes

Total marketable debt securities

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

Schedule of Maturities of Debt Securities Available-for-sale

Due within one year

debt securities classified as available-for-sale are due to mature within one year of March 31, 2024.

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

1 unchanged sentence

Government Notes

Corporate Debt Securities

Total 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

debt securities classified as available-for-sale are due to mature within one year of December 31, 2023.

5 - Fair Value Measurements

20 unchanged sentences

Fair Value Hierarchy

September 30, 2023

March 31, 2024

Marketable Debt Securities:

Treasury Bonds

Government Notes

4 unchanged sentences

Government Notes

Corporate Debt Securities

Assets and liabilities carried at fair value

treasury bonds are classified within Level 1 of the fair value hierarchy because they are valued using quoted market prices for identical

1 unchanged sentence

Marketable debt securities consisting of U.S.

government notes and corporate debt securities are classified

as Level 2 and are valued using quoted market prices in markets that are not active.

government notes are classified as Level 2 and are valued using

quoted market prices in markets that are not active.

6 – Leasehold Improvements and Equipment

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

improvements and equipment, summarized by major category, consist of the following as of March 31, 2024 and December 31, 2023:

Schedule of Leasehold Improvements and Equipment

September 30, 2023

December 31, 2023

3 unchanged sentences

Leasehold improvements and equipment, net

and amortization expense for the three and nine months ended September 30, 2023 was $ 98 and $ 288 , respectively, and the three and nine

months ended September 30, 2022 was $ 89 and $ 244 , respectively.

During the nine month period ended September 30, 2023, the Company purchased

equipment of $ 218 , and no leasehold improvements.

During the nine month period ended September 30, 2022, the Company purchased equipment

of $ 629 , and leasehold improvements of $ 221 .

and amortization expense for the three months ended March 31, 2024 and 2023 was $ 94 and $ 93 , respectively.

7 – Accrued Expenses and Other Liabilities

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

Expenses, summarized by major category, as of March 31, 2024 and December 31, 2023 consist of the following:

Schedule of Accrued Expenses

September 30, 2023

March 31, 2024

December 31, 2023

2 unchanged sentences

Research and development expenses

Deferred revenue *

Other deferred liabilities **

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

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 related to an award agreement with the Cystic Fibrosis Foundation (the “CFF Agreement).

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

Company has various lease agreements, including leases of office space, a laboratory and manufacturing facility, and various equipment.

10 unchanged sentences

lease obligations

Company incurred lease expense for its operating leases of $ 225 and $ 194 for each of the three month periods ended September 30, 2023

and 2022, respectively, and $ 677 and $ 646 for each of the nine month periods ended September 30, 2023 and 2022, respectively.

incurred amortization expense on its operating lease right-of-use assets of $ 139 and $ 406 for the three and nine months ended September

30, 2023, respectively, and $ 138 and $ 413 for the three and nine months ended September 30, 2022, respectively.

Company incurred interest expense on its finance leases of $ 0 and $ 2 for the three and nine months ended September 30, 2023, respectively,

and $ 0 and $ 1 for the three and nine months ended September 30, 2022, respectively.

The Company incurred amortization expense on its

finance lease right-of-use assets of $ 2 and $ 7 for the three and nine months ended September 30, 2023, respectively, and $ 3 and $ 15 for

the three and nine months ended September 30, 2022, respectively.

Company incurred lease expense for its operating leases of $ 226 for each of the three month periods ended March 31, 2024 and 2023, respectively.

The Company incurred amortization expense on its operating lease right-of-use assets of $ 145 and $ 132 for the three months ended March

31, 2024 and 2023, respectively.

Company incurred interest expense on its finance leases of $ 1 for the three months ended March 31, 2024 and 2023.

The Company incurred

amortization expense on its finance lease right-of-use assets of $ 1 and $ 4 for the three months ended March 31, 2024 and 2023, respectively.

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

finance leases as of September 30, 2023:

finance leases as of March 31, 2024:

Schedule of Maturity of Operating and Finance Liabilities

33 unchanged sentences

from the BioNTech Agreement.

Fibrosis Foundation Therapeutics Development Award

November 19, 2020, the Company entered into the CFF Agreement with the Cystic Fibrosis Foundation (“CFF”), pursuant to which

it received a Therapeutics Development Award of up to $ 4.2 million (the “Award”) (of which $ 484 had been previously received)

to support the preclinical development (the “Development Program”) of the Company’s MAT2501 product candidate.

19, 2021, the Company and CFF entered into an Amendment to the CFF Agreement which added an additional milestone payment in the amount

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

of September 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 September 30,

2023 and December 31, 2022, respectively.

During the fourth quarter of 2022, for financial and technical reasons, the Company determined

that it was not commercially reasonable to continue the development of MAT2501 and instead elected to focus existing resources on other

As a result, the Company will not receive the balance of the Award and has no further obligations to CFF.

Feasibility Study Agreement

9 unchanged sentences

During the three months ended March 31, 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 nine month periods ended September 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.

