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Item 1. Financial Statements

2025-08-14 compared with 2025-05-15 · 378 added, 385 removed, 159 unchanged (83% of the section changed)

FINANCIAL STATEMENTS

Matinas BioPharma Holdings, Inc.

Condensed Consolidated Balance Sheets

(in thousands, except for share data)

March 31, 2025

BioPharma Holdings, Inc.

Consolidated Balance Sheets

thousands, except for share data)

June 30, 2025

December 31, 2024

6 unchanged sentences

Leasehold improvements and equipment – net

Assets held for sale - net

Operating lease right-of-use assets – net

14 unchanged sentences

Financing lease liabilities – net of current portion

Warrant liability

Total non-current liabilities

1 unchanged sentence

Stockholders’ equity:

Series C Convertible preferred stock, stated value $ 1,000 per share, par value $ 0.001 per share, 10,000,000 shares authorized at March 31, 2025 and December 31, 2024;

1,650 and 0 issued and outstanding as of March 31, 2025 and December 31, 2024, respectively.

Liquidation preference of $ 1,650,000 as of March 31, 2025.

Common stock par value $ 0.0001 per share, 250,000,000 shares authorized at March 31, 2025 and December 31, 2024;

5,086,985 issued and outstanding as of March 31, 2025 and December 31, 2024, respectively

Series C Convertible preferred stock, stated value $ 1,000 per share, par value $ 0.001 per share, 10,000,000 shares authorized at June 30, 2025 and December 31, 2024;

3,300 and 0 issued and outstanding as of June 30, 2025 and December 31, 2024, respectively.

Liquidation preference of $ 3,300,000 as of June 30, 2025.

Common stock par value $ 0.0001 per share, 250,000,000 shares authorized at June 30, 2025 and December 31, 2024;

5,086,985 issued and outstanding as of June 30, 2025 and December 31, 2024, respectively

Additional paid-in capital

2 unchanged sentences

Total liabilities and stockholders’ equity

The accompanying notes are an integral part of these

condensed consolidated financial statements.

Matinas BioPharma Holdings, Inc.

Condensed Consolidated Statements of Operations

and Comprehensive Loss

(in thousands, except for share and per share data)

Three Months Ended March 31,

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

BioPharma Holdings, Inc.

Consolidated Statements of Operations and Comprehensive Loss

thousands, except for share and per share data)

Three Months Ended

Six Months Ended

Costs and expenses:

4 unchanged sentences

Change in fair value of warrant liability

Other (expense)/income, net

Gain on sale of assets, net

Other income, net

Net loss per share – basic and diluted

5 unchanged sentences

Comprehensive loss

The accompanying notes are an integral part of these

condensed consolidated financial statements.

Matinas BioPharma Holdings, Inc.

Condensed Consolidated Statements of Stockholders’

(in thousands, except for share data)

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

BioPharma Holdings, Inc.

Consolidated Statements of Stockholders’ Equity

thousands, except for share data)

(loss)/Income

Accumulated Other

Preferred Stock Series C

6 unchanged sentences

Issuance of preferred stock and warrants in public offering, net of stock issuance costs ($ 29 )

Balance, March 31, 2025

Reclassification of warrants from liability to equity

Balance, June 30, 2025

$ ( 206,725 )

3 unchanged sentences

(loss)/Income

Balance, December 31, 2023

Balance, March 31, 2025

$ ( 201,480 )

Stock-based compensation

Issuance of preferred stock and warrants in public offering, net of stock issuance costs ($ 27 )

Reclassification of warrants from liability to equity

Balance, June 30, 2025

$ ( 206,725 )

(Loss)/Income

Comprehensive

Stockholders’

(Loss)/Income

Balance, December 31, 2023

$ ( 175,573 )

Stock-based compensation

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

Issuance of common stock in public offering, net of stock issuance cost

Other comprehensive loss

Issuance of common stock and warrants in public offering, net of stock issuance cost ($ 812 )

Other comprehensive income

Balance, June 30, 2024

$ ( 187,116 )

Accumulated Other

Comprehensive

Stockholders’

(Loss)/Income

Balance, March 31, 2024

1 unchanged sentence

$ ( 181,397 )

The accompanying notes are an integral part of these

condensed consolidated financial statements.

Matinas BioPharma Holdings, Inc.

Condensed Consolidated Statements of Cash Flow

(in thousands)

Three Months Ended March 31,

Stock-based compensation

Issuance of common stock and warrants in public offering, net of stock issuance cost ($ 810 )

Issuance of common stock and warrants in public offering, net of stock issuance cost

Other comprehensive income

Balance, June 30, 2024

$ ( 187,116 )

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

BioPharma Holdings, Inc.

Consolidated Statements of Cash Flow

Six Months Ended June 30,

Cash flows from operating activities:

1 unchanged sentence

Depreciation and amortization

Gain on sale of assets

Stock based compensation expense

Amortization of operating lease right-of-use assets

Amortization of finance lease right-of-use assets

Change in operating lease right-of-use assets

Change in finance lease right-of-use assets

Amortization of bond discount

7 unchanged sentences

Cash flows from investing activities:

Purchase of marketable debt securities

Proceeds from maturities of marketable debt securities

Net cash provided by investing activities

Net cash used in investing activities

Cash flows from financing activities:

1 unchanged sentence

Transaction costs paid pursuant to private placement

Net proceeds from public offering of common stock

Net proceeds from public offering of common stock and warrants

Payments of finance lease liability – principal

4 unchanged sentences

Supplemental non-cash financing and investing activities:

Fair value at issuance of liability classified warrants

Reclassification of warrants from liability to equity

Sale of assets

Unrealized gain on marketable debt securities

The accompanying notes are an integral part of these

condensed consolidated financial statements.

