Capricor Therapeutics (CAPR) 10-K 15 Mar 21 2020 FY Annual report Financial data

Document and Entity Information

Document and Entity Information - USD ($)	12 Months Ended
	Dec. 31, 2020	Mar. 12, 2021	Jun. 30, 2020
Document and Entity Information
Document Type	10-K
Document Period End Date	Dec. 31, 2020
Entity Registrant Name	CAPRICOR THERAPEUTICS, INC.
Entity Filer Category	Non-accelerated Filer
Title of 12(b) Security	Common Stock, par value $0.001 per share
Trading Symbol	CAPR
Security Exchange Name	NASDAQ
Entity Well-known Seasoned Issuer	No
Entity Voluntary Filers	No
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Small Business	true
Entity Emerging Growth Company	false
Entity Shell Company	false
Entity Common Stock, Shares Outstanding		22,797,930
Entity Public Float			$ 86,525,913
Entity Central Index Key	0001133869
Document Fiscal Year Focus	2020
Current Fiscal Year End Date	--12-31
Document Fiscal Period Focus	FY
Amendment Flag	false

CONSOLIDATED BALANCE SHEETS

CONSOLIDATED BALANCE SHEETS - USD ($)	Dec. 31, 2020	Dec. 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
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

CONSOLIDATED BALANCE SHEETS (Pa

CONSOLIDATED BALANCE SHEETS (Parenthetical) - USD ($)	Dec. 31, 2020	Dec. 31, 2019
CONSOLIDATED BALANCE SHEETS
Net of accumulated amortization (in dollars)	$ 257,517	$ 253,187
Preferred stock, par value (in dollars per share)	$ 0.001	$ 0.001
Preferred stock, shares authorized	5,000,000	5,000,000
Preferred stock, shares issued	0	0
Preferred stock, shares outstanding	0	0
Common Stock, par value (in dollars per share)	$ 0.001	$ 0.001
Common stock, shares authorized	50,000,000	50,000,000
Common stock, shares issued	20,577,123	5,227,398
Common stock, shares outstanding	20,577,123	5,227,398

CONSOLIDATED STATEMENTS OF OPER

CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($)	12 Months Ended
	Dec. 31, 2020	Dec. 31, 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	0	(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

CONSOLIDATED STATEMENTS OF CHAN

CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY - USD ($)	COMMON STOCK [Member]	ADDITIONAL PAID-IN CAPITAL [Member]	OTHER COMPREHENSIVE INCOME (LOSS) [Member]	ACCUMULATED DEFICIT [Member]	Total
Balance at Dec. 31, 2018	$ 3,138	$ 71,338,970	$ 12,393	$ (66,738,914)	$ 4,615,587
Balance (in shares) at Dec. 31, 2018	3,138,748
Issuance of common stock, net of fees	$ 1,638	9,173,115	0	0	9,174,753
Issuance of common stock, net of fees (in shares)	1,637,849
Exercise of pre-funded common stock warrants	$ 450	0	0	0	450
Exercise of pre-funded common stock warrants (in shares)	450,000
Stock-based compensation	$ 0	700,984	0	0	700,984
Fractional shares eliminated pursuant to reverse stock split	$ 0	(193)	0	0	(193)
Fractional shares eliminated pursuant to reverse stock split (in shares)	(27)
Unrealized loss on marketable securities	$ 0	0	(13,150)	0	(13,150)
Stock options exercised	$ 1	2,771	0	0	2,772
Stock options exercised (in shares)	828
Net loss	$ 0	0	0	(7,641,817)	(7,641,817)
Balance at Dec. 31, 2019	$ 5,227	81,215,647	(757)	(74,380,731)	6,839,386
Balance (in shares) at Dec. 31, 2019	5,227,398
Issuance of common stock, net of fees	$ 4,174	27,338,895	0	0	27,343,069
Issuance of common stock, net of fees (in shares)	4,173,478
Exercise of pre-funded common stock warrants	$ 3,158	0	0	0	3,158
Exercise of pre-funded common stock warrants (in shares)	3,158,304
Exercise of common warrants	$ 4,417	5,680,943	0	0	5,685,360
Exercise of common warrants (in shares)	4,417,219
Issuance of shares in abeyance	$ 3,556	(3,556)	0	0
Issuance of shares in abeyance (in shares)	3,555,500
Stock-based compensation	$ 0	1,952,679	0	0	1,952,679
Unrealized loss on marketable securities	0	0	757	0	757
Stock options exercised	$ 45	32,358	0	0	32,403
Stock options exercised (in shares)	45,224
Net loss	$ 0	0	0	(13,657,028)	(13,657,028)
Balance at Dec. 31, 2020	$ 20,577	$ 116,216,966	$ 0	$ (88,037,759)	$ 28,199,784
Balance (in shares) at Dec. 31, 2020	20,577,123

