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 March 31, 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 May 15, 2025, there were 5,086,985 shares of
the registrant’s common stock, $ 0.0001 par value, outstanding.
MATINAS BIOPHARMA HOLDINGS, INC.
Form 10-Q
Quarter Ended March 31, 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
14
Item 3.
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
19
Item 4.
CONTROLS AND PROCEDURES
19
PART - II OTHER INFORMATION
21
Item 1.
LEGAL PROCEEDINGS
21
Item 1A.
RISK FACTORS
21
Item 2.
UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
21
Item 3.
DEFAULTS UPON SENIOR SECURITIES
21
Item 4.
MINE SAFETY DISCLOSURES
21
Item 5.
OTHER INFORMATION
21
Item 6.
EXHIBITS
23
2
PART - I FINANCIAL INFORMATION
Item 1. FINANCIAL STATEMENTS
Matinas BioPharma Holdings, Inc.
Condensed Consolidated Balance Sheets
(in thousands, except for share data)
March 31, 2025
December 31, 2024
(Unaudited)
(Audited)
ASSETS:
Current assets:
Cash and cash equivalents
$ 6,924
$ 7,284
Restricted cash – security deposit
50
50
Prepaid expenses and other current assets
573
691
Total current assets
7,547
8,025
Non-current assets:
Leasehold improvements and equipment – net
450
468
Operating lease right-of-use assets – net
1,571
1,680
Finance lease right-of-use assets – net
7
8
In-process research and development
2,260
2,260
Restricted cash – security deposit
200
200
Total non-current assets
4,488
4,616
Total assets
$ 12,035
$ 12,641
LIABILITIES AND STOCKHOLDERS’ EQUITY:
Current liabilities:
Accounts payable
$ 282
$ 95
Accrued expenses
1,179
1,805
Operating lease liabilities – current
788
761
Financing lease liabilities – current
6
5
Total current liabilities
2,255
2,666
Non-current liabilities:
Deferred tax liability
257
257
Operating lease liabilities – net of current portion
1,909
2,116
Financing lease liabilities – net of current portion
11
12
Warrant liability
1,333
—
Total non-current liabilities
3,510
2,385
Total liabilities
5,765
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 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
1
1
Additional paid-in capital
207,749
207,413
Accumulated deficit
( 201,480 )
( 199,824 )
Total stockholders’ equity
6,270
7,590
Total liabilities and stockholders’ equity
$ 12,035
$ 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
Three Months Ended March 31,
2025
2024
Costs and Expenses:
Research and development
$ 85
$ 3,446
General and administrative
1,861
2,456
Total costs and expenses
1,946
5,902
Loss from operations
( 1,946 )
( 5,902 )
Change in fair value of warrant liability
294
—
Other (expense)/income, net
( 4 )
78
Net loss
$ ( 1,656 )
$ ( 5,824 )
Net loss per share – basic and diluted
$ ( 0.33 )
$ ( 1.34 )
Weighted average common shares outstanding:
Basic and diluted
5,086,985
4,347,162
Other comprehensive gain, net of tax
Unrealized gain on securities available-for-sale
—
87
Other comprehensive gain, net of tax
—
87
Comprehensive loss
$ ( 1,656 )
$ ( 5,737 )
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
Additional
Accumulated Other
Total
Preferred Stock Series C
Common Stock
Paid - in
Accumulated
Comprehensive
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
—
—
—
—
315
—
—
315
Issuance of preferred stock and warrants in public offering, net of stock issuance costs ($ 2 )
1,650
—
—
—
21
—
—
21
Net loss
—
—
—
—
—
( 1,656 )
( 1,656 )
Balance, March 31, 2025
1,650
$ —
5,086,985
$ 1
$ 207,749
$ ( 201,480 )
$ —
$ 6,270
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, 2023
—
$ —
4,345,291
$ —
$ 195,040
$ ( 175,573 )
$ ( 221 )
$ 19,246
Balance
—
$ —
4,345,291
$ —
$ 195,040
$ ( 175,573 )
$ ( 221 )
$ 19,246
Stock-based compensation
—
—
—
—
995
—
—
995
Issuance of common stock in public offering, net of stock issuance cost ($ 2 )
—
—
4,366
—
54
—
—
54
Issuance of common stock in public offering, net of stock issuance cost
—
—
4,366
—
54
—
—
54
Other comprehensive loss
—
—
—
—
—
—
87
87
Net loss
—
—
—
—
—
( 5,824 )
—
( 5,824 )
Balance, March 31, 2024
—
$ —
4,349,657
$ —
$ 196,089
$ ( 181,397 )
$ ( 134 )
$ 14,558
Balance
—
$ —
4,349,657
$ —
$ 196,089
$ ( 181,397 )
$ ( 134 )
$ 14,558
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
Three Months Ended March 31,
2025
2024
Cash flows from operating activities:
Net loss
$ ( 1,656 )
$ ( 5,824 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization
18
94
Stock based compensation expense
315
995
Amortization of operating lease right-of-use assets
109
145
Amortization of finance lease right-of-use assets
1
1
Amortization of bond discount
—
18
Change in fair value of warrant liability
( 294
)
—
Changes in operating assets and liabilities:
Operating lease liabilities
( 179 )
( 154 )
Prepaid expenses and other current assets
119
( 393 )
Accounts payable
187
( 41 )
Accrued expenses and other liabilities
( 627 )
( 610 )
Net cash used in operating activities
( 2,007 )
( 5,769 )
Cash flows from investing activities:
Proceeds from maturities of marketable debt securities
—
2,000
Net cash provided by investing activities
—
2,000
Cash flows from financing activities:
Gross proceeds from private placement of preferred stock and common stock warrants
1,650
—
Transaction costs paid pursuant to private placement
( 2 )
—
Net proceeds from public offering of common stock