MATINAS BIOPHARMA HOLDINGS, INC.

Notes to Unaudited Condensed Consolidated Financial

(Tabular dollars and shares in thousands, except

per share data)

Note 1 – Description of Business

Matinas BioPharma Holdings Inc.

is a Delaware corporation formed in 2013.

Holdings is the parent company of Matinas BioPharma, Inc.

(“BioPharma”), and Matinas

BioPharma Nanotechnologies, Inc.

(“Nanotechnologies,” formerly known as Aquarius Biotechnologies, Inc.), its operating subsidiaries

(“Nanotechnologies”, and together with “Holdings” and “BioPharma”, “the Company”).

Company is a clinical-stage biopharmaceutical company focused on delivering groundbreaking therapies using its lipid nanocrystal (LNC)

platform delivery technology (LNC Platform).

Note 2 – Liquidity, Plan of Operations and

Going Concern

The Company has experienced net losses and negative

cash flows from operations each period since its inception.

Through March 31, 2025, the Company had an accumulated deficit of $ 201,480 .

The Company’s net loss for the three months ended March 31, 2025 and 2024 was $ 1,656 and $ 5,824 , respectively.

The Company expects operating expenses to be lower

in the near term compared to recent years until such time as additional funding is secured to support initiation of the Phase 3 registration

trial for MAT2203 and advancement of the LNC platform delivery technology.

The Company expects that its research and development expenses

will increase if it moves forward with additional clinical studies for its current product candidates and development of additional product

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

BIOPHARMA HOLDINGS, INC.

to Unaudited Condensed Consolidated Financial Statements

dollars and shares in thousands, except per share data)

1 – Description of Business

BioPharma Holdings Inc.

(“Holdings”) is a Delaware corporation formed in 2013.

Holdings is the parent company of Matinas

BioPharma, Inc.

(“BioPharma”), and Matinas BioPharma Nanotechnologies, Inc.

(“Nanotechnologies,” formerly known

as Aquarius Biotechnologies, Inc.), its operating subsidiaries (“Nanotechnologies”, and together with “Holdings”

and “BioPharma”, “the Company”).

The Company is a clinical-stage biopharmaceutical company focused on delivering

groundbreaking therapies using its lipid nanocrystal (LNC) platform delivery technology (LNC Platform).

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 June 30, 2025, the

Company had an accumulated deficit of $ 206,725 .

The Company’s net loss for the six months ended June 30, 2025 and 2024 was $ 6,901

and $ 11,543 , respectively.

Company expects operating expenses to be lower in the near term compared to recent years until such time as additional funding is secured

to support initiation of the Phase 3 registration trial for MAT2203 and advancement of the LNC platform delivery technology.

expects that its research and development expenses will increase if it moves forward with additional clinical studies for its current

product candidates and development of additional product candidates.

If the Company obtains U.S.

Food and Drug Administration (“FDA”) approval for one or more of its product candidates,

the Company expects that its expenses will continue to increase once the Company reaches commercial launch.

As a result, the Company expects

to continue to incur substantial losses for the foreseeable future, and that these losses will be increasing.

As of March 31, 2025, the Company

had cash and cash equivalents of $ 6,924 and

restricted cash of $ 250 .

In addition, on April 8,

2025, the Company generated net proceeds of $ 1,520 from

the Second Closing of the sale of Preferred Stock (see Note 12).

The Company does not believe the cash and cash equivalents 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

The ability of the Company to continue

as a going concern is dependent upon securing one or more partners to monetize the value of MAT2203, the ability to control its operating

expenses, future sales of common stock through the At-The-Market Sales Agreement (“Sales Agreement”) 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.

In particular, utilization of the Sales Agreement may not be viable due to market conditions and new financing may

not be available on acceptable terms, or at all.

Moreover, under the terms of the Preferred Stock sales agreement, the Company is prohibited,

subject to certain exceptions, from issuing, entering into any agreement to issue, or announcing the issuance or proposed issuance of

any shares of common stock or common stock equivalents until November 2025.

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 concern.

Note 3 – Summary of Significant Accounting

Basis of presentation and principles of consolidation

The accompanying unaudited condensed consolidated

financial statements include the consolidated accounts of Holdings and its wholly owned subsidiaries, BioPharma, and Nanotechnologies.

The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally

accepted in the United States (“U.S.

GAAP”) and reflect the operations of the Company and its wholly owned subsidiaries.

intercompany transactions have been eliminated in consolidation.

Other than the policies listed below, there have been

no material changes to the Company’s significant accounting policies are described in Note 3 within the Company’s Notes to

Consolidated Financial Statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024.

In August 2020, the FASB issued Accounting Standard

Food and Drug Administration (“FDA”)

approval for one or more of its product candidates, the Company expects that its expenses will continue to increase once the Company

reaches commercial launch.

As a result, the Company expects to continue to incur substantial losses for the foreseeable future, and that

these losses will be increasing.

of June 30, 2025, the Company had cash and cash equivalents of $ 6,525 and restricted cash of $ 250 .

The Company does not believe the cash

and cash equivalents on hand are sufficient to fund planned operations beyond the next twelve months from the filing date of these financial

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 securing one or more partners to monetize the value of MAT2203,

the ability to control its operating expenses, future sales of common stock through the At-The-Market Sales Agreement (“Sales Agreement”)

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.

In particular, utilization of the Sales Agreement may not be viable due to market conditions

and new financing may not be available on acceptable terms, or at all.

Moreover, under the terms of the Preferred Stock sales agreement,

the Company is prohibited, subject to certain exceptions, from issuing, entering into any agreement to issue, or announcing the issuance

or proposed issuance of any shares of common stock or common stock equivalents until November 2025.

