Capricor Therapeutics (CAPR) 10-Q 14 Nov 23 2023 Q3 Quarterly report Financial data

Document and Entity Information

Document and Entity Information - shares	9 Months Ended
	Sep. 30, 2023	Nov. 13, 2023
Document and Entity Information
Document Type	10-Q
Document Quarterly Report	true
Document Period End Date	Sep. 30, 2023
Document Transition Report	false
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		30,792,869
Entity Central Index Key	0001133869
Current Fiscal Year End Date	--12-31
Document Fiscal Year Focus	2023
Document Fiscal Period Focus	Q3
Amendment Flag	false

CONDENSED CONSOLIDATED BALANCE

CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($)	Sep. 30, 2023	Dec. 31, 2022
CURRENT ASSETS
Cash and cash equivalents	$ 8,984,667	$ 9,603,242
Marketable securities	19,536,805	31,818,020
Receivables	547,580	547,580
Prepaid expenses and other current assets	458,417	919,892
TOTAL CURRENT ASSETS	29,527,469	42,888,734
PROPERTY AND EQUIPMENT, net	5,139,680	4,588,030
OTHER ASSETS
Lease right-of-use assets, net	2,217,009	2,349,974
Other assets	268,172	268,172
TOTAL ASSETS	37,152,330	50,094,910
CURRENT LIABILITIES
Accounts payable and accrued expenses	6,771,772	4,834,683
Accounts payable and accrued expenses, related party	20,178	89,234
Lease liabilities, current	729,567	682,039
Deferred revenue, current	25,405,084	17,980,599
TOTAL CURRENT LIABILITIES	32,926,601	23,586,555
LONG-TERM LIABILITIES
CIRM liability	3,376,259	3,376,259
Lease liabilities, net of current	1,683,656	1,878,070
Deferred revenue, net of current	953,470	9,467,932
TOTAL LONG-TERM LIABILITIES	6,013,385	14,722,261
TOTAL LIABILITIES	38,939,986	38,308,816
COMMITMENTS AND CONTINGENCIES (NOTE 6)
STOCKHOLDERS' EQUITY (DEFICIT)
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, 25,855,070 and 25,241,402 shares issued and outstanding, respectively	25,855	25,241
Additional paid-in capital	156,678,545	148,735,420
Accumulated other comprehensive income	113,208	105,244
Accumulated deficit	(158,605,264)	(137,079,811)
TOTAL STOCKHOLDERS' EQUITY (DEFICIT)	(1,787,656)	11,786,094
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT)	$ 37,152,330	$ 50,094,910

CONDENSED CONSOLIDATED BALANC_2

CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares	Sep. 30, 2023	Dec. 31, 2022
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	25,855,070	25,241,402
Common stock, shares outstanding	25,855,070	25,241,402

CONDENSED CONSOLIDATED STATEMEN

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (UNAUDITED) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
REVENUE
Revenue	$ 6,185,814	$ 1,591,566	$ 13,089,977	$ 1,591,566
TOTAL REVENUE	6,185,814	1,591,566	13,089,977	1,591,566
OPERATING EXPENSES
Research and development	10,028,964	5,504,356	26,507,872	15,585,143
General and administrative	3,021,450	2,564,960	9,378,672	7,637,461
TOTAL OPERATING EXPENSES	13,050,414	8,069,316	35,886,544	23,222,604
LOSS FROM OPERATIONS	(6,864,600)	(6,477,750)	(22,796,567)	(21,631,038)
OTHER INCOME (EXPENSE)
Other income				190,582
Investment income	479,380	106,635	1,276,502	141,836
Loss on disposal of fixed assets	(5,388)		(5,388)	0
TOTAL OTHER INCOME (EXPENSE)	473,992	106,635	1,271,114	332,418
NET LOSS	(6,390,608)	(6,371,115)	(21,525,453)	(21,298,620)
OTHER COMPREHENSIVE INCOME (LOSS)
Net unrealized gain (loss) on marketable securities	(66,485)	99,637	7,964	122,467
COMPREHENSIVE LOSS	$ (6,457,093)	$ (6,271,478)	$ (21,517,489)	$ (21,176,153)
Net loss per share, basic	$ (0.25)	$ (0.26)	$ (0.85)	$ (0.87)
Net loss per share, diluted	$ (0.25)	$ (0.26)	$ (0.85)	$ (0.87)
Weighted-average number of shares of common stock outstanding basic	25,817,676	24,431,787	25,468,880	24,346,775
Weighted-average number of shares of common stock outstanding diluted	25,817,676	24,431,787	25,468,880	24,346,775

CONDENSED CONSOLIDATED STATEM_2

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY (DEFICIT) (UNAUDITED) - USD ($)	COMMON STOCK [Member]	ADDITIONAL PAID-IN CAPITAL [Member]	OTHER COMPREHENSIVE INCOME [Member]	ACCUMULATED DEFICIT [Member]	Total
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
Balance at Dec. 31, 2022	$ 25,241	148,735,420	105,244	(137,079,811)	11,786,094
Balance (in shares) at Dec. 31, 2022	25,241,402
Stock-based compensation		2,194,784			2,194,784
Stock options exercised	$ 14	3,881			3,895
Stock options exercised (in shares)	13,752
Unrealized gain on marketable securities			(10,258)		(10,258)
Net loss				(7,768,266)	(7,768,266)
Balance at Mar. 31, 2023	$ 25,255	150,934,085	94,986	(144,848,077)	6,206,249
Balance (in shares) at Mar. 31, 2023	25,255,154
Balance at Dec. 31, 2022	$ 25,241	148,735,420	105,244	(137,079,811)	11,786,094
Balance (in shares) at Dec. 31, 2022	25,241,402
Unrealized gain on marketable securities					7,964
Net loss					(21,525,453)
Balance at Sep. 30, 2023	$ 25,855	156,678,545	113,208	(158,605,264)	(1,787,656)
Balance (in shares) at Sep. 30, 2023	25,855,070
Balance at Mar. 31, 2023	$ 25,255	150,934,085	94,986	(144,848,077)	6,206,249
Balance (in shares) at Mar. 31, 2023	25,255,154
Issuance of common stock, net of fees	$ 452	2,129,943			2,130,395
Issuance of common stock, net of fees (in shares)	452,385
Stock-based compensation		1,618,712			1,618,712
Stock options exercised	$ 57	57,622			57,679
Stock options exercised (in shares)	56,773
Unrealized gain on marketable securities			84,707		84,707
Net loss				(7,366,579)	(7,366,579)
Balance at Jun. 30, 2023	$ 25,764	154,740,362	179,693	(152,214,656)	2,731,163
Balance (in shares) at Jun. 30, 2023	25,764,312
Issuance of common stock, net of fees	$ 70	221,011			221,081
Issuance of common stock, net of fees (in shares)	69,985
Stock-based compensation		1,717,193			1,717,193
Stock options exercised	$ 21	(21)
Stock options exercised (in shares)	20,773
Unrealized gain on marketable securities			(66,485)		(66,485)
Net loss				(6,390,608)	(6,390,608)
Balance at Sep. 30, 2023	$ 25,855	$ 156,678,545	$ 113,208	$ (158,605,264)	$ (1,787,656)
Balance (in shares) at Sep. 30, 2023	25,855,070

