Capricor Therapeutics (CAPR) 10-Q10 Nov 222022 Q3 Quarterly reportFinancial data

Company Profile

Document and Entity Information

Document and Entity Information - shares	9 Months Ended
Document and Entity Information - shares	Sep. 30, 2022	Nov. 09, 2022
Document and Entity Information
Document Type	10-Q
Document Quarterly Report	true
Document Transition Report	false
Document Period End Date	Sep. 30, 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	858
Local Phone Number	727-1755
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		25,241,402
Current Fiscal Year End Date	--12-31
Document Fiscal Year Focus	2022
Document Fiscal Period Focus	Q3
Entity Central Index Key	0001133869
Amendment Flag	false

CONDENSED CONSOLIDATED BALANCE

CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($)	Sep. 30, 2022	Dec. 31, 2021
CURRENT ASSETS
Cash and cash equivalents	$ 8,413,653	$ 34,885,274
Marketable securities	38,199,859	0
Receivables	547,580	391,750
Prepaid expenses and other current assets	343,684	1,159,937
TOTAL CURRENT ASSETS	47,504,776	36,436,961
PROPERTY AND EQUIPMENT, net	3,591,397	1,795,696
OTHER ASSETS
Lease right-of-use assets, net	2,563,762	2,821,944
Other assets	268,172	275,722
TOTAL ASSETS	53,928,107	41,330,323
CURRENT LIABILITIES
Accounts payable and accrued expenses	3,852,356	3,116,371
Accounts payable and accrued expenses, related party	84,156	599,388
Lease liabilities, current	697,561	417,632
Deferred revenue, current	18,560,430	0
TOTAL CURRENT LIABILITIES	23,194,503	4,133,391
LONG-TERM LIABILITIES
CIRM liability	3,376,259	3,376,259
Lease liabilities, net of current	2,082,849	2,452,707
Deferred revenue, net of current	9,848,004	0
TOTAL LONG-TERM LIABILITIES	15,307,112	5,828,966
TOTAL LIABILITIES	38,501,615	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, 24,702,684 and 24,185,001 shares issued and outstanding, respectively	24,703	24,185
Additional paid-in capital	144,638,221	139,404,060
Accumulated other comprehensive income	122,467	0
Accumulated deficit	(129,358,899)	(108,060,279)
TOTAL STOCKHOLDERS' EQUITY	15,426,492	31,367,966
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY	$ 53,928,107	$ 41,330,323

CONDENSED CONSOLIDATED BALANC_2

CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares	Sep. 30, 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	24,702,684	24,185,001
Common stock, shares outstanding	24,702,684	24,185,001

CONDENSED CONSOLIDATED STATEMEN

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021
REVENUE
Revenue	$ 1,591,566		$ 1,591,566	$ 244,898
TOTAL REVENUE	1,591,566		1,591,566	244,898
OPERATING EXPENSES
Research and development	5,504,356	$ 2,513,915	15,585,143	9,307,512
General and administrative	2,564,960	1,800,630	7,637,461	5,496,186
TOTAL OPERATING EXPENSES	8,069,316	4,314,545	23,222,604	14,803,698
LOSS FROM OPERATIONS	(6,477,750)	(4,314,545)	(21,631,038)	(14,558,800)
OTHER INCOME (EXPENSE)
Other income		367,168	190,582	367,168
Investment income	106,635	15,570	141,836	41,476
Gain from forgiveness of debt				318,160
TOTAL OTHER INCOME (EXPENSE)	106,635	382,738	332,418	726,804
NET LOSS	(6,371,115)	(3,931,807)	(21,298,620)	(13,831,996)
OTHER COMPREHENSIVE INCOME (LOSS)
Net unrealized gain on marketable securities	99,637		122,467
COMPREHENSIVE INCOME (LOSS)	$ (6,271,478)	$ (3,931,807)	$ (21,176,153)	$ (13,831,996)
Net loss per share, basic	$ (0.26)	$ (0.17)	$ (0.87)	$ (0.61)
Net loss per share, diluted	$ (0.26)	$ (0.17)	$ (0.87)	$ (0.61)
Weighted-average number of shares of common stock outstanding basic	24,431,787	23,095,375	24,346,775	22,731,638
Weighted-average number of shares of common stock outstanding diluted	24,431,787	23,095,375	24,346,775	22,731,638