CONSOLIDATED STATEMENTS OF CASH

CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($)	12 Months Ended
	Dec. 31, 2020	Dec. 31, 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	0	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)	0
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	0
Proceeds from exercise of warrants	5,688,518	450
Repurchase of fractional shares pursuant to reverse stock split	0	(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	0	0
Income taxes paid in cash	$ 0	$ 0

ORGANIZATION AND SUMMARY OF SIG

ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES	12 Months Ended
	Dec. 31, 2020
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES	1. 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. 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. 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. 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. 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. 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. 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 dilutive 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. 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.

NOTE PAYABLE

NOTE PAYABLE	12 Months Ended
	Dec. 31, 2020
NOTE PAYABLE
NOTE PAYABLE	2. 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.

STOCKHOLDER'S EQUITY

STOCKHOLDER'S EQUITY	12 Months Ended
	Dec. 31, 2020
STOCKHOLDER'S EQUITY
STOCKHOLDER'S EQUITY	3. 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. 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. 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.

STOCK AWARDS, WARRANTS AND OPTI

STOCK AWARDS, WARRANTS AND OPTIONS	12 Months Ended
	Dec. 31, 2020
STOCK AWARDS, WARRANTS AND OPTIONS
STOCK AWARDS, WARRANTS AND OPTIONS	4. Warrants The following table summarizes all warrant activity for the years ended December 31, 2020 and 2019: Weighted Average Warrants 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: December 31, December 31, Exercise Price Expiration Type Grant Date 2020 2019 per Share Date Common Warrants 12/19/2019 61,173 4,139,477 $ 1.10 12/19/2024 Common Warrants 12/19/2019 — 203,915 $ 12/17/2024 Pre-Funded Warrants 12/19/2019 — 3,158,304 $ N/A Common Warrants 3/27/2020 65,000 — $ 3/27/2025 126,173 7,501,696 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. 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 Weighted Average Weighted Average Range of Ex. Prices Options Outstanding Term (yrs.) 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 Weighted Average Weighted Average Range of Ex. Prices Options Exercisable Term (yrs.) 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 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 Weighted Average Aggregate Options Exercise Price 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.

CONCENTRATIONS

CONCENTRATIONS	12 Months Ended
	Dec. 31, 2020
CONCENTRATIONS
CONCENTRATIONS	5. 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.

GOVERNMENT GRANT AWARDS

GOVERNMENT GRANT AWARDS	12 Months Ended
	Dec. 31, 2020
GOVERNMENT GRANT AWARDS
GOVERNMENT GRANT AWARDS	6. 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. 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.

COMMITMENTS AND CONTINGENCIES

COMMITMENTS AND CONTINGENCIES	12 Months Ended
	Dec. 31, 2020
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES	7. 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. 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.

LICENSE AGREEMENTS

LICENSE AGREEMENTS	12 Months Ended
	Dec. 31, 2020
LICENSE AGREEMENTS
LICENSE AGREEMENTS	8. 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. 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. 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. 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.

RELATED PARTY TRANSACTIONS

RELATED PARTY TRANSACTIONS	12 Months Ended
	Dec. 31, 2020
RELATED PARTY TRANSACTIONS
RELATED PARTY TRANSACTIONS	9. 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. For 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. 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.

SUBSEQUENT EVENTS

SUBSEQUENT EVENTS	12 Months Ended
	Dec. 31, 2020
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS	10. 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.

ORGANIZATION AND SUMMARY OF S_2

ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies)	12 Months Ended
	Dec. 31, 2020
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Description of Business	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	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	Reclassification Certain reclassification of prior period amounts has been made to conform to the current year presentation.
Liquidity	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. 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	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	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	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 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. 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	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	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	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. 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	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 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. 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	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) 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.
Clinical Trail Expense	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	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. 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	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 dilutive 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.
Fair Value Measurements	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	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.