CONDENSED CONSOLIDATED STATEM_3

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED) - USD ($)	9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022
Cash flows from operating activities:
Net loss	$ (21,525,453)	$ (21,298,620)
Adjustments to reconcile net loss to net cash provided by operating activities:
Loss on disposal of fixed assets	5,388	0
Depreciation and amortization	761,274	341,529
Stock-based compensation	5,530,689	3,310,366
Changes in lease liabilities	(13,921)	168,254
Changes in operating assets and liabilities:
Receivables		(155,830)
Prepaid expenses and other current assets	461,475	816,253
Other assets		7,550
Accounts payable and accrued expenses	1,937,089	735,985
Accounts payable and accrued expenses, related party	(69,057)	(515,232)
Deferred revenue	(1,089,977)	28,408,434
Net cash provided by (used in) operating activities	(14,002,493)	11,818,689
Cash flows from investing activities:
Purchase of marketable securities	(72,665,821)	(82,175,353)
Proceeds from sales and maturities of marketable securities	84,955,000	44,097,961
Purchases of property and equipment	(753,056)	(1,306,199)
Payments for leasehold improvements	(565,255)	(831,032)
Net cash provided by (used in) investing activities	10,970,868	(40,214,623)
Cash flows from financing activities:
Net proceeds from sale of common stock	2,351,476	1,880,324
Proceeds from exercise of stock awards	61,574	43,989
Net cash provided by financing activities	2,413,050	1,924,313
Net decrease in cash and cash equivalents	(618,575)	(26,471,621)
Cash and cash equivalents balance at beginning of period	9,603,242	34,885,274
Cash and cash equivalents balance at end of period	$ 8,984,667	8,413,653
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
	Sep. 30, 2023
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES	1. ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Description of Business Capricor Therapeutics, Inc., a Delaware corporation (referred to herein as “Capricor Therapeutics” or the “Company” or “we”), is a clinical-stage biotechnology company focused on the development of transformative cell and exosome-based therapeutics for treating Duchenne muscular dystrophy (“DMD”), a rare form of muscular dystrophy which results in muscle degeneration and premature death, and other diseases with high unmet medical needs. Capricor, Inc. (“Capricor”), a wholly-owned subsidiary of Capricor Therapeutics, was founded in 2005 as a Delaware corporation based on the innovative work of its founder, Eduardo Marbán, M.D., Ph.D. After completion of a merger between Capricor and a subsidiary of Nile Therapeutics, Inc., a Delaware corporation (“Nile”), on November 20, 2013, Capricor became a wholly-owned subsidiary of Nile and Nile formally changed its name to Capricor Therapeutics, Inc. Capricor Therapeutics, together with its subsidiary, Capricor, has multiple therapeutic drug 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 17, 2023, from which the December 31, 2022 consolidated balance sheet was derived. Interim results are not necessarily indicative of the results that may be expected for the year ending December 31, 2023. 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, 2023 were approximately $28.5 million, compared to approximately $41.4 million as of December 31, 2022. Subsequent to September 30, 2023, the Company completed a registered direct offering for gross proceeds of approximately $23.0 million (see Note 9 – “Subsequent Events”). In the first quarter of 2023, the Company received an upfront payment of $12.0 million from Nippon Shinyaku Co., Ltd. (“Nippon Shinyaku”), a Japanese corporation, in accordance with its Japan Exclusive Commercialization and Distribution Agreement (see Note 7 – “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 2 - "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 our research and development activities, clinical trials and preclinical studies, including the enrollment and progress of our ongoing HOPE-3 Phase 3 clinical trial of CAP-1002 in DMD; ● the timing and costs associated with the manufacturing of our 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 our product candidates; ● the number and scope of our 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 and research and development 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 presented substantial public health and economic challenges around the world. Our business operations and financial condition and results have been impacted to varying degrees. ​ In light of past uncertainties due to COVID-19 and its economic and other impacts, 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, 2023, the Company has recorded a receivable for $547,580 for the remainder of funds expected to be received. Subsequent to September 30, 2023, the Company received $191,463 in ERC funds for previously submitted credits. ​ 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. Management uses its historical records and knowledge of its business in making these estimates. Accordingly, actual results may differ from these estimates. Cash and Cash Equivalents The Company considers all highly liquid investments with a maturity of less than 30 days at the date of purchase to be cash equivalents. Marketable Securities The Company determines the appropriate classification of its marketable securities at the time of purchase and reevaluates such designation at each balance sheet date. All of the Company’s marketable securities are considered as available-for-sale and are carried at estimated fair values. Realized gains and losses on the sale of debt and equity securities are determined using the specific identification method. Unrealized gains and losses on available-for-sale securities are presented as other comprehensive income (loss) as a separate component of stockholders’ equity (deficit). As of September 30, 2023, marketable securities consist primarily of short-term United States treasuries. 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, ​ 2023 2022 Furniture and fixtures ​ $ 158,198 ​ $ 139,336 Laboratory equipment ​ 4,923,838 ​ 4,237,089 Leasehold improvements ​ 1,958,485 ​ 1,393,230 ​ ​ 7,040,521 ​ 5,769,655 Less accumulated depreciation ​ (1,900,841) ​ (1,181,625) Property and equipment, net ​ $ 5,139,680 ​ $ 4,588,030 ​ 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 6 - “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 adopted ASU 606, Revenue for Contracts from Customers ​ The revenue standard provides a five-step framework for recognizing revenue as control of promised goods or services is transferred to a customer at an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. To determine revenue recognition for arrangements that it determines are within the scope of the revenue standard, the Company performs the following five steps: (i) identify the contract; (ii) identify the performance obligations; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the Company satisfies a performance obligation. At contract inception, the Company assesses whether the goods or services promised within each contract are distinct and, therefore, represent a separate performance obligation, or whether they are not distinct and are combined with other goods and services until a distinct bundle is identified. The Company then determines the transaction price, which typically includes upfront payments and any variable consideration that the Company determines is probable to not cause a significant reversal in the amount of cumulative revenue recognized when the uncertainty associated with the variable consideration is resolved. The Company then allocates the transaction price to each performance obligation and recognizes the associated revenue when, or as, each performance obligation is satisfied. ​ The Company’s distribution agreements may entitle it to additional payments upon the achievement of milestones or shares of product revenue. The milestones are generally categorized into three types: development milestones, regulatory milestones and sales-based milestones. The Company evaluates whether it is probable that the consideration associated with each milestone or shared revenue payments will not be subject to a significant reversal in the cumulative amount of revenue recognized. Amounts that meet this threshold are included in the transaction price using the most likely amount method, whereas amounts that do not meet this threshold are excluded from the transaction price until they meet this threshold. At the end of each subsequent reporting period, the Company re-evaluates the probability of a significant reversal of the cumulative revenue recognized for its milestones and royalties, and, if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect revenues and net income (loss) in the Company’s condensed consolidated statements of operation and comprehensive loss. Typically, milestone payments and shared revenue payments are achieved after the Company’s performance obligations associated with the distribution agreements have been completed and after the customer has assumed responsibility for the commercialization program. Milestones or shared revenue payments achieved after the Company’s performance obligations have been completed are recognized as revenue in the period the milestone or shared revenue payments was achieved. If a milestone payment is achieved during the performance period, the milestone payment would be recognized as revenue to the extent performance had been completed at that point, and the remaining balance would be recorded as deferred revenue. ​ The revenue standard requires the Company to assess whether a significant financing component exists in determining the transaction price. The Company performs this assessment at the onset of its distribution agreements. Typically, a significant financing component does not exist because the customer is paying for services in advance with an upfront payment. Additionally, future shared revenue payments are not substantially within the control of the Company or the customer. ​ Whenever the Company determines that goods or services promised in a contract should be accounted for as a combined performance obligation over time, the Company determines the period over which the performance obligations will be performed and revenue will be recognized. Revenue is recognized using either the proportional performance method or on a straight-line basis if efforts will be expended evenly over time. Percentage of completion of patient visits in clinical trials are used as the measure of performance. The Company feels this method of measurement to be the best depiction of the transfer of services and recognition of revenue. Significant management judgment is required in determining the level of effort required under an arrangement and the period over which the Company is expected to complete its performance obligations. If the Company determines that the performance obligation is satisfied over time, any upfront payment received is initially recorded as deferred revenue on its condensed consolidated balance sheets. ​ Certain judgments affect the application of the Company’s revenue recognition policy. For example, the Company records short-term (less than one year) and long-term (over one year) deferred revenue based on its best estimate of when such revenue will be recognized. This estimate is based on the Company’s current operating plan, and the Company may recognize a different amount of deferred revenue over the next 12-month period if its plan changes in the future. ​ Under the Exclusive Commercialization and Distribution Agreement for the U.S. (the “U.S. Distribution Agreement”) with Nippon Shinyaku the transaction price consists of variable shared revenue payments and fixed components in the form of an upfront payment and milestones. The timing of the fixed component of the transaction price is upfront, however, the performance obligation is satisfied over a period of time, which is the estimated duration of the HOPE-3 clinical trial. Therefore, upon receipt of the upfront payment, a contract liability is recorded which represents deferred revenue. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the related revenue recognition. 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 5 - “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. No grant income was recognized for the three and nine months ended September 30, 2023 and 2022. 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 (deficit) during the period except those resulting from investments by, or distributions to, stockholders. The Company’s comprehensive loss was approximately $6.5 million and $6.3 million for the three months ended September 30, 2023 and 2022, respectively, and approximately $21.5 million and $21.2 million for the nine months ended September 30, 2023 and 2022, respectively. Clinical Trial Expense As part of the process of preparing our condensed consolidated financial statements, we are required to estimate our accrued expenses. Our clinical trial accrual process is designed to account for expenses resulting from our obligations under contracts with vendors, consultants, contract research organizations (“CROs”), and clinical site agreements in connection with conducting clinical trials. The financial terms of these contracts are subject to negotiations, which vary from contract to contract and may result in payment flows that do not match the periods over which materials or services are provided to us under such contracts. Our objective is to reflect the appropriate clinical trial expenses in our condensed 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 condensed 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. For the three and nine months ended September 30, 2023, warrants and options to purchase 8,303,253 and 6,059,552 shares of common stock, respectively, have been excluded from the computation of potentially dilutive securities. Potentially dilutive shares of common stock, which primarily consist of stock options issued to employees, consultants, and directors as well as warrants issued, have been excluded from the diluted loss per share calculation because their effect is anti-dilutive. Because the impact of these items is anti-dilutive during periods of net loss, there was no difference between basic and diluted loss per share for the three and nine months ended September 30, 2023 and 2022. 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, 2023 and December 31, 2022 for assets and liabilities measured at fair value on a recurring basis: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ September 30, 2023 ​ Level I Level II Level III Total Marketable Securities ​ $ 19,536,805 ​ $ — ​ $ — ​ $ 19,536,805 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ December 31, 2022 ​ Level I Level II Level III Total Marketable Securities ​ $ 31,818,020 ​ $ — ​ $ — ​ $ 31,818,020 ​ Carrying amounts reported in the balance sheet of cash and cash equivalents, receivables, 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. As of September 30, 2023 and December 31, 2022, the amortized cost for these marketable securities was $19,423,597 and $31,712,777, respectively. ​ Recent Accounting Pronouncements 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.

