Capricor Therapeutics (CAPR) 10-Q 11 May 22 2022 Q1 Quarterly report Financial data

Document and Entity Information

Document and Entity Information - shares	3 Months Ended
	Mar. 31, 2022	May 10, 2022
Document and Entity Information
Document Type	10-Q
Document Quarterly Report	true
Document Transition Report	false
Document Period End Date	Mar. 31, 2022
Entity File Number	001-34058
Entity Registrant Name	CAPRICOR THERAPEUTICS, INC.
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	88-0363465
Entity Address, Address Line One	10865 Road to the Cure, Suite 150, San Diego
Entity Address, City or Town	San Diego
Entity Address, State or Province	CA
Entity Address, Postal Zip Code	92121
City Area Code	310
Local Phone Number	358-3200
Title of 12(b) Security	Common Stock, par value $0.001 per share
Trading Symbol	CAPR
Security Exchange Name	NASDAQ
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Non-accelerated Filer
Entity Small Business	true
Entity Emerging Growth Company	false
Entity Shell Company	false
Entity Common Stock, Shares Outstanding		24,324,156
Current Fiscal Year End Date	--12-31
Document Fiscal Year Focus	2022
Document Fiscal Period Focus	Q1
Entity Central Index Key	0001133869
Amendment Flag	false

CONDENSED CONSOLIDATED BALANCE

CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($)	Mar. 31, 2022	Dec. 31, 2021
CURRENT ASSETS
Cash and cash equivalents	$ 58,333,945	$ 34,885,274
Receivables	356,997	391,750
Prepaid expenses and other current assets	943,246	1,159,937
TOTAL CURRENT ASSETS	59,634,188	36,436,961
PROPERTY AND EQUIPMENT, net	2,328,565	1,795,696
OTHER ASSETS
Lease right-of-use assets, net	2,683,443	2,821,944
Other assets	275,722	275,722
TOTAL ASSETS	64,921,918	41,330,323
CURRENT LIABILITIES
Accounts payable and accrued expenses	3,523,574	3,116,371
Accounts payable and accrued expenses, related party	574,848	599,388
Lease liabilities, current	498,374	417,632
Deferred revenue, current	9,726,501	0
TOTAL CURRENT LIABILITIES	14,323,297	4,133,391
LONG-TERM LIABILITIES
CIRM liability	3,376,259	3,376,259
Lease liabilities, net of current	2,306,197	2,452,707
Deferred revenue, net of current	20,273,499	0
TOTAL LONG-TERM LIABILITIES	25,955,955	5,828,966
TOTAL LIABILITIES	40,279,252	9,962,357
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, 24,324,156 and 24,185,001 shares issued and outstanding, respectively	24,324	24,185
Additional paid-in capital	140,496,715	139,404,060
Accumulated deficit	(115,878,373)	(108,060,279)
TOTAL STOCKHOLDERS' EQUITY	24,642,666	31,367,966
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY	$ 64,921,918	$ 41,330,323

CONDENSED CONSOLIDATED BALANC_2

CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares	Mar. 31, 2022	Dec. 31, 2021
CONDENSED CONSOLIDATED BALANCE SHEETS
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	24,324,156	24,185,001
Common stock, shares outstanding	24,324,156	24,185,001

CONDENSED CONSOLIDATED STATEMEN

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($)	3 Months Ended
	Mar. 31, 2022	Mar. 31, 2021
REVENUE
Revenue		$ 40,816
TOTAL REVENUE		40,816
OPERATING EXPENSES
Research and development	$ 5,115,699	3,296,322
General and administrative	2,715,835	1,905,582
TOTAL OPERATING EXPENSES	7,831,534	5,201,904
LOSS FROM OPERATIONS	(7,831,534)	(5,161,088)
OTHER INCOME (EXPENSE)
Investment income	13,440	9,165
TOTAL OTHER INCOME (EXPENSE)	13,440	9,165
NET LOSS	$ (7,818,094)	$ (5,151,923)
Net loss per share, basic	$ (0.32)	$ (0.23)
Net loss per share, diluted	$ (0.32)	$ (0.23)
Weighted-average number of shares of common stock outstanding basic	24,282,743	22,228,723
Weighted-average number of shares of common stock outstanding diluted	24,282,743	22,228,723

CONDENSED CONSOLIDATED STATEM_2

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY - USD ($)	COMMON STOCK [Member]	ADDITIONAL PAID-IN CAPITAL [Member]	ACCUMULATED DEFICIT [Member]	Total
Balance at Dec. 31, 2020	$ 20,577	$ 116,216,966	$ (88,037,759)	$ 28,199,784
Balance (in shares) at Dec. 31, 2020	20,577,123
Issuance of common stock, net of fees	$ 2,219	12,576,307		12,578,526
Issuance of common stock, net of fees (in shares)	2,218,874
Stock-based compensation		752,962		752,962
Stock options exercised	$ 2	1,434		1,436
Stock options exercised (in shares)	1,933
Net loss			(5,151,923)	(5,151,923)
Balance at Mar. 31, 2021	$ 22,798	129,547,669	(93,189,682)	36,380,785
Balance (in shares) at Mar. 31, 2021	22,797,930
Balance at Dec. 31, 2021	$ 24,185	139,404,060	(108,060,279)	31,367,966
Balance (in shares) at Dec. 31, 2021	24,185,001
Stock-based compensation		1,065,329		1,065,329
Stock options exercised	$ 139	27,326		27,465
Stock options exercised (in shares)	139,155
Net loss			(7,818,094)	(7,818,094)
Balance at Mar. 31, 2022	$ 24,324	$ 140,496,715	$ (115,878,373)	$ 24,642,666
Balance (in shares) at Mar. 31, 2022	24,324,156

CONDENSED CONSOLIDATED STATEM_3

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($)	3 Months Ended
	Mar. 31, 2022	Mar. 31, 2021
Cash flows from operating activities:
Net loss	$ (7,818,094)	$ (5,151,923)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization	92,490	50,137
Stock-based compensation	1,065,329	752,962
Non-cash lease expense	158,086	0
Change in assets - (increase) decrease:
Receivables	34,753	0
Prepaid expenses and other current assets	216,691	274,851
Change in liabilities - increase (decrease):
Accounts payable and accrued expenses	407,203	432,241
Accounts payable and accrued expenses, related party	(24,540)	312,362
Operating lease liabilities	(85,352)	0
Deferred revenue	30,000,000	0
Net cash provided by (used in) operating activities	24,046,566	(3,329,370)
Cash flows from investing activities:
Purchases of property and equipment	(567,616)	(36,912)
Payments for leasehold improvements	(57,744)	0
Net cash used in investing activities	(625,360)	(36,912)
Cash flows from financing activities:
Net proceeds from sale of common stock		12,578,526
Proceeds from exercise of stock awards	27,465	1,436
Net cash provided by financing activities	27,465	12,579,962
Net increase in cash and cash equivalents	23,448,671	9,213,680
Cash and cash equivalents balance at beginning of period	34,885,274	32,665,874
Cash and cash equivalents balance at end of period	$ 58,333,945	41,879,554
Supplemental disclosures of cash flow information:
Interest paid in cash		0
Income taxes paid in cash		$ 0