CONDENSED CONSOLIDATED STATEM_2

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY - USD ($)	COMMON STOCK [Member]	ADDITIONAL PAID-IN CAPITAL [Member]	OTHER COMPREHENSIVE INCOME [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, 2020	$ 20,577	116,216,966		(88,037,759)	28,199,784
Balance (in shares) at Dec. 31, 2020	20,577,123
Net loss					(13,831,996)
Balance at Sep. 30, 2021	$ 24,149	138,581,576		(101,869,755)	36,735,970
Balance (in shares) at Sep. 30, 2021	24,149,155
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
Issuance of common stock, net of fees	$ 200	1,035,112			1,035,312
Issuance of common stock, net of fees (in shares)	200,504
Stock-based compensation		712,299			712,299
Net loss				(4,748,266)	(4,748,266)
Balance at Jun. 30, 2021	$ 22,998	131,295,080		(97,937,948)	33,380,130
Balance (in shares) at Jun. 30, 2021	22,998,434
Issuance of common stock, net of fees	$ 1,147	6,561,006			6,562,153
Issuance of common stock, net of fees (in shares)	1,146,971
Stock-based compensation		720,281			720,281
Stock options exercised	$ 4	5,209			5,213
Stock options exercised (in shares)	3,750
Net loss				(3,931,807)	(3,931,807)
Balance at Sep. 30, 2021	$ 24,149	138,581,576		(101,869,755)	36,735,970
Balance (in shares) at Sep. 30, 2021	24,149,155
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
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
Unrealized gain on marketable securities					122,467
Net loss					(21,298,620)
Balance at Sep. 30, 2022	$ 24,703	144,638,221	$ 122,467	(129,358,899)	15,426,492
Balance (in shares) at Sep. 30, 2022	24,702,684
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
Stock-based compensation		1,157,904			1,157,904
Stock options exercised	$ 11	14,995			15,006
Stock options exercised (in shares)	10,796
Unrealized gain on marketable securities			22,830		22,830
Net loss				(7,109,411)	(7,109,411)
Balance at Jun. 30, 2022	$ 24,335	141,669,614	22,830	(122,987,784)	18,728,995
Balance (in shares) at Jun. 30, 2022	24,334,952
Issuance of common stock, net of fees	$ 340	1,879,984			1,880,324
Issuance of common stock, net of fees (in shares)	340,264
Stock-based compensation		1,087,133			1,087,133
Stock options exercised	$ 28	1,490			1,518
Stock options exercised (in shares)	27,468
Unrealized gain on marketable securities			99,637		99,637
Net loss				(6,371,115)	(6,371,115)
Balance at Sep. 30, 2022	$ 24,703	$ 144,638,221	$ 122,467	$ (129,358,899)	$ 15,426,492
Balance (in shares) at Sep. 30, 2022	24,702,684

CONDENSED CONSOLIDATED STATEM_3

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($)	9 Months Ended
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($)	Sep. 30, 2022	Sep. 30, 2021
Cash flows from operating activities:
Net loss	$ (21,298,620)	$ (13,831,996)
Adjustments to reconcile net loss to net cash provided by (used in) operating activities:
Depreciation and amortization	341,529	167,052
Stock-based compensation	3,310,366	2,185,542
Gain on forgiveness of debt		(318,160)
Changes in lease liabilities	168,254	0
Changes in operating assets and liabilities:
Receivables	(155,830)	(180,178)
Prepaid expenses and other current assets	816,253	732,300
Other assets	7,550	(200,000)
Accounts payable and accrued expenses	735,985	(224,409)
Accounts payable and accrued expenses, related party	(515,232)	488,108
Deferred revenue	28,408,434	0
Net cash provided by (used in) operating activities	11,818,689	(11,181,741)
Cash flows from investing activities:
Purchase of marketable securities	(82,175,353)	0
Proceeds from sales and maturities of marketable securities	44,097,961	0
Purchases of property and equipment	(1,306,199)	(827,615)
Payments for leasehold improvements	(831,032)	0
Net cash used in investing activities	(40,214,623)	(827,615)
Cash flows from financing activities:
Net proceeds from sale of common stock	1,880,324	20,175,991
Proceeds from exercise of stock awards	43,989	6,649
Net cash provided by financing activities	1,924,313	20,182,640
Net increase (decrease) in cash and cash equivalents	(26,471,621)	8,173,284
Cash and cash equivalents balance at beginning of period	34,885,274	32,665,874
Cash and cash equivalents balance at end of period	$ 8,413,653	40,839,158
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	9 Months Ended
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES	Sep. 30, 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”), in November 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 distribution agreements and collaboration partners. Cash, cash equivalents, and marketable securities as of September 30, 2022 were approximately $46.6 million, compared to approximately $34.9 million as of December 31, 2021. In the first quarter of 2022, 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, including the enrollment and progress of our HOPE-3 Phase 3 clinical study of CAP-1002 in DMD; ● the timing and costs associated with the manufacturing of its product candidates, including the expansion of our manufacturing capacity to support the potential commercialization of CAP-1002 for DMD; ● the timing and costs associated with potential commercialization of its product candidates; ● the number and scope of its research programs, including the expansion of our exosomes program; 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 distribution and other partnering opportunities, and from government grants. The Company will require substantial additional capital to fund its operations. 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 the impact may continue in future quarters as we conduct our HOPE-3 trial and expand our exosomes-based research and development programs. 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 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, which was established by the CARES Act. The Company has submitted $738,778 in ERC for applicable 2020 and 2021 periods, receiving $191,199 in 2021. As of September 30, 2022, the Company has recorded a receivable for $547,580 for the remainder of funds due. 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. Marketable Securities As of September 30, 2022, marketable securities consist primarily of short-term United States treasuries. These investments are considered available-for-sale. Realized gains and losses on the sale of debt and equity securities are determined on the specific identification method. Unrealized gains and losses are presented as other comprehensive income (loss). 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 Property and equipment, net consisted of the following: September 30, December 31, 2022 2021 Furniture and fixtures $ 139,336 $ 43,123 Laboratory equipment 3,666,890 2,475,543 Leasehold improvements 864,774 33,742 4,671,000 2,552,408 Less accumulated depreciation (1,079,603) (756,712) Property and equipment, net $ 3,591,397 $ 1,795,696 Leases ASC Topic 842, Leases 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 Comprehensive Income (Loss) Comprehensive income (loss) generally represents all changes in stockholders’ equity during the period except those resulting from investments by, or distributions to, stockholders. The Company’s comprehensive loss was approximately $6.3 million and approximately $3.9 million for the three months ended September 30, 2022 and 2021, respectively, and approximately $21.2 million and approximately $13.8 million for the nine months ended September 30, 2022 and 2021, respectively. The Company’s other comprehensive income (loss) is related to a net unrealized gain on marketable securities. 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 September 30, 2022 and 2021, warrants and options to purchase 6,059,552 and 3,968,546 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 nine months ended September 30, 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. The following table summarizes fair value measurements by level at September 30, 2022 for assets and liabilities measured at fair value on a recurring basis: September 30, 2022 Level I Level II Level III Total Marketable Securities $ 38,199,859 $ — $ — $ 38,199,859 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	9 Months Ended
NOTE PAYABLE	Sep. 30, 2022
NOTE PAYABLE
NOTE PAYABLE	2. NOTE PAYABLE Paycheck Protection Program Loan In 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. In the second quarter of 2021, the Loan was forgiven, and the Company recognized a gain of $318,160 on the forgiveness.