ORGANIZATION AND SUMMARY OF S_3

ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables)	12 Months Ended
	Dec. 31, 2020
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Schedule of property, plant and equipment	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
Schedule of future amortization expense	A summary of future amortization expense as of December 31, 2020 is as follows: Years ended Amortization Expense 2021 2,165
Schedule of basic and diluted earnings (loss) per share	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
Schedule of fair value measurements	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

STOCK AWARDS, WARRANTS AND OP_2

STOCK AWARDS, WARRANTS AND OPTIONS (Tables)	12 Months Ended
	Dec. 31, 2020
Schedule of employee and non-employee stock based compensation expense	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
Summary of Stock Option Outstanding And Exercisable	The following table summarizes information about stock options outstanding and exercisable at December 31, 2020: Options Outstanding Weighted Average Weighted Average Range of Ex. Prices Options Outstanding Term (yrs.) 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 Weighted Average Weighted Average Range of Ex. Prices Options Exercisable Term (yrs.) 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
Warrant [Member]
Summary of warrant activity	The following table summarizes all warrant activity for the years ended December 31, 2020 and 2019: Weighted Average Warrants 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
Schedule of outstanding warrants	The following table summarizes all outstanding warrants to purchase shares of the Company’s common stock: December 31, December 31, Exercise Price Expiration Type Grant Date 2020 2019 per Share Date Common Warrants 12/19/2019 61,173 4,139,477 $ 1.10 12/19/2024 Common Warrants 12/19/2019 — 203,915 $ 12/17/2024 Pre-Funded Warrants 12/19/2019 — 3,158,304 $ N/A Common Warrants 3/27/2020 65,000 — $ 3/27/2025 126,173 7,501,696
Stock Option [Member]
Schedule of fair value of option using Black-Scholes option	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 %
Schedule of employee and non-employee stock option	The following is a schedule summarizing employee and non-employee stock option activity for the years ended December 31, 2020 and 2019: Number of Weighted Average Aggregate Options Exercise Price 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

COMMITMENTS AND CONTINGENCIES (

COMMITMENTS AND CONTINGENCIES (Tables)	12 Months Ended
	Dec. 31, 2020
COMMITMENTS AND CONTINGENCIES
Schedule of Future Minimum Rental Payments	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

ORGANIZATION AND SUMMARY OF S_4

ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Property and Equipment (Details) - USD ($)	Dec. 31, 2020	Dec. 31, 2019
Property, Plant and Equipment, Gross	$ 1,569,427	$ 1,021,826
Less accumulated depreciation	(718,580)	(579,020)
Property and equipment, net	850,847	442,806
Furniture and fixtures [Member]
Property, Plant and Equipment, Gross	48,676	43,617
Laboratory equipment [Member]
Property, Plant and Equipment, Gross	1,473,708	931,166
Leasehold improvements [Member]
Property, Plant and Equipment, Gross	$ 47,043	$ 47,043

ORGANIZATION AND SUMMARY OF S_5

ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Intangible Assets (Details)	Dec. 31, 2020USD ($)
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
2021	$ 2,165

ORGANIZATION AND SUMMARY OF S_6

ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Earnings (Loss) per share (Details) - USD ($)	12 Months Ended
	Dec. 31, 2020	Dec. 31, 2019
Numerator
Net loss	$ (13,657,028)	$ (7,641,817)
Denominator
Weighted-average number of common shares outstanding	15,571,056	3,711,333
Dilutive effect of stock options	0	0
Common stock and common stock equivalents used for diluted loss per share	15,571,056	3,711,333

ORGANIZATION AND SUMMARY OF S_7

ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Fair Value Measurements (Details)	Dec. 31, 2019USD ($)
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Marketable Securities	$ 5,986,050
Level I [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Marketable Securities	5,986,050
Level II [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Marketable Securities	0
Level III [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Marketable Securities	$ 0

ORGANIZATION AND SUMMARY OF S_8

ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Additional Information (Details)	Jun. 24, 2019	Dec. 31, 2020USD ($)$ / sharesshares	Dec. 31, 2019USD ($)$ / sharesshares	Jun. 30, 2020USD ($)	Apr. 29, 2020USD ($)
Accounting Policies [Line Items]
Cash, Cash Equivalents, and Marketable Securities		$ 32,700,000	$ 9,900,000
Common stock, par value | $ / shares		$ 0.001	$ 0.001
Other Comprehensive Income (Loss), Unrealized Holding Gain (Loss) on Securities Arising During Period, Net of Tax		$ 757	$ (13,150)
Amortization of Intangible Assets		4,330	43,276
Depreciation		139,560	128,680
Research and Development Expense		8,457,000	5,141,805
Reverse stock split ratio	0.10
Goodwill and Intangible Asset Impairment		0	0
Comprehensive Income (Loss), Net of Tax, Attributable to Parent		(13,656,271)	$ (7,654,967)
Tax Credit Carryforward, Amount		$ 76,100,000
Paycheck Protection Program Loan
Accounting Policies [Line Items]
Amount of loan applied				$ 318,160	$ 318,160
Warrant [Member]
Accounting Policies [Line Items]
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | shares		2,488,046	8,256,609
Common Warrants
Accounting Policies [Line Items]
Common stock, par value | $ / shares			$ 0.001
Research Tax Credit Carryforward [Member]
Accounting Policies [Line Items]
Tax Credit Carryforward, Amount		$ 1,400,000
Tax Credit Carry forwards Expiration Year		2027
General Business Tax Credit Carryforward [Member]
Accounting Policies [Line Items]
Operating Loss Carry forwards Expiration Year		2035
Tax Credit Carryforward, Amount		$ 3,100,000
Domestic Tax Authority [Member]
Accounting Policies [Line Items]
Operating Loss Carry Forwards Indefinitely		$ 31,500,000
Tax Credit Carryforward, Limitations on Use		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.
Operating Loss Carryforwards		$ 107,600,000
Operating Loss Carry forwards Expiration Year		2026
State and Local Jurisdiction [Member]
Accounting Policies [Line Items]
Operating Loss Carryforwards		$ 103,700,000
Operating Loss Carry forwards Expiration Year		2028
Minimum [Member]
Accounting Policies [Line Items]
Estimated useful lives (in years)		5 years
Intangible assets, useful lives (in years)		5 years
Maximum [Member]
Accounting Policies [Line Items]
Estimated useful lives (in years)		7 years
Intangible assets, useful lives (in years)		15 years