STOCKHOLDER'S EQUITY

STOCKHOLDER'S EQUITY	9 Months Ended
	Sep. 30, 2023
STOCKHOLDER'S EQUITY
STOCKHOLDER'S EQUITY	2. STOCKHOLDER’S EQUITY ATM Program The Company established an “at-the-market” program (the “ATM Program”) on June 21, 2021, with an aggregate offering price of up to $75.0 million, pursuant to a Common Stock Sales Agreement with Wainwright by which Wainwright has 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. From June 21, 2021 through September 30, 2023, the Company sold an aggregate of 2,620,703 shares of common stock under the ATM Program at an average price of approximately $5.74 per share for gross proceeds of approximately $15.0 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 $0.5 million. Subsequent to September 30, 2023 and through the date of this filing, no shares were sold under the ATM Program. Outstanding Shares At September 30, 2023, the Company had 25,855,070 shares of common stock issued and outstanding

STOCK AWARDS, WARRANTS AND OPTI

STOCK AWARDS, WARRANTS AND OPTIONS	9 Months Ended
	Sep. 30, 2023
STOCK AWARDS, WARRANTS AND OPTIONS
STOCK AWARDS, WARRANTS AND OPTIONS	3. STOCK AWARDS, WARRANTS AND OPTIONS Warrants The following table summarizes all warrant activity for the nine months ended September 30, 2023: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Weighted Average ​ Warrants Exercise Price Outstanding at December 31, 2022 105,782 ​ $ 1.37 Granted ​ — ​ ​ — Exercised ​ — ​ ​ — Outstanding at September 30, 2023 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 2023 2022 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 2020 Plan and the 2021 Plan and no longer issues options under the 2006 Stock Option Plan, the 2012 Plan, or the 2012 Non-Employee Director Plan. 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 were 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 the lesser of 5% of the outstanding shares of Common Stock as of the last day of the immediately preceding fiscal year or such number of shares determined by the compensation committee of the Board. On January 1, 2023 and 2022, 1,262,070 and 1,209,250 shares were added under the 2021 Plan, respectively. As of September 30, 2023, 1,264,429 options remain available for issuance under the stock option plans. The Company’s stock option plans are administered by the Board, in conjunction with 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, 2023 and 2022 were approximately $4.93 and $4.41 per share, respectively. The estimated weighted average fair value of the options granted during the nine months ended September 30, 2023 and 2022 were approximately $3.88 and $3.04 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, 2023 and 2022: ​ ​ ​ ​ ​ ​ ​ ​ Nine months ended September 30, ​ ​ 2023 ​ 2022 ​ Expected volatility 111 - 121 % 123 - 124 % Expected term 5 6 ​ Dividend yield 0 % 0 % Risk-free interest rates 3.5 - 4.5 % 1.5 - 3.9 % ​ Employee and non-employee stock-based compensation expense was as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Three months ended September 30, ​ Nine months ended September 30, ​ ​ 2023 2022 2023 2022 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ General and administrative ​ $ 1,235,219 ​ $ 943,075 ​ $ 4,157,704 ​ $ 2,711,296 ​ Research and development ​ 481,974 ​ 144,058 ​ 1,372,985 ​ 599,070 ​ Total ​ $ 1,717,193 ​ $ 1,087,133 ​ $ 5,530,689 ​ $ 3,310,366 ​ ​ 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. The Company accounts for forfeitures upon occurrence. As of September 30, 2023, the total unrecognized fair value compensation cost related to non-vested stock options was approximately $14.4 million, which is expected to be recognized over a weighted average period of approximately 1.5 years. ​ The following is a schedule summarizing employee and non-employee stock option activity for the nine months ended September 30, 2023: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Number of ​ Weighted Average ​ Aggregate ​ Options Exercise Price Intrinsic Value Outstanding at December 31, 2022 5,776,839 ​ $ 2.97 ​ ​ Granted 3,287,979 ​ 4.36 ​ Exercised (180,227) ​ 2.56 $ 364,525 Expired/Cancelled (687,120) ​ 3.80 ​ Outstanding at September 30, 2023 8,197,471 ​ $ 3.47 ​ $ 3,692,525 Exercisable at September 30, 2023 3,859,994 ​ $ 2.83 ​ $ 3,173,089 ​ 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
	Sep. 30, 2023
CONCENTRATIONS
CONCENTRATIONS	4. 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 maintains accounts at three financial institutions. These accounts are insured by the Federal Deposit Insurance Corporation (the “FDIC”) for up to $250,000 and/or the Securities Investor Protection Corporation, as applicable. The Company’s cash, cash equivalents, and marketable securities in excess of the FDIC insured limits as of September 30, 2023, were approximately $28.3 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
	Sep. 30, 2023
GOVERNMENT GRANT AWARDS
GOVERNMENT GRANT AWARDS	5. 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 DMD-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, 2023, Capricor’s liability balance for the CIRM Award was approximately $3.4 million.