STOCKHOLDER'S EQUITY

STOCKHOLDER'S EQUITY	9 Months Ended
STOCKHOLDER'S EQUITY	Sep. 30, 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 established 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 established the June 2021 ATM Program with an aggregate offering price of up to $75.0 million. From June 21, 2021 through September 30, 2022, the Company sold an aggregate of 1,607,739 shares of common stock under the June 2021 ATM Program at an average price of approximately $5.86 per share for gross proceeds of approximately $9.4 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. Additionally, subsequent to September 30, 2022, the Company sold shares under the June 2021 ATM Program (see Note 10 – “Subsequent Events”). Outstanding Shares At September 30, 2022, the Company had 24,702,684 shares of common stock issued and outstanding

STOCK AWARDS, WARRANTS AND OPTI

STOCK AWARDS, WARRANTS AND OPTIONS	9 Months Ended
STOCK AWARDS, WARRANTS AND OPTIONS	Sep. 30, 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 nine months ended September 30, 2022: Weighted Average Warrants Exercise Price Outstanding at December 31, 2021 105,782 $ 1.37 Granted — — Exercised — — Outstanding at September 30, 2022 105,782 $ 1.37 The following table summarizes all outstanding warrants to purchase shares of the Company’s common stock: Warrants Outstanding September 30, 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”). At this time, the Company only issues options under the 2012 Plan, the 2020 Plan and 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. The 2012 Non-Employee Director Plan expired in September 2022, therefore, no additional stock option awards may be granted from the 2012 Non-Employee Director Plan. 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. The 2012 Plan expires on November 13, 2022. 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. Once the 2021 Plan was approved 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 September 30, 2022, 2,642,241 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 September 30, 2022 and 2021 were approximately $4.41 and $4.03 per share, respectively. The estimated weighted average fair value of the options granted during the nine months ended September 30, 2022 and 2021 were approximately $3.04 and $3.40 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 nine months ended September 30, 2022 and 2021: September 30, 2022 September 30, 2021 Expected volatility 123 - 124 % 123 - 124 % Expected term 6 6 years Dividend yield 0 % 0 % Risk-free interest rates 1.5 - 3.9 % 0.5 - 1.1 % Employee and non-employee stock-based compensation expense was as follows: Three months ended September 30, Nine months ended September 30, 2022 2021 2022 2021 General and administrative $ 943,075 $ 654,744 $ 2,711,296 $ 1,913,005 Research and development 144,058 65,537 599,070 272,537 Total $ 1,087,133 $ 720,281 $ 3,310,366 $ 2,185,542 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 September 30, 2022, the total unrecognized fair value compensation cost related to non-vested stock options was approximately $11.6 million, which is expected to be recognized over a weighted average period of approximately 1.4 years. The following is a schedule summarizing employee and non-employee stock option activity for the nine months ended September 30, 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 2,817,370 3.46 Exercised (270,735) 1.39 $ 614,699 Expired/Cancelled (386,689) 4.36 Outstanding at September 30, 2022 5,953,770 $ 3.00 $ 17,861,893 Exercisable at September 30, 2022 2,262,485 $ 2.49 $ 7,957,503 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	9 Months Ended
CONCENTRATIONS	Sep. 30, 2022
CONCENTRATIONS
CONCENTRATIONS	5. CONCENTRATIONS Concentration of Risk Financial instruments, which potentially subject the Company to concentrations of credit risk, principally consist of cash, cash equivalents, and marketable securities. The Company has historically maintained accounts at two financial institutions. These accounts are each insured by the Federal Deposit Insurance Corporation (the “FDIC”) for up to $250,000. The Company’s cash, cash equivalents, and marketable securities in excess of the FDIC insured limits as of September 30, 2022, were approximately $46.3 million. Historically, the Company has not experienced any significant losses in such accounts and does not believe it is exposed to any significant credit risk due to the quality nature of the financial instruments in which the money is held.

