Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2021 | Mar. 09, 2022 | Jun. 30, 2021 | |
Document and Entity Information | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Document Period End Date | Dec. 31, 2021 | ||
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 | ||
Entity Address, City or Town | San Diego | ||
Entity Address, State or Province | CA | ||
Entity Address, Postal Zip Code | 92121 | ||
City Area Code | 310 | ||
Local Phone Number | 358-3200 | ||
Title of 12(b) Security | Common Stock, par value $0.001 per share | ||
Trading Symbol | CAPR | ||
Security Exchange Name | NASDAQ | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
Entity Shell Company | false | ||
Entity Common Stock, Shares Outstanding | 24,298,406 | ||
Entity Public Float | $ 115,331,070 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Fiscal Year Focus | 2021 | ||
Document Fiscal Period Focus | FY | ||
Entity Central Index Key | 0001133869 | ||
Amendment Flag | false | ||
ICFR Auditor Attestation Flag | false | ||
Auditor Name | Rose, Snyder & Jacobs LLP | ||
Auditor Firm ID | 468 | ||
Auditor Location | Encino, California |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 |
CURRENT ASSETS | ||
Cash and cash equivalents | $ 34,885,274 | $ 32,665,874 |
Receivables | 391,750 | 0 |
Prepaid expenses and other current assets | 1,159,937 | 1,011,209 |
TOTAL CURRENT ASSETS | 36,436,961 | 33,677,083 |
PROPERTY AND EQUIPMENT, net | 1,795,696 | 850,847 |
OTHER ASSETS | ||
Intangible assets, net of accumulated amortization of $259,682 and $257,517, respectively | 0 | 2,165 |
Lease right-of-use assets, net | 2,821,944 | 0 |
Other assets | 275,722 | 88,701 |
TOTAL ASSETS | 41,330,323 | 34,618,796 |
CURRENT LIABILITIES | ||
Accounts payable and accrued expenses | 3,116,371 | 2,715,621 |
Accounts payable and accrued expenses, related party | 599,388 | 8,972 |
Note payable, current | 0 | 246,689 |
Lease liabilities, current | 417,632 | 0 |
TOTAL CURRENT LIABILITIES | 4,133,391 | 2,971,282 |
LONG-TERM LIABILITIES | ||
Note payable, net of current | 0 | 71,471 |
CIRM liability | 3,376,259 | 3,376,259 |
Lease liabilities, net of current | 2,452,707 | 0 |
TOTAL LONG-TERM LIABILITIES | 5,828,966 | 3,447,730 |
TOTAL LIABILITIES | 9,962,357 | 6,419,012 |
COMMITMENTS AND CONTINGENCIES (NOTE 7) | ||
STOCKHOLDERS' EQUITY | ||
Preferred stock, $0.001 par value, 5,000,000 shares authorized, none issued and outstanding | ||
Common stock, $0.001 par value, 50,000,000 shares authorized, 24,185,001 and 20,577,123 shares issued and outstanding, respectively | 24,185 | 20,577 |
Additional paid-in capital | 139,404,060 | 116,216,966 |
Accumulated deficit | (108,060,279) | (88,037,759) |
TOTAL STOCKHOLDERS' EQUITY | 31,367,966 | 28,199,784 |
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $ 41,330,323 | $ 34,618,796 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 |
CONSOLIDATED BALANCE SHEETS | ||
Net of accumulated amortization (in dollars) | $ 259,682 | $ 257,517 |
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 5,000,000 | 5,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common Stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 50,000,000 | 50,000,000 |
Common stock, shares issued | 24,185,001 | 20,577,123 |
Common stock, shares outstanding | 24,185,001 | 20,577,123 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
REVENUE | ||
Revenue | $ 244,898 | $ 310,250 |
TOTAL REVENUE | 244,898 | 310,250 |
OPERATING EXPENSES | ||
Research and development | 13,571,045 | 8,457,000 |
General and administrative | 7,612,295 | 5,543,221 |
TOTAL OPERATING EXPENSES | 21,183,340 | 14,000,221 |
LOSS FROM OPERATIONS | (20,938,442) | (13,689,971) |
OTHER INCOME (EXPENSE) | ||
Other income | 548,207 | |
Investment income | 57,460 | 32,943 |
Forgiveness of debt | 318,160 | 0 |
Loss on disposal of fixed asset | (7,905) | 0 |
TOTAL OTHER INCOME (EXPENSE) | 915,922 | 32,943 |
NET LOSS | (20,022,520) | (13,657,028) |
OTHER COMPREHENSIVE INCOME (LOSS) | ||
Net unrealized gain on marketable securities | 0 | 757 |
COMPREHENSIVE LOSS | $ (20,022,520) | $ (13,656,271) |
Net loss per share, basic | $ (0.87) | $ (0.88) |
Net loss per share, diluted | $ (0.87) | $ (0.88) |
Weighted-average number of shares of common stock outstanding basic | 23,089,323 | 15,571,056 |
Weighted-average number of shares of common stock outstanding diluted | 23,089,323 | 15,571,056 |
CONSOLIDATED STATEMENTS OF CHAN
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY - USD ($) | COMMON STOCK [Member] | ADDITIONAL PAID-IN CAPITAL [Member] | OTHER COMPREHENSIVE INCOME (LOSS) [Member] | ACCUMULATED DEFICIT [Member] | Total |
Balance at Dec. 31, 2019 | $ 5,227 | $ 81,215,647 | $ (757) | $ (74,380,731) | $ 6,839,386 |
Balance (in shares) at Dec. 31, 2019 | 5,227,398 | ||||
Issuance of common stock, net of fees | $ 4,174 | 27,338,895 | 27,343,069 | ||
Issuance of common stock, net of fees (in shares) | 4,173,478 | ||||
Exercise of pre-funded common stock warrants | $ 3,158 | 3,158 | |||
Exercise of pre-funded common stock warrants (in shares) | 3,158,304 | ||||
Exercise of common warrants | $ 4,417 | 5,680,943 | 5,685,360 | ||
Exercise of common warrants (in shares) | 4,417,219 | ||||
Issuance of shares in abeyance | $ 3,556 | (3,556) | |||
Issuance of shares in abeyance (in shares) | 3,555,500 | ||||
Stock-based compensation | 1,952,679 | 1,952,679 | |||
Stock options exercised | $ 45 | 32,358 | 32,403 | ||
Stock options exercised (in shares) | 45,224 | ||||
Unrealized gain on marketable securities | $ 757 | 757 | |||
Net loss | (13,657,028) | (13,657,028) | |||
Balance at Dec. 31, 2020 | $ 20,577 | 116,216,966 | (88,037,759) | 28,199,784 | |
Balance (in shares) at Dec. 31, 2020 | 20,577,123 | ||||
Issuance of common stock, net of fees | $ 3,566 | 20,170,882 | 20,174,448 | ||
Issuance of common stock, net of fees (in shares) | 3,566,349 | ||||
Exercise of common warrants | $ 20 | 22,410 | 22,430 | ||
Exercise of common warrants (in shares) | 20,391 | ||||
Stock-based compensation | 2,965,692 | 2,965,692 | |||
Stock options exercised | $ 22 | 28,110 | 28,132 | ||
Stock options exercised (in shares) | 21,138 | ||||
Unrealized gain on marketable securities | 0 | ||||
Net loss | (20,022,520) | (20,022,520) | |||
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 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Cash flows from operating activities: | ||
Net loss | $ (20,022,520) | $ (13,657,028) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Loss on disposal of fixed assets | 7,905 | 0 |
Depreciation and amortization | 245,697 | 143,890 |
Stock-based compensation | 2,965,692 | 1,952,679 |
Forgiveness of debt | (318,160) | 0 |
Non-cash lease expense | 129,726 | 0 |
Change in assets - (increase) decrease: | ||
Receivables | (391,750) | 87,968 |
Prepaid expenses and other current assets | (148,728) | (439,827) |
Other assets | (187,021) | 30,907 |
Change in liabilities - increase (decrease): | ||
Accounts payable and accrued expenses | 400,750 | 1,839,944 |
Accounts payable and accrued expenses, related party | 590,416 | (13,343) |
Operating lease liabilities | (81,331) | 0 |
Net cash used in operating activities | (16,809,324) | (10,054,810) |
Cash flows from investing activities: | ||
Purchase of marketable securities | 0 | (6,130,193) |
Proceeds from sales and maturities of marketable securities | 0 | 12,117,000 |
Purchases of property and equipment | (1,196,286) | (547,601) |
Net cash provided by (used in) investing activities | (1,196,286) | 5,439,206 |
Cash flows from financing activities: | ||
Net proceeds from sale of common stock | 20,174,448 | 27,343,069 |
Proceeds from note payable | 0 | 318,160 |
Proceeds from exercise of stock awards | 50,562 | 5,720,921 |
Net cash provided by financing activities | 20,225,010 | 33,382,150 |
Net increase in cash and cash equivalents | 2,219,400 | 28,766,546 |
Cash and cash equivalents balance at beginning of period | 32,665,874 | 3,899,328 |
Cash and cash equivalents balance at end of period | 34,885,274 | 32,665,874 |
Supplemental disclosures of cash flow information: | ||
Interest paid in cash | 0 | 0 |
Income taxes paid in cash | $ 0 | $ 0 |
ORGANIZATION AND SUMMARY OF SIG
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 12 Months Ended |
Dec. 31, 2021 | |
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 biotechnology company focused on the development of transformative cell and exosome-based therapeutics for the treatment and prevention of a broad spectrum of diseases. Capricor, Inc. (“Capricor”), a wholly-owned subsidiary of Capricor Therapeutics, was founded in 2005 as a Delaware corporation based on the innovative work of its founder, Eduardo Marbán, M.D., Ph.D. After completion of a merger between Capricor and a subsidiary of Nile Therapeutics, Inc., a Delaware corporation (“Nile”), on November 20, 2013, Capricor became a wholly-owned subsidiary of Nile and Nile formally changed its name to Capricor Therapeutics, Inc. Capricor Therapeutics, together with its subsidiary, Capricor, has multiple active drug and vaccine candidates in various stages of development. Basis of Consolidation Our consolidated financial statements include the accounts of the Company and our wholly-owned subsidiary. All intercompany transactions have been eliminated in consolidation. Reclassification Certain reclassification of prior period amounts has been made to conform to the current year presentation. Liquidity The Company has historically financed its research and development activities as well as operational expenses from equity financings, government grants, a payment from a former collaboration partner, a loan award and a grant from the California Institute for Regenerative Medicine (“CIRM”). Cash and cash equivalents as of December 31, 2021 were approximately $34.9 million, compared to approximately $32.7 million as of December 31, 2020. The Company has entered into a Common Stock Sales Agreement with H.C. Wainwright & Co. LLC (“Wainwright”) to create at-the-market equity programs under which the Company from time to time offered and sold shares of its common stock, par value $0.001 per share (see Note 3 – “Stockholders’ Equity”). The Company’s principal uses of cash are for research and development expenses, general and administrative expenses, capital expenditures and other working capital requirements. The Company’s future expenditures and capital requirements may be substantial and will depend on many factors, including, but not limited to, the following: ● the timing and costs associated with its research and development activities, clinical trials and preclinical studies; ● the timing and costs associated with the manufacturing of its product candidates; ● the timing and costs associated with commercialization of its product candidates; ● the number and scope of its research programs; and ● the costs involved in prosecuting and enforcing patent claims and other intellectual property rights. The Company’s options for raising additional capital include potentially seeking additional financing primarily from, but not limited to, the sale and issuance of equity or debt securities, the licensing or sale of its technology and other assets, potential partnering opportunities, and from government grants. The Company will require substantial additional capital to fund its operations, in particular if it elects to expand its clinical programs as contemplated by its current business plan. The Company cannot provide assurances that financing will be available when and