UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
☒
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the quarterly period ended September 30, 2025
OR
☐
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the transition period from to
Commission
File Number: 001-38022
MATINAS
BIOPHARMA HOLDINGS, INC.
(Exact
name of registrant as specified in its charter)
Delaware
No.
46-3011414
(State
or other jurisdiction of
(I.R.S.
Employer
incorporation
or organization)
Identification
No.)
1545
Route 206 South , Suite 302
Bedminster ,
New Jersey 07921
(Address
of principal executive offices) (Zip Code)
908 - 484-8805
(Registrant’s
telephone number, including area code)
(Former
Name, Former Address and Former Fiscal Year,
if
Changed Since Last Report)
Securities
registered pursuant to Section 12(b) of the Act:
Title
of Each Class
Trading
Symbol(s)
Name
of Each Exchange on Which Registered
Common
Stock
MTNB
NYSE
American
Indicate
by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)
has been subject to such filing requirements for the past 90 days.
Yes
☒ No ☐
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule
405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant
was required to submit such files).
Yes
☒ No ☐
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting
company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,”
“smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large
accelerated filer
☐
Accelerated
filer
☐
Non-accelerated
filer
☒
Smaller
reporting company
☒
Emerging
growth company
☐
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
As
of November 6, 2025, there were 6,406,191 shares of the registrant’s common stock, $ 0.0001 par value, outstanding.
MATINAS
BIOPHARMA HOLDINGS, INC.
Form
10-Q
Quarter
Ended September 30, 2025
Table
of Contents
Page
PART - I FINANCIAL INFORMATION
3
Item
1.
FINANCIAL STATEMENTS
3
Item
2.
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
16
Item
3.
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
22
Item
4.
CONTROLS AND PROCEDURES
22
PART - II OTHER INFORMATION
23
Item
1.
LEGAL PROCEEDINGS
23
Item
1A.
RISK FACTORS
24
Item
2.
UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
24
Item
3.
DEFAULTS UPON SENIOR SECURITIES
24
Item
4.
MINE SAFETY DISCLOSURES
24
Item
5.
OTHER INFORMATION
24
Item
6.
EXHIBITS
24
2
PART
- I FINANCIAL INFORMATION
Item
1. FINANCIAL STATEMENTS
Matinas
BioPharma Holdings, Inc.
Condensed
Consolidated Balance Sheets
(in
thousands, except for share data)
September 30,
2025
December 31,
2024
(Unaudited)
(Audited)
ASSETS:
Current assets:
Cash and cash equivalents
$ 5,435
$ 7,284
Restricted cash – security deposit
50
50
Prepaid expenses and other current assets
168
691
Total current assets
5,653
8,025
Non-current assets:
Leasehold improvements and equipment – net
156
468
Assets held for sale - net
70
—
Operating lease right-of-use assets – net
1,351
1,680
Finance lease right-of-use assets – net
5
8
In-process research and development
2,260
2,260
Restricted cash – security deposit
200
200
Total non-current assets
4,042
4,616
Total assets
$ 9,695
$ 12,641
LIABILITIES AND STOCKHOLDERS’ EQUITY:
Current liabilities:
Accounts payable
$ 80
$ 95
Accrued expenses
564
1,805
Operating lease liabilities – current
846
761
Financing lease liabilities – current
5
5
Total current liabilities
1,495
2,666
Non-current liabilities:
Deferred tax liability
257
257
Operating lease liabilities – net of current portion
1,472
2,116
Financing lease liabilities – net of current portion
11
12
Total non-current liabilities
1,740
2,385
Total liabilities
3,235
5,051
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 September 30, 2025 and December 31, 2024; 3,155 and 0 issued and outstanding as of September 30, 2025 and December 31, 2024, respectively. Liquidation preference of $ 3,155,000 as of September 30, 2025.
—
—
Common stock par value $ 0.0001 per share, 500,000,000 and 250,000,000 shares authorized at September 30, 2025 and December 31, 2024, respectively; 5,901,091 and 5,086,985 issued and outstanding as of September 30, 2025 and December 31, 2024, respectively
1
1
Additional paid-in capital
215,334
207,413
Accumulated deficit
( 208,875 )
( 199,824 )
Total stockholders’ equity
6,460
7,590
Total liabilities and stockholders’ equity
$ 9,695
$ 12,641
The
accompanying notes are an integral part of these condensed consolidated financial statements.
3
Matinas
BioPharma Holdings, Inc.
Condensed
Consolidated Statements of Operations and Comprehensive Loss
(in
thousands, except for share and per share data)
Unaudited
2025
2024
2025
2024
Three Months Ended
September 30,
Nine Months Ended
September 30,
2025
2024
2025
2024
Costs and expenses:
Research and development
$ —
$ 2,239
$ 85
$ 9,057
General and administrative
1,577
2,142
5,275
7,067
Total costs and expenses
1,577
4,381
5,360
16,124
Loss from operations
( 1,577 )
( 4,381 )
( 5,360 )
( 16,124 )
Change in fair value of warrant liability
—
—
( 3,161 )
—
Gain on sale of assets, net
—
—
110
—
Other income/(expenses), net
45
106
( 22 )
306
Net loss
$ ( 1,532 )
$ ( 4,275 )
$ ( 8,433 )
$ ( 15,818 )
Deemed dividend relating to warrant exchange
( 618 )
—
( 618 )
—
Net loss attributable to common shareholders
$ ( 2,150 )
$ ( 4,275 )
$ ( 9,051 )
$ ( 15,818 )
Net loss per share – basic and diluted
$ ( 0.40 )
$ ( 0.85 )
$ ( 1.74 )
$ ( 3.30 )
Weighted average common shares outstanding:
Basic and diluted
5,435,829
5,037,829
5,204,544
4,791,572
Other comprehensive gain, net of tax
Unrealized gain on securities available-for-sale
—
51
—
221
Other comprehensive gain, net of tax
—
51
—
221
Comprehensive loss
$ ( 1,532 )
$ ( 4,224 )
$ ( 8,433 )
$ ( 15,597 )
The
accompanying notes are an integral part of these condensed consolidated financial statements.
4
Matinas
BioPharma Holdings, Inc.