GOVERNMENT GRANT AWARDS

GOVERNMENT GRANT AWARDS	9 Months Ended
GOVERNMENT GRANT AWARDS	Sep. 30, 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 2019, Capricor completed all milestones and close-out activities associated with the CIRM Award and expended all funds received. As of September 30, 2022, Capricor’s liability balance for the CIRM Award was approximately $3.4 million.

COMMITMENTS AND CONTINGENCIES

COMMITMENTS AND CONTINGENCIES	9 Months Ended
COMMITMENTS AND CONTINGENCIES	Sep. 30, 2022
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES	7. COMMITMENTS AND CONTINGENCIES Short-Term Operating Leases Capricor leases office space in Beverly Hills, California from The Bubble Real Estate Company, LLC ("Bubble Real Estate") pursuant to a lease beginning in 2013. Capricor subsequently entered into several amendments modifying certain terms of the lease. 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. In July 2022, Capricor added additional office space increasing the monthly lease payment to $7,869 per month. The lease is terminable by either party upon 90 days’ written notice to the other party. Expenses incurred under short-term operating leases for the three months ended September 30, 2022 and 2021 were $23,340 and $39,219, respectively. Expenses incurred under short-term operating leases for the nine months ended September 30, 2022 and 2021 were $58,128 and $117,657, respectively. Long-Term Operating Leases Capricor leases facilities in Los Angeles, California from Cedars-Sinai Medical Center (“CSMC”), a related party (see Note 9 – “Related Party Transactions”), pursuant to a lease (the “Facilities Lease”) beginning in 2014. Capricor has subsequently entered into several amendments modifying certain terms of the lease. In July 2020, Capricor exercised its option to extend the term of the Facilities Lease for an additional 12-month 12-month 24-month The Company entered into a lease agreement commencing October 1, 2021 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 $48,859 per month, for which the Company received certain rent abatements during the initial year. Additionally, the rent is subject to a 3.0% annual rent increase during the initial lease term of five years, plus certain operating expenses and taxes. The lease contains an option for Capricor to renew for an additional term of five years. Effective July 1, 2022 the Company entered into an amendment to the lease increasing the square footage to 9,485 square feet with a monthly lease payment of $49,322 per month. In November 2022, we entered into an amendment increasing the square footage to 9,605 square feet with a new monthly lease payment of $51,444 per month effective December 1, 2022. Effective November 1, 2021, the Company entered into a vivarium agreement with Explora BioLabs, Inc. (“Explora”), a Charles River Company, 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 located in San Diego, California. The lease term is for one-year one-year 60-day 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 September 30, 2022: 2022 (remainder of the year) $ 196,588 2023 790,922 2024 755,815 2025 699,848 2026 539,821 Total minimum lease payments 2,982,994 Less: imputed interest (202,584) Total operating lease liabilities $ 2,780,410 Included in the condensed consolidated balance sheet: Current portion of lease liabilities $ 697,561 Lease liabilities, net of current 2,082,849 Total operating lease liabilities $ 2,780,410 Other Information: Weighted average remaining lease term 3.83 years Weighted average discount rate 3.61% As of September 30, 2022, ROU assets for operating leases were approximately $2.6 million and operating lease liability were approximately $2.8 million. The following table contains a summary of the lease costs recognized and lease payments pertaining to the Company’s operating leases under ASC 842 for the period indicated: Three months ended September 30, Nine months ended September 30, 2022 2021 2022 2021 Lease costs, unrelated parties $ 157,924 $ — $ 474,092 $ — Lease costs, related parties 32,120 37,218 96,359 132,048 Lease payments, unrelated parties 135,137 — 305,840 — Lease payments, related parties 32,120 37,218 96,359 132,048 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 under these severance packages has been recorded as of September 30, 2022.

LICENSE AGREEMENTS

LICENSE AGREEMENTS	9 Months Ended
LICENSE AGREEMENTS	Sep. 30, 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. 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. 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. Various amendments were entered into to revise certain provisions of the JHU License Agreement. 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 maximum aggregate amount of milestone payments payable under the JHU License Agreement, as amended, is $1,850,000. 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 expired in July 2022. Capricor decided not to further develop this technology. 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 the other party 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. 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 in connection with 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 Co., Ltd. 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 Capricor 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 the total estimated number of patient visits. For the three and nine months ended September 30, 2022, the Company recognized approximately $1.6 million as revenue. Additionally, as of September 30, 2022, the Company recorded approximately $18.6 million as current deferred revenue and approximately $9.8 million as deferred revenue, net of current portion, on the Company’s Condensed Consolidated Balance Sheets.

