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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, 2024
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 3, 2024, there were 250,816,164 shares of the registrant’s common stock, $0.0001 par value, outstanding.
MATINAS
BIOPHARMA HOLDINGS, INC.
Form
10-Q
Quarter
Ended March 31, 2024
Table
of Contents
PART
- I FINANCIAL INFORMATION
Item
1. FINANCIAL STATEMENTS
Matinas
BioPharma Holdings, Inc.
Condensed
Consolidated Balance Sheets
(in
thousands, except for share data)
| |
March 31, 2024 | | |
December 31, 2023 | |
| |
(Unaudited) | | |
(Audited) | |
ASSETS: | |
| | | |
| | |
Current assets: | |
| | | |
| | |
Cash and cash equivalents | |
$ | 1,071 | | |
$ | 4,787 | |
Marketable debt securities | |
| 7,039 | | |
| 8,969 | |
Restricted cash – security deposit | |
| 50 | | |
| 50 | |
Prepaid expenses and other current assets | |
| 2,129 | | |
| 1,737 | |
Total current assets | |
| 10,289 | | |
| 15,543 | |
| |
| | | |
| | |
Non-current assets: | |
| | | |
| | |
Leasehold improvements and equipment – net | |
| 1,829 | | |
| 1,923 | |
Operating lease right-of-use assets – net | |
| 2,919 | | |
| 3,064 | |
Finance lease right-of-use assets – net | |
| 20 | | |
| 21 | |
In-process research and development | |
| 3,017 | | |
| 3,017 | |
Goodwill | |
| 1,336 | | |
| 1,336 | |
Restricted cash – security deposit | |
| 200 | | |
| 200 | |
Total non-current assets | |
| 9,321 | | |
| 9,561 | |
Total assets | |
$ | 19,610 | | |
$ | 25,104 | |
| |
| | | |
| | |
LIABILITIES AND STOCKHOLDERS’ EQUITY: | |
| | | |
| | |
| |
| | | |
| | |
Current liabilities: | |
| | | |
| | |
Accounts payable | |
$ | 473 | | |
$ | 514 | |
Accrued expenses | |
| 839 | | |
| 1,447 | |
Operating lease liabilities – current | |
| 681 | | |
| 656 | |
Financing lease liabilities – current | |
| 5 | | |
| 5 | |
Total current liabilities | |
| 1,998 | | |
| 2,622 | |
| |
| | | |
| | |
Non-current liabilities: | |
| | | |
| | |
Deferred tax liability | |
| 341 | | |
| 341 | |
Operating lease liabilities – net of current portion | |
| 2,697 | | |
| 2,877 | |
Financing lease liabilities – net of current portion | |
| 16 | | |
| 18 | |
Total non-current liabilities | |
| 3,054 | | |
| 3,236 | |
Total liabilities | |
| 5,052 | | |
| 5,858 | |
| |
| | | |
| | |
Stockholders’ equity: | |
| | | |
| | |
Common stock par value $0.0001 per share, 500,000,000 shares authorized at March 31, 2024 and December 31, 2023; 217,482,830 and 217,264,526 issued and outstanding as of March 31, 2024 and December 31, 2023, respectively | |
| 22 | | |
| 22 | |
Additional paid-in capital | |
| 196,067 | | |
| 195,018 | |
Accumulated deficit | |
| (181,397 | ) | |
| (175,573 | ) |
Accumulated other comprehensive loss | |
| (134 | ) | |
| (221 | ) |
Total stockholders’ equity | |
| 14,558 | | |
| 19,246 | |
Total liabilities and stockholders’ equity | |
$ | 19,610 | | |
$ | 25,104 | |
The
accompanying notes are an integral part of these condensed consolidated financial statements
Matinas
BioPharma Holdings, Inc.
Condensed
Consolidated Statements of Operations and Comprehensive Loss
(in
thousands, except for share and per share data)
Unaudited
| |
2024 | | |
2023 | |
| |
Three Months Ended March 31, | |
| |
2024 | | |
2023 | |
Revenue: | |
| | | |
| | |
Contract revenue | |
$ | — | | |
$ | 1,096 | |
Costs and Expenses: | |
| | | |
| | |
Research and development | |
| 3,446 | | |
| 3,970 | |
General and administrative | |
| 2,456 | | |
| 2,712 | |
| |
| | | |
| | |
Total costs and expenses | |
| 5,902 | | |
| 6,682 | |
| |
| | | |
| | |
Loss from operations | |
| (5,902 | ) | |
| (5,586 | ) |
Other income, net | |
| 78 | | |
| 73 | |
| |
| | | |
| | |
Net loss | |
$ | (5,824 | ) | |
$ | (5,513 | ) |
Net loss per share – basic and diluted | |
$ | (0.03 | ) | |
$ | (0.03 | ) |
Weighted average common shares outstanding: | |
| | | |
| | |
Basic and diluted | |
| 217,358,085 | | |
| 217,264,526 | |
Other comprehensive gain, net of tax | |
| | | |
| | |
Unrealized gain on securities available-for-sale | |
| 87 | | |
| 229 | |
Other comprehensive gain, net of tax | |
| 87 | | |
| 229 | |
Comprehensive loss | |
$ | (5,737 | ) | |
$ | (5,284 | ) |
The
accompanying notes are an integral part of these condensed consolidated financial statements
Matinas
BioPharma Holdings, Inc.
Condensed
Consolidated Statements of Stockholders’ Equity
(in
thousands, except for share data)
Unaudited
| |
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 | |
| 217,264,526 | | |
$ | 22 | | |
$ | 195,018 | | |
$ | (175,573 | ) | |
$ | (221 | ) | |
$ | 19,246 | |
Stock-based compensation | |
| — | | |
| — | | |
| 995 | | |
| — | | |
| — | | |
| 995 | |
Issuance of common stock in public offering, net of stock issuance cost ($2) | |
| 218,304 | | |
| — | | |
| 54 | | |
| — | | |
| — | | |
| 54 | |
Other comprehensive income | |
| — | | |
| — | | |
| — | | |
| — | | |
| 87 | | |
| 87 | |
Net loss | |
| — | | |
| — | | |
| — | | |
| (5,824 | ) | |
| — | | |
| (5,824 | ) |
Balance, March 31, 2024 | |
| 217,482,830 | | |
$ | 22 | | |
$ | 196,067 | | |
$ | (181,397 | ) | |
$ | (134 | ) | |
$ | 14,558 | |
| |
Common Stock | | |
Additional Paid - in | | |
Accumulated | | |
Accumulated Other Comprehensive | | |
Total Stockholders’ | |
| |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
(Loss)/Income | | |
Equity | |
Balance, December 31, 2022 | |
| 217,264,526 | | |
$ | 22 | | |
$ | 190,070 | | |
$ | (152,631 | ) | |
$ | (824 | ) | |
$ | 36,637 | |
Balance | |
| 217,264,526 | | |
$ | 22 | | |
$ | 190,070 | | |
$ | (152,631 | ) | |
$ | (824 | ) | |
$ | 36,637 | |
Stock-based compensation | |
| — | | |
| — | | |
| 1,272 | | |
| — | | |
| — | | |
| 1,272 | |
Other comprehensive income | |
| — | | |
| — | | |
| — | | |
| — | | |
| 229 | | |
| 229 | |
Net loss | |
| — | | |
| — | | |
| — | | |
| (5,513 | ) | |
| — | | |
| (5,513 | ) |
Balance, March 31, 2023 | |
| 217,264,526 | | |
$ | 22 | | |
$ | 191,342 | | |
$ | (158,144 | ) | |
$ | (595 | ) | |
$ | 32,625 | |
Balance | |
| 217,264,526 | | |
$ | 22 | | |
$ | 191,342 | | |
$ | (158,144 | ) | |
$ | (595 | ) | |
$ | 32,625 | |
The
accompanying notes are an integral part of these condensed consolidated financial statements
Matinas
BioPharma Holdings, Inc.