NOTE PAYABLE (Details)

NOTE PAYABLE (Details) - Paycheck Protection Program Loan - USD ($)	Dec. 31, 2020	Jun. 30, 2020	Apr. 29, 2020
Debt Instrument [Line Items]
Amount of loan applied		$ 318,160	$ 318,160
Bears interest rate, percentage	1.00%

STOCKHOLDER'S EQUITY (Details)

STOCKHOLDER'S EQUITY (Details) - USD ($)	Mar. 25, 2020	Aug. 23, 2019	Dec. 31, 2019	Jul. 31, 2019	Mar. 12, 2021	Dec. 31, 2019	Mar. 12, 2021	Dec. 31, 2020	Dec. 31, 2019	May 04, 2020	Dec. 31, 2018
Class of Stock [Line Items]
Common stock, shares outstanding			5,227,398			5,227,398		20,577,123	5,227,398
Common stock, shares issued			5,227,398			5,227,398		20,577,123	5,227,398
Number of warrants issued			7,501,696			7,501,696		126,173	7,501,696		84,607
Number of shares being held in abeyance	3,275,500
Beneficial ownership limitation	4.99%
Issuance costs	$ 400,000
Proceeds from issuance of warrants	$ 4,900,000
Proceeds from Issuance of Common Stock								$ 27,343,069	$ 9,174,753
Commission rate on sale price per share				3.00%
Common Stock, Par or Stated Value Per Share			$ 0.001			$ 0.001		$ 0.001	$ 0.001
Stock issued aggregate value								$ 27,343,069	$ 9,174,753
Effective warrant terms	6 months
Warrants Outstanding			7,501,696			7,501,696		126,173	7,501,696		84,607
Common Warrants
Class of Stock [Line Items]
Common Stock, Par or Stated Value Per Share			$ 0.001			$ 0.001			$ 0.001
Pre-funded warrants
Class of Stock [Line Items]
Number of warrants issued			3,158,304			3,158,304		0	3,158,304
Exercise price of warrant								$ 0.001
Warrants Outstanding			3,158,304			3,158,304		0	3,158,304
Placement Agent Warrants
Class of Stock [Line Items]
Number of warrants issued	200,000							65,000
Exercise price of warrant	$ 1.5313
Warrants Outstanding	200,000							65,000
Exercising Holder [Member]
Class of Stock [Line Items]
Number of shares issued to the exercising holders	724,500
New Warrants [Member]
Class of Stock [Line Items]
Exercise price of warrant	$ 1.27
Effective warrant terms	5 years 6 months
July 2019 ATM Program [Member]
Class of Stock [Line Items]
Number of common stock shares issued		418,450
Issuance costs		$ 100,000
Proceeds from Issuance of Common Stock		$ 1,800,000
Common Stock, Par or Stated Value Per Share		$ 4.30
August 2019 ATM Program [Member]
Class of Stock [Line Items]
Issuance costs						$ 100,000
Average price (in per share)			$ 3.07			$ 3.07			$ 3.07
Proceeds from Issuance of Common Stock						$ 1,100,000
Stock issued aggregate value						$ 360,316
December 2019 Financing [Member]
Class of Stock [Line Items]
Number of common stock shares issued			531,173
December 2019 Financing [Member] | Common Warrants
Class of Stock [Line Items]
Exercise price of warrant			$ 1.226			$ 1.226			1.226
December 2019 Financing [Member] | Pre-funded warrants
Class of Stock [Line Items]
Exercise price of warrant			$ 1.225			$ 1.225			$ 1.225
Gross proceeds from offering common stock and warrants			$ 5,100,000
December 2019 Financing [Member] | Placement Agent Warrants
Class of Stock [Line Items]
Number of warrants issued			203,915			203,915		61,173	203,915
Exercise price of warrant			$ 1.5325			$ 1.5325			$ 1.5325
Issuance costs			$ 700,000
Proceeds from issuance of warrants			$ 4,400,000
Warrants Outstanding			203,915			203,915		61,173	203,915
May 2020 ATM Program
Class of Stock [Line Items]
Number of common stock shares issued							5,947,852
Issuance costs							$ 1,200,000
Proceeds from Issuance of Common Stock							$ 36,600,000
Maximum aggregate offering price										$ 40,000,000
Average price					$ 6.16		$ 6.16
May 2020 ATM Program | Subsequent event
Class of Stock [Line Items]
Number of common stock shares issued					2,281,874
Issuance costs					$ 400,000
Proceeds from Issuance of Common Stock					$ 13,000,000
Average price					$ 5.85		$ 5.85
Maximum [Member] | December 2019 Financing [Member] | Common Warrants
Class of Stock [Line Items]
Number of warrants issued			4,139,477			4,139,477			4,139,477
Warrants Outstanding			4,139,477			4,139,477			4,139,477
Maximum [Member] | December 2019 Financing [Member] | Pre-funded warrants
Class of Stock [Line Items]
Number of warrants issued			3,608,304			3,608,304			3,608,304
Warrants Outstanding			3,608,304			3,608,304			3,608,304
Exercise Agreement [Member]
Class of Stock [Line Items]
Exercise price of warrant	$ 1.10
Exercise Agreement [Member] | Exercising Holder [Member]
Class of Stock [Line Items]
Exercise price of warrant	$ 1.225
Warrant issued exercised	4,000,000
Exercise Agreement [Member] | New Warrants [Member]
Class of Stock [Line Items]
Exercise price of warrant	$ 0.125
Warrant issued exercised	4,000,000

