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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 September 30, 2023
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
![](https://www.sec.gov/Archives/edgar/data/1582554/000149315223039892/form10-q_001.jpg)
MATINAS
BIOPHARMA HOLDINGS, INC.
(Exact
name of registrant as specified in its charter)
Delaware |
|
No.
46-3011414 |
(State
or other jurisdiction of |
|
(I.R.S.
Employer |
incorporation
or organization) |
|
Identification
No.) |
1545
Route 206 South, Suite 302
Bedminster,
New Jersey 07921
(Address
of principal executive offices) (Zip Code)
908-484-8805
(Registrant’s
telephone number, including area code)
(Former
Name, Former Address and Former Fiscal Year,
if
Changed Since Last Report)
Securities
registered pursuant to Section 12(b) of the Act:
Title
of Each Class |
|
Trading
Symbol(s) |
|
Name
of Each Exchange on Which Registered |
Common
Stock |
|
MTNB |
|
NYSE
American |
Indicate
by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)
has been subject to such filing requirements for the past 90 days.
Yes
☒ No ☐
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule
405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant
was required to submit such files).
Yes
☒ No ☐
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting
company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,”
“smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large
accelerated filer |
☐ |
Accelerated
filer |
☐ |
|
|
|
|
Non-accelerated
Filer |
☒ |
Smaller
reporting company |
☒ |
|
|
|
|
|
|
Emerging
growth company |
☐ |
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
As
of November 3, 2023, there were 217,264,526 shares of the registrant’s common stock, $0.0001 par value, outstanding.
DOCUMENTS
INCORPORATED BY REFERENCE
None.
MATINAS
BIOPHARMA HOLDINGS, INC.
Form
10-Q
Quarter
Ended September 30, 2023
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)
| |
September 30, 2023 | | |
December 31, 2022 | |
| |
(Unaudited) | | |
(Audited) | |
ASSETS: | |
| | | |
| | |
Current assets: | |
| | | |
| | |
Cash and cash equivalents | |
$ | 6,407 | | |
$ | 6,830 | |
Marketable debt securities | |
| 11,809 | | |
| 21,933 | |
Restricted cash – security deposit | |
| 50 | | |
| 50 | |
Prepaid expenses and other current assets | |
| 1,723 | | |
| 5,719 | |
Total current assets | |
| 19,989 | | |
| 34,532 | |
| |
| | | |
| | |
Non-current assets: | |
| | | |
| | |
Leasehold improvements and equipment – net | |
| 2,021 | | |
| 2,091 | |
Operating lease right-of-use assets – net | |
| 3,206 | | |
| 3,613 | |
Finance lease right-of-use assets – net | |
| 22 | | |
| 30 | |
In-process research and development | |
| 3,017 | | |
| 3,017 | |
Goodwill | |
| 1,336 | | |
| 1,336 | |
Restricted cash – security deposit | |
| 200 | | |
| 200 | |
Total non-current assets | |
| 9,802 | | |
| 10,287 | |
Total assets | |
$ | 29,791 | | |
$ | 44,819 | |
| |
| | | |
| | |
LIABILITIES AND STOCKHOLDERS’ EQUITY: | |
| | | |
| | |
| |
| | | |
| | |
Current liabilities: | |
| | | |
| | |
Accounts payable | |
$ | 835 | | |
$ | 618 | |
Accrued expenses | |
| 1,757 | | |
| 3,099 | |
Operating lease liabilities – current | |
| 632 | | |
| 562 | |
Financing lease liabilities – current | |
| 5 | | |
| 7 | |
Total current liabilities | |
| 3,229 | | |
| 4,286 | |
| |
| | | |
| | |
Non-current liabilities: | |
| | | |
| | |
Deferred tax liability | |
| 341 | | |
| 341 | |
Operating lease liabilities – net of current portion | |
| 3,052 | | |
| 3,533 | |
Financing lease liabilities – net of current portion | |
| 19 | | |
| 22 | |
Total non-current liabilities | |
| 3,412 | | |
| 3,896 | |
Total liabilities | |
| 6,641 | | |
| 8,182 | |
| |
| | | |
| | |
Stockholders’ equity: | |
| | | |
| | |
Common stock par value $0.0001 per share, 500,000,000 shares authorized at September 30, 2023 and December 31, 2022; 217,264,526 issued and outstanding as of September 30, 2023 and December 31, 2022 | |
| 22 | | |
| 22 | |
Additional paid-in capital | |
| 193,746 | | |
| 190,070 | |
Accumulated deficit | |
| (170,259 | ) | |
| (152,631 | ) |
Accumulated other comprehensive loss | |
| (359 | ) | |
| (824 | ) |
Total stockholders’ equity | |
| 23,150 | | |
| 36,637 | |
Total liabilities and stockholders’ equity | |
$ | 29,791 | | |
$ | 44,819 | |
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 share and per share data)
Unaudited
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
Three Months Ended September 30, | | |
Nine Months Ended September 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Revenue: | |
| | |
| | |
| | |
| |
Contract Revenue | |
$ | — | | |
$ | 1,063 | | |
$ | 1,096 | | |
$ | 2,125 | |
Costs and expenses: | |
| | | |
| | | |
| | | |
| | |
Research and development | |
| 3,295 | | |
| 3,707 | | |
| 10,824 | | |
| 12,811 | |
General and administrative | |
| 2,839 | | |
| 2,818 | | |
| 8,151 | | |
| 8,424 | |
| |
| | | |
| | | |
| | | |
| | |
Total costs and expenses | |
| 6,134 | | |
| 6,525 | | |
| 18,975 | | |
| 21,235 | |
| |
| | | |
| | | |
| | | |
| | |
Loss from operations | |
| (6,134 | ) | |
| (5,462 | ) | |
| (17,879 | ) | |
| (19,110 | ) |
Sale of New Jersey net operating losses & tax credits | |
| — | | |
| — | | |
| — | | |
| 1,734 | |
Other income, net | |
| 79 | | |
| — | | |
| 251 | | |
| 13 | |
| |
| | | |
| | | |
| | | |
| | |
Net loss | |
$ | (6,055 | ) | |
$ | (5,462 | ) | |
$ | (17,628 | ) | |
$ | (17,363 | ) |
Net loss per share – basic and diluted | |
$ | (0.03 | ) | |
$ | (0.03 | ) | |
$ | (0.08 | ) | |
$ | (0.08 | ) |
Weighted average common shares outstanding: | |
| | | |
| | | |
| | | |
| | |
Basic and diluted | |
| 217,264,526 | | |
| 216,864,526 | | |
| 217,264,526 | | |
| 216,792,083 | |
Other comprehensive gain/(loss), net of tax | |
| | | |
| | | |
| | | |
| | |
Unrealized gain/(loss) on securities available-for-sale | |
| 155 | | |
| (181 | ) | |
| 465 | | |
| (790 | ) |
Other comprehensive gain/(loss), net of tax | |
| 155 | | |
| (181 | ) | |
| 465 | | |
| (790 | ) |
Comprehensive loss | |
$ | (5,900 | ) | |
$ | (5,643 | ) | |
$ | (17,163 | ) | |
$ | (18,153 | ) |
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
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| |
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 | |
Stock-based compensation | |
| — | | |
| — | | |
| 3,676 | | |
| — | | |
| — | | |
| 3,676 | |
Other comprehensive income | |
| — | | |
| — | | |
| — | | |
| — | | |
| 465 | | |
| 465 | |
Net loss | |
| — | | |
| — | | |
| — | | |
| (17,628 | ) | |
| — | | |
| (17,628 | ) |
Balance, September 30, 2023 | |
| 217,264,526 | | |
$ | 22 | | |
$ | 193,746 | | |
$ | (170,259 | ) | |
$ | (359 | ) | |
$ | 23,150 | |
| |
Common Stock | | |
Additional Paid - in | | |
Accumulated | | |
Accumulated Other Comprehensive | | |
Total Stockholders’ | |
| |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
(Loss)/Income | | |
Equity | |
Balance, June 30, 2023 | |
| 217,264,526 | | |
$ | 22 | | |
$ | 192,550 | | |
$ | (164,204 | ) | |
$ | (514 | ) | |
$ | 27,854 | |
Stock-based compensation | |
| — | | |
| — | | |
| 1,196 | | |
| — | | |
| — | | |
| 1,196 | |
Other comprehensive income | |
| — | | |
| — | | |
| — | | |
| — | | |
| 155 | | |
| 155 | |
Net loss | |
| — | | |
| — | | |
| — | | |
| (6,055 | ) | |
| — | | |
| (6,055 | ) |
Balance, September 30, 2023 | |
| 217,264,526 | | |
$ | 22 | | |
$ | 193,746 | | |
$ | (170,259 | ) | |
$ | (359 | ) | |
$ | 23,150 | |
| |
Common Stock | | |
Additional Paid - in | | |
Accumulated | | |
Accumulated Other Comprehensive | | |
Total Stockholders’ | |
| |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
Loss | | |
Equity | |
Balance, December 31, 2021 | |
| 216,269,450 | | |
$ | 22 | | |
$ | 184,251 | | |
$ | (131,634 | ) | |
$ | (145 | ) | |
$ | 52,494 | |
Stock-based compensation | |
| — | | |
| — | | |
| 3,888 | | |
| — | | |
| — | | |
| 3,888 | |
Issuance of common stock in exchange for Options | |
| 195,076 | | |
| — | | |
| 99 | | |
| — | | |
| — | | |
| 99 | |
Issuance of common stock pursuant to license agreement amendment | |
| 400,000 | | |
| — | | |
| 291 | | |
| — | | |
| — | | |
| 291 | |
Other comprehensive loss | |
| — | | |
| — | | |
| - | | |
| — | | |
| (790 | ) | |
| (790 | ) |
Net loss | |
| — | | |
| — | | |
| - | | |
| (17,363 | ) | |
| — | | |
| (17,363 | ) |
Balance, September 30, 2022 | |
| 216,864,526 | | |
$ | 22 | | |
$ | 188,529 | | |
$ | (148,997 | ) | |
$ | (935 | ) | |
$ | 38,619 | |
| |
Common Stock | | |
Additional Paid - in | | |
Accumulated | | |
Accumulated Other Comprehensive | | |
Total Stockholders’ | |
| |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
Loss | | |
Equity | |
Balance, June 30, 2022 | |
| 216,864,526 | | |
$ | 22 | | |
$ | 187,116 | | |
$ | (143,535 | ) | |
$ | (754 | ) | |
$ | 42,849 | |
Balance | |
| 216,864,526 | | |
$ | 22 | | |
$ | 187,116 | | |
$ | (143,535 | ) | |
$ | (754 | ) | |
$ | 42,849 | |
Stock-based compensation | |
| — | | |
| — | | |
| 1,413 | | |
| — | | |
| — | | |
| 1,413 | |
Other comprehensive loss | |
| — | | |
| — | | |
| — | | |
| — | | |
| (181 | ) | |
| (181 | ) |
Other comprehensive income (loss) | |
| — | | |
| — | | |
| — | | |
| — | | |
| (181 | ) | |
| (181 | ) |
Net loss | |
| — | | |
| — | | |
| — | | |
| (5,462 | ) | |
| — | | |
| (5,462 | ) |
Balance, September 30, 2022 | |
| 216,864,526 | | |
$ | 22 | | |
$ | 188,529 | | |
$ | (148,997 | ) | |
$ | (935 | ) | |
$ | 38,619 | |
Balance | |
| 216,864,526 | | |
$ | 22 | | |
$ | 188,529 | | |
$ | (148,997 | ) | |
$ | (935 | ) | |
$ | 38,619 | |
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
| |
2023 | | |
2022 | |
| |
Nine Months Ended September 30, | |
| |
2023 | | |
2022 | |
Cash flows from operating activities: | |
| | | |
| | |
Net loss | |
$ | (17,628 | ) | |
$ | (17,363 | ) |
Adjustments to reconcile net loss to net cash used in operating activities: | |
| | | |
| | |
Depreciation and amortization | |
| 288 | | |
| 244 | |
Stock based compensation expense | |
| 3,676 | | |
| 3,888 | |
Amortization of operating lease right-of-use assets | |
| 406 | | |
| 413 | |
Amortization of finance lease right-of-use assets | |
| 7 | | |
| 15 | |
Amortization of bond discount | |
| 90 | | |
| 158 | |
Stock issued pursuant to license agreement amendment | |
| — | | |
| 291 | |
Changes in operating assets and liabilities: | |
| | | |
| | |
Operating lease liabilities | |
| (411 | ) | |
| (391 | ) |
Prepaid expenses and other current assets | |
| 3,996 | | |
| (2,676 | ) |
Accounts payable | |
| 217 | | |
| (282 | ) |
Accrued expenses and other liabilities | |
| (1,340 | ) | |
| 846 | |
Net cash used in operating activities | |
| (10,699 | ) | |
| (14,857 | ) |
| |
| | | |
| | |
Cash flows from investing activities: | |
| | | |
| | |
Proceeds from maturities of marketable debt securities | |
| 10,500 | | |
| 15,250 | |
Purchases of leasehold improvements and equipment | |
| (218 | ) | |
| (850 | ) |
Net cash provided by investing activities | |
| 10,282 | | |
| 4,919 | |
| |
| | | |
| | |
Cash flows from financing activities: | |
| | | |
| | |
Proceeds from exercise of options | |
| — | | |
| 99 | |
Payments of finance lease liability – principal | |
| (6 | ) | |
| (15 | ) |
Net cash (used in)/provided by financing activities | |
| (6 | ) | |
| 84 | |
| |
| | | |
| | |
Net decrease in cash, cash equivalents and restricted cash | |
| (423 | ) | |
| (9,854 | ) |
Cash, cash equivalents and restricted cash at beginning of period | |
| 7,080 | | |
| 21,280 | |
| |
| | | |
| | |
Cash, cash equivalents and restricted cash at end of period | |
$ | 6,657 | | |
$ | 11,426 | |
| |
| | | |
| | |
Supplemental non-cash financing and investing activities: | |
| | | |
| | |
Unrealized gain/(loss) on marketable debt securities | |
$ | 465 | | |
$ | (790 | ) |
Right of use asset in exchange from liabilities from operating lease | |
$ | — | | |
$ | (64 | ) |
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 September 30, 2023,
the Company had an accumulated deficit of $170,259. The Company’s net loss was $17,628 for the nine months ended September 30,
2023.