as needed or that, if available, financing will be available on favorable or acceptable terms. If the Company is unable to obtain additional financing when and if required, it would have a material adverse effect on the Company’s business and results of operations. The Company would likely need to delay, curtail or terminate all or portions of its clinical trial programs. To the extent the Company issues additional equity securities, its existing stockholders would experience substantial dilution. Business Uncertainty Related to the Coronavirus The COVID-19 pandemic has presented a substantial public health and economic challenge around the world. Our business operations and financial condition and results have been impacted to varying degrees, and we expect the impact will continue in future quarters. We are continuing to assess and plan our development for the ongoing and potential impact of the COVID-19 pandemic on our business, operations and financial condition and results. Despite careful tracking and planning, however, we are unable to accurately predict the extent of the impact of the pandemic on our business, results of operations and financial condition due to the uncertainty of future developments involving the pandemic and its impact on our employees and operations. The full extent to which the COVID-19 pandemic will directly or indirectly impact our business, results of operations and financial condition will depend on future developments that are highly uncertain and cannot be accurately predicted, including new information that may emerge concerning COVID-19, the actions taken to contain it or treat its impact and the economic impact on local, regional, national and international markets. In addition, there may be risks to the Company’s ability to obtain financing from other sources due to the impact of the coronavirus. There could be other financial impacts on our business due to the coronavirus, the specifics of which are unknown at this time. In light of uncertainties due to COVID-19 and its economic and other impacts and to uncertainties around the timing and availability of grant disbursements, the loss of revenue from the delays of the REGRESS and ALPHA trials as well as any potential equity and debt financings, the Company applied for a loan under the Small Business Administration (the “SBA”) Paycheck Protection Program of the Coronavirus Aid, Relief and Economic Security Act of 2020 (the “CARES Act”). On April 29, 2020, the Company was approved and received a loan of $318,160 (the “Loan”) under the SBA Paycheck Protection Program of the CARES Act (see Note 2 – “Note Payable”). The Employee Retention Credit (“ERC”), a credit against certain payroll taxes allowed to an eligible employer for qualifying wages, was established by the CARES Act. The Company recorded $548,207 in ERC as other income for the year ended December 31, 2021, of which $356,997 is recorded as a receivable as of December 31, 2021. The Company may submit for additional credits under the CARES Act in the future, as applicable. Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements. Estimates also affect the reported amounts of revenues and expenses during the reporting period. The most sensitive estimates relate to the assumptions used to estimate stock-based compensation expense. Management uses its historical records and knowledge of its business in making these estimates. Accordingly, actual results may differ from these estimates. Cash and Cash Equivalents The Company considers all highly liquid investments with a maturity of less than 30 days at the date of purchase to be cash equivalents. Marketable Securities The Company determines the appropriate classification of its marketable securities at the time of purchase and reevaluates such designation at each balance sheet date. All of the Company’s marketable securities are considered as available-for-sale and carried at estimated fair values. Realized gains and losses on the sale of debt and equity securities are determined using the specific identification method. Unrealized gains and losses on available-for-sale securities are excluded from net income (loss) and reported in accumulated other comprehensive income (loss) as a separate component of stockholders’ equity. Property and Equipment Property and equipment are stated at cost. Repairs and maintenance costs are expensed in the period incurred. Depreciation is computed using the straight-line method over the related estimated useful life of the asset, which such estimated useful lives range from five Property and equipment, net consisted of the following: December 31, December 31, 2021 2020 Furniture and fixtures $ 43,123 $ 48,676 Laboratory equipment 2,475,543 1,473,708 Leasehold improvements 33,742 47,043 2,552,408 1,569,427 Less accumulated depreciation (756,712) (718,580) Property and equipment, net $ 1,795,696 $ 850,847 Intangible Assets Amounts attributable to intellectual property consist primarily of the costs associated with the acquisition of certain technologies, patents, pending patents and related intangible assets with respect to research and development activities. Certain intellectual property assets are stated at cost and amortized on a straight-line basis over the respective estimated useful lives of the assets ranging from five The Company reviews goodwill and intangible assets at least annually for possible impairment. Goodwill and intangible assets are reviewed for possible impairment between annual tests if an event occurs or circumstances change that would more likely than not reduce the fair value of the reporting unit below its carrying value. No impairment was recorded for the years ended December 31, 2021 and 2020. Long-Lived Assets The Company accounts for the impairment and disposition of long-lived assets in accordance with guidance issued by the FASB. Long-lived assets to be held and used are reviewed for events or changes in circumstances that indicate that their carrying value may not be recoverable, or annually. No impairment related to long-lived assets was recorded for the years ended December 31, 2021 and 2020. Leases ASC Topic 842, “Leases” (“ASC 842”), as adopted in the first quarter of 2019, requires lessees to recognize most leases on the balance sheet with a corresponding right-to-use asset (“ROU asset”). ROU assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent the Company’s obligation to make lease payments arising from the lease. The assets and lease liabilities are recognized at the lease commencement date based on the estimated present value of fixed lease payments over the lease term. ROU assets are evaluated for impairment using the long-lived assets impairment guidance. Leases will be classified as financing or operating, which will drive the expense recognition pattern. The Company elects to exclude short-term leases if and when the Company has them. The Company leases office and laboratory space, all of which are operating leases (see Note 7 - “Commitments and Contingencies”). Most leases include the option to renew and the exercise of the renewal options is at the Company’s sole discretion. Options to renew a lease are not included in the Company’s assessment unless there is reasonable certainty that the Company will renew. In addition, the Company’s lease agreements generally do not contain any residual value guarantees or restrictive covenants. The interest rate implicit in lease contracts is typically not readily determinable. As a result, the Company utilizes its incremental borrowing rate, which reflects the fixed rate at which the Company could borrow on a collateralized basis the amount of the lease payments in the same currency, for a similar term, in a similar economic environment. For real estate leases, the Company has elected the practical expedient under ASC 842 to account for the lease and non-lease components together for existing classes of underlying assets and allocates the contract consideration to the lease component only. This practical expedient is not elected for manufacturing facilities and equipment embedded in product supply arrangements. Revenue Recognition The company applies ASU 606, Revenue from Contracts with Customers Government Research Grants Generally, government research grants that provide funding for research and development activities are recognized as income when the related expenses are incurred, as applicable. Because the terms of the grant award from CIRM (the “CIRM Award”) allow Capricor to elect to convert the grant into a loan after the end of the project period, the CIRM Award is being classified as a liability rather than income (see Note 6 - “Government Grant Awards”). Grant income is due upon submission of a reimbursement request. The transaction price varies for grant income based on the expenses incurred under the awards. Miscellaneous Income Revenue is recognized in connection with the delivery of doses which were developed as part of our past R&D efforts. Income is recorded when the Company has satisfied the obligations as identified in the contracts with the customer (see Note 9 – “Related Party Transactions”). Miscellaneous income is due upon billing. Miscellaneous income is based on contracts with fixed transaction prices. Income Taxes Income taxes are recognized for the amount of taxes payable or refundable for the current year and deferred tax liabilities and assets are recognized for the future tax consequences of transactions that have been recognized in the Company’s financial statements or tax returns. A valuation allowance is provided when it is more likely than not that some portion or the entire deferred tax asset will not be realized. The Company uses guidance issued by the FASB that clarifies the accounting for uncertainty in income taxes recognized in an enterprise’s financial statements and prescribes a recognition threshold of more likely than not and a measurement process for financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. In making this assessment, a company must determine whether it is more likely than not that a tax position will be sustained upon examination, based solely on the technical merits of the position, and must assume that the tax position will be examined by taxing authorities. As of December 31, 2021, the Company had federal net operating loss carryforwards of approximately $124.3 million, available to reduce future taxable income, of which $76.1 million will begin to expire in 2027. The post December 31, 2017 net operating losses generated of $48.2 million will carryforward indefinitely, but may be subject to an 80% limitation upon utilization. As of December 31, 2021, the Company had state net operating loss carryforwards of approximately $121.1 million, available to reduce future taxable income, which will begin to expire in 2028. Utilization of these net operating losses could be limited under Section 382 of the Internal Revenue Code of 1986, as amended (the “Code”), and similar state laws based on ownership changes and the value of the Company’s stock. Additionally, currently, the Company has approximately $1.4 million of federal research and development credits and approximately $3.4 million of federal orphan drug credits, available to offset future taxable income. These federal research and development and orphan drug credits begin to expire in 2027 and 2035, respectively. Under Section 382 of the Code, the Company’s ability to utilize NOL carryforwards or other tax attributes, such as federal