COMMITMENTS AND CONTINGENCIES

COMMITMENTS AND CONTINGENCIES	9 Months Ended
	Sep. 30, 2023
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES	6. 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 Bubble Real Estate, which is terminable by either party upon 90 days’ written notice to the other party. Commencing in July 2022, the monthly lease payment was $7,869 per month. Effective July 1, 2023, the monthly lease payment was reduced to $7,619 per month. Expenses incurred under short-term operating leases to unrelated parties for the three months ended September 30, 2023 and 2022 were $22,857 and $23,340, respectively. Expenses incurred under short-term operating leases to unrelated parties for the nine months ended September 30, 2023 and 2022 were $70,071 and $58,128, respectively. Long-Term Operating Leases Capricor leases facilities in Los Angeles, California from Cedars-Sinai Medical Center (“CSMC”), a related party (see Note 8 – “Related Party Transactions”), pursuant to a lease (the “Facilities Lease”) entered into in 2014. Capricor has subsequently entered into several amendments modifying certain terms of the lease. In July 2022, we entered into an amendment for an additional 24-month The Company entered into a lease agreement commencing October 1, 2021 with Altman Investment Co, LLC (“Altman”) for office and laboratory space located at 10865 Road to the Cure, Suite 150, in San Diego, California (the “San Diego Lease”). 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 San Diego Lease contains an option for Capricor to renew it for an additional term of five years. The Company has subsequently entered into several amendments to the San Diego Lease increasing the square footage of the premises and effective July 1, 2022, the monthly lease payment was increased to $49,322 per month. Effective December 1, 2022, the monthly lease payment was increased to $51,444 per month. Effective October 1, 2023, the monthly lease payment was increased to $58,409 per month. 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 Company is obligated to pay a base rent of $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, 2023: ​ ​ ​ ​ ​ 2023 (remainder) ​ $ 219,952 2024 ​ ​ 886,672 2025 ​ ​ 910,106 2026 ​ ​ 676,908 2027 ​ ​ — Total minimum lease payments ​ ​ 2,693,638 Less: imputed interest ​ ​ (280,415) Total operating lease liabilities ​ $ 2,413,223 Included in the condensed consolidated balance sheet: ​ ​ ​ Current portion of lease liabilities ​ $ 729,567 Lease liabilities, net of current ​ ​ 1,683,656 Total operating lease liabilities ​ $ 2,413,223 ​ ​ ​ ​ Other Information: ​ ​ ​ Weighted average remaining lease term ​ ​ 2.98 years Weighted average discount rate ​ ​ 7.24% ​ As of September 30, 2023, ROU assets for operating leases were approximately $2.2 million and operating lease liabilities were approximately $2.4 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, ​ 2023 2022 2023 2022 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Lease costs, unrelated parties ​ $ 165,921 ​ $ 157,924 ​ $ 486,894 ​ $ 474,092 Lease costs, related parties ​ 32,120 ​ 32,120 ​ ​ 96,359 ​ ​ 96,359 Lease payments, unrelated parties ​ ​ 166,938 ​ 135,137 ​ ​ 500,814 ​ ​ 305,840 Lease payments, related parties ​ ​ 32,120 ​ 32,120 ​ ​ 96,359 ​ ​ 96,359 ​ 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 7 – “License and Distribution Agreements”). Additionally, the Company is a party to various agreements with contract research, manufacturing and other 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 approves 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, 2023.

LICENSE AND DISTRIBUTION AGREEM

LICENSE AND DISTRIBUTION AGREEMENTS	9 Months Ended
	Sep. 30, 2023
LICENSE AND DISTRIBUTION AGREEMENTS
LICENSE AND DISTRIBUTION AGREEMENTS	7. 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 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 TM 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 cardiosphere-derived cell (“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, July 27, 2021, and August 7, 2023, Capricor and CSMC entered into several 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 and extend the timing of certain development milestones, 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 CDC-derived 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, March 19, 2021 and July 14, 2023, Capricor and CSMC entered into 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. 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 2022 and additional milestone fees may become due based on the progress of our development program. ​ Commercialization and Distribution Agreement with Nippon Shinyaku (Territory: United States) On January 24, 2022, Capricor entered into the U.S. Distribution Agreement with Nippon Shinyaku, a Japanese corporation. Under the terms of the U.S. Distribution Agreement, Capricor appointed Nippon Shinyaku as its exclusive distributor in the United States of CAP-1002, for the treatment of DMD. Under the terms of the U.S. 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. In the first quarter of 2022, Capricor received an upfront payment of $30.0 million. Additionally, there are various potential development, regulatory, and if commercialized, sales-based milestones tied to the achievement of certain sales thresholds for annual net sales of CAP-1002 of up to $705.0 million. In addition to the $30.0 million upfront payment already received, there are potential milestones totaling up to $100.0 million leading up to and including the Biologics License Application (“BLA”) approval. The first milestone payment will be triggered upon completion of the interim futility analysis of the HOPE-3 trial whereby the outcome is determined to not be futile. Further, pursuant to the U.S. 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 mid-range double-digit share of product revenue. The Company has evaluated the U.S. Distribution Agreement in accordance with ASU 606, Revenue for Contracts from Customers The Company determined the initial transaction price totaled $30.0 million, which was the upfront payment fee. The Company has excluded any future milestone or shared revenue payments from this transaction price to date based on probability. The Company has allocated the total $30.0 million initial transaction price to its one distinct performance obligation. Revenue will be recognized using a proportional performance method in relation to the completion of the HOPE-3 clinical trial to determine the extent of progress towards completion. Under this method, the transaction price is recognized over the contract’s entire performance period using a cost percentage per patient visit relative to the total estimated cost of patient visits. For the three months ended September 30, 2023, the Company recognized approximately $6.2 million as revenue. For the nine months ended September 30, 2023, the Company recognized approximately $13.1 million as revenue. In relation to the U.S. Distribution Agreement, as of September 30, 2023, the Company recorded approximately $13.4 million as current deferred revenue and approximately $1.0 million as noncurrent deferred revenue on the Company’s condensed consolidated balance sheets. The Company had no opening or closing contract asset balances recognized. The difference between the opening and closing balances of the Company’s contract liability results from the Company performance of services in connection to its performance obligation. The transaction price allocated to remaining performance obligations represents contracted revenue that has not yet been recognized. As of September 30, 2023, remaining performance obligations related to the U.S. Distribution Agreement were approximately $14.4 million. At this time, we estimate that 93% of the remaining performance obligations are expected to be recognized over the next 12 months, with the remainder thereafter Commercialization and Distribution Agreement with Nippon Shinyaku (Territory: Japan) On February 10, 2023, Capricor entered into an Exclusive Commercialization and Distribution Agreement (the “Japan Distribution Agreement”) with Nippon Shinyaku. Under the terms of the Japan Distribution Agreement, Capricor appointed Nippon Shinyaku as its exclusive distributor in Japan of CAP-1002 for the treatment of DMD. Under the terms of the Japan Distribution Agreement, Capricor received an upfront payment of $12.0 million in the first quarter of 2023, and in addition, Capricor will potentially receive additional development and sales-based milestone payments of up to approximately $89 million, subject to foreign currency exchange rates, and a meaningful double-digit share of product revenue. Nippon Shinyaku will be responsible for the distribution of CAP-1002 in Japan. Capricor will be responsible for the conduct of clinical development in Japan, as may be required, as well as the manufacturing of CAP-1002. Capricor will sell commercial product to Nippon Shinyaku. In addition, Capricor or its designee will hold the Marketing Authorization in Japan if the product is approved in that territory. The Company has evaluated the Japan Distribution Agreement in accordance with ASU 606, Revenue for Contracts from Customers

RELATED PARTY TRANSACTIONS

RELATED PARTY TRANSACTIONS	9 Months Ended
	Sep. 30, 2023
RELATED PARTY TRANSACTIONS
RELATED PARTY TRANSACTIONS	8. RELATED PARTY TRANSACTIONS Lease and Sub-Lease Agreement As noted above, Capricor is a party to lease agreements with CSMC (see Note 6 – “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, 2023 and December 31, 2022, the Company had accounts payable and accrued expenses to related parties totaling approximately $20,178 and $89,234, respectively. CSMC accounts for approximately $10,022 and $79,234 of the total accounts payable and accrued expense to related parties as of September 30, 2023 and December 31, 2022, 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, 2023 and 2022, the Company paid CSMC approximately $194,400 and $752,800, respectively, for such costs.