STOCK AWARDS, WARRANTS AND OP_3

STOCK AWARDS, WARRANTS AND OPTIONS - Warrants (Details) - $ / shares	12 Months Ended
	Dec. 31, 2020	Dec. 31, 2019
STOCK AWARDS, WARRANTS AND OPTIONS
Warrants Outstanding at Beginning	7,501,696	84,607
Warrants Expired		(84,607)
Warrants Granted	4,200,000	7,951,696
Warrants Exercised	(11,575,523)	(450,000)
Warrants Outstanding at Ending	126,173	7,501,696
Weighted Average Exercise Price Outstanding at Beginning	$ 0.65	$ 45
Weighted Average Exercise Price Expired		45
Weighted Average Exercise Price Granted	1.28	0.61
Weighted Average Exercise Price Exercised	0.870	0.001
Weighted Average Exercise Price Outstanding at Ending	$ 1.32	$ 0.65

STOCK AWARDS, WARRANTS AND OP_4

STOCK AWARDS, WARRANTS AND OPTIONS - Outstanding Warrants (Details) - $ / shares	12 Months Ended
	Dec. 31, 2020	Dec. 31, 2019	Dec. 31, 2018
Class of Warrant or Right [Line Items]
Warrants Outstanding	126,173	7,501,696	84,607
Common Warrants with Expiration on December 2024 One
Class of Warrant or Right [Line Items]
Grant Date	Dec. 19, 2019
Warrants Outstanding	61,173	4,139,477
Exercise Price per Share	$ 1.10
Expiration Date	Dec. 19, 2024
Common Warrants with Expiration on December 2024 Two
Class of Warrant or Right [Line Items]
Grant Date	Dec. 19, 2019
Warrants Outstanding	0	203,915
Exercise Price per Share	$ 1.5325
Expiration Date	Dec. 17, 2024
Common Stock Warrants With Expiration On December 2025 Two
Class of Warrant or Right [Line Items]
Grant Date	Mar. 27, 2020
Warrants Outstanding	65,000
Exercise Price per Share	$ 1.5313
Expiration Date	Mar. 27, 2025
Pre-funded warrants
Class of Warrant or Right [Line Items]
Grant Date	Dec. 19, 2019
Warrants Outstanding	0	3,158,304
Exercise Price per Share	$ 0.001

STOCK AWARDS, WARRANTS AND OP_5

STOCK AWARDS, WARRANTS AND OPTIONS - Assumptions (Details)	12 Months Ended
	Dec. 31, 2020	Dec. 31, 2019
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Dividend yield	0.00%	0.00%
Maximum [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Expected volatility	124.00%	128.00%
Expected term	6 years	6 years
Risk-free interest rates	1.50%	1.60%
Minimum [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Expected volatility	104.00%	106.00%
Expected term	5 years	5 years
Risk-free interest rates	0.40%	1.40%