tax credits, in any taxable year may be limited if the Company has experienced an “ownership change.” Generally, a Section 382 ownership change occurs if one or more stockholders or groups of stockholders who owns at least 5% of a corporation’s stock increases its ownership by more than 50 percentage points over its lowest ownership percentage within a specified testing period. Similar rules may apply under state tax laws. We have experienced an ownership change that we believe under Section 382 of the Code will result in limitation in our ability to utilize net operating losses and credits. In addition, the Company may experience future ownership changes as a result of future offerings or other changes in ownership of its stock. As a result, the amount of the NOLs and tax credit carryforward presented in the financial statement could be limited and may expire unutilized. The Company’s net operating loss carryforwards are subject to Internal Revenue Service (“IRS”) examination until they are fully utilized and such tax years are closed. The Company’s policy is to include interest and penalties related to unrecognized tax benefits in income tax expense. The Company incurred no interest or penalties for the years ended December 31, 2021 and 2020. The Company files income tax returns with the IRS and the California Franchise Tax Board. Research and Development Costs relating to the design and development of new products are expensed as research and development as incurred in accordance with Financial Accounting Standards Board (“FASB”) ASC 730-10, Research and Development Comprehensive Income (Loss) Comprehensive income (loss) generally represents all changes in stockholders’ equity during the period except those resulting from investments by, or distributions to, stockholders. The Company’s comprehensive loss was approximately $20.0 million and $13.7 million for the years ended December 31, 2021 and 2020, respectively. The Company’s other comprehensive income (loss) is related to a net unrealized gain (loss) on marketable securities. For the years ended December 31, 2021 and 2020, the Company’s other comprehensive income was zero and $757, respectively. Clinical Trial Expense As part of the process of preparing our consolidated financial statements, we are required to estimate our accrued expenses. Our clinical trial accrual process is designed to account for expenses resulting from our obligations under contracts with vendors, consultants, and contract research organizations (“CROs”), and clinical site agreements in connection with conducting clinical trials. The financial terms of these contracts are subject to negotiations, which vary from contract to contract and may result in payment flows that do not match the periods over which materials or services are provided to us under such contracts. Our objective is to reflect the appropriate clinical trial expenses in our consolidated financial statements by matching the appropriate expenses with the period in which services are provided and efforts are expended. We account for these expenses according to the progress of the trial as measured by patient progression and the timing of various aspects of the trial. We determine accrual estimates through financial models that take into account discussion with applicable personnel and outside service providers as to the progress or state of completion of trials, or the services completed. During the course of a clinical trial, we adjust our clinical expense recognition if actual results differ from our estimates. We make estimates of our accrued expenses as of each balance sheet date in our consolidated financial statements based on the facts and circumstances known to us at that time. Our clinical trial accrual and prepaid assets are dependent, in part, upon the receipt of timely and accurate reporting from CROs and other third-party vendors. Although we do not expect our estimates to be materially different from amounts actually incurred, our understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and may result in us reporting amounts that are too high or too low for any particular period. 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. December 31, 2021 December 31, 2020 Numerator Net loss $ (20,022,520) $ (13,657,028) Denominator Weighted-average number of shares of common stock outstanding 23,089,323 15,571,056 Dilutive effect of stock options — — Common stock and common stock equivalents used for diluted loss per share 23,089,323 15,571,056 For the years ended December 31, 2021 and 2020, warrants and options to purchase 3,899,606 and 2,488,046 shares of common stock, respectively, have been excluded from the computation of potentially dilutive securities. Potentially dilutive common shares, which primarily consist of stock options issued to employees, consultants, and directors as well as warrants issued, have been excluded from the diluted loss per share calculation because their effect is anti-dilutive. Because the impact of these items is anti-dilutive during periods of net loss, there was no difference between basic and diluted loss per share for the years ended December 31, 2021 and 2020. Fair Value Measurements Assets and liabilities recorded at fair value in the balance sheet are categorized based upon the level of judgment associated with the inputs used to measure their fair value. The categories are as follows: Level Input: Input Definition: Level I Inputs are unadjusted, quoted prices for identical assets or liabilities in active markets at the measurement date. Level II Inputs, other than quoted prices included in Level I, that are observable for the asset or liability through corroboration with market data at the measurement date. Level III Unobservable inputs that reflect management’s best estimate of what market participants would use in pricing the asset or liability at the measurement date. Carrying amounts reported in the balance sheet of cash and cash equivalents, 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. Recent Accounting Pronouncements In October 2019, the FASB issued ASU 2019-12, which affects general principles within Topic 740, Income Taxes. The amendments of ASU 2019-12 are meant to simplify and reduce the cost of accounting for income taxes. For public business entities, the amendments in this Update are effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2020. The Company adopted ASU 2019-12 in the first quarter of 2021. The adoption of this update did not have a material impact on the Company’s financial statements and footnote disclosures. In November 2021, the FASB issued ASU 2021-10, Government Assistance (Topic 832) Other recent accounting pronouncements issued by the FASB, including its Emerging Issues Task Force, the American Institute of Certified Public Accountants, and the SEC, did not or are not believed by management to have a material impact on the Company’s present or future consolidated financial statement presentation or disclosures. |
NOTE PAYABLE
NOTE PAYABLE | 12 Months Ended |
Dec. 31, 2021 | |
NOTE PAYABLE | |
NOTE PAYABLE | 2. NOTE PAYABLE Paycheck Protection Program Loan In the second quarter of 2020, Capricor applied to City National Bank ("CNB") under the SBA Paycheck Protection Program of the CARES Act for the Loan in the amount of $318,160. The Loan was approved and Capricor received the Loan proceeds, which were used for covered payroll costs in accordance with the relevant terms and conditions of the CARES Act. The Loan, which took the form of a promissory note issued by Capricor (the "Promissory Note"), had a two-year term, was set to mature on April 29, 2022, and was to bear interest at a rate of 1.0% per annum. Monthly principal and interest payments, less the amount of any potential forgiveness, were to commence 10 months after the end of the covered period for the borrower's loan forgiveness (either 8 or 24 weeks). Loan payments were to be deferred for borrowers who apply for loan forgiveness until SBA remits the borrower's loan forgiveness amount to the lender. Capricor did not provide any collateral or guarantees for the Loan, nor did Capricor pay any facility charge to obtain the Loan. The Promissory Note provided for customary events of default, including, among others, those relating to failure to make payment, bankruptcy, breaches of representations and material adverse events. Capricor had the right to prepay the principal of the Loan at any time without incurring any prepayment charges. The Company submitted a loan forgiveness application to CNB in the first quarter of 2021. The Company was notified in April 2021 by the SBA that the Loan was forgiven. The Company recognized a gain on forgiveness of the full amount in 2021. |
STOCKHOLDER'S EQUITY
STOCKHOLDER'S EQUITY | 12 Months Ended |
Dec. 31, 2021 | |
STOCKHOLDER'S EQUITY | |
STOCKHOLDER'S EQUITY | 3. STOCKHOLDERS’ EQUITY ATM Programs and Other Offerings The Company has established multiple “at-the-market” (“ATM”), programs pursuant to a Common Stock Sales Agreement with Wainwright by which Wainwright sold and may continue to sell our common stock at the market prices prevailing at the time of sale. Wainwright is entitled to compensation for its services at a commission rate of 3.0% of the gross sales price per share of common stock sold plus reimbursement of certain expenses. These programs are referred to below as the “May 2020 ATM Program” and the “June 2021 ATM Program” based on when each program was initiated. In addition, the Company completed a warrant inducement offer in March 2020. May 2020 ATM Program On May 4, 2020, the Company initiated the May 2020 ATM Program. The Company filed the May 2020 ATM with an aggregate offering price of up to $40.0 million. From May 4, 2020 through June 21, 2021, the Company sold an aggregate of 6,027,852 shares of common stock under the May 2020 ATM Program at an average price of approximately $6.15 per share for gross proceeds of approximately $37.1 million. The Company paid cash commissions on the gross proceeds, plus reimbursement of expenses to Wainwright, as well as legal and accounting fees in the aggregate amount of approximately $1.2 million. As of June 21, 2021, the May 2020 ATM Program expired and was replaced with the June 2021 ATM Program described below. June 2021 ATM Program On June 21, 2021, the Company initiated the June 2021 ATM Program. The Company filed the June 2021 ATM with an aggregate offering price of up to $75.0 million. From June 21, 2021 through December 31, 2021, the Company sold an aggregate of 1,267,475 shares of common stock under the June 2021 ATM Program at an average price of approximately $5.89 per share for gross proceeds of approximately $7.5 million. The Company paid cash commissions on the gross proceeds, plus reimbursement of expenses to Wainwright, as well as legal and accounting fees in the aggregate amount of approximately $0.3 million. March 2020 Warrant Inducement On March 25, 2020, the Company entered into a letter agreement (the “Exercise Agreement”) with a holder (the “Exercising Holder”) of then outstanding warrants to purchase Common Stock (the “Prior Warrants”). Pursuant to the Exercise Agreement, in connection with the exercise by the Exercising Holder of the remaining 4,000,000 Prior Warrants held by the Exercising Holder which had not been previously exercised, the Company agreed to issue 4,000,000 additional warrants (the “New Warrants”) to purchase Common Stock. The Prior Warrants had a per share exercise price of $1.10, and pursuant to the Exercise Agreement, the Exercising Holder agreed to pay $1.225 per share to cover both the exercise price of the Prior Warrants and a $0.125 per share purchase price for the New Warrants. The New Warrants have an exercise price of $1.27 per share. A total of 724,500 shares were issued to the Exercising Holder, with the remaining 3,275,500 shares being held in abeyance until such time as it would not result in the Exercising Holder exceeding its beneficial ownership limitation of 4.99% of the Company’s outstanding common stock. In the second quarter of 2020, the Company issued all shares that were being held in abeyance. The New Warrants and the shares of Common Stock issuable upon the exercise of the New Warrants were not registered under the Securities Act of 1933, as amended (the “Securities Act”), and were offered pursuant to the exemption provided in Section 4(a)(2) under the Securities Act or Rule 506(b) promulgated thereunder. The New Warrants were exercisable immediately upon issuance, and have a term of exercise of 5 1/2 The exercise of Prior Warrants by the Exercising Holder generated gross proceeds of approximately $4.9 million. Fees paid in conjunction with the Exercise Agreement, which included placement agent commissions, legal costs, and other offering expenses, amounted to approximately $0.4 million. In connection with the Exercise Agreement, certain employees of the placement agent were issued new warrants (the “Placement Agent Warrants”) to purchase an aggregate of 200,000 shares of common stock. The Placement Agent Warrants have an exercise price of $1.5313 per share and expire in March 2025. The holders of each of the New Warrants and of the Placement Agent Warrants had the option to make a cashless exercise of such warrant if no resale registration statement covering the shares of the Company’s Common Stock underlying such warrant is effective after six months. On May 7, 2020, the Company filed a resale registration statement on Form S-3 for the shares underlying the New Warrants and Placement Agent Warrants, and that resale registration statement was declared effective by the SEC on May 19, 2020. As of December 31, 2021, 65,000 Placement Agent Warrants and no New Warrants remained outstanding. Outstanding Shares At December 31, 2021, the Company had 24,185,001 shares of common stock issued and outstanding |
STOCK AWARDS, WARRANTS AND OPTI
STOCK AWARDS, WARRANTS AND OPTIONS | 12 Months Ended |
Dec. 31, 2021 | |
STOCK AWARDS, WARRANTS AND OPTIONS | |
STOCK AWARDS, WARRANTS AND OPTIONS | 4. STOCK AWARDS, WARRANTS AND OPTIONS Warrants The following table summarizes all warrant activity for the years ended December 31, 2021 and 2020: Weighted Average Warrants Exercise Price Outstanding at January 1, 2020 7,501,696 $ 0.65 Granted 4,200,000 1.28 Exercised (11,575,523) 0.87 Outstanding at December 31, 2020 126,173 $ 1.32 Exercised (20,391) 1.10 Outstanding at December 31, 2021 105,782 $ 1.37 The following table summarizes all outstanding warrants to purchase shares of the Company’s common stock: Warrants Outstanding December 31, December 31, Exercise Price Expiration Type Grant Date 2021 2020 per Share Date Common Warrants 12/19/2019 40,782 61,173 $ 1.10 12/19/2024 Common Warrants 3/27/2020 65,000 65,000 $ 1.5313 3/27/2025 105,782 126,173 Stock Options The Company’s Board of Directors (the “Board”) has approved five stock option plans: (i) the 2006 Stock Option Plan, (ii) the 2012 Restated Equity Incentive Plan (which superseded the 2006 Stock Option Plan) (the “2012 Plan”), (iii) the 2012 Non-Employee Director Stock Option Plan (the “2012 Non-Employee Director Plan”), (iv) the 2020 Equity Incentive Plan (the “2020 Plan”), and (v) the 2021 Equity Incentive Plan (the “2021 Plan”). In September 2012, the Board approved the 2012 Non-Employee Director Plan, which authorized 269,731 shares of common stock, reserved for issuance of non-qualified options to members of the Board who are not employees of the Company. In November 2012, the Board approved the 2012 Plan, which superseded the 2006 Stock Option Plan. Under the 2012 Plan, the Company may grant stock options, stock appreciation rights, restricted stock awards, and performance/unit share awards to employees, consultants and other service providers. Pursuant to the 2012 Plan, inclusive of annual evergreen provisions and amendments, the Company is authorized to issue 710,142 shares of common stock under the 2012 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. Upon approval of the 2021 Plan on June 11, 2021, no new shares have been or will be added to the share reserve under the 2020 Plan pursuant to its “evergreen” provisions. In June 2021, the Company’s stockholders approved the 2021 Plan, which authorized 3,500,000 shares of common stock reserved under the 2021 Plan for the issuance of stock awards. The number of shares available for issuance under the 2021 Plan shall be automatically increased on January 1 of each year, commencing with January 1, 2022, by an amount equal to 5% of the outstanding shares of Common Stock as of the last day of the immediately preceding fiscal year. On January 1, 2022, 1,209,250 shares were added under the 2021 Plan. As of December 31, 2021, 3,869,682 options remain available for future issuance under the respective stock option plans. Each of the Company’s stock option plans are administered by the Board, or the compensation committee of the Board, which determines the recipients and types of awards to be granted, as well as the number of shares subject to the awards, the exercise price and the vesting schedule. Each stock option granted will be designated in the award agreement as either an incentive stock option or a nonstatutory stock option. Notwithstanding such designation, however, to the extent that the aggregate fair market value of the shares with respect to which incentive stock options are exercisable for the first time by the participant during any calendar year (under all plans of the Company and any parent or subsidiary) exceeds $100,000, such options will be treated as nonstatutory stock options. Stock options are granted with an exercise price equal to the closing price of the Company’s common stock on the date of grant, and generally vest over a period of one The estimated weighted average fair value of the options granted during 2021 and 2020 were approximately $3.45 and $3.93 per share, respectively. The Company estimates the fair value of each option award using the Black-Scholes option-pricing model. The Company used the following assumptions to estimate the fair value of stock options issued in the years ended December 31, 2021 and 2020: December 31, 2021 December 31, 2020 Expected volatility 123% - 124 % 104% - 124 % Expected term 6 years 5 - 6 years Dividend yield 0 % 0 % Risk-free interest rates 0.5 - 1.1 % 0.4 - 1.5 % Employee and non-employee stock-based compensation expense was as follows: 2021 2020 General and administrative $ 2,566,883 $ 1,705,477 Research and development 398,809 247,202 Total $ 2,965,692 $ 1,952,679 The Company does not recognize an income tax benefit as the Company believes that an actual income tax benefit may not be realized. For non-qualified stock options, the loss creates a timing difference, resulting in a deferred tax asset, which is fully reserved by a valuation allowance. Common stock, stock options or other equity instruments issued to non-employees (including consultants) as consideration for goods or services received by the Company are accounted for based on the fair value of the equity instruments issued. The fair value of stock options is determined using the Black-Scholes option-pricing model. The Company calculates the fair value for non-qualified options as of the date of grant and expenses over the applicable vesting periods. We account for forfeitures upon occurrence. On February 12, 2020, the board of directors of the Company approved a program under which outstanding options and other awards granted under the 2012 Plan and the 2012 Director Plan to employees, officers and directors and designated service providers of the Company were repriced to their then current fair market value. There were 662,968 outstanding options which were repriced to $1.39 per share, which was the market price of our common stock on the date of the approval of the repricing. The effect of the modification generated a total incremental cost of approximately $178,000, of which approximately $171,000 was recognized in the first quarter of 2020 stock-based compensation expense with the remainder to be expensed over the remaining unvested period terms. The following table summarizes information about stock options outstanding and exercisable at December 31, 2021: Options Outstanding Weighted Average Weighted Average Range of Ex. Prices Options Outstanding Term (yrs.) Exercise Price $1.18 - $1.39 2,006,916 6.50 $ 1.39 $2.54 - $3.74 1,291,158 8.95 $ 3.73 $4.37 - $6.30 495,750 9.18 $ 5.22 3,793,824 $ 2.68 Options Exercisable Weighted Average Weighted Average Range of Ex. Prices Options Exercisable Term (yrs.) Exercise Price $1.18 - $1.39 1,250,375 5.54 $ 1.38 $2.54 - $3.74 310,007 8.74 $ 3.70 $4.37 - $6.30 65,673 8.39 $ 5.79 1,626,055 $ 2.00 As of December 31, 2021, the total unrecognized fair value compensation cost related to non-vested stock options was approximately $7.7 million, which is expected to be recognized over a weighted average period of approximately 1.4 years. The following is a schedule summarizing employee and non-employee stock option activity for the years ended December 31, 2021 and 2020: Number of Weighted Average Aggregate Options Exercise Price Intrinsic Value Outstanding at January 1, 2020 754,913 $ 12.63 $ — Granted 1,878,058 2.14 Exercised (63,774) 3.19 $ 329,035 Expired/Cancelled (207,324) 5.73 Outstanding at December 31, 2020 2,361,873 $ 1.89 $ 4,236,737 Granted 1,636,324 3.95 Exercised (21,338) 1.39 $ 51,044 Expired/Cancelled (183,035) 3.84 Outstanding at December 31, 2021 3,793,824 $ 2.68 $ 3,104,631 Exercisable at December 31, 2021 1,626,055 $ 2.00 $ 1,938,298 The aggregate intrinsic value represents the difference between the exercise price of the options and the estimated fair value of the Company’s common stock for each of the respective periods. |
CONCENTRATIONS
CONCENTRATIONS | 12 Months Ended |
Dec. 31, 2021 | |
CONCENTRATIONS | |
CONCENTRATIONS | 5. CONCENTRATIONS Cash Concentration The Company has historically maintained checking accounts at two financial institutions. These accounts are each insured by the Federal Deposit Insurance Corporation for up to $250,000. Historically, the Company has not experienced any significant losses in such accounts and believes it is not exposed to any significant credit risk on cash, cash equivalents and marketable securities. As of December 31, 2021, the Company maintained approximately $34.4 million of uninsured deposits. |
GOVERNMENT GRANT AWARDS
GOVERNMENT GRANT AWARDS | 12 Months Ended |
Dec. 31, 2021 | |
GOVERNMENT GRANT AWARDS | |