SUBSEQUENT EVENTS

SUBSEQUENT EVENTS	9 Months Ended
	Sep. 30, 2023
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS	9. SUBSEQUENT EVENTS October 2023 Financing On October 3, 2023, the Company entered into Securities Purchase Agreements with its commercial partner, Nippon Shinyaku, Co., Ltd. and funds associated with Highbridge Capital Management, LLC (the “Investors”), pursuant to which the Company agreed to issue and sell to the Investors, in a registered direct offering (the “Registered Direct Offering”), an aggregate of 4,935,621 shares of its common stock, par value $0.001 per share, at a price per share of $4.66 for an aggregate purchase price of approximately $23.0 million. Each share of common stock offered was sold with a warrant to purchase one share of common stock at an exercise price of $5.70 per share. Each warrant will be exercisable beginning six months after issuance and will expire seven years from the date of issuance. As part of the Registered Direct Offering, the Company agreed not to issue or sell shares (subject to customary exceptions for employee stock option issuances and other customary exceptions) for a period of 30 days following the date of the prospectus supplement that was used in the Registered Direct Offering. That prospectus was dated September 29, 2023, so the Company “lock-up” expired on October 29, 2023. The Company’s directors and executive officers also entered into “lock-up” agreements with the placement agent in the Registered Direct Offering, which agreements are scheduled to expire on the 60 ​

ORGANIZATION AND SUMMARY OF S_2

ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies)	9 Months Ended
	Sep. 30, 2023
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Description of Business	Description of Business Capricor Therapeutics, Inc., a Delaware corporation (referred to herein as “Capricor Therapeutics” or the “Company” or “we”), is a clinical-stage biotechnology company focused on the development of transformative cell and exosome-based therapeutics for treating Duchenne muscular dystrophy (“DMD”), a rare form of muscular dystrophy which results in muscle degeneration and premature death, and other diseases with high unmet medical needs. Capricor, Inc. (“Capricor”), a wholly-owned subsidiary of Capricor Therapeutics, was founded in 2005 as a Delaware corporation based on the innovative work of its founder, Eduardo Marbán, M.D., Ph.D. After completion of a merger between Capricor and a subsidiary of Nile Therapeutics, Inc., a Delaware corporation (“Nile”), on November 20, 2013, Capricor became a wholly-owned subsidiary of Nile and Nile formally changed its name to Capricor Therapeutics, Inc. Capricor Therapeutics, together with its subsidiary, Capricor, has multiple therapeutic drug candidates in various stages of development.
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 17, 2023, from which the December 31, 2022 consolidated balance sheet was derived. Interim results are not necessarily indicative of the results that may be expected for the year ending December 31, 2023.
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, 2023 were approximately $28.5 million, compared to approximately $41.4 million as of December 31, 2022. Subsequent to September 30, 2023, the Company completed a registered direct offering for gross proceeds of approximately $23.0 million (see Note 9 – “Subsequent Events”). In the first quarter of 2023, the Company received an upfront payment of $12.0 million from Nippon Shinyaku Co., Ltd. (“Nippon Shinyaku”), a Japanese corporation, in accordance with its Japan Exclusive Commercialization and Distribution Agreement (see Note 7 – “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 2 - "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 our research and development activities, clinical trials and preclinical studies, including the enrollment and progress of our ongoing HOPE-3 Phase 3 clinical trial of CAP-1002 in DMD; ● the timing and costs associated with the manufacturing of our 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 our product candidates; ● the number and scope of our 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 and research and development 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 presented substantial public health and economic challenges around the world. Our business operations and financial condition and results have been impacted to varying degrees. ​ In light of past uncertainties due to COVID-19 and its economic and other impacts, 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, 2023, the Company has recorded a receivable for $547,580 for the remainder of funds expected to be received. Subsequent to September 30, 2023, the Company received $191,463 in ERC funds for previously submitted credits.
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. Management uses its historical records and knowledge of its business in making these estimates. Accordingly, actual results may differ from these estimates.
Cash and Cash Equivalents	Cash and Cash Equivalents The Company considers all highly liquid investments with a maturity of less than 30 days at the date of purchase to be cash equivalents.
Marketable Securities	Marketable Securities The Company determines the appropriate classification of its marketable securities at the time of purchase and reevaluates such designation at each balance sheet date. All of the Company’s marketable securities are considered as available-for-sale and are carried at estimated fair values. Realized gains and losses on the sale of debt and equity securities are determined using the specific identification method. Unrealized gains and losses on available-for-sale securities are presented as other comprehensive income (loss) as a separate component of stockholders’ equity (deficit). As of September 30, 2023, marketable securities consist primarily of short-term United States treasuries.
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, ​ 2023 2022 Furniture and fixtures ​ $ 158,198 ​ $ 139,336 Laboratory equipment ​ 4,923,838 ​ 4,237,089 Leasehold improvements ​ 1,958,485 ​ 1,393,230 ​ ​ 7,040,521 ​ 5,769,655 Less accumulated depreciation ​ (1,900,841) ​ (1,181,625) Property and equipment, net ​ $ 5,139,680 ​ $ 4,588,030 ​
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 6 - “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 adopted ASU 606, Revenue for Contracts from Customers ​ The revenue standard provides a five-step framework for recognizing revenue as control of promised goods or services is transferred to a customer at an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. To determine revenue recognition for arrangements that it determines are within the scope of the revenue standard, the Company performs the following five steps: (i) identify the contract; (ii) identify the performance obligations; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the Company satisfies a performance obligation. At contract inception, the Company assesses whether the goods or services promised within each contract are distinct and, therefore, represent a separate performance obligation, or whether they are not distinct and are combined with other goods and services until a distinct bundle is identified. The Company then determines the transaction price, which typically includes upfront payments and any variable consideration that the Company determines is probable to not cause a significant reversal in the amount of cumulative revenue recognized when the uncertainty associated with the variable consideration is resolved. The Company then allocates the transaction price to each performance obligation and recognizes the associated revenue when, or as, each performance obligation is satisfied. ​ The Company’s distribution agreements may entitle it to additional payments upon the achievement of milestones or shares of product revenue. The milestones are generally categorized into three types: development milestones, regulatory milestones and sales-based milestones. The Company evaluates whether it is probable that the consideration associated with each milestone or shared revenue payments will not be subject to a significant reversal in the cumulative amount of revenue recognized. Amounts that meet this threshold are included in the transaction price using the most likely amount method, whereas amounts that do not meet this threshold are excluded from the transaction price until they meet this threshold. At the end of each subsequent reporting period, the Company re-evaluates the probability of a significant reversal of the cumulative revenue recognized for its milestones and royalties, and, if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect revenues and net income (loss) in the Company’s condensed consolidated statements of operation and comprehensive loss. Typically, milestone payments and shared revenue payments are achieved after the Company’s performance obligations associated with the distribution agreements have been completed and after the customer has assumed responsibility for the commercialization program. Milestones or shared revenue payments achieved after the Company’s performance obligations have been completed are recognized as revenue in the period the milestone or shared revenue payments was achieved. If a milestone payment is achieved during the performance period, the milestone payment would be recognized as revenue to the extent performance had been completed at that point, and the remaining balance would be recorded as deferred revenue. ​ The revenue standard requires the Company to assess whether a significant financing component exists in determining the transaction price. The Company performs this assessment at the onset of its distribution agreements. Typically, a significant financing component does not exist because the customer is paying for services in advance with an upfront payment. Additionally, future shared revenue payments are not substantially within the control of the Company or the customer. ​ Whenever the Company determines that goods or services promised in a contract should be accounted for as a combined performance obligation over time, the Company determines the period over which the performance obligations will be performed and revenue will be recognized. Revenue is recognized using either the proportional performance method or on a straight-line basis if efforts will be expended evenly over time. Percentage of completion of patient visits in clinical trials are used as the measure of performance. The Company feels this method of measurement to be the best depiction of the transfer of services and recognition of revenue. Significant management judgment is required in determining the level of effort required under an arrangement and the period over which the Company is expected to complete its performance obligations. If the Company determines that the performance obligation is satisfied over time, any upfront payment received is initially recorded as deferred revenue on its condensed consolidated balance sheets. ​ Certain judgments affect the application of the Company’s revenue recognition policy. For example, the Company records short-term (less than one year) and long-term (over one year) deferred revenue based on its best estimate of when such revenue will be recognized. This estimate is based on the Company’s current operating plan, and the Company may recognize a different amount of deferred revenue over the next 12-month period if its plan changes in the future. ​ Under the Exclusive Commercialization and Distribution Agreement for the U.S. (the “U.S. Distribution Agreement”) with Nippon Shinyaku the transaction price consists of variable shared revenue payments and fixed components in the form of an upfront payment and milestones. The timing of the fixed component of the transaction price is upfront, however, the performance obligation is satisfied over a period of time, which is the estimated duration of the HOPE-3 clinical trial. Therefore, upon receipt of the upfront payment, a contract liability is recorded which represents deferred revenue. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the related revenue recognition. 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 5 - “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. No grant income was recognized for the three and nine months ended September 30, 2023 and 2022.
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 (deficit) during the period except those resulting from investments by, or distributions to, stockholders. The Company’s comprehensive loss was approximately $6.5 million and $6.3 million for the three months ended September 30, 2023 and 2022, respectively, and approximately $21.5 million and $21.2 million for the nine months ended September 30, 2023 and 2022, respectively.
Clinical Trial Expense	Clinical Trial Expense As part of the process of preparing our condensed consolidated financial statements, we are required to estimate our accrued expenses. Our clinical trial accrual process is designed to account for expenses resulting from our obligations under contracts with vendors, consultants, contract research organizations (“CROs”), and clinical site agreements in connection with conducting clinical trials. The financial terms of these contracts are subject to negotiations, which vary from contract to contract and may result in payment flows that do not match the periods over which materials or services are provided to us under such contracts. Our objective is to reflect the appropriate clinical trial expenses in our condensed 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 condensed 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. For the three and nine months ended September 30, 2023, warrants and options to purchase 8,303,253 and 6,059,552 shares of common stock, respectively, have been excluded from the computation of potentially dilutive securities. Potentially dilutive shares of common stock, which primarily consist of stock options issued to employees, consultants, and directors as well as warrants issued, have been excluded from the diluted loss per share calculation because their effect is anti-dilutive. Because the impact of these items is anti-dilutive during periods of net loss, there was no difference between basic and diluted loss per share for the three and nine months ended September 30, 2023 and 2022.
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, 2023 and December 31, 2022 for assets and liabilities measured at fair value on a recurring basis: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ September 30, 2023 ​ Level I Level II Level III Total Marketable Securities ​ $ 19,536,805 ​ $ — ​ $ — ​ $ 19,536,805 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ December 31, 2022 ​ Level I Level II Level III Total Marketable Securities ​ $ 31,818,020 ​ $ — ​ $ — ​ $ 31,818,020 ​ Carrying amounts reported in the balance sheet of cash and cash equivalents, receivables, 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. As of September 30, 2023 and December 31, 2022, the amortized cost for these marketable securities was $19,423,597 and $31,712,777, respectively.
Recent Accounting Pronouncements	Recent Accounting Pronouncements 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, 2023
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, ​ 2023 2022 Furniture and fixtures ​ $ 158,198 ​ $ 139,336 Laboratory equipment ​ 4,923,838 ​ 4,237,089 Leasehold improvements ​ 1,958,485 ​ 1,393,230 ​ ​ 7,040,521 ​ 5,769,655 Less accumulated depreciation ​ (1,900,841) ​ (1,181,625) Property and equipment, net ​ $ 5,139,680 ​ $ 4,588,030
Schedule of fair value measurements	​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ September 30, 2023 ​ Level I Level II Level III Total Marketable Securities ​ $ 19,536,805 ​ $ — ​ $ — ​ $ 19,536,805 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ December 31, 2022 ​ Level I Level II Level III Total Marketable Securities ​ $ 31,818,020 ​ $ — ​ $ — ​ $ 31,818,020