Condensed
Consolidated Statements of Cash Flow
(in
thousands)
Unaudited
| |
2024 | | |
2023 | |
| |
Three Months Ended March 31, | |
| |
2024 | | |
2023 | |
Cash flows from operating activities: | |
| | | |
| | |
Net loss | |
$ | (5,824 | ) | |
$ | (5,513 | ) |
Adjustments to reconcile net loss to net cash used in operating activities: | |
| | | |
| | |
Depreciation and amortization | |
| 94 | | |
| 93 | |
Stock based compensation expense | |
| 995 | | |
| 1,272 | |
Amortization of operating lease right-of-use assets | |
| 145 | | |
| 132 | |
Amortization of finance lease right-of-use assets | |
| 1 | | |
| 4 | |
Amortization of bond discount | |
| 18 | | |
| 44 | |
Changes in operating assets and liabilities: | |
| | | |
| | |
Operating lease liabilities | |
| (154 | ) | |
| (132 | ) |
Prepaid expenses and other current assets | |
| (393 | ) | |
| 2,420 | |
Accounts payable | |
| (41 | ) | |
| (102 | ) |
Accrued expenses and other liabilities | |
| (610 | ) | |
| (2,305 | ) |
Net cash used in operating activities | |
| (5,769 | ) | |
| (4,087 | ) |
| |
| | | |
| | |
Cash flows from investing activities: | |
| | | |
| | |
Proceeds from maturities of marketable debt securities | |
| 2,000 | | |
| 3,000 | |
Net cash provided by investing activities | |
| 2,000 | | |
| 3,000 | |
| |
| | | |
| | |
Cash flows from financing activities: | |
| | | |
| | |
Net proceeds from public offering of common stock | |
| 54 | | |
| — | |
Payments of finance lease liability – principal | |
| (1 | ) | |
| (4 | ) |
Net cash provided by/(used in) financing activities | |
| 53 | | |
| (4 | ) |
| |
| | | |
| | |
Net decrease in cash, cash equivalents and restricted cash | |
| (3,716 | ) | |
| (1,091 | ) |
Cash, cash equivalents and restricted cash at beginning of period | |
| 5,037 | | |
| 7,080 | |
| |
| | | |
| | |
Cash, cash equivalents and restricted cash at end of period | |
$ | 1,321 | | |
$ | 5,989 | |
| |
| | | |
| | |
Supplemental non-cash financing and investing activities: | |
| | | |
| | |
Unrealized gain on marketable debt securities | |
$ | 87 | | |
$ | 229 | |
The
accompanying notes are an integral part of these condensed consolidated financial statements
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 with a focus on identifying
and developing novel pharmaceutical products.
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, 2024, the
Company had an accumulated deficit of $181,397. The Company’s net loss was $5,824 for the three months ended March 31, 2024.
The
Company has been engaged in developing its lipid nanocrystal (“LNC”) platform delivery technology and a pipeline of associated
product candidates, including MAT2203 and MAT2501, since 2011. To date, the Company has not obtained regulatory approval for any of its
product candidates nor generated any revenue from product sales, and the Company expects to incur significant expenses to complete development
of its product candidates. The Company may never be able to obtain regulatory approval for the marketing of any of its product candidates
in any indication in the United States or internationally and there can be no assurance that the Company will generate revenues or ever
achieve profitability.
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. The Company also expects that its research
and development expenses will continue to increase as it moves forward with additional clinical studies for its current product candidates
and development of additional product candidates. 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, 2024, the Company had cash and cash equivalents of $1,071, marketable debt securities of $7,039 and restricted cash of $250.
In addition, on April 5, 2024, the Company completed a registered direct offering of its common stock, raising $9,250, net of fees and
expenses (see Note 13). The Company does not believe the cash and cash equivalents and marketable debt securities on hand are sufficient
to fund planned operations beyond the next twelve months from the filing date of these financial statements. As a result, substantial
doubt exists about the Company’s ability to continue as a going concern.
The
ability of the Company to continue as a going concern is dependent upon control over its operating expenses, anticipated proceeds from
future sales of common stock through its At-The-Market Sales Agreement (“ATM”) with BTIG, LLC. and securing additional financing.
While the Company believes in the viability of this strategy and believes the actions presently being taken by the Company provide the
opportunity for it to continue as a going concern, there can be no assurance the Company will be successful in its implementation. In
particular, utilization of the ATM 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.
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, 2023.
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.
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, 2024 and December 31, 2023 of $250 represents funds the Company is required to set aside as collateral, primarily for
one of the Company’s operating leases.
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, 2024, December 31, 2023, March
31, 2023 and December 31, 2022:
Schedule of Cash, Cash Equivalents and Restricted Cash
| |
March 31, 2024 | | |
December 31, 2023 | | |
March 31, 2023 | | |
December 31, 2022 | |
Cash and cash equivalents | |
$ | 1,071 | | |
$ | 4,787 | | |
$ | 5,739 | | |
$ | 6,830 | |
Restricted cash included in current/non-current assets | |
| 250 | | |
| 250 | | |
| 250 | | |
| 250 | |
Cash, cash equivalents and restricted cash in the statement of cash flows | |
$ | 1,321 | | |
$ | 5,037 | | |
$ | 5,989 | | |
$ | 7,080 | |
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, 2024 and 2023. For the three months ended
March 31, 2024 and 2023, the Company recorded unrealized gains of $87 and $229, respectively. As of March 31, 2024 and December 31, 2023,
the Company had net accumulated unrealized losses of $134 and $221, respectively.
The
following tables summarize the Company’s marketable debt securities as of March 31, 2024:
Schedule
of Marketable Debt Securities
| |
Amortized Cost | | |
Unrealized Gain | | |
Unrealized (Loss) | | |
Fair Value | |
| |
Amortized | | |
Unrealized | | |
Unrealized | | |
| |
| |
Cost | | |
Gain | | |
(Loss) | | |
Fair Value | |
U.S. Government Notes | |
$ | 7,173 | | |
$ | — | | |
$ | (134 | ) | |
$ | 7,039 | |
Total marketable debt securities | |
$ | 7,173 | | |
$ | — | | |
$ | (134 | ) | |
$ | 7,039 | |
All
debt securities classified as available-for-sale are due to mature within one year of March 31, 2024.
The
following tables summarize the Company’s marketable debt securities as of December 31, 2023:
| |
Amortized | | |
Unrealized | | |
Unrealized | | |
| |
| |
Cost | | |
Gain | | |
(Loss) | | |
Fair Value | |
U.S. Treasury Bonds | |
$ | 999 | | |
$ | — | | |
$ | (3 | ) | |
$ | 996 | |
U.S. Government Notes | |
| 8,191 | | |
| — | | |
| (218 | ) | |
| 7,973 | |
Total marketable debt securities | |
$ | 9,190 | | |
$ | — | | |
$ | (221 | ) | |
$ | 8,969 | |
All
debt securities classified as available-for-sale are due to mature within one year of December 31, 2023.
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 considers 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.
A
summary of the assets and liabilities carried at fair value in accordance with the hierarchy defined above is as follows:
Schedule of Fair Value Measurement of Assets and Liabilities
| |
| | | |
| | | |
| | | |
| | |
| |
| | |
Fair Value Hierarchy | |
March 31, 2024 | |
Total | | |
(Level 1) | | |
(Level 2) | | |
(Level 3) | |
Assets | |
| | | |
| | | |
| | | |
| | |
Marketable Debt Securities: | |
| | | |
| | | |
| | | |
| | |
U.S. Government Notes | |
$ | 7,039 | | |
$ | — | | |
$ | 7,039 | | |
$ | — | |
Total | |
$ | 7,039 | | |
$ | — | | |
$ | 7,039 | | |
$ | — | |
| |
| | | |
| | | |
| | | |
| | |
| |
| | |
Fair Value Hierarchy | |
December 31, 2023 | |
Total | | |
(Level 1) | | |
(Level 2) | | |
(Level 3) | |
Assets | |
| | | |
| | | |
| | | |
| | |
Marketable Debt Securities: | |
| | | |
| | | |
| | | |
| | |
U.S. Treasury Bonds | |
$ | 996 | | |
$ | 996 | | |
$ | — | | |
$ | — | |
U.S. Government Notes | |
| 7,973 | | |
| — | | |
| 7,973 | | |
| — | |
Total | |
$ | 8,969 | | |
$ | 996 | | |
$ | 7,973 | | |
$ | — | |
U.S.
treasury bonds are classified within Level 1 of the fair value hierarchy because they are valued using quoted market prices for identical
assets in active markets. Marketable debt securities consisting of U.S. government notes are classified as Level 2 and are valued using
quoted market prices in markets that are not active.