STOCK AWARDS, WARRANTS AND OP_6

STOCK AWARDS, WARRANTS AND OPTIONS - Stock-based Compensation Expense (Details) - USD ($)	12 Months Ended
	Dec. 31, 2020	Dec. 31, 2019
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items]
Stock-based compensation cost	$ 1,952,679	$ 700,984
General and administrative [Member]
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items]
Stock-based compensation cost	1,705,477	509,212
Research and development [Member]
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items]
Stock-based compensation cost	$ 247,202	$ 191,772

STOCK AWARDS, WARRANTS AND OP_7

STOCK AWARDS, WARRANTS AND OPTIONS - Stock options outstanding and exercisable (Details)	12 Months Ended
	Dec. 31, 2020$ / sharesshares
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items]
Outstanding, Options | shares	2,361,873
Outstanding, Weighted Average Exercise Price	$ 1.89
Exercisable, Options | shares	913,251
Exercisable, Weighted Average Exercise Price	$ 1.50
Range One [Member]
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items]
Range of Exercise Prices, lower range	$ 1.18
Outstanding, Options | shares	48,000
Outstanding, Weighted Average Term	9 years 1 month 28 days
Outstanding, Weighted Average Exercise Price	$ 1.18
Exercisable, Options | shares	18,000
Exercisable, Weighted Average Term	9 years 1 month 28 days
Exercisable, Weighted Average Exercise Price	$ 1.18
Range Two [Member]
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items]
Range of Exercise Prices, lower range	$ 1.39
Outstanding, Options | shares	1,995,876
Outstanding, Weighted Average Term	7 years 5 months 16 days
Outstanding, Weighted Average Exercise Price	$ 1.39
Exercisable, Options | shares	866,183
Exercisable, Weighted Average Term	5 years 4 months 6 days
Exercisable, Weighted Average Exercise Price	$ 1.39
Range Three [Member]
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items]
Range of Exercise Prices, lower range	1.50
Range of Exercise Prices, upper range	$ 12.10
Outstanding, Options | shares	317,997
Outstanding, Weighted Average Term	9 years 5 months 5 days
Outstanding, Weighted Average Exercise Price	$ 5.12
Exercisable, Options | shares	29,068
Exercisable, Weighted Average Term	7 years 9 months 4 days
Exercisable, Weighted Average Exercise Price	$ 4.97

STOCK AWARDS, WARRANTS AND OP_8

STOCK AWARDS, WARRANTS AND OPTIONS - Stock Option Activity (Details) - USD ($)	Feb. 12, 2020	Dec. 31, 2020	Dec. 31, 2019
Number of Options
Outstanding at Ending of the period	662,968
Weighted Average Exercise Price
Granted	$ 1.39
Stock Option [Member]
Number of Options
Outstanding at Beginning of the period		754,913	701,287
Stock options granted		1,878,058	130,000
Exercised		(63,774)	(828)
Expired/Cancelled		(207,324)	(75,546)
Outstanding at Ending of the period		2,361,873	754,913
Exercisable		913,251
Weighted Average Exercise Price
Outstanding at Beginning of the period		$ 12.63	$ 16.18
Granted		2.14	3.20
Exercised		3.19	3.35
Expired/Cancelled		5.73	29.48
Outstanding at Ending of the period		1.89	$ 12.63
Exercisable		$ 1.50
Aggregate Intrinsic Value
Outstanding
Exercised		$ 329,035	$ 1,987
Outstanding		4,236,737
Exercisable		$ 1,813,910