STOCK AWARDS, WARRANTS AND OP_2

STOCK AWARDS, WARRANTS AND OPTIONS (Tables)	9 Months Ended
	Sep. 30, 2023
Warrant [Member]
Summary of warrant activity	The following table summarizes all warrant activity for the nine months ended September 30, 2023: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Weighted Average ​ Warrants Exercise Price Outstanding at December 31, 2022 105,782 ​ $ 1.37 Granted ​ — ​ ​ — Exercised ​ — ​ ​ — Outstanding at September 30, 2023 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 2023 2022 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, 2023 and 2022: ​ ​ ​ ​ ​ ​ ​ ​ Nine months ended September 30, ​ ​ 2023 ​ 2022 ​ Expected volatility 111 - 121 % 123 - 124 % Expected term 5 6 ​ Dividend yield 0 % 0 % Risk-free interest rates 3.5 - 4.5 % 1.5 - 3.9 %
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, ​ ​ 2023 2022 2023 2022 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ General and administrative ​ $ 1,235,219 ​ $ 943,075 ​ $ 4,157,704 ​ $ 2,711,296 ​ Research and development ​ 481,974 ​ 144,058 ​ 1,372,985 ​ 599,070 ​ Total ​ $ 1,717,193 ​ $ 1,087,133 ​ $ 5,530,689 ​ $ 3,310,366 ​
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, 2023: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Number of ​ Weighted Average ​ Aggregate ​ Options Exercise Price Intrinsic Value Outstanding at December 31, 2022 5,776,839 ​ $ 2.97 ​ ​ Granted 3,287,979 ​ 4.36 ​ Exercised (180,227) ​ 2.56 $ 364,525 Expired/Cancelled (687,120) ​ 3.80 ​ Outstanding at September 30, 2023 8,197,471 ​ $ 3.47 ​ $ 3,692,525 Exercisable at September 30, 2023 3,859,994 ​ $ 2.83 ​ $ 3,173,089

COMMITMENTS AND CONTINGENCIES (

COMMITMENTS AND CONTINGENCIES (Tables)	9 Months Ended
	Sep. 30, 2023
COMMITMENTS AND CONTINGENCIES
Schedule of Future Minimum Rental Payments	​ ​ ​ ​ ​ 2023 (remainder) ​ $ 219,952 2024 ​ ​ 886,672 2025 ​ ​ 910,106 2026 ​ ​ 676,908 2027 ​ ​ — Total minimum lease payments ​ ​ 2,693,638 Less: imputed interest ​ ​ (280,415) Total operating lease liabilities ​ $ 2,413,223 Included in the condensed consolidated balance sheet: ​ ​ ​ Current portion of lease liabilities ​ $ 729,567 Lease liabilities, net of current ​ ​ 1,683,656 Total operating lease liabilities ​ $ 2,413,223 ​ ​ ​ ​ Other Information: ​ ​ ​ Weighted average remaining lease term ​ ​ 2.98 years Weighted average discount rate ​ ​ 7.24%
Schedule of operating lease cost	​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Three months ended September 30, ​ Nine months ended September 30, ​ 2023 2022 2023 2022 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Lease costs, unrelated parties ​ $ 165,921 ​ $ 157,924 ​ $ 486,894 ​ $ 474,092 Lease costs, related parties ​ 32,120 ​ 32,120 ​ ​ 96,359 ​ ​ 96,359 Lease payments, unrelated parties ​ ​ 166,938 ​ 135,137 ​ ​ 500,814 ​ ​ 305,840 Lease payments, related parties ​ ​ 32,120 ​ 32,120 ​ ​ 96,359 ​ ​ 96,359