Note
6 – Leasehold Improvements and Equipment
Leasehold
improvements and equipment, summarized by major category, consist of the following as of March 31, 2024 and December 31, 2023:
Schedule of Leasehold Improvements and Equipment
| |
March 31,
2024 | | |
December 31, 2023 | |
Equipment | |
$ | 2,463 | | |
$ | 2,463 | |
Leasehold improvements | |
| 1,155 | | |
| 1,155 | |
Total | |
| 3,618 | | |
| 3,618 | |
Leasehold improvements and equipment, gross | |
| 3,618 | | |
| 3,618 | |
Less: accumulated depreciation and amortization | |
| 1,789 | | |
| 1,695 | |
Leasehold improvements and equipment, net | |
$ | 1,829 | | |
$ | 1,923 | |
Depreciation
and amortization expense for the three months ended March 31, 2024 and 2023 was $94 and $93, respectively.
Note
7 – Accrued Expenses and Other Liabilities
Accrued
Expenses, summarized by major category, as of March 31, 2024 and December 31, 2023 consist of the following:
Schedule of Accrued Expenses
| |
March 31, 2024 | | |
December 31, 2023 | |
Payroll and incentives | |
$ | 501 | | |
$ | 1,176 | |
General and administrative expenses | |
| 223 | | |
| 196 | |
Research and development expenses | |
| 115 | | |
| 75 | |
Total | |
$ | 839 | | |
$ | 1,447 | |
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 $226 for each of the three month periods ended March 31, 2024 and 2023, respectively.
The Company incurred amortization expense on its operating lease right-of-use assets of $145 and $132 for the three months ended March
31, 2024 and 2023, respectively.
Finance
Leases
The
Company incurred interest expense on its finance leases of $1 for the three months ended March 31, 2024 and 2023. The Company incurred
amortization expense on its finance lease right-of-use assets of $1 and $4 for the three months ended March 31, 2024 and 2023, respectively.
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, 2024:
Schedule of Maturity of Operating and Finance Liabilities
Maturity of Lease Liabilities | |
Operating Lease Liabilities | | |
Finance Lease Liabilities | |
Remainder of 2024 | |
$ | 721 | | |
$ | 5 | |
2025 | |
| 998 | | |
| 7 | |
2026 | |
| 1,040 | | |
| 7 | |
2027 | |
| 944 | | |
| 7 | |
2028 | |
| 273 | | |
| — | |
Thereafter | |
| 138 | | |
| — | |
2028 | |
| 273 | | |
| — | |
Thereafter | |
| 138 | | |
| - | |
Total undiscounted operating lease payments | |
$ | 4,114 | | |
$ | 26 | |
Less: Imputed interest | |
| 736 | | |
| 5 | |
Present value of operating lease liabilities | |
$ | 3,378 | | |
$ | 21 | |
| |
| | | |
| | |
Weighted average remaining lease term in years | |
| 4.1 | | |
| 3.7 | |
Weighted average discount rate | |
| 9.2 | % | |
| 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, 2023:
Maturity of Lease Liabilities | |
Operating Lease Liabilities | | |
Finance Lease Liabilities | |
2024 | |
$ | 956 | | |
$ | 7 | |
2025 | |
| 998 | | |
| 7 | |
2026 | |
| 1,040 | | |
| 7 | |
2027 | |
| 944 | | |
| 7 | |
2028 | |
| 273 | | |
| — | |
Thereafter | |
| 138 | | |
| - | |
Total undiscounted operating lease payments | |
$ | 4,349 | | |
$ | 28 | |
Less: Imputed interest | |
| 816 | | |
| 5 | |
Present value of operating lease liabilities | |
$ | 3,533 | | |
$ | 23 | |
| |
| | | |
| | |
Weighted average remaining lease term in years | |
| 4.3 | | |
| 3.9 | |
Weighted average discount rate | |
| 9.2 | % | |
| 11.6 | % |
Note
9 – Revenue Recognition, Collaboration Agreements and Other
BioNTech
Research Collaboration
On
April 8, 2022, the Company entered into the BioNTech Agreement to evaluate the combination of mRNA formats utilizing the Company’s
proprietary LNC platform delivery technology. Under the terms of the BioNTech Agreement, the Company received an exclusivity fee in the
amount of $2,750, and BioNTech SE funded certain of the Company’s research expenses that were incurred under the agreement. The
term of the agreement began on the effective date and expired on April 8, 2023.
The
$2,750 license fee was recorded as deferred revenue and was recognized over the term of the contract performance obligation period, which
the Company concluded to be 12 months after the execution of the contract. The clinical research services were invoiced as service revenue
was earned on a monthly basis during the term of the contract.
During
the first quarter of 2023, $688 of the contract research revenue was recognized from the license fee and $375 was earned from the monthly
clinical research services performed by the Company. As of March 31, 2023, the Company had recognized all of contract research revenue
from the BioNTech Agreement.
Genentech
Feasibility Study Agreement
On
December 12, 2019, the Company entered into the Genentech Agreement which involves the development of oral formulations using the Company’s
LNC platform delivery technology. Under the terms of the Genentech Agreement, Genentech paid the Company a total of $100 for the development
of three molecules, or $33 per molecule, which is being recognized upon the Company fulfilling its obligations for each molecule under
the Genentech Agreement. The Company recorded the upfront consideration as deferred revenue, which is included in accrued expenses on
the consolidated balance sheets. As of December 31, 2022, the Company completed its obligations related to the first and second of the
three molecules. During the three months ended March 31, 2023, the Company completed its obligations related to the remaining molecule.
Note
10 – Stockholders’ Equity
Common
Stock
For
the three months ended March 31, 2024 and 2023, the Company sold 218,304 and 0, respectively, shares of its common stock under the ATM
with BTIG, LLC.
Warrants
As
of March 31, 2024, the Company did not have any outstanding warrants to purchase shares of the Company’s common stock.
Basic
and diluted net loss per common share
During
the three months ended March 31, 2024 and 2023, diluted loss per common share is the same as basic loss per common share because, as
the Company incurred a net loss during each period presented, the potentially dilutive securities from the assumed exercise of all outstanding
stock options and warrants, would have an anti-dilutive effect. The following outstanding shares of potentially dilutive securities were
excluded from the computation of diluted net loss per share because including them would have been anti-dilutive as of March 31, 2024
and 2023:
Schedule of Anti-dilutive Securities Excluded from Computation of Earning Per Share
| |
As of March 31, | |
| |
2024 | | |
2023 | |
Stock options | |
| 46,031,560 | | |
| 34,677,699 | |
Warrants | |
| — | | |
| 238,000 | |
Total | |
| 46,031,560 | | |
| 34,915,699 | |
Note
11 – Accumulated Other Comprehensive Loss
The
following table summarizes the changes in accumulated other comprehensive loss by component during the three months ended March 31, 2024
and 2023:
Schedule of Components of Accumulated Other Comprehensive (Loss) Income
| |
Net Unrealized Gain/(Loss) on Available-for-Sale Securities | | |
Accumulated Other Comprehensive Loss | |
Balance, December 31, 2023 | |
$ | (221 | ) | |
$ | (221 | ) |
Net unrealized gain on securities available-for-sale | |
| 87 | | |
| 87 | |
Balance, March 31, 2024 | |
$ | (134 | ) | |
$ | (134 | ) |
| |
| | | |
| | |
Balance, December 31, 2022 | |
$ | (824 | ) | |
$ | (824 | ) |
Net unrealized loss on securities available-for-sale | |
| 229 | | |
| 229 | |
Balance, March 31, 2023 | |
$ | (595 | ) | |
$ | (595 | ) |
All
components of accumulated other comprehensive income are net of tax.