GOVERNMENT GRANT AWARDS | 6. GOVERNMENT GRANT AWARDS CIRM Grant Award (HOPE) On June 16, 2016, Capricor entered into the CIRM Award with CIRM in the amount of approximately $3.4 million to fund, in part, Capricor’s Phase I/II HOPE-Duchenne clinical trial investigating CAP-1002 for the treatment of Duchenne muscular dystrophy-associated cardiomyopathy. Pursuant to terms of the CIRM Award, the disbursements were tied to the achievement of specified operational milestones. In addition, the terms of the CIRM Award included a co-funding requirement pursuant to which Capricor was required to spend approximately $2.3 million of its own capital to fund the CIRM funded research project. The CIRM Award is further subject to the conditions and requirements set forth in the CIRM Grants Administration Policy for Clinical Stage Projects. Such requirements include, without limitation, the filing of quarterly and annual reports with CIRM, the sharing of intellectual property pursuant to Title 17, California Code of Regulations (CCR) Sections 100600-100612, and the sharing with the State of California of a fraction of licensing revenue received from a CIRM funded research project and net commercial revenue from a commercialized product which resulted from the CIRM funded research as set forth in Title 17, CCR Section 100608. The maximum royalty on net commercial revenue that Capricor may be required to pay to CIRM is equal to nine times the total amount awarded and paid to Capricor. After completing the CIRM funded research project and at any time after the award period end date (but no later than the ten-year anniversary of the date of the award), Capricor has the right to convert the CIRM Award into a loan, the terms of which will be determined based on various factors, including the stage of the research and development of the program at the time the election is made. On June 20, 2016, Capricor entered into a Loan Election Agreement with CIRM whereby, among other things, CIRM and Capricor agreed that if Capricor elects to convert the grant into a loan, the term of the loan could be up to five years from the date of execution of the applicable loan agreement; provided that the maturity date of the loan will not surpass the ten-year anniversary of the grant date of the CIRM Award. Beginning on the date of the loan, the loan shall bear interest on the unpaid principal balance, plus the interest that has accrued prior to the election point according to the terms set forth in CIRM’s Loan Policy (the “New Loan Balance”), at a per annum rate equal to the LIBOR rate for a three-month deposit in U.S. dollars, as published by the Wall Street Journal on the loan date, plus one percent. Interest shall be compounded annually on the outstanding New Loan Balance commencing with the loan date and the interest shall be payable, together with the New Loan Balance, upon the due date of the loan. If Capricor elects to convert the CIRM Award into a loan, certain requirements of the CIRM Award will no longer be applicable, including the revenue sharing requirements. Capricor has not yet made its decision as to whether it will elect to convert the CIRM Award into a loan. If we elect to do so, Capricor would be required to repay some or all of the amounts awarded by CIRM; therefore, the Company accounts for this award as a liability rather than income. In June 2019, Capricor completed all milestones associated with the CIRM Award and expended all funds received. In the third quarter of 2019, Capricor completed all final close-out documentation associated with this award. As of December 31, 2021, Capricor’s liability balance for the CIRM Award was approximately $3.4 million. U.S. Department of Defense Grant Award In September 2016, Capricor was approved for a grant award from the United States Department of Defense in the amount of approximately $2.4 million to be used toward developing a scalable, commercial-ready process to manufacture CAP-2003, Capricor’s exosomes product candidate. Under the terms of the award, disbursements were made to Capricor over a period of approximately four years, subject to annual and quarterly reporting requirements. The Company utilized approximately $2.3 million under the terms of the award. No revenue was recognized in 2021 in relation to this award. In the third quarter of 2021, Capricor completed all final close-out documentation associated with this award. |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 12 Months Ended |
Dec. 31, 2021 | |
COMMITMENTS AND CONTINGENCIES | |
COMMITMENTS AND CONTINGENCIES | 7. COMMITMENTS AND CONTINGENCIES Short-Term Operating Leases Capricor leases space for its corporate offices from The Bubble Real Estate Company, LLC (“Bubble Real Estate”) pursuant to a lease that was originally effective for a two-year period beginning July 1, 2013 with an option to extend the lease for an additional twelve months. Capricor subsequently entered into several amendments extending the term of the lease and modifying its terms. Effective January 1, 2021, we entered into a month-to-month lease amendment with the Bubble Real Estate. The monthly lease payment was $13,073. In November 2021, Capricor entered into an amendment to the lease pursuant to which the square footage of the premises was reduced with a monthly lease payment of $5,548 per month commencing November 1, 2021. The lease is terminable by either party upon 90 days' written notice to the other party. Capricor leases facilities from Cedars-Sinai Medical Center (“CSMC”), a related party (see Note 9 – “Related Party Transactions”), pursuant to a lease (the “Facilities Lease”) that was originally effective for a three-year period beginning June 1, 2014. Capricor has subsequently entered into several amendments extending the term of the lease and modifying its terms. In July 2021, Capricor exercised its option to extend the term of the Facilities Lease for an additional 12-month Expenses incurred under the short-term operating leases to unrelated parties for the years ended December 31, 2021 and 2020 were $141,923 and $194,748, respectively. Expenses incurred under short-term operating leases to related parties for the years ended December 31, 2021 and 2020 were $164,168 and $189,660, respectively. Long-Term Operating Leases On July 16, 2021, the Company entered into a lease agreement with Altman Investment Co, LLC (“Altman”) for 9,396 square feet of office and laboratory space located at 10865 Road to the Cure, Suite 150, in San Diego, California. Under the terms of the lease, the base rent will be approximately $0.6 million per year, which rent is subject to a 3.0% annual rent increase during the initial lease term, plus certain operating expenses and taxes. This lease term commenced on October 1, 2021 and will expire on October 15, 2026. The lease contains an option for Capricor to renew for an additional term of five years. The Company estimates the aggregate ROU asset and liability Effective November 1, 2021, the Company entered into a vivarium agreement with Explora BioLabs, Inc. (“Explora”) for vivarium space and services. Under the terms of the agreement, the base rent will be $4,021 per month for an exclusive large vivarium room. The lease term is for one-year and will automatically renew for additional successive one-year renewal terms unless either party provides the other party with 60-day written notice prior to the end of the then-current term. For ASC 842 purposes, we applied a lease term of five years. The long-term real estate operating leases are included in “lease right-of-use assets, net” on the Company’s balance sheet and represents 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 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 December 31, 2021: 2022 $ 492,380 2023 656,678 2024 674,931 2025 693,732 2026 562,627 Total minimum lease payments 3,080,348 Less: imputed interest (210,009) Total operating lease liabilities $ 2,870,339 Included in the consolidated balance sheet: Current portion of lease liabilities $ 417,632 Lease liabilities, net of current 2,452,707 Total operating lease liabilities $ 2,870,339 Other Information: Weighted average remaining lease term 4.79 years Weighted average discount rate 2.75% Long-term operating lease costs recognized under ASC 842 for the year ended December 31, 2021 was $129,726. Long-term operating lease payments for the year ended December 31, 2021 was $81,331. The Company had no long-term leases pursuant to ASC 842 in 2020. Legal Contingencies The Company is not a party to any material legal proceedings at this time. From time to time, the Company may become involved in various legal proceedings that arise in the ordinary course of its business or otherwise. Accounts Payable During the normal course of business, disputes with vendors may arise. If a vendor disputed payment is probable and able to be estimated, we will record an estimated liability. Other Funding Commitments The Company is a party to various agreements, principally relating to licensed technology, that require future payments relating to milestones that may be met in subsequent periods or royalties on future sales of specific products (see Note 8 - "License Agreements"). Additionally, the Company is a party to various agreements with contract research organizations and contract manufacturers that generally provide for termination upon notice, with the exact amounts owed in the event of termination to be based on the timing of termination and the terms of the agreement. Employee Severances The Board of Directors approved severance packages for specific full-time employees based on their length of service and position ranging up to six months of their base salaries, in the event of termination of their employment, subject to certain conditions. No liability has been recorded as of December 31, 2021. |
LICENSE AGREEMENTS
LICENSE AGREEMENTS | 12 Months Ended |
Dec. 31, 2021 | |
LICENSE AGREEMENTS | |
LICENSE AGREEMENTS | 8. LICENSE AGREEMENTS Intellectual Property Rights for Capricor’s Technology - CAP-1002 and Exosomes Capricor has entered into exclusive license agreements for intellectual property rights related to certain cardiac-derived cells with Università Degli Studi Di Roma La Sapienza (the” University of Rome”), Johns Hopkins University (“JHU”) and CSMC. Capricor has also entered into an exclusive license agreement for intellectual property rights related to exosomes with CSMC and JHU as well as a non-exclusive license agreement with JHU related to the imaging-based serology technology for COVID-19. In addition, Capricor has filed patent applications related to the technology developed by its own scientists. University of Rome License Agreement Capricor and the University of Rome entered into a License Agreement, dated June 21, 2006 (the “Rome License Agreement”), which provides for the grant of an exclusive, world-wide, royalty-bearing license by the University of Rome to Capricor (with the right to sublicense) to develop and commercialize licensed products under the licensed patent rights in all fields. Capricor has a right of first negotiation, for a certain period of time, to obtain a license to any new and separate patent applications owned by the University of Rome utilizing cardiac stem cells in cardiac care. Pursuant to the Rome License Agreement, Capricor paid the University of Rome a license issue fee, is currently paying minimum annual royalties in the amount of 20,000 Euros per year, and is obligated to pay a lower-end of a mid-range double-digit percentage on all royalties received as a result of sublicenses granted, which are net of any royalties paid to third parties under a license agreement from such third party to Capricor. The minimum annual royalties are creditable against future royalty payments. The Rome License Agreement will, unless extended or sooner terminated, remain in effect until the later of the last claim of any patent or until any patent application comprising licensed patent rights has expired