Condensed
Consolidated Statements of Stockholders’ Equity
(in
thousands, except for share data)
Unaudited
Shares
Amount
Shares
Amount
Capital
Deficit
(loss)/Income
Equity
Convertible
Preferred Stock
Series C
Common Stock
Additional
Paid - in
Accumulated
Accumulated
Other
Comprehensive
Total
Stockholders’
Shares
Amount
Shares
Amount
Capital
Deficit
(loss)/Income
Equity
Balance, December 31, 2024
—
$ —
5,086,985
$ 1
$ 207,413
$ ( 199,824 )
$ —
$ 7,590
Stock-based compensation
—
—
—
—
806
—
—
806
Issuance of preferred stock and warrants in public offering, net of stock issuance costs ($ 29 )
3,300
—
—
—
330
—
—
330
Reclassification of warrants from liability to equity
—
—
—
—
6,103
—
—
6,103
Issuance of Common Stock in exchange for warrants
—
—
466,666
—
618
—
—
618
Deemed dividend
—
—
—
—
—
( 618 )
—
( 618 )
Issuance of Common Stock upon conversion of preferred stock
( 145 )
—
247,440
—
—
—
—
—
Issuance of Common Stock upon exercise of warrants
—
—
100,000
—
64
—
—
64
Net loss
—
—
—
—
—
( 8,433 )
( 8,433 )
Balance, September 30, 2025
3,155
$ —
5,901,091
$ 1
$ 215,334
$ ( 208,875 )
$ —
$ 6,460
Convertible
Preferred Stock Series C
Common Stock
Additional
Paid - in
Accumulated
Accumulated
Other
Comprehensive
Total
Stockholders’
Shares
Amount
Shares
Amount
Capital
Deficit
(loss)/Income
Equity
Balance, June 30, 2025
3,300
$ —
5,086,985
$ 1
$ 214,399
$ ( 206,725 )
$ —
$ 7,675
Stock-based compensation
—
—
—
—
253
—
—
253
Issuance of Common Stock in exchange for warrants
—
—
466,666
—
618
—
—
618
Deemed dividend
—
—
—
—
—
( 618 )
—
( 618 )
Issuance of Common Stock upon conversion of preferred stock
( 145 )
—
247,440
—
—
—
—
—
Issuance of Common Stock upon exercise of warrants
—
—
100,000
—
64
—
—
64
Net loss
—
—
—
—
—
( 1,532 )
( 1,532 )
Balance, September 30, 2025
3,155
$ —
5,901,091
$ 1
$ 215,334
$ ( 208,875 )
$ —
$ 6,460
Shares
Amount
Capital
Deficit
(Loss)/Income
Equity
Common Stock
Additional
Paid - in
Accumulated
Accumulated
Other
Comprehensive
Total
Stockholders’
Shares
Amount
Capital
Deficit
(Loss)/Income
Equity
Balance, December 31, 2023
4,345,291
$ —
$ 195,040
$ ( 175,573 )
$ ( 221 )
$ 19,246
Stock-based compensation
—
—
2,951
—
—
2,951
Issuance of common stock and warrants in public offering, net of stock issuance cost ($ 877 )
671,033
1
9,178
—
—
9,179
Issuance of common stock in reverse stock split
70,661
—
—
—
—
—
Other comprehensive income
—
—
—
—
221
221
Net loss
—
—
—
( 15,818 )
—
( 15,818 )
Balance, September 30, 2024
5,086,985
$ 1
$ 207,169
$ ( 191,391 )
$ —
$ 15,779
Common Stock
Additional
Paid - in
Accumulated
Accumulated Other
Comprehensive
Total
Stockholders’
Shares
Amount
Capital
Deficit
(Loss)/Income
Equity
Balance, June 30, 2024
5,016,324
$ 1
$ 206,269
$ ( 187,116 )
$ ( 51 )
$ 19,103
Balance
5,016,324
$ 1
$ 206,269
$ ( 187,116 )
$ ( 51 )
$ 19,103
Stock-based compensation
—
—
965
—
—
965
Issuance of common stock and warrants in public offering, net of stock issuance cost ($ 65 )
—
—
( 65 )
—
—
( 65 )
Issuance of common stock and warrants in public offering, net of stock issuance
cost
—
—
( 65 )
—
—
( 65 )
Issuance of common stock in reverse stock split
70,661
—
—
—
—
—
Other comprehensive income
—
—
—
—
51
51
Net loss
—
—
—
( 4,275 )
—
( 4,275 )
Balance, September 30, 2024
5,086,985
$ 1
$ 207,169
$ ( 191,391 )
$ —
$ 15,779
Balance
5,086,985
$ 1
$ 207,169
$ ( 191,391 )
$ —
$ 15,779
The
accompanying notes are an integral part of these condensed consolidated financial statements.
5
Matinas
BioPharma Holdings, Inc.
Condensed
Consolidated Statements of Cash Flow
(in
thousands)
Unaudited
2025
2024
Nine Months Ended September 30,
2025
2024
Cash flows from operating activities:
Net loss
$ ( 8,433 )
$ ( 15,818 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization
29
275
Gain on sale of assets
( 110 )
—
Stock based compensation expense
806
2,951
Change in operating lease right-of-use assets
329
446
Change in finance lease right-of-use assets
3
4
Amortization of bond premium
—
( 16 )
Change in fair value of warrant liability
3,161
—
Changes in operating assets and liabilities:
Operating lease liabilities
( 558 )
( 481 )
Prepaid expenses and other current assets
524
839
Accounts payable
( 15 )
( 165 )
Accrued expenses and other liabilities
( 1,238 )
( 410 )
Net cash used in operating activities
( 5,502 )
( 12,375 )
Cash flows from investing activities:
Proceeds from sale of assets
320
—
Purchase of marketable debt securities
—
( 8,437 )
Proceeds from maturities of marketable debt securities
—
17,145
Net cash provided by investing activities
320
8,708
Cash flows from financing activities:
Gross proceeds from private placement of preferred stock and common stock warrants
3,300
—
Transaction costs paid pursuant to private placement
( 29 )
—
Net proceeds from exercise of warrants
64
—
Net proceeds from public offering of common stock and warrants
—
9,179
Payments of finance lease liability – principal
( 2 )
( 4 )
Net cash provided by financing activities
3,333
9,175
Net (decrease)/increase in cash, cash equivalents and restricted cash
( 1,849 )
5,508
Cash, cash equivalents and restricted cash at beginning of period
7,534
5,037
Cash, cash equivalents and restricted cash at end of period
$ 5,685
$ 10,545
Supplemental non-cash financing and investing activities:
Reclassification of warrants from liability to equity
$ 6,103
$ —
Unrealized gain on marketable debt securities
$ —
$ 221
Exchange of warrants for shares of common stock
$ 618
$ —
The
accompanying notes are an integral part of these condensed consolidated financial statements.
6
MATINAS
BIOPHARMA HOLDINGS, INC.