RELATED PARTY TRANSACTIONS

RELATED PARTY TRANSACTIONS	9 Months Ended
RELATED PARTY TRANSACTIONS	Sep. 30, 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 September 30, 2022 and December 31, 2021, the Company had accounts payable and accrued expenses to related parties totaling $84,156 and $599,388, respectively. CSMC accounts for $84,156 and $589,388 of the total accounts payable and accrued expense to related parties as of September 30, 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 nine months ended September 30, 2022 and 2021, the Company paid CSMC approximately $752,800 and $292,400, 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 nine months ended September 30, 2021, the Company recognized approximately $245,000 as revenue. No

SUBSEQUENT EVENTS

SUBSEQUENT EVENTS	6 Months Ended
SUBSEQUENT EVENTS	Jun. 30, 2022
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS	10. SUBSEQUENT EVENTS Additional Sales Under June 2021 ATM Program Subsequent to September 30, 2022 and through November 9, 2022, the Company sold an aggregate of 490,594 common shares under the June 2021 ATM Program at an average price of approximately $6.16 per common share for gross proceeds of approximately $3.0 million. The Company paid cash commissions on the gross proceeds, plus reimbursement of expenses to the placement agent in the aggregate amount of approximately $95,100.

ORGANIZATION AND SUMMARY OF S_2

ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies)	9 Months Ended
	Sep. 30, 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 distribution agreements and collaboration partners. Cash, cash equivalents, and marketable securities as of September 30, 2022 were approximately $46.6 million, compared to approximately $34.9 million as of December 31, 2021. In the first quarter of 2022, 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, including the enrollment and progress of our HOPE-3 Phase 3 clinical study of CAP-1002 in DMD; ● the timing and costs associated with the manufacturing of its product candidates, including the expansion of our manufacturing capacity to support the potential commercialization of CAP-1002 for DMD; ● the timing and costs associated with potential commercialization of its product candidates; ● the number and scope of its research programs, including the expansion of our exosomes program; 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 distribution and other partnering opportunities, and from government grants. The Company will require substantial additional capital to fund its operations. 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 the impact may continue in future quarters as we conduct our HOPE-3 trial and expand our exosomes-based research and development programs. 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 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, which was established by the CARES Act. The Company has submitted $738,778 in ERC for applicable 2020 and 2021 periods, receiving $191,199 in 2021. As of September 30, 2022, the Company has recorded a receivable for $547,580 for the remainder of funds due.
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.
Marketable Securities	Marketable Securities As of September 30, 2022, marketable securities consist primarily of short-term United States treasuries. These investments are considered available-for-sale. Realized gains and losses on the sale of debt and equity securities are determined on the specific identification method. Unrealized gains and losses are presented as other comprehensive income (loss).
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 Property and equipment, net consisted of the following: September 30, December 31, 2022 2021 Furniture and fixtures $ 139,336 $ 43,123 Laboratory equipment 3,666,890 2,475,543 Leasehold improvements 864,774 33,742 4,671,000 2,552,408 Less accumulated depreciation (1,079,603) (756,712) Property and equipment, net $ 3,591,397 $ 1,795,696
Leases	Leases ASC Topic 842, Leases 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
Comprehensive Income (Loss)	Comprehensive Income (Loss) Comprehensive income (loss) generally represents all changes in stockholders’ equity during the period except those resulting from investments by, or distributions to, stockholders. The Company’s comprehensive loss was approximately $6.3 million and approximately $3.9 million for the three months ended September 30, 2022 and 2021, respectively, and approximately $21.2 million and approximately $13.8 million for the nine months ended September 30, 2022 and 2021, respectively. The Company’s other comprehensive income (loss) is related to a net unrealized gain on marketable securities.
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 September 30, 2022 and 2021, warrants and options to purchase 6,059,552 and 3,968,546 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 nine months ended September 30, 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. The following table summarizes fair value measurements by level at September 30, 2022 for assets and liabilities measured at fair value on a recurring basis: September 30, 2022 Level I Level II Level III Total Marketable Securities $ 38,199,859 $ — $ — $ 38,199,859
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)	9 Months Ended
	Sep. 30, 2022
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Schedule of property, plant and equipment	Property and equipment, net consisted of the following: September 30, December 31, 2022 2021 Furniture and fixtures $ 139,336 $ 43,123 Laboratory equipment 3,666,890 2,475,543 Leasehold improvements 864,774 33,742 4,671,000 2,552,408 Less accumulated depreciation (1,079,603) (756,712) Property and equipment, net $ 3,591,397 $ 1,795,696
Schedule of fair value measurements	September 30, 2022 Level I Level II Level III Total Marketable Securities $ 38,199,859 $ — $ — $ 38,199,859

STOCK AWARDS, WARRANTS AND OP_2

STOCK AWARDS, WARRANTS AND OPTIONS (Tables)	9 Months Ended
STOCK AWARDS, WARRANTS AND OPTIONS (Tables)	Sep. 30, 2022
Warrant [Member]
Summary of warrant activity	The following table summarizes all warrant activity for the nine months ended September 30, 2022: Weighted Average Warrants Exercise Price Outstanding at December 31, 2021 105,782 $ 1.37 Granted — — Exercised — — Outstanding at September 30, 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 September 30, 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 nine months ended September 30, 2022 and 2021: September 30, 2022 September 30, 2021 Expected volatility 123 - 124 % 123 - 124 % Expected term 6 6 years Dividend yield 0 % 0 % Risk-free interest rates 1.5 - 3.9 % 0.5 - 1.1 %
Schedule of employee and non-employee stock based compensation expense	Employee and non-employee stock-based compensation expense was as follows: Three months ended September 30, Nine months ended September 30, 2022 2021 2022 2021 General and administrative $ 943,075 $ 654,744 $ 2,711,296 $ 1,913,005 Research and development 144,058 65,537 599,070 272,537 Total $ 1,087,133 $ 720,281 $ 3,310,366 $ 2,185,542
Schedule of employee and non-employee stock option	The following is a schedule summarizing employee and non-employee stock option activity for the nine months ended September 30, 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 2,817,370 3.46 Exercised (270,735) 1.39 $ 614,699 Expired/Cancelled (386,689) 4.36 Outstanding at September 30, 2022 5,953,770 $ 3.00 $ 17,861,893 Exercisable at September 30, 2022 2,262,485 $ 2.49 $ 7,957,503