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 September 30, 2023, the Company had cash and cash equivalents of $6,407, marketable debt securities of $11,809 and restricted cash
of $250. The Company believes the cash and cash equivalents and marketable debt securities on hand are sufficient to fund planned operations
into the third quarter of 2024, but not beyond. As a result, substantial doubt exists about the Company’s ability to continue as
a going concern.
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 the 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, 2022.
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 consisted of cash in bank checking and savings accounts, money market funds and short-term
U.S. treasury bonds that mature within three months of settlement date.
Cash,
Cash Equivalents and Restricted Cash
The
Company presents restricted cash with cash and cash equivalents in the Condensed Consolidated Statements of Cash Flows. Restricted cash
at both September 30, 2023 and December 31, 2022 of $250 represents funds the Company is required to set aside as collateral, primarily
for one of the Company’s operating leases and other purposes.
The
following table provides a reconciliation of cash, cash equivalents and restricted cash reported in the Condensed Consolidated Balance
Sheets to the total of the amounts in the Condensed Consolidated Statements of Cash Flows as of September 30, 2023, December 31, 2022,
September 30, 2022 and December 31, 2021:
Schedule of Cash, Cash Equivalents and Restricted Cash
| |
September 30, 2023 | | |
December 31, 2022 | | |
September 30, 2022 | | |
December 31, 2021 | |
Cash and cash equivalents | |
$ | 6,407 | | |
$ | 6,830 | | |
$ | 11,176 | | |
$ | 21,030 | |
Restricted cash included in current/non-current assets | |
| 250 | | |
| 250 | | |
| 250 | | |
| 250 | |
Cash, cash equivalents and restricted cash in the statement of cash flows | |
$ | 6,657 | | |
$ | 7,080 | | |
$ | 11,426 | | |
$ | 21,280 | |
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.
For the three and nine months ended September 30, 2023, the Company recorded unrealized gains of $155 and $465, respectively. For the
three and nine months ended September 30, 2022, the Company recorded unrealized losses of $181 and $790, respectively. As of September
30, 2023 and December 31, 2022, the Company had net accumulated unrealized losses of $359 and $824, respectively.
The
following tables summarize the Company’s marketable debt securities as of September 30, 2023:
Schedule of Marketable Securities
| |
Amortized Cost | | |
Unrealized Gain | | |
Unrealized (Loss) | | |
Fair Value | |
| |
Amortized | | |
Unrealized | | |
Unrealized | | |
| |
| |
Cost | | |
Gain | | |
(Loss) | | |
Fair Value | |
U.S. Treasury Bonds | |
$ | 998 | | |
$ | — | | |
$ | (13 | ) | |
$ | 985 | |
U.S. Government Notes | |
| 11,170 | | |
| — | | |
| (346 | ) | |
| 10,824 | |
Total marketable debt securities | |
$ | 12,168 | | |
$ | — | | |
$ | (359 | ) | |
$ | 11,809 | |
Maturities
of debt securities classified as available-for-sale were as follows at September 30, 2023:
Schedule of Maturities of Debt Securities Available-for-sale
| |
Fair Value | |
Due within one year | |
$ | 11,809 | |
The
following tables summarize the Company’s marketable debt securities as of December 31, 2022:
| |
Amortized Cost | | |
Unrealized Gain | | |
Unrealized (Loss) | | |
Fair Value | |
U.S. Treasury Bonds | |
$ | 993 | | |
$ | — | | |
$ | (34 | ) | |
$ | 959 | |
U.S. Government Notes | |
| 16,324 | | |
| — | | |
| (721 | ) | |
| 15,603 | |
Corporate Debt Securities | |
| 5,440 | | |
| — | | |
| (69 | ) | |
| 5,371 | |
Total marketable debt securities | |
$ | 22,757 | | |
$ | — | | |
$ | (824 | ) | |
$ | 21,933 | |
Maturities
of debt securities classified as available-for-sale were as follows at December 31, 2022:
| |
Fair Value | |
Due within one year | |
$ | 13,240 | |
Due after one year through five years | |
| 8,693 | |
| |
$ | 21,933 | |
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 | |
September 30, 2023 | |
Total | | |
(Level 1) | | |
(Level 2) | | |
(Level 3) | |
Assets | |
| | |
| | |
| | |
| |
Marketable Debt Securities: | |
| | | |
| | | |
| | | |
| | |
U.S. Treasury Bonds | |
$ | 985 | | |
$ | 985 | | |
$ | — | | |
$ | — | |
U.S. Government Notes | |
| 10,824 | | |
| — | | |
| 10,824 | | |
| — | |
Total | |
$ | 11,809 | | |
$ | 985 | | |
$ | 10,824 | | |
$ | — | |
| |
| | | |
| | | |
| | | |
| | |
| |
| | |
Fair Value Hierarchy | |
December 31, 2022 | |
Total | | |
(Level 1) | | |
(Level 2) | | |
(Level 3) | |
Assets | |
| | |
| | |
| | |
| |
Marketable Debt Securities: | |
| | | |
| | | |
| | | |
| | |
U.S. Treasury Bonds | |
$ | 959 | | |
$ | 959 | | |
$ | — | | |
$ | — | |
U.S. Government Notes | |
| 15,603 | | |
| — | | |
| 15,603 | | |
| — | |
Corporate Debt Securities | |
| 5,371 | | |
| — | | |
| 5,371 | | |
| — | |
Total | |
$ | 21,933 | | |
$ | 959 | | |
$ | 20,974 | | |
$ | — | |
Assets and liabilities carried at fair value | |
$ | 21,933 | | |
$ | 959 | | |
$ | 20,974 | | |
$ | — | |
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 and corporate debt securities 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 September 30, 2023 and December 31, 2022:
Schedule of Leasehold Improvements and Equipment
| |
September 30, 2023 | | |
December 31, 2022 | |
Equipment | |
$ | 2,523 | | |
$ | 2,305 | |
Leasehold improvements | |
| 1,155 | | |
| 1,155 | |
Total | |
| 3,678 | | |
| 3,460 | |
Leasehold improvements and equipment, gross | |
| 3,678 | | |
| 3,460 | |
Less: accumulated depreciation and amortization | |
| 1,657 | | |
| 1,369 | |
Leasehold improvements and equipment, net | |
$ | 2,021 | | |
$ | 2,091 | |
Depreciation
and amortization expense for the three and nine months ended September 30, 2023 was $98 and $288, respectively, and the three and nine
months ended September 30, 2022 was $89 and $244, respectively. During the nine month period ended September 30, 2023, the Company purchased
equipment of $218, and no leasehold improvements. During the nine month period ended September 30, 2022, the Company purchased equipment
of $629, and leasehold improvements of $221.
Note
7 – Accrued Expenses and Other Liabilities
Accrued
Expenses, summarized by major category, as of September 30, 2023 and December 31, 2022 consist of the following:
Schedule of Accrued Expenses
| |
September 30, 2023 | | |
December 31, 2022 | |
Payroll and incentives | |
$ | 1,290 | | |
$ | 1,705 | |
General and administrative expenses | |
| 407 | | |
| 455 | |
Research and development expenses | |
| 60 | | |
| 130 | |
Deferred revenue * | |
| — | | |
| 721 | |
Other deferred liabilities ** | |
| — | | |
| 88 | |
Total | |
$ | 1,757 | | |
$ | 3,099 | |
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 $225 and $194 for each of the three month periods ended September 30, 2023
and 2022, respectively, and $677 and $646 for each of the nine month periods ended September 30, 2023 and 2022, respectively. The Company
incurred amortization expense on its operating lease right-of-use assets of $139 and $406 for the three and nine months ended September
30, 2023, respectively, and $138 and $413 for the three and nine months ended September 30, 2022, respectively.
Finance
Leases
The
Company incurred interest expense on its finance leases of $0 and $2 for the three and nine months ended September 30, 2023, respectively,
and $0 and $1 for the three and nine months ended September 30, 2022, respectively. The Company incurred amortization expense on its
finance lease right-of-use assets of $2 and $7 for the three and nine months ended September 30, 2023, respectively, and $3 and $15 for
the three and nine months ended September 30, 2022, respectively.
The
following table presents information about the amount and timing of liabilities arising from the Company’s operating leases and
finance leases as of September 30, 2023:
Schedule of Maturity of Operating and Finance Liabilities
Maturity of Lease Liabilities | |
Operating Lease Liabilities | | |
Finance Lease Liabilities | |
Remainder of 2023 | |
$ | 235 | | |
$ | 2 | |
2024 | |
| 956 | | |
| 7 | |
2025 | |
| 998 | | |
| 7 | |
2026 | |
| 1,040 | | |
| 7 | |
2027 | |
| 944 | | |
| 7 | |
Thereafter | |
| 411 | | |
| — | |
Total undiscounted operating lease payments | |
$ | 4,584 | | |
$ | 30 | |
Less: Imputed interest | |
| 900 | | |
| 6 | |
Present value of operating lease liabilities | |
$ | 3,684 | | |
$ | 24 | |
| |
| | | |
| | |
Weighted average remaining lease term in years | |
| 4.6 | | |
| 4.2 | |
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, 2022:
Maturity of Lease Liabilities | |
Operating Lease Liabilities | | |
Finance Lease Liabilities | |
2023 | |
$ | 916 | | |
$ | 10 | |
2024 | |
| 956 | | |
| 7 | |
2025 | |
| 998 | | |
| 7 | |
2026 | |
| 1,040 | | |
| 7 | |
2027 | |
| 944 | | |
| 7 | |
Thereafter | |
| 411 | | |
| — | |
Total undiscounted operating lease payments | |
$ | 5,265 | | |
$ | 38 | |
Less: Imputed interest | |
| 1,170 | | |
| 9 | |
Present value of operating lease liabilities | |
$ | 4,095 | | |
$ | 29 | |
| |
| | | |
| | |
Weighted average remaining lease term in years | |
| 5.3 | | |
| 4.5 | |
Weighted average discount rate | |
| 9.2 | % | |
| 11.1 | % |
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.
Cystic
Fibrosis Foundation Therapeutics Development Award
On
November 19, 2020, the Company entered into the CFF Agreement with the Cystic Fibrosis Foundation (“CFF”), pursuant to which
it received a Therapeutics Development Award of up to $4.2 million (the “Award”) (of which $484 had been previously received)
to support the preclinical development (the “Development Program”) of the Company’s MAT2501 product candidate. On November
19, 2021, the Company and CFF entered into an Amendment to the CFF Agreement which added an additional milestone payment in the amount
of $321, which was received in the fourth quarter of 2021.
As
of September 30, 2023, the Company has received approximately $3.6 million of the $4.5 million Award, including the Amendment’s
additional milestone payment, and a related deferred liability balance of $0 and $88 is included in accrued expenses at September 30,
2023 and December 31, 2022, respectively. During the fourth quarter of 2022, for financial and technical reasons, the Company determined
that it was not commercially reasonable to continue the development of MAT2501 and instead elected to focus existing resources on other
initiatives. As a result, the Company will not receive the balance of the Award and has no further obligations to CFF.
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 – Income Taxes
Sale
of net operating losses (NOLs) & tax credits
The
Company recognized $0 and $1,734 for the nine month periods ended September 30, 2023 and 2022, respectively, in connection with the sale
of certain state net operating losses (“NOLs”) and research and development tax credits to a third party under the New Jersey
Technology Business Tax Certificate Transfer Program.
Note
11 – Stockholders’ Equity
Common
Stock
On
February 8, 2022, the Company issued 400,000 unregistered shares of its common stock to Rutgers, The State University of New Jersey (“Rutgers”),
as partial consideration pursuant to the Second Amended and Restated Exclusive License Agreement between the Company and Rutgers. The
agreement provides for (1) royalties on a tiered basis between low single digits and the mid-single digits of net sales of products using
such licensed technology, (2) a one-time sales milestone fee of $100 when and if sales of products using the licensed technology reach
the specified sales threshold and (3) an annual license fee of $50 over the term of the license agreement. There was also a reduction
in the consideration paid to Rutgers in the event of a sublicense to a third party of the exclusive patent rights granted pursuant to
the Agreement. The Company recorded a $291 research and development expense related to the issuance of the 400,000 shares based on the
closing price of the Company’s common stock of $0.728 on the date of issuance.