ORGANIZATION AND SUMMARY OF SIG

ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES	3 Months Ended
	Mar. 31, 2022
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES	1. ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Description of Business Capricor Therapeutics, Inc., a Delaware corporation (referred to herein as “Capricor Therapeutics” or the “Company” or “we”), is a clinical-stage biotechnology company focused on the development of transformative cell and exosome-based therapeutics for treating Duchenne muscular dystrophy (“DMD”), a rare form of muscular dystrophy which results in muscle degeneration and premature death, and other diseases with high unmet medical needs. 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 multiple drug and vaccine candidates in various stages of development. ​ Basis of Presentation The accompanying unaudited interim condensed consolidated financial statements for Capricor Therapeutics and its wholly-owned subsidiary have been prepared in accordance with generally accepted accounting principles in the United States of America (“U.S. GAAP”) and with the instructions to Form 10-Q and, therefore, do not include all disclosures necessary for a complete presentation of financial position, results of operations and cash flows in conformity with U.S. GAAP. In the Company’s opinion, all adjustments, consisting of normal and recurring adjustments, considered necessary for a fair presentation have been included. The accompanying financial information should be read in conjunction with the financial statements and the notes thereto in the Company’s most recent Annual Report on Form 10-K, as filed with the Securities and Exchange Commission (the “SEC”) on March 11, 2022, from which the December 31, 2021 consolidated balance sheet has been derived. Interim results are not necessarily indicative of the results that may be expected for the year ending December 31, 2022. Certain reclassification of prior period amounts has been made to conform to the current year presentation. Basis of Consolidation Our condensed consolidated financial statements include the accounts of the Company and our wholly-owned subsidiary. All intercompany transactions have been eliminated in consolidation. Liquidity The Company has historically financed its research and development activities as well as operational expenses primarily from equity financings, government grants, and payments from collaboration partners. Cash and cash equivalents as of March 31, 2022 were approximately $58.3 million, compared to approximately $34.9 million as of December 31, 2021. The Company received an upfront payment of $30.0 million from Nippon Shinyaku Co., Ltd., a Japanese corporation, (“Nippon Shinyaku”), in accordance with its Exclusive Commercialization and Distribution Agreement (see Note 8 – “License and Distribution Agreements”). Additionally, the Company has a Common Stock Sales Agreement in place with H.C. Wainwright & Co. LLC ("Wainwright") to create at-the-market equity programs under which the Company, from time to time, sells shares of its common stock (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 research and development activities, 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, potential partnering opportunities, 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 portions of its clinical trial programs. To the extent the Company issues additional equity securities, its existing stockholders would experience substantial dilution. ​ Business Uncertainty Related to the Coronavirus The COVID-19 pandemic has presented a substantial public health and economic challenge around the world. Our business operations and financial condition and results have been impacted to varying degrees, and we expect the impact will continue in future quarters. ​ We are continuing to assess and plan our development for the ongoing and potential impact of the COVID-19 pandemic on our business, operations and financial condition and results. Despite careful tracking and planning, however, we are unable to accurately predict the extent of the impact of the pandemic on our business, results of operations and financial condition due to the uncertainty of future developments involving the pandemic and its impact on our employees and operations. The full extent to which the COVID-19 pandemic will directly or indirectly impact our business, results of operations and financial condition will depend on future developments that are highly uncertain and cannot be accurately predicted, including new information that may emerge concerning COVID-19, the actions taken to contain it or treat its impact and the economic impact on local, regional, national and international markets. ​ In addition, 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 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 submitted for the Employee Retention Credit (“ERC”), a credit against certain payroll taxes allowed to an eligible employer for qualifying wages, was established by the CARES Act. The Company recorded $548,207 in ERC as other income for the year ended December 31, 2021, of which $356,997 is recorded as a receivable as of March 31, 2022 and December 31, 2021. The Company may submit for additional credits under the CARES Act in the future, as applicable. ​ 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 condensed consolidated financial statements. Estimates also affect the reported amounts of revenues and expenses during the reporting period. The most sensitive estimates relate to 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. 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 seven years Property and equipment, net consisted of the following: ​ ​ ​ ​ ​ ​ ​ ​ ​ March 31, December 31, ​ 2022 2021 Furniture and fixtures ​ $ 104,069 ​ $ 43,123 Laboratory equipment ​ 2,963,575 ​ 2,475,543 Leasehold improvements ​ 91,486 ​ 33,742 ​ ​ 3,159,130 ​ 2,552,408 Less accumulated depreciation ​ (830,565) ​ (756,712) Property and equipment, net ​ $ 2,328,565 ​ $ 1,795,696 ​ Leases ASC Topic 842, “Leases” (“ASC 842”), as adopted in the first quarter of 2019, requires lessees to recognize most leases on the balance sheet with a corresponding right-to-use asset (“ROU asset”). ROU assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent the Company’s obligation to make lease payments arising from the lease. The assets and lease liabilities are recognized at the lease commencement date based on the estimated present value of fixed lease payments over the lease term. ROU assets are evaluated for impairment using the long-lived assets impairment guidance. Leases will be classified as financing or operating, which will drive the expense recognition pattern. The Company elects to exclude short-term leases if and when the Company has them. The Company leases office and laboratory space, all of which are operating leases (see Note 7 - “Commitments and Contingencies”). Most leases include the option to renew and the exercise of the renewal options is at the Company’s sole discretion. Options to renew a lease are not included in the Company’s assessment unless there is reasonable certainty that the Company will renew. In addition, the Company’s lease agreements generally do not contain any residual value guarantees or restrictive covenants. 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. For real estate leases, the Company has elected the practical expedient under ASC 842 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 The company applies ASU 606, Revenue from Contracts with Customers Clinical Development Income Income is recorded over time as the Company satisfies distinct performance obligations outlined in the contracts with the customer or partner. The transaction price of the income includes the upfront payment. Additional payments due upon achievement of milestones and targets as defined in the contract (see Note 8 – “License and Distribution Agreements”), may increase the transaction price to be recognized. Grant Income 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 grant award (the “CIRM Award”) from the California Institute for Regenerative Medicine (“CIRM”) 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 research and development (“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. 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 Net Income (Loss) Net 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 net loss was approximately $7.8 million and $5.2 million for the three months ended March 31, 2022 and 2021, respectively. Clinical Trial Expense As part of the process of preparing our condensed 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, 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 discussions 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. 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 and comprehensive loss. 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. As of March 31, 2022 and 2021, warrants and options to purchase 5,674,191 and 3,793,237 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 three months ended March 31, 2022 and 2021. 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. ​ Carrying amounts reported in the balance sheet of cash and cash equivalents, 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 2021, the FASB issued ASU 2021-10, Government Assistance (Topic 832) 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	3 Months Ended
	Mar. 31, 2022
NOTE PAYABLE
NOTE PAYABLE	2. NOTE PAYABLE Paycheck Protection Program Loan In the second quarter of 2020, Capricor applied to City National Bank (“CNB”) under the SBA Paycheck Protection Program of the CARES Act for the Loan in the amount of $318,160. The Loan was approved and Capricor received the Loan proceeds, which were 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”), had a two-year The Company submitted a loan forgiveness application to CNB in the first quarter of 2021. The Company was notified in April 2021 by the SBA that the Loan was forgiven. The Company recognized a gain on forgiveness in the second quarter of 2021.