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 concern.

3 – Summary of Significant Accounting Policies

of presentation and principles of consolidation

accompanying unaudited condensed consolidated financial statements include the consolidated accounts of Holdings and its wholly owned

subsidiaries, BioPharma, and Nanotechnologies.

The accompanying unaudited condensed consolidated financial statements have been prepared

in accordance with accounting principles generally accepted in the United States (“U.S.

GAAP”) and reflect the operations

of the Company and its wholly owned subsidiaries.

All intercompany transactions have been eliminated in consolidation.

than the policies listed below, there have been no material changes to the Company’s significant accounting policies are described

in Note 3 within the Company’s Notes to Consolidated Financial Statements included in the Company’s Annual Report on Form

10-K for the year ended December 31, 2024.

August 2020, the FASB issued Accounting Standard Update No.

2020-06 – Debt:

Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging – Contracts

in Entity’s Own Equity (Subtopic 815-40):

Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity ,

which simplifies accounting for convertible instruments by removing major separation models required under current GAAP.

The ASU removes

certain settlement conditions that are required for equity contracts to qualify for the derivative scope exception, and it also simplifies

the diluted earnings per share calculation in certain areas.

This ASU is effective for annual reporting periods beginning after December

15, 2021, including interim periods within those fiscal years.

The Company adopted the ASU on January 1, 2025.

This update permits the

use of either the modified retrospective or fully retrospective method of transition.

The Company’s management has considered

all recent accounting pronouncements issued and believes that these recent pronouncements will not have a material effect on the Company’s

financial statements.

The Company accounts for warrants as

either equity-classified or liability-classified instruments based on an assessment of the warrant’s specific terms and

applicable authoritative guidance in ASC 480, Distinguishing Liabilities from Equity and ASC 815, Derivatives and Hedging.

classified as equity are recorded at fair value as of the date of issuance on the Company’s condensed consolidated balance

sheets and no further adjustments to their initial valuation are subsequently made.

Warrants that require separate accounting as

liabilities are recorded on the Company’s condensed consolidated balance sheets at their fair value on the date of issuance

Debt with Conversion and Other Options (Subtopic

470-20) and Derivatives and Hedging – Contracts in Entity’s Own Equity (Subtopic 815-40):

Accounting for Convertible Instruments

and Contracts in an Entity’s Own Equity , which simplifies accounting for convertible instruments by removing major separation

models required under current GAAP.

The ASU removes certain settlement conditions that are required for equity contracts to qualify for

the derivative scope exception, and it also simplifies the diluted earnings per share calculation in certain areas.

This ASU is effective

for annual reporting periods beginning after December 15, 2021, including interim periods within those fiscal years.

The Company adopted

the ASU on January 1, 2025.

This update permits the use of either the modified retrospective or fully retrospective method of transition.

Company’s management has considered all recent accounting pronouncements issued and believes that these recent pronouncements will

not have a material effect on the Company’s financial statements.

Company accounts for warrants as either equity-classified or liability-classified instruments based on an assessment of the warrant’s

specific terms and applicable authoritative guidance in ASC 480, Distinguishing Liabilities from Equity and ASC 815, Derivatives and

Warrants classified as equity are recorded at fair value as of the date of issuance on the Company’s condensed consolidated

balance sheets and no further adjustments to their initial valuation are subsequently made.

Warrants that require separate accounting

as liabilities are recorded on the Company’s condensed consolidated balance sheets at their fair value on the date of issuance

and are revalued on each subsequent balance sheet date until such instruments are exercised or expired, with any changes in the fair

value between reporting periods recorded on the condensed consolidated statement of operations.

The assessment of whether the

warrants are accounted for as equity-classified or liability-classified instruments is re-evaluated on a periodic basis.

Note 4 – Cash, Cash Equivalents, Restricted

Cash and Marketable Debt Securities

The Company considers all highly liquid financial

instruments with original maturities of three months or less when purchased to be cash and cash equivalents and all investments with maturities

of greater than three months from date of purchase are classified as marketable debt securities.

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

Cash, Cash Equivalents and Restricted Cash

The Company presents restricted cash with cash and

cash equivalents in the Condensed Consolidated Statements of Cash Flows.

Restricted cash at both March 31, 2025 and December 31, 2024

of $ 250 represents funds the Company is required to set aside as collateral, primarily for one of the Company’s operating leases.

The 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, 2025, December 31, 2024, March 31, 2024 and December 31, 2023:

The assessment of whether the warrants

are accounted for as equity-classified or liability-classified instruments is re-evaluated on a periodic basis.

See Note 9 - Stockholders’ Equity for a discussion on the Company’s warrants.

4 – Cash, Cash Equivalents, Restricted Cash and Marketable Debt Securities

Company considers all highly liquid financial instruments with original maturities of three months or less when purchased to be cash

and cash equivalents and all investments with maturities of greater than three months from date of purchase are classified as marketable

debt securities.

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.

Cash Equivalents and Restricted Cash

Company presents restricted cash with cash and cash equivalents in the Condensed Consolidated Statements of Cash Flows.

Restricted cash

at both June 30, 2025 and December 31, 2024 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 June 30, 2025, December 31, 2024, June

30, 2024 and December 31, 2023:

Schedule of Cash, Cash Equivalents

and Restricted Cash

June 30, 2025

December 31, 2024

June 30, 2024

December 31, 2023

Cash and cash equivalents

1 unchanged sentence

Cash, cash equivalents and restricted cash in the statement of cash flows

Marketable Debt Securities

The Company has classified its investments in marketable

debt securities as available-for-sale and as a current asset.

The Company’s investments in marketable debt securities are carried

at fair value, with unrealized gains and losses included as a separate component of stockholders’ equity.