For
the nine months ended September 30, 2023 and 2022, the Company did not sell any shares of its common stock under its At-The-Market Sales
Agreement with BTIG, LLC.
Warrants
As
of September 30, 2023, the Company did not have any outstanding warrants to purchase shares of the Company’s common stock. The
following table summarizes the changes in warrants outstanding during 2022 and for the nine months ended September 30, 2023:
Summary of Shareholder Equity Warrants Outstanding
| |
Shares | |
Outstanding at December 31, 2021 | |
| 988 | |
Issued | |
| — | |
Exercised | |
| (400 | ) |
Expired | |
| (350 | ) |
Outstanding at December 31, 2022 | |
| 238 | |
Issued | |
| — | |
Exercised | |
| — | |
Expired | |
| (238 | ) |
Outstanding at September 30, 2023 | |
| — | |
Basic
and diluted net loss per common share
During
the three and nine months ended September 30, 2023 and 2022, diluted loss per common share is the same as basic loss per common share
because, as the Company incurred a net loss during each period presented, the potentially dilutive securities from the assumed exercise
of all outstanding stock options and warrants, would have an anti-dilutive effect. The following outstanding shares of potentially dilutive
securities were excluded from the computation of diluted net loss per share because including them would have been anti-dilutive as of
September 30, 2023 and 2022:
Schedule of Anti-dilutive Securities Excluded from Computation of Earning Per Share
| |
As of September 30, | |
| |
2023 | | |
2022 | |
Stock options | |
| 33,234 | | |
| 27,729 | |
Warrants | |
| — | | |
| 988 | |
Total | |
| 33,234 | | |
| 28,717 | |
Note
12 – Accumulated Other Comprehensive Loss
The
following table summarizes the changes in accumulated other comprehensive loss by component during the nine months ended September 30,
2023 and 2022:
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, 2022 | |
$ | (824 | ) | |
$ | (824 | ) |
Net
unrealized gain on securities available-for-sale | |
| 465 | | |
| 465 | |
Balance,
September 30, 2023 | |
$ | (359 | ) | |
$ | (359 | ) |
| |
| | | |
| | |
Balance,
December 31, 2021 | |
$ | (145 | ) | |
$ | (145 | ) |
Net
unrealized loss on securities available-for-sale | |
| (790 | ) | |
| (790 | ) |
Balance,
September 30, 2022 | |
$ | (935 | ) | |
$ | (935 | ) |
All
components of accumulated other comprehensive income are net of tax.
Note
13 – Stock-based Compensation
The
Company’s Amended and Restated 2013 Equity Compensation Plan (the “Plan”) provides for the granting of incentive stock
options, nonqualified stock options, restricted stock units, performance units, and stock purchase rights. There were no significant
modifications to the Plan during the nine month periods ended September 30, 2023 and 2022. The term of the Plan is for 10 years and will
expire on May 7, 2024, if not amended before then.
The
following table contains information about the Company’s stock plan at September 30, 2023:
Schedule of Equtiy Compensation Plan by Arrangements
| |
Awards Reserved for Issuance | | |
Awards Issued & Exercised | | |
Awards Available for Grant | |
2013 Equity Compensation Plan | |
| 54,294 | * | |
| 37,915 | ** | |
| 16,379 | |
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 September 30, | | |
Nine Months Ended September 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Research and Development | |
$ | 507 | | |
$ | 554 | | |
$ | 1,576 | | |
$ | 1,660 | |
General and Administrative | |
| 689 | | |
| 859 | | |
| 2,100 | | |
| 2,228 | |
Total | |
$ | 1,196 | | |
$ | 1,413 | | |
$ | 3,676 | | |
$ | 3,888 | |
As
of September 30, 2023, total compensation costs related to unvested awards not yet recognized was $6,204 and the weighted-average periods
over which the awards are expected to be recognized was 2.2 years.
Stock
Options
The
following table summarizes the activity for Company’ stock options for the nine months ended September 30, 2023:
Schedule of Stock Option Activity
| |
Stock Options | |
Outstanding at December 31, 2022 | |
| 34,739 | |
Granted | |
| 105 | |
Exercised | |
| — | |
Forfeited | |
| (296 | ) |
Expired | |
| (1,314 | ) |
Outstanding at September 30, 2023 | |
| 33,234 | |
Note
14 – Subsequent Events
On
November 1, 2023, at a Special Meeting of the Company’s stockholders, a proposal for an amendment to the Company’s Certificate
of Incorporation to effect a reverse stock split of its common stock at a ratio in the range of 1-for-2 to 1-for-50, with such reverse
stock split to be effected at a ratio, time and date, if at all, as determined by the Company’s Board of Directors in its sole
discretion. The Board may choose to exercise its discretion at any time prior to November 1, 2024, which is the first anniversary of
its approval by stockholders.
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, 2022 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, including risks and uncertainties related to the impact of COVID-19, 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, which is 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 may be adversely impacted by COVID-19; and |
|
|
● |
the
factors listed under the heading “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2022,
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) to maximize global clinical impact and patient access. The Company is developing an internal portfolio
of products and strives to be the partner of choice for leading pharmaceutical companies seeking to develop novel formulations that capitalize
on the unique characteristics of the LNC Platform to facilitate, enhance and optimize the delivery of complex nucleic acids. Our current
internal pipeline consists of MAT2203 (oral amphotericin B), a highly potent antifungal drug which we have successfully made oral, safe,
and well-tolerated for patients. We also have internal discovery programs ongoing in the formulation and delivery of small oligonucleotides,
namely antisense oligonucleotides (ASOs) and silencing or short interfering RNAs (siRNAs). We are also intent on expanding the application
of our LNC Platform through collaborations with well-respected pharmaceutical companies whose molecules and compounds benefit from the
unique capabilities of our delivery technology, which can provide oral bioavailability and facilitate non-toxic and efficient intracellular
delivery of nucleic acids, particularly in the fields of mRNA and DNA.
Key
elements of our strategy include:
● |
Advancing
our LNC Platform and expanding the utilization of this promising technology into areas of innovative medicine beyond small molecules,
including nucleic acids (e.g., mRNA, DNA, ASOs) and proteins. |
|
|
● |
Positioning
MAT2203 for an NDA filing for various indications for the treatment of serious IFIs, including cryptococcal meningitis. We are seeking
non-dilutive funds from prospective third-party pharmaceutical partners and various governmental sources of capital, such as the
Biomedical Advanced Research and Development Authority (BARDA) and the NIH to continue the development of MAT2203 into Phase 3. We
are also seeking the input and guidance of the FDA for an additional Phase 3 study of various IFIs. |
● |
Building
an external pipeline of collaborations focused on our LNC Platform with leading pharmaceutical companies like Genentech and National
Resilience to provide delivery solutions for their complex nucleic acid drug products. |
For
the nine month periods ended September 30, 2023 and 2022, our net loss was $17,628 and $17,363, respectively. We have incurred losses
for each period from our inception and expect to incur additional losses for the foreseeable future. We believe the cash, cash equivalents
and marketable debt securities on hand are sufficient to fund planned operations into the third quarter of 2024, but not beyond. We will
seek to fund our operations through public or private equity offerings, debt financing, government or other third-party funding, collaborations
and licensing arrangements. 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 and nine months ended September 30, 2023, we generated $0 and $1,096, respectively, in contract research revenue resulting
from the research collaborations with BioNTech SE and Genentech Inc., and $1,063 and $2,125 during the three and nine months ended September
30, 2022, respectively, from the research collaboration with BioNTech SE. 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
and nine months ended September 30, 2023 and 2022. 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 September 30, | | |
Nine months ended September 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Direct research and development expenses: | |
| | | |
| | | |
| | | |
| | |
Manufacturing process development | |
$ | 349 | | |
$ | 417 | | |
$ | 942 | | |
$ | 1,988 | |
Preclinical trials | |
| 101 | | |
| 86 | | |
| 350 | | |
| 711 | |
Clinical development | |
| 314 | | |
| 492 | | |
| 1,183 | | |
| 1,702 | |
Regulatory | |
| 133 | | |
| 160 | | |
| 463 | | |
| 562 | |
Internal staffing, overhead and other | |
| 2,398 | | |
| 2,552 | | |
| 7,886 | | |
| 7,848 | |
Total research and development | |
$ | 3,295 | | |
$ | 3,707 | | |
$ | 10,824 | | |
$ | 12,811 | |
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 2023 will be lower than expenses incurred in 2022 as we pause the development of MAT2501 to focus our existing
resources on MAT2203 and advancement of our LNC platform delivery technology.
General
and Administrative Expenses
General
and administrative expense for the three and nine months ended September 30, 2023 were $2,839 and $8,151, respectively, and for the three
and nine months ended September 30, 2022 were $2,818 and $8,424, 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 2023 will remain relatively consistent with expenses incurred during
2022.
Sale
of Net Operating Losses (NOLs) & Tax Credits
Income
obtained from selling unused net operating losses (NOLs) and research and development tax credits under the New Jersey Technology Business
Tax Certificate Transfer Program was $0 and $1,734 for the nine month periods ended September 30, 2023 and 2022, respectively.
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 2022 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) Stock-based compensation,
(ii) Fair value measurements, (iii) Research and development costs, and (iv) 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 September 30, 2023 to the three months ended September 30, 2022
The
following tables summarize our revenues and operating expenses for the periods presented:
| |
Three Months Ended September 30, | |
| |
2023 | | |
2022 | |
Revenues | |
$ | — | | |
$ | 1,063 | |
| |
| | | |
| | |
Expenses: | |
| | | |
| | |
Research and development | |
$ | 3,295 | | |
$ | 3,707 | |
General and administrative | |
| 2,839 | | |
| 2,818 | |
Operating Expenses | |
$ | 6,134 | | |
$ | 6,525 | |
Revenues.
During the three months ended September 30, 2023 and 2022, we generated revenue of $0 and $1,063. The amount earned during the
prior year resulted from the exclusive research collaborations with BioNTech SE.
Research
and Development expenses. Research and Development (R&D) expense for the three months ended September 30, 2023 and 2022 was
$3,295 and $3,707, respectively. The decrease in R&D expense was primarily attributable to the decrease in manufacturing costs of
clinical trial materials, in clinical trial consulting costs and in headcount costs.
General
and Administrative expenses. General and administrative expense for the three months ended September 30, 2023 and 2022 was relatively
consistent at $2,839 and $2,818, respectively, as higher legal fees were offset by lower stock based compensation, insurance premiums
and consulting costs.
Comparison
of the nine months ended September 30, 2023 to the nine months ended September 30, 2022
The
following tables summarize our revenues and operating expenses for the periods presented:
| |
Nine Months Ended September 30, | |
| |
2023 | | |
2022 | |
Revenues | |
$ | 1,096 | | |
$ | 2,125 | |
| |
| | | |
| | |
Expenses: | |
| | | |
| | |
Research and development | |
$ | 10,824 | | |
$ | 12,811 | |
General and administrative | |
| 8,151 | | |
| 8,424 | |
Operating Expenses | |
$ | 18,975 | | |
$ | 21,235 | |
| |
| | | |
| | |
Sale of New Jersey net operating losses (NOLs) and tax credits | |
$ | — | | |
$ | 1,734 | |
Revenues.
During the nine month periods ended September 30, 2023 and 2022, we generated revenue of $1,096 and $2,125. The amount earned
during the current year consists of contract research revenue resulting from the research collaboration with BioNTech SE and Genentech
Inc., while the amount earned during the prior year resulted from the research collaboration with BioNTech SE.
Research
and Development expenses. Research and Development (R&D) expense for the nine month periods ended September 30, 2023 and
2022 was $10,824 and $12,811, respectively. The decrease in R&D expense was primarily attributable to decreases in manufacturing
costs of clinical trial materials and in clinical trial consulting costs, partially offset by an increase in headcount costs.
General
and Administrative expenses. General and administrative expense for the nine month periods ended September 30, 2023 and 2022
was $8,151 and $8,424, respectively. The decrease in general and administrative expense between periods was primarily due to decreases
in consulting fees, insurance premiums and stock based compensation expense, partially offset by increases in legal fees and headcount
costs.
Sale
of New Jersey net operating losses (NOLs) & tax credits. The Company recognized $0 and $1,734 for the nine month periods
ended September 30, 2023 and 2022, respectively, in connection with the sale of state net operating losses and research and development
tax credits to third parties under the New Jersey Technology Business Tax Certificate Transfer Program.
Liquidity
and capital resources
Sources
of Liquidity
We
have funded our operations since inception through private placements and public offerings of our equity securities. As of September
30, 2023, we have raised a total of $156.7 million in gross proceeds and $143.9 million, net, from sales of our equity securities.
As
of September 30, 2023, we had cash, cash equivalents and marketable debt securities totaling $18,216.