STOCKHOLDER'S EQUITY

STOCKHOLDER'S EQUITY	3 Months Ended
	Mar. 31, 2022
STOCKHOLDER'S EQUITY
STOCKHOLDER'S EQUITY	3. STOCKHOLDER’S EQUITY ATM Programs and Other Offerings The Company has established multiple “at-the-market” (“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 “May 2020 ATM Program” and the “June 2021 ATM Program” based on when each program was initiated. 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. From May 4, 2020 through June 21, 2021, the Company sold an aggregate of 6,027,852 shares of common stock under the May 2020 ATM Program at an average price of approximately $6.15 per share for gross proceeds of approximately $37.1 million. The Company paid cash commissions on the gross proceeds, plus reimbursement of expenses to Wainwright, as well as legal and accounting fees in the aggregate amount of approximately $1.2 million. As of June 21, 2021, the May 2020 ATM Program expired and was replaced with the June 2021 ATM Program described below. June 2021 ATM Program On June 21, 2021, the Company initiated the June 2021 ATM Program. The Company filed the June 2021 ATM Program with an aggregate offering price of up to $75.0 million. From June 21, 2021 through September 30, 2021, the Company sold an aggregate of 1,267,475 shares of common stock under the June 2021 ATM Program at an average price of approximately $5.89 per share for gross proceeds of approximately $7.5 million. The Company paid cash commissions on the gross proceeds, plus reimbursement of expenses to Wainwright, as well as legal and accounting fees in the aggregate amount of approximately $0.3 million. No shares were sold in the fourth quarter of 2021 or the first quarter of 2022 under the June 2021 ATM Program. Outstanding Shares At March 31, 2022, the Company had 24,324,156 shares of common stock issued and outstanding

STOCK AWARDS, WARRANTS AND OPTI

STOCK AWARDS, WARRANTS AND OPTIONS	3 Months Ended
	Mar. 31, 2022
STOCK AWARDS, WARRANTS AND OPTIONS
STOCK AWARDS, WARRANTS AND OPTIONS	4. STOCK AWARDS, WARRANTS AND OPTIONS Warrants The following table summarizes all warrant activity for the three months ended March 31, 2022: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Weighted Average ​ Warrants Exercise Price Outstanding at December 31, 2021 105,782 ​ $ 1.37 Granted ​ — ​ ​ — Exercised ​ — ​ ​ — Outstanding at March 31, 2022 105,782 ​ $ 1.37 ​ The following table summarizes all outstanding warrants to purchase shares of the Company’s common stock: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Warrants Outstanding ​ ​ ​ ​ ​ ​ ​ ​ ​ March 31, ​ December 31, ​ Exercise Price ​ Expiration Type Grant Date 2022 2021 per Share Date ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Common Warrants ​ 12/19/2019 ​ 40,782 40,782 ​ $ 1.10 ​ 12/19/2024 Common Warrants ​ 3/27/2020 ​ 65,000 65,000 ​ $ 1.5313 ​ 3/27/2025 ​ ​ ​ ​ 105,782 ​ 105,782 ​ ​ ​ ​ ​ ​ Stock Options The Company’s Board of Directors (the “Board”) has approved five 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”), (iv) the 2020 Equity Incentive Plan (the “2020 Plan”), and (v) the 2021 Equity Incentive Plan (the “2021 Plan”). In September 2012, the Board approved the 2012 Non-Employee Director Plan, which authorized 269,731 shares of common stock, reserved for issuance of non-qualified options to members of the Board who are not employees of the Company. In November 2012, the Board approved the 2012 Plan, which superseded the 2006 Stock Option Plan. Under the 2012 Plan, the Company may grant stock options, stock appreciation rights, restricted stock awards, and performance/unit share awards to employees, consultants and other service providers. Pursuant to the 2012 Plan, inclusive of annual evergreen provisions and amendments, the Company is authorized to issue 710,142 shares of common stock. In June 2020, the Company’s stockholders approved the 2020 Equity Incentive Plan (the “2020 Plan”), which authorized 2,500,000 shares of common stock to be issued and allows for the grant of stock options as well as other forms of equity-based compensation. Pursuant to the “evergreen” provision, on January 1, 2021, 823,084 shares were added under the 2020 Plan. Upon approval of the 2021 Plan on June 11, 2021, no new shares have been or will be added to the share reserve under the 2020 Plan pursuant to its “evergreen” provisions. In June 2021, the Company’s stockholders approved the 2021 Plan, which authorized 3,500,000 shares of common stock reserved under the 2021 Plan for the issuance of stock awards. The number of shares available for issuance under the 2021 Plan shall be automatically increased on January 1 of each year, commencing with January 1, 2022, by an amount equal to 5% of the outstanding shares of Common Stock as of the last day of the immediately preceding fiscal year. On January 1, 2022, 1,209,250 shares were added under the 2021 Plan. As of March 31, 2022, 3,080,031 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. 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. 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 The estimated weighted average fair value of the options granted during the three months ended March 31, 2022 and 2021 were approximately $2.87 and $3.26 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 three months ended March 31, 2022 and 2021: ​ ​ ​ ​ ​ ​ ​ ​ March 31, 2022 March 31, 2021 Expected volatility 123 % 124 % Expected term 6 years 6 years ​ Dividend yield 0 % 0 % Risk-free interest rates 1.5 - 1.7 % 0.5 % ​ Employee and non-employee stock-based compensation expense was as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Three months ended March 31, ​ ​ 2022 2021 ​ ​ ​ ​ ​ ​ ​ ​ ​ General and administrative ​ $ 857,583 ​ $ 633,120 ​ Research and development ​ 207,746 ​ 119,842 ​ Total ​ $ 1,065,329 ​ $ 752,962 ​ ​ 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. As of March 31, 2022, the total unrecognized fair value compensation cost related to non-vested stock options was approximately $12.4 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 three months ended March 31, 2022: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Number of ​ Weighted Average ​ Aggregate ​ Options Exercise Price Intrinsic Value Outstanding at December 31, 2021 3,793,824 ​ $ 2.68 $ 3,104,631 Granted 2,044,370 ​ 3.28 ​ Exercised (224,316) ​ 1.39 $ 431,485 Expired/Cancelled (45,469) ​ 4.19 ​ Outstanding at March 31, 2022 5,568,409 ​ $ 2.94 ​ $ 4,157,717 Exercisable at March 31, 2022 1,653,835 ​ $ 2.21 ​ $ 2,321,841 ​ 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	3 Months Ended
	Mar. 31, 2022
CONCENTRATIONS
CONCENTRATIONS	5. CONCENTRATIONS Cash Concentration The Company has historically maintained checking accounts at two financial institutions. These accounts are each insured by the Federal Deposit Insurance Corporation for up to $250,000. Historically, the Company has not experienced any significant losses in such accounts and believes it is not exposed to any significant credit risk on cash, cash equivalents and marketable securities. As of March 31, 2022, the Company maintained approximately $57.9 million of uninsured deposits.

GOVERNMENT GRANT AWARDS

GOVERNMENT GRANT AWARDS	3 Months Ended
	Mar. 31, 2022
GOVERNMENT GRANT AWARDS
GOVERNMENT GRANT AWARDS	6. GOVERNMENT GRANT AWARDS CIRM Grant Award (HOPE) On June 16, 2016, Capricor entered into the CIRM Award with CIRM in the amount of approximately $3.4 million to fund, in part, Capricor’s Phase I/II HOPE-Duchenne clinical trial investigating CAP-1002 for the treatment of Duchenne muscular dystrophy-associated cardiomyopathy. Pursuant to terms of the CIRM Award, the disbursements were tied to the achievement of specified operational milestones. In addition, the terms of the CIRM Award included a co-funding requirement pursuant to which Capricor was required to spend approximately $2.3 million of its own capital to fund the CIRM funded research project. The CIRM Award is further subject to the conditions and requirements set forth in the CIRM Grants Administration Policy for Clinical Stage Projects. Such requirements include, without limitation, the filing of quarterly and annual reports with CIRM, the sharing of intellectual property pursuant to Title 17, California Code of Regulations (CCR) Sections 100600-100612, and the sharing with the State of California of a fraction of licensing revenue received from a CIRM funded research project and net commercial revenue from a commercialized product which resulted from the CIRM funded research as set forth in Title 17, CCR Section 100608. The maximum royalty on net commercial revenue that Capricor may be required to pay to CIRM is equal to nine times the total amount awarded and paid to Capricor. 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 March 31, 2022, Capricor’s liability balance for the CIRM Award was approximately $3.4 million.