COMMITMENTS AND CONTINGENCIES (

COMMITMENTS AND CONTINGENCIES (Tables)	9 Months Ended
COMMITMENTS AND CONTINGENCIES (Tables)	Sep. 30, 2022
COMMITMENTS AND CONTINGENCIES
Schedule of Future Minimum Rental Payments	2022 (remainder of the year) $ 196,588 2023 790,922 2024 755,815 2025 699,848 2026 539,821 Total minimum lease payments 2,982,994 Less: imputed interest (202,584) Total operating lease liabilities $ 2,780,410 Included in the condensed consolidated balance sheet: Current portion of lease liabilities $ 697,561 Lease liabilities, net of current 2,082,849 Total operating lease liabilities $ 2,780,410 Other Information: Weighted average remaining lease term 3.83 years Weighted average discount rate 3.61%
Schedule of operating lease cost	Three months ended September 30, Nine months ended September 30, 2022 2021 2022 2021 Lease costs, unrelated parties $ 157,924 $ — $ 474,092 $ — Lease costs, related parties 32,120 37,218 96,359 132,048 Lease payments, unrelated parties 135,137 — 305,840 — Lease payments, related parties 32,120 37,218 96,359 132,048

ORGANIZATION AND SUMMARY OF S_4

ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Property and Equipment (Details) - USD ($)	Sep. 30, 2022	Dec. 31, 2021
Property, Plant and Equipment, Gross	$ 4,671,000	$ 2,552,408
Less accumulated depreciation	(1,079,603)	(756,712)
Property and equipment, net	3,591,397	1,795,696
Furniture and fixtures
Property, Plant and Equipment, Gross	139,336	43,123
Laboratory equipment
Property, Plant and Equipment, Gross	3,666,890	2,475,543
Leasehold improvements
Property, Plant and Equipment, Gross	$ 864,774	$ 33,742

ORGANIZATION AND SUMMARY OF S_5

ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Additional Information (Details) - USD ($)	3 Months Ended			9 Months Ended		12 Months Ended
	Sep. 30, 2022	Mar. 31, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021	Dec. 31, 2021	Dec. 31, 2020
Accounting Policies [Line Items]
Cash, cash equivalents, and marketable securities	$ 46,600,000			$ 46,600,000		$ 34,900,000
Milestone payment received		$ 30,000,000		28,408,434	$ 0
Revenue recognized under "ERC"						191,199
Receivables under "ERC"	547,580			547,580		$ 738,778	$ 738,778
Depreciation				341,529	164,887
Research and development	5,504,356		$ 2,513,915	15,585,143	9,307,512
Comprehensive loss	$ 6,271,478		$ 3,931,807	$ 21,176,153	$ 13,831,996
Antidilutive securities				6,059,552	3,968,546
Minimum
Accounting Policies [Line Items]
Estimated useful lives (in years)				5 years
Maximum
Accounting Policies [Line Items]
Estimated useful lives (in years)				7 years

ORGANIZATION AND SUMMARY OF S_6

ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Fair value measurements by Levels (Details) - Recurring	Sep. 30, 2022 USD ($)
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Marketable Securities	$ 38,199,859
Level 1
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Marketable Securities	$ 38,199,859

NOTE PAYABLE (Details)

NOTE PAYABLE (Details) - USD ($)	3 Months Ended	9 Months Ended
NOTE PAYABLE (Details) - USD ($)	Jun. 30, 2021	Sep. 30, 2021	Dec. 31, 2020
Debt Instrument [Line Items]
Gain from forgiveness of debt	$ 318,160	$ 318,160
Paycheck Protection Program Loan
Debt Instrument [Line Items]
Amount of loan applied			$ 318,160

STOCKHOLDER'S EQUITY (Details)

STOCKHOLDER'S EQUITY (Details) - USD ($)			1 Months Ended	3 Months Ended	9 Months Ended		14 Months Ended
STOCKHOLDER'S EQUITY (Details) - USD ($)	Jun. 22, 2021	May 04, 2020	Nov. 09, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021	Jun. 21, 2021	Dec. 31, 2021
Class of Stock [Line Items]
Commission rate on sale price per share					3%
Gross proceeds from sale of common stock					$ 1,880,324	$ 20,175,991
Common stock, shares issued					24,702,684			24,185,001
Common stock, shares outstanding					24,702,684			24,185,001
Subsequent event
Class of Stock [Line Items]
Number of common stock shares issued			490,594
Average price			$ 6.16
Gross proceeds from sale of common stock			$ 3,000,000
Issuance costs			$ 95,100
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				1,607,739
Average price				$ 5.86		$ 5.86
Gross proceeds from sale of common stock				$ 9,400,000
Issuance costs				$ 300,000

