Item 8. Financial Statements and Supplementary Data
ITEM 8. Financial
Statements and Supplementary Data
CAPRICOR THERAPEUTICS, INC.
Index
to Financial Statements
Page
Report
of Independent Registered Public Accounting Firm
91
Consolidated
Balance Sheets
92
Consolidated
Statements of Operations and Comprehensive Loss
93
Consolidated
Statements of Stockholders’ Equity
94
Consolidated
Statements of Cash Flows
95
Notes
to Consolidated Financial Statements
96
90
REPORT OF INDEPENDENT REGISTERED PUBLIC
ACCOUNTING FIRM
To the Board of Directors and Stockholders of
Capricor Therapeutics, Inc. and Subsidiary
Opinion on the Consolidated Financial
Statements
We have audited the accompanying consolidated
balance sheets of Capricor Therapeutics, Inc. and Subsidiary (the Company) as of December 31, 2020 and 2019, and the
related consolidated statements of operations and comprehensive income (loss), stockholders’ equity (deficit), and cash flows
for each of the years in the two-year period ended December 31, 2020, and the related notes (collectively referred to as the
consolidated financial statements). In our opinion, the consolidated financial statements present fairly, in all material respects,
the consolidated financial position of the Company as of December 31, 2020 and 2019, and the consolidated results of its operations
and its cash flows for each of the years in the two-year period ended December 31, 2020, in conformity with accounting principles
generally accepted in the United States of America.
Basis for Opinion
These consolidated financial statements
are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s consolidated
financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight
Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal
securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with
the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether
the consolidated financial statements are free of material misstatement, whether due to error or fraud. The Company is not required
to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits, we are
required to obtain an understanding of internal control over financial reporting, but not for the purpose of expressing an opinion
on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures
to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing
procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and
disclosures in the consolidated financial statements. Our audits also included evaluating the accounting principles used and significant
estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements. We believe
that our audits provide a reasonable basis for our opinion.
Critical Audit Matters
Critical audit matters arising from the
current period audit of the financial statements that were communicated or required to be communicated to the audit committee and
that: (1) relate to accounts or disclosures that are material to the financial statements and (2) involved our especially
challenging, subjective, or complex judgements. We determined that there are no critical audit matters.
/s/ Rose, Snyder & Jacobs LLP
Rose, Snyder & Jacobs LLP
We have served as the Company’s auditor since 2011.
Encino, California
March 15, 2021
91
CAPRICOR
THERAPEUTICS, INC.
CONSOLIDATED
BALANCE SHEETS
DECEMBER
31, 2020 AND 2019
ASSETS
December
31, 2020
December
31, 2019
CURRENT ASSETS
Cash and cash equivalents
$ 32,665,874
$ 3,899,328
Marketable securities
-
5,986,050
Grant receivable
-
87,968
Prepaid expenses and other current assets
1,011,209
571,382
TOTAL CURRENT ASSETS
33,677,083
10,544,728
PROPERTY AND EQUIPMENT, net
850,847
442,806
OTHER ASSETS
Intangible assets, net of accumulated amortization of $257,517 and $253,187, respectively
2,165
6,495
Other assets
88,701
119,608
TOTAL ASSETS
$ 34,618,796
$ 11,113,637
LIABILITIES AND STOCKHOLDERS' EQUITY
CURRENT LIABILITIES
Accounts payable and accrued expenses
$ 2,724,593
$ 897,992
Note payable, current
246,689
-
TOTAL CURRENT LIABILITIES
2,971,282
897,992
LONG-TERM LIABILITIES
Note payable, net of current
71,471
-
CIRM liability
3,376,259
3,376,259
TOTAL LONG-TERM LIABILITIES
3,447,730
3,376,259
TOTAL LIABILITIES
6,419,012
4,274,251
COMMITMENTS AND CONTINGENCIES (NOTE 7)
STOCKHOLDERS' EQUITY
Preferred stock, $0.001 par value, 5,000,000 shares authorized, none issued and outstanding
-
-
Common stock, $0.001 par value, 50,000,000 shares authorized, 20,577,123 and 5,227,398 shares issued and outstanding, respectively
20,577
5,227
Additional paid-in capital
116,216,966
81,215,647
Accumulated other comprehensive income (loss)
-
(757 )
Accumulated deficit
(88,037,759 )
(74,380,731 )
TOTAL STOCKHOLDERS' EQUITY
28,199,784
6,839,386
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY
$ 34,618,796
$ 11,113,637
See accompanying notes to the audited consolidated
financial statements.
92
CAPRICOR
THERAPEUTICS, INC.
CONSOLIDATED
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
FOR
THE YEARS ENDED DECEMBER 31, 2020 AND 2019
Years
ended December 31,
2020
2019
REVENUE
Revenue
$ 310,250
$ 1,005,028
TOTAL REVENUE
310,250
1,005,028
OPERATING EXPENSES
Research and development
8,457,000
5,141,805
General and administrative
5,543,221
3,597,111
TOTAL OPERATING EXPENSES
14,000,221
8,738,916
LOSS FROM OPERATIONS
(13,689,971 )
(7,733,888 )
OTHER INCOME (EXPENSE)
Investment income
32,943
94,791
Loss on disposal of fixed asset
-
(2,720 )
TOTAL OTHER INCOME (EXPENSE)
32,943
92,071
NET LOSS
(13,657,028 )
(7,641,817 )
OTHER COMPREHENSIVE INCOME (LOSS)
Net unrealized gain (loss) on marketable securities
757
(13,150 )
COMPREHENSIVE LOSS
$ (13,656,271 )
$ (7,654,967 )
Net loss per share, basic and diluted
$ (0.88 )
$ (2.06 )
Weighted average number of shares, basic and diluted
15,571,056
3,711,333
See accompanying notes to the audited consolidated
financial statements.
93
CAPRICOR
THERAPEUTICS, INC.
CONSOLIDATED
STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY
FOR
THE PERIOD FROM DECEMBER 31, 2018 THROUGH DECEMBER 31, 2020
COMMON STOCK
ADDITIONAL
OTHER
TOTAL
PAID-IN
COMPREHENSIVE
ACCUMULATED
STOCKHOLDERS'
SHARES
AMOUNT
CAPITAL
INCOME (LOSS)
DEFICIT
EQUITY
Balance at December 31, 2018
3,138,748
$ 3,138
$ 71,338,970
$ 12,393
$ (66,738,914 )
$ 4,615,587
Issuance of common stock, net of fees
1,637,849
1,638
9,173,115
-
-
9,174,753
Exercise of pre-funded common stock warrants
450,000
450
-
-
-
450
Stock-based compensation
-
-
700,984
-
-
700,984
Fractional shares eliminated pursuant to reverse stock split
(27 )
-
(193 )
-
-
(193 )
Unrealized loss on marketable securities
-
-
-
(13,150 )
-
(13,150 )
Stock options exercised
828
1
2,771
-
-
2,772
Net loss
-
-
-
-
(7,641,817 )
(7,641,817 )
Balance at December 31, 2019
5,227,398
$ 5,227
$ 81,215,647
$ (757 )
$ (74,380,731 )
$ 6,839,386
Issuance of common stock, net of fees
4,173,478
4,174
27,338,895
-
-
27,343,069
Exercise of pre-funded common stock warrants
3,158,304
3,158
-
-
-
3,158
Exercise of common warrants
4,417,219
4,417
5,680,943
-
-
5,685,360
Issuance of shares in abeyance
3,555,500
3,556
(3,556 )
-
-
-
Stock-based compensation
-
-
1,952,679
-
-
1,952,679
Stock options exercised
45,224
45
32,358
-
-
32,403
Unrealized gain on marketable securities
-
-
-
757
-
757
Net loss
-
-
-
-
(13,657,028 )
$ (13,657,028 )
Balance at December 31, 2020
20,577,123
$ 20,577
$ 116,216,966
$ -
$ (88,037,759 )
$ 28,199,784
See accompanying notes to the audited consolidated
financial statements.
94
CAPRICOR THERAPEUTICS, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
FOR
THE YEARS ENDED DECEMBER 31, 2020 AND 2019
Years ended December 31,
2020
2019
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss
$ (13,657,028 )
$ (7,641,817 )
Adjustments to reconcile net loss to net cash used in operating activities:
Loss on disposal of fixed asset
-
2,720
Depreciation and amortization
143,890
171,956
Stock-based compensation
1,952,679
700,984
Change in assets - (increase) decrease:
Receivables
87,968
116,900
Prepaid expenses and other current assets
(439,827 )
152,802
Other assets
30,907
32,180
Change in liabilities - increase (decrease):
Accounts payable and accrued expenses
1,826,601
(357,226 )
NET CASH USED IN OPERATING ACTIVITIES
(10,054,810 )
(6,821,501 )
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchase of marketable securities
(6,130,193 )
(6,002,050 )
Proceeds from sales and maturities of marketable securities
12,117,000
3,000,000
Purchases of property and equipment
(547,601 )
-
NET CASH PROVIDED BY (USED IN) INVESTING ACTIVITIES
5,439,206
(3,002,050 )
CASH FLOWS FROM FINANCING ACTIVITIES:
Net proceeds from sale of common stock
27,343,069
9,174,753
Proceeds from note payable
318,160
-
Proceeds from exercise of warrants
5,688,518
450
Repurchase of fractional shares pursuant to reverse stock split
-
(193 )
Proceeds from stock options
32,403
2,772
NET CASH PROVIDED BY FINANCING ACTIVITIES
33,382,150
9,177,782
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS
28,766,546
(645,769 )
Cash and cash equivalents balance at beginning of period
3,899,328
4,545,097
Cash and cash equivalents balance at end of period
$ 32,665,874
$ 3,899,328
SUPPLEMENTAL DISCLOSURES:
Interest paid in cash
$ -
$ -
Income taxes paid in cash
$ -
$ -
See accompanying notes to the audited consolidated
financial statements.