—
54
Payments of finance lease liability – principal
( 1 )
( 1 )
Net cash provided by financing activities
1,647
53
Net decrease in cash, cash equivalents and restricted cash
( 360 )
( 3,716 )
Cash, cash equivalents and restricted cash at beginning of period
7,534
5,037
Cash, cash equivalents and restricted cash at end of period
$ 7,174
$ 1,321
Supplemental non-cash financing and investing activities:
Fair value at issuance of liability classified warrants
$ 1,627
$ —
Unrealized gain on marketable debt securities
$ —
$ 87
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 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
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
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. 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
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.
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.
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.
7
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 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:
Schedule of Cash, Cash Equivalents
and Restricted Cash
March 31,
2025
December 31,
2024
March 31,
2024
December 31,
2023
Cash and cash equivalents
$ 6,924
$ 7,284
$ 1,071
$ 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
$ 7,174
$ 7,534
$ 1,321
$ 5,037
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.
8
A
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
Total
(Level 1)
(Level 2)
(Level 3)
Fair Value Hierarchy
March 31, 2025
Total
(Level 1)
(Level 2)
(Level 3)
Liabilities
Warrant liability
1,333
—
—
1,333
Total
$ 1,333
$ —
$ —
$ 1,333
The
Company did not have any financial assets or liabilities that were carried at fair value using the hierarchy as of December 31, 2024.
The
table below presents a summary of changes in fair value of the Warrant liability that is 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
1,627
Change in fair value
( 294 )
Balance at March 31, 2025
1,333
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:
Schedule
of Warrant Liability
Expected volatility
54.0 % - 56.0
%
Risk-free interest rate
3.95 % - 4.39
%
Stock price on valuation
date
$
0.52 - 0.60
Exercise price
$
0.64
Dividend yield
0.00
%
Expected term
4.9 - 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:
Schedule of Leasehold Improvements
and Equipment
March 31,
2025
December 31,
2024
Equipment
$ 283
$ 283
Leasehold improvements
218
218
Total
501
501
Leasehold improvements and equipment, gross
501
501
Less: accumulated depreciation and amortization
51
33
Leasehold improvements and equipment, net
$ 450
$ 468
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:
Schedule of Accrued Expenses
March 31,
2025
December 31,
2024
Severance
$ 922
$ 1,509
General and administrative expenses
257
296
Total
$ 1,179
$ 1,805
9
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:
Schedule of Maturity of Operating
and Finance Leases Liabilities
Maturity of Lease Liabilities
Operating Lease
Liabilities
Finance Lease
Liabilities
Remainder of 2025
$ 753
$ 5
2026
1,040
7
2027
944
7
2028
273
—
2029
138
—
-
-
Total undiscounted operating lease payments
$ 3,148
$ 19
Less: Imputed interest
451
2
Present value of operating lease liabilities
$ 2,697
$ 17
Weighted average remaining lease term in years
3.1
2.7
Weighted average discount rate
9.3 %
11.6 %
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 %
10
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 .
Common Stock
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. 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 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.
11
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.
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.
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 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 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
own stock. 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:
Schedule of Shareholder Equity
Warrants Outstanding
Shares
Outstanding at December 31, 2024
666,667
Issued
5,631,404
Exercised
—
Tendered
—
Expired
—
Outstanding at March 31, 2025
6,298,071
Basic and diluted net loss per common
share
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
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 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 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:
12
Schedule of Anti-dilutive Securities
Excluded from Computation of Earning Per Share
As of March 31,
2025
2024
Stock options
483,489
920,631
Convertible preferred stock upon conversion
2,815,702
—
Warrants
6,298,071
—
Total
9,597,262
920,631
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. The term of the 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 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
Three Months Ended March 31,
2025
2024
Research and Development
$ 85
$ 415
General and Administrative
230
580
Total
$ 315
$ 995
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:
Schedule of Stock Option Activity
Stock Options
Outstanding at December 31, 2024
687,356
Granted
—
Exercised
—
Forfeited
( 3,101 )
Expired
( 200,766 )
Outstanding at March 31, 2025
483,489
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.