or been abandoned. Under the terms of the Rome License Agreement, either party may terminate the agreement should the other party become insolvent or file a petition in bankruptcy. Either party may terminate the agreement upon the other party’s material breach, provided that the breaching party will have up to 90 days to cure its material breach. Capricor may also terminate for any reason upon 90 days’ written notice to the University of Rome. The Johns Hopkins University License Agreements License Agreement for CDCs Capricor and JHU entered into an Exclusive License Agreement, effective June 22, 2006 (the “JHU License Agreement”), which provides for the grant of an exclusive, world-wide, royalty-bearing license by JHU to Capricor (with the right to sublicense) to develop and commercialize licensed products and licensed services under the licensed patent rights in all fields and a nonexclusive right to the know-how. In May 2009, the JHU License Agreement was amended to add additional patent rights to the JHU License Agreement in consideration of a payment to JHU and reimbursement of patent costs. Capricor and JHU executed a Second Amendment to the JHU License Agreement, effective as of December 20, 2013, pursuant to which, among other things, certain definitions were added or amended, the timing of certain obligations was revised and other obligations of the parties were clarified. Under the JHU License Agreement, Capricor is required to exercise commercially reasonable and diligent efforts to develop and commercialize licensed products covered by the licenses from JHU. Pursuant to the JHU License Agreement, JHU was paid an initial license fee and, thereafter, Capricor is required to pay minimum annual royalties on the anniversary dates of the JHU License Agreement. The minimum annual royalties are creditable against a low single-digit running royalty on net sales of products and net service revenues, which Capricor is also required to pay under the JHU License Agreement, which running royalty may be subject to further reduction in the event that Capricor is required to pay royalties on any patent rights to third parties in order to make or sell a licensed product. In addition, Capricor is required to pay a low double-digit percentage of the consideration received by it from sublicenses granted and is required to pay JHU certain defined development milestone payments upon the successful completion of certain phases of its clinical studies and upon receiving approval from the U.S. Food and Drug Administration (the “FDA”). The development milestones range from $100,000 upon successful completion of a full Phase I clinical study to $1,000,000 upon full FDA market approval and are fully creditable against payments owed by Capricor to JHU on account of sublicense consideration attributable to milestone payments received from a sublicensee. The maximum aggregate amount of milestone payments payable under the JHU License Agreement, as amended, is $1,850,000. In May 2015, Capricor paid the development milestone related to the Phase I study that was owed to JHU pursuant to the terms of the JHU License Agreement. The Company recorded the $250,000 milestone payment for successful completion of a Phase II study in accounts payable and accrued expenses as of December 31, 2021. Payment of this milestone is expected to be made in the first quarter of 2022. The next milestone is triggered upon successful completion of a full Phase III study for which a payment of $500,000 will be due. The JHU License Agreement will, unless sooner terminated, continue in effect in each applicable country until the date of expiration of the last to expire patent within the patent rights, or, if no patents are issued, then for twenty years from the effective date. Under the terms of the JHU License Agreement, either party may terminate the agreement should the other party become insolvent or file a petition in bankruptcy, or fail to cure a material breach within 30 days after notice. In addition, Capricor may terminate for any reason upon 60 days’ written notice. License Agreement for Serology Diagnostic Capricor and JHU entered into a Nonexclusive License Agreement (the “JHU Serology License Agreement”), effective January 6, 2021, which provides for the grant of a non-exclusive, world-wide, non-royalty-bearing license by JHU to Capricor to develop and commercialize licensed products under the licensed patent rights for COVID-19. The JHU Serology License Agreement is due to expire July 2022 and at this time, Capricor does not intend to convert it to an exclusive license or extend the JHU Serology License Agreement. License Agreement for Exosome-based Vaccines and Therapeutics Capricor and JHU entered into an Exclusive License Agreement (the “JHU Exosome License Agreement”) effective April 28, 2021 for its co-owned interest in certain intellectual property rights related to exosome-mRNA vaccines and therapeutics. The JHU Exosome License Agreement provides for the grant of an exclusive, world-wide, royalty-bearing license of JHU’s co-owned rights by JHU to Capricor, with the right to sublicense, in order to conduct research using the patent rights and know-how and to develop and commercialize products in the field using the patent rights and know-how. Pursuant to the JHU Exosome License Agreement, JHU was paid an upfront license fee of $10,000 and Capricor has agreed to reimburse JHU for certain fees and costs incurred in connection with the prosecution of certain patent rights. Additionally, Capricor is required to meet certain development milestones for which a milestone payment fee shall be due and is obligated to pay low single-digit royalties on sales of royalty-bearing products as well as a double-digit percentage of any non-royalty consideration received from any sublicenses, subject to certain exclusions. The above-mentioned royalties are subject to reduction in the event Capricor becomes obligated to pay royalties on one or more third party patents as a requirement to make or sell a licensed product. In addition, Capricor will, beginning with the third year of the JHU Exosome License Agreement, be obligated to pay JHU a minimum annual royalty which is non-refundable but will be credited against royalties incurred by Capricor for the year in which the minimum annual royalty becomes due. The JHU Exosome License Agreement will, unless sooner terminated, continue in each country until the date of expiration of the last to expire patent included within the patent rights in that country, or if no patents issue, then for 20 years. The JHU Exosome License Agreement may be terminated by Capricor upon 90 days’ written notice in its discretion and with 60 days’ notice with respect to any particular patent or application or as to any particular licensed product. The JHU Exosome License Agreement may also be terminated by either party if it fails to perform or otherwise breaches any of its obligations and fails to cure such breach within a 60-day cure period commencing upon notice. A material breach by Capricor may include (a) a delinquency with respect to payment or reporting; (b) the failure by Capricor to timely achieve a specified milestone or otherwise failing to diligently develop, commercialize, and sell licensed products throughout the term of the JHU Exosome License Agreement; (c) non-compliance with record keeping or audit obligations; (d) voluntary bankruptcy or insolvency of Capricor; and (e) non-compliance with Capricor’s insurance obligations. Cedars-Sinai Medical Center License Agreements License Agreement for CDCs On January 4, 2010, Capricor entered into an Exclusive License Agreement with CSMC (the “Original CSMC License Agreement”), for certain intellectual property related to its CDC technology. In 2013, the Original CSMC License Agreement was amended twice resulting in, among other things, a reduction in the percentage of sublicense fees which would have been payable to CSMC. Effective December 30, 2013, Capricor entered into an Amended and Restated Exclusive License Agreement with CSMC (the “Amended CSMC License Agreement”), which amended, restated, and superseded the Original CSMC License Agreement, pursuant to which, among other things, certain definitions were added or amended, the timing of certain obligations was revised and other obligations of the parties were clarified. The Amended CSMC License Agreement provides for the grant of an exclusive, world-wide, royalty-bearing license by CSMC to Capricor (with the right to sublicense) to conduct research using the patent rights and know-how and develop and commercialize products in the field using the patent rights and know-how. In addition, Capricor has the exclusive right to negotiate for an exclusive license to any future rights arising from related work conducted by or under the direction of Dr. Eduardo Marbán on behalf of CSMC. In the event the parties fail to agree upon the terms of an exclusive license for any future rights, Capricor will have a non-exclusive license to such future rights, subject to royalty obligations. Pursuant to the Original CSMC License Agreement, CSMC was paid a license fee and Capricor was obligated to reimburse CSMC for certain fees and costs incurred in connection with the prosecution of certain patent rights. Additionally, Capricor is required to meet certain spending and development milestones. Pursuant to the Amended CSMC License Agreement, Capricor remains obligated to pay low single-digit royalties on sales of royalty-bearing products as well as a low double-digit percentage of the consideration received from any sublicenses or other grant of rights. The above-mentioned royalties are subject to reduction in the event Capricor becomes obligated to obtain a license from a third party for patent rights in connection with the royalty-bearing product. In 2010, Capricor discontinued its research under some of the patents. The Amended CSMC License Agreement will, unless sooner terminated, continue in effect on a country by country basis until the last to expire of the patents covering the patent rights or future patent rights. Under the terms of the Amended CSMC License Agreement, unless waived by CSMC, the agreement shall automatically terminate: (i) if Capricor ceases, dissolves or winds up its business operations; (ii) in the event of the insolvency or bankruptcy of Capricor or if Capricor makes an assignment for the benefit of its creditors; (iii) if performance by either party jeopardizes the licensure, accreditation or tax exempt status of CSMC or the agreement is deemed illegal by a governmental body; (iv) within 30 days for non-payment of royalties; (v) after 90 days’ notice from CSMC if Capricor fails to undertake commercially reasonable efforts to exploit the patent rights or future patent rights; (vi) if a material breach has not been cured within 90 days; or (vii) if Capricor challenges any of the CSMC patent rights. If Capricor fails to undertake commercially reasonable efforts to exploit the patent rights or future patent rights and fails to cure that breach after 90 days’ notice from CSMC, instead of terminating the license, CSMC has the option to convert any exclusive license to Capricor to a non-exclusive or co-exclusive license. Capricor may terminate the agreement if CSMC fails to cure any material breach within 90 days after notice. On March 20, 2015, August 5, 2016, December 26, 2017, June 20, 2018, and July 27, 2021, Capricor and CSMC entered into a number of amendments