Note
12 – 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 and 2023. The term of the Plan
was for 10 years. The Company intends to adopt a new equity compensation plan at its 2024 Annual Meeting, pending shareholder approval.
The
following table contains information about the Company’s stock plan at March 31, 2024:
Schedule of Equtiy Compensation Plan by Arrangements
| |
Awards Reserved for Issuance | | |
Awards Issued & Exercised | | |
Awards Available for Grant | |
2013 Equity Compensation Plan | |
| 62,984,400 | * | |
| 50,712,275 | ** | |
| 12,272,125 | |
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, | |
| |
2024 | | |
2023 | |
Research and Development | |
$ | 415 | | |
$ | 553 | |
General and Administrative | |
| 580 | | |
| 719 | |
Total | |
$ | 995 | | |
$ | 1,272 | |
As
of March 31, 2024, total compensation costs related to unvested awards not yet recognized was $6,840 and the weighted-average periods
over which the awards are expected to be recognized was 2.4 years.
Stock
Options
The
following table summarizes the activity for Company’ stock options for the three months ended March 31, 2024:
Schedule of Stock Option Activity
| |
Stock Options | |
Outstanding at December 31, 2023 | |
| 46,707,934 | |
Granted | |
| — | |
Exercised | |
| — | |
Forfeited | |
| — | |
Expired | |
| (676,374 | ) |
Outstanding at March 31, 2024 | |
| 46,031,560 | |
Note
13 – Subsequent Events
On
April 5, 2024, the Company closed a registered direct offering of 33,333,334 shares of its common stock and warrants to purchase up to
an aggregate of 33,333,334 additional shares of common stock, at a combined purchase price of $0.30 per share and accompanying warrant.
The company generated gross proceeds of approximately $10,000 and net proceeds of approximately $9,250, after deducting underwriting
discounts and commissions and other offering expenses.
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, 2023 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 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 of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934,
as amended. 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 raise additional capital to fund our operations and to develop our product candidates; |
|
|
● |
our
anticipated timing for preclinical development, regulatory submissions, commencement and completion of clinical trials and product
approvals; |
|
|
● |
our
history of operating losses in each year since inception and the expectation that we will continue to incur operating losses for
the foreseeable future; |
|
|
● |
our
dependence on product candidates which are still in an early development stage; |
|
|
● |
our
reliance on our proprietary lipid nanocrystal (LNC) platform delivery technology, and certain related patents which are exclusively
licensed to us by Rutgers University; |
|
|
● |
our
ability to manufacture GMP batches of our product candidates which are required for preclinical and clinical trials and, subsequently,
if regulatory approval is obtained for any of our products, our ability to manufacture commercial quantities; |
|
|
● |
our
ability to complete required clinical trials for our lead product candidate and other product candidates and obtain approval from
the FDA or other regulatory agents in different jurisdictions; |
|
|
● |
our
dependence on third parties, including third parties to manufacture our intermediates and final product formulations and third-party
contract research organizations to conduct our clinical trials; |
|
|
● |
our
ability to maintain or protect the validity of our patents and other intellectual property; |
|
|
● |
our
ability to retain and recruit key personnel; |
● |
our
ability to internally develop new inventions and intellectual property; |
|
|
● |
interpretations
of current laws and the passages of future laws; |
|
|
● |
our
lack of a sales and marketing organization and our ability to commercialize products, if we obtain regulatory approval, whether alone
or through potential future collaborators; |
|
|
● |
our
ability to successfully commercialize, and our expectations regarding future therapeutic and commercial potential with respect to,
our product candidates; |
|
|
● |
the
accuracy of our estimates regarding expenses, ongoing losses, future revenue, capital requirements and our needs for or ability to
obtain additional financing; |
|
|
● |
developments
and projections relating to our competitors or our industry; |
|
|
● |
our
operations, business and financial results could be adversely impacted by global instability caused by armed conflicts, pandemics
and geo-political uncertainty; and |
|
|
● |
the
factors listed under the heading “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2023,
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). We are seeking to develop an internal pipeline of products utilizing the LNC Platform to successfully
encapsulate small molecules and small oligonucleotides and facilitate targeted and extrahepatic delivery to desired cell tissues without
toxicity.
Key
elements of our strategy include:
|
●
|
Advancing
MAT2203 into the ORALTO trial for the treatment of invasive aspergillosis in patients with limited treatment options by securing
a development and/or commercial partner. This initial indication is designed to be a gateway indication to establish the pharmacodynamic
bridge necessary to expand the use of MAT2203 into other indications to treat deadly invasive fungal infections (e.g., mucormycosis,
candidiasis and the endemic mycoses) through limited additional clinical work under a 505(b)(2) pathway, thereby making MAT2203 a
pipeline in a product. |
|
|
|
|
● |
Expanding
the utilization of our LNC Platform with other small molecules and small oligonucleotides into inflammation and oncology in order
to develop an internal pipeline of differentiated drug candidates. Oral, extrahepatic and non-toxic intracellular delivery of these
molecules would represent a significant advancement. |
|
|
|
|
●
|
Building
an external pipeline of collaborations focused on our LNC Platform with leading pharmaceutical companies to provide delivery solutions
for their complex small molecules and small oligonucleotides, including ASOs and siRNAs. |
For
the three month periods ended March 31, 2024 and 2023, our net loss was $5,824 and $5,513, respectively. We have incurred losses for
each period from our inception and expect to incur additional losses for the foreseeable future. We do not believe the cash, cash equivalents
and marketable debt securities on hand are sufficient to fund planned operations beyond the next twelve months from the filing date of
these financial statements. We seek to fund our operations through public or private equity offerings, debt financing, government or
other third-party funding, collaborations and licensing arrangements. These financing alternatives may not be available to us on acceptable
terms, or at all. As a result, substantial doubt exists about our ability to continue as a going concern.
Financial
Operations Overview
Revenue
During
the three months ended March 31, 2024 and 2023, we generated $0 and $1,096, respectively, in contract research revenue resulting from
the research collaborations with BioNTech SE and Genentech Inc. Our ability to generate product revenue, which we do not expect to occur
for many years, if ever, will depend heavily on the successful development and eventual commercialization of our early-stage product
candidates.
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
delivery technology, which include:
● |
the
cost of conducting pre-clinical work; |
|
|
● |
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 National Institutes of Health (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. |
The
table below summarizes our direct research and development expenses for our product candidates and development platform for the three
months ended March 31, 2024 and 2023. Our direct research and development expenses consist principally of external costs, such as fees
paid to contractors, consultants, analytical laboratories and CROs and/or the NIH, in connection with our development work. We typically
use our employee and infrastructure resources for manufacturing clinical trial materials, conducting product analysis, study protocol
development and overseeing outside vendors. Included in “Internal staffing, overhead and other” below is the cost of laboratory
space, supplies, research and development (R&D) employee costs (including stock-based compensation), travel and medical education.
| |
Three Months Ended March 31, | |
| |
2024 | | |
2023 | |
Direct research and development expenses: | |
| | | |
| | |
Manufacturing process development | |
$ | 270 | | |
$ | 304 | |
Preclinical trials | |
| 436 | | |
| 162 | |
Clinical development | |
| 156 | | |
| 528 | |
Regulatory | |
| 81 | | |
| 193 | |
Internal staffing, overhead and other | |
| 2,503 | | |
| 2,783 | |
Total research and development | |
$ | 3,446 | | |
$ | 3,970 | |
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 2024 will be lower compared with expenses incurred during 2023 until such time as we are able to secure additional
funding to support initiation of our ORALTO trial for MAT2203 and advancement of our LNC platform delivery technology.