STOCK AWARDS, WARRANTS AND OP_9

STOCK AWARDS, WARRANTS AND OPTIONS - Additional Information (Details) - USD ($)	Jun. 05, 2020	Feb. 12, 2020	Jun. 02, 2016	Jan. 31, 2021	Jan. 31, 2020	Jan. 31, 2019	Dec. 31, 2020	Dec. 31, 2019	Mar. 31, 2020
Disclosure Stockholders Equity, stock Options And Warrants Additional Information [Line Items]
Estimated weighted fair value of option granted (in per share)							$ 3.93	$ 2.73
Share-based Compensation Arrangement by Share-based Payment Award, Expiration Period							10 years
Number of options available for issuance							999,887
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized, Period for Recognition							1 year 7 months 6 days
Number of options repriced		662,968
Reprice of options		$ 1.39
Total incremental cost		$ 178,000
Total incremental cost to be recognized							$ 5,700,000		$ 171,000
Amount Authorized in Plans After Merger			414,971
Stock Option Plan 2012 [Member]
Disclosure Stockholders Equity, stock Options And Warrants Additional Information [Line Items]
Share-based Compensation Arrangement by Share-based Payment Award, Number of Additional Shares Authorized					104,547	62,775
Share-based Compensation Arrangement By Share-based Payment Award, Percentage Of Annual Increase In Number Of Shares Authorized			2.00%
Non-Employee Director Plan 2012 [Member]
Disclosure Stockholders Equity, stock Options And Warrants Additional Information [Line Items]
Amount Authorized in Plans After Merger							269,731
Stock Option Plan 2020 [Member]
Disclosure Stockholders Equity, stock Options And Warrants Additional Information [Line Items]
Share-based Compensation Arrangement by Share-based Payment Award, Number of Additional Shares Authorized				823,084
Stock Option [Member] | Stock Option Plan 2012 [Member]
Disclosure Stockholders Equity, stock Options And Warrants Additional Information [Line Items]
Share-based Compensation Arrangement By Share-based Payment Award, Percentage Of Annual Increase In Number Of Shares Authorized			2.00%
Amount Authorized in Plans After Merger							414,971
Stock Option [Member] | Stock Option Plan 2020 [Member]
Disclosure Stockholders Equity, stock Options And Warrants Additional Information [Line Items]
Share-based Compensation Arrangement By Share-based Payment Award, Percentage Of Annual Increase In Number Of Shares Authorized	4.00%
Maximum number of common stock reserved under the Plan	2,500,000
Incentive Stock Option [Member] | Stock Option Plan 2012 [Member]
Disclosure Stockholders Equity, stock Options And Warrants Additional Information [Line Items]
Minimum Limit Of Fair Market Value To Be Treated As Non-Statutory Stock							$ 100,000
Minimum [Member]
Disclosure Stockholders Equity, stock Options And Warrants Additional Information [Line Items]
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Period							1 year
Maximum [Member]
Disclosure Stockholders Equity, stock Options And Warrants Additional Information [Line Items]
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Period							4 years

CONCENTRATIONS (Details)

CONCENTRATIONS (Details)	Dec. 31, 2020USD ($)
Concentration Risk [Line Items]
Cash, Uninsured Amount	$ 32,200,000
Financial Institution One [Member]
Concentration Risk [Line Items]
Cash, FDIC Insured Amount	$ 250,000

GOVERNMENT GRANT AWARDS (Detail

GOVERNMENT GRANT AWARDS (Details) - USD ($) $ in Millions	1 Months Ended	12 Months Ended
	Jun. 16, 2016	Dec. 31, 2020	Sep. 30, 2016
Disbursement Amount Under Grant Award		$ 3.4
California Institute for Regenerative Medicine [Member]
Grant Award Liability	$ 3.4
Minimum Expected Contribution	$ 2.3
NIH Grant Award HLHS [Member]
Maximum Amount Approved for Grant Award			$ 4.2
Cost Incurred Under Award		0.7
U.S. Department of Defense Grant Award [Member]
Cost Incurred Under Award		$ 2.3
Approved For Grant Award			$ 2.4

COMMITMENTS AND CONTINGENCIES -

COMMITMENTS AND CONTINGENCIES - Future Minimum Rental Payments (Details)	Dec. 31, 2020USD ($)
COMMITMENTS AND CONTINGENCIES
2021	$ 110,635

COMMITMENTS AND CONTINGENCIES_2

COMMITMENTS AND CONTINGENCIES - Additional Information (Details) - USD ($)	1 Months Ended		12 Months Ended
	Jan. 31, 2021	Jul. 31, 2020	Dec. 31, 2021	Dec. 31, 2020	Dec. 31, 2019	Jul. 01, 2013
Commitments and Contingencies Disclosure [Line Items]
Lease Term						2 years
Maximum [Member]
Commitments and Contingencies Disclosure [Line Items]
Operating Leases, Rent Expense				$ 110,635
Minimum [Member]
Commitments and Contingencies Disclosure [Line Items]
Operating Leases, Rent Expense		$ 15,805
Sixth Lease Amendment [Member] | Scenario, Forecast [Member]
Commitments and Contingencies Disclosure [Line Items]
Written notice period for termination of lease			90 days
Operating Leases, Rent Expense	$ 13,073
Facilities Lease
Commitments and Contingencies Disclosure [Line Items]
Leases Monthly Payments For Additional Twelve Months		$ 10,707
Unrelated Party [Member]
Commitments and Contingencies Disclosure [Line Items]
Operating Leases, Rent Expense				194,748	$ 317,404
Related party [Member]
Commitments and Contingencies Disclosure [Line Items]
Operating Leases, Rent Expense				$ 189,660	$ 197,562

LICENSE AGREEMENTS (Details)