95
CAPRICOR
THERAPEUTICS, INC.
Notes
to CONSOLIDATED financial statements
DECEMBER
31, 2020 AND 2019
1. ORGANIZATION
AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Description of Business
Capricor
Therapeutics, Inc., a Delaware corporation (referred to herein as “Capricor Therapeutics” or the “Company”
or “we”), is a biotechnology company focused on the development of transformative cell- and exosome-based therapeutics
for the treatment and prevention of a broad spectrum of diseases. Capricor, Inc. (“Capricor”), a wholly-owned
subsidiary of Capricor Therapeutics, was founded in 2005 as a Delaware corporation based on the innovative work of its founder,
Eduardo Marbán, M.D., Ph.D. After completion of a merger between Capricor and a subsidiary of Nile Therapeutics, Inc.,
a Delaware corporation (“Nile”), on November 20, 2013, Capricor became a wholly-owned subsidiary of Nile and Nile
formally changed its name to Capricor Therapeutics, Inc. Capricor Therapeutics, together with its subsidiary, Capricor, has
two active drug candidates in various stages of development.
Basis of Consolidation
Our consolidated financial
statements include the accounts of the Company and our wholly-owned subsidiary. All intercompany transactions have been eliminated
in consolidation.
Reclassification
Certain reclassification of prior period amounts has been made to conform to the current year presentation.
Liquidity
The Company has historically
financed its research and development activities as well as operational expenses from equity financings, government grants, a payment
from a former collaboration partner and a loan award and a grant from the California Institute for Regenerative Medicine (“CIRM”).
Cash, cash equivalents,
and marketable securities as of December 31, 2020 were approximately $32.7 million, compared to approximately $9.9 million
as of December 31, 2019. The Company has entered into various Common Stock Sales Agreements with H.C. Wainwright &
Co. LLC (“Wainwright”) to create at-the-market equity programs under which the Company from time to time offered and
sold shares of its common stock, par value $0.001 per share (see Note 3 – “Stockholders’ Equity”).
The Company’s
principal uses of cash are for research and development expenses, general and administrative expenses, capital expenditures and
other working capital requirements.
The
Company’s future expenditures and capital requirements may be substantial and will depend on many factors, including,
but not limited to, the following:
· the timing and costs associated with its clinical trials and preclinical studies;
· the timing and costs associated with the manufacturing of its product candidates;
· the timing and costs associated with commercialization of its product candidates;
· the number and scope of its research programs; and
· the costs involved in prosecuting and enforcing patent claims and other intellectual property rights.
The Company’s
options for raising additional capital include potentially seeking additional financing primarily from, but not limited to, the
sale and issuance of equity or debt securities, the licensing or sale of its technology and other assets, and from government grants.
The Company will require
substantial additional capital to fund its operations, in particular if it elects to expand its clinical programs as contemplated
by its current business plan. The Company cannot provide assurances that financing will be available when and as needed or that,
if available, financing will be available on favorable or acceptable terms. If the Company is unable to obtain additional financing
when and if required, it would have a material adverse effect on the Company’s business and results of operations. The Company
would likely need to delay, curtail or terminate all or portions of its clinical trial programs. To the extent the Company issues
additional equity securities, its existing stockholders would experience substantial dilution.
96
CAPRICOR
THERAPEUTICS, INC.
Notes
to CONSOLIDATED financial statements
DECEMBER
31, 2020 AND 2019
1. ORGANIZATION AND SUMMARY
OF SIGNIFICANT ACCOUNTING POLICIES (Continued)
Reverse Stock Split
On June 4, 2019,
the Company effected a reverse stock split of its outstanding shares of common stock at a ratio of one-for-ten pursuant to a Certificate
of Amendment to the Company’s Certificate of Incorporation filed with the Secretary of State of the State of Delaware. The
reverse stock split was reflected on the Nasdaq Capital Market (“Nasdaq”) beginning with the opening of trading on
June 5, 2019. Pursuant to the reverse stock split, every ten shares of the Company’s issued and outstanding shares of
common stock were automatically combined into one issued and outstanding share of common stock, without any change in the par value
per share of the common stock. Unless otherwise indicated, all share and per share amounts of the common stock included in the
accompanying consolidated financial statements have been retrospectively adjusted to give effect to the reverse stock split for
all periods presented, including reclassifying an amount equal to the reduction in par value to additional paid-in capital. The
number of authorized shares of the Company’s common stock remained unchanged. The reverse stock split affected all issued
and outstanding shares of the Company’s common stock, and the respective numbers of shares of common stock underlying outstanding
stock options, outstanding warrants and the Company’s equity incentive plans were proportionately adjusted.
Use of Estimates
The preparation of
financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported
amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial
statements. Estimates also affect the reported amounts of revenues and expenses during the reporting period. The most sensitive
estimates relate to the recoverability and fair value of intangible assets and the assumptions used to estimate stock-based compensation
expense. Management uses its historical records and knowledge of its business in making these estimates. Accordingly, actual results
may differ from these estimates.
Cash and Cash Equivalents
The Company considers
all highly liquid investments with a maturity of less than 30 days at the date of purchase to be cash equivalents.
Marketable Securities
The Company determines
the appropriate classification of its marketable securities at the time of purchase and reevaluates such designation at each balance
sheet date. All of the Company’s marketable securities are considered as available-for-sale and carried at estimated fair
values. Realized gains and losses on the sale of debt and equity securities are determined using the specific identification method.
Unrealized gains and losses on available-for-sale securities are excluded from net income (loss) and reported in accumulated other
comprehensive income (loss) as a separate component of stockholders’ equity.
Property and Equipment
Property and equipment
are stated at cost. Repairs and maintenance costs are expensed in the period incurred. Depreciation is computed using the straight-line
method over the related estimated useful life of the asset, which such estimated useful lives range from five to seven years. Leasehold
improvements are depreciated on a straight-line basis over the shorter of the useful life of the asset or the lease term. Depreciation
was $139,560 and $128,680 for the years ended December 31, 2020 and 2019, respectively.
97
CAPRICOR
THERAPEUTICS, INC.
Notes
to CONSOLIDATED financial statements
DECEMBER
31, 2020 AND 2019
1. ORGANIZATION AND SUMMARY
OF SIGNIFICANT ACCOUNTING POLICIES (Continued)
Property and equipment,
net consisted of the following at December 31:
2020
2019
Furniture and fixtures
$ 48,676
$ 43,617
Laboratory equipment
1,473,708
931,166
Leasehold improvements
47,043
47,043
1,569,427
1,021,826
Less accumulated depreciation
(718,580 )
(579,020 )
Property and equipment, net
$ 850,847
$ 442,806
Intangible Assets
Amounts
attributable to intellectual property consist primarily of the costs associated with the acquisition of certain technologies, patents,
pending patents and related intangible assets with respect to research and development activities. Certain intellectual property
assets are stated at cost and are amortized on a straight-line basis over the respective estimated useful lives of the assets ranging
from five to fifteen years. Total amortization expense was $4,330 and $43,276 for the years ended December 31, 2020 and 2019,
respectively. A summary of future amortization expense as of December 31, 2020 is as follows:
Years ended
Amortization Expense
2021
2,165
The Company reviews
goodwill and intangible assets at least annually for possible impairment. Goodwill and intangible assets are reviewed for possible
impairment between annual tests if an event occurs or circumstances change that would more likely than not reduce the fair value
of the reporting unit below its carrying value. No impairment was recorded for the years ended December 31, 2020 and 2019.
Long-Lived Assets
The Company accounts
for the impairment and disposition of long-lived assets in accordance with guidance issued by the FASB. Long-lived assets to be
held and used are reviewed for events or changes in circumstances that indicate that their carrying value may not be recoverable,
or annually. No impairment related to long-lived assets was recorded for the years ended December 31, 2020 and 2019.
Leases
Effective January 1,
2019, the Company adopted ASC Topic 842, “Leases” (“ASC 842”), using the optional transition method
utilizing the effective date as its date of initial application, for which prior periods are presented in accordance with the previous
guidance in ASC Topic 840, “Leases” (“ASC 840”).
At the inception of
an arrangement, the Company determines whether the arrangement is or contains a lease based on the unique facts and circumstances
present in the arrangement. Leases with a term greater than 12 months are recognized on the balance sheet as right of use assets
and short-term and long-term lease liabilities, as applicable. The Company has elected not to recognize on the balance sheet leases
with terms of 12 months or less. The Company typically only includes an initial lease term in its assessment of a lease arrangement.
Options to renew a lease are not included in the Company’s assessment unless there is reasonable certainty that the Company
will renew. The Company monitors its plans to renew its leases no less than on a quarterly basis. In addition, the Company’s
lease agreements generally do not contain any residual value guarantees or restrictive covenants.
98
CAPRICOR
THERAPEUTICS, INC.
Notes
to CONSOLIDATED financial statements
DECEMBER
31, 2020 AND 2019
1. ORGANIZATION AND SUMMARY
OF SIGNIFICANT ACCOUNTING POLICIES (Continued)
Operating lease liabilities
and their corresponding right of use assets are recorded based on the present value of future lease payments over the expected
remaining lease term at lease commencement. Lease cost for operating leases is recognized on a straight-line basis over the lease
term as an operating expense. Certain adjustments to the right of use asset may be required for items such as lease prepayments
or incentives received. The interest rate implicit in lease contracts is typically not readily determinable. As a result, the Company
utilizes its incremental borrowing rate, which reflects the fixed rate at which the Company could borrow on a collateralized basis
the amount of the lease payments in the same currency, for a similar term, in a similar economic environment. In transition to
ASC 842, the Company utilized the remaining lease term of its leases in determining the appropriate incremental borrowing rate.