General
and Administrative Expenses
General
and administrative expense for the three months ended March 31, 2024 and 2023 were $2,456 and $2,712, 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 2024 will decrease slightly compared to expenses incurred
during 2023.
Other
Income, net
Other
income, net is largely comprised of interest income/(expense) and dividends.
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 operation 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 2023 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
costs, and (ii) Goodwill and other intangible assets.
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, through clinical development toward an initial
indication for the treatment of CM and expanding application of our LNC Platform through both internal efforts and collaborations with
third parties. Our R&D expenses consist of manufacturing work and the cost of active pharmaceutical ingredients and excipients used
in such work, 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 plan to continue 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 future will be incurred in support of our current and future preclinical and
clinical development programs. These expenditures are subject to numerous uncertainties relating to timing and cost to completion. We
test compounds in numerous preclinical studies for safety, toxicology, and efficacy. At the appropriate time, subject to the approval
of regulatory authorities, we expect to conduct early-stage clinical trials. We anticipate funding these trials ourselves, and possibly
with the assistance of federal grants, contracts, or other agreements. As we obtain results from trials, we may elect to discontinue
or delay clinical trials for certain products to focus our resources on more promising products. Completion of clinical trials may take
several years, and the length of time varies substantially according to the type, complexity, novelty and intended use of a product candidate.
The
commencement and completion of clinical trials for our products may be delayed by many factors, including lack of efficacy during clinical
trials, unforeseen safety issues, slower than expected participant recruitment, lack of funding or government delays. In addition, we
may encounter regulatory delays or rejections as a result of many factors, including results that do not support the intended safety
or efficacy of our product candidates, perceived defects in the design of clinical trials and changes in regulatory policy during the
period of product development. As a result of these risks and uncertainties, we are unable to accurately estimate the specific timing
and costs of our clinical development programs or the timing of material cash inflows, if any, from our product candidates. Our business,
financial condition and results of operations may be materially adversely affected by any delays in, or termination of, our clinical
trials or a determination by the FDA that the results of our trials are inadequate to justify regulatory approval, insofar as cash in-flows
from the relevant drug or program would be delayed or would not occur.
Results
of Operations
Comparison
of the three months ended March 31, 2024 to the three months ended March 31, 2023
The
following tables summarize our revenues and operating expenses for the periods presented:
| |
Three Months Ended March 31, | |
| |
2024 | | |
2023 | |
Revenues | |
$ | — | | |
$ | 1,096 | |
| |
| | | |
| | |
Expenses: | |
| | | |
| | |
Research and development | |
$ | 3,446 | | |
$ | 3,970 | |
General and administrative | |
| 2,456 | | |
| 2,712 | |
Operating Expenses | |
$ | 5,902 | | |
$ | 6,682 | |
Revenues.
During the three months ended March 31, 2024 and 2023, we generated revenue of $0 and $1,096. The amount earned during the prior
year resulted from the exclusive research collaborations with BioNTech SE and Genentech Inc.
Research
and Development expenses. Research and Development (R&D) expense for the three months ended March 31, 2024 and 2023 was $3,446
and $3,970, respectively. The decrease in R&D expense was primarily attributable to the decrease in clinical trial consulting costs
and in headcount costs.
General
and Administrative expenses. General and Administrative (G&A) expense for the three months ended March 31, 2024 and 2023
was $2,456 and $2,712, respectively. The decrease in G&A expense was primarily attributable to lower stock based compensation expense
and decreased insurance premiums.
Liquidity
and capital resources
Sources
of Liquidity
We
have funded our operations since inception primarily through private placements and public offerings of our equity securities. As of
March 31, 2024, we have raised a total of $156,907 in gross proceeds and $144,195, net, from sales of our equity securities.
As
of March 31, 2024, we had cash, cash equivalents and marketable debt securities totaling $8,110.
2024
Registered Direct Offering
On
April 5, 2024, the Company closed a registered direct offering of 33,333,334 shares of its common stock and warrants to purchase up to
an aggregate of 33,333,334 additional shares of common stock, at a combined purchase price of $0.30 per share and accompanying warrant.
The Company generated gross proceeds of approximately $10,000 and net proceeds of approximately $9,250, after deducting underwriting
discounts and commissions and other offering expenses.
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, | |
| |
2024 | | |
2023 | |
Cash used in operating activities | |
$ | (5,769 | ) | |
$ | (4,087 | ) |
Cash provided by investing activities | |
| 2,000 | | |
| 3,000 | |
Cash provided by/(used in) financing activities | |
| 53 | | |
| (4 | ) |
Net decrease in cash and cash equivalents and restricted cash | |
$ | (3,716 | ) | |
$ | (1,091 | ) |
Operating
Activities
Net
cash used in operating activities was $5,769 and $4,087 for the three month periods ended March 31, 2024 and 2023, respectively. Net
losses of $5,824 and $5,513 for the three month periods ended March 31, 2024 and 2023, respectively, were partially offset by working
capital adjustments due to the timing of receipts and payments in the ordinary course of business and adjustments for non-cash stock
based compensation expense.
Investing
Activities
Net
cash provided by investing activities was $2,000 and $3,000 for the three month periods ended March 31, 2024 and 2023, respectively.
The decrease of cash provided by investing activities was due to a $1,000 decrease in maturities of marketable debt securities.
Financing
Activities
Net
cash provided by/(used in) financing activities was $53 and ($4) for the three month periods ended March 31, 2024 and 2023, respectively.
The increase in cash provided by financing activities is primarily due to the proceeds from the sale of our common stock under the ATM
with BTIG, LLC.
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 expect that our existing cash, cash equivalents and marketable debt securities will be sufficient to fund our operating expenses
and capital expenditure requirements 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.
Until
such time, if ever, that we can generate product 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 oversee the development of our 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. If we are unable to raise additional funds through equity or debt financings
when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant
rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.
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, 2024, 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 Securities Exchange Act of 1934, as amended (the “Exchange Act”). Based on that evaluation, our principal
executive officer and principal financial officer concluded that our disclosure controls and procedures were effective at the reasonable
assurance level as of March 31, 2024.
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.
Changes
in Internal Control Over Financial Reporting
There
were no changes in our internal control over financial reporting identified in connection with the above evaluation that occurred during
the first quarter of 2024 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.
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, 2023. You should carefully consider the risk factors contained
in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023 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, 2023, 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.
None.
Item
3. DEFAULTS UPON SENIOR SECURITIES.
None.
Item
4. MINE SAFETY DISCLOSURES.
Not
applicable.
Item
5. OTHER INFORMATION.
None.
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.
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 9, 2024 |
Jerome
D. Jabbour |
|
Chief
Executive Officer (Principal Executive Officer) |
|
|
|
/s/
Keith A. Kucinski |
Dated:
May 9, 2024 |
Keith
A. Kucinski |
|
Chief
Financial Officer |
|
(Principal
Financial and Accounting Officer) |
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). |
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). |
*4.6 |
|
Description of Securities. |
10.1 |
|
Securities Purchase Agreement, dated April 2, 2024 (incorporated herein by reference to the Company’s Current Report on Form 8-K filed with the SEC on April 5, 2024). |
10.2 |
|
Placement Agency Agreement, dated April 2, 2024 (incorporated herein by reference to the Company’s Current Report on Form 8-K filed with the SEC on April 5, 2024). |
*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.
Exhibit
4.6
DESCRIPTION
OF THE REGISTRANT’S SECURITIES REGISTERED PURSUANT
TO
SECTION 12 OF THE SECURITIES EXCHANGE ACT OF 1934
The
following is a description of our common stock and preferred stock as set forth in our certificate of incorporation and bylaws, each
of which are incorporated by reference as an exhibit to the Annual Report on Form 10-K to which this Exhibit 4.6 is a part. This summary
does not purport to be complete and is qualified in its entirety by the full text of our aforementioned certificate of incorporation
and bylaws and by applicable law.