Notes
to Unaudited Condensed Consolidated Financial Statements
(Tabular
dollars and shares in thousands, except per share data)
Note
1 – Description of Business
Matinas
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).
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 September 30, 2025,
the Company had an accumulated deficit of $ 208,875 . The Company’s net loss for the nine months ended September 30, 2025 and 2024
was $ 8,433 and $ 15,818 , respectively.
The
Company expects operating expenses to be lower in the near term compared to recent years until such time as it is able to consummate
a licensing, sale or other similar transaction with a prospective partner that will provide funding 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 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 September 30, 2025, the Company had cash and cash equivalents of $ 5,435 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 statements. As a result, substantial doubt exists about the Company’s ability to continue as a going concern.
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. 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 Policies
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. All 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.
7
In
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.
In November 2023, the FASB released ASU No. 2023-07 – Segment
Reporting (Topic 280) – Improvements to Reportable Segment Disclosures, which aims to improve the disclosures public entities
provide regarding significant segment expenses so that investors can “better understand an entity’s overall performance”
and assess “potential future cash flows”. This update requires public companies to provide more transparency in both quarterly
and annual reports about the expenses they incur from revenue-generating business units. The amendments improve reportable segment disclosure
requirements through enhanced disclosures about significant segment expenses. The amendments introduce a new requirement to disclose significant
segment expenses regularly provided to the chief operating decision maker and extend certain annual disclosures to interim periods. The
amendments in this update became effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years
beginning after December 15, 2024. The Company does not judge an operating segment identified as reportable segment but has a consolidated
single reportable segment, therefore this update did not have a material impact on its condensed consolidated financial statements and
related disclosures.
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.
Warrants
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. 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. See Note 9 - Stockholders’
Equity for a discussion on the Company’s warrants.
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 date.
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 September 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.
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 September 30, 2025, December 31, 2024,
September 30, 2024 and December 31, 2023:
Schedule of Cash, Cash Equivalents
and Restricted Cash
September 30, 2025
December 31, 2024
September 30, 2024
December 31, 2023
Cash and cash equivalents
$ 5,435
$ 7,284
$ 10,295
$ 4,787
Restricted cash included in current/non-current assets
250
250
250
250
Cash, cash equivalents and restricted cash in the statement of cash flows
$ 5,685
$ 7,534
$ 10,545
$ 5,037
8
Marketable
Debt Securities
The
Company has historically classified its investments in marketable debt securities as available-for-sale and as a current asset. The
Company’s investments in marketable debt securities were carried at fair value, with unrealized gains and losses included as a
separate component of stockholders’ equity. Unrealized losses and gains were classified as other comprehensive (loss)/income
and costs were determined on a specific identification basis. Realized gains and losses from our marketable debt securities were
recorded in other income, net. The Company did not incur any realized gains and losses during the nine months ended September 30,
2025 and 2024. For the nine months ended September 30, 2025 and 2024, the Company recorded unrealized gains of $ 0
and $ 221 ,
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 and accrued expenses approximate fair value due to the short-term nature of these instruments.
The
Company did not have any financial assets or liabilities that were carried at fair value using the hierarchy as of either September 30,
2025 or December 31, 2024.
The
table below presents a summary of changes in fair value of the warrant liability that was measured at fair value on a recurring basis:
Schedule
of Fair Value of Warrant Liability
Warrant Liability
Balance at January 31, 2025
—
Issuance of warrants reported at fair value
2,942
Change in fair value
3,161
Reclassification to equity
( 6,103 )
Balance at September 30, 2025
—
On
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).
The
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.
9
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. 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.
For
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.
The
warrant liabilities were valued on the various measurement dates during the nine months ended September 30, 2025 using the following
range of assumptions:
Schedule
of Warrant Liability
Expected volatility
54.0 % - 61.0 %
Risk-free interest rate
3.77 % – 4.39 %
Stock price on valuation date
$ 0.52 - 0.94
Exercise price
$ 0.64
Dividend yield
0.00 %
Expected term
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 September 30, 2025 and December 31, 2024:
Schedule of Leasehold Improvements
and Equipment
September 30,
2025
December 31,
2024
Equipment
$ —
$ 283
Leasehold improvements
218
218
Total
218
501
Less: accumulated depreciation and amortization
62
33
Leasehold improvements and equipment, net
$ 156
$ 468
Depreciation
and amortization expense for the three and nine months ended September 30, 2025 was $ 2 and $ 29 , respectively. Depreciation and
amortization expense for the three and nine months ended September 30, 2024 was $ 90 and $ 275 , respectively.
Assets
held for sale, net
On
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 nine months ended September 30, 2025, the Company sold $ 210 of the equipment, generating proceeds
of $ 320 and a gain of $ 110 . As of September 30, 2025, the remaining $ 70 of equipment is classified as held for sale on the Company’s
balance sheet. We expect the remaining equipment to be sold prior to December 31, 2025.
10
Note
7 – Accrued Expenses and Other Liabilities
Accrued
expenses, summarized by major category, as of September 30, 2025 and December 31, 2024 consist of the following:
Schedule of Accrued Expenses
September 30,
2025
December 31,
2024
Severance
$ 120
$ 1,509
General and administrative expenses
444
296
Total
$ 564
$ 1,805
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 $ 168 and $ 225 for the three months ended September 30, 2025 and 2025, respectively,
and $ 513 and $ 667 for the nine months ended September 30, 2025 and 2024, respectively. The Company incurred amortization expense on its
operating lease right-of-use assets of $ 111 and $ 152 for the three months ended September 30, 2025 and 2024, respectively, and $ 329 and
$ 446 for the nine months ended September 30, 2025 and 2024, respectively.
Finance
Leases
The
Company incurred interest expense on its finance leases of $ 0 and $ 1 for the three months ended September 30, 2025 and 2024 and $ 0 and
$ 2 for the nine months ended September 30, 2025 and 2024, respectively. The Company incurred amortization expense on its finance lease
right-of-use assets of $ 1 for the three months ended September 30, 2025 and 2024, and $ 3 and $ 4 for the nine months ended September 30,
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 September 30, 2025:
Schedule of Maturity of Operating
and Finance Leases Liabilities
Maturity of Lease Liabilities
Operating Lease
Liabilities
Finance Lease
Liabilities
Remainder of 2025
$ 255
$ 4
2026
1,040
7
2027
944
7
2028
273
—
2029
138
—
-
-
Total undiscounted operating lease payments
$ 2,650
$ 18
Less: Imputed interest
332
2
Present value of operating lease liabilities
$ 2,318
$ 16
Weighted average remaining lease term in years
2.7
2.2
Weighted average discount rate
9.4 %
11.6 %
11
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:
Maturity of Lease Liabilities
Operating Lease
Liabilities
Finance Lease
Liabilities
2025
$ 998
$ 7
2026
1,040
7
2027
944
7
2028
273
—
2029
138
—
Total undiscounted operating lease payments
$ 3,393
$ 21
Less: Imputed interest
516
4
Present value of operating lease liabilities
$ 2,877
$ 17
Weighted average remaining lease term in years
3.3
2.9
Weighted average discount rate
9.3 %
11.6 %
Note
9 – Stockholders’ Equity
As
of September 30, 2025, in accordance with the Certificate of Incorporation, the Company was authorized to issue 500,000,000
shares of common stock and 10,000,000
shares of preferred stock, each share having a par value of $ 0.0001 .