COMMITMENTS AND CONTINGENCIES

COMMITMENTS AND CONTINGENCIES	3 Months Ended
	Mar. 31, 2022
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES	7. COMMITMENTS AND CONTINGENCIES Short-Term Operating 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 a month-to-month lease amendment with the Bubble Real Estate. The monthly lease payment was $13,073. In November 2021, Capricor entered into an amendment to the lease pursuant to which the square footage of the premises was reduced with a monthly lease payment of $5,548 per month commencing November 1, 2021. The lease is terminable by either party upon 90 days’ written notice to the other party. Capricor leases facilities from Cedars-Sinai Medical Center (“CSMC”), a related party (see Note 9 – “Related Party Transactions”), 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 Expenses incurred under short-term operating leases to unrelated parties for the three months ended March 31, 2022 and 2021 were $17,394 and $39,219, respectively. Expenses incurred under short-term operating leases to related parties for the three months ended March 31, 2022 and 2021 were $32,120 and $47,415, respectively. Long-Term Operating Leases On July 16, 2021, the Company entered into a lease agreement with Altman Investment Co, LLC (“Altman”) for 9,396 square feet of office and laboratory space located at 10865 Road to the Cure, Suite 150, in San Diego, California. Under the terms of the lease, the base rent will be approximately $0.6 million per year, which rent is subject to a 3.0% annual rent increase during the initial lease term, plus certain operating expenses and taxes. This lease term commenced on October 1, 2021 and will expire on October 15, 2026. The lease contains an option for Capricor to renew for an additional term of five years. The Company estimates the aggregate ROU asset and liability to be approximately $2.7 million relating to this lease as of the commencement date of October 1, 2021 Effective November 1, 2021, the Company entered into a vivarium agreement with Explora BioLabs, Inc. (“Explora”) for vivarium space and services. Under the terms of the agreement, the base rent will be $4,021 per month for an exclusive large vivarium room. The lease term is for one-year one-year 60-day five years The long-term real estate operating leases are included in “lease right-of-use assets, net” on the Company’s condensed consolidated balance sheet and represent the Company’s right-to-use the underlying assets for the lease term. The Company’s obligation to make lease payments are included in “lease liabilities, current” and “lease liabilities, net of current” on the Company’s condensed consolidated balance sheet. The table below excludes short-term operating leases. The following table summarizes maturities of lease liabilities and the reconciliation of lease liabilities as of March 31, 2022: ​ ​ ​ ​ ​ 2022 ​ $ 407,029 2023 ​ ​ 656,678 2024 ​ ​ 674,931 2025 ​ ​ 693,732 2026 ​ ​ 562,627 Total minimum lease payments ​ ​ 2,994,997 Less: imputed interest ​ ​ (190,426) Total operating lease liabilities ​ $ 2,804,571 Included in the condensed consolidated balance sheet: ​ ​ ​ Current portion of lease liabilities ​ $ 498,374 Lease liabilities, net of current ​ ​ 2,306,197 Total operating lease liabilities ​ $ 2,804,571 ​ ​ ​ ​ Other Information: ​ ​ ​ Weighted average remaining lease term ​ ​ 4.54 years Weighted average discount rate ​ ​ 2.75% ​ Long-term operating lease costs recognized under ASC 842 for the three months ended March 31, 2022 were $158,084 and zero, respectively. Long-term operating lease payments for the three months ended March 31, 2022 were $85,352 and zero, 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 During the normal course of business, disputes with vendors may arise. If a vendor disputed 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 specific products (see Note 8 – “License and Distribution Agreements”). Additionally, the Company is a party to various agreements with contract research and/or manufacturing organizations that generally provide for termination upon notice, with the exact amounts owed in the event of termination to be based on the timing of termination and the terms of the agreement. Employee Severances 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, in the event of termination of their employment, subject to certain conditions. No liability has been recorded as of March 31, 2022.

LICENSE AGREEMENTS

LICENSE AGREEMENTS	3 Months Ended
	Mar. 31, 2022
LICENSE AGREEMENTS
LICENSE AGREEMENTS	8. LICENSE AND DISTRIBUTION AGREEMENTS Intellectual Property Rights for 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 (the “University of Rome”), Johns Hopkins University (“JHU”) and CSMC. Capricor has also entered into an exclusive license agreement for intellectual property rights related to exosomes with CSMC and JHU as well as 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 (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 (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 (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 the Phase I study that was owed to JHU pursuant to the terms of the JHU License Agreement. In March 2022, Capricor paid the $250,000 development milestone related to the Phase 2 study pursuant to the terms of the JHU License Agreement. The next milestone is triggered upon successful completion of a full Phase 3 study for which a payment of $500,000 will be 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 (the “JHU Serology License Agreement”), effective January 6, 2021, 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. The JHU Serology License Agreement is due to expire July 2022 and at this time, Capricor does not intend to convert it to an exclusive license or extend the JHU Serology License Agreement. License Agreement for Exosome-based Vaccines and Therapeutics Capricor and JHU entered into an Exclusive License Agreement (the “JHU Exosome License Agreement”) effective April 28, 2021 for its co-owned interest in certain intellectual property rights related to exosome-mRNA vaccines and therapeutics. The JHU Exosome License Agreement provides for the grant of an exclusive, world-wide, royalty-bearing license of JHU’s co-owned rights by JHU 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. Pursuant to the JHU Exosome License Agreement, JHU was paid an upfront license fee of $10,000 and Capricor has agreed to reimburse JHU for certain fees and costs incurred in connection with the prosecution of certain patent rights. Additionally, Capricor is required to meet certain development milestones for which a milestone payment fee shall be due and is obligated to pay low single-digit royalties on sales of royalty-bearing products as well as a double-digit percentage of any non-royalty consideration received from any sublicenses, subject to certain exclusions. The above-mentioned royalties are subject to reduction in the event Capricor becomes obligated to pay royalties on one or more third party patents as a requirement to make or sell a licensed product. In addition, Capricor will, beginning with the third year of the JHU Exosome License Agreement, be obligated to pay JHU a minimum annual royalty which is non-refundable but will be credited against royalties incurred by Capricor for the year in which the minimum annual royalty becomes due. The JHU Exosome License Agreement will, unless sooner terminated, continue in each country until the date of expiration of the last to expire patent included within the patent rights in that country, or if no patents issue, then for 20 years. The JHU Exosome License Agreement may be terminated by Capricor upon 90 days’ written notice in its discretion and with 60 days’ notice with respect to any particular patent or application or as to any particular licensed product. The JHU Exosome License Agreement may also be terminated by either party if it fails to perform or otherwise breaches any of its obligations and fails to cure such breach within a 60-day Cedars-Sinai Medical Center License Agreements License Agreement for CDCs On January 4, 2010, Capricor entered into an Exclusive License Agreement with CSMC (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 (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, June 20, 2018, and July 27, 2021, 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, among other things. 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 (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, August 28, 2020, and March 19, 2021, Capricor and CSMC entered into a number of amendments to the Exosomes License Agreement. Collectively, 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 (the “SRA”), with JHU pursuant to which researchers in the lab of Dr. Stephen Gould have been performing certain research activities in connection with our exosomes program. Pursuant to the SRA, we funded certain research activities and have the right to negotiate for exclusive or non-exclusive rights to intellectual property that may result from such research activities. This SRA expired in accordance with its terms on March 31, 2022. ​ Cell Line License Agreement with Life Technologies On March 7, 2022, Capricor entered into a non-exclusive cell line license agreement with Life Technologies Corporation, a subsidiary of Thermo Fisher Scientific, Inc., for the supply of certain cells which we will use to support the development of our exosomes platform. An initial license fee payment was made in the first quarter of 2022 and additional milestone fees may become due on the progress of our development program. ​ Commercialization and Distribution Agreement On January 24, 2022, Capricor entered into an Exclusive Commercialization and Distribution Agreement (the “NS Distribution Agreement”) with Nippon Shinyaku. Under the terms of the NS Distribution Agreement, Capricor appointed Nippon Shinyaku as its exclusive distributor in the United States for CAP-1002, the Company’s lead product candidate, for the treatment of DMD. Under the terms of the NS Distribution Agreement, Capricor will be responsible for the conduct of the HOPE-3 trial as well as the manufacturing of CAP-1002. Nippon Shinyaku will be responsible for the distribution of CAP-1002 in the United States. Pursuant to the NS Distribution Agreement, Capricor has the obligation to sell commercial product to Nippon Shinyaku, subject to regulatory approval, and in addition will have the right to receive a meaningful, double-digit share of product revenue and additional development and sales-based milestone payments, if achieved. In the first quarter of 2022, Capricor received an upfront payment of $30.0 million. Pursuant to the terms of the NS Distribution Agreement, there are potential additional sales and development milestone payments of up to $705.0 million. The Company has evaluated the NS Distribution Agreement in accordance with ASU 606, Revenue from Contracts with Customers The Company determined the initial transaction price to be recognized totaled $30.0 million, which is the upfront payment. The Company has excluded any future milestone payments from the transaction price due to uncertainty. The Company has allocated the total $30.0 million initial transaction price to its one distinct performance obligation, the completion of the HOPE-3, Phase 3 clinical study. Revenue will be recognized using a proportional performance method in relation to the completion of the HOPE-3 clinical study to determine the extent of progress towards completion. Under this method, the transaction price is recognized over the contract’s entire performance period using patient visit status relative to total estimate amount of patient visits. No revenue has been recognized as of March 31, 2022 as no patient visits have been completed. As of March 31, 2022, the Company recorded approximately $9.7 million as current deferred revenue and approximately $20.3 million as deferred revenue, net of current portion on the Company’s Condensed Consolidated Balance Sheets. The Company plans to begin recognizing this revenue beginning in the second quarter of 2022.