Unrealized losses and

gains are classified as other comprehensive (loss)/income and costs are determined on a specific identification basis.

Realized gains

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

The Company did not incur any realized gains and losses

during the three months ended March 31, 2025 and 2024.

For the three months ended March 31, 2025 and 2024, the Company recorded unrealized

gains of $ 0 and $ 87 , respectively.

Note 5 - Fair Value Measurements

The Company uses the fair value hierarchy to measure

the value of its financial instruments.

The fair value hierarchy is based on inputs to valuation techniques that are used to measure fair

value that are either observable or unobservable.

Observable inputs reflect assumptions market participants would use in pricing an asset

or liability based on market data obtained from independent sources, while unobservable inputs reflect a reporting entity’s pricing

based upon its own market assumptions.

The basis for fair value measurements for each level within the hierarchy is described below:

Level 1 – Quoted prices for identical assets or liabilities in active markets.

Level 2 – Quoted prices for identical or similar assets and liabilities in markets that are not active;

or other model-derived valuations whose inputs are directly or indirectly observable or whose significant value drivers are observable.

Level 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.

The Company utilizes valuation techniques that maximize

the use of observable inputs and minimize the use of unobservable inputs to the extent possible as well as counterparty credit

risk in its assessment of fair value.

The carrying amounts of cash equivalents,

current portion of restricted cash, prepaid expenses and other current assets, accounts payable, current portion of lease liabilities

and accrued expenses approximate fair value due to the short-term nature of these instruments.

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

Schedule of Assets and Liabilities Carried at Fair Value

March 31, 2025

Fair Value Hierarchy

March 31, 2025

Warrant liability

Company did not have any financial assets or liabilities that were carried at fair value using the hierarchy as of December 31, 2024.

table below presents a summary of changes in fair value of the Warrant liability that is measured at fair value on a recurring basis:

Debt Securities

Company has classified its investments in marketable debt securities as available-for-sale and as a current asset.

The Company’s

investments in marketable debt securities are carried at fair value, with unrealized gains and losses included as a separate component

of stockholders’ equity.

Unrealized losses and gains are classified as other comprehensive (loss)/income and costs are determined

on a specific identification basis.

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

The Company did not incur any realized gains and losses during the six months ended June 30, 2025 and 2024.

For the six months ended

June 30, 2025 and 2024, the Company recorded unrealized gains of $ 0 and $ 170 , respectively.

5 - Fair Value Measurements

Company uses the fair value hierarchy to measure the value of its financial instruments.

The fair value hierarchy is based on inputs

to valuation techniques that are used to measure fair value that are either observable or unobservable.

Observable inputs reflect assumptions

market participants would use in pricing an asset or liability based on market data obtained from independent sources, while unobservable

inputs reflect a reporting entity’s pricing based upon its own market assumptions.

The basis for fair value measurements for each

level within the hierarchy is described below:

Level 1 – Quoted

prices for identical assets or liabilities in active markets.

Level 2 – Quoted

prices for identical or similar assets and liabilities in markets that are not active;

or other model-derived valuations whose inputs

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

Level 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

possible as well as counterparty credit risk in its assessment of fair value.

carrying amounts of cash equivalents, current portion of restricted cash, prepaid expenses and other current assets, accounts payable,

current portion of lease liabilities and accrued expenses approximate fair value due to the short-term nature of these instruments.

Company did not have any financial assets or liabilities that were carried at fair value using the hierarchy as of either June 30, 2025

or December 31, 2024.

table below presents a summary of changes in fair value of the warrant liability that was measured at fair value on a recurring basis:

of Fair Value of Warrant Liability

3 unchanged sentences

Change in fair value

Balance at March 31, 2025

On February 13, 2025, the Company entered into a securities

purchase agreement with certain investors and, pursuant to an initial closing of the agreement issued and sold the investors (i) 1,650

shares of convertible preferred stock and (ii) warrants to purchase up to an aggregate of 5,631,404 shares of the Company’s common

stock (see Note 9).

The Company determined that the warrants do not satisfy the conditions

to be accounted for as equity instruments as the warrants are not considered indexed to the Company’s own stock.

The Company classified

the warrants as a liability upon issuance.

Accordingly, proceeds from the transaction are first allocated to the warrants which are recorded

at fair value at issuance, and any residual value allocated to preferred stock.

Subsequent changes in fair value of the warrants are recognized

in the Company’s condensed consolidated statements of operations and comprehensive loss until either exercised or expired.

The Company’s warrant liability

is measured at fair value each reporting period utilizing a Monte Carlo simulation model, which requires assumptions including the value

of the stock on the measurement date, exercise price, expected term, expected volatility, and the risk-free interest rate.

Certain assumptions,

including the expected term and expected volatility, are subjective and require judgment to develop.

As a result, if factors or expected

outcomes change and the Company uses significantly different assumptions or estimates, the warrant liability could be materially different.

The warrant liability was valued on the date of issuance

and March 31, 2025 using the following range of assumptions:

Reclassification to equity

Balance at June 30, 2025

February 13, 2025, the Company entered into a securities purchase agreement with certain investors and, pursuant to an initial and

second closing under the agreement, issued and sold to the investors an aggregate of (i) 3,300

shares of convertible preferred stock and (ii) warrants (the “Warrants”) to purchase up to 11,262,808

shares of the Company’s common stock (see Note 9).

Company classified the Warrants as a liability upon issuance.

Accordingly, proceeds from the transaction were first allocated to the

Warrants which were recorded at fair value at issuance, and any residual value allocated to preferred stock.

Subsequent changes in fair

value of the Warrants were recognized in the Company’s condensed consolidated statements of operations and comprehensive loss.