Common
Stock
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 shares. The Certificate of Amendment became effective upon
filing.
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. BTIG will be paid a 3 % commission on the gross proceeds from each sale. The
Company may terminate the Sales Agreement at any time; BTIG may terminate the Sales Agreement in certain limited circumstances. The Company
did no t sell any shares under the Sales Agreement during the nine months ended September 30, 2025. During the nine months ended September
30, 2024, the Company sold 4,366 shares of its common stock generating net proceeds of $ 54 . As of September 30, 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.
12
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 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.
The
following table summarizes the changes in Preferred Stock outstanding for the nine months ended September 30, 2025:
Schedule
of Changes in Preferred Stock Outstanding
Shares
Outstanding at December 31, 2024
—
Issued
3,300
Converted to Common Stock
( 145 )
Outstanding at September 30, 2025
3,155
Warrants
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 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 Warrant Agreement. The Warrants expire
on April 4, 2030 . The Warrants include anti-dilution protection provisions. 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.
On
August 15, 2025, the Company entered into Warrant Exchange Agreements (the “Exchange Agreements”) with the holders (the “Holders”)
of common stock purchase warrants exercisable for an aggregate of up to 466,666 shares of the Company’s common stock originally
issued on April 5, 2024 and having a current exercise price of $ 17.50 (the “2024 Warrants”). Pursuant to the Exchange Agreements,
on August 15, 2025, the Company issued to the Holders one share of common stock for each 2024 Warrant, for an aggregate of 466,666 shares
of common stock (the “Exchange Shares”), in exchange for the 2024 Warrants (the “Exchange”), in reliance on an
exemption from registration provided by Section 3(a)(9) of the Securities Act of 1933, as amended (the “Securities Act”).
Following the consummation of the Exchange, the 2024 Warrants were cancelled and no further shares are issuable pursuant to the 2024
Warrants.
13
The
fair value of the 2024 Warrants immediately prior to Exchange was $ 483 and the total fair value of common stock issued was $ 1,101 . The
Company determined that the excess of fair value of the common stock issued over the fair value of the 2024 Warrants is not associated
with anything other than the Exchange. Thus, the excess amount of $ 618 was recognized as a deemed dividend. As the
Company does not have retained earnings, the dividend will be recognized through accumulated deficit. For purposes of calculating earnings
per share, the Company reduced the income available to common stockholders by $ 618 .
The
following table summarizes the changes in warrants outstanding for the nine months ended September 30, 2025:
Schedule of Shareholder Equity
Warrants Outstanding
Shares
Outstanding at December 31, 2024
666,667
Issued
11,262,808
Exercised
( 100,000 )
Exchanged
( 466,666 )
Expired
—
-
Outstanding at September 30, 2025
11,362,809
The
following table summarizes the changes in warrants outstanding for the nine months ended September 30, 2024:
Shares
Outstanding at December 31, 2023
-
Issued
666,667
Exercised
-
Tendered
-
Expired
-
Outstanding at September 30, 2024
666,667
Net
Loss Per Share
The
following table sets forth the computation of basic and dilutive net loss per share:
Schedule
of Computation of Basic and Dilutive Net Loss Per Share
2025
2024
2025
2024
Three Months Ended
September 30,
Nine Months Ended
September 30,
2025
2024
2025
2024
Numerator:
Net loss attributable to common stockholders
$ ( 1,532 )
$ ( 4,275 )
$ ( 8,433 )
$ ( 15,818 )
Adjustment for deemed dividend (*)
( 618 )
—
( 618 )
—
Adjusted net loss used for basic and diluted calculation
$ ( 2,150 )
$ ( 4,275 )
$ ( 9,051 )
$ ( 15,818 )
Denominator:
Weighted-average common shares, basic and diluted
5,435,829
5,037,829
5,204,544
4,791,572
Net loss per common share:
Basic and diluted
$ ( 0.40 )
$ ( 0.85 )
$ ( 1.74 )
$ ( 3.30 )
(*) Deemed dividend
represents the excess of fair value of common stock issued over the fair value of warrants immediately prior to exchange, which reduces
income available to common stockholders used for the basic and diluted net loss per common share calculation.
14
Basic
and diluted net loss per common share
The
Company had two classes of stock outstanding during the nine months ended September 30, 2025, common stock and preferred stock, and had
only common stock outstanding during the nine months ended September 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.
Under
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. Diluted net loss per share
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 and nine months ended September 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 September 30, 2025 and 2024:
Schedule of Anti-dilutive Securities
Excluded from Computation of Earning Per Share
As of September 30,
2025
2024
Stock options
457,219
872,063
Convertible preferred stock upon conversion
5,383,964
—
Warrants
11,362,809
666,667
Total
17,203,992
1,538,730
Note
10 – Stock-based Compensation
2013
Plan
The
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
rights. The term of the 2013 Plan was for 10 years .
As
of September 30, 2025, there were 434,334 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.
2025
Plan
On
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.
As
of September 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.
The
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
2025
2024
2025
2024
Three Months Ended
September 30,
Nine Months Ended
September 30,
2025
2024
2025
2024
Research and Development
$ —
$ 387
$ 85
$ 1,212
General and Administrative
253
578
721
1,739
Total
$ 253
$ 965
$ 806
$ 2,951
As
of September 30, 2025, total compensation costs related to unvested awards not yet recognized was $ 990 and the weighted-average
periods over which the awards are expected to be recognized was 1.7 years.