LICENSE AGREEMENTS (Details)	12 Months Ended
	Dec. 31, 2020EUR (€)	Dec. 31, 2020USD ($)	May 31, 2015USD ($)
LICENSE AGREEMENTS [Line Items]
Written Notice Period	90 days
Rome License Agreement [Member]
LICENSE AGREEMENTS [Line Items]
Payments for Royalties | €	€ 20,000
Written Notice Period	90 days
JHU License Agreement [Member]
LICENSE AGREEMENTS [Line Items]
Written Notice Period	60 days
CSMC License Agreement [Member]
LICENSE AGREEMENTS [Line Items]
Written Notice Period	90 days
Exosomes License Agreement [Member]
LICENSE AGREEMENTS [Line Items]
Written Notice Period	90 days
Maximum [Member] | JHU License Agreement [Member]
LICENSE AGREEMENTS [Line Items]
Potential Milestone Payments		$ 1,850,000
Completion of Phase One [Member] | Minimum [Member]
LICENSE AGREEMENTS [Line Items]
Range of Milestone Payments, Payable Upon Successful Completion of Certain Phases		100,000
Obtention of FDA Approval [Member] | Maximum [Member]
LICENSE AGREEMENTS [Line Items]
Range of Milestone Payments, Payable Upon Successful Completion of Certain Phases		$ 1,000,000
Completion Of Phase Two Due [Member] | JHU License Agreement [Member]
LICENSE AGREEMENTS [Line Items]
Milestone Payments To Be Made Upon Successful Completion Of Certain Phases			$ 250,000

RELATED PARTY TRANSACTIONS (Det

RELATED PARTY TRANSACTIONS (Details) - USD ($)	Apr. 30, 2013	Jul. 31, 2020	Jan. 01, 2013	Dec. 31, 2020	Dec. 31, 2019
Related Party Transaction [Line Items]
Accounts Payable and Accrued Expenses Related Party Current				$ 8,972	$ 22,315
Compensation Receivable In Connection to Services to be Provided				2,100,000
Related Party Transaction, Other Revenues from Transactions with Related Party				120,000	460,000
CSMC [Member]
Related Party Transaction [Line Items]
Payments for Reimbursement for Research and Development Expenses Incurred Related Party				307,000	336,000
Prepaid Expenses and Other Current Assets [Member]
Related Party Transaction [Line Items]
Due to Related Parties				56,000	58,000
Enrollment and certain conditions under the agreements [Member]
Related Party Transaction [Line Items]
Amount to be received				600,000
Advisory Services Agreement [Member] | Dr Eduardo Marban [Member]
Related Party Transaction [Line Items]
Granted option		50,000
Board of Directors Chairman [Member] | Sublease Agreement with Frank Litvack [Member]
Related Party Transaction [Line Items]
Monthly Sub-lease Income	$ 2,500			20,000	30,000
Board of Directors Chairman [Member] | Consulting Agreement with Frank Litvack [Member]
Related Party Transaction [Line Items]
Monthly Consulting Fees to Related Party			$ 10,000
Affiliated Entity [Member] | Transaction other than Sub-Award Agreement [Member]
Related Party Transaction [Line Items]
Accounts Payable and Accrued Expenses Related Party Current				$ 8,972	$ 12,315

SUBSEQUENT EVENTS (Details)

SUBSEQUENT EVENTS (Details) - USD ($)	Jan. 01, 2021	Mar. 25, 2020	Feb. 12, 2020	Jan. 31, 2021	Mar. 12, 2021	Mar. 12, 2021	Dec. 31, 2020	Dec. 31, 2019	May 04, 2020	Mar. 31, 2020
Proceeds from Issuance of Common Stock							$ 27,343,069	$ 9,174,753
Payments of Stock Issuance Costs		$ 400,000
Total incremental cost to be recognized							5,700,000			$ 171,000
Number of options repriced			662,968
Total incremental cost			$ 178,000
Reprice of options			$ 1.39
Proceeds from Warrant Exercises							$ 5,688,518	$ 450
May 2020 ATM Program
Maximum aggregate offering price									$ 40,000,000
Number of common stock shares issued						5,947,852
Average price					$ 6.16	$ 6.16
Proceeds from Issuance of Common Stock						$ 36,600,000
Payments of Stock Issuance Costs						$ 1,200,000
Subsequent event
Operating Leases, Rent Expense	$ 13,073
Subsequent event | May 2020 ATM Program
Number of common stock shares issued					2,281,874
Average price					$ 5.85	$ 5.85
Proceeds from Issuance of Common Stock					$ 13,000,000
Payments of Stock Issuance Costs					$ 400,000
Subsequent event | Employees, non-employee consultants and directors
Stock options granted				1,333,824