June 26, 2025, the terms of the Warrants were amended to remove the provision that provided for a potential adjustment to the Warrants

that did not meet the indexation requirements.

The Company determined that the Warrants now satisfy the conditions to be accounted for

as equity instruments.

The change in fair value of the Warrants until June 26, 2025 was recorded in the income statement and fair value

of the Warrants on June 26, 2025, was reclassified to equity.

There will be no subsequent measurement for the equity classified Warrants

as long as the indexation and equity classification criteria continue to be met.

each reporting period during which the Warrants were classified as a liability, the Company’s warrant liability was measured at

fair value utilizing a Monte Carlo simulation model, which required assumptions including the value of the stock on the measurement date,

exercise price, expected term, expected volatility, and the risk-free interest rate.

Certain assumptions, including the expected term

and expected volatility, were subjective and require judgment to develop.

warrant liabilities were valued on the various measurement dates during the six months ended June 30, 2025 using the following range

of assumptions:

of Warrant Liability

8 unchanged sentences

4.8 - 5.0 years

Note 6 – Leasehold Improvements and Equipment

Leasehold improvements and equipment, summarized by

major category, consist of the following as of March 31, 2025 and December 31, 2024:

6 – Leasehold Improvements and Equipment

improvements and equipment, summarized by major category, consist of the following as of June 30, 2025 and December 31, 2024:

Schedule of Leasehold Improvements

and Equipment

June 30, 2025

December 31, 2024

Leasehold improvements

Leasehold improvements and equipment, gross

accumulated depreciation and amortization

Leasehold improvements and equipment, net

Depreciation and amortization expense for the three

months ended March 31, 2025 and 2024 was $ 18 and $ 94 , respectively.

Note 7 – Accrued Expenses and Other Liabilities

Accrued expenses, summarized by major category, as

of March 31, 2025 and December 31, 2024 consist of the following:

and amortization expense for the three and six months ended June 30, 2025 and 2024 was $ 12 and $ 30 , respectively.

Depreciation and amortization

expense for the three and six months ended June 30, 2024 was $ 90 and $ 184 , respectively.

held for sale, net

April 19, 2025, the Company initiated a process to sell certain unused laboratory equipment that was previously impaired and carried

a net book value of $ 280 .

During the three months ended June 30, 2025, the Company sold $ 210 of the equipment, generating proceeds of

$ 320 and a gain of $ 110 .

As of June 30, 2025, the remaining $ 70 of equipment is classified as held for sale on the Company’s balance

We expect the remaining equipment to be sold prior to December 31, 2025.

7 – Accrued Expenses and Other Liabilities

expenses, summarized by major category, as of June 30, 2025 and December 31, 2024 consist of the following:

Schedule of Accrued Expenses

June 30, 2025

December 31, 2024

General and administrative expenses

Note 8 – Leases

The Company has various lease agreements, including

leases of office space, a laboratory and manufacturing facility, and various equipment.

Some leases include purchase, termination or extension

options for one or more years.

These options are included in the lease term when it is reasonably certain that the option will be exercised.

The assets and liabilities from operating and finance

leases are recognized at the lease commencement date based on the present value of remaining lease payments over the lease term using

the Company’s incremental borrowing rates or implicit rates, when readily determinable.

Short-term leases, which have an initial

term of 12 months or less, are not recorded on the balance sheet.

The Company’s operating leases do not provide implicit rates,

therefore the Company utilized a discount rate based on its incremental borrowing rate to record the lease obligations.

The Company’s

finance leases provide readily determinable implicit rates.

Operating lease obligations

The Company incurred lease expense for its operating

leases of $ 174 and $ 226 for the three months ended March 31, 2025 and 2024, respectively.

The Company incurred amortization expense on

its operating lease right-of-use assets of $ 109 and $ 145 for the three months ended March 31, 2025 and 2024, respectively.

Finance Leases

The Company incurred interest expense on its finance

leases of $ 0 and $ 1 for the three months ended March 31, 2025 and 2024.

The Company incurred amortization expense on its finance lease

right-of-use assets of $ 1 for the three months ended March 31, 2025 and 2024, respectively.

The 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, 2025:

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

Some leases include purchase, termination or extension options for one or more years.

These options are included in the lease term when

it is reasonably certain that the option will be exercised.

assets and liabilities from operating and finance leases are recognized at the lease commencement date based on the present value of

remaining lease payments over the lease term using the Company’s incremental borrowing rates or implicit rates, when readily determinable.

Short-term leases, which have an initial term of 12 months or less, are not recorded on the balance sheet.

The Company’s operating

leases do not provide implicit rates, therefore the Company utilized a discount rate based on its incremental borrowing rate to record

the lease obligations.

The Company’s finance leases provide readily determinable implicit rates.

lease obligations

Company incurred lease expense for its operating leases of $ 171 and $ 226 for the three months ended June 30, 2025 and 2025, respectively,

and $ 345 and $ 452 for the six months ended June 30, 2025 and 2024, respectively.

The Company incurred amortization expense on its operating

lease right-of-use assets of $ 111 and $ 149 for the three months ended June 30, 2025 and 2024, respectively, and $ 218 and $ 294 for the

six months ended June 30, 2025 and 2024, respectively.

Company incurred interest expense on its finance leases of $ 0 for the three months ended June 30, 2025 and 2024 and $ 0 and $ 1 for the

six months ended June 30, 2025 and 2024, respectively.

The Company incurred amortization expense on its finance lease right-of-use assets

of $ 1 and $ 2 for the three months ended June 30, 2025 and 2024, respectively, and $ 2 and $ 3 for the six months ended June 30, 2025 and

2024, respectively.