In accordance with
ASC 842, components of a lease should be bifurcated between lease components and non-lease components. The fixed and in-substance
fixed contract consideration identified must then be allocated based on the respective relative fair values to the lease components
and non-lease components. However, ASC 842 provides a practical expedient that allows an accounting policy election to not separate
lease and non-lease components by class of underlying assets. In using this expedient, the lease component and non-lease
components are accounted for together as a single component. For real estate leases, the Company has elected to account
for the lease and non-lease components together for existing classes of underlying assets and allocates the contract consideration
to the lease component only. This practical expedient is not elected for manufacturing facilities and equipment embedded in
product supply arrangements.
Revenue Recognition
For contracts completed
as of December 31, 2017, revenue was recognized in accordance with ASC 605 and other superseded standards. The company applied
ASU 606 using the modified retrospective approach for all contracts in process as of January 1, 2018.
Government Research Grants
Generally,
government research grants that provide funding for research and development activities are recognized as income when the related
expenses are incurred, as applicable. Because the terms of the CIRM Award allow Capricor to elect to convert the grant into a loan
after the end of the project period, the CIRM Award is being classified as a liability rather than income (see Note 6 -
“Government Grant Awards”). Grant income is due upon submission of a reimbursement request. The transaction price varies
for grant income based on the expenses incurred under the awards.
Miscellaneous Income
Revenue
is recognized in connection with the delivery of doses which were developed as part of our past R&D efforts. Income is recorded
when the Company has satisfied the obligations as identified in the contracts with the customer (see Note 9 – “Related
Party Transactions”). Miscellaneous income is due upon billing. Miscellaneous income is based on contracts with fixed
transaction prices.
Income Taxes
Income taxes are recognized for the amount
of taxes payable or refundable for the current year and deferred tax liabilities and assets are recognized for the future tax consequences
of transactions that have been recognized in the Company’s financial statements or tax returns. A valuation allowance is
provided when it is more likely than not that some portion or the entire deferred tax asset will not be realized.
The Company uses guidance
issued by the FASB that clarifies the accounting for uncertainty in income taxes recognized in an enterprise's financial statements
and prescribes a recognition threshold of more likely than not and a measurement process for financial statement recognition and
measurement of a tax position taken or expected to be taken in a tax return. In making this assessment, a company must determine
whether it is more likely than not that a tax position will be sustained upon examination, based solely on the technical merits
of the position, and must assume that the tax position will be examined by taxing authorities.
99
CAPRICOR
THERAPEUTICS, INC.
Notes
to CONSOLIDATED financial statements
DECEMBER
31, 2020 AND 2019
1. ORGANIZATION AND SUMMARY
OF SIGNIFICANT ACCOUNTING POLICIES (Continued)
As of December 31,
2020, the Company had federal net operating loss carryforwards of approximately $107.6 million, available to reduce future taxable
income, of which $76.1 million will begin to expire in 2026. The post December 31, 2017 net operating losses generated of
$31.5 million will carryforward indefinitely, but may be subject to an 80% limitation upon utilization. As of December 31,
2020, the Company had state net operating loss carryforwards of approximately $103.7 million, available to reduce future taxable
income, which will begin to expire in 2028. Utilization of these net operating losses could be limited under Section 382 of
the Internal Revenue Code of 1986, as amended (the “Code”), and similar state laws based on ownership changes and the
value of the Company’s stock. Additionally, currently, the Company has approximately $1.4 million of federal research and
development credits and approximately $3.1 million of federal orphan drug credits, available to offset future taxable income. These
federal research and development and orphan drug credits begin to expire in 2027 and 2035, respectively.
Under Section 382
of the Code, the Company’s ability to utilize NOL carryforwards or other tax attributes, such as federal tax credits, in
any taxable year may be limited if the Company has experienced an “ownership change.” Generally, a Section 382
ownership change occurs if one or more stockholders or groups of stockholders who owns at least 5% of a corporation’s
stock increases its ownership by more than 50 percentage points over its lowest ownership percentage within a specified testing
period. Similar rules may apply under state tax laws. We have experienced an ownership change that we believe under Section 382
of the Code will result in limitation in our ability to utilize net operating losses and credits. In addition, the Company may
experience future ownership changes as a result of future offerings or other changes in ownership of its stock. As a result, the
amount of the NOLs and tax credit carryforward presented in the financial statement could be limited and may expire unutilized.
The Company’s net operating loss carryforwards are subject to Internal Revenue Service (“IRS”) examination until
they are fully utilized and such tax years are closed.
The Company’s
policy is to include interest and penalties related to unrecognized tax benefits in income tax expense. The Company incurred no
interest or penalties for the years ended December 31, 2020 and 2019. The Company files income tax returns with the IRS and
the California Franchise Tax Board.
Research and Development
Costs relating to the
design and development of new products are expensed as research and development as incurred in accordance with Financial Accounting
Standards Board (“FASB”) ASC 730-10, Research and Development . Research and development costs amounted to approximately
$8.5 million and $5.1 million for the years ended December 31, 2020 and 2019, respectively.
Comprehensive Income (Loss)
Comprehensive income
(loss) generally represents all changes in stockholders’ equity during the period except those resulting from investments
by, or distributions to, stockholders. The Company’s comprehensive loss was approximately $13.7 million and $7.7 million
for the years ended December 31, 2020 and 2019, respectively. The Company’s other comprehensive income (loss) is related
to a net unrealized gain (loss) on marketable securities. For the years ended December 31, 2020 and 2019, the Company’s
other comprehensive income (loss) was $757 and $(13,150), respectively.
100
CAPRICOR
THERAPEUTICS, INC.
Notes
to CONSOLIDATED financial statements
DECEMBER
31, 2020 AND 2019
1. ORGANIZATION AND SUMMARY
OF SIGNIFICANT ACCOUNTING POLICIES (Continued)
Clinical Trial Expense
As
part of the process of preparing our consolidated financial statements, we are required to estimate our accrued expenses. Our clinical
trial accrual process is designed to account for expenses resulting from our obligations under contracts with vendors, consultants,
and contract research organizations (“CROs”), and clinical site agreements in connection with conducting clinical trials.
The financial terms of these contracts are subject to negotiations, which vary from contract to contract and may result in payment
flows that do not match the periods over which materials or services are provided to us under such contracts. Our objective is
to reflect the appropriate clinical trial expenses in our consolidated financial statements by matching the appropriate expenses
with the period in which services are provided and efforts are expended. We account for these expenses according to the progress
of the trial as measured by patient progression and the timing of various aspects of the trial. We
determine accrual estimates through financial models that take into account discussion with applicable personnel and outside service
providers as to the progress or state of completion of trials, or the services completed. During the course of a clinical trial,
we adjust our clinical expense recognition if actual results differ from our estimates. We make estimates of our accrued expenses
as of each balance sheet date in our consolidated financial statements based on the facts and circumstances known to us at that
time. Our clinical trial accrual and prepaid assets are dependent, in part, upon the receipt of timely and accurate reporting from
CROs and other third-party vendors. Although we do not expect our estimates to be materially different from amounts actually incurred,
our understanding of the status and timing of services performed relative to the actual status and timing of services performed
may vary and may result in us reporting amounts that are too high or too low for any particular period.
Business Uncertainty Related to the
Coronavirus
As a result of the
spread of the COVID-19 coronavirus, uncertainties have arisen that could potentially impact enrollment of and the ability to conduct
clinical trials, deliverables related to contract performance, payments from trial sponsors including Cedars-Sinai Medical Center,
as we describe further below, workforce stability, supply chain disruptions or delays, timing of grant disbursements as well as
other potential business operations. While the disruption is currently expected to be temporary, there is considerable uncertainty
around its expected duration and as a result, the Company is considering the impact of COVID-19 on its ability to conduct both
preclinical development and clinical studies. In addition to potential impact on grant disbursements, there may be risks to the
Company’s ability to obtain financing from other sources due to the impact of the coronavirus. There could be other financial
impacts on our business due to the coronavirus, the specifics of which are unknown at this time.
In light of the increased
uncertainties due to COVID-19 and its economic and other impacts and to uncertainties around the timing and availability of grant
disbursements, the loss of revenue from the delays of the REGRESS and ALPHA trials as well as any potential equity and debt financings,
the Company applied for a loan under the Small Business Administration (the “SBA”) Paycheck Protection Program of the
Coronavirus Aid, Relief and Economic Security Act of 2020 (the “CARES Act”). On April 29, 2020, the Company was
approved and received a loan of $318,160 (the “Loan”) under the SBA Paycheck Protection Program of the CARES Act. The
Company utilized the funds for covered payroll costs, all which the Company believes were in accordance with the relevant terms
and conditions of the CARES Act (see Note 2 – “Note Payable”).
Stock-Based Compensation
The Company accounts
for stock-based employee compensation arrangements in accordance with guidance issued by the FASB, which requires the measurement
and recognition of compensation expense for all share-based payment awards made to employees, consultants, and directors based
on estimated fair values.
101
CAPRICOR
THERAPEUTICS, INC.
Notes
to CONSOLIDATED financial statements
DECEMBER
31, 2020 AND 2019
1. ORGANIZATION AND SUMMARY
OF SIGNIFICANT ACCOUNTING POLICIES (Continued)
The Company estimates
the fair value of stock-based compensation awards on the date of grant using an option-pricing model. The value of the portion
of the award that is ultimately expected to vest is recognized as an expense over the requisite service periods in the Company’s
statements of operations. The Company estimates the fair value of stock-based compensation awards using the Black-Scholes model.