Stock
Options
The
following table summarizes the activity for Company’ stock options for the nine months ended September 30, 2025:
Schedule of Stock Option Activity
Stock Options
Outstanding at December 31, 2024
687,356
Granted
116,500
Exercised
—
Forfeited
( 3,101 )
Expired
( 343,536 )
Outstanding at September 30, 2025
457,219
15
Item
2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The
following discussion and analysis of our financial condition and results of operations should be read together with our financial statements
and the related notes and the other financial information included elsewhere in this Quarterly Report on Form 10-Q. This discussion contains
forward-looking statements that involve risks and uncertainties. Our actual results could differ materially from those anticipated in
these forward-looking statements as a result of various factors, including those discussed below and elsewhere in this Quarterly Report
on Form 10-Q, in our Annual Report on Form 10-K for the year ended December 31, 2024 and in other reports we file with the Securities
and Exchange Commission, particularly those under “Risk Factors.” Dollars in tabular format are presented in thousands, except
per share data, or as otherwise indicated.
CAUTIONARY
NOTE REGARDING FORWARD-LOOKING STATEMENTS
This
report on Form 10-Q contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation
Reform Act of 1995 under Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange
Act”). Forward-looking statements include statements with respect to our beliefs, plans, objectives, goals, expectations, anticipations,
assumptions, estimates, intentions and future performance, and involve known and unknown risks, uncertainties and other factors, which
may be beyond our control, and which may cause our actual results, performance or achievements to be materially different from future
results, performance or achievements expressed or implied by such forward-looking statements. All statements other than statements of
historical fact are statements that could be forward-looking statements. You can identify these forward-looking statements through our
use of words such as “may,” “can,” “anticipate,” “assume,” “should,” “indicate,”
“would,” “believe,” “contemplate,” “expect,” “seek,” “estimate,”
“continue,” “plan,” “point to,” “project,” “predict,” “could,”
“intend,” “target,” “potential” and other similar words and expressions of the future.
There
are a number of important factors that could cause the actual results to differ materially from those expressed in any forward-looking
statement made by us. These factors include, but are not limited to:
●
our ability to complete
one or more strategic transactions that will maximize our assets or otherwise provide value to stockholders;
●
our ability to raise capital
when needed;
●
our ability to maintain
or protect the validity of our patents and other intellectual property; and
●
the factors listed under
the heading “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2024, elsewhere in this
report and other reports that we file with the Securities and Exchange Commission.
All
forward-looking statements are expressly qualified in their entirety by this cautionary notice. You are cautioned not to place undue
reliance on any forward-looking statements, which speak only as of the date of this report or the date of the document incorporated by
reference into this report. We have no obligation, and expressly disclaim any obligation, to update, revise or correct any of the forward-
looking statements, whether as a result of new information, future events or otherwise. We have expressed our expectations, beliefs and
projections in good faith, and we believe they have a reasonable basis. However, we cannot assure you that our expectations, beliefs
or projections will result or be achieved or accomplished.
Overview
We
are a clinical-stage biopharmaceutical company focused on delivering groundbreaking therapies using our lipid nanocrystal (LNC) platform
delivery technology (LNC Platform).
16
Key
elements of our strategy now include:
●
Securing one or more partners
to monetize the value of MAT2203 in the short term and raise additional non-dilutive capital through the licensing or sale of our
lead LNC Platform product candidate. A partnership would likely seek to advance MAT2203 into Phase 3 development as quickly as possible,
which could position a partner to commercialize MAT2203 upon approval and which could bring additional longer-term value to the Company
and its shareholders.
●
Conserving our cash resources
while identifying and evaluating other strategic options for the Company, which could include the in-license of one or more assets
or seeking a merger partner for the Company.
For
the nine month periods ended September 30, 2025 and 2024, our net loss was $8,433 and $15,818, respectively. We have incurred losses for
each period from our inception and expect to incur additional losses for the foreseeable future. We will seek to fund our operations
through public or private equity offerings, debt financing, government or other third-party funding, collaborations and licensing arrangements.
Adequate additional financing may not be available to us on acceptable terms, or at all. Our failure to raise capital as and when needed
would impact our going concern and would have a negative impact on our financial condition and our ability to pursue our business strategy
and continue as a going concern. We will need to generate significant revenues to achieve profitability, and we may never do so.
Financial
Operations Overview
Research
and Development Expenses
Research
and development expenses consist of costs incurred for the development of product candidate MAT2203 and advancement of our LNC platform,
which include:
●
the
cost of acquiring, developing, and manufacturing pre-clinical and human clinical trial materials;
●
costs
for consultants and contractors associated with Chemistry and Manufacturing Controls (CMC), pre-clinical and clinical activities
and regulatory operations;
●
expenses
incurred under agreements with contract research organizations, or CROs, including the NIH, that conduct our pre-clinical or clinical
trials; and
●
employee-related
expenses, including salaries and stock-based compensation expense for those employees involved in the research and development process.
Research
and development activities are central to our business model. We expect our research and development expenses to increase over time because
product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical
development, primarily due to the increased size and duration of later-stage human trials. However, we anticipate that our research and
development expenses during 2025 will be lower compared with expenses incurred during 2024 until such time, if at all, as we are able
to secure additional funding to support initiation of our Phase 3 registration trial for MAT2203 and advancement of our LNC platform
delivery technology.
General
and Administrative Expenses
General
and administrative expense for the three and nine months ended September 30, 2025 were $1,577 and $5,275, respectively, and the three
and nine months ended September 30, 2024 were $2,142 and $7,067, respectively. General and administrative expenses consist principally
of salaries and related costs for personnel in executive and finance functions. Other general and administrative expenses include facility
costs, insurance, investor relations expenses, professional fees for legal, patent review, consulting and accounting/audit services.
Our general and administrative expenses during 2025 decreased slightly compared to expenses incurred during 2024
as a result of cost-cutting measures implemented to conserve cash.
17
Change
in fair value of warrant liability
In
a series of transactions on February 13, 2025, and April 8, 2025, the Company closed a private placement investment with certain investors
in which the investors received shares of Series C Preferred Stock and Warrants to purchase shares the Company’s common stock.
The Warrants were initially classified as a liability upon each issuance date with the fair value estimated using a Monte Carlo simulation
model. The terms of the Warrants were amended after issuance enabling for reclassification of the Warrants as equity. Changes in fair
value between the dates of issuance and the date of amendment were recognized in other (expense)/income, net at each reporting period.
A
loss of $3,161 was recognized for the nine months ended September 30, 2025, representing the change in fair value of the warrant liability
between the issuance dates of February 13, 2025 and April 8, 2025 and the amendment date of June 26, 2025.
Gain
on sale of assets, net
During
the nine months ended September 30, 2025, the company sold equipment with a net book value of $210. Proceeds from the sale were $320,
resulting in a gain of $110.