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

finance leases as of June 30, 2025:

Schedule of Maturity of Operating

9 unchanged sentences

Weighted average discount rate

The following table presents information about the

amount and timing of liabilities arising from the Company’s operating leases and finance leases as of December 31, 2024:

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

finance leases as of December 31, 2024:

Maturity of Lease Liabilities

Operating Lease Liabilities

Finance Lease Liabilities

Operating Lease

Finance Lease

Total undiscounted operating lease payments

3 unchanged sentences

Weighted average discount rate

Note 9 – Stockholders’ Equity

In accordance with the Certificate

of Incorporation, the Company is authorized to issue 250,000,000 shares

of common stock and 10,000,000 shares of preferred stock, each shares having a par value of $ 0.001 .

Reverse Stock Split

On August 30, 2024, the Company effected a one-for-fifty

(1:50) reverse stock split (the “Reverse Stock Split”), pursuant to which each of the Company’s stockholders received

one share of the Company’s common stock for every 50 shares of the Company’s common stock that such stockholder held immediately

prior to the effective time of the Reverse Stock Split.

The Reverse Stock Split affected all of the Company’s issued and outstanding

shares of common stock equally provided that no fractional shares of common stock were issued as a result of the Reverse Stock Split as

fractional shares of common stock were rounded up to the nearest whole share.

The Reverse Stock Split also affected the Company’s

outstanding stock-based awards, warrants and other exercisable or convertible securities and resulted in the shares of common stock underlying

such instruments being reduced and the exercise price or conversion price being increased proportionally by the Reverse Stock Split ratio.

In connection with the Reverse Stock Split, the number

of shares of common stock authorized for issuance was adjusted from 500,000,000 to 250,000,000 , and the par value of $ 0.0001 per share

was not affected.

Additionally, the number of issued and outstanding shares of the Company’s common stock was adjusted from 250,816,164

shares to 5,086,985 shares on August 30, 2024, including the issuance of an additional 70,661 shares to those stockholders that would

otherwise would have been entitled to a fractional share of common stock as a result of the Reverse Stock Split.

April 2024 Purchase Agreement

On April 5, 2024, the Company closed a registered

direct offering of 666,667 shares of its common stock and warrants to purchase up to an aggregate of 666,667 additional shares of common

stock, at a combined purchase price of $ 15.00 per share and accompanying warrant.

The Company generated gross proceeds of $ 10,000 and

net proceeds of $ 9,125 , after deducting underwriting discounts and commissions and other offering expenses.

At-The-Market Equity Offering

On July 2, 2020, the Company entered into an At-The-Market

Sales Agreement (the “Sales Agreement”) with BTIG, LLC (“BTIG”), pursuant to which the Company may offer and sell,

from time to time, through BTIG, as sales agent and/or principal, shares of its common stock having an aggregate offering price of up

to $ 50,000 , subject to certain limitations on the amount of common stock that may be offered and sold by the Company set forth in the

Sales Agreement.

9 – Stockholders’ Equity

As of June 30, 2025, in

accordance with the Certificate of Incorporation, the Company was authorized to issue 250,000,000 shares of common stock and 10,000,000

shares of preferred stock, each share having a par value of $ 0.0001 .

On June 23, 2025, the

Company received shareholder approval to increase the number of shares of common stock authorized for issuance to 500,000,000 .

On August 6, 2025, the Company filed a Certificate of Amendment (the

“Certificate of Amendment”) to the Company’s Certificate of Incorporation, as amended, with the Secretary of State of

the State of Delaware to increase the number of authorized shares of the Company’s common stock from 250,000,000 shares to 500,000,000

The Certificate of Amendment became effective upon filing.

2024 Purchase Agreement

April 5, 2024, the Company closed a registered direct offering of 666,667 shares of its common stock and warrants to purchase up to an

aggregate of 666,667 additional shares of common stock, at a combined purchase price of $ 15.00 per share and accompanying warrant.

Company generated gross proceeds of $ 10,000 and net proceeds of $ 9,125 , after deducting underwriting discounts and commissions and other

offering expenses.

At-The-Market

Equity Offering

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

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

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

and sold by the Company set forth in the Sales Agreement.

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

The Company may terminate the Sales Agreement

Company may terminate the Sales Agreement at any time;

BTIG may terminate the Sales Agreement in certain limited circumstances.

The Company did not sell any shares under the Sales

Agreement during the three months ended March 31, 2025.

During the three months ended March 31, 2024, the Company sold 4,366 shares of

its common stock generating net proceeds of $ 54 .

As of March 31, 2025, the Sales Agreement’s available capacity is $ 44,191 .

As of the filing of this Form 10-Q, the Company is

subject to the General Instruction I.B.6 to Form S-3, known as the “baby shelf rules,” which limit the number of securities

it can sell under the Sales Agreement and its registration statement on Form S-3.

Preferred Stock

On February 13, 2025, the Company entered

into a Securities Purchase Agreement (the “Purchase Agreement”) with certain investors (the “Purchasers”), pursuant

to which the Company sold, in a private placement (the “Offering”), an aggregate of 3,300

shares of the Company’s Series C Convertible Preferred Stock, par value $ 0.0001

per share (the “Preferred Stock”), initially convertible into up to 5,631,404

shares of the Company’s common stock with a stated value of $ 1,000

per share (the “Stated Value”), and warrants (the “Warrants”) to purchase up to an aggregate of 200 %

of the shares of Common Stock into which the shares of Preferred Stock are initially convertible, or 11,262,808

shares of Common Stock, for an offering price of $ 1,000

per share of Preferred Stock and accompanying Warrants in two equal tranches, the second of which closed on April 8, 2025.

Pursuant to the Purchase Agreement, on February 13,

2025, the Company issued and sold in an initial closing of the Offering (the “Initial Closing”), 1,650 shares of Preferred

did no t sell any shares under the Sales Agreement during the six months ended June 30, 2025.