This model requires the Company to estimate the expected volatility and value of its common stock and the expected term of the
stock options, all of which are highly complex and subjective variables. The variables take into consideration, among other things,
actual and projected stock option exercise behavior. For employees and directors, the expected life was calculated based on the
simplified method as described by the SEC Staff Accounting Bulletin No. 110, Share-Based Payment. For other service providers,
the expected life was calculated using the contractual term of the award. The Company's estimate of expected volatility was based
on the historical stock price of the Company. The Company has selected a risk-free rate based on the implied yield available on
U.S. Treasury securities with a maturity equivalent to the expected term of the options.
Basic and Diluted Loss per Share
The Company reports
earnings per share in accordance with FASB ASC 260-10, Earnings per Share. Basic earnings (loss) per share is computed by
dividing income (loss) available to common stockholders by the weighted-average number of shares of common stock outstanding during
the period. Diluted earnings (loss) per share is computed similarly to basic earnings (loss) per share except that the denominator
is increased to include the number of additional shares of common stock that would have been outstanding if the potential shares
of common stock had been issued and if the additional shares of common stock were dilutive. The components of basic and diluted
earnings (loss) per share for the years ended December 31, 2020 and 2019 were as follows:
December 31, 2020
December 31, 2019
Numerator
Net loss
$ (13,657,028 )
$ (7,641,817 )
Denominator
Weighted-average number of shares of common stock outstanding
15,571,056
3,711,333
Dilutive effect of stock options
-
-
Common stock and common
stock equivalents used for diluted loss per share
15,571,056
3,711,333
For
the years ended December 31, 2020 and 2019, warrants and options to purchase 2,488,046 and 8,256,609 shares of common stock,
respectively, have been excluded from the computation of potentially dilutive securities. Potentially d ilutive common shares,
which primarily consist of stock options issued to employees, consultants, and directors as well as warrants issued, have been
excluded from the diluted loss per share calculation because their effect is anti-dilutive. Because the impact of these items is
anti-dilutive during periods of net loss, there was no difference between basic and diluted loss per share for the years ended
December 31, 2020 and 2019.
102
CAPRICOR
THERAPEUTICS, INC.
Notes
to CONSOLIDATED financial statements
DECEMBER
31, 2020 AND 2019
1. ORGANIZATION AND SUMMARY
OF SIGNIFICANT ACCOUNTING POLICIES (Continued)
Fair Value Measurements
Assets and liabilities
recorded at fair value in the balance sheet are categorized based upon the level of judgment associated with the inputs used to
measure their fair value. The categories are as follows:
Level Input:
Input Definition:
Level I
Inputs are unadjusted, quoted prices for identical assets or liabilities in active markets at the measurement date.
Level II
Inputs, other than quoted prices included in Level I, that are observable for the asset or liability through corroboration with market data at the measurement date.
Level III
Unobservable inputs that reflect management’s best estimate of what market participants would use in pricing the asset or liability at the measurement date.
The following tables
summarize the fair value measurements by level for assets and liabilities measured at fair value on a recurring basis:
December 31, 2019
Level I
Level II
Level III
Total
Marketable Securities
$ 5,986,050
$ -
$ -
$ 5,986,050
Carrying amounts reported
in the balance sheet of cash and cash equivalents, grants receivable, accounts payable and accrued expenses approximate fair value
due to their relatively short maturity. The carrying amounts of the Company’s marketable securities are based on market quotations
from national exchanges at the balance sheet date. Interest and dividend income are recognized separately on the income statement
based on classifications provided by the brokerage firm holding the investments. The fair value of borrowings is not considered
to be significantly different from its carrying amount because the stated rates for such debt reflect current market rates and
conditions.
Recent Accounting Pronouncements
In November 2018,
the FASB issued ASU 2018-18, Collaborative Arrangements (Topic 808): clarifying the interaction between Topic 808 and Topic
606. The amendments in the update clarify that certain transactions between collaborative arrangement participants should be accounted
for as revenue under Topic 606 when the collaborative arrangement participant is a customer in the context of a unit of account;
adds unit-of-account guidance in Topic 808 to align with the guidance in Topic 606 when an entity is assessing whether the collaborative
arrangement or a party to the arrangement is within the scope of Topic 606; requires that in a transaction with a collaborative
arrangement participant that is not directly related to sales to third parties, presenting the transaction together with revenue
recognized under Topic 606 is precluded if the collaborative arrangement participant is not a customer. The amendments for this
update are effective for fiscal years beginning after December 15, 2019, and interim periods within those fiscal years. The
Company adopted ASU 2018-18 and all subsequent updates related to this topic in the first quarter of 2020. The adoption of this
update did not have a material impact on the Company’s financial statements.
In October 2019,
the FASB issued ASU 2019-12, which affects general principles within Topic 740, Income Taxes. The amendments of ASU 2019-12 are
meant to simplify and reduce the cost of accounting for income taxes. For public business entities, the amendments in this Update
are effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2020. The Company
believes that the adoption of this new accounting guidance will not have a material impact on its financial statements and footnote
disclosures.
Other recent accounting
pronouncements issued by the FASB, including its Emerging Issues Task Force, the American Institute of Certified Public Accountants,
and the SEC, did not or are not believed by management to have a material impact on the Company’s present or future consolidated
financial statement presentation or disclosures.
103
CAPRICOR
THERAPEUTICS, INC.
Notes
to CONSOLIDATED financial statements
DECEMBER
31, 2020 AND 2019
2. NOTE PAYABLE
Paycheck Protection Program Loan
In the second quarter
of 2020, Capricor applied to City National Bank (“CNB”) under the SBA Paycheck Protection Program of the CARES Act
for the Loan in the amount of $318,160. The Loan was approved and Capricor received the Loan proceeds, which we used for covered
payroll costs in accordance with the relevant terms and conditions of the CARES Act.
The Loan, which took
the form of a promissory note issued by Capricor (the “Promissory Note”), has a two-year term, matures on April 29,
2022, and bears interest at a rate of 1.0% per annum. Monthly principal and interest payments, less the amount of any potential
forgiveness, will commence 10 months after the end of the covered period for the borrower’s loan forgiveness (either 8 or
24 weeks). Loan payments are deferred for borrowers who apply for loan forgiveness until SBA remits the borrower’s loan forgiveness
amount to the lender. Capricor did not provide any collateral or guarantees for the Loan, nor did Capricor pay any facility charge
to obtain the Loan. The Promissory Note provides for customary events of default, including, among others, those relating to failure
to make payment, bankruptcy, breaches of representations and material adverse events. Capricor may prepay the principal of the
Loan at any time without incurring any prepayment charges.
The Loan may be forgiven
partially or fully if the Loan proceeds are used for eligible purposes, including payroll costs, rent and utilities, provided that
such amounts are incurred during an 8 or 24-week period that commenced on April 29, 2020. Any forgiveness of the Loan will
be subject to approval by the SBA and CNB and will require Capricor to apply for such treatment. The Company submitted a loan forgiveness
application to CNB in the first quarter of 2021. CNB has 60 days to review and comment on the loan forgiveness application, otherwise,
it will be sent to the SBA, who has 90 days to review from date of submission from CNB. In the event the Loan, or any portion thereof,
is forgiven pursuant to the SBA, the amount forgiven is applied to the outstanding principal. Any unforgiven portion of the Loan
will be payable in accordance with the terms of the Promissory Note as described above. While the Company currently believes that
its use of the loan proceeds will meet the conditions for forgiveness of the Loan, it cannot be sure that it will be eligible for
forgiveness, in whole or in part.
3. STOCKHOLDER’S
EQUITY
ATM Programs
Since July 2019,
the Company has established multiple “at-the-market”, or ATM, programs pursuant to a Common Stock Sales Agreement with
Wainwright by which Wainwright sold and may continue to sell our common stock at the market prices prevailing at the time of sale.
Wainwright is entitled to compensation for its services at a commission rate of 3.0% of the gross sales price per share of common
stock sold plus reimbursement of certain expenses. These programs are referred to below as the “July 2019 ATM Program,”
the “August 2019 ATM Program,” and the “May 2020 ATM Program” based on when each program was
initiated. In addition, the Company completed a public offering of its common stock in December 2019 and a warrant inducement
offer in March 2020.
July 2019 ATM Program
From July 22,
2019 through expiration of the July 2019 ATM Program on August 23, 2019, the Company sold an aggregate of 418,450 shares
of common stock under the July 2019 ATM Program at an average price of approximately $4.30 per share for gross proceeds of
approximately $1.8 million. The Company paid cash commissions on the gross proceeds, plus reimbursement of expenses of Wainwright
and legal fees in the aggregate amount of approximately $0.1 million.
August 2019 ATM Program
On August 29,
2019, the Company initiated the August 2019 ATM Program. From August 29, 2019 through May 4, 2020, the Company sold
an aggregate of 360,316 shares of common stock under the August 2019 ATM Program at an average price of approximately $3.07
per share for gross proceeds of approximately $1.1 million. The Company paid cash commissions on the gross proceeds, plus reimbursement
of expenses of Wainwright and legal fees in the aggregate amount of approximately $0.1 million. As of May 4, 2020, the August 2019
ATM Program has expired and been replaced with the May 2020 ATM Program described below.
104
CAPRICOR
THERAPEUTICS, INC.
Notes
to CONSOLIDATED financial statements
DECEMBER
31, 2020 AND 2019
3. STOCKHOLDER’S
EQUITY (Continued)
May 2020 ATM Program
On May 4, 2020,
the Company initiated the May 2020 ATM Program. The Company filed the May 2020 ATM with an aggregate offering price of
up to $40.0 million. Since May 4, 2020 and through March 12, 2021, the Company has sold an aggregate of 5,947,852 shares
of common stock under the May 2020 ATM Program at an average price of approximately $6.16 per share for gross proceeds of
approximately $36.6 million. The Company paid cash commissions on the gross proceeds, plus reimbursement of expenses of Wainwright
and legal fees in the aggregate amount of approximately $1.2 million.