Other
(expense)/income, net
Other
(expense)/income, net for the nine months ended September 30, 2025 and 2024 were ($22) and $306, respectively. Other (expense)/income,
net decreased compared to the prior period primarily due to recording issuance costs of $251 in connection with the Company’s private
placement of Series C Preferred Stock and warrants.
Application
of Critical Accounting Policies and Accounting Estimates
A
critical accounting policy is one that is both important to the portrayal of our financial condition and results of operations and requires
management’s most difficult, subjective or complex judgments, often as a result of the need to make estimates about the effect
of matters that are inherently uncertain.
For
a description of our significant accounting policies, refer to “Note 3 – Summary of Significant Accounting Policies ”
in our 2024 Form 10-K. Of these policies, the following are considered critical to an understanding of our Unaudited Condensed Consolidated
Financial Statements as they require the application of the most difficult, subjective and complex judgments: (i) Other intangible assets,
and (ii) Warrants.
Warrants
We
account 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.
Warrants classified as equity are recorded at fair value as of the date of issuance on our condensed consolidated balance sheets and
no further adjustments to their valuation are made. Warrants that require separate accounting as liabilities are recorded on our 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 expire, 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. See Note 9 - Stockholders’ Equity for a discussion on the Company’s warrants.
Recent
Accounting Pronouncements
Refer
to “Note 3 – Summary of Significant Accounting Policies” in the Notes to Unaudited Condensed Consolidated Financial
Statements for a discussion of recently adopted accounting pronouncements and their expected impact on our financial positions and results
of operations.
18
Current
Operating Trends
Our
current R&D efforts are focused on advancing our lead LNC product candidate, MAT2203. Our R&D expenses consist of fees paid to
consultants for work related to clinical trial design and regulatory activities, fees paid to providers for conducting various clinical
studies as well as for the analysis of the results of such studies, and for other medical research addressing the potential efficacy
and safety of our drugs. We believe that significant investment in product development is a competitive necessity, and we are seeking
a partner to assist us in continuing to make these investments to be in a position to realize the potential of our product candidates
and proprietary technologies.
We
expect that most of our R&D expenses in the near-term, if any, will be incurred in support of MAT2203 and positioning that drug for
a partnership with a well-funded and experienced third party biotech or pharmaceutical company.
Results
of Operations
Comparison
of the three months ended September 30, 2025 to the three months ended September 30, 2024
The
following tables summarize our revenues and operating expenses for the periods presented:
Three Months Ended September 30,
2025
2024
Expenses:
Research and development
$ —
$ 2,239
General and administrative
1,577
2,142
Operating Expenses
$ 1,577
$ 4,381
Research
and Development expenses. Research and Development (R&D) expense for the three months ended September 30, 2025 and 2024 were
$0 and $2,239, respectively. The decrease in R&D expenses was primarily attributable to the decrease in clinical trial consulting
costs related to the pause of our MAT2203 development program and in headcount costs resulting from our reduction in force.
General
and Administrative expenses. General and Administrative (G&A) expense for the three months ended September 30, 2025 and 2024
was $1,577 and $2,142, respectively. The decrease in G&A expenses was primarily attributable to lower stock based compensation expense
and decreased headcount.
Comparison
of the nine months ended September 30, 2025 to the nine months ended September 30, 2024
The
following tables summarize our revenues and operating expenses for the periods presented:
Nine Months Ended September 30,
2025
2024
Expenses:
Research and development
$ 85
$ 9,057
General and administrative
5,275
7,067
Operating Expenses
$ 5,360
$ 16,124
Research
and Development expenses. Research and Development (R&D) expense for the nine months ended September 30, 2025 and 2024 were
$85 and $9,057, respectively. The decrease in R&D expenses was primarily attributable to the decrease in clinical trial consulting
costs related to the pause of our MAT2203 development program and in headcount costs resulting from our reduction in force.
General
and Administrative expenses. General and Administrative (G&A) expense for the nine months ended September 30, 2025 and 2024
was $5,275 and $7,067, respectively. The decrease in G&A expenses was primarily attributable to lower stock based compensation expense
and decreased headcount.
19
Liquidity
and capital resources
Sources
of Liquidity
We
have funded our operations since inception primarily through private placements of our preferred stock and our common stock and common
stock warrants. As of September 30, 2025, we have raised a total of $170,271 in gross proceeds and $156,529, net, from sales of our equity
securities.
As
of September 30, 2025, we had cash and cash equivalents, excluding restricted cash, totaling $5,435.
2025
Private Placement
On
February 13, 2025, we entered into a Securities Purchase Agreement (the “Purchase Agreement”) with certain investors (the
“Purchasers”), pursuant to which we agreed to issue and sell, in a private placement (the “Offering”), an aggregate
of 3,300 shares of our Series C Convertible Preferred Stock, par value $0.0001 per share (the “Preferred Stock”), initially
convertible into up to 5,631,404 shares of our common stock, par value $0.0001 per share (the “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. The Purchase Agreement contains customary
representations, warranties and agreements by us and customary conditions to closing.
Pursuant
to the Purchase Agreement, on February 13, 2025, we issued and sold in an initial closing of the Offering 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 of $1.65 million. On April 4, 2025, we obtained shareholder approval for the issuance of the
Preferred Stock and Warrants, as required by the rules and regulations of NYSE American LLC, including Section 713 of the NYSE American
Company Guide, and issued and sold, in a second closing of the Offering, 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 of $1.65 million.
2024
Registered Direct Offering
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 approximately $10,000 and net proceeds of approximately $9,125, after deducting underwriting discounts
and commissions and other offering expenses.
2020
At-The-Market Sales Agreement
On
July 2, 2020, we entered into an At-The-Market Sales Agreement (the “Sales Agreement”) with BTIG, LLC (“BTIG”),
pursuant to which we may offer and sell, from time to time, through BTIG, as sales agent and/or principal, shares of our common stock
having an aggregate offering price of up to $50 million, subject to certain limitations on the amount of common stock that may be offered
and sold by us set forth in the Sales Agreement. BTIG will be paid a 3% commission on the gross proceeds from each sale. We 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 nine months ended September 30, 2025. During the nine months ended June 30, 2024, the Company
sold 4 shares of its common stock generating net proceeds of $54. As of September 30, 2025, the Sales Agreement’s available capacity
is $44,191.
Cash
Flows
The
following table sets forth the primary sources and uses of cash, cash equivalents and restricted cash for each of the periods set forth
below:
Nine Months Ended September 30,
2025
2024
Cash used in operating activities
$ (5,502 )
$ (12,375 )
Cash provided by investing activities
320
8,708
Cash provided by financing activities
3,333
9,175
Net (decrease)/increase in cash and cash equivalents and restricted cash
$ (1,849 )
$ 5,508
20
Operating
Activities
Net
cash used in operating activities was $5,502 and $12,375 for the nine month periods ended September 30, 2025 and 2024, respectively.