ORGANIZATION AND SUMMARY OF S_4

ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Property and Equipment (Details) - USD ($)	Sep. 30, 2023	Dec. 31, 2022
Property, Plant and Equipment, Gross	$ 7,040,521	$ 5,769,655
Less accumulated depreciation	(1,900,841)	(1,181,625)
Property and equipment, net	5,139,680	4,588,030
Furniture and fixtures
Property, Plant and Equipment, Gross	158,198	139,336
Laboratory equipment
Property, Plant and Equipment, Gross	4,923,838	4,237,089
Leasehold improvements
Property, Plant and Equipment, Gross	$ 1,958,485	$ 1,393,230

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, 2023	Sep. 30, 2023	Mar. 31, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022	Dec. 31, 2021	Dec. 31, 2022	Dec. 31, 2020
Accounting Policies [Line Items]
Cash, cash equivalents, and marketable securities	$ 28,500,000	$ 28,500,000			$ 28,500,000			$ 41,400,000
Milestone payment received					(1,089,977)	$ 28,408,434
Revenue recognized under "ERC"	191,463						$ 191,199
Receivables under "ERC"	$ 547,580	547,580			547,580		$ 738,778		$ 738,778
Depreciation		276,471		$ 137,028	761,274	341,529
Research and development		10,028,964		5,504,356	26,507,872	15,585,143
Comprehensive loss		$ 6,457,093		$ 6,271,478	$ 21,517,489	$ 21,176,153
Antidilutive securities		8,303,253		6,059,552	8,303,253	6,059,552
Grant Income		$ 0		$ 0	$ 0	$ 0
Commercialization and Distribution Agreement with Nippon Shinyaku Co, Limited, Japan
Accounting Policies [Line Items]
Milestone payment received			$ 12,000,000
Minimum
Accounting Policies [Line Items]
Estimated useful lives (in years)	5 years	5 years			5 years
Maximum
Accounting Policies [Line Items]
Estimated useful lives (in years)	7 years	7 years			7 years

ORGANIZATION AND SUMMARY OF S_6

ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Fair value measurements by Levels (Details) - USD ($)	Sep. 30, 2023	Dec. 31, 2022
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Amortized Cost of Marketable Securities	$ 19,423,597	$ 31,712,777
Recurring
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Marketable Securities	19,536,805	31,818,020
Level 1 | Recurring
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Marketable Securities	$ 19,536,805	$ 31,818,020

STOCKHOLDER'S EQUITY (Details)

STOCKHOLDER'S EQUITY (Details) - USD ($)		9 Months Ended		27 Months Ended
	Jun. 22, 2021	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Dec. 31, 2022
Class of Stock [Line Items]
Commission rate on sale price per share		3%
Gross proceeds from sale of common stock		$ 2,351,476	$ 1,880,324
Common stock, shares issued		25,855,070		25,855,070	25,241,402
Common stock, shares outstanding		25,855,070		25,855,070	25,241,402
June 2021 ATM Program
Class of Stock [Line Items]
Maximum aggregate offering price	$ 75,000,000
Number of common stock shares issued				2,620,703
Average price		$ 5.74		$ 5.74
Gross proceeds from sale of common stock				$ 15,000,000
Issuance costs				$ 500,000

STOCK AWARDS, WARRANTS AND OP_3

STOCK AWARDS, WARRANTS AND OPTIONS - Warrants (Details)	Sep. 30, 2023 $ / 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, 2023	Dec. 31, 2022
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
	Sep. 30, 2023	Sep. 30, 2022
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Expected volatility, Maximum	121%	124%
Expected volatility, Minimum	111%	123%
Dividend yield	0%	0%
Risk-free interest rates, Minimum	3.50%	1.50%
Risk-free interest rates, Maximum	4.50%	3.90%
Minimum
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Expected term	5 years	6 years
Maximum
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Expected term	7 years	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, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items]
Stock-based compensation cost	$ 1,717,193	$ 1,087,133	$ 5,530,689	$ 3,310,366
General and administrative
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items]
Stock-based compensation cost	1,235,219	943,075	4,157,704	2,711,296
Research and development
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items]
Stock-based compensation cost	$ 481,974	$ 144,058	$ 1,372,985	$ 599,070

STOCK AWARDS, WARRANTS AND OP_7

STOCK AWARDS, WARRANTS AND OPTIONS - Stock Option Activity (Details) - Stock Option - USD ($)	9 Months Ended
	Sep. 30, 2023
Number of Options
Outstanding at Beginning of the period	5,776,839
Granted	3,287,979
Exercised	(180,227)
Expired/Cancelled	(687,120)
Outstanding at End of the period	8,197,471
Exercisable	3,859,994
Weighted Average Exercise Price
Outstanding at Beginning of the period	$ 2.97
Granted	4.36
Exercised	2.56
Expired/Cancelled	3.80
Outstanding at Ending of the period	3.47
Exercisable	$ 2.83
Aggregate Intrinsic Value
Exercised	$ 364,525
Outstanding	3,692,525
Exercisable	$ 3,173,089

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, 2023 shares	Jan. 01, 2022 shares	Jun. 11, 2021 shares	Jan. 01, 2021 shares	Jun. 30, 2021 shares	Sep. 30, 2023 USD ($) $ / shares shares	Sep. 30, 2022 $ / shares	Sep. 30, 2023 USD ($) item $ / shares shares	Sep. 30, 2022 $ / shares	Jun. 30, 2020 shares
Disclosure Stockholders Equity, stock Options And Warrants Additional Information [Line Items]
Number of plans | item								5
Percentage of outstanding shares					5%
Number of shares available for issuance						1,264,429		1,264,429
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						$ 4.93	$ 4.41	$ 3.88	$ 3.04
Total unrecognized fair value compensation cost | $						$ 14,400,000		$ 14,400,000
Weighted average period								1 year 6 months
Stock Option | Stock Option Plan 2020
Disclosure Stockholders Equity, stock Options And Warrants Additional Information [Line Items]
Number of shares authorized for issuance										2,500,000
Number of additional shares authorized			0	823,084
Stock Option | Stock Option Plan 2021
Disclosure Stockholders Equity, stock Options And Warrants Additional Information [Line Items]
Number of shares authorized for issuance					3,500,000
Number of additional shares authorized	1,262,070	1,209,250
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, 2023 USD ($) item
CONCENTRATIONS
Number of financial institutions | item	3
Cash, FDIC insured amount	$ 250,000
Cash, uninsured deposits	$ 28,300,000

GOVERNMENT GRANT AWARDS (Detail

GOVERNMENT GRANT AWARDS (Details) - California Institute for Regenerative Medicine $ in Millions		9 Months Ended
	Jun. 16, 2016 USD ($) item	Sep. 30, 2023 USD ($)
Minimum expected contribution	$ 2.3
Number of times, maximum royalty to be paid on total amount of award | item	9
Term of award		10 years
Debt term		5 years
Grant award liability	$ 3.4	$ 3.4
LIBOR Member
Interest rate		1%