Cash
Flows
The
following table sets forth the primary sources and uses of cash, cash equivalents and restricted cash for each of the periods set forth
below:
| |
Nine Months Ended September 30, | |
| |
2023 | | |
2022 | |
Cash used in operating activities | |
$ | (10,699 | ) | |
$ | (14,857 | ) |
Cash provided by investing activities | |
| 10,282 | | |
| 4,919 | |
Cash (used in)/provided by financing activities | |
| (6 | ) | |
| 84 | |
Net decrease in cash and cash equivalents and restricted cash | |
$ | (423 | ) | |
$ | (9,854 | ) |
Operating
Activities
Net
cash used in operating activities was $10,699 and $14,857 for the nine month periods ended September 30, 2023 and 2022, respectively.
Net losses of $17,628 and $17,363 for the nine month periods ended September 30, 2023 and 2022, respectively, were partially offset by
working capital adjustments due to the timing of receipts and payments in the ordinary course of business.
Investing
Activities
Net
cash provided by investing activities was $10,282 and 4,919 for the nine month periods ended September 30, 2023 and 2022, respectively.
The increase of cash provided by investing activities of $5,363 was primarily due to the $9,481 decrease in purchases of marketable debt
securities, the $632 decrease in purchases of leasehold improvements and equipment, offset by the $4,750 decrease in maturities of marketable
debt securities.
Financing
Activities
Net
cash (used in)/provided by financing activities was ($6) and $84 for the nine month periods ended September 30, 2023 and 2022, respectively.
The decrease of $90 is primarily due to the decrease in the receipt of proceeds of $99 from the exercise of stock options.
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
expect that our existing cash, cash equivalents and marketable debt securities will be sufficient to fund our operating expenses and
capital expenditures requirements into the third quarter of 2024, but not beyond. As a result, substantial doubt exists about the Company’s
ability to continue as a going concern.
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 September 30, 2023, 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 September 30, 2023.
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 third quarter of 2023 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, 2022. You should carefully consider the risk factors contained
in our Annual Report on Form 10-K for the fiscal year ended December 31, 2022 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, 2022, 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.
We
could be delisted from the NYSE American, which could seriously harm the liquidity of our stock and our ability to raise capital.
We
are currently having, and may continue to have, difficulty satisfying NYSE American listing requirements for our common stock. We are
currently not in compliance with NYSE American listing requirements, specifically the minimum bid price requirement, and must regain
compliance prior to March 21, 2024. If we are unable to regain such compliance, we will cease to be eligible to trade on Nasdaq. In such
event:
| ● | We
may have to pursue trading on a less recognized or accepted market, such as the OTC Bulletin
Board or the “pink sheets.” |
| ● | Shares
of our common stock could be less liquid and marketable, thereby reducing the ability of
stockholders to purchase or sell our shares as quickly and as inexpensively as they have
done historically. If our stock is traded as a “penny stock,” transactions in
our stock would be more difficult and cumbersome. |
| ● | We
may be unable to access capital on favorable terms or at all, as companies trading on alternative
markets may be viewed as less attractive investments with higher associated risks, such that
existing or prospective institutional investors may be less interested in, or prohibited
from, investing in our common stock. This may also cause the market price of our common stock
to decline. |
A
reverse-stock split of our common stock may not have the intended consequences.
On
November 1, 2023, our shareholders approved an amendment to our Certificate of Incorporation to effect a reverse stock split at a ratio
in the range of 1-for-2 to 1-for-50, to be determined at the discretion of the Board, and to reduce the total number of authorized shares
of common stock from 500,000,000 to 250,000,000, which we refer to as the reverse stock split and authorized share reduction, respectively.
We believe that the reverse stock split may result in our regaining compliance with the listing standards of the NYSE American, an increase
to the market price of our common stock, enhance the appeal of our common stock to the financial community, improve the trading liquidity
of our common stock, make it possible for us to “up-list” our common stock to a higher tier stock exchange, and make us eligible
for inclusion on certain biotechnology and pharmaceutical trading indices and exchange-traded funds.
However,
we cannot assure you that the reverse stock split, if implemented, will result in any anticipated benefits, including compliance with
the NYSE American minimum bid price requirement, an increase of the market price of our common stock in proportion to the reduction in
the number of shares of our common stock outstanding. Moreover, a reverse-stock split may have the effect of decreasing our overall market
value. There can be no assurance that the reverse stock split will result in a per share price that will attract institutional investors
or investment funds or that such share price will satisfy the investing guidelines of institutional investors or investment funds or
improve the trading liquidity of our common stock.
Moreover,
the number of shares of our common stock available for issuance following the implementation of the reverse stock split would increase
to the extent the reverse stock split reduces the number of outstanding shares of our common stock relative to the number of authorized
shares. Such available shares may be used for future corporate purposes, including future acquisitions, investment opportunities, the
establishment of collaboration or other strategic agreements, capital raising transactions involving equity or convertible debt securities,
future at the market offerings of common stock, or issuance under current or future employee equity plans, and the issuance of equity
securities in connection with such transactions may result in potentially significant dilution of our current stockholders’ ownership
interests in us.
Item
2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
None.
Item
3. DEFAULTS UNDER SENIOR SECURITIES
None.
Item
4. MINE SAFETY DISCLOSURES
Not
applicable.
Item
5. OTHER INFORMATION
The
information set forth below is included herein for the purpose of proving the disclosure required under “Item 5.02 Departure of
Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers”.
(e)
On November 7, 2023, the Company entered into an arrangement with Keith Kucinski, its chief financial officer and principal
accounting officer, whereby it agreed to make incentive bonus payments in the amount of $40,000 on or before December 31, 2023, and
$60,000 on April 1, 2024, to Mr. Kucinski if he is actively employed in good standing on each such date. If Mr. Kucinski resigns for
any reason (other than for Good Reason) or if the Company terminates Mr. Kucinski for Cause (as such terms are defined in Mr.
Kucinski’s employment agreement), within 60 days of such date, he is required to return the incentive bonus payment made to
him on such date.
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:
November 8, 2023 |
Jerome
D. Jabbour |
|
Chief
Executive Officer (Principal Executive Officer) |
|
|
|
/s/
Keith A. Kucinski |
Dated:
November 8, 2023 |
Keith
A. Kucinski |
|
Chief
Financial Officer |
|
(Principal
Financial and Accounting Officer) |
EXHIBIT
INDEX
*
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
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:
November 8, 2023 |
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:
November 8, 2023 |
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: November 8, 2023 |
By: |
/s/ Jerome D. Jabbour |
|
Name: |
Jerome D. Jabbour |
|
Title: |
Chief Executive Officer |
|
|
|
Date: November 8, 2023 |
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.
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v3.23.3
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands |
Sep. 30, 2023 |
Dec. 31, 2022 |
Current assets: |
|
|
Cash and cash equivalents |
$ 6,407
|
$ 6,830
|
Marketable debt securities |
11,809
|
21,933
|
Restricted cash – security deposit |
50
|
50
|
Prepaid expenses and other current assets |
1,723
|
5,719
|
Total current assets |
19,989
|
34,532
|
Non-current assets: |
|
|
Leasehold improvements and equipment – net |
2,021
|
2,091
|
Operating lease right-of-use assets – net |
3,206
|
3,613
|
Finance lease right-of-use assets – net |
22
|
30
|
In-process research and development |
3,017
|
3,017
|
Goodwill |
1,336
|
1,336
|
Restricted cash – security deposit |
200
|
200
|
Total non-current assets |
9,802
|
10,287
|
Total assets |
29,791
|
44,819
|
Current liabilities: |
|
|
Accounts payable |
835
|
618
|
Accrued expenses |
1,757
|
3,099
|
Operating lease liabilities – current |
632
|
562
|
Financing lease liabilities – current |
5
|
7
|
Total current liabilities |
3,229
|
4,286
|
Non-current liabilities: |
|
|
Deferred tax liability |
341
|
341
|
Operating lease liabilities – net of current portion |
3,052
|
3,533
|
Financing lease liabilities – net of current portion |
19
|
22
|
Total non-current liabilities |
3,412
|
3,896
|
Total liabilities |
6,641
|
8,182
|
Stockholders’ equity: |
|
|
Common stock par value $0.0001 per share, 500,000,000 shares authorized at September 30, 2023 and December 31, 2022; 217,264,526 issued and outstanding as of September 30, 2023 and December 31, 2022 |
22
|
22
|
Additional paid-in capital |
193,746
|
190,070
|
Accumulated deficit |
(170,259)
|
(152,631)
|
Accumulated other comprehensive loss |
(359)
|
(824)
|
Total stockholders’ equity |
23,150
|
36,637
|
Total liabilities and stockholders’ equity |
$ 29,791
|
$ 44,819
|
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v3.23.3
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares
|
Sep. 30, 2023 |
Dec. 31, 2022 |
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 |
217,264,526
|
217,264,526
|
Common stock, shares outstanding |
217,264,526
|
217,264,526
|
X |
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v3.23.3
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($) $ in Thousands |
3 Months Ended |
9 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Revenue: |
|
|
|
|
Contract Revenue |
|
$ 1,063
|
$ 1,096
|
$ 2,125
|
Costs and expenses: |
|
|
|
|
Research and development |
3,295
|
3,707
|
10,824
|
12,811
|
General and administrative |
2,839
|
2,818
|
8,151
|
8,424
|
Total costs and expenses |
6,134
|
6,525
|
18,975
|
21,235
|
Loss from operations |
(6,134)
|
(5,462)
|
(17,879)
|
(19,110)
|
Sale of New Jersey net operating losses & tax credits |
|
|
|
1,734
|
Other income, net |
79
|
|
251
|
13
|
Net loss |
$ (6,055)
|
$ (5,462)
|
$ (17,628)
|
$ (17,363)
|
Net loss per share - basic |
$ (0.03)
|
$ (0.03)
|
$ (0.08)
|
$ (0.08)
|
Net loss per share - diluted |
$ (0.03)
|
$ (0.03)
|
$ (0.08)
|
$ (0.08)
|
Weighted average common shares outstanding: |
|
|
|
|
Weighted average common shares outstanding - basic |
217,264,526
|
216,864,526
|
217,264,526
|
216,792,083
|
Weighted average common shares outstanding - diluted |
217,264,526
|
216,864,526
|
217,264,526
|
216,792,083
|
Other comprehensive gain/(loss), net of tax |
|
|
|
|
Unrealized gain/(loss) on securities available-for-sale |
$ 155
|
$ (181)
|
$ 465
|
$ (790)
|
Other comprehensive gain/(loss), net of tax |
155
|
(181)
|
465
|
(790)
|
Comprehensive loss |
$ (5,900)
|
$ (5,643)
|
$ (17,163)
|
$ (18,153)
|
X |
- DefinitionAmount after tax of increase (decrease) in equity from transactions and other events and circumstances from net income and other comprehensive income, attributable to parent entity. Excludes changes in equity resulting from investments by owners and distributions to owners.
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v3.23.3
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, 2021 |
$ 22
|
$ 184,251
|
$ (131,634)
|
$ (145)
|
$ 52,494
|
Balance, shares at Dec. 31, 2021 |
216,269,450
|
|
|
|
|
Stock-based compensation |
|
3,888
|
|
|
3,888
|
Other comprehensive income (loss) |
|
|
|
(790)
|
(790)
|
Net loss |
|
|
(17,363)
|
|
(17,363)
|
Issuance of common stock in exchange for Options |
|
99
|
|
|
99
|
Issuance of common stock in exchange for Options, shares |
195,076
|
|
|
|
|
Issuance of common stock pursuant to license agreement amendment |
|
291
|
|
|
291
|
Issuance of common stock pursuant to license agreement amendment, shares |
400,000
|
|
|
|
|
Balance at Sep. 30, 2022 |
$ 22
|
188,529
|
(148,997)
|
(935)
|
38,619
|
Balance, shares at Sep. 30, 2022 |
216,864,526
|
|
|
|
|
Balance at Jun. 30, 2022 |
$ 22
|
187,116
|
(143,535)
|
(754)
|
42,849
|
Balance, shares at Jun. 30, 2022 |
216,864,526
|
|
|
|
|
Stock-based compensation |
|
1,413
|
|
|
1,413
|
Other comprehensive income (loss) |
|
|
|
(181)
|
(181)
|
Net loss |
|
|
(5,462)
|
|
(5,462)
|
Balance at Sep. 30, 2022 |
$ 22
|
188,529
|
(148,997)
|
(935)
|
38,619
|
Balance, shares at Sep. 30, 2022 |
216,864,526
|
|
|
|
|
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 |
|
3,676
|
|
|
3,676
|
Other comprehensive income (loss) |
|
|
|
465
|
465
|
Net loss |
|
|
(17,628)
|
|
(17,628)
|
Balance at Sep. 30, 2023 |
$ 22
|
193,746
|
(170,259)
|
(359)
|
23,150
|
Balance, shares at Sep. 30, 2023 |
217,264,526
|
|
|
|
|
Balance at Jun. 30, 2023 |
$ 22
|
192,550
|
(164,204)
|
(514)
|
27,854
|
Balance, shares at Jun. 30, 2023 |
217,264,526
|
|
|
|
|
Stock-based compensation |
|
1,196
|
|
|
1,196
|
Other comprehensive income (loss) |
|
|
|
155
|
155
|
Net loss |
|
|
(6,055)
|
|
(6,055)
|
Balance at Sep. 30, 2023 |
$ 22
|
$ 193,746
|
$ (170,259)
|
$ (359)
|
$ 23,150
|
Balance, shares at Sep. 30, 2023 |
217,264,526
|
|
|
|
|
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v3.23.3
Condensed Consolidated Statements of Cash Flow (Unaudited) - USD ($) $ in Thousands |
9 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Cash flows from operating activities: |
|
|
Net loss |
$ (17,628)
|
$ (17,363)
|
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
Depreciation and amortization |
288
|
244
|
Stock based compensation expense |
3,676
|
3,888
|
Amortization of operating lease right-of-use assets |
406
|
413
|
Amortization of finance lease right-of-use assets |
7
|
15
|
Amortization of bond discount |
90
|
158
|
Stock issued pursuant to license agreement amendment |
|
291
|
Changes in operating assets and liabilities: |
|
|
Operating lease liabilities |
(411)
|
(391)
|
Prepaid expenses and other current assets |
3,996
|
(2,676)
|
Accounts payable |
217
|
(282)
|
Accrued expenses and other liabilities |
(1,340)
|
846
|
Net cash used in operating activities |
(10,699)
|
(14,857)
|
Cash flows from investing activities: |
|
|
Purchase of marketable debt securities |
|
(9,481)
|
Proceeds from maturities of marketable debt securities |
10,500
|
15,250
|
Purchases of leasehold improvements and equipment |
(218)
|
(850)
|
Net cash provided by investing activities |
10,282
|
4,919
|
Cash flows from financing activities: |
|
|
Proceeds from exercise of options |
|
99
|
Payments of finance lease liability – principal |
(6)
|
(15)
|
Net cash (used in)/provided by financing activities |
(6)
|
84
|
Net decrease in cash, cash equivalents and restricted cash |
(423)
|
(9,854)
|
Cash, cash equivalents and restricted cash at beginning of period |
7,080
|
21,280
|
Cash, cash equivalents and restricted cash at end of period |
6,657
|
11,426
|
Supplemental non-cash financing and investing activities: |
|
|
Unrealized gain/(loss) on marketable debt securities |
465
|
(790)
|
Right of use asset in exchange from liabilities from operating lease |
|
$ (64)
|
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v3.23.3
Insider Trading Arrangements
|
3 Months Ended |
Sep. 30, 2023
shares
|
Trading Arrangements, by Individual [Table] |
|
Material Terms of Trading Arrangement |
The
information set forth below is included herein for the purpose of proving the disclosure required under “Item 5.02 Departure of
Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers”.