RELATED PARTY TRANSACTIONS

RELATED PARTY TRANSACTIONS	3 Months Ended
	Mar. 31, 2022
RELATED PARTY TRANSACTIONS
RELATED PARTY TRANSACTIONS	9. RELATED PARTY TRANSACTIONS Lease and Sub-Lease Agreement As noted above, Capricor is a party to lease agreements with CSMC (see Note 7 – “Commitments and Contingencies”), and CSMC has served as an investigative site in Capricor’s clinical trials. Additionally, Dr. Eduardo Marbán, who is a stockholder of Capricor Therapeutics and has participated from time to time as an observer at the Company’s meetings of the Board of Directors, is the Director of the Cedars-Sinai Smidt Heart Institute, and co-founder of Capricor. 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. Additionally, in January 2022, Dr. Eduardo Marbán was granted an additional option grant to purchase 50,000 shares of the Company’s common stock. Payables to Related Party As of March 31, 2022 and December 31, 2021, the Company had accounts payable and accrued expenses to related parties totaling $574,848 and $599,388, respectively. CSMC accounts for $574,848 and $589,388 of the total accounts payable and accrued expense to related parties as of March 31, 2022 and December 31, 2021, respectively. CSMC expenses relate to research and development costs, clinical trial costs, license and patent fees, and facilities rent. During the three months ended March 31, 2022 and 2021, the Company paid CSMC approximately $66,600 and $57,700, respectively, for such costs. Related Party Clinical Trials Capricor provided 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 provided the necessary number of doses of cells and received a total of approximately $1.7 million of monetary compensation. For the three months ended March 31, 2021, the Company recognized approximately $40,800 as revenue. No

ORGANIZATION AND SUMMARY OF S_2

ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies)	3 Months Ended
	Mar. 31, 2022
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Basis of Presentation	Basis of Presentation The accompanying unaudited interim condensed consolidated financial statements for Capricor Therapeutics and its wholly-owned subsidiary have been prepared in accordance with generally accepted accounting principles in the United States of America (“U.S. GAAP”) and with the instructions to Form 10-Q and, therefore, do not include all disclosures necessary for a complete presentation of financial position, results of operations and cash flows in conformity with U.S. GAAP. In the Company’s opinion, all adjustments, consisting of normal and recurring adjustments, considered necessary for a fair presentation have been included. The accompanying financial information should be read in conjunction with the financial statements and the notes thereto in the Company’s most recent Annual Report on Form 10-K, as filed with the Securities and Exchange Commission (the “SEC”) on March 11, 2022, from which the December 31, 2021 consolidated balance sheet has been derived. Interim results are not necessarily indicative of the results that may be expected for the year ending December 31, 2022.
Reclassification	Certain reclassification of prior period amounts has been made to conform to the current year presentation.
Basis of Consolidation	Basis of Consolidation Our condensed consolidated financial statements include the accounts of the Company and our wholly-owned subsidiary. All intercompany transactions have been eliminated in consolidation.
Liquidity	Liquidity The Company has historically financed its research and development activities as well as operational expenses primarily from equity financings, government grants, and payments from collaboration partners. Cash and cash equivalents as of March 31, 2022 were approximately $58.3 million, compared to approximately $34.9 million as of December 31, 2021. The Company received an upfront payment of $30.0 million from Nippon Shinyaku Co., Ltd., a Japanese corporation, (“Nippon Shinyaku”), in accordance with its Exclusive Commercialization and Distribution Agreement (see Note 8 – “License and Distribution Agreements”). Additionally, the Company has a Common Stock Sales Agreement in place with H.C. Wainwright & Co. LLC ("Wainwright") to create at-the-market equity programs under which the Company, from time to time, sells shares of its common stock (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 research and development activities, 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, potential partnering opportunities, 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 portions of its clinical trial programs. To the extent the Company issues additional equity securities, its existing stockholders would experience substantial dilution.
Business Uncertainty Related to the Coronavirus	Business Uncertainty Related to the Coronavirus The COVID-19 pandemic has presented a substantial public health and economic challenge around the world. Our business operations and financial condition and results have been impacted to varying degrees, and we expect the impact will continue in future quarters. ​ We are continuing to assess and plan our development for the ongoing and potential impact of the COVID-19 pandemic on our business, operations and financial condition and results. Despite careful tracking and planning, however, we are unable to accurately predict the extent of the impact of the pandemic on our business, results of operations and financial condition due to the uncertainty of future developments involving the pandemic and its impact on our employees and operations. The full extent to which the COVID-19 pandemic will directly or indirectly impact our business, results of operations and financial condition will depend on future developments that are highly uncertain and cannot be accurately predicted, including new information that may emerge concerning COVID-19, the actions taken to contain it or treat its impact and the economic impact on local, regional, national and international markets. ​ In addition, 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 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 submitted for the Employee Retention Credit (“ERC”), a credit against certain payroll taxes allowed to an eligible employer for qualifying wages, was established by the CARES Act. The Company recorded $548,207 in ERC as other income for the year ended December 31, 2021, of which $356,997 is recorded as a receivable as of March 31, 2022 and December 31, 2021. The Company may submit for additional credits under the CARES Act in the future, as applicable.
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 condensed consolidated financial statements. Estimates also affect the reported amounts of revenues and expenses during the reporting period. The most sensitive estimates relate to 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.
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 seven years Property and equipment, net consisted of the following: ​ ​ ​ ​ ​ ​ ​ ​ ​ March 31, December 31, ​ 2022 2021 Furniture and fixtures ​ $ 104,069 ​ $ 43,123 Laboratory equipment ​ 2,963,575 ​ 2,475,543 Leasehold improvements ​ 91,486 ​ 33,742 ​ ​ 3,159,130 ​ 2,552,408 Less accumulated depreciation ​ (830,565) ​ (756,712) Property and equipment, net ​ $ 2,328,565 ​ $ 1,795,696 ​
Leases	Leases ASC Topic 842, “Leases” (“ASC 842”), as adopted in the first quarter of 2019, requires lessees to recognize most leases on the balance sheet with a corresponding right-to-use asset (“ROU asset”). ROU assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent the Company’s obligation to make lease payments arising from the lease. The assets and lease liabilities are recognized at the lease commencement date based on the estimated present value of fixed lease payments over the lease term. ROU assets are evaluated for impairment using the long-lived assets impairment guidance. Leases will be classified as financing or operating, which will drive the expense recognition pattern. The Company elects to exclude short-term leases if and when the Company has them. The Company leases office and laboratory space, all of which are operating leases (see Note 7 - “Commitments and Contingencies”). Most leases include the option to renew and the exercise of the renewal options is at the Company’s sole discretion. Options to renew a lease are not included in the Company’s assessment unless there is reasonable certainty that the Company will renew. In addition, the Company’s lease agreements generally do not contain any residual value guarantees or restrictive covenants. 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. For real estate leases, the Company has elected the practical expedient under ASC 842 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 The company applies ASU 606, Revenue from Contracts with Customers Clinical Development Income Income is recorded over time as the Company satisfies distinct performance obligations outlined in the contracts with the customer or partner. The transaction price of the income includes the upfront payment. Additional payments due upon achievement of milestones and targets as defined in the contract (see Note 8 – “License and Distribution Agreements”), may increase the transaction price to be recognized. Grant Income 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 grant award (the “CIRM Award”) from the California Institute for Regenerative Medicine (“CIRM”) 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 research and development (“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.
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
Net Income (Loss)	Net Income (Loss) Net 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 net loss was approximately $7.8 million and $5.2 million for the three months ended March 31, 2022 and 2021, respectively.
Clinical Trial Expense	Clinical Trial Expense As part of the process of preparing our condensed 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, 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 discussions 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.
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 and comprehensive loss. 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. As of March 31, 2022 and 2021, warrants and options to purchase 5,674,191 and 3,793,237 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 three months ended March 31, 2022 and 2021.
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. ​ Carrying amounts reported in the balance sheet of cash and cash equivalents, 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 2021, the FASB issued ASU 2021-10, Government Assistance (Topic 832) 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)	3 Months Ended
	Mar. 31, 2022
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Schedule of property, plant and equipment	Property and equipment, net consisted of the following: ​ ​ ​ ​ ​ ​ ​ ​ ​ March 31, December 31, ​ 2022 2021 Furniture and fixtures ​ $ 104,069 ​ $ 43,123 Laboratory equipment ​ 2,963,575 ​ 2,475,543 Leasehold improvements ​ 91,486 ​ 33,742 ​ ​ 3,159,130 ​ 2,552,408 Less accumulated depreciation ​ (830,565) ​ (756,712) Property and equipment, net ​ $ 2,328,565 ​ $ 1,795,696