December 2019 Financing
In December 2019,
the Company completed a public offering pursuant to which the Company issued (i) 531,173 shares of its common stock, (ii) warrants
(the “December 2019 Common Warrants”) to purchase up to 4,139,477 shares of common stock, and (iii) pre-funded
warrants to purchase up to 3,608,304 shares of common stock, at a combined purchase price of $1.226 per share and associated common
warrant and $1.225 per pre-funded warrant and associated common warrant, for an aggregate purchase price of approximately $5.1
million. The Company issued (a) to each purchaser of shares in the offering a common warrant to purchase a number of shares
of common stock equal to the number of shares purchased by such purchaser in the offering, and (b) to each purchaser of pre-funded
warrants in the offering a common warrant to purchase a number of shares of common stock equal to the number of pre-funded warrant
shares underlying the pre-funded warrants purchased by such purchaser in the offering. In connection with the offering, the Company
issued to designees of Wainwright, the placement agent for the offering, warrants (the “December 2019 Placement Agent
Warrants”) to purchase an aggregate of 203,915 shares of common stock. The December 2019 Placement Agent Warrants have
an exercise price of $1.5325 per share, are immediately exercisable and expire in December 2024. Fees paid in conjunction
with the deal, which included placement agent commissions, management fees, legal costs, and other offering expenses, amount to
approximately $0.7 million in the aggregate and were recorded as a reduction to additional paid-in capital, resulting in net proceeds
of approximately $4.4 million. As of December 31, 2020, 61,173 December 2019 Common Warrants remained outstanding under
the December 2019 Financing.
March 2020 Warrant Inducement
On March 25, 2020,
the Company entered into a letter agreement (the “Exercise Agreement”) with a holder of December 2019 Common Warrants
(the “Exercising Holder”). Pursuant to the Exercise Agreement, in connection with exercise by the Exercising Holder
of the remaining 4,000,000 December 2019 Common Warrants held by the Exercising Holder which had not been previously exercised,
the Company agreed to issue 4,000,000 additional warrants (the “New Warrants”) to purchase Common Stock. The December 2019
Common Warrants had a per share exercise price of $1.10, and pursuant to the Exercise Agreement, the Exercising Holder agreed to
pay $1.225 per share to cover both the exercise price of the December 2019 Common Warrants and a $0.125 per share purchase
price for the New Warrants. The New Warrants have an exercise price of $1.27 per share. A total of 724,500 shares were issued to
the Exercising Holder, with the remaining 3,275,500 shares being held in abeyance until such time as it would not result in the
Exercising Holder exceeding its beneficial ownership limitation of 4.99% of the Company’s outstanding common stock. In the
second quarter of 2020, the Company issued all shares that were being held in abeyance.
The New Warrants and
the shares of Common Stock issuable upon the exercise of the New Warrants were not registered under the Securities Act of 1933,
as amended (the “Securities Act”), and were offered pursuant to the exemption provided in Section 4(a)(2) under
the Securities Act or Rule 506(b) promulgated thereunder. The New Warrants are exercisable immediately upon issuance,
and have a term of exercise of 5 1/2 years.
105
CAPRICOR
THERAPEUTICS, INC.
Notes
to CONSOLIDATED financial statements
DECEMBER
31, 2020 AND 2019
3. STOCKHOLDER’S
EQUITY (Continued)
The exercise of December 2019
Common Warrants by the Exercising Holder generated gross proceeds of approximately $4.9 million. Fees paid in conjunction with
the Exercise Agreement, which included placement agent commissions, legal costs, and other offering expenses, amount to approximately
$0.4 million. In connection with the Exercise Agreement, certain employees of the placement agent were issued new warrants (the
“March 2020 Placement Agent Warrants”) to purchase an aggregate of 200,000 shares of common stock. The March 2020
Placement Agent Warrants have an exercise price of $1.5313 per share and expire in March 2025. The holders of each of the
New Warrants and of the March 2020 Placement Agent Warrants have the option to make a cashless exercise of such warrant if
no resale registration statement covering the shares of the Company’s Common Stock underlying such warrant is effective after
six months. On May 7, 2020, the Company filed a resale registration statement on Form S-3 for the shares underlying the
New Warrants and March 2020 Placement Agent Warrants, and that resale registration statement was declared effective by the
SEC on May 19, 2020. As of December 31, 2020, 65,000 March 2020 Placement Agent Warrants remained outstanding under
the March 2020 Warrant Inducement.
Outstanding Shares
At December 31, 2020, the Company had
20,577,123 shares of common stock issued and outstanding.
4. STOCK AWARDS, WARRANTS
AND OPTIONS
Warrants
The following table
summarizes all warrant activity for the years ended December 31, 2020 and 2019:
Warrants
Weighted Average Exercise Price
Outstanding at January 1, 2019
84,607
$ 45.00
Expired
(84,607 )
45.00
Granted
7,951,696
0.61
Exercised
(450,000 )
0.001
Outstanding at December 31, 2019
7,501,696
$ 0.65
Granted
4,200,000
1.28
Exercised
(11,575,523 )
0.87
Outstanding at December 31, 2020
126,173
$ 1.32
The following table
summarizes all outstanding warrants to purchase shares of the Company’s common stock:
Type
Grant Date
December 31, 2020
December 31, 2019
Exercise Price per Share
Expiration Date
Common Warrants
12/19/2019
61,173
4,139,477
$ 1.10
12/19/2024
Common Warrants
12/19/2019
-
203,915
$ 1.5325
12/17/2024
Pre-Funded Warrants
12/19/2019
-
3,158,304
$ 0.001
N/A
Common Warrants
3/27/2020
65,000
-
$ 1.5313
3/27/2025
126,173
7,501,696
106
CAPRICOR
THERAPEUTICS, INC.
Notes
to CONSOLIDATED financial statements
DECEMBER
31, 2020 AND 2019
4. STOCK AWARDS, WARRANTS
AND OPTIONS (Continued)
Stock Options
The Company’s
Board of Directors (the “Board”) has approved four stock option plans: (i) the 2006 Stock Option Plan, (ii) the
2012 Restated Equity Incentive Plan (which superseded the 2006 Stock Option Plan) (the “2012 Plan”), (iii) the
2012 Non-Employee Director Stock Option Plan (the “2012 Non-Employee Director Plan”), and (iv) the 2020 Equity
Incentive Plan (the “2020 Plan”).
At the time the merger
between Capricor and Nile became effective, 414,971 shares of common stock were reserved under the 2012 Plan for the issuance of
stock options, stock appreciation rights, restricted stock awards and performance unit/share awards to employees, consultants and
other service providers. Included in the 2012 Plan are the shares of common stock that were originally reserved under the 2006
Stock Option Plan. Under the 2012 Plan, each stock option granted will be designated in the award agreement as either an incentive
stock option or a nonstatutory stock option. Notwithstanding such designation, however, to the extent that the aggregate fair market
value of the shares with respect to which incentive stock options are exercisable for the first time by the participant during
any calendar year (under all plans of the Company and any parent or subsidiary) exceeds $100,000, such options will be treated
as nonstatutory stock options.
On
June 2, 2016, at the Company’s annual stockholder meeting, the stockholders approved a proposal to amend the 2012 Plan,
to, among other things, increase the number of shares of common stock of the Company that may be issued under the 2012 Plan to
equal the sum of 414,971 plus 2% of the outstanding shares of common stock as of December 31, 2015, with the number of shares
that may be issued under the 2012 Plan automatically increasing thereafter on January 1 of each year, commencing with January 1,
2017, by 2% of the outstanding shares of common stock as of the last day of the immediately preceding fiscal year (rounded down
to the nearest whole share). For the fiscal years beginning on January 1, 2020 and 2019, the number of shares added
was equal to 104,547 and 62,775 shares, respectively.
At the time the merger
between Capricor and Nile became effective, 269,731 shares of common stock were reserved under the 2012 Non-Employee Director Plan
for the issuance of stock options to members of the Board who are not employees of the Company.
On June 5, 2020,
at the Company’s annual stockholder meeting, the stockholders approved the 2020 Plan with 2,500,000 shares of common stock
reserved under the 2020 Plan for the issuance of stock awards. The number of Shares available for issuance under the 2020 Plan
shall be automatically increased on January 1 of each year, commencing with January 1, 2021, by an amount equal to the
lesser of (i) four percent (4%) of the outstanding shares of Common Stock as of the last day of the immediately preceding
fiscal year or (ii) such number of shares of Common Stock determined by the Compensation Committee in its sole discretion.
For the fiscal year beginning on January 1, 2021, the number of shares added was equal to 823,084 shares.
As of December 31,
2020, 999,887 options remain available for issuance under the respective stock option plans.
Each of the Company’s
stock option plans are administered by the Board, or the compensation committee of the Board, which determines the recipients and
types of awards to be granted, as well as the number of shares subject to the awards, the exercise price and the vesting schedule.
Stock options are granted with an exercise price equal to the closing price of the Company’s common stock on the date of
grant, and generally vest over a period of one to four years. The term of stock options granted under each of the plans cannot
exceed ten years.
The estimated weighted
average fair value of the options granted during 2020 and 2019 were approximately $3.93 and $2.73 per share, respectively.
107
CAPRICOR
THERAPEUTICS, INC.