(e)
On November 7, 2023, the Company entered into an arrangement with Keith Kucinski, its chief financial officer and principal
accounting officer, whereby it agreed to make incentive bonus payments in the amount of $40,000 on or before December 31, 2023, and
$60,000 on April 1, 2024, to Mr. Kucinski if he is actively employed in good standing on each such date. If Mr. Kucinski resigns for
any reason (other than for Good Reason) or if the Company terminates Mr. Kucinski for Cause (as such terms are defined in Mr.
Kucinski’s employment agreement), within 60 days of such date, he is required to return the incentive bonus payment made to
him on such date.
|
Name |
Keith Kucinski
|
Title |
chief financial officer and principal
accounting officer
|
Adoption Date |
November 7, 2023
|
Termination Date |
December 31, 2023
|
Aggregate Available |
40,000
|
Keith Kucinski [Member] |
|
Trading Arrangements, by Individual [Table] |
|
Termination Date |
April 1, 2024
|
Aggregate Available |
60,000
|
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v3.23.3
Description of Business
|
9 Months Ended |
Sep. 30, 2023 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
Description of Business |
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.
|
X |
- DefinitionThe entire disclosure for the nature of an entity's business, major products or services, principal markets including location, and the relative importance of its operations in each business and the basis for the determination, including but not limited to, assets, revenues, or earnings. For an entity that has not commenced principal operations, disclosures about the risks and uncertainties related to the activities in which the entity is currently engaged and an understanding of what those activities are being directed toward.
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v3.23.3
Liquidity, Plan of Operations and Going Concern
|
9 Months Ended |
Sep. 30, 2023 |
Liquidity Plan Of Operations And Going Concern |
|
Liquidity, Plan of Operations and Going Concern |
Note
2 – Liquidity, Plan of Operations and Going Concern
The
Company has experienced net losses and negative cash flows from operations each period since its inception. Through September 30, 2023,
the Company had an accumulated deficit of $170,259. The Company’s net loss was $17,628 for the nine months ended September 30,
2023.
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 September 30, 2023, the Company had cash and cash equivalents of $6,407, marketable debt securities of $11,809 and restricted cash
of $250. The Company believes the cash and cash equivalents and marketable debt securities on hand are sufficient to fund planned operations
into the third quarter of 2024, but not beyond. As a result, substantial doubt exists about the Company’s ability to continue as
a going concern.
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 the 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.
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v3.23.3
Summary of Significant Accounting Policies
|
9 Months Ended |
Sep. 30, 2023 |
Accounting Policies [Abstract] |
|
Summary of Significant Accounting Policies |
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, 2022.
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.
|
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- DefinitionThe entire disclosure for all significant accounting policies of the reporting entity.
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v3.23.3
Cash, Cash Equivalents, Restricted Cash and Marketable Debt Securities
|
9 Months Ended |
Sep. 30, 2023 |
Cash and Cash Equivalents [Abstract] |
|
Cash, Cash Equivalents, Restricted Cash and Marketable Debt Securities |
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 consisted of cash in bank checking and savings accounts, money market funds and short-term
U.S. treasury bonds that mature within three months of settlement date.
Cash,
Cash Equivalents and Restricted Cash
The
Company presents restricted cash with cash and cash equivalents in the Condensed Consolidated Statements of Cash Flows. Restricted cash
at both September 30, 2023 and December 31, 2022 of $250 represents funds the Company is required to set aside as collateral, primarily
for one of the Company’s operating leases and other purposes.
The
following table provides a reconciliation of cash, cash equivalents and restricted cash reported in the Condensed Consolidated Balance
Sheets to the total of the amounts in the Condensed Consolidated Statements of Cash Flows as of September 30, 2023, December 31, 2022,
September 30, 2022 and December 31, 2021:
Schedule of Cash, Cash Equivalents and Restricted Cash
| |
September 30, 2023 | | |
December 31, 2022 | | |
September 30, 2022 | | |
December 31, 2021 | |
Cash and cash equivalents | |
$ | 6,407 | | |
$ | 6,830 | | |
$ | 11,176 | | |
$ | 21,030 | |
Restricted cash included in current/non-current assets | |
| 250 | | |
| 250 | | |
| 250 | | |
| 250 | |
Cash, cash equivalents and restricted cash in the statement of cash flows | |
$ | 6,657 | | |
$ | 7,080 | | |
$ | 11,426 | | |
$ | 21,280 | |
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.
For the three and nine months ended September 30, 2023, the Company recorded unrealized gains of $155 and $465, respectively. For the
three and nine months ended September 30, 2022, the Company recorded unrealized losses of $181 and $790, respectively. As of September
30, 2023 and December 31, 2022, the Company had net accumulated unrealized losses of $359 and $824, respectively.
The
following tables summarize the Company’s marketable debt securities as of September 30, 2023:
Schedule of Marketable Securities
| |
Amortized Cost | | |
Unrealized Gain | | |
Unrealized (Loss) | | |
Fair Value | |
| |
Amortized | | |
Unrealized | | |
Unrealized | | |
| |
| |
Cost | | |
Gain | | |
(Loss) | | |
Fair Value | |
U.S. Treasury Bonds | |
$ | 998 | | |
$ | — | | |
$ | (13 | ) | |
$ | 985 | |
U.S. Government Notes | |
| 11,170 | | |
| — | | |
| (346 | ) | |
| 10,824 | |
Total marketable debt securities | |
$ | 12,168 | | |
$ | — | | |
$ | (359 | ) | |
$ | 11,809 | |
Maturities
of debt securities classified as available-for-sale were as follows at September 30, 2023:
Schedule of Maturities of Debt Securities Available-for-sale
| |
Fair Value | |
Due within one year | |
$ | 11,809 | |
The
following tables summarize the Company’s marketable debt securities as of December 31, 2022:
| |
Amortized Cost | | |
Unrealized Gain | | |
Unrealized (Loss) | | |
Fair Value | |
U.S. Treasury Bonds | |
$ | 993 | | |
$ | — | | |
$ | (34 | ) | |
$ | 959 | |
U.S. Government Notes | |
| 16,324 | | |
| — | | |
| (721 | ) | |
| 15,603 | |
Corporate Debt Securities | |
| 5,440 | | |
| — | | |
| (69 | ) | |
| 5,371 | |
Total marketable debt securities | |
$ | 22,757 | | |
$ | — | | |
$ | (824 | ) | |
$ | 21,933 | |
Maturities
of debt securities classified as available-for-sale were as follows at December 31, 2022:
| |
Fair Value | |
Due within one year | |
$ | 13,240 | |
Due after one year through five years | |
| 8,693 | |
| |
$ | 21,933 | |
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v3.23.3
Fair Value Measurements
|
9 Months Ended |
Sep. 30, 2023 |
Fair Value Disclosures [Abstract] |
|
Fair Value Measurements |
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 | |
September 30, 2023 | |
Total | | |
(Level 1) | | |
(Level 2) | | |
(Level 3) | |
Assets | |
| | |
| | |
| | |
| |
Marketable Debt Securities: | |
| | | |
| | | |
| | | |
| | |
U.S. Treasury Bonds | |
$ | 985 | | |
$ | 985 | | |
$ | — | | |
$ | — | |
U.S. Government Notes | |
| 10,824 | | |
| — | | |
| 10,824 | | |
| — | |
Total | |
$ | 11,809 | | |
$ | 985 | | |
$ | 10,824 | | |
$ | — | |
| |
| | | |
| | | |
| | | |
| | |
| |
| | |
Fair Value Hierarchy | |
December 31, 2022 | |
Total | | |
(Level 1) | | |
(Level 2) | | |
(Level 3) | |
Assets | |
| | |
| | |
| | |
| |
Marketable Debt Securities: | |
| | | |
| | | |
| | | |
| | |
U.S. Treasury Bonds | |
$ | 959 | | |
$ | 959 | | |
$ | — | | |
$ | — | |
U.S. Government Notes | |
| 15,603 | | |
| — | | |
| 15,603 | | |
| — | |
Corporate Debt Securities | |
| 5,371 | | |
| — | | |
| 5,371 | | |
| — | |
Total | |
$ | 21,933 | | |
$ | 959 | | |
$ | 20,974 | | |
$ | — | |
Assets and liabilities carried at fair value | |
$ | 21,933 | | |
$ | 959 | | |
$ | 20,974 | | |
$ | — | |
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 and corporate debt securities are classified
as Level 2 and are valued using quoted market prices in markets that are not active.
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v3.23.3
Leasehold Improvements and Equipment
|
9 Months Ended |
Sep. 30, 2023 |
Property, Plant and Equipment [Abstract] |
|
Leasehold Improvements and Equipment |
Note
6 – Leasehold Improvements and Equipment
Leasehold
improvements and equipment, summarized by major category, consist of the following as of September 30, 2023 and December 31, 2022:
Schedule of Leasehold Improvements and Equipment
| |
September 30, 2023 | | |
December 31, 2022 | |
Equipment | |
$ | 2,523 | | |
$ | 2,305 | |
Leasehold improvements | |
| 1,155 | | |
| 1,155 | |
Total | |
| 3,678 | | |
| 3,460 | |
Leasehold improvements and equipment, gross | |
| 3,678 | | |
| 3,460 | |
Less: accumulated depreciation and amortization | |
| 1,657 | | |
| 1,369 | |
Leasehold improvements and equipment, net | |
$ | 2,021 | | |
$ | 2,091 | |
Depreciation
and amortization expense for the three and nine months ended September 30, 2023 was $98 and $288, respectively, and the three and nine
months ended September 30, 2022 was $89 and $244, respectively. During the nine month period ended September 30, 2023, the Company purchased
equipment of $218, and no leasehold improvements. During the nine month period ended September 30, 2022, the Company purchased equipment
of $629, and leasehold improvements of $221.
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v3.23.3
Accrued Expenses and Other Liabilities
|
9 Months Ended |
Sep. 30, 2023 |
Payables and Accruals [Abstract] |
|
Accrued Expenses and Other Liabilities |
Note
7 – Accrued Expenses and Other Liabilities
Accrued
Expenses, summarized by major category, as of September 30, 2023 and December 31, 2022 consist of the following:
Schedule of Accrued Expenses
| |
September 30, 2023 | | |
December 31, 2022 | |
Payroll and incentives | |
$ | 1,290 | | |
$ | 1,705 | |
General and administrative expenses | |
| 407 | | |
| 455 | |
Research and development expenses | |
| 60 | | |
| 130 | |
Deferred revenue * | |
| — | | |
| 721 | |
Other deferred liabilities ** | |
| — | | |
| 88 | |
Total | |
$ | 1,757 | | |
$ | 3,099 | |
|
* |
At
December 31, 2022, the balance included $688 related to an exclusive research collaboration with BioNTech SE (the “BioNTech
Agreement”) and $33 related to a feasibility study agreement with Genentech, Inc. (the “Genentech Agreement”).