13
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).
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.
14
For the three month periods ended March 31, 2025 and
2024, our net loss was $1,656 and $5,824, 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.
15
General and Administrative Expenses
General and administrative expenses for the three
months ended March 31, 2025 and 2024 were $1,861 and $2,456, 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. We
anticipate that our general and administrative expenses during 2025 will decrease slightly compared to expenses incurred during 2024 as
a result of cost-cutting measures implemented to conserve cash.
Change in fair value of warrant liability
On February 13, 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 classified as a liability upon issuance with the fair value estimated using
a Monte Carlo simulation model. Future changes in fair value will be recognized in other (expense)/income, net at each reporting period
until the warrants are either exercised or expired.
A gain of $294 was recognized for the
three months ended March 31, 2025, representing the change in fair value of the warrant liability between the issuance date of February
13, 2025 and March 31, 2025.
Other (expense)/income, net
Other (expense)/income, net for the three months ended March 31, 2025 and 2024 were ($4) and $78, respectively. Other (expense)/income, net decreased compared to
the prior period primarily due to recording issuance costs of $148 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) Research and development expenses, (ii) Goodwill and other
intangible assets, and (iii) 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.
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.
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 March 31,
2025 to the three months ended March 31, 2024
The following tables summarize our revenues and operating
expenses for the periods presented:
Three Months Ended March 31,
2025
2024
Expenses:
Research and development
$ 85
$ 3,446
General and administrative
1,861
2,456
Operating Expenses
$ 1,946
$ 5,902
16
Research and Development expenses. Research
and Development (R&D) expense for the three months ended March 31, 2025 and 2024 were $85 and $3,446, respectively. The decrease
in R&D expenses were 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 March 31, 2025 and 2024 was $1,861 and $2,456, respectively. The
decrease in G&A expenses were primarily attributable to lower stock based compensation expense and decreased headcount partially offset
by increased legal and consulting fees.
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 March 31, 2025, we have raised
a total of $168,557 in gross proceeds and $154,945, net, from sales of our equity securities.
As of March 31, 2025, we had cash and cash equivalents,
excluding restricted cash, totaling $6,924.
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 (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 of $1.65 million. On April 4, 2025, we 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 of $1.65 million.
Under the terms of the Securities Purchase Agreement,
we are 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.
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 three months
ended March 31, 2025. During the three months ended March 31, 2024, the Company sold 4 shares of its common stock generating net proceeds
of $54. As of March 31, 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:
Three Months Ended March 31,
2025
2024
Cash used in operating activities
$ (2,007 )
$ (5,769 )
Cash provided by investing activities
—
2,000
Cash provided by financing activities
1,647
53
Net decrease in cash and cash equivalents and restricted cash
$ (360 )
$ (3,716 )
17
Operating Activities
Net cash used in operating activities was $2,007 and
$5,769 for the three month periods ended March 31, 2025 and 2024, respectively. Net losses of $1,656 and $5,824 for the three month periods
ended March 31, 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 $0 and
$2,000 for the three month periods ended March 31, 2025 and 2024, respectively. The decrease of cash provided by investing activities
was due to a $2,000 decrease in maturities of marketable debt securities.
Financing Activities
Net cash provided by financing
activities was $1,647 and $53 for the three month periods ended March 31, 2025 and 2024, respectively. The increase in cash provided
by financing activities is primarily due to the net proceeds from the sale of our preferred stock of $1,648 during the three months
ended March 31, 2025, compared to net proceeds from the sale of our common stock of $54 under the ATM with BTIG, LLC during the
three months ended March 31, 2024.
Funding Requirements and Other Liquidity Matters
We expect to continue to incur significant expenses
and increasing 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.
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. Moreover, under the terms of a recent financing, we are 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.
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.
18
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 March 31, 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 March
31, 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.
19
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 first
quarter of 2025 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
20
PART II - OTHER INFORMATION
Item 1. LEGAL PROCEEDINGS.
None.
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 March 31, 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.
21
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: May 15, 2025
Jerome D. Jabbour
Chief Executive Officer (Principal Executive Officer)
/s/ Keith A. Kucinski
Dated: May 15, 2025
Keith A. Kucinski
Chief Financial Officer
(Principal Financial and Accounting Officer)
22
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).
4.1
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 April 5, 2024 and incorporated herein by reference)
4.4
Form of 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 Securities Purchase Agreement (filed as an exhibit to the Current Report on Form 8-K, filed with the Commission on February 13, 2025 and incorporated herein)
*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.
23
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.