to the Amended CSMC License Agreement, pursuant to which the parties agreed to add and delete certain patent applications from the list of scheduled patents, among other things. Capricor reimbursed CSMC for certain attorneys’ fees and filing fees incurred in connection with the additional patent applications. License Agreement for Exosomes On May 5, 2014, Capricor entered into an Exclusive License Agreement with CSMC (the “Exosomes License Agreement”), for certain intellectual property rights related to exosomes technology. The Exosomes License Agreement provides for the grant of an exclusive, world-wide, royalty-bearing license by CSMC to Capricor (with the right to sublicense) in order to conduct research using the patent rights and know-how and to develop and commercialize products in the field using the patent rights and know-how. In addition, Capricor has the exclusive right to negotiate for an exclusive license to any future rights arising from related work conducted by or under the direction of Dr. Eduardo Marbán on behalf of CSMC. In the event the parties fail to agree upon the terms of an exclusive license, Capricor shall have a non-exclusive license to such future rights, subject to royalty obligations. Pursuant to the Exosomes License Agreement, CSMC was paid a license fee and Capricor reimbursed CSMC for certain fees and costs incurred in connection with the preparation and prosecution of certain patent applications. Additionally, Capricor is required to meet certain non-monetary development milestones and is obligated to pay low single-digit royalties on sales of royalty-bearing products as well as a single-digit percentage of the consideration received from any sublicenses or other grant of rights. The above-mentioned royalties are subject to reduction in the event Capricor becomes obligated to obtain a license from a third party for patent rights in connection with the royalty bearing product. The Exosomes License Agreement will, unless sooner terminated, continue in effect on a country by country basis until the last to expire of the patents covering the patent rights or future patent rights. Under the terms of the Exosomes License Agreement, unless waived by CSMC, the agreement shall automatically terminate: (i) if Capricor ceases, dissolves or winds up its business operations; (ii) in the event of the insolvency or bankruptcy of Capricor or if Capricor makes an assignment for the benefit of its creditors; (iii) if performance by either party jeopardizes the licensure, accreditation or tax exempt status of CSMC or the agreement is deemed illegal by a governmental body; (iv) within 30 days for non-payment of royalties; (v) after 90 days if Capricor fails to undertake commercially reasonable efforts to exploit the patent rights or future patent rights; (vi) if a material breach has not been cured within 90 days; or (vii) if Capricor challenges any of the CSMC patent rights. If Capricor fails to undertake commercially reasonable efforts to exploit the patent rights or future patent rights, and fails to cure that breach after 90 days’ notice from CSMC, instead of terminating the license, CSMC has the option to convert any exclusive license to Capricor to a non-exclusive or co-exclusive license. Capricor may terminate the agreement if CSMC fails to cure any material breach within 90 days after notice. On February 27, 2015, June 10, 2015, August 5, 2016, December 26, 2017, June 20, 2018, September 25, 2018, August 19, 2020, August 28, 2020, and March 19, 2021, Capricor and CSMC entered into a number of amendments to the Exosomes License Agreement. Collectively, these amendments added additional patent applications and patent families to the Exosomes License Agreement, added certain defined product development milestone payments, modified certain milestone deadlines, and added certain performance milestones with respect to product candidates covered by certain future patent rights in order to maintain an exclusive license to those future patent rights; failure to meet those milestones would cause CSMC to have the right to convert the license from exclusive to non-exclusive or co-exclusive, or to terminate the license, subject to Capricor’s right to license such patent rights for internal research purposes on a non-exclusive basis. These amendments also obligated Capricor to reimburse CSMC for certain attorneys’ fees and filing fees in connection with the additional patent applications and patent families. Sponsored Research Agreement with Johns Hopkins University On April 1, 2020 we entered into a Sponsored Research Agreement (the “SRA”), with JHU pursuant to which researchers in the lab of Dr. Stephen Gould are performing certain research activities in connection with our exosomes program. Pursuant to the SRA, we are funding certain research activities and have the right to negotiate for exclusive or non-exclusive rights to intellectual property that may result from such research activities. Unless renewed, the SRA is scheduled to expire on March 31, 2022. |
RELATED PARTY TRANSACTIONS
RELATED PARTY TRANSACTIONS | 12 Months Ended |
Dec. 31, 2021 | |
RELATED PARTY TRANSACTIONS | |
RELATED PARTY TRANSACTIONS | 9. RELATED PARTY TRANSACTIONS Lease and Sub-Lease Agreement As noted above, Capricor is a party to lease agreements with CSMC (see Note 7 – “Commitments and Contingencies”), and CSMC has served as an investigative site in Capricor’s clinical trials. Additionally, Dr. Eduardo Marbán, who is a stockholder of Capricor Therapeutics and has participated from time to time as an observer at the Company’s meetings of the Board of Directors, is the Director of the Cedars-Sinai Smidt Heart Institute, and co-founder of Capricor. On April 1, 2013, Capricor entered into a sublease with Reprise Technologies, LLC, a limited liability company which is wholly owned by Dr. Frank Litvack, the Company’s Executive Chairman and member of its Board of Directors, for $2,500 per month. The sublease was on a month-to-month basis and was terminated effective September 1, 2020. For the years ended December 31, 2021 and 2020, Capricor recognized zero and $20,000, respectively, in sublease income from the related party. Sublease income is recorded as a reduction to general and administrative expenses. Consulting Agreements In 2013, Capricor entered into a Consulting Agreement with Dr. Frank Litvack, the Company’s Executive Chairman and a member of its Board of Directors, whereby Capricor agreed to pay Dr. Litvack $10,000 per month for consulting services. The agreement is terminable upon 30 days’ notice. In July 2020, Capricor entered into an Advisory Services Agreement with Dr. Eduardo Marbán whereby he was granted an option to purchase 50,000 shares of the Company's common stock. 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 December 31, 2021 and 2020, the Company had accounts payable and accrued expenses to related parties totaling $599,388 and $8,972, respectively. CSMC accounts for $589,388 and $8,972 of the total accounts payable and accrued expenses to related parties as of December 31, 2021 and 31, 2020, respectively. CSMC expenses relate to clinical trial costs, research and development costs, license and patent fees, and facilities rent. During the years ended December 31, 2021 and 2020, the Company paid CSMC approximately $341,000 and $307,000, respectively, for such costs. Related Party Clinical Trials Capricor provided CAP-1002 for investigational purposes in two clinical trials sponsored by CSMC. This product was developed as part of the Company’s past research and development efforts. The first trial is known as “Regression of Fibrosis and Reversal of Diastolic Dysfunction in HFpEF Patients Treated with Allogeneic CDCs”, or REGRESS. Dr. Eduardo Marbán is the named principal investigator under the study. The second trial is known as “Pulmonary Arterial Hypertension treated with Cardiosphere-derived Allogeneic Stem Cells” or ALPHA. In both studies, Capricor provided the necessary number of doses of cells and received a total of approximately $1.7 million of monetary compensation. For the years ended December 31, 2021 and 2020, the Company recognized approximately $245,000 and $120,000, respectively, as revenue. As of December 31, 2021 and 2020, approximately zero and $56,000, respectively, is outstanding and recorded in prepaid expenses and other current assets. CSMC informed us that the enrollment of the REGRESS and ALPHA studies have been completed and as a result, we do not expect to receive any further material revenues from these trials. |
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS | 12 Months Ended |
Dec. 31, 2021 | |
SUBSEQUENT EVENTS | |
SUBSEQUENT EVENTS | 10. SUBSEQUENT EVENTS Commercialization and Distribution Agreement On January 24, 2022, Capricor entered into an Exclusive Commercialization and Distribution Agreement (the “NS Distribution Agreement”) with Nippon Shinyaku, Co., Ltd., a Japanese corporation, (“Nippon Shinyaku”). Under the terms of the NS Distribution Agreement, Capricor appointed Nippon Shinyaku as its exclusive distributor for the United States of CAP-1002, the Company’s lead product candidate, for the treatment of DMD. Under the terms of the NS Distribution Agreement, Capricor will be responsible for the conduct of HOPE-3 as well as the manufacturing of CAP-1002. Nippon Shinyaku will be responsible for the distribution of CAP-1002 in the United States. Capricor will sell commercial product to Nippon Shinyaku and in addition will receive a meaningful, double-digit share of product revenue and additional development and sales-based milestone payments. Capricor expects to receive an upfront payment of $30.0 million with potential additional sales and development milestone payments of up to $705.0 million. Stock Option Grants In January 2022, the Company granted a total of 1,769,370 stock options to its employees, certain non-employee consultants, and directors. |
ORGANIZATION AND SUMMARY OF S_2
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 12 Months Ended |
Dec. 31, 2021 | |
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
Description of Business | Description of Business Capricor Therapeutics, Inc., a Delaware corporation (referred to herein as “Capricor Therapeutics” or the “Company” or “we”), is a biotechnology company focused on the development of transformative cell and exosome-based therapeutics for the treatment and prevention of a broad spectrum of diseases. Capricor, Inc. (“Capricor”), a wholly-owned subsidiary of Capricor Therapeutics, was founded in 2005 as a Delaware corporation based on the innovative work of its founder, Eduardo Marbán, M.D., Ph.D. After completion of a merger between Capricor and a subsidiary of Nile Therapeutics, Inc., a Delaware corporation (“Nile”), on November 20, 2013, Capricor became a wholly-owned subsidiary of Nile and Nile formally changed its name to Capricor Therapeutics, Inc. Capricor Therapeutics, together with its subsidiary, Capricor, has multiple active drug and vaccine candidates in various stages of development. |
Basis of Consolidation | Basis of Consolidation Our consolidated financial statements include the accounts of the Company and our wholly-owned subsidiary. All intercompany transactions have been eliminated in consolidation. |
Reclassification | Reclassification Certain reclassification of prior period amounts has been made to conform to the current year presentation. |