STOCK AWARDS, WARRANTS AND OP_2

STOCK AWARDS, WARRANTS AND OPTIONS (Tables)	3 Months Ended
	Mar. 31, 2022
Warrant [Member]
Summary of warrant activity	The following table summarizes all warrant activity for the three months ended March 31, 2022: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Weighted Average ​ Warrants Exercise Price Outstanding at December 31, 2021 105,782 ​ $ 1.37 Granted ​ — ​ ​ — Exercised ​ — ​ ​ — Outstanding at March 31, 2022 105,782 ​ $ 1.37 ​
Schedule of outstanding warrants	The following table summarizes all outstanding warrants to purchase shares of the Company’s common stock: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Warrants Outstanding ​ ​ ​ ​ ​ ​ ​ ​ ​ March 31, ​ December 31, ​ Exercise Price ​ Expiration Type Grant Date 2022 2021 per Share Date ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Common Warrants ​ 12/19/2019 ​ 40,782 40,782 ​ $ 1.10 ​ 12/19/2024 Common Warrants ​ 3/27/2020 ​ 65,000 65,000 ​ $ 1.5313 ​ 3/27/2025 ​ ​ ​ ​ 105,782 ​ 105,782 ​ ​ ​ ​ ​
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 three months ended March 31, 2022 and 2021: ​ ​ ​ ​ ​ ​ ​ ​ March 31, 2022 March 31, 2021 Expected volatility 123 % 124 % Expected term 6 years 6 years ​ Dividend yield 0 % 0 % Risk-free interest rates 1.5 - 1.7 % 0.5 %
Schedule of employee and non-employee stock based compensation expense	Employee and non-employee stock-based compensation expense was as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Three months ended March 31, ​ ​ 2022 2021 ​ ​ ​ ​ ​ ​ ​ ​ ​ General and administrative ​ $ 857,583 ​ $ 633,120 ​ Research and development ​ 207,746 ​ 119,842 ​ Total ​ $ 1,065,329 ​ $ 752,962 ​
Schedule of employee and non-employee stock option	The following is a schedule summarizing employee and non-employee stock option activity for the three months ended March 31, 2022: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Number of ​ Weighted Average ​ Aggregate ​ Options Exercise Price Intrinsic Value Outstanding at December 31, 2021 3,793,824 ​ $ 2.68 $ 3,104,631 Granted 2,044,370 ​ 3.28 ​ Exercised (224,316) ​ 1.39 $ 431,485 Expired/Cancelled (45,469) ​ 4.19 ​ Outstanding at March 31, 2022 5,568,409 ​ $ 2.94 ​ $ 4,157,717 Exercisable at March 31, 2022 1,653,835 ​ $ 2.21 ​ $ 2,321,841

COMMITMENTS AND CONTINGENCIES (

COMMITMENTS AND CONTINGENCIES (Tables)	3 Months Ended
	Mar. 31, 2022
COMMITMENTS AND CONTINGENCIES
Schedule of Future Minimum Rental Payments	​ ​ ​ ​ ​ 2022 ​ $ 407,029 2023 ​ ​ 656,678 2024 ​ ​ 674,931 2025 ​ ​ 693,732 2026 ​ ​ 562,627 Total minimum lease payments ​ ​ 2,994,997 Less: imputed interest ​ ​ (190,426) Total operating lease liabilities ​ $ 2,804,571 Included in the condensed consolidated balance sheet: ​ ​ ​ Current portion of lease liabilities ​ $ 498,374 Lease liabilities, net of current ​ ​ 2,306,197 Total operating lease liabilities ​ $ 2,804,571 ​ ​ ​ ​ Other Information: ​ ​ ​ Weighted average remaining lease term ​ ​ 4.54 years Weighted average discount rate ​ ​ 2.75%

ORGANIZATION AND SUMMARY OF S_4

ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Property and Equipment (Details) - USD ($)	Mar. 31, 2022	Dec. 31, 2021
Property, Plant and Equipment, Gross	$ 3,159,130	$ 2,552,408
Less accumulated depreciation	(830,565)	(756,712)
Property and equipment, net	2,328,565	1,795,696
Furniture and fixtures
Property, Plant and Equipment, Gross	104,069	43,123
Laboratory equipment
Property, Plant and Equipment, Gross	2,963,575	2,475,543
Leasehold improvements
Property, Plant and Equipment, Gross	$ 91,486	$ 33,742