During the six months ended June 30, 2024,

the Company sold 4,366 shares of its common stock generating net proceeds of $ 54 .

As of June 30, 2025, the Sales Agreement’s available

capacity is $ 44,191 .

of the filing of this Form 10-Q, the Company is subject to the General Instruction I.B.6 to Form S-3, known as the “baby shelf

rules,” which limit the number of securities it can sell under the Sales Agreement and its registration statement on Form S-3.

February 13, 2025, the Company entered into a Securities Purchase Agreement (the “Purchase Agreement”) with certain investors

(the “Purchasers”), pursuant to which the Company sold, in a private placement (the “Offering”), an aggregate

of 3,300 shares of the Company’s Series C Convertible Preferred Stock, par value $ 0.0001 per share (the “Preferred Stock”),

initially convertible into up to 5,631,404 shares of the Company’s common stock with a stated value of $ 1,000 per share (the “Stated

Value”), and warrants (the “Warrants”) to purchase up to an aggregate of 200 % of the shares of Common Stock into which

the shares of Preferred Stock are initially convertible, or 11,262,808 shares of Common Stock, for an offering price of $ 1,000 per share

of Preferred Stock and accompanying Warrants in two equal tranches, the second of which closed on April 8, 2025.

to the Purchase Agreement, on February 13, 2025, the Company issued and sold in an initial closing of the Offering (the “Initial

Closing”), 1,650 shares of Preferred Stock, initially convertible into up to 2,815,702 shares of Common Stock, and accompanying

Warrants, initially exercisable for up to 5,631,404 shares of Common Stock, for gross proceeds to the Company of $ 1.65 million.

4, 2025, the Company obtained shareholder approval (“Shareholder Approval”) for the issuance of the Preferred Stock and Warrants,

as required by the rules and regulations of NYSE American LLC (the “ NYSE”), including Section 713 of the NYSE American Company

Guide, and issued and sold, in a second closing of the Offering (the “Second Closing”), an additional 1,650 shares of Preferred

Stock, initially convertible into up to 2,815,702 shares of Common Stock, and accompanying Warrants, initially exercisable for up to

5,631,404 shares of Common Stock, for gross proceeds to the Company of $ 1.65 million.

On April 4, 2025, the Company obtained shareholder approval

(“Shareholder Approval”) for the issuance of the Preferred Stock and Warrants, as required by the rules and regulations of

NYSE American LLC (the “ NYSE”), including Section 713 of the NYSE American Company Guide, and issued and sold, in a second

closing of the Offering (the “Second Closing”), an additional 1,650 shares of Preferred Stock, initially convertible into

up to 2,815,702 shares of Common Stock, and accompanying Warrants, initially exercisable for up to 5,631,404 shares of Common Stock, for

gross proceeds to the Company of $ 1.65 million.

Under the terms of the Purchase Agreement, the Company

is prohibited, subject to certain exceptions, from issuing, entering into any agreement to issue, or announcing the issuance or proposed

issuance of any shares of common stock or common stock equivalents until November 2025.

On April 5, 2024, the Company issued warrants to purchase

666,667 shares of the Company’s common stock at an exercise price of $ 17.50 per share.

On February 13, 2025, the Company

issued the Warrants to purchase 5,631,404 shares

of the Company’s common stock under the Purchase Agreement.

The exercise price is $ 0.64 per

share and is subject to adjustments in accordance with the terms of the Warrants agreement.

The Warrants expire five years from the

Shareholder Approval date.

the terms of the Purchase Agreement, the Company is prohibited, subject to certain exceptions, from issuing, entering into any agreement

to issue, or announcing the issuance or proposed issuance of any shares of common stock or common stock equivalents until November 2025.

April 5, 2024, the Company issued warrants to purchase 666,667 shares of the Company’s common stock at an exercise price of $ 17.50

February 13, 2025, the Company issued the Warrants to purchase 5,631,404 shares of the Company’s common stock in the Initial Closing.

Warrants to purchase an additional 5,631,404 shares of the Company’s common stock were issued on April 8, 2025, in the Second Closing.

The exercise price is $ 0.64 per share, subject to adjustment in accordance with the terms of the Warrants agreement.

The Warrants expire

on April 4, 2030 .

The Warrants include anti-dilution protection provisions.

The Company determined that the Warrants do not

satisfy the conditions to be accounted for as equity instruments as the Warrants are not considered indexed to the Company’s

The Company classified the Warrants as a liability upon issuance.

The Warrants are recorded at fair value with changes in

fair value recognized in the Company’s condensed consolidated statements of operations and comprehensive loss until either

exercised or expired.

The valuation of the warrants is considered under Level 3 of the fair value hierarchy due to the need to use

assumptions in the valuation that are both significant to the fair value measurement and unobservable (see Note 5).

The Company did not have any warrants outstanding

for the three months ended March 31, 2024.

The following table summarizes the changes in warrants outstanding for the three months ended

March 31, 2025:

The Company determined that the Warrants did not satisfy

the conditions to be accounted for as equity instruments as the Warrants were not considered indexed to the Company’s own stock

and were classified as a liability upon issuance.

The Warrants were recorded at fair value with changes in fair value recognized in the

Company’s condensed consolidated statements of operations and comprehensive loss.

The valuation of the Warrants was considered

under Level 3 of the fair value hierarchy due to the need to use assumptions in the valuation that were both significant to the fair

value measurement and unobservable (see Note 5).

On June 26, 2025, the terms of the Warrants were amended to remove the provision that

provided for a potential adjustment to the Warrants that did not meet the indexation requirements.