Our
authorized capital stock consists of 500,000,000 shares of common stock, par value $0.0001 per share and 10,000,000 shares of Preferred
Stock, par value $0.0001 per share.
The
additional shares of our authorized stock available for issuance might be issued at times and under circumstances so as to have a dilutive
effect on earnings per share and on the equity ownership of the holders of our common stock. The ability of our board of directors to
issue additional shares of stock could enhance the board’s ability to negotiate on behalf of the stockholders in a takeover situation
but could also be used by the board to make a change-in-control more difficult, thereby denying stockholders the potential to sell their
shares at a premium and entrenching current management. The following description is a summary of the material provisions of our capital
stock. You should refer to our amended and restated certificate of incorporation and by-laws, both of which are on file with the SEC
as exhibits to previous SEC filings, for additional information. The summary below is qualified by provisions of applicable law.
Common
Stock
Voting.
The holders of our common stock are entitled to one vote for each share held of record on all matters on which the holders are entitled
to vote (or consent to).
Dividends.
The holders of our common stock are entitled to receive, ratably, dividends only if, when and as declared by our board of directors
out of funds legally available therefor and after provision is made for each class of capital stock having preference over the common
stock (including the common stock).
Liquidation
Rights. In the event of our liquidation, dissolution or winding-up, the holders of our common stock are entitled to share, ratably,
in all assets remaining available for distribution after payment of all liabilities and after provision is made for each class of capital
stock having preference over the common stock (including the common stock).
Conversion
Rights. The holders of our common stock have no conversion rights.
Preemptive
and Similar Rights. The holders of our common stock have no preemptive or similar rights.
Redemption/Put
Rights. There are no redemption or sinking fund provisions applicable to the common stock. All of the outstanding shares of our common
stock are fully-paid and nonassessable.
Transfer
Agent and Registrar. The transfer agent and registrar for our common stock is VStock Transfer, LLC.
Preferred
Stock
We
are authorized to issue up to 10,000,000 shares of preferred stock, par value $0.0001 per share, with such designations, rights, and
preferences as may be determined from time to time by our board of directors. Accordingly, our board of directors is empowered, without
stockholder approval, to issue preferred stock with dividend, liquidation, conversion, voting, or other rights that could adversely affect
the voting power or other rights of the holders of our common stock. The issuance of preferred stock could have the effect of restricting
dividends on our common stock, diluting the voting power of our common stock, impairing the liquidation rights of our common stock, or
delaying or preventing a change in control of our company, all without further action by our stockholders.
Our
board of directors has the authority, within the limitations and restrictions prescribed by law and without stockholder approval, to
provide by resolution for the issuance of shares of preferred stock, and to fix the rights, preferences, privileges and restrictions
thereof, including dividend rights, conversion rights, voting rights, terms of redemption, liquidation preference and the number of shares
constituting any series of the designation of such series, by delivering an appropriate certificate of amendment to our amended and restated
certificate of incorporation to the Delaware Secretary of State pursuant to the Delaware General Corporation Law (the “DGCL”).
The issuance of preferred stock could have the effect of decreasing the market price of the common stock, impeding or delaying a possible
takeover and adversely affecting the voting and other rights of the holders of our common stock.
If
we offer a specific series of preferred stock under this prospectus, we will describe the terms of the preferred stock in the prospectus
supplement for such offering and will file a copy of the certificate establishing the terms of the preferred stock with the SEC. To the
extent required, this description will include:
● |
the
title and stated value; |
|
|
● |
the
number of shares offered, the liquidation preference per share and the purchase price; |
|
|
● |
the
dividend rate(s), period(s) and/or payment date(s), or method(s) of calculation for such dividends; |
|
|
● |
whether
dividends will be cumulative or non-cumulative and, if cumulative, the date from which dividends will accumulate; |
|
|
● |
the
procedures for any auction and remarketing, if any; |
|
|
● |
the
provisions for a sinking fund, if any; |
|
|
● |
the
provisions for redemption, if applicable; |
|
|
● |
any
listing of the preferred stock on any securities exchange or market; |
|
|
● |
whether
the preferred stock will be convertible into our common stock, and, if applicable, the conversion price (or how it will be
calculated) and conversion period; |
|
|
● |
whether
the preferred stock will be exchangeable into debt securities, and, if applicable, the exchange price (or how it will be calculated)
and exchange period; |
|
|
● |
voting
rights, if any, of the preferred stock; |
|
|
● |
a
discussion of any material and/or special U.S. federal income tax considerations applicable to the preferred stock; |
|
|
● |
the
relative ranking and preferences of the preferred stock as to dividend rights and rights upon liquidation, dissolution or winding up
of the affairs of Matinas; and |
|
|
● |
any
material limitations on issuance of any class or series of preferred stock ranking senior to or on a parity with the series of
preferred stock as to dividend rights and rights upon liquidation, dissolution or winding up of Matinas. |
Transfer
Agent and Registrar for Preferred Stock. The transfer agent and registrar for any series or class of preferred stock will be set
forth in each applicable prospectus supplement.
Anti-takeover
Effects of Delaware Law and of our Amended and Restated Certificate of Incorporation
The
following paragraphs summarize certain provisions of the DGCL and our amended and restated certificate of incorporation that may have
the effect of discouraging an acquisition of Matinas. The summary does not purport to be complete and is subject to and qualified in
its entirety by reference to the DGCL and our amended and restated certificate of incorporation and by-laws, copies of which are on file
with the SEC. Please refer to “Additional Information” below for directions on obtaining these documents.
Section
203 of the Delaware General Corporation Law
We
are subject to Section 203 of the Delaware General Corporation Law, which prohibits a Delaware corporation from engaging in any business
combination with any interested stockholder for a period of three years after the date that such stockholder became an interested stockholder,
with the following exceptions:
● |
before
such date, the board of directors of the corporation approved either the business combination or the transaction that resulted in
the stockholder becoming an interested stockholder; |
|
|
● |
upon
completion of the transaction that resulted in the stockholder becoming an interested stockholder, the interested stockholder owned
at least 85% of the voting stock of the corporation outstanding at the time the transaction began, excluding for purposes of determining
the voting stock outstanding (but not the outstanding voting stock owned by the interested stockholder) those shares owned (i) by
persons who are directors and also officers and (ii) employee stock plans in which employee participants do not have the right to
determine confidentially whether shares held subject to the plan will be tendered in a tender or exchange offer; or
|
|
|
● |
on
or after such date, the business combination is approved by the board of directors and authorized at an annual or special meeting
of the stockholders, and not by written consent, by the affirmative vote of at least 66 2/3% of the outstanding voting stock that
is not owned by the interested stockholder. |
In
general, Section 203 defines business combination to include the following:
● |
any
merger or consolidation involving the corporation and the interested stockholder; |
|
|
● |
any
sale, transfer, pledge or other disposition of 10% or more of the assets of the corporation involving the interested stockholder; |
|
|
● |
subject
to certain exceptions, any transaction that results in the issuance or transfer by the corporation of any stock of the corporation
to the interested stockholder; |
|
|
● |
any
transaction involving the corporation that has the effect of increasing the proportionate share of the stock or any class or series
of the corporation beneficially owned by the interested stockholder; or |
|
|
● |
the
receipt by the interested stockholder of the benefit of any loss, advances, guarantees, pledges or other financial benefits by or
through the corporation. |
In
general, Section 203 defines an “interested stockholder” as an entity or person who, together with the person’s affiliates
and associates, beneficially owns, or within three years prior to the time of determination of interested stockholder status did own,
15% or more of the outstanding voting stock of the corporation.