ORGANIZATION AND SUMMARY OF S_5

ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Additional Information (Details) - USD ($)	3 Months Ended		12 Months Ended
	Mar. 31, 2022	Mar. 31, 2021	Dec. 31, 2021
Accounting Policies [Line Items]
Cash and cash equivalents	$ 58,333,945		$ 34,885,274
Milestone payment received	30,000,000	$ 0
Receivables under "ERC"	356,997		356,997
Depreciation	92,490	49,054
Research and development	5,115,699	3,296,322
Comprehensive loss	$ 7,800,000	$ 5,200,000
Antidilutive securities	5,674,191	3,793,237
Other income
Accounting Policies [Line Items]
Revenue recognized under "ERC"			$ 548,207
Minimum
Accounting Policies [Line Items]
Estimated useful lives (in years)	5 years
Maximum
Accounting Policies [Line Items]
Estimated useful lives (in years)	7 years

NOTE PAYABLE (Details)

NOTE PAYABLE (Details) - Paycheck Protection Program Loan	Apr. 29, 2020USD ($)
Debt Instrument [Line Items]
Amount of loan applied	$ 318,160
Debt term	2 years
Bears interest rate, percentage	1.00%

STOCKHOLDER'S EQUITY (Details)

STOCKHOLDER'S EQUITY (Details) - USD ($)	Jun. 22, 2021	May 04, 2020	Mar. 31, 2022	Sep. 30, 2021	Mar. 31, 2021	Jun. 21, 2021	Dec. 31, 2021
Class of Stock [Line Items]
Commission rate on sale price per share			3.00%
Gross proceeds from sale of common stock					$ 12,578,526
Common stock, shares issued			24,324,156				24,185,001
Common stock, shares outstanding			24,324,156				24,185,001
May 2020 ATM Program
Class of Stock [Line Items]
Maximum aggregate offering price		$ 40,000,000
Number of common stock shares issued						6,027,852
Average price						$ 6.15
Gross proceeds from sale of common stock						$ 37,100,000
Issuance costs						$ 1,200,000
June 2021 ATM Program
Class of Stock [Line Items]
Maximum aggregate offering price	$ 75,000,000
Number of common stock shares issued				1,267,475
Average price				$ 5.89
Gross proceeds from sale of common stock				$ 7,500,000
Issuance costs				$ 300,000

STOCK AWARDS, WARRANTS AND OP_3

STOCK AWARDS, WARRANTS AND OPTIONS - Warrants (Details)	Mar. 31, 2022$ / sharesshares
STOCK AWARDS, WARRANTS AND OPTIONS
Warrants Outstanding at Beginning | shares	105,782
Warrants Outstanding at Ending | shares	105,782
Weighted Average Exercise Price Outstanding at Beginning | $ / shares	$ 1.37
Weighted Average Exercise Price Outstanding at Ending | $ / shares	$ 1.37

STOCK AWARDS, WARRANTS AND OP_4

STOCK AWARDS, WARRANTS AND OPTIONS - Outstanding Warrants (Details) - $ / shares	3 Months Ended
	Mar. 31, 2022	Dec. 31, 2021
Class of Warrant or Right [Line Items]
Warrants Outstanding	105,782	105,782
Common Warrants with Expiration on December 2024 One
Class of Warrant or Right [Line Items]
Grant Date	Dec. 19, 2019
Warrants Outstanding	40,782	40,782
Exercise Price per Share	$ 1.10
Expiration Date	Dec. 19, 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	65,000
Exercise Price per Share	$ 1.5313
Expiration Date	Mar. 27, 2025

STOCK AWARDS, WARRANTS AND OP_5

STOCK AWARDS, WARRANTS AND OPTIONS - Assumptions (Details)	3 Months Ended
	Mar. 31, 2022	Mar. 31, 2021
STOCK AWARDS, WARRANTS AND OPTIONS
Expected volatility	123.00%	124.00%
Expected term	6 years	6 years
Dividend yield	0.00%	0.00%
Risk-free interest rates		0.50%
Risk-free interest rates, Minimum	1.50%
Risk-free interest rates, Maximum	1.70%

STOCK AWARDS, WARRANTS AND OP_6

STOCK AWARDS, WARRANTS AND OPTIONS - Stock-based Compensation Expense (Details) - USD ($)	3 Months Ended
	Mar. 31, 2022	Mar. 31, 2021
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items]
Stock-based compensation cost	$ 1,065,329	$ 752,962
General and administrative
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items]
Stock-based compensation cost	857,583	633,120
Research and development
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items]
Stock-based compensation cost	$ 207,746	$ 119,842

STOCK AWARDS, WARRANTS AND OP_7

STOCK AWARDS, WARRANTS AND OPTIONS - Stock Option Activity (Details) - Stock Option - USD ($)	3 Months Ended
	Mar. 31, 2022	Dec. 31, 2021
Number of Options
Outstanding at Beginning of the period	3,793,824
Granted	2,044,370
Exercised	(224,316)
Expired/Cancelled	(45,469)
Outstanding at End of the period	5,568,409
Exercisable	1,653,835
Weighted Average Exercise Price
Outstanding at Beginning of the period	$ 2.68
Granted	3.28
Exercised	1.39
Expired/Cancelled	4.19
Outstanding at Ending of the period	2.94
Exercisable	$ 2.21
Aggregate Intrinsic Value
Exercised	$ 431,485
Outstanding	4,157,717	$ 3,104,631
Exercisable	$ 2,321,841

STOCK AWARDS, WARRANTS AND OP_8

STOCK AWARDS, WARRANTS AND OPTIONS - Additional Information (Details)	Jan. 01, 2022shares	Jan. 01, 2021shares	Jun. 30, 2021shares	Mar. 31, 2022USD ($)item$ / sharesshares	Mar. 31, 2021$ / shares	Jun. 30, 2020shares	Nov. 30, 2012shares	Sep. 30, 2012shares
Disclosure Stockholders Equity, stock Options And Warrants Additional Information [Line Items]
Number of plans | item				5
Number of shares authorized for issuance			3,500,000			2,500,000	710,142	269,731
Number of additional shares authorized	1,209,250	823,084
Percentage of outstanding shares			5.00%
Number of options available for issuance				3,080,031
Minimum limit of fair market value to be treated as non-statutory stock | $				$ 100,000
Terms of stock option plans				10 years
Estimated weighted fair value of option granted (in per share) | $ / shares				$ 2.87	$ 3.26
Total unrecognized fair value compensation cost | $				$ 12,400,000
Weighted average period				1 year 7 months 6 days
Minimum
Disclosure Stockholders Equity, stock Options And Warrants Additional Information [Line Items]
Vesting period				1 year
Maximum
Disclosure Stockholders Equity, stock Options And Warrants Additional Information [Line Items]
Vesting period				4 years

CONCENTRATIONS (Details)

CONCENTRATIONS (Details)	Mar. 31, 2022USD ($)item
CONCENTRATIONS
Number of financial institutions | item	2
Cash, FDIC insured amount	$ 250,000
Cash, uninsured deposits	$ 57,900,000

GOVERNMENT GRANT AWARDS (Detail

GOVERNMENT GRANT AWARDS (Details)	Jun. 16, 2016USD ($)item	Jun. 16, 2016USD ($)	Mar. 31, 2022USD ($)	Dec. 31, 2021USD ($)
CIRM liability			$ 3,376,259	$ 3,376,259
California Institute for Regenerative Medicine
CIRM liability	$ 3,400,000	$ 3,400,000	$ 3,400,000
Minimum expected contribution		$ 2,300,000
Number of times, maximum royalty to be paid on total amount of award | item	9
Term of award			10 years
Debt term			5 years
California Institute for Regenerative Medicine | LIBOR
Interest rate			1.00%