Net losses of $8,433 and $15,818 for the nine month periods ended September 30, 2025 and 2024, respectively, were partially offset by
working capital adjustments due to the timing of receipts and payments in the ordinary course of business, adjustments for non-cash stock
based compensation expense and change in fair value of the warrant liability.
Investing
Activities
Net
cash provided by investing activities was $320 and $8,708 for the nine month periods ended September 30, 2025 and 2024, respectively. The
decrease in cash provided by investing activities was primarily due to a
year over year decrease of $8,708 in net maturities of marketable debt securities, partially offset by $320 from the sale of assets in 2025.
Financing
Activities
Net
cash provided by financing activities was $3,333 and $9,175 for the nine month periods ended September 30, 2025 and 2024, respectively.
The decrease in cash provided by financing activities is primarily due to the net proceeds from the sale of our Series C preferred stock
of $3,271 and the exercise of warrants $64 during the nine months ended September 30, 2025, being less than the net proceeds from the
registered direct sale of our common stock of $9,179 during the nine months ended September 30, 2024.
Funding
Requirements and Other Liquidity Matters
We
expect to continue to incur significant expenses and operating losses for the foreseeable future. We anticipate that our expenses will
increase substantially if and as we:
●
conduct
further preclinical and clinical studies of MAT2203, our lead product candidate, even if such studies are primarily financed with
non-dilutive funding from the NIH;
●
seek
to discover and develop additional product candidates;
●
seek
regulatory approvals for any product candidates that successfully complete clinical trials;
●
require
the manufacture of larger quantities of product candidates for clinical development and potentially commercialization;
●
maintain,
expand and protect our intellectual property portfolio;
●
hire
additional clinical, quality control and scientific personnel; and
●
add
operational, financial and management information systems and personnel, including personnel to support our product development and
planned future commercialization efforts and personnel and infrastructure necessary to help us comply with our obligations as a public
company.
We
do not believe that our existing cash and cash equivalents will be sufficient to fund our operating expenses and capital expenditures
requirements beyond the next twelve months from the filing date of this Quarterly Report. As a result, substantial doubt exists about
the Company’s ability to continue as a going concern.
21
Until
such time, if ever, that we can generate revenues sufficient to achieve profitability, we expect to finance our cash needs through a
combination of private and public equity offerings, debt financings, government or other third-party funding, collaborations, and licensing
arrangements. To the extent that we raise additional capital through the sale of common stock, convertible securities or other equity
securities, the ownership interest of our stockholders may be materially diluted, and the terms of these securities may include liquidation
or other preferences that adversely affect your rights of our common stockholders. Debt financing and preferred equity financing, if
available, would result in increased fixed payment obligations and may involve agreements that include covenants limiting or restricting
our ability to take specific actions, such as incurring additional debt, making capital expenditures, or declaring dividends, that could
adversely impact our ability to conduct our business. Securing additional financing could require a substantial amount of time and attention
from our management and may divert a disproportionate amount of their attention away from day-to-day activities, which may adversely
affect our management’s ability to secure one or more partners to monetize the value of MAT2203 or future product candidates.
If
we raise additional funds through collaborations, strategic alliances or marketing, distribution, or licensing arrangements with third
parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates
or grant licenses on terms that may not be favorable to us.
Our
financial condition and results of operations may also be impacted by other factors we may not be able to control, such as global supply
chain disruptions, global trade disputes and/or political instability. Increases in interest rates, especially if coupled with reduced
government spending and volatility in financial markets, may have the effect of further increasing economic uncertainty and heightening
these risks. Additionally, rising inflation rates may affect us by increasing operating expenses, such as employee-related costs and
clinical trial expenses, negatively impacting our results of operations.
Off-Balance
Sheet Arrangements
We
did not have during the periods presented, and we do not currently have, any off-balance sheet arrangements, as defined under SEC rules,
such as relationships with unconsolidated entities or financial partnerships, which are often referred to as structured finance or special
purpose entities, established for the purpose of facilitating financing transactions that are not required to be reflected on our balance
sheets.
Item
3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.
Not
applicable.
Item
4. CONTROLS AND PROCEDURES.
Evaluation
of Disclosure Controls and Procedures.
Disclosure
Controls and Procedures:
As
of September 30, 2025, under the supervision and with the participation of our principal executive officer and principal financial officer
we have evaluated, the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Rules 13a-15(e)
and 15d-15(e) under the Exchange Act. Based on that evaluation, our principal executive officer and principal financial officer concluded
that because remediation of the deficiency in internal control over financial reporting described in our Annual Report on Form 10-K for
the year ended December 31, 2024 has not been completed as described below, our disclosure controls and procedures were not effective
at the reasonable assurance level as of September 30, 2025.
Our
disclosure controls and procedures are designed to provide reasonable assurance that information required to be disclosed in the reports
that we filed or submitted under the Exchange Act is recorded, processed, summarized and reported within time periods specified by the
SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure
that information required to be disclosed in our reports filed under the Exchange Act is accumulated and communicated to our management,
including principal executive officer and principal financial officer, as appropriate to allow timely decisions regarding required disclosure.
22
Management’s
Report on Internal Control over Financial Reporting:
Our
management is responsible for establishing and maintaining adequate internal control over financial reporting. Internal control over
financial reporting is a process designed by, or under the supervision of, our principal executive officer and principal financial officer
to provide reasonable assurance regarding the reliability of financial reporting and the preparation of consolidated financial statements
for external purposes in accordance with generally accepted accounting principles. Our control over financial reporting includes those
policies and procedures that (1) pertain to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions
and dispositions of our assets; (2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of
financial statements in accordance with generally accepted accounting principles, and that our receipts and expenditures are being made
only in accordance with authorizations of our management and directors; and (3) provide reasonable assurance regarding prevention or
timely detection of unauthorized acquisition, use or disposition of our assets that could have a material effect on the consolidated
financial statements.
Because
of inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, any projections of
any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions,
or that the degree of compliance with policies and procedures may deteriorate.
A
material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is
a reasonable possibility that a material misstatement of the annual or interim consolidated financial statements will not be prevented
or detected on a timely basis.