10 – Stockholders’ Equity

February 8, 2022, the Company issued 400,000 unregistered shares of its common stock to Rutgers, The State University of New Jersey (“Rutgers”),

as partial consideration pursuant to the Second Amended and Restated Exclusive License Agreement between the Company and Rutgers.

agreement provides for (1) royalties on a tiered basis between low single digits and the mid-single digits of net sales of products using

such licensed technology, (2) a one-time sales milestone fee of $ 100 when and if sales of products using the licensed technology reach

the specified sales threshold and (3) an annual license fee of $ 50 over the term of the license agreement.

There was also a reduction

in the consideration paid to Rutgers in the event of a sublicense to a third party of the exclusive patent rights granted pursuant to

the Agreement.

The Company recorded a $ 291 research and development expense related to the issuance of the 400,000 shares based on the

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

the nine months ended September 30, 2023 and 2022, the Company did not sell any shares of its common stock under its At-The-Market Sales

Agreement with BTIG, LLC.

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

following table summarizes the changes in warrants outstanding during 2022 and for the nine months ended September 30, 2023:

Summary of Shareholder Equity Warrants Outstanding

Outstanding at December 31, 2021

Outstanding at December 31, 2022

Outstanding at September 30, 2023

the three months ended March 31, 2024 and 2023, the Company sold 218,304 and 0 , respectively, shares of its common stock under the ATM

with BTIG, LLC.

of March 31, 2024, the Company did not have any outstanding warrants to purchase shares of the Company’s common stock.

and diluted net loss per common share

the three and nine months ended September 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

September 30, 2023 and 2022:

the three months ended March 31, 2024 and 2023, 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, 2024

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

As of September 30,

As of March 31,

Stock options

11 – Accumulated Other Comprehensive Loss

following table summarizes the changes in accumulated other comprehensive loss by component during the nine months ended September 30,

2023 and 2022:

following table summarizes the changes in accumulated other comprehensive loss by component during the three months ended March 31, 2024

Schedule of Components of Accumulated Other Comprehensive (Loss) Income

Net Unrealized

Gain/(Loss) on

1 unchanged sentence

Comprehensive

December 31, 2022

unrealized gain on securities available-for-sale

September 30, 2023

December 31, 2021

unrealized loss on securities available-for-sale

September 30, 2022

Balance, December 31, 2023

Net unrealized gain on securities available-for-sale

Balance, March 31, 2024

Balance, December 31, 2022

Net unrealized loss on securities available-for-sale

Balance, March 31, 2023

components of accumulated other comprehensive income are net of tax.

12 – Stock-based Compensation

Company’s Amended and Restated 2013 Equity Compensation Plan (the “Plan”) provides for the granting of incentive stock

options, nonqualified stock options, restricted stock units, performance units, and stock purchase rights.

There were no significant

modifications to the Plan during the nine month periods ended September 30, 2023 and 2022.

The term of the Plan is for 10 years and will

expire on May 7, 2024, if not amended before then.

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

Company’s Amended and Restated 2013 Equity Compensation Plan (the “Plan”), which expired on May 7, 2024, provided for

the granting of incentive stock options, nonqualified stock options, restricted stock units, performance units, and stock purchase rights.

There were no significant modifications to the Plan during the three month periods ended March 31, 2024 and 2023.

The term of the Plan

was for 10 years .

The Company intends to adopt a new equity compensation plan at its 2024 Annual Meeting, pending shareholder approval.

following table contains information about the Company’s stock plan at March 31, 2024:

Schedule of Equtiy Compensation Plan by Arrangements

2013 Equity Compensation Plan

50,712,275 **

by 8,690,581 on January 1, 2024, representing 4 % of the total number of shares of common stock outstanding on December 31, 2023.

3 unchanged sentences

Schedule of Recognized Stock Based Compensation

Three Months Ended

September 30,

Nine Months Ended

September 30,

Three Months Ended March 31,

Research and Development

General and Administrative

of September 30, 2023, total compensation costs related to unvested awards not yet recognized was $ 6,204 and the weighted-average periods

of March 31, 2024, total compensation costs related to unvested awards not yet recognized was $ 6,840 and the weighted-average periods

over which the awards are expected to be recognized was 2.4 years.

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

following table summarizes the activity for Company’ stock options for the three months ended March 31, 2024:

Schedule of Stock Option Activity

1 unchanged sentence

Outstanding at December 31, 2023

Outstanding at September 30, 2023

Outstanding at March 31, 2024

13 – Subsequent Events

November 1, 2023, at a Special Meeting of the Company’s stockholders, a proposal for an amendment to the Company’s Certificate

of Incorporation to effect a reverse stock split of its common stock at a ratio in the range of 1-for-2 to 1-for-50, with such reverse

stock split to be effected at a ratio, time and date, if at all, as determined by the Company’s Board of Directors in its sole

The Board may choose to exercise its discretion at any time prior to November 1, 2024, which is the first anniversary of

its approval by stockholders.

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.

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