Item 1. Financial Statements
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
3
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
4
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
5
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:
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 )
The
accompanying notes are an integral part of these condensed consolidated financial statements
6
MATINAS
BIOPHARMA HOLDINGS, INC.
Notes
to Unaudited Condensed Consolidated Financial Statements
(Tabular
dollars and shares in thousands, except per share data)
Note
1 – Description of Business
Matinas
BioPharma Holdings Inc. (“Holdings”) is a Delaware corporation formed in 2013. Holdings is the parent company of Matinas
BioPharma, Inc. (“BioPharma”), and Matinas BioPharma Nanotechnologies, Inc. (“Nanotechnologies,” formerly known
as Aquarius Biotechnologies, Inc.), its operating subsidiaries (“Nanotechnologies”, and together with “Holdings”
and “BioPharma”, “the Company”). The Company is a clinical-stage biopharmaceutical company 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.
7
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
8
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.
9
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
*
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).
10
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 %
11
The
following table presents information about the amount and timing of liabilities arising from the Company’s operating leases and
finance leases as of December 31, 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.
12
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
—
13
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
*
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
14
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.
15
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.