Certificate
of Incorporation and Bylaws
Our
certificate of incorporation and bylaws contain provisions that could have the effect of discouraging potential acquisition proposals
or tender offers or delaying or preventing a change of control of our company. These provisions are as follows:
● |
they
provide that special meetings of stockholders may be called only by the board of directors, President or our Chairman of the board
of directors, or at the request in writing by stockholders of record owning at least fifty (50%) percent of the issued and outstanding
voting shares of common stock; |
|
|
● |
they
do not include a provision for cumulative voting in the election of directors. Under cumulative voting, a minority stockholder holding
a sufficient number of shares may be able to ensure the election of one or more directors. The absence of cumulative voting may have
the effect of limiting the ability of minority stockholders to effect changes in our board of directors; and |
|
|
● |
they
allow us to issue “blank check” preferred stock, the terms of which may be established and shares of which may be issued
without stockholder approval. |
Potential
Effects of Authorized but Unissued Stock
We
have shares of common stock and preferred stock available for future issuance without stockholder approval. We may utilize these additional
shares for a variety of corporate purposes, including future public offerings to raise additional capital, to facilitate corporate acquisitions
or payment as a dividend on the capital stock.
The
existence of unissued and unreserved common stock and preferred stock may enable our board of directors to issue shares to persons friendly
to current management or to issue preferred stock with terms that could render more difficult or discourage a third-party attempt to
obtain control of us by means of a merger, tender offer, proxy contest or otherwise, thereby protecting the continuity of our management.
In addition, the board of directors has the discretion to determine designations, rights, preferences, privileges and restrictions, including
voting rights, dividend rights, conversion rights, redemption privileges and liquidation preferences of each series of preferred stock,
all to the fullest extent permissible under the DGCL and subject to any limitations set forth in our amended and restated certificate
of incorporation. The purpose of authorizing the board of directors to issue preferred stock and to determine the rights and preferences
applicable to such preferred stock is to eliminate delays associated with a stockholder vote on specific issuances. The issuance of preferred
stock, while providing desirable flexibility in connection with possible financings, acquisitions and other corporate purposes, could
have the effect of making it more difficult for a third-party to acquire, or could discourage a third-party from acquiring, a majority
of our outstanding voting stock.
DESCRIPTION
OF STOCK WARRANTS
Warrants
The
following is a summary of the material terms and provisions of warrants to purchase shares of our common stock issued on April 4, 2024
(the “Warrants”). The summary is subject to and qualified in its entirety by the form of Warrant, which has been filed with
the Securities and Exchange Commission as an exhibit to a Current Report on Form 8-K on April 4, 2024 and incorporated by reference herein.
Duration
and Exercise Price
The
Warrants have an exercise price of $0.35 per share. The Warrants are exercisable six months from the date of issuance, April 2, 2024,
and will be exercisable for five and one-half years from the date of issuance. The exercise price and number of shares of common stock
issuable upon exercise are subject to appropriate adjustment in the event of share dividends, share splits, reorganizations or similar
events affecting our shares of common stock. Warrants are issued in certificated form only.
Exercisability
The
Warrants are exercisable, at the option of each holder, in whole or in part, by delivering to us a duly executed exercise notice accompanied
by payment in full for the number of shares of common stock purchased upon such exercise (except in the case of a cashless exercise as
discussed below). A holder (together with its affiliates) may not exercise any portion of such holder’s warrants to the extent
that the holder would own more than 4.99% (or, at the election of the purchaser, 9.99%) of our outstanding shares of common stock immediately
after exercise, except that upon at least 61 days’ prior notice from the holder to us, the holder may increase the amount of ownership
of outstanding shares of common stock after exercising the holder’s Warrants up to 9.99% of the number of shares of common stock
outstanding immediately after giving effect to the exercise, as such percentage ownership is determined in accordance with the terms
of the Warrants. Purchasers in the April 2024 offering may also elect prior to the issuance of Warrants to have the initial exercise
limitation set at 9.99% of our outstanding shares of common stock.
Cashless
Exercise
If
at the time of exercise of the Warrant there is no effective registration statement registering, or the prospectus contained therein
is not available for the resale of the shares of common stock issuable upon exercise of the Warrant, then the Warrants will only be exercisable
on a “cashless exercise” basis under which the holder will receive upon such exercise a net number of common shares determined
according to a formula set forth in the Warrants.
Fundamental
Transactions
In
the event of any fundamental transaction, as described in the Warrants and generally including any merger with or into another entity,
sale of all or substantially all of our assets, tender offer or exchange offer, or reclassification of our shares of common stock, then
upon any subsequent exercise of a Warrant, the holder will have the right to receive as alternative consideration, for each share of
common stock that would have been issuable upon such exercise immediately prior to the occurrence of such fundamental transaction, the
number of shares of common stock of the successor or acquiring corporation or of our company, if it is the surviving corporation, and
any additional consideration receivable upon or as a result of such transaction by a holder of the number of shares of common stock for
which the Warrant is exercisable immediately prior to such event. In certain circumstances, the holder will have the right to receive
the Black Scholes Value of the warrant calculated pursuant to a formula set forth in the Warrants, payable either in cash or in the same
type or form of consideration that is being offered and being paid to the holders of our common stock as described in the Warrants.
Transferability
In
accordance with its terms and subject to applicable laws, a Warrant may be transferred at the option of the holder upon surrender of
the Warrant to us together with the appropriate instruments of transfer and payment of funds sufficient to pay any transfer taxes (if
applicable).
Fractional
Shares
No
fractional shares of common stock will be issued upon the exercise of the Warrants. Rather, the number of shares of common stock to be
issued will, at our election, either be rounded up to the nearest whole number or we will pay a cash adjustment in respect of such final
fraction in an amount equal to such fraction multiplied by the exercise price.
Trading
Market
There
is no established trading market for the Warrants, and we do not expect a market to develop. We do not intend to apply for a listing
for the Warrants on any securities exchange or other nationally recognized trading system. Without an active trading market, the liquidity
of the Warrants will be limited.
Rights
as a Shareholder
Except
as otherwise provided in the Warrants or by virtue of the holders’ ownership of shares of common stock, the holders of Warrants
do not have the rights or privileges of holders of our shares of common stock, including any voting rights, until such Warrant holders
exercise their warrants.
Listing
on NYSE American
Our
common stock is listed on NYSE American under the symbol “MTNB”. There is no established public trading market for the Warrants,
and we do not expect a market to develop. We do not intend to apply for a listing for the Warrants on any securities exchange or other
nationally recognized trading system. Without an active trading market, the liquidity of the Warrants will be limited.
Exhibit
31.1
CERTIFICATION
I,
Jerome D. Jabbour, certify that:
1.
I have reviewed this report on Form 10-Q of Matinas BioPharma Holdings, Inc.;
2.
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary
to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the
period covered by this report;
3.
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material
respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this
report;
4.
The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures
(as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act
Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
(a)
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision,
to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others
within those entities, particularly during the period in which this report is being prepared;
(b)
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under
our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements
for external purposes in accordance with generally accepted accounting principles;
(c)
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions
about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation;
and
(d)
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s
most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected,
or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5.
The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial
reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing
the equivalent functions):
(a)
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are
reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information;
and
(b)
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s
internal control over financial reporting.
Date:
May 9, 2024 |
By: |
/s/
Jerome D. Jabbour |
|
Name:
|
Jerome
D. Jabbour |
|
Title: |
Chief
Executive Officer |
Exhibit
31.2
CERTIFICATION
I,
Keith A. Kucinski, certify that:
1.
I have reviewed this report on Form 10-Q of Matinas BioPharma Holdings, Inc.;
2.
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary
to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the
period covered by this report;
3.
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material
respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this
report;
4.
The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures
(as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and 15d-15(e)) and internal control over financial reporting (as defined in
Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
(a)
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision,
to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others
within those entities, particularly during the period in which this report is being prepared;
(b)
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under
our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements
for external purposes in accordance with generally accepted accounting principles;
(c)
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions
about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation;
and
(d)
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s
most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected,
or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5.
The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial
reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing
the equivalent functions):
(a)
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are
reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information;
and
(b)
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s
internal control over financial reporting.