(See Note 9 – Revenue Recognition, Collaboration Agreements and Other). |
|
|
|
|
** |
At
December 31, 2022, the balances of $88 related to an award agreement with the Cystic Fibrosis Foundation (the “CFF Agreement).
(See Note 9 – Revenue Recognition, Collaboration Agreements and Other). |
|
X |
- DefinitionThe entire disclosure for accounts payable and accrued liabilities at the end of the reporting period.
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v3.23.3
Leases
|
9 Months Ended |
Sep. 30, 2023 |
Leases |
|
Leases |
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 $225 and $194 for each of the three month periods ended September 30, 2023
and 2022, respectively, and $677 and $646 for each of the nine month periods ended September 30, 2023 and 2022, respectively. The Company
incurred amortization expense on its operating lease right-of-use assets of $139 and $406 for the three and nine months ended September
30, 2023, respectively, and $138 and $413 for the three and nine months ended September 30, 2022, respectively.
Finance
Leases
The
Company incurred interest expense on its finance leases of $0 and $2 for the three and nine months ended September 30, 2023, respectively,
and $0 and $1 for the three and nine months ended September 30, 2022, respectively. The Company incurred amortization expense on its
finance lease right-of-use assets of $2 and $7 for the three and nine months ended September 30, 2023, respectively, and $3 and $15 for
the three and nine months ended September 30, 2022, respectively.
The
following table presents information about the amount and timing of liabilities arising from the Company’s operating leases and
finance leases as of September 30, 2023:
Schedule of Maturity of Operating and Finance Liabilities
Maturity of Lease Liabilities | |
Operating Lease Liabilities | | |
Finance Lease Liabilities | |
Remainder of 2023 | |
$ | 235 | | |
$ | 2 | |
2024 | |
| 956 | | |
| 7 | |
2025 | |
| 998 | | |
| 7 | |
2026 | |
| 1,040 | | |
| 7 | |
2027 | |
| 944 | | |
| 7 | |
Thereafter | |
| 411 | | |
| — | |
Total undiscounted operating lease payments | |
$ | 4,584 | | |
$ | 30 | |
Less: Imputed interest | |
| 900 | | |
| 6 | |
Present value of operating lease liabilities | |
$ | 3,684 | | |
$ | 24 | |
| |
| | | |
| | |
Weighted average remaining lease term in years | |
| 4.6 | | |
| 4.2 | |
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, 2022:
Maturity of Lease Liabilities | |
Operating Lease Liabilities | | |
Finance Lease Liabilities | |
2023 | |
$ | 916 | | |
$ | 10 | |
2024 | |
| 956 | | |
| 7 | |
2025 | |
| 998 | | |
| 7 | |
2026 | |
| 1,040 | | |
| 7 | |
2027 | |
| 944 | | |
| 7 | |
Thereafter | |
| 411 | | |
| — | |
Total undiscounted operating lease payments | |
$ | 5,265 | | |
$ | 38 | |
Less: Imputed interest | |
| 1,170 | | |
| 9 | |
Present value of operating lease liabilities | |
$ | 4,095 | | |
$ | 29 | |
| |
| | | |
| | |
Weighted average remaining lease term in years | |
| 5.3 | | |
| 4.5 | |
Weighted average discount rate | |
| 9.2 | % | |
| 11.1 | % |
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v3.23.3
Revenue Recognition, Collaboration Agreements and Other
|
9 Months Ended |
Sep. 30, 2023 |
Revenue Recognition Collaboration Agreements And Other |
|
Revenue Recognition, Collaboration Agreements and Other |
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.
Cystic
Fibrosis Foundation Therapeutics Development Award
On
November 19, 2020, the Company entered into the CFF Agreement with the Cystic Fibrosis Foundation (“CFF”), pursuant to which
it received a Therapeutics Development Award of up to $4.2 million (the “Award”) (of which $484 had been previously received)
to support the preclinical development (the “Development Program”) of the Company’s MAT2501 product candidate. On November
19, 2021, the Company and CFF entered into an Amendment to the CFF Agreement which added an additional milestone payment in the amount
of $321, which was received in the fourth quarter of 2021.
As
of September 30, 2023, the Company has received approximately $3.6 million of the $4.5 million Award, including the Amendment’s
additional milestone payment, and a related deferred liability balance of $0 and $88 is included in accrued expenses at September 30,
2023 and December 31, 2022, respectively. During the fourth quarter of 2022, for financial and technical reasons, the Company determined
that it was not commercially reasonable to continue the development of MAT2501 and instead elected to focus existing resources on other
initiatives. As a result, the Company will not receive the balance of the Award and has no further obligations to CFF.
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.
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v3.23.3
Income Taxes
|
9 Months Ended |
Sep. 30, 2023 |
Income Tax Disclosure [Abstract] |
|
Income Taxes |
Note
10 – Income Taxes
Sale
of net operating losses (NOLs) & tax credits
The
Company recognized $0 and $1,734 for the nine month periods ended September 30, 2023 and 2022, respectively, in connection with the sale
of certain state net operating losses (“NOLs”) and research and development tax credits to a third party under the New Jersey
Technology Business Tax Certificate Transfer Program.
|
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v3.23.3
Stockholders’ Equity
|
9 Months Ended |
Sep. 30, 2023 |
Equity [Abstract] |
|
Stockholders’ Equity |
Note
11 – Stockholders’ Equity
Common
Stock
On
February 8, 2022, the Company issued 400,000 unregistered shares of its common stock to Rutgers, The State University of New Jersey (“Rutgers”),
as partial consideration pursuant to the Second Amended and Restated Exclusive License Agreement between the Company and Rutgers. The
agreement provides for (1) royalties on a tiered basis between low single digits and the mid-single digits of net sales of products using
such licensed technology, (2) a one-time sales milestone fee of $100 when and if sales of products using the licensed technology reach
the specified sales threshold and (3) an annual license fee of $50 over the term of the license agreement. There was also a reduction
in the consideration paid to Rutgers in the event of a sublicense to a third party of the exclusive patent rights granted pursuant to
the Agreement. The Company recorded a $291 research and development expense related to the issuance of the 400,000 shares based on the
closing price of the Company’s common stock of $0.728 on the date of issuance.
For
the nine months ended September 30, 2023 and 2022, the Company did not sell any shares of its common stock under its At-The-Market Sales
Agreement with BTIG, LLC.
Warrants
As
of September 30, 2023, the Company did not have any outstanding warrants to purchase shares of the Company’s common stock. The
following table summarizes the changes in warrants outstanding during 2022 and for the nine months ended September 30, 2023:
Summary of Shareholder Equity Warrants Outstanding
| |
Shares | |
Outstanding at December 31, 2021 | |
| 988 | |
Issued | |
| — | |
Exercised | |
| (400 | ) |
Expired | |
| (350 | ) |
Outstanding at December 31, 2022 | |
| 238 | |
Issued | |
| — | |
Exercised | |
| — | |
Expired | |
| (238 | ) |
Outstanding at September 30, 2023 | |
| — | |
Basic
and diluted net loss per common share
During
the three and nine months ended September 30, 2023 and 2022, diluted loss per common share is the same as basic loss per common share
because, as the Company incurred a net loss during each period presented, the potentially dilutive securities from the assumed exercise
of all outstanding stock options and warrants, would have an anti-dilutive effect. The following outstanding shares of potentially dilutive
securities were excluded from the computation of diluted net loss per share because including them would have been anti-dilutive as of
September 30, 2023 and 2022:
Schedule of Anti-dilutive Securities Excluded from Computation of Earning Per Share
| |
As of September 30, | |
| |
2023 | | |
2022 | |
Stock options | |
| 33,234 | | |
| 27,729 | |
Warrants | |
| — | | |
| 988 | |
Total | |
| 33,234 | | |
| 28,717 | |
|
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- DefinitionThe entire disclosure for equity.
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v3.23.3
Accumulated Other Comprehensive Loss
|
9 Months Ended |
Sep. 30, 2023 |
Equity [Abstract] |
|
Accumulated Other Comprehensive Loss |
Note
12 – Accumulated Other Comprehensive Loss
The
following table summarizes the changes in accumulated other comprehensive loss by component during the nine months ended September 30,
2023 and 2022:
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, 2022 | |
$ | (824 | ) | |
$ | (824 | ) |
Net
unrealized gain on securities available-for-sale | |
| 465 | | |
| 465 | |
Balance,
September 30, 2023 | |
$ | (359 | ) | |
$ | (359 | ) |
| |
| | | |
| | |
Balance,
December 31, 2021 | |
$ | (145 | ) | |
$ | (145 | ) |
Net
unrealized loss on securities available-for-sale | |
| (790 | ) | |
| (790 | ) |
Balance,
September 30, 2022 | |
$ | (935 | ) | |
$ | (935 | ) |
All
components of accumulated other comprehensive income are net of tax.
|
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v3.23.3
Stock-based Compensation
|
9 Months Ended |
Sep. 30, 2023 |
Share-Based Payment Arrangement [Abstract] |
|
Stock-based Compensation |
Note
13 – Stock-based Compensation
The
Company’s Amended and Restated 2013 Equity Compensation Plan (the “Plan”) provides for the granting of incentive stock
options, nonqualified stock options, restricted stock units, performance units, and stock purchase rights. There were no significant
modifications to the Plan during the nine month periods ended September 30, 2023 and 2022. The term of the Plan is for 10 years and will
expire on May 7, 2024, if not amended before then.
The
following table contains information about the Company’s stock plan at September 30, 2023:
Schedule of Equtiy Compensation Plan by Arrangements
| |
Awards Reserved for Issuance | | |
Awards Issued & Exercised | | |
Awards Available for Grant | |
2013 Equity Compensation Plan | |
| 54,294 | * | |
| 37,915 | ** | |
| 16,379 | |
* |
Increased
by 8,691 on January 1, 2023, representing 4% of the total number of shares of common stock outstanding on December 31, 2022. |
** |
Includes
both restricted stock grants and option grants |
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 September 30, | | |
Nine Months Ended September 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Research and Development | |
$ | 507 | | |
$ | 554 | | |
$ | 1,576 | | |
$ | 1,660 | |
General and Administrative | |
| 689 | | |
| 859 | | |
| 2,100 | | |
| 2,228 | |
Total | |
$ | 1,196 | | |
$ | 1,413 | | |
$ | 3,676 | | |
$ | 3,888 | |
As
of September 30, 2023, total compensation costs related to unvested awards not yet recognized was $6,204 and the weighted-average periods
over which the awards are expected to be recognized was 2.2 years.
Stock
Options
The
following table summarizes the activity for Company’ stock options for the nine months ended September 30, 2023:
Schedule of Stock Option Activity
| |
Stock Options | |
Outstanding at December 31, 2022 | |
| 34,739 | |
Granted | |
| 105 | |
Exercised | |
| — | |
Forfeited | |
| (296 | ) |
Expired | |
| (1,314 | ) |
Outstanding at September 30, 2023 | |
| 33,234 | |
|
X |
- DefinitionThe entire disclosure for share-based payment arrangement.
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v3.23.3
Subsequent Events
|
9 Months Ended |
Sep. 30, 2023 |
Subsequent Events [Abstract] |
|
Subsequent Events |
Note
14 – Subsequent Events
On
November 1, 2023, at a Special Meeting of the Company’s stockholders, a proposal for an amendment to the Company’s Certificate
of Incorporation to effect a reverse stock split of its common stock at a ratio in the range of 1-for-2 to 1-for-50, with such reverse
stock split to be effected at a ratio, time and date, if at all, as determined by the Company’s Board of Directors in its sole
discretion. The Board may choose to exercise its discretion at any time prior to November 1, 2024, which is the first anniversary of
its approval by stockholders.
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- DefinitionThe entire disclosure for significant events or transactions that occurred after the balance sheet date through the date the financial statements were issued or the date the financial statements were available to be issued. Examples include: the sale of a capital stock issue, purchase of a business, settlement of litigation, catastrophic loss, significant foreign exchange rate changes, loans to insiders or affiliates, and transactions not in the ordinary course of business.
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v3.23.3
The information set forth below is included herein for the purpose of proving the disclosure required under “Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers”.
|
3 Months Ended |
Sep. 30, 2023 |
Insider Trading Arrangements [Line Items] |
|
The information set forth below is included herein for the purpose of proving the disclosure required under “Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers”. |
The
information set forth below is included herein for the purpose of proving the disclosure required under “Item 5.02 Departure of
Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers”.
(e)
On November 7, 2023, the Company entered into an arrangement with Keith Kucinski, its chief financial officer and principal
accounting officer, whereby it agreed to make incentive bonus payments in the amount of $40,000 on or before December 31, 2023, and
$60,000 on April 1, 2024, to Mr. Kucinski if he is actively employed in good standing on each such date. If Mr. Kucinski resigns for
any reason (other than for Good Reason) or if the Company terminates Mr. Kucinski for Cause (as such terms are defined in Mr.
Kucinski’s employment agreement), within 60 days of such date, he is required to return the incentive bonus payment made to
him on such date.
|
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v3.23.3
Summary of Significant Accounting Policies (Policies)
|
9 Months Ended |
Sep. 30, 2023 |
Accounting Policies [Abstract] |
|
Basis of presentation and principles of consolidation |
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, 2022.