As a result of the amendment, the

Company determined that the Warrants satisfy the conditions to be accounted for as equity instruments and the fair value of the Warrants

was reclassified to equity.

There will be no subsequent measurement for the equity classified Warrants as long as the indexation and

equity classification criteria continue to be met.

following table summarizes the changes in warrants outstanding for the six months ended June 30, 2025:

Schedule of Shareholder Equity

1 unchanged sentence

Outstanding at December 31, 2024

Outstanding at March 31, 2025

Basic and diluted net loss per common

The Company had two classes of stock

outstanding during the three months ended March 31, 2025, common stock and preferred stock, and had only common stock outstanding during

the three months ended March 31, 2024.

The Company computes net loss per share using the two-class method, as the Series C Preferred

Stock participates in distributions with the Company’s common stock.

The two-class method of computing net loss per share is an

earnings allocation formula that determines net loss for common stock and any participating securities according to dividends declared

and participation rights in undistributed earnings.

Under the two-class method, basic net loss per share attributable to common stockholders is computed by dividing the net income attributable

Outstanding at June 30, 2025

following table summarizes the changes in warrants outstanding for the six months ended June 30, 2024:

Outstanding at December 31, 2023

Outstanding at June 30, 2024

and diluted net loss per common share

Company had two classes of stock outstanding during the six months ended June 30, 2025, common stock and preferred stock, and had only

common stock outstanding during the six months ended June 30, 2024.

The Company computes net loss per share using the two-class method,

as the Preferred Stock participates in distributions with the Company’s common stock.

The two-class method of computing net loss

per share is an earnings allocation formula that determines net loss for common stock and any participating securities according to dividends

declared and participation rights in undistributed earnings.

the two-class method, basic net loss per share attributable to common stockholders is computed by dividing the net income attributable

to common stockholders by the weighted-average number of shares of common stock outstanding during the period.

1 unchanged sentence

attributable to common stockholders is computed using the more dilutive of (1) the two-class method or (2) the if-converted method.

During the three months ended March

31, 2025 and 2024, 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,

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

the three and six months ended June 30, 2025 and 2024, 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, warrants and preferred stock, 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, 2025 and 2024:

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, 2025 and 2024:

Schedule of Anti-dilutive Securities

Excluded from Computation of Earning Per Share

As of March 31,

As of June 30,

Stock options

Convertible preferred stock upon conversion

Note 10 – Stock-based Compensation

The 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.

10 – Stock-based Compensation

Company’s Amended and Restated 2013 Equity Compensation Plan (the “2013 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

The term of the 2013 Plan was for 10 years.

The Company intends to adopt a new equity

compensation plan at its 2025 Annual Meeting, pending shareholder approval.

As of March 31, 2025, there were 577,104 awards, including

both restricted stock grants and option grants, issued and exercised under the Plan and no remaining shares available for grant under

The Company recognized stock-based compensation expense

(options and restricted share grants) in its condensed consolidated statements of operations as follows:

of June 30, 2025, there were 577,104 awards, including both restricted stock grants and option grants, issued and exercised under the

2013 Plan and no remaining shares available for grant under the 2013 Plan.

April 30, 2025, the Company’s board of directors (the “Board”), subject to the approval of its stockholders which was

received on June 23, 2025, adopted a new 2025 Equity Incentive Plan (the “2025 Plan”) to succeed the 2013 Plan.

of June 30, 2025, there were 116,500 option grant awards issued and outstanding under the 2025 Plan and 646,548 awards available for

grant under the 2025 Plan.

Company recognized stock-based compensation expense (options and restricted share grants) in its condensed consolidated statements of

operations as follows:

Schedule of Recognized Stock-Based Compensation

Three Months Ended March 31,

Three Months Ended

Six Months Ended

Research and Development

General and Administrative

As of March 31, 2025, total compensation costs related

to unvested awards not yet recognized was $ 1,385 and the weighted-average periods over which the awards are expected to be recognized

was 1.9 years.

Stock Options

The following table summarizes the activity for Company’

stock options for the three months ended March 31, 2025:

of June 30, 2025, total compensation costs related to unvested awards not yet recognized was $ 1,243 and the weighted-average periods

over which the awards are expected to be recognized was 1.8 years.

following table summarizes the activity for the Company’s stock options for the six months ended June 30, 2025:

Schedule of Stock Option Activity

Stock Options

Outstanding at December 31, 2024

Outstanding at March 31, 2025

Note 11 – Subsequent Events

On April 8, 2025, pursuant to the Purchase Agreement,

the Company sold to the Purchasers, in the second and final closing of the Offering (the “Second Closing”), 1,650 shares of

Preferred Stock, initially convertible into up to 2,815,702 shares of Common Stock, and accompanying Warrants, initially exercisable for

up to 5,631,404 shares of Common Stock, for gross proceeds to the Company of $ 1.65 million.

The shares of Preferred Stock and Warrants

issued in the Second Closing were sold without registration under the Securities Act of 1933, as amended (the “Securities Act”),

or state securities laws in reliance on the exemption provided by Section 4(a)(2) of the Securities Act and/or Regulation D promulgated

thereunder and in reliance on similar exemptions under applicable state laws.

The Company registered the shares of Common Stock

underlying the Preferred Stock and Warrants on a Form S-3 Registration Statement, filed with the Securities and Exchange Commission on

April 22, 2025, and declared effective on April 29, 2025.

Outstanding at June 30,

11 – Subsequent Events

On August 6, 2025, the Company filed the Certificate

of Amendment to increase the number of authorized shares of the Company’s common stock from 250,000,000 shares to 500,000,000 shares.

The Certificate of Amendment was approved by the Company’s stockholders at the 2025 annual meeting on June 23, 2025 and became effective

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