Notes
to CONSOLIDATED financial statements
DECEMBER
31, 2020 AND 2019
4. STOCK AWARDS, WARRANTS
AND OPTIONS (Continued)
The Company estimates
the fair value of each option award using the Black-Scholes option-pricing model. The Company used the following assumptions to
estimate the fair value of stock options issued in the years ended December 31, 2020 and 2019:
December 31, 2020
December 31, 2019
Expected volatility
104% – 124%
106% – 128%
Expected term
5 – 6 years
5 – 6 years
Dividend yield
0%
0%
Risk-free interest rates
0.4 – 1.5%
1.4 – 1.6%
Employee and non-employee
stock-based compensation expense for the years ended December 31, 2020 and 2019 was as follows:
2020
2019
General and administrative
$ 1,705,477
$ 509,212
Research and development
247,202
191,772
Total
$ 1,952,679
$ 700,984
The Company does not
recognize an income tax benefit as the Company believes that an actual income tax benefit may not be realized. For non-qualified
stock options, the loss creates a timing difference, resulting in a deferred tax asset, which is fully reserved by a valuation
allowance.
Common stock, stock
options or other equity instruments issued to non-employees (including consultants) as consideration for goods or services received
by the Company are accounted for based on the fair value of the equity instruments issued. The fair value of stock options is determined
using the Black-Scholes option-pricing model. The Company calculates the fair value for non-qualified options as of the date of
grant and expenses over the applicable vesting periods. We account for forfeitures upon occurrence.
On
February 12, 2020, pursuant to the authority granted to it under the 2012 Restated Equity Incentive Plan and the 2012 Non-Employee
Director Stock Option Plan, the board of directors of the Company approved a program under which outstanding options and other
awards granted under the 2012 Plan and the 2012 Director Plan to employees, officers and directors and designated service providers
of the Company were repriced to their then current fair market value. There were 662,968 outstanding options which were
repriced to $1.39 per share, which was the market price of our common stock on the date of the approval of the repricing. The effect
of the modification generated a total incremental cost of approximately $178,000, of which approximately $171,000 was recognized
in the first quarter of 2020 stock-based compensation expense with the remainder to be expensed over the remaining unvested period
terms.
The following table
summarizes information about stock options outstanding and exercisable at December 31, 2020:
Options Outstanding
Range of Ex. Prices
Options Outstanding
Weighted Average
Term (yrs.)
Weighted Average
Exercise Price
$ 1.18
48,000
9.16
$ 1.18
$ 1.39
1,995,876
7.46
$ 1.39
$1.50 - $12.10
317,997
9.43
$ 5.12
2,361,873
$ 1.89
Options Exercisable
Range of Ex. Prices
Options Exercisable
Weighted Average
Term (yrs.)
Weighted Average
Exercise Price
$ 1.18
18,000
9.16
$ 1.18
$ 1.39
866,183
5.35
$ 1.39
$1.50 - $12.10
29,068
7.76
$ 4.97
913,251
$ 1.50
108
CAPRICOR
THERAPEUTICS, INC.
Notes
to CONSOLIDATED financial statements
DECEMBER
31, 2020 AND 2019
4. STOCK AWARDS, WARRANTS
AND OPTIONS (Continued)
As of December 31,
2020, the total unrecognized fair value compensation cost related to non-vested stock options was approximately $5.7 million, which
is expected to be recognized over a weighted average period of approximately 1.6 years.
The following is a
schedule summarizing employee and non-employee stock option activity for the years ended December 31, 2020 and 2019:
Number of
Options
Weighted Average
Exercise Price
Aggregate
Intrinsic Value
Outstanding at January 1, 2019
701,287
$ 16.18
$ -
Granted
130,000
3.20
Exercised
(828 )
3.35
$ 1,987
Expired/Cancelled
(75,546 )
29.48
Outstanding at December 31, 2019
754,913
$ 12.63
$ -
Granted
1,878,058
2.14
Exercised
(63,774 )
3.19
$ 329,035
Expired/Cancelled
(207,324 )
5.73
Outstanding at December 31, 2020
2,361,873
$ 1.89
$ 4,236,737
Exercisable at December 31, 2020
913,251
$ 1.50
$ 1,813,910
The
aggregate intrinsic value represents the difference between the exercise price of the options and the estimated fair value of the
Company’s common stock for each of the respective periods.
5. CONCENTRATIONS
Cash Concentration
The Company has historically
maintained checking accounts at two financial institutions. These accounts are each insured by the Federal Deposit Insurance Corporation
for up to $250,000. Historically, the Company has not experienced any significant losses in such accounts and believes it is not
exposed to any significant credit risk on cash, cash equivalents and marketable securities. As of December 31, 2020, the Company
maintained approximately $32.2 million of uninsured deposits.
6. GOVERNMENT GRANT AWARDS
CIRM Grant Award (HOPE)
On June 16, 2016,
Capricor entered into the CIRM Award with CIRM in the amount of approximately $3.4 million to fund, in part, Capricor’s
Phase I/II HOPE-Duchenne clinical trial investigating CAP-1002 for the treatment of Duchenne muscular dystrophy-associated cardiomyopathy.
Pursuant to terms of the CIRM Award, the disbursements were tied to the achievement of specified operational milestones. In addition,
the terms of the CIRM Award included a co-funding requirement pursuant to which Capricor was required to spend approximately $2.3
million of its own capital to fund the CIRM funded research project. The CIRM Award is further subject to the conditions and requirements
set forth in the CIRM Grants Administration Policy for Clinical Stage Projects. Such requirements include, without limitation,
the filing of quarterly and annual reports with CIRM, the sharing of intellectual property pursuant to Title 17, California Code
of Regulations (CCR) Sections 100600-100612, and the sharing with the State of California of a fraction of licensing revenue received
from a CIRM funded research project and net commercial revenue from a commercialized product which resulted from the CIRM funded
research as set forth in Title 17, CCR Section 100608. The maximum royalty on net commercial revenue that Capricor may be
required to pay to CIRM is equal to nine times the total amount awarded and paid to Capricor.
109
CAPRICOR
THERAPEUTICS, INC.
Notes
to CONSOLIDATED financial statements
DECEMBER
31, 2020 AND 2019
6. GOVERNMENT GRANT AWARDS
(Continued)
After completing the
CIRM funded research project and at any time after the award period end date (but no later than the ten-year anniversary of the
date of the award), Capricor has the right to convert the CIRM Award into a loan, the terms of which will be determined based on
various factors, including the stage of the research and development of the program at the time the election is made. On June 20,
2016, Capricor entered into a Loan Election Agreement with CIRM whereby, among other things, CIRM and Capricor agreed that
if Capricor elects to convert the grant into a loan, the term of the loan could be up to five years from the date of execution
of the applicable loan agreement; provided that the maturity date of the loan will not surpass the ten-year anniversary of the
grant date of the CIRM Award. Beginning on the date of the loan, the loan shall bear interest on the unpaid principal balance,
plus the interest that has accrued prior to the election point according to the terms set forth in CIRM’s Loan Policy (the
“New Loan Balance”), at a per annum rate equal to the LIBOR rate for a three-month deposit in U.S. dollars, as published
by the Wall Street Journal on the loan date, plus one percent. Interest shall be compounded annually on the outstanding New Loan
Balance commencing with the loan date and the interest shall be payable, together with the New Loan Balance, upon the due date
of the loan. If Capricor elects to convert the CIRM Award into a loan, certain requirements of the CIRM Award will no longer be
applicable, including the revenue sharing requirements. Capricor has not yet made its decision as to whether it will elect to convert
the CIRM Award into a loan. If we elect to do so, Capricor would be required to repay some or all of the amounts awarded by CIRM;
therefore, the Company accounts for this award as a liability rather than income.
In
June 2019, Capricor completed all milestones associated with the CIRM Award and expended all funds received. In the third
quarter of 2019, Capricor completed all final close-out documentation associated with this award. As of December 31, 2020,
Capricor’s liability balance for the CIRM Award was approximately $3.4 million.
NIH Grant Award (HLHS)
In September 2016,
Capricor was approved for a grant from the NIH to study CAP-2003 (cardiosphere-derived cell exosomes) for hypoplastic left heart
syndrome (HLHS). Under the terms of the NIH grant, Capricor is eligible to receive disbursements in an amount up to approximately
$4.2 million, subject to annual and quarterly reporting requirements as well as completion of the study objectives. The Company
utilized approximately $0.7 million under the terms of the NIH grant award. In the second quarter of 2019, the award was closed,
and all filings were completed.
U.S. Department of Defense Grant Award
In September 2016,
Capricor was approved for a grant award from the Department of Defense in the amount of approximately $2.4 million to be used toward
developing a scalable, commercially-ready process to manufacture CAP-2003. Under the terms of the award, disbursements were made
to Capricor over a period of approximately four years, subject to annual and quarterly reporting requirements. The Company was
granted a no-cost extension until September 29, 2020 to be able to utilize these funds. The Company utilized approximately
$2.3 million under the terms of the award. We are currently completing all close-out documentation associated with this award.
7. COMMITMENTS AND CONTINGENCIES
Leases
Capricor
leases space for its corporate offices from The Bubble Real Estate Company, LLC (“Bubble Real Estate”) pursuant to
a lease that was originally effective for a two-year period beginning July 1, 2013 with an option to extend the lease for
an additional twelve months. Capricor subsequently entered into several amendments extending the term of the lease and modifying
its terms. Effective January 1, 2021, we entered into an amendment with the Bubble Real Estate Company, LLC pursuant
to which we extended our lease for an additional year ending December 31, 2021. The lease is terminable by either party upon
90 days’ written notice to the other party. The monthly rental payment is $13,073 for this annual period.
Capricor
leases facilities from Cedars-Sinai Medical Center (“CSMC”) pursuant to a lease (the “Facilities Lease”)
that was originally effective for a three-year period beginning June 1, 2014. Capricor has subsequently entered into several
amendments extending the term of the lease and modifying its terms. In July 2020, Capricor exercised its option to
extend the term of the Facilities Lease for an additional 12-month period through July 31, 2021 with a monthly lease payment
of $15,805. The Company has a further option to extend the Facilities Lease with respect to a portion of the leased premises through
July 31, 2022 and a monthly lease payment of $10,707. At this time, we are actively considering new facilities for our research,
development and/or manufacturing activities or the possible extension of our current lease.