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.
|
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v3.23.3
Cash, Cash Equivalents, Restricted Cash and Marketable Debt Securities (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Cash and Cash Equivalents [Abstract] |
|
Schedule of Cash, Cash Equivalents and Restricted Cash |
The
following table provides a reconciliation of cash, cash equivalents and restricted cash reported in the Condensed Consolidated Balance
Sheets to the total of the amounts in the Condensed Consolidated Statements of Cash Flows as of September 30, 2023, December 31, 2022,
September 30, 2022 and December 31, 2021:
Schedule of Cash, Cash Equivalents and Restricted Cash
| |
September 30, 2023 | | |
December 31, 2022 | | |
September 30, 2022 | | |
December 31, 2021 | |
Cash and cash equivalents | |
$ | 6,407 | | |
$ | 6,830 | | |
$ | 11,176 | | |
$ | 21,030 | |
Restricted cash included in current/non-current assets | |
| 250 | | |
| 250 | | |
| 250 | | |
| 250 | |
Cash, cash equivalents and restricted cash in the statement of cash flows | |
$ | 6,657 | | |
$ | 7,080 | | |
$ | 11,426 | | |
$ | 21,280 | |
|
Schedule of Marketable Securities |
The
following tables summarize the Company’s marketable debt securities as of September 30, 2023:
Schedule of Marketable Securities
| |
Amortized Cost | | |
Unrealized Gain | | |
Unrealized (Loss) | | |
Fair Value | |
| |
Amortized | | |
Unrealized | | |
Unrealized | | |
| |
| |
Cost | | |
Gain | | |
(Loss) | | |
Fair Value | |
U.S. Treasury Bonds | |
$ | 998 | | |
$ | — | | |
$ | (13 | ) | |
$ | 985 | |
U.S. Government Notes | |
| 11,170 | | |
| — | | |
| (346 | ) | |
| 10,824 | |
Total marketable debt securities | |
$ | 12,168 | | |
$ | — | | |
$ | (359 | ) | |
$ | 11,809 | |
The
following tables summarize the Company’s marketable debt securities as of December 31, 2022:
| |
Amortized Cost | | |
Unrealized Gain | | |
Unrealized (Loss) | | |
Fair Value | |
U.S. Treasury Bonds | |
$ | 993 | | |
$ | — | | |
$ | (34 | ) | |
$ | 959 | |
U.S. Government Notes | |
| 16,324 | | |
| — | | |
| (721 | ) | |
| 15,603 | |
Corporate Debt Securities | |
| 5,440 | | |
| — | | |
| (69 | ) | |
| 5,371 | |
Total marketable debt securities | |
$ | 22,757 | | |
$ | — | | |
$ | (824 | ) | |
$ | 21,933 | |
|
Schedule of Maturities of Debt Securities Available-for-sale |
Maturities
of debt securities classified as available-for-sale were as follows at September 30, 2023:
Schedule of Maturities of Debt Securities Available-for-sale
| |
Fair Value | |
Due within one year | |
$ | 11,809 | |
Maturities
of debt securities classified as available-for-sale were as follows at December 31, 2022:
| |
Fair Value | |
Due within one year | |
$ | 13,240 | |
Due after one year through five years | |
| 8,693 | |
| |
$ | 21,933 | |
|
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v3.23.3
Fair Value Measurements (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Fair Value Disclosures [Abstract] |
|
Schedule of Fair Value Measurement of Assets and Liabilities |
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 | |
September 30, 2023 | |
Total | | |
(Level 1) | | |
(Level 2) | | |
(Level 3) | |
Assets | |
| | |
| | |
| | |
| |
Marketable Debt Securities: | |
| | | |
| | | |
| | | |
| | |
U.S. Treasury Bonds | |
$ | 985 | | |
$ | 985 | | |
$ | — | | |
$ | — | |
U.S. Government Notes | |
| 10,824 | | |
| — | | |
| 10,824 | | |
| — | |
Total | |
$ | 11,809 | | |
$ | 985 | | |
$ | 10,824 | | |
$ | — | |
| |
| | | |
| | | |
| | | |
| | |
| |
| | |
Fair Value Hierarchy | |
December 31, 2022 | |
Total | | |
(Level 1) | | |
(Level 2) | | |
(Level 3) | |
Assets | |
| | |
| | |
| | |
| |
Marketable Debt Securities: | |
| | | |
| | | |
| | | |
| | |
U.S. Treasury Bonds | |
$ | 959 | | |
$ | 959 | | |
$ | — | | |
$ | — | |
U.S. Government Notes | |
| 15,603 | | |
| — | | |
| 15,603 | | |
| — | |
Corporate Debt Securities | |
| 5,371 | | |
| — | | |
| 5,371 | | |
| — | |
Total | |
$ | 21,933 | | |
$ | 959 | | |
$ | 20,974 | | |
$ | — | |
Assets and liabilities carried at fair value | |
$ | 21,933 | | |
$ | 959 | | |
$ | 20,974 | | |
$ | — | |
|
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v3.23.3
Leasehold Improvements and Equipment (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Property, Plant and Equipment [Abstract] |
|
Schedule of Leasehold Improvements and Equipment |
Leasehold
improvements and equipment, summarized by major category, consist of the following as of September 30, 2023 and December 31, 2022:
Schedule of Leasehold Improvements and Equipment
| |
September 30, 2023 | | |
December 31, 2022 | |
Equipment | |
$ | 2,523 | | |
$ | 2,305 | |
Leasehold improvements | |
| 1,155 | | |
| 1,155 | |
Total | |
| 3,678 | | |
| 3,460 | |
Leasehold improvements and equipment, gross | |
| 3,678 | | |
| 3,460 | |
Less: accumulated depreciation and amortization | |
| 1,657 | | |
| 1,369 | |
Leasehold improvements and equipment, net | |
$ | 2,021 | | |
$ | 2,091 | |
|
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v3.23.3
Accrued Expenses and Other Liabilities (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Payables and Accruals [Abstract] |
|
Schedule of Accrued Expenses |
Accrued
Expenses, summarized by major category, as of September 30, 2023 and December 31, 2022 consist of the following:
Schedule of Accrued Expenses
| |
September 30, 2023 | | |
December 31, 2022 | |
Payroll and incentives | |
$ | 1,290 | | |
$ | 1,705 | |
General and administrative expenses | |
| 407 | | |
| 455 | |
Research and development expenses | |
| 60 | | |
| 130 | |
Deferred revenue * | |
| — | | |
| 721 | |
Other deferred liabilities ** | |
| — | | |
| 88 | |
Total | |
$ | 1,757 | | |
$ | 3,099 | |
|
* |
At
December 31, 2022, the balance included $688 related to an exclusive research collaboration with BioNTech SE (the “BioNTech
Agreement”) and $33 related to a feasibility study agreement with Genentech, Inc. (the “Genentech Agreement”).
(See Note 9 – Revenue Recognition, Collaboration Agreements and Other). |
|
|
|
|
** |
At
December 31, 2022, the balances of $88 related to an award agreement with the Cystic Fibrosis Foundation (the “CFF Agreement).
(See Note 9 – Revenue Recognition, Collaboration Agreements and Other). |
|
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v3.23.3
Leases (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Leases |
|
Schedule of Maturity of Operating and Finance Liabilities |
The
following table presents information about the amount and timing of liabilities arising from the Company’s operating leases and
finance leases as of September 30, 2023:
Schedule of Maturity of Operating and Finance Liabilities
Maturity of Lease Liabilities | |
Operating Lease Liabilities | | |
Finance Lease Liabilities | |
Remainder of 2023 | |
$ | 235 | | |
$ | 2 | |
2024 | |
| 956 | | |
| 7 | |
2025 | |
| 998 | | |
| 7 | |
2026 | |
| 1,040 | | |
| 7 | |
2027 | |
| 944 | | |
| 7 | |
Thereafter | |
| 411 | | |
| — | |
Total undiscounted operating lease payments | |
$ | 4,584 | | |
$ | 30 | |
Less: Imputed interest | |
| 900 | | |
| 6 | |
Present value of operating lease liabilities | |
$ | 3,684 | | |
$ | 24 | |
| |
| | | |
| | |
Weighted average remaining lease term in years | |
| 4.6 | | |
| 4.2 | |
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, 2022:
Maturity of Lease Liabilities | |
Operating Lease Liabilities | | |
Finance Lease Liabilities | |
2023 | |
$ | 916 | | |
$ | 10 | |
2024 | |
| 956 | | |
| 7 | |
2025 | |
| 998 | | |
| 7 | |
2026 | |
| 1,040 | | |
| 7 | |
2027 | |
| 944 | | |
| 7 | |
Thereafter | |
| 411 | | |
| — | |
Total undiscounted operating lease payments | |
$ | 5,265 | | |
$ | 38 | |
Less: Imputed interest | |
| 1,170 | | |
| 9 | |
Present value of operating lease liabilities | |
$ | 4,095 | | |
$ | 29 | |
| |
| | | |
| | |
Weighted average remaining lease term in years | |
| 5.3 | | |
| 4.5 | |
Weighted average discount rate | |
| 9.2 | % | |
| 11.1 | % |
|
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X |
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v3.23.3
Accumulated Other Comprehensive Loss (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Equity [Abstract] |
|
Schedule of Components of Accumulated Other Comprehensive (Loss) Income |
The
following table summarizes the changes in accumulated other comprehensive loss by component during the nine months ended September 30,
2023 and 2022:
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, 2022 | |
$ | (824 | ) | |
$ | (824 | ) |
Net
unrealized gain on securities available-for-sale | |
| 465 | | |
| 465 | |
Balance,
September 30, 2023 | |
$ | (359 | ) | |
$ | (359 | ) |
| |
| | | |
| | |
Balance,
December 31, 2021 | |
$ | (145 | ) | |
$ | (145 | ) |
Net
unrealized loss on securities available-for-sale | |
| (790 | ) | |
| (790 | ) |
Balance,
September 30, 2022 | |
$ | (935 | ) | |
$ | (935 | ) |
|
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v3.23.3
Stock-based Compensation (Tables)
|
9 Months Ended |
Sep. 30, 2023 |
Share-Based Payment Arrangement [Abstract] |
|
Schedule of Equtiy Compensation Plan by Arrangements |
The
following table contains information about the Company’s stock plan at September 30, 2023:
Schedule of Equtiy Compensation Plan by Arrangements
| |
Awards Reserved for Issuance | | |
Awards Issued & Exercised | | |
Awards Available for Grant | |
2013 Equity Compensation Plan | |
| 54,294 | * | |
| 37,915 | ** | |
| 16,379 | |
* |
Increased
by 8,691 on January 1, 2023, representing 4% of the total number of shares of common stock outstanding on December 31, 2022. |
** |
Includes
both restricted stock grants and option grants |
|
Schedule of Recognized Stock Based Compensation |
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 September 30, | | |
Nine Months Ended September 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Research and Development | |
$ | 507 | | |
$ | 554 | | |
$ | 1,576 | | |
$ | 1,660 | |
General and Administrative | |
| 689 | | |
| 859 | | |
| 2,100 | | |
| 2,228 | |
Total | |
$ | 1,196 | | |
$ | 1,413 | | |
$ | 3,676 | | |
$ | 3,888 | |
|
Schedule of Stock Option Activity |
The
following table summarizes the activity for Company’ stock options for the nine months ended September 30, 2023:
Schedule of Stock Option Activity
| |
Stock Options | |
Outstanding at December 31, 2022 | |
| 34,739 | |
Granted | |
| 105 | |
Exercised | |
| — | |
Forfeited | |
| (296 | ) |
Expired | |
| (1,314 | ) |
Outstanding at September 30, 2023 | |
| 33,234 | |
|
X |
- DefinitionTabular disclosure of share-based payment arrangement.