STOCK AWARDS, WARRANTS AND OP_3

STOCK AWARDS, WARRANTS AND OPTIONS - Warrants (Details)	Sep. 30, 2022 $ / shares shares
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	9 Months Ended
	Sep. 30, 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)	9 Months Ended
STOCK AWARDS, WARRANTS AND OPTIONS - Assumptions (Details)	Sep. 30, 2022	Sep. 30, 2021
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Expected volatility, Maximum	124%	124%
Expected volatility, Minimum	123%	123%
Expected term		6 years
Dividend yield	0%	0%
Risk-free interest rates, Minimum	1.50%	0.50%
Risk-free interest rates, Maximum	3.90%	1.10%
Minimum
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Expected term	6 years
Maximum
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Expected term	7 years

STOCK AWARDS, WARRANTS AND OP_6

STOCK AWARDS, WARRANTS AND OPTIONS - Stock-based Compensation Expense (Details) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items]
Stock-based compensation cost	$ 1,087,133	$ 720,281	$ 3,310,366	$ 2,185,542
General and administrative
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items]
Stock-based compensation cost	943,075	654,744	2,711,296	1,913,005
Research and development
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items]
Stock-based compensation cost	$ 144,058	$ 65,537	$ 599,070	$ 272,537

STOCK AWARDS, WARRANTS AND OP_7

STOCK AWARDS, WARRANTS AND OPTIONS - Stock Option Activity (Details) - Stock Option	9 Months Ended
	Sep. 30, 2022 USD ($) $ / shares shares	Dec. 31, 2021 USD ($)
Number of Options
Outstanding at Beginning of the period \| shares	3,793,824
Granted \| shares	2,817,370
Exercised \| shares	(270,735)
Expired/Cancelled \| shares	(386,689)
Outstanding at End of the period \| shares	5,953,770
Exercisable \| shares	2,262,485
Weighted Average Exercise Price
Outstanding at Beginning of the period \| $ / shares	$ 2.68
Granted \| $ / shares	3.46
Exercised \| $ / shares	1.39
Expired/Cancelled \| $ / shares	4.36
Outstanding at Ending of the period \| $ / shares	3
Exercisable \| $ / shares	$ 2.49
Aggregate Intrinsic Value
Exercised \| $	$ 614,699
Outstanding \| $	17,861,893	$ 3,104,631
Exercisable \| $	$ 7,957,503

STOCK AWARDS, WARRANTS AND OP_8

STOCK AWARDS, WARRANTS AND OPTIONS - Additional Information (Details)			1 Months Ended	3 Months Ended		9 Months Ended
	Jan. 01, 2022 shares	Jan. 01, 2021 shares	Jun. 30, 2021 shares	Sep. 30, 2022 USD ($) $ / shares shares	Sep. 30, 2021 $ / shares	Sep. 30, 2022 USD ($) item $ / shares shares	Sep. 30, 2021 $ / shares	Jun. 30, 2020 shares	Sep. 30, 2012 shares
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	710,142		710,142		2,500,000	269,731
Number of additional shares authorized	1,209,250	823,084
Percentage of outstanding shares			5%
Number of shares available for issuance				2,642,241		2,642,241
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				$ 4.41	$ 4.03	$ 3.04	$ 3.40
Total unrecognized fair value compensation cost \| $				$ 11,600,000		$ 11,600,000
Weighted average period						1 year 4 months 24 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)	Sep. 30, 2022 USD ($) item
CONCENTRATIONS
Number of financial institutions \| item	2
Cash, FDIC insured amount	$ 250,000
Cash, uninsured deposits	$ 46,300,000

GOVERNMENT GRANT AWARDS (Detail

GOVERNMENT GRANT AWARDS (Details)		9 Months Ended
GOVERNMENT GRANT AWARDS (Details)	Jun. 16, 2016 USD ($) item	Sep. 30, 2022 USD ($)	Dec. 31, 2021 USD ($)
CIRM liability		$ 3,376,259	$ 3,376,259
California Institute for Regenerative Medicine
CIRM liability	$ 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%

COMMITMENTS AND CONTINGENCIES -

COMMITMENTS AND CONTINGENCIES - Future Minimum Rental Payments (Details) - USD ($)	Sep. 30, 2022	Dec. 31, 2021
COMMITMENTS AND CONTINGENCIES
2022	$ 196,588
2023	790,922
2024	755,815
2025	699,848
2026	539,821
Total minimum lease payments	2,982,994
Less: imputed interest	(202,584)
Total operating lease liabilities	2,780,410
Included in the condensed consolidated balance sheet:
Current portion of lease liabilities	697,561	$ 417,632
Lease liabilities, net of current	2,082,849	$ 2,452,707
Total operating lease liabilities	$ 2,780,410
Weighted average remaining lease term	3 years 9 months 29 days
Weighted average discount rate	3.61%