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CAPRICOR
THERAPEUTICS, INC.
Notes
to CONSOLIDATED financial statements
DECEMBER
31, 2020 AND 2019
7. COMMITMENTS AND CONTINGENCIES
(Continued)
Included within the
table below, future minimum rental payments to related parties totaled $110,635. A summary of future minimum rental payments required
under operating leases as of December 31, 2020 is as follows:
Years ended
Operating Leases
2021
$ 110,635
Expenses incurred under
operating leases to unrelated parties for the years ended December 31, 2020 and 2019 were $194,748 and $317,404, respectively.
Expenses incurred under operating leases to related parties for the years ended December 31, 2020 and 2019 were $189,660 and
$197,562, respectively.
Legal Contingencies
The Company is not
a party to any material legal proceedings at this time. From time to time, the Company may become involved in various
legal proceedings that arise in the ordinary course of its business or otherwise.
Accounts Payable
Over the normal course
of business, disputes with vendors may arise. If a vendor dispute payment is probable and able to be estimated, we will record
an estimated liability.
Other Funding Commitments
The Company is a party to various agreements,
principally relating to licensed technology, that require future payments relating to milestones that may be met in subsequent
periods or royalties on future sales of specified products (see Note 8 – “License Agreements”).
Additionally, the Company is a party to various agreements with
contract research organizations and contract manufacturers that generally provide for termination upon notice, with the exact amounts
owed in the event of termination to be based on the timing of the termination and the terms of the agreement.
Employee Severances
In the event of a termination,
subject to certain conditions, the Board of Directors approved severance packages for specific full-time employees based on their
length of service and position ranging up to six months of their base salaries. No liability has been recorded as of December 31,
2020.
8. LICENSE AGREEMENTS
Capricor’s Technology - CAP-1002
and Exosomes
Capricor has entered
into exclusive license agreements for intellectual property rights related to certain cardiac-derived cells with Università
Degli Studi Di Roma La Sapienza, or the University of Rome, JHU and CSMC. Capricor has also entered into an exclusive license agreement
for intellectual property rights related to exosomes with CSMC and a non-exclusive license agreement with JHU related to the imaging-based
serology technology for COVID-19. In addition, Capricor has filed patent applications related to the technology developed by its
own scientists.
University of Rome
License Agreement
Capricor and the University
of Rome entered into a License Agreement, dated June 21, 2006, or the Rome License Agreement, which provides for the grant
of an exclusive, world-wide, royalty-bearing license by the University of Rome to Capricor (with the right to sublicense) to develop
and commercialize licensed products under the licensed patent rights in all fields. Capricor has a right of first negotiation,
for a certain period of time, to obtain a license to any new and separate patent applications owned by the University of Rome utilizing
cardiac stem cells in cardiac care.
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CAPRICOR
THERAPEUTICS, INC.
Notes
to CONSOLIDATED financial statements
DECEMBER
31, 2020 AND 2019
8. LICENSE AGREEMENTS (Continued)
Pursuant to the Rome
License Agreement, Capricor paid the University of Rome a license issue fee, is currently paying minimum annual royalties in the
amount of 20,000 Euros per year, and is obligated to pay a lower-end of a mid-range double-digit percentage on all royalties received
as a result of sublicenses granted, which are net of any royalties paid to third parties under a license agreement from such third
party to Capricor. The minimum annual royalties are creditable against future royalty payments.
The Rome License Agreement
will, unless extended or sooner terminated, remain in effect until the later of the last claim of any patent or until any patent
application comprising licensed patent rights has expired or been abandoned. Under the terms of the Rome License Agreement, either
party may terminate the agreement should the other party become insolvent or file a petition in bankruptcy. Either party may terminate
the agreement upon the other party’s material breach, provided that the breaching party will have up to 90 days to cure its
material breach. Capricor may also terminate for any reason upon 90 days’ written notice to the University of Rome.
The Johns Hopkins University License
Agreements
License Agreement
for CDCs
Capricor and JHU entered
into an Exclusive License Agreement, effective June 22, 2006, or the JHU License Agreement, which provides for the grant of
an exclusive, world-wide, royalty-bearing license by JHU to Capricor (with the right to sublicense) to develop and commercialize
licensed products and licensed services under the licensed patent rights in all fields and a nonexclusive right to the know-how.
In May 2009, the JHU License Agreement was amended to add additional patent rights to the JHU License Agreement in consideration
of a payment to JHU and reimbursement of patent costs. Capricor and JHU executed a Second Amendment to the JHU License Agreement,
effective as of December 20, 2013, pursuant to which, among other things, certain definitions were added or amended, the timing
of certain obligations was revised and other obligations of the parties were clarified. Under the JHU License Agreement, Capricor
is required to exercise commercially reasonable and diligent efforts to develop and commercialize licensed products covered by
the licenses from JHU.
Pursuant
to the JHU License Agreement, JHU was paid an initial license fee and, thereafter, Capricor is required to pay minimum annual royalties
on the anniversary dates of the JHU License Agreement. The minimum annual royalties are creditable against a low single-digit running
royalty on net sales of products and net service revenues, which Capricor is also required to pay under the JHU License Agreement,
which running royalty may be subject to further reduction in the event that Capricor is required to pay royalties on any patent
rights to third parties in order to make or sell a licensed product. In addition, Capricor is required to pay a low double-digit
percentage of the consideration received by it from sublicenses granted, and is required to pay JHU certain defined development
milestone payments upon the successful completion of certain phases of its clinical studies and upon receiving approval from
the U.S. Food and Drug Administration, or the FDA. The development milestones range from $100,000 upon successful completion of
a full Phase I clinical study to $1,000,000 upon full FDA market approval and are fully creditable against payments owed by Capricor
to JHU on account of sublicense consideration attributable to milestone payments received from a sublicensee. The maximum aggregate
amount of milestone payments payable under the JHU License Agreement, as amended, is $1,850,000. In May 2015, Capricor paid
the development milestone related to Phase I that was owed to JHU pursuant to the terms of the JHU License Agreement. The next
milestone is triggered upon successful completion of a full Phase II study for which a payment of $250,000 will be due. At this
time, it is uncertain as to whether the $250,000 milestone payment will become due.
The JHU License Agreement
will, unless sooner terminated, continue in effect in each applicable country until the date of expiration of the last to expire
patent within the patent rights, or, if no patents are issued, then for twenty years from the effective date. Under the terms of
the JHU License Agreement, either party may terminate the agreement should the other party become insolvent or file a petition
in bankruptcy, or fail to cure a material breach within 30 days after notice. In addition, Capricor may terminate for any reason
upon 60 days’ written notice.
License Agreement
for Serology Diagnostic
Capricor and JHU entered
into a Nonexclusive License Agreement, effective January 6, 2021, or the JHU Serology License Agreement, which provides for
the grant of a non-exclusive, world-wide, non-royalty-bearing license by JHU to Capricor to develop and commercialize licensed
products under the licensed patent rights for COVID-19.
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CAPRICOR
THERAPEUTICS, INC.
Notes
to CONSOLIDATED financial statements
DECEMBER
31, 2020 AND 2019
8. LICENSE AGREEMENTS (Continued)
Cedars-Sinai Medical Center License Agreements
License Agreement for CDCs
On January 4,
2010, Capricor entered into an Exclusive License Agreement with CSMC, or the Original CSMC License Agreement, for certain intellectual
property related to its CDC technology. In 2013, the Original CSMC License Agreement was amended twice resulting in, among other
things, a reduction in the percentage of sublicense fees which would have been payable to CSMC. Effective December 30, 2013,
Capricor entered into an Amended and Restated Exclusive License Agreement with CSMC, or the Amended CSMC License Agreement, which
amended, restated, and superseded the Original CSMC License Agreement, pursuant to which, among other things, certain definitions
were added or amended, the timing of certain obligations was revised and other obligations of the parties were clarified.
The Amended CSMC License
Agreement provides for the grant of an exclusive, world-wide, royalty-bearing license by CSMC to Capricor (with the right to sublicense)
to conduct research using the patent rights and know-how and develop and commercialize products in the field using the patent rights
and know-how. In addition, Capricor has the exclusive right to negotiate for an exclusive license to any future rights arising
from related work conducted by or under the direction of Dr. Eduardo Marbán on behalf of CSMC. In the event the parties
fail to agree upon the terms of an exclusive license for any future rights, Capricor will have a non-exclusive license to such
future rights, subject to royalty obligations.
Pursuant to the Original
CSMC License Agreement, CSMC was paid a license fee and Capricor was obligated to reimburse CSMC for certain fees and costs incurred
in connection with the prosecution of certain patent rights. Additionally, Capricor is required to meet certain spending and development
milestones.
Pursuant to the Amended
CSMC License Agreement, Capricor remains obligated to pay low single-digit royalties on sales of royalty-bearing products as well
as a low double-digit percentage of the consideration received from any sublicenses or other grant of rights. The above-mentioned
royalties are subject to reduction in the event Capricor becomes obligated to obtain a license from a third party for patent rights
in connection with the royalty-bearing product. In 2010, Capricor discontinued its research under some of the patents.