COMMITMENTS AND CONTINGENCIES -

COMMITMENTS AND CONTINGENCIES - Future Minimum Rental Payments (Details) - USD ($)	Mar. 31, 2022	Dec. 31, 2021
COMMITMENTS AND CONTINGENCIES
2022	$ 407,029
2023	656,678
2024	674,931
2025	693,732
2026	562,627
Total minimum lease payments	2,994,997
Less: imputed interest	(190,426)
Total operating lease liabilities	2,804,571
Included in the consolidated balance sheet:
Current portion of lease liabilities	498,374	$ 417,632
Lease liabilities, net of current	2,306,197	$ 2,452,707
Total operating lease liabilities	$ 2,804,571
Weighted average remaining lease term	4 years 6 months 14 days
Weighted average discount rate	2.75%

COMMITMENTS AND CONTINGENCIES_2

COMMITMENTS AND CONTINGENCIES - Additional Information (Details)

Nov. 01, 2021USD ($)

Jul. 16, 2021USD ($)ft²

Jan. 01, 2021USD ($)

Jul. 01, 2013

Nov. 30, 2021USD ($)

Jul. 31, 2021USD ($)

Jul. 31, 2020USD ($)

Mar. 31, 2022USD ($)

Mar. 31, 2021USD ($)

Dec. 31, 2021USD ($)

Oct. 01, 2021USD ($)

Jun. 01, 2014

COMMITMENTS AND CONTINGENCIES

Operating lease, ROU asset

$ 2,683,443

$ 2,821,944

Operating lease, ROU liability

$ 2,804,571

Number of months of base salary

6 months

Restructuring reserve

$ 0

Corporate Offices Lease [Member]

COMMITMENTS AND CONTINGENCIES

Lease term

2 years

Lease, option to extend

true

Lease renewal term

12 months

Base rent per month

$ 13,073

$ 5,548

Written Notice Period

90 days

Operating lease expense

$ 17,394

$ 39,219

Facilities Lease

COMMITMENTS AND CONTINGENCIES

Lease term

3 years

Lease, option to extend

true

Lease renewal term

12 months

Base rent per month

$ 10,707

$ 15,805

Long Term Operating Leases [Member]

COMMITMENTS AND CONTINGENCIES

Operating lease expense

158,084

0

Operating lease payments

85,352

0

Property Located at 10865 Road to Cure in Diego

COMMITMENTS AND CONTINGENCIES

Lease renewal term

5 years

Ground leases | ft²

9,396

Annual lease rent

$ 600,000

Operating lease percentage

3.00%

Operating lease, ROU asset

$ 2,700,000

Operating lease, ROU liability

$ 2,700,000

Vivarium Space Lease [Member]

COMMITMENTS AND CONTINGENCIES

Lease renewal term

1 year

Base rent per month

$ 4,021

Written Notice Period

60 days

Vivarium Space Lease [Member] | Minimum

COMMITMENTS AND CONTINGENCIES

Lease term

1 year

Vivarium Space Lease [Member] | Maximum

COMMITMENTS AND CONTINGENCIES

Lease term

5 years

CSMC | Facilities Lease

COMMITMENTS AND CONTINGENCIES

Operating lease expense

$ 32,120

$ 47,415

LICENSE AGREEMENTS (Details)

LICENSE AGREEMENTS (Details)	Apr. 28, 2021USD ($)	Mar. 31, 2022USD ($)	Mar. 31, 2022USD ($)	Mar. 31, 2022EUR (€)	Mar. 31, 2021USD ($)	Jan. 24, 2022USD ($)	Dec. 31, 2021USD ($)
LICENSE AGREEMENTS
Potential milestone payments						$ 705,000,000
Milestone payment received			$ 30,000,000		$ 0
Deferred revenue, current		$ 9,726,501	9,726,501				$ 0
Deferred revenue, net of current		20,273,499	$ 20,273,499				$ 0
Rome License Agreement
LICENSE AGREEMENTS
Notice period			90 days	90 days
JHU License Agreement
LICENSE AGREEMENTS
Notice period			60 days	60 days
Milestone payments to be made upon completion of certain phases		500,000	$ 500,000
Threshold period to cure breach			30 days	30 days
CSMC License Agreement
LICENSE AGREEMENTS
Notice period			90 days	90 days
Exosomes License Agreement
LICENSE AGREEMENTS
Notice period	90 days		90 days	90 days
Upfront Payment	$ 10,000
Minimum | Rome License Agreement
LICENSE AGREEMENTS
Minimum annual royalty payments | €				€ 20,000
Maximum | JHU License Agreement
LICENSE AGREEMENTS
Potential milestone payments		1,850,000	$ 1,850,000
Completion of Phase One | Minimum
LICENSE AGREEMENTS
Milestone payments to be made upon completion of certain phases		100,000	100,000
Obtention of FDA Approval | Maximum
LICENSE AGREEMENTS
Milestone payments to be made upon completion of certain phases		1,000,000	$ 1,000,000
Completion Of Phase Two Due | JHU License Agreement
LICENSE AGREEMENTS
Milestones paid		$ 250,000
Patent rights | JHU License Agreement
LICENSE AGREEMENTS
Agreement effective period			20 years	20 years
Patent rights | Exosomes License Agreement
LICENSE AGREEMENTS
Agreement effective period	20 years
Particular Patent or Application or Any Particular Licensed Product | Exosomes License Agreement
LICENSE AGREEMENTS
Notice period	60 days
Non Payment of Royalties | CSMC License Agreement
LICENSE AGREEMENTS
Agreement termination period			30 days	30 days
Non Payment of Royalties | Exosomes License Agreement
LICENSE AGREEMENTS
Threshold period to cure breach			30 days	30 days
CSMC Agreement Compliance | CSMC License Agreement
LICENSE AGREEMENTS
Agreement termination period			90 days	90 days
CSMC Agreement Compliance | Exosomes License Agreement
LICENSE AGREEMENTS
Threshold period to cure breach			90 days	90 days
Material Breach Has Not Been Cured | CSMC License Agreement
LICENSE AGREEMENTS
Agreement termination period			90 days	90 days
Material Breach Has Not Been Cured | Exosomes License Agreement
LICENSE AGREEMENTS
Threshold period to cure breach			90 days	90 days
Fails To Cure Breach after Notice From CSMC | CSMC License Agreement
LICENSE AGREEMENTS
Agreement termination period			90 days	90 days
Fails To Cure Breach after Notice From CSMC | Exosomes License Agreement
LICENSE AGREEMENTS
Threshold period to cure breach	60 days		90 days	90 days

RELATED PARTY TRANSACTIONS (Det

RELATED PARTY TRANSACTIONS (Details)	1 Months Ended		3 Months Ended		12 Months Ended
	Jan. 31, 2022shares	Jul. 31, 2020shares	Mar. 31, 2022USD ($)item	Mar. 31, 2021USD ($)	Dec. 31, 2013USD ($)	Dec. 31, 2021USD ($)
RELATED PARTY TRANSACTIONS
Accounts payable and accrued expenses, related party			$ 574,848			$ 599,388
Amount of related party transaction			1,700,000
Other revenues from related party			0	$ 40,800
Board of Directors Chairman | Consulting Agreement [Member]
RELATED PARTY TRANSACTIONS
Monthly consulting fees					$ 10,000
Notice period for termination of agreement					30 days
Dr Eduardo Marban | Consulting Agreement [Member]
RELATED PARTY TRANSACTIONS
Granted option | shares	50,000	50,000
CSMC
RELATED PARTY TRANSACTIONS
Accounts payable and accrued expenses, related party			574,848			$ 589,388
Payment for reimbursement for research and development, license and patent fees and facilities rent expenses incurred by related party			$ 66,600	$ 57,700
Number of clinical trial sponsored | item			2