COMMITMENTS AND CONTINGENCIES -

COMMITMENTS AND CONTINGENCIES - Future Minimum Rental Payments (Details) - USD ($)	Sep. 30, 2023	Dec. 31, 2022
COMMITMENTS AND CONTINGENCIES
2023 (remainder)	$ 219,952
2024	886,672
2025	910,106
2026	676,908
Total minimum lease payments	2,693,638
Less: imputed interest	(280,415)
Total operating lease liabilities	2,413,223
Included in the condensed consolidated balance sheet:
Current portion of lease liabilities	729,567	$ 682,039
Lease liabilities, net of current	1,683,656	$ 1,878,070
Total operating lease liabilities	$ 2,413,223
Weighted average remaining lease term	2 years 11 months 23 days
Weighted average discount rate	7.24%

COMMITMENTS AND CONTINGENCIES_2

COMMITMENTS AND CONTINGENCIES - Additional Information (Details) - USD ($)

1 Months Ended

3 Months Ended

9 Months Ended

Oct. 01, 2023

Jul. 01, 2023

Dec. 01, 2022

Jul. 01, 2022

Nov. 01, 2021

Oct. 01, 2021

Sep. 30, 2023

Dec. 31, 2022

Jul. 31, 2022

Sep. 30, 2023

Sep. 30, 2022

Sep. 30, 2023

Sep. 30, 2022

COMMITMENTS AND CONTINGENCIES

Base rent per month

$ 58,409

Operating lease, ROU asset

$ 2,217,009

$ 2,349,974

$ 2,217,009

$ 2,217,009

Operating lease, ROU liability

2,413,223

2,413,223

$ 2,413,223

Number of months of base salary

6 months

Restructuring reserve

$ 0

$ 0

$ 0

Short-term offices lease

COMMITMENTS AND CONTINGENCIES

Base rent per month

$ 7,619

$ 7,869

Written Notice Period

90 days

Facilities Lease

COMMITMENTS AND CONTINGENCIES

Lease renewal term

24 months

24 months

24 months

24 months

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

$ 51,444

Operating lease percentage

3%

Monthly lease payment

$ 49,322

Vivarium Space Lease [Member]

COMMITMENTS AND CONTINGENCIES

Lease renewal term

1 year

Base rent per month

$ 4,021

$ 4,202

Written Notice Period

60 days

Monthly rent escalation, percentage

4.50%

Vivarium Space Lease [Member] | Minimum

COMMITMENTS AND CONTINGENCIES

Lease term

1 year

Vivarium Space Lease [Member] | Maximum

COMMITMENTS AND CONTINGENCIES

Lease term

5 years

Facilities Lease

COMMITMENTS AND CONTINGENCIES

Base rent per month

$ 11,028

$ 10,707

Unrelated Party

COMMITMENTS AND CONTINGENCIES

Operating lease expense

$ 165,921

$ 157,924

$ 486,894

$ 474,092

Operating lease payments

166,938

135,137

500,814

305,840

Unrelated Party | Short-term offices lease

COMMITMENTS AND CONTINGENCIES

Operating lease expense

22,857

23,340

70,071

58,128

Related Party [Member]

COMMITMENTS AND CONTINGENCIES

Operating lease expense

32,120

32,120

96,359

96,359

Operating lease payments

$ 32,120

$ 32,120

$ 96,359

$ 96,359

LICENSE AGREEMENTS (Details)

LICENSE AGREEMENTS (Details)		1 Months Ended	3 Months Ended				9 Months Ended
	Apr. 28, 2021 USD ($)	Mar. 31, 2022 USD ($)	Sep. 30, 2023 USD ($)	Mar. 31, 2023 USD ($)	Sep. 30, 2022 USD ($)	Mar. 31, 2022 USD ($)	Sep. 30, 2023 USD ($)	Sep. 30, 2023 EUR (€)	Sep. 30, 2022 USD ($)	Dec. 31, 2022 USD ($)	Jan. 24, 2022 USD ($)
LICENSE AGREEMENTS
Milestone payment received							$ (1,089,977)		$ 28,408,434
Revenue			$ 6,185,814		$ 1,591,566		13,089,977		$ 1,591,566
Deferred revenue, current			25,405,084				25,405,084			$ 17,980,599
Deferred revenue, net of current			953,470				953,470			$ 9,467,932
Commercialization and Distribution Agreement with Nippon Shinyaku Co, Limited, United States
LICENSE AGREEMENTS
Potential milestone payments			100,000,000				100,000,000
Upfront Payment						$ 30,000,000
Deferred revenue liability		$ 30,000,000	14,400,000			30,000,000	14,400,000
Revenue			6,200,000				13,100,000
Deferred revenue, current			13,400,000				13,400,000
Deferred revenue, net of current			$ 1,000,000				$ 1,000,000
Commercialization and Distribution Agreement with Nippon Shinyaku Co, Limited, United States | Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2023-07-01
LICENSE AGREEMENTS
Revenue, Remaining Performance Obligation, Percentage			93%				93%
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Period			3 months				3 months
Commercialization and Distribution Agreement with Nippon Shinyaku Co, Limited, United States | Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2024-07-01
LICENSE AGREEMENTS
Revenue, Remaining Performance Obligation, Percentage			93%				93%
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Period			12 months				12 months
Commercialization and Distribution Agreement with Nippon Shinyaku Co, Limited, Japan
LICENSE AGREEMENTS
Potential milestone payments				$ 89,000,000
Upfront Payment				12,000,000
Milestone payment received				$ 12,000,000
Deferred revenue liability			$ 12,000,000				$ 12,000,000
Deferred revenue, current			12,000,000				$ 12,000,000
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 | Commercialization and Distribution Agreement with Nippon Shinyaku Co, Limited, United States
LICENSE AGREEMENTS
Potential milestone payments											$ 705,000,000
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) - USD ($)	1 Months Ended		9 Months Ended		12 Months Ended
	Jan. 31, 2022	Jul. 31, 2020	Sep. 30, 2023	Sep. 30, 2022	Dec. 31, 2013	Dec. 31, 2022
RELATED PARTY TRANSACTIONS
Accounts payable and accrued expenses, related party			$ 20,178			$ 89,234
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	50,000	50,000
CSMC
RELATED PARTY TRANSACTIONS
Accounts payable and accrued expenses, related party			10,022			$ 79,234
Payment for reimbursement for research and development, license and patent fees and facilities rent expenses incurred by related party			$ 194,400	$ 752,800

SUBSEQUENT EVENTS (Details)

SUBSEQUENT EVENTS (Details) - USD ($)		9 Months Ended
	Oct. 03, 2023	Sep. 30, 2023	Sep. 30, 2022	Dec. 31, 2022
SUBSEQUENT EVENTS
Common Stock, par value (in dollars per share)		$ 0.001		$ 0.001
Gross proceeds from sale of common stock		$ 2,351,476	$ 1,880,324
Registered Direct Offering [Member]
SUBSEQUENT EVENTS
Gross proceeds from sale of common stock	$ 23,000,000
Registered Direct Offering [Member] | Maximum
SUBSEQUENT EVENTS
Number of common stock shares issued	4,935,621
Subsequent event | Registered Direct Offering
SUBSEQUENT EVENTS
Number of common stock shares issued	4,935,621
Common Stock, par value (in dollars per share)	$ 0.001
Average price	$ 4.66
Gross proceeds from sale of common stock	$ 23,000,000
Exercise Price per Share	$ 5.70
Warrant to purchase	1
Lock up period, not to issue or sell shares	30 days
Agreement expiry term	60 days
Subsequent event | Registered Direct Offering | Minimum
SUBSEQUENT EVENTS
Warrants and rights outstanding, term	6 months
Subsequent event | Registered Direct Offering | Maximum
SUBSEQUENT EVENTS
Warrants and rights outstanding, term	7 years