As
previously disclosed in our Annual Report on Form 10-K for the year ended December 31, 2024, an evaluation was conducted under the supervision
and with the participation of management, including our CEO and CFO, on the effectiveness of the Company’s internal control over
financial reporting as of December 31, 2024 based on criteria related to internal control over financial reporting described in Internal
Control – Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO 2013
Framework). Based on this evaluation, management determined that because of the material weaknesses described below, the Company’s
internal control over financial reporting was not effective as of December 31, 2024.
We
did not maintain an effective internal control environment to ensure the processing of and reporting of non-routine transactions are
complete, accurate and timely, including the Company’s indefinite-lived assets impairment assessment.
The
material weakness identified above could result in a misstatement to the aforementioned asset balances and disclosures that would result
in a material misstatement to the annual or interim consolidated financial statements that would not be prevented or detected on a timely
basis.
Remediation
Plan:
Management
has initiated a remediation plan to address the control deficiency that led to the material weakness. The remediation plan includes,
but is not limited to, engagement of additional external accounting resources to assist with the preparation and review of the Company’s
non-routine transactions.
Changes
in Internal Control Over Financial Reporting
Except
for changes being implemented by the Company to address the material weakness identified above, there were no changes in our internal
control over financial reporting during the third quarter of 2025 that have materially affected, or are reasonably likely to materially
affect, our internal control over financial reporting.
PART
II - OTHER INFORMATION
Item
1. LEGAL PROCEEDINGS.
None.
23
Item
1A. RISK FACTORS.
Except
as set forth below, there were no material changes from the risk factors set forth under Part I, Item 1A., “Risk Factors”
in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024. You should carefully consider the risk factors contained
in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024 in addition to the other information set forth in this
report which could materially affect our business, financial condition or future results. The risks and uncertainties described in this
report and in our Annual Report on Form 10-K for the year ended December 31, 2024, as well as other reports and statements that we file
with the SEC, are not the only risks and uncertainties facing us. Additional risks and uncertainties not currently known to us or that
we currently deem to be immaterial may also have a material adverse effect on our financial position, results of operations or cash flows.
Item
2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS.
On
February 13, 2025 and April 8, 2025, pursuant to the Purchase Agreement, the Company sold to the Purchasers, in two equal tranches, an
aggregate of 3,300 shares of Preferred Stock, initially convertible into up to 5,631,404 shares of Common Stock, and accompanying Warrants,
initially exercisable for up to 11,262,808 shares of Common Stock, for gross proceeds to the Company of an aggregate of $3.3 million.
The shares of Preferred Stock and Warrants were sold without registration under the Securities Ac, 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.
Item
3. DEFAULTS UPON SENIOR SECURITIES.
None.
Item
4. MINE SAFETY DISCLOSURES.
Not
applicable.
Item
5. OTHER INFORMATION.
Rule
10b5-1 Trading Arrangements and Non-Rule 10b5-1 Trading Arrangements
During
the fiscal quarter ended September 30, 2025, none of our officers or directors, as those terms are defined in Rule 16a-1(f), adopted
or terminated a “Rule 10b5-1 trading arrangement” or a “non-Rule 10b5-1 trading arrangement,” as those terms
are defined in Item 408 of Regulation S-K.
Item
6. EXHIBITS.
See
the Exhibit Index following the signature page to this Quarterly Report on Form 10-Q for a list of exhibits filed or furnished with this
report, which Exhibit Index is incorporated herein by reference.
24
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned thereunto duly authorized.
MATINAS BIOPHARMA HOLDINGS, INC.
BY:
/s/ Jerome
D. Jabbour
Dated: November 10, 2025
Jerome D. Jabbour
Chief Executive Officer (Principal Executive Officer)
/s/ Keith
A. Kucinski
Dated: November 10, 2025
Keith A. Kucinski
Chief Financial Officer
(Principal Financial and Accounting Officer)
25
EXHIBIT
INDEX
3.1
Certificate of Incorporation (incorporated by reference to Exhibit 3.1 to Amendment No. 1 to the Company’s Registration Statement on Form S-1 filed with the SEC on February 7, 2014).
3.2
Bylaws (incorporated by reference to Exhibit 3.2 to Amendment No. 1 to the Company’s Registration Statement on Form S-1 filed with the SEC on February 7, 2014).
3.3
Certificate of Amendment, dated October 29, 2015 to Certificate of Incorporation. (incorporated herein by reference to the Company’s Current Report on Form 8-K filed with the SEC on November 5, 2015).
3.4
Certificate of Amendment of Certificate of Incorporation, dated August 30, 2024 (filed as an exhibit to the Current Report on Form 8-K, filed with the Commission on September 3, 2024 and incorporated herein by reference).
3.5
Form of Certificate of Designation of Series C Convertible Preferred Stock (filed as an exhibit to the Current Report on Form 8-K filed with the Commission on February 13, 2025 and incorporated herein by reference).
3.6
Certificate of Amendment of Certificate of Incorporation, as amended, of Matinas BioPharma Holdings, Inc., dated August 6, 2025 (filed as an exhibit to the Current Report on Form 8-K filed with the Commission on August 6, 2025 and incorporated herein by reference).
4.1
Form of Common Stock Purchase Warrant, dated April 5, 2024 (incorporated herein by reference to the Company’s Current Report on Form 8-K filed with the SEC on April 5, 2024).
4.2
Description of Securities (filed as an exhibit to the Annual Report on Form 10-K filed with the Commission on April 15, 2025 and incorporated herein by reference).
4.3
Form of Common Stock Purchase Warrant (filed as an exhibit to the Current Report on Form 8-K filed with the Commission on February 13, 2025 and incorporated herein by reference).
10.1
Form of Warrant Exchange Agreement, dated August 15, 2025 (filed as an exhibit to the Current Report on Form 8-K filed with the Commission on August 18, 2025 and incorporated herein by reference).
*31.1
Certification of Chief Executive Officer
*31.2
Certification of Chief Financial Officer
*32.1
Section 1350 Certifications
*101.1
Inline XBRL Instance Document.
*101.2
Inline XBRL Taxonomy Extension
Schema Document.
*101.3
Inline XBRL Taxonomy Extension
Calculation Linkbase Document.
*101.4
Inline XBRL Taxonomy Extension
Definition Linkbase Document.
*101.5
Inline XBRL Taxonomy Extension
Label Linkbase Document.
*101.6
Inline XBRL Taxonomy Extension
Presentation Linkbase Document.
104
Cover Page Interactive
Data File (embedded within the Inline XBRL document)
*
Filed herewith.
†
Indicates a management contract or compensation plan, contract or arrangement. Certain portions of this exhibit, that are not material
and would likely cause competitive harm to the registrant if publicly disclosed, have been redacted pursuant to Item 601(b)(10) of Regulation
S-K.
26
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.