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v3.23.3
Liquidity, Plan of Operations and Going Concern (Details Narrative) - USD ($) $ in Thousands |
3 Months Ended |
9 Months Ended |
|
|
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Dec. 31, 2022 |
Dec. 31, 2021 |
Liquidity Plan Of Operations And Going Concern |
|
|
|
|
|
|
Accumulated deficit |
$ 170,259
|
|
$ 170,259
|
|
$ 152,631
|
|
Net loss |
6,055
|
$ 5,462
|
17,628
|
$ 17,363
|
|
|
Cash and cash equivalents |
6,407
|
11,176
|
6,407
|
11,176
|
6,830
|
$ 21,030
|
Marketable securities |
11,809
|
|
11,809
|
|
21,933
|
|
Restricted cash |
$ 250
|
$ 250
|
$ 250
|
$ 250
|
$ 250
|
$ 250
|
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v3.23.3
Schedule of Cash, Cash Equivalents and Restricted Cash (Details) - USD ($) $ in Thousands |
Sep. 30, 2023 |
Dec. 31, 2022 |
Sep. 30, 2022 |
Dec. 31, 2021 |
Cash and Cash Equivalents [Abstract] |
|
|
|
|
Cash and cash equivalents |
$ 6,407
|
$ 6,830
|
$ 11,176
|
$ 21,030
|
Restricted cash included in current/non-current assets |
250
|
250
|
250
|
250
|
Cash, cash equivalents and restricted cash in the statement of cash flows |
$ 6,657
|
$ 7,080
|
$ 11,426
|
$ 21,280
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v3.23.3
Schedule of Marketable Securities (Details) - USD ($) $ in Thousands |
Sep. 30, 2023 |
Dec. 31, 2022 |
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] |
|
|
Debt Securities, Available-for-Sale, Amortized Cost |
$ 12,168
|
$ 22,757
|
Debt Securities, Available-for-Sale, Accumulated Gross Unrealized Gain, before Tax |
|
|
Debt Securities, Available-for-Sale, Accumulated Gross Unrealized Loss, before Tax |
(359)
|
(824)
|
Debt Securities, Available-for-Sale |
11,809
|
21,933
|
US Treasury Securities [Member] |
|
|
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] |
|
|
Debt Securities, Available-for-Sale, Amortized Cost |
998
|
993
|
Debt Securities, Available-for-Sale, Accumulated Gross Unrealized Gain, before Tax |
|
|
Debt Securities, Available-for-Sale, Accumulated Gross Unrealized Loss, before Tax |
(13)
|
(34)
|
Debt Securities, Available-for-Sale |
985
|
959
|
US Government Agencies Debt Securities [Member] |
|
|
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] |
|
|
Debt Securities, Available-for-Sale, Amortized Cost |
11,170
|
16,324
|
Debt Securities, Available-for-Sale, Accumulated Gross Unrealized Gain, before Tax |
|
|
Debt Securities, Available-for-Sale, Accumulated Gross Unrealized Loss, before Tax |
(346)
|
(721)
|
Debt Securities, Available-for-Sale |
$ 10,824
|
15,603
|
Corporate Debt Securities [Member] |
|
|
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] |
|
|
Debt Securities, Available-for-Sale, Amortized Cost |
|
5,440
|
Debt Securities, Available-for-Sale, Accumulated Gross Unrealized Gain, before Tax |
|
|
Debt Securities, Available-for-Sale, Accumulated Gross Unrealized Loss, before Tax |
|
(69)
|
Debt Securities, Available-for-Sale |
|
$ 5,371
|
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v3.23.3
Schedule of Fair Value Measurement of Assets and Liabilities (Details) - USD ($) $ in Thousands |
Sep. 30, 2023 |
Dec. 31, 2022 |
Fair Value, off-Balance-Sheet Risks, Disclosure Information [Line Items] |
|
|
Total |
$ 11,809
|
$ 21,933
|
Assets and liabilities carried at fair value |
|
21,933
|
Fair Value, Inputs, Level 1 [Member] |
|
|
Fair Value, off-Balance-Sheet Risks, Disclosure Information [Line Items] |
|
|
Total |
985
|
959
|
Assets and liabilities carried at fair value |
|
959
|
Fair Value, Inputs, Level 2 [Member] |
|
|
Fair Value, off-Balance-Sheet Risks, Disclosure Information [Line Items] |
|
|
Total |
10,824
|
20,974
|
Assets and liabilities carried at fair value |
|
20,974
|
Fair Value, Inputs, Level 3 [Member] |
|
|
Fair Value, off-Balance-Sheet Risks, Disclosure Information [Line Items] |
|
|
Total |
|
|
Assets and liabilities carried at fair value |
|
|
US Treasury Securities [Member] |
|
|
Fair Value, off-Balance-Sheet Risks, Disclosure Information [Line Items] |
|
|
Total |
985
|
959
|
US Treasury Securities [Member] | Fair Value, Inputs, Level 1 [Member] |
|
|
Fair Value, off-Balance-Sheet Risks, Disclosure Information [Line Items] |
|
|
Total |
985
|
959
|
US Treasury Securities [Member] | Fair Value, Inputs, Level 2 [Member] |
|
|
Fair Value, off-Balance-Sheet Risks, Disclosure Information [Line Items] |
|
|
Total |
|
|
US Treasury Securities [Member] | Fair Value, Inputs, Level 3 [Member] |
|
|
Fair Value, off-Balance-Sheet Risks, Disclosure Information [Line Items] |
|
|
Total |
|
|
US Government Agencies Debt Securities [Member] |
|
|
Fair Value, off-Balance-Sheet Risks, Disclosure Information [Line Items] |
|
|
Total |
10,824
|
15,603
|
US Government Agencies Debt Securities [Member] | Fair Value, Inputs, Level 1 [Member] |
|
|
Fair Value, off-Balance-Sheet Risks, Disclosure Information [Line Items] |
|
|
Total |
|
|
US Government Agencies Debt Securities [Member] | Fair Value, Inputs, Level 2 [Member] |
|
|
Fair Value, off-Balance-Sheet Risks, Disclosure Information [Line Items] |
|
|
Total |
10,824
|
15,603
|
US Government Agencies Debt Securities [Member] | Fair Value, Inputs, Level 3 [Member] |
|
|
Fair Value, off-Balance-Sheet Risks, Disclosure Information [Line Items] |
|
|
Total |
|
|
Corporate Debt Securities [Member] |
|
|
Fair Value, off-Balance-Sheet Risks, Disclosure Information [Line Items] |
|
|
Total |
|
5,371
|
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|
|
Fair Value, off-Balance-Sheet Risks, Disclosure Information [Line Items] |
|
|
Total |
|
|
Corporate Debt Securities [Member] | Fair Value, Inputs, Level 2 [Member] |
|
|
Fair Value, off-Balance-Sheet Risks, Disclosure Information [Line Items] |
|
|
Total |
|
5,371
|
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|
|
Fair Value, off-Balance-Sheet Risks, Disclosure Information [Line Items] |
|
|
Total |
|
|
X |
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v3.23.3
Schedule of Leasehold Improvements and Equipment (Details) - USD ($) $ in Thousands |
Sep. 30, 2023 |
Dec. 31, 2022 |
Sep. 30, 2022 |
Property, Plant and Equipment [Line Items] |
|
|
|
Leasehold improvements and equipment, gross |
$ 3,678
|
$ 3,460
|
|
Less: accumulated depreciation and amortization |
1,657
|
1,369
|
|
Leasehold improvements and equipment, net |
2,021
|
2,091
|
|
Equipment [Member] |
|
|
|
Property, Plant and Equipment [Line Items] |
|
|
|
Leasehold improvements and equipment, gross |
2,523
|
2,305
|
|
Leasehold Improvements [Member] |
|
|
|
Property, Plant and Equipment [Line Items] |
|
|
|
Leasehold improvements and equipment, gross |
1,155
|
$ 1,155
|
|
Leasehold improvements and equipment, net |
$ 0
|
|
$ 221
|
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- DefinitionAmount of accumulated depreciation, depletion and amortization for physical assets used in the normal conduct of business to produce goods and services.
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v3.23.3
Leasehold Improvements and Equipment (Details Narrative) - USD ($) $ in Thousands |
3 Months Ended |
9 Months Ended |
|
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Dec. 31, 2022 |
Property, Plant and Equipment [Line Items] |
|
|
|
|
|
Depreciation and amortization expenses |
$ 98
|
$ 89
|
$ 288
|
$ 244
|
|
Purchases of leasehold improvements and equipment |
|
|
218
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850
|
|
Leasehold improvements and equipment |
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2,021
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|
$ 2,091
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629
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$ 221
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$ 0
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$ 221
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|
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v3.23.3
Schedule of Maturity of Operating and Finance Liabilities (Details) - USD ($) $ in Thousands |
Sep. 30, 2023 |
Dec. 31, 2022 |
Leases |
|
|
Operating Lease Liabilities, Remainder of Fiscal Year |
$ 235
|
|
Finance Lease Liabilities, Remainder of Fiscal Year |
2
|
|
Operating Lease Liabilities, Year One |
956
|
$ 916
|
Finance Lease Liabilities, Year One |
7
|
10
|
Operating Lease Liabilities, Year Two |
998
|
956
|
Finance Lease Liabilities, Year Two |
7
|
7
|
Operating Lease Liabilities, Year Three |
1,040
|
998
|
Finance Lease Liabilities, Year Three |
7
|
7
|
Operating Lease Liabilities, Year Four |
944
|
1,040
|
Finance Lease Liabilities, Year Four |
7
|
7
|
Operating lease Liabilities, Year After Four |
411
|
|
Finance Lease Liabilities, Year After Four |
|
|
Total undiscounted operating lease payments |
4,584
|
5,265
|
Total undiscounted finance lease payments |
30
|
38
|
Operating Lease Liabilities, less: Imputed interest |
900
|
1,170
|
Finance Lease Liabilities, less: Imputed interest |
6
|
9
|
Present value of operating lease liabilities |
3,684
|
$ 4,095
|
Present value of finance lease liabilities |
$ 24
|
|
Operating Lease Liabilities, weighted average remaining lease term in years |
4 years 7 months 6 days
|
5 years 3 months 18 days
|
Finance Lease Liabilities, weighted average remaining lease term in years |
4 years 2 months 12 days
|
4 years 6 months
|
Operating Lease Liabilities, weighted average discount rate |
9.20%
|
9.20%
|
Finance Lease Liabilities, weighted average discount rate |
11.60%
|
11.10%
|
Operating lease Liabilities, Year Five |
|
$ 944
|
Finance Lease Liabilities, Year Five |
|
7
|
Operating Lease Liabilities, Thereafter |
|
411
|
Finance Lease Liabilities, Thereafter |
|
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v3.23.3
Revenue Recognition, Collaboration Agreements and Other (Details Narrative) - USD ($) $ in Thousands |
|
|
|
|
3 Months Ended |
9 Months Ended |
Dec. 31, 2022 |
Apr. 08, 2022 |
Nov. 19, 2020 |
Dec. 12, 2019 |
Dec. 12, 2019 |
Sep. 30, 2023 |
Mar. 31, 2023 |
Sep. 30, 2022 |
Dec. 31, 2021 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Revenue |
|
|
|
|
|
|
|
$ 1,063
|
|
$ 1,096
|
$ 2,125
|
BioNTech Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
|
Fees received |
|
$ 2,750
|
|
|
|
|
|
|
|
|
|
Revenue recognized |
$ 688
|
$ 2,750
|
|
|
|
|
$ 688
|
|
|
|
|
Revenue |
|
|
|
|
|
|
$ 375
|
|
|
|
|
CFF Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
|
Grants receivable |
|
|
|
|
|
3,600
|
|
|
|
3,600
|
|
Additional milestone payment |
|
|
|
|
|
4,500
|
|
|
|
4,500
|
|
CFF Agreement [Member] | Accrued Liabilities [Member] |
|
|
|
|
|
|
|
|
|
|
|
Other Liabilities |
$ 88
|
|
|
|
|
$ 0
|
|
|
|
$ 0
|
|
CFF Agreement [Member] | Cystic Fibrosis Foundation [Member] |
|
|
|
|
|
|
|
|
|
|
|
Therapeutics development award |
|
|
$ 4,200
|
|
|
|
|
|
|
|
|
Proceeds from award |
|
|
$ 484
|
|
|
|
|
|
|
|
|
Additional milestone payment |
|
|
|
|
|
|
|
|
$ 321
|
|
|
Genentech Feasibility Study Agreement [Member] | Genentech [Member] |
|
|
|
|
|
|
|
|
|
|
|
Revenue |
|
|
|
|
$ 33
|
|
|
|
|
|
|
Agreement description |
|
|
|
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.
|
|
|
|
|
|
|
|
Aggregate revenue |
|
|
|
|
$ 100
|
|
|
|
|
|
|
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v3.23.3
Stockholders’ Equity (Details Narrative) - USD ($) $ / shares in Units, $ in Thousands |
|
3 Months Ended |
9 Months Ended |
Feb. 08, 2022 |
Feb. 08, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Class of Stock [Line Items] |
|
|
|
|
|
|
Research and development expense |
|
|
$ 3,295
|
$ 3,707
|
$ 10,824
|
$ 12,811
|
Restated Exclusive License Agreement [Member] |
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
Milestone fee |
|
$ 100
|
|
|
|
|
License fee |
|
50
|
|
|
|
|
Research and development expense |
|
$ 291
|
|
|
|
|
Stock issued during new issued, shares |
|
400,000
|
|
|
|
|
Share price |
$ 0.728
|
$ 0.728
|
|
|
|
|
Restated Exclusive License Agreement [Member] | Unregistered Shares [Member] | Rutgers [Member] |
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
Business acquisition, equity iterest issued or issuable, shares |
400,000
|
|
|
|
|
|
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3 Months Ended |
9 Months Ended |
Sep. 30, 2023 |
Sep. 30, 2022 |
Sep. 30, 2023 |
Sep. 30, 2022 |
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] |
|
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$ 1,196
|
$ 1,413
|
$ 3,676
|
$ 3,888
|
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|
|
|
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|
|
|
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507
|
554
|
1,576
|
1,660
|
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|
|
|
|
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|
|
|
|
Share-based compensation expense |
$ 689
|
$ 859
|
$ 2,100
|
$ 2,228
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9 Months Ended |
Sep. 30, 2023
shares
|
Share-Based Payment Arrangement [Abstract] |
|
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Outstanding, Number, Beginning Balance |
34,739
|
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Grants in Period, Gross |
105
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Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Exercises in Period |
|
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Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Expirations in Period |
(1,314)
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Matinas Biopharma (AMEX:MTNB)
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From Aug 2024 to Sep 2024
Matinas Biopharma (AMEX:MTNB)
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From Sep 2023 to Sep 2024