Date:
May 9, 2024 |
By: |
/s/
Keith A. Kucinski |
|
Name:
|
Keith
A. Kucinski |
|
Title: |
Chief
Financial Officer |
Exhibit
32.1
SECTION
1350 CERTIFICATIONS
Pursuant
to 18 U.S.C. §1350 as adopted pursuant to §906 of the Sarbanes-Oxley Act of 2002, the undersigned officers of Matinas BioPharma
Holdings, Inc. (the “Company”) hereby certify that to their knowledge and in their respective capacities that the Company’s
quarterly report on Form 10-Q to which this certification is attached (the “Report”), fully complies with the requirements
of Section 13(a) or 15(d), as applicable, of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and that
the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations
of the Company.
Date:
May 9, 2024 |
By: |
/s/
Jerome D. Jabbour |
|
Name:
|
Jerome
D. Jabbour |
|
Title: |
Chief
Executive Officer |
|
|
|
Date:
May 9, 2024 |
By: |
/s/
Keith A. Kucinski |
|
Name: |
Keith
A. Kucinski |
|
Title: |
Chief
Financial Officer |
This
certification shall not be deemed “filed” for any purpose, nor shall it be deemed to be incorporated by reference into any
filing under the Securities Act of 1933 or the Exchange Act. A signed original of this written statement required by Section 906, or
other document authenticating, acknowledging, or otherwise adopting the signature that appears in typed form within the electronic version
of this written statement required by Section 906, has been provided to Matinas BioPharma Holdings, Inc. and will be retained by Matinas
BioPharma Holdings, Inc. and furnished to the Securities and Exchange Commission or its staff upon request.
v3.24.1.u1
Cover - shares
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3 Months Ended |
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Mar. 31, 2024 |
May 03, 2024 |
Cover [Abstract] |
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|
|
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Q1
|
|
Document Fiscal Year Focus |
2024
|
|
Current Fiscal Year End Date |
--12-31
|
|
Entity File Number |
001-38022
|
|
Entity Registrant Name |
MATINAS
BIOPHARMA HOLDINGS, INC.
|
|
Entity Central Index Key |
0001582554
|
|
Entity Tax Identification Number |
46-3011414
|
|
Entity Incorporation, State or Country Code |
DE
|
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1545
Route 206 South
|
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Suite 302
|
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Bedminster
|
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NJ
|
|
Entity Address, Postal Zip Code |
07921
|
|
City Area Code |
908
|
|
Local Phone Number |
484-8805
|
|
Title of 12(b) Security |
Common
Stock
|
|
Trading Symbol |
MTNB
|
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Security Exchange Name |
NYSEAMER
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v3.24.1.u1
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands |
Mar. 31, 2024 |
Dec. 31, 2023 |
Current assets: |
|
|
Cash and cash equivalents |
$ 1,071
|
$ 4,787
|
Marketable debt securities |
7,039
|
8,969
|
Restricted cash – security deposit |
50
|
50
|
Prepaid expenses and other current assets |
2,129
|
1,737
|
Total current assets |
10,289
|
15,543
|
Non-current assets: |
|
|
Leasehold improvements and equipment – net |
1,829
|
1,923
|
Operating lease right-of-use assets – net |
2,919
|
3,064
|
Finance lease right-of-use assets – net |
20
|
21
|
In-process research and development |
3,017
|
3,017
|
Goodwill |
1,336
|
1,336
|
Restricted cash – security deposit |
200
|
200
|
Total non-current assets |
9,321
|
9,561
|
Total assets |
19,610
|
25,104
|
Current liabilities: |
|
|
Accounts payable |
473
|
514
|
Accrued expenses |
839
|
1,447
|
Operating lease liabilities – current |
681
|
656
|
Financing lease liabilities – current |
5
|
5
|
Total current liabilities |
1,998
|
2,622
|
Non-current liabilities: |
|
|
Deferred tax liability |
341
|
341
|
Operating lease liabilities – net of current portion |
2,697
|
2,877
|
Financing lease liabilities – net of current portion |
16
|
18
|
Total non-current liabilities |
3,054
|
3,236
|
Total liabilities |
5,052
|
5,858
|
Stockholders’ equity: |
|
|
Common stock par value $0.0001 per share, 500,000,000 shares authorized at March 31, 2024 and December 31, 2023; 217,482,830 and 217,264,526 issued and outstanding as of March 31, 2024 and December 31, 2023, respectively |
22
|
22
|
Additional paid-in capital |
196,067
|
195,018
|
Accumulated deficit |
(181,397)
|
(175,573)
|
Accumulated other comprehensive loss |
(134)
|
(221)
|
Total stockholders’ equity |
14,558
|
19,246
|
Total liabilities and stockholders’ equity |
$ 19,610
|
$ 25,104
|
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v3.24.1.u1
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares
|
Mar. 31, 2024 |
Dec. 31, 2023 |
Statement of Financial Position [Abstract] |
|
|
Common stock, par value |
$ 0.0001
|
$ 0.0001
|
Common stock, shares authorized |
500,000,000
|
500,000,000
|
Common stock, shares issued |
217,482,830
|
217,264,526
|
Common stock, shares outsatnding |
217,482,830
|
217,264,526
|
X |
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v3.24.1.u1
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($) $ in Thousands |
3 Months Ended |
Mar. 31, 2024 |
Mar. 31, 2023 |
Revenue: |
|
|
Contract revenue |
|
$ 1,096
|
Costs and Expenses: |
|
|
Research and development |
3,446
|
3,970
|
General and administrative |
2,456
|
2,712
|
Total costs and expenses |
5,902
|
6,682
|
Loss from operations |
(5,902)
|
(5,586)
|
Other income, net |
78
|
73
|
Net loss |
$ (5,824)
|
$ (5,513)
|
Net loss per share - basic |
$ (0.03)
|
$ (0.03)
|
Net loss per share - diluted |
$ (0.03)
|
$ (0.03)
|
Weighted average common shares outstanding: |
|
|
Weighted average common shares outstanding - basic |
217,358,085
|
217,264,526
|
Weighted average common shares outstanding - diluted |
217,358,085
|
217,264,526
|
Other comprehensive gain, net of tax |
|
|
Unrealized gain on securities available-for-sale |
$ 87
|
$ 229
|
Other comprehensive gain, net of tax |
87
|
229
|
Comprehensive loss |
$ (5,737)
|
$ (5,284)
|
X |
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v3.24.1.u1
Condensed Consolidated Statements of Stockholders' Equity (Unaudited) - USD ($) $ in Thousands |
Common Stock [Member] |
Additional Paid-in Capital [Member] |
Retained Earnings [Member] |
AOCI Attributable to Parent [Member] |
Total |
Balance at Dec. 31, 2022 |
$ 22
|
$ 190,070
|
$ (152,631)
|
$ (824)
|
$ 36,637
|
Balance, shares at Dec. 31, 2022 |
217,264,526
|
|
|
|
|
Stock-based compensation |
|
1,272
|
|
|
1,272
|
Other comprehensive income |
|
|
|
229
|
229
|
Net loss |
|
|
(5,513)
|
|
(5,513)
|
Balance at Mar. 31, 2023 |
$ 22
|
191,342
|
(158,144)
|
(595)
|
32,625
|
Balance, shares at Mar. 31, 2023 |
217,264,526
|
|
|
|
|
Balance at Dec. 31, 2023 |
$ 22
|
195,018
|
(175,573)
|
(221)
|
19,246
|
Balance, shares at Dec. 31, 2023 |
217,264,526
|
|
|
|
|
Stock-based compensation |
|
995
|
|
|
995
|
Issuance of common stock in public offering, net of stock issuance cost ($2) |
|
54
|
|
|
54
|
Issuance of common stock in public offering, net of stock issuance cost ($2) , shares |
218,304
|
|
|
|
|
Other comprehensive income |
|
|
|
87
|
87
|
Net loss |
|
|
(5,824)
|
|
(5,824)
|
Balance at Mar. 31, 2024 |
$ 22
|
$ 196,067
|
$ (181,397)
|
$ (134)
|
$ 14,558
|
Balance, shares at Mar. 31, 2024 |
217,482,830
|
|
|
|
|
X |
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