COMMITMENTS AND CONTINGENCIES_2

COMMITMENTS AND CONTINGENCIES - Additional Information (Details)

1 Months Ended

3 Months Ended

9 Months Ended

Jul. 01, 2022 USD ($) ft²

Nov. 01, 2021 USD ($)

Oct. 01, 2021 USD ($) ft²

Jan. 01, 2021 USD ($)

Nov. 30, 2022 USD ($) ft²

Jul. 31, 2022 USD ($)

Nov. 30, 2021 USD ($)

Jul. 31, 2021 USD ($)

Jul. 31, 2020 USD ($)

Sep. 30, 2022 USD ($)

Sep. 30, 2021 USD ($)

Sep. 30, 2022 USD ($)

Sep. 30, 2021 USD ($)

Dec. 31, 2021 USD ($)

COMMITMENTS AND CONTINGENCIES

Operating lease, ROU asset

$ 2,563,762

$ 2,821,944

Operating lease, ROU liability

2,780,410

$ 2,780,410

Number of months of base salary

6 months

Restructuring reserve

$ 0

Short-term offices lease

COMMITMENTS AND CONTINGENCIES

Base rent per month

$ 13,073

$ 7,869

$ 5,548

Written Notice Period

90 days

Operating lease expense

23,340

$ 39,219

$ 58,128

$ 117,657

Facilities Lease

COMMITMENTS AND CONTINGENCIES

Lease renewal term

24 months

12 months

Base rent per month

$ 10,707

$ 15,805

Property Located at 10865 Road to Cure in Diego

COMMITMENTS AND CONTINGENCIES

Lease term

5 years

Lease renewal term

5 years

Base rent per month

$ 48,859

Leased area | ft²

9,485

9,396

Operating lease percentage

Monthly lease payment

$ 49,322

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

Subsequent event | Property Located at 10865 Road to Cure in Diego

COMMITMENTS AND CONTINGENCIES

Base rent per month

$ 51,444

Leased area | ft²

9,605

Unrelated Party

COMMITMENTS AND CONTINGENCIES

Operating lease expense

157,924

474,092

Operating lease payments

135,137

305,840

Related party

COMMITMENTS AND CONTINGENCIES

Operating lease expense

32,120

37,218

96,359

132,048

Operating lease payments

$ 32,120

$ 37,218

$ 96,359

$ 132,048

LICENSE AGREEMENTS (Details)

LICENSE AGREEMENTS (Details)		1 Months Ended	3 Months Ended		9 Months Ended
LICENSE AGREEMENTS (Details)	Apr. 28, 2021 USD ($)	Mar. 31, 2022 USD ($)	Sep. 30, 2022 USD ($)	Mar. 31, 2022 USD ($)	Sep. 30, 2022 USD ($)	Sep. 30, 2022 EUR (€)	Sep. 30, 2021 USD ($)	Jan. 24, 2022 USD ($)	Dec. 31, 2021 USD ($)
LICENSE AGREEMENTS
Potential milestone payments								$ 705,000,000
Milestone payment received				$ 30,000,000	$ 28,408,434		$ 0
Deferred revenue liability		$ 30,000,000		30,000,000
Revenue			$ 1,591,566		1,591,566		$ 244,898
Deferred revenue, current			18,560,430		18,560,430				$ 0
Deferred revenue, net of current			9,848,004		$ 9,848,004				$ 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 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		9 Months Ended
RELATED PARTY TRANSACTIONS (Details)	Jan. 31, 2022 shares	Jul. 31, 2020 shares	Sep. 30, 2022 USD ($) item	Sep. 30, 2021 USD ($)	Dec. 31, 2021 USD ($)
RELATED PARTY TRANSACTIONS
Accounts payable and accrued expenses, related party			$ 84,156		$ 599,388
Amount of related party transaction			1,700,000
Other revenues from related party			0	$ 245,000
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			$ 84,156		$ 589,388
Payment for reimbursement for research and development, license and patent fees and facilities rent expenses incurred by related party			$ 752,800	$ 292,400
Number of clinical trial sponsored \| item			2

SUBSEQUENT EVENTS (Details)

SUBSEQUENT EVENTS (Details) - USD ($)	1 Months Ended	3 Months Ended	9 Months Ended		14 Months Ended
SUBSEQUENT EVENTS (Details) - USD ($)	Nov. 09, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021	Jun. 21, 2021
SUBSEQUENT EVENTS
Gross proceeds from sale of common stock			$ 1,880,324	$ 20,175,991
June 2021 ATM Program
SUBSEQUENT EVENTS
Number of common stock shares issued		1,607,739
Average price		$ 5.86		$ 5.86
Gross proceeds from sale of common stock		$ 9,400,000
Re-imbursement of expense to the placement agent		$ 300,000
May 2020 ATM Program
SUBSEQUENT EVENTS
Number of common stock shares issued					6,027,852
Average price					$ 6.15
Gross proceeds from sale of common stock					$ 37,100,000
Re-imbursement of expense to the placement agent					$ 1,200,000
Subsequent event
SUBSEQUENT EVENTS
Number of common stock shares issued	490,594
Average price	$ 6.16
Gross proceeds from sale of common stock	$ 3,000,000
Re-imbursement of expense to the placement agent	$ 95,100