The Amended CSMC License
Agreement will, unless sooner terminated, continue in effect on a country by country basis until the last to expire of the patents
covering the patent rights or future patent rights. Under the terms of the Amended CSMC License Agreement, unless waived by CSMC,
the agreement shall automatically terminate: (i) if Capricor ceases, dissolves or winds up its business operations; (ii) in
the event of the insolvency or bankruptcy of Capricor or if Capricor makes an assignment for the benefit of its creditors; (iii) if
performance by either party jeopardizes the licensure, accreditation or tax exempt status of CSMC or the agreement is deemed illegal
by a governmental body; (iv) within 30 days for non-payment of royalties; (v) after 90 days’ notice from CSMC if
Capricor fails to undertake commercially reasonable efforts to exploit the patent rights or future patent rights; (vi) if
a material breach has not been cured within 90 days; or (vii) if Capricor challenges any of the CSMC patent rights. If Capricor
fails to undertake commercially reasonable efforts to exploit the patent rights or future patent rights, and fails to cure that
breach after 90 days’ notice from CSMC, instead of terminating the license, CSMC has the option to convert any exclusive
license to Capricor to a non-exclusive or co-exclusive license. Capricor may terminate the agreement if CSMC fails to cure any
material breach within 90 days after notice.
On March 20, 2015,
August 5, 2016, December 26, 2017, and June 20, 2018, Capricor and CSMC entered into a number of amendments to the
Amended CSMC License Agreement, pursuant to which the parties agreed to add and delete certain patent applications from the list
of scheduled patents. Capricor reimbursed CSMC for certain attorneys’ fees and filing fees incurred in connection with the
additional patent applications.
License Agreement for Exosomes
On May 5, 2014,
Capricor entered into an Exclusive License Agreement with CSMC, or the Exosomes License Agreement, for certain intellectual property
rights related to exosomes technology. The Exosomes License Agreement provides for the grant of an exclusive, world-wide, royalty-bearing
license by CSMC to Capricor (with the right to sublicense) in order to conduct research using the patent rights and know-how and
to develop and commercialize products in the field using the patent rights and know-how. In addition, Capricor has the exclusive
right to negotiate for an exclusive license to any future rights arising from related work conducted by or under the direction
of Dr. Eduardo Marbán on behalf of CSMC. In the event the parties fail to agree upon the terms of an exclusive license,
Capricor shall have a non-exclusive license to such future rights, subject to royalty obligations.
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CAPRICOR
THERAPEUTICS, INC.
Notes
to CONSOLIDATED financial statements
DECEMBER
31, 2020 AND 2019
8. LICENSE AGREEMENTS (Continued)
Pursuant to the Exosomes
License Agreement, CSMC was paid a license fee and Capricor reimbursed CSMC for certain fees and costs incurred in connection with
the preparation and prosecution of certain patent applications. Additionally, Capricor is required to meet certain non-monetary
development milestones and is obligated to pay low single-digit royalties on sales of royalty-bearing products as well as a single-digit
percentage of the consideration received from any sublicenses or other grant of rights. The above-mentioned royalties are subject
to reduction in the event Capricor becomes obligated to obtain a license from a third party for patent rights in connection with
the royalty bearing product.
The Exosomes License
Agreement will, unless sooner terminated, continue in effect on a country by country basis until the last to expire of the patents
covering the patent rights or future patent rights. Under the terms of the Exosomes License Agreement, unless waived by CSMC, the
agreement shall automatically terminate: (i) if Capricor ceases, dissolves or winds up its business operations; (ii) in
the event of the insolvency or bankruptcy of Capricor or if Capricor makes an assignment for the benefit of its creditors; (iii) if
performance by either party jeopardizes the licensure, accreditation or tax exempt status of CSMC or the agreement is deemed illegal
by a governmental body; (iv) within 30 days for non-payment of royalties; (v) after 90 days if Capricor fails to undertake
commercially reasonable efforts to exploit the patent rights or future patent rights; (vi) if a material breach has not been
cured within 90 days; or (vii) if Capricor challenges any of the CSMC patent rights. If Capricor fails to undertake commercially
reasonable efforts to exploit the patent rights or future patent rights, and fails to cure that breach after 90 days’ notice
from CSMC, instead of terminating the license, CSMC has the option to convert any exclusive license to Capricor to a non-exclusive
or co-exclusive license. Capricor may terminate the agreement if CSMC fails to cure any material breach within 90 days after notice.
On
February 27, 2015, June 10, 2015, August 5, 2016, December 26, 2017, June 20, 2018, September 25,
2018, August 19, 2020, and August 28, 2020 Capricor and CSMC entered into a number of amendments to the Exosomes License
Agreement. These amendments added additional patent applications and patent families to the Exosomes License Agreement, added certain
defined product development milestone payments, modified certain milestone deadlines, and added certain performance milestones
with respect to product candidates covered by certain future patent rights in order to maintain an exclusive license to
those future patent rights; failure to meet those milestones would cause CSMC to have the right to convert the license from exclusive
to non-exclusive or co-exclusive, or to terminate the license, subject to Capricor’s right to license such patent rights
for internal research purposes on a non-exclusive basis. These amendments also obligated Capricor to reimburse CSMC for certain
attorneys’ fees and filing fees in connection with the additional patent applications and patent families.
Sponsored Research Agreement with Johns
Hopkins University
On April 1, 2020
we entered into a Sponsored Research Agreement, or the SRA, with JHU pursuant to which researchers in the lab of Dr. Stephen
Gould will perform certain research activities in connection with our exosomes program. Pursuant to the SRA, we have agreed to
fund certain research activities and will have the right to negotiate for exclusive or non-exclusive rights to intellectual property
that may result from such research activities.
9. RELATED PARTY TRANSACTIONS
Lease and Sub-Lease Agreement
As noted above, Capricor
is a party to lease agreements with CSMC(see Note 7 – “Commitments and Contingencies”), and CSMC has served as
an investigative site in Capricor’s clinical trials. Additionally, Dr. Eduardo Marbán, who is a stockholder of
Capricor Therapeutics and has participated from time to time as an observer at the Company’s meetings of the Board of Directors,
is the Director of the Cedars-Sinai Smidt Heart Institute, and co-founder of Capricor.
On
April 1, 2013, Capricor entered into a sublease with Reprise Technologies, LLC, a limited liability company which is wholly
owned by Dr. Frank Litvack, the Company’s Executive Chairman and member of its Board of Directors, for $2,500 per month. The
sublease was on a month-to-month basis and was terminated effective September 1, 2020. F or the years ended December 31,
2020 and 2019, Capricor recognized $20,000 and $30,000, respectively, in sublease income from the related party. Sublease income
is recorded as a reduction to general and administrative expenses.
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CAPRICOR
THERAPEUTICS, INC.
Notes
to CONSOLIDATED financial statements
DECEMBER
31, 2020 AND 2019
9. RELATED PARTY TRANSACTIONS
(Continued)
Consulting Agreements
In 2013, Capricor entered
into a Consulting Agreement with Dr. Frank Litvack, the Company’s Executive Chairman and a member of its Board of Directors,
whereby Capricor agreed to pay Dr. Litvack $10,000 per month for consulting services. The agreement is terminable upon 30
days’ notice.
In July 2020,
Capricor entered into an Advisory Services Agreement with Dr. Eduardo Marbán whereby he was granted an option to purchase
50,000 shares of the Company’s common stock.
Payables to Related Party
As of December 31,
2020 and 2019, the Company had accounts payable and accrued expenses to related parties totaling $8,972 and $22,315, respectively.
CSMC accounts for $8,972 and $12,315 of the total accounts payable and accrued expenses to related parties as of December 31,
2020 and 31, 2019, respectively. CSMC expenses relate to research and development costs, license and patent fees, and facilities
rent. During the years ended December 31, 2020 and 2019, the Company paid CSMC approximately $307,000 and $336,000, respectively,
for such costs.
Related Party Clinical Trials
Capricor has agreed
to provide CAP-1002 for investigational purposes in two clinical trials sponsored by CSMC. This product was developed as part of
the Company’s past research and development efforts. The first trial is known as “Regression of Fibrosis and Reversal
of Diastolic Dysfunction in HFpEF Patients Treated with Allogeneic CDCs”, or REGRESS. Dr. Eduardo Marbán is the
named principal investigator under the study. The second trial is known as “Pulmonary Arterial Hypertension treated with
Cardiosphere-derived Allogeneic Stem Cells” or ALPHA. In both studies, Capricor is providing the necessary number of doses
of cells and will receive a negotiated amount of monetary compensation which is estimated to be approximately $2.1 million over
several years. For the years ended December 31, 2020 and 2019, the Company recognized approximately $120,000 and $460,000,
respectively, as revenue. As of December 31, 2020, and 2019, approximately $56,000 and $58,000, respectively, is outstanding
and recorded in prepaid expenses and other current assets. As of December 31, 2020, there remains approximately $0.6 million
to be received by the Company, subject to enrollment and certain conditions under the agreements. Due to the current COVID-19 pandemic,
additional testing in each of the ALPHA and REGRESS trials has been delayed and as a result, purchases of additional doses of CAP-1002
have been delayed.
10. SUBSEQUENT EVENTS
Corporate Offices Lease Amendment
Effective January 1,
2021, the Company entered into a Sixth Amendment with the Bubble Real Estate Company, LLC pursuant to which we extended our lease
for an additional year ending December 31, 2021 and reduced the square footage. The monthly rental payment is $13,073 for
this annual period.
Stock Option Grants
In January 2021,
the Company granted a total of 1,333,824 stock options to its employees, certain non-employee consultants, and directors.
Additional Sales Under May 2020
ATM Program
Subsequent to December 31,
2020 and through March 12, 2021, the Company sold an aggregate of 2,281,874 common shares under the May 2020 ATM Program
at an average price of approximately $5.85 per common share for gross proceeds of approximately $13.0 million. The Company paid
cash commissions on the gross proceeds, plus reimbursement of expenses of the placement agent and legal fees in the aggregate amount
of approximately $0.4 million.
115
Item 9. Changes in and Disagreements With Accountants on Accounting and
Financial Disclosure
None.