Liquidity | Liquidity The Company has historically financed its research and development activities as well as operational expenses from equity financings, government grants, a payment from a former collaboration partner, a loan award and a grant from the California Institute for Regenerative Medicine (“CIRM”). Cash and cash equivalents as of December 31, 2021 were approximately $34.9 million, compared to approximately $32.7 million as of December 31, 2020. The Company has entered into a Common Stock Sales Agreement with H.C. Wainwright & Co. LLC (“Wainwright”) to create at-the-market equity programs under which the Company from time to time offered and sold shares of its common stock, par value $0.001 per share (see Note 3 – “Stockholders’ Equity”). The Company’s principal uses of cash are for research and development expenses, general and administrative expenses, capital expenditures and other working capital requirements. The Company’s future expenditures and capital requirements may be substantial and will depend on many factors, including, but not limited to, the following: ● the timing and costs associated with its research and development activities, clinical trials and preclinical studies; ● the timing and costs associated with the manufacturing of its product candidates; ● the timing and costs associated with commercialization of its product candidates; ● the number and scope of its research programs; and ● the costs involved in prosecuting and enforcing patent claims and other intellectual property rights. The Company’s options for raising additional capital include potentially seeking additional financing primarily from, but not limited to, the sale and issuance of equity or debt securities, the licensing or sale of its technology and other assets, potential partnering opportunities, and from government grants. The Company will require substantial additional capital to fund its operations, in particular if it elects to expand its clinical programs as contemplated by its current business plan. The Company cannot provide assurances that financing will be available when and as needed or that, if available, financing will be available on favorable or acceptable terms. If the Company is unable to obtain additional financing when and if required, it would have a material adverse effect on the Company’s business and results of operations. The Company would likely need to delay, curtail or terminate all or portions of its clinical trial programs. To the extent the Company issues additional equity securities, its existing stockholders would experience substantial dilution. Business Uncertainty Related to the Coronavirus The COVID-19 pandemic has presented a substantial public health and economic challenge around the world. Our business operations and financial condition and results have been impacted to varying degrees, and we expect the impact will continue in future quarters. We are continuing to assess and plan our development for the ongoing and potential impact of the COVID-19 pandemic on our business, operations and financial condition and results. Despite careful tracking and planning, however, we are unable to accurately predict the extent of the impact of the pandemic on our business, results of operations and financial condition due to the uncertainty of future developments involving the pandemic and its impact on our employees and operations. The full extent to which the COVID-19 pandemic will directly or indirectly impact our business, results of operations and financial condition will depend on future developments that are highly uncertain and cannot be accurately predicted, including new information that may emerge concerning COVID-19, the actions taken to contain it or treat its impact and the economic impact on local, regional, national and international markets. In addition, there may be risks to the Company’s ability to obtain financing from other sources due to the impact of the coronavirus. There could be other financial impacts on our business due to the coronavirus, the specifics of which are unknown at this time. In light of uncertainties due to COVID-19 and its economic and other impacts and to uncertainties around the timing and availability of grant disbursements, the loss of revenue from the delays of the REGRESS and ALPHA trials as well as any potential equity and debt financings, the Company applied for a loan under the Small Business Administration (the “SBA”) Paycheck Protection Program of the Coronavirus Aid, Relief and Economic Security Act of 2020 (the “CARES Act”). On April 29, 2020, the Company was approved and received a loan of $318,160 (the “Loan”) under the SBA Paycheck Protection Program of the CARES Act (see Note 2 – “Note Payable”). The Employee Retention Credit (“ERC”), a credit against certain payroll taxes allowed to an eligible employer for qualifying wages, was established by the CARES Act. The Company recorded $548,207 in ERC as other income for the year ended December 31, 2021, of which $356,997 is recorded as a receivable as of December 31, 2021. The Company may submit for additional credits under the CARES Act in the future, as applicable. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements. Estimates also affect the reported amounts of revenues and expenses during the reporting period. The most sensitive estimates relate to the assumptions used to estimate stock-based compensation expense. Management uses its historical records and knowledge of its business in making these estimates. Accordingly, actual results may differ from these estimates. |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers all highly liquid investments with a maturity of less than 30 days at the date of purchase to be cash equivalents. |
Marketable Securities | Marketable Securities The Company determines the appropriate classification of its marketable securities at the time of purchase and reevaluates such designation at each balance sheet date. All of the Company’s marketable securities are considered as available-for-sale and carried at estimated fair values. Realized gains and losses on the sale of debt and equity securities are determined using the specific identification method. Unrealized gains and losses on available-for-sale securities are excluded from net income (loss) and reported in accumulated other comprehensive income (loss) as a separate component of stockholders’ equity. |
Property and Equipment | Property and Equipment Property and equipment are stated at cost. Repairs and maintenance costs are expensed in the period incurred. Depreciation is computed using the straight-line method over the related estimated useful life of the asset, which such estimated useful lives range from five Property and equipment, net consisted of the following: December 31, December 31, 2021 2020 Furniture and fixtures $ 43,123 $ 48,676 Laboratory equipment 2,475,543 1,473,708 Leasehold improvements 33,742 47,043 2,552,408 1,569,427 Less accumulated depreciation (756,712) (718,580) Property and equipment, net $ 1,795,696 $ 850,847 |
Intangible Assets | Intangible Assets Amounts attributable to intellectual property consist primarily of the costs associated with the acquisition of certain technologies, patents, pending patents and related intangible assets with respect to research and development activities. Certain intellectual property assets are stated at cost and amortized on a straight-line basis over the respective estimated useful lives of the assets ranging from five The Company reviews goodwill and intangible assets at least annually for possible impairment. Goodwill and intangible assets are reviewed for possible impairment between annual tests if an event occurs or circumstances change that would more likely than not reduce the fair value of the reporting unit below its carrying value. No impairment was recorded for the years ended December 31, 2021 and 2020. |
Long-Lived Assets | Long-Lived Assets The Company accounts for the impairment and disposition of long-lived assets in accordance with guidance issued by the FASB. Long-lived assets to be held and used are reviewed for events or changes in circumstances that indicate that their carrying value may not be recoverable, or annually. No impairment related to long-lived assets was recorded for the years ended December 31, 2021 and 2020. |
Leases | Leases ASC Topic 842, “Leases” (“ASC 842”), as adopted in the first quarter of 2019, requires lessees to recognize most leases on the balance sheet with a corresponding right-to-use asset (“ROU asset”). ROU assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent the Company’s obligation to make lease payments arising from the lease. The assets and lease liabilities are recognized at the lease commencement date based on the estimated present value of fixed lease payments over the lease term. ROU assets are evaluated for impairment using the long-lived assets impairment guidance. Leases will be classified as financing or operating, which will drive the expense recognition pattern. The Company elects to exclude short-term leases if and when the Company has them. The Company leases office and laboratory space, all of which are operating leases (see Note 7 - “Commitments and Contingencies”). Most leases include the option to renew and the exercise of the renewal options is at the Company’s sole discretion. Options to renew a lease are not included in the Company’s assessment unless there is reasonable certainty that the Company will renew. In addition, the Company’s lease agreements generally do not contain any residual value guarantees or restrictive covenants. The interest rate implicit in lease contracts is typically not readily determinable. As a result, the Company utilizes its incremental borrowing rate, which reflects the fixed rate at which the Company could borrow on a collateralized basis the amount of the lease payments in the same currency, for a similar term, in a similar economic environment. For real estate leases, the Company has elected the practical expedient under ASC 842 to account for the lease and non-lease components together for existing classes of underlying assets and allocates the contract consideration to the lease component only. This practical expedient is not elected for manufacturing facilities and equipment embedded in product supply arrangements. |
Revenue Recognition | Revenue Recognition The company applies ASU 606, Revenue from Contracts with Customers Government Research Grants Generally, government research grants that provide funding for research and development activities are recognized as income when the related expenses are incurred, as applicable. Because the terms of the grant award from CIRM (the “CIRM Award”) allow Capricor to elect to convert the grant into a loan after the end of the project period, the CIRM Award is being classified as a liability rather than income (see Note 6 - “Government Grant Awards”). Grant income is due upon submission of a reimbursement request. The transaction price varies for grant income based on the expenses incurred under the awards. Miscellaneous Income Revenue is recognized in connection with the delivery of doses which were developed as part of our past R&D efforts. Income is recorded when the Company has satisfied the obligations as identified in the contracts with the customer (see Note 9 – “Related Party Transactions”). Miscellaneous income is due upon billing. Miscellaneous income is based on contracts with fixed transaction prices. |
Income Taxes | Income Taxes Income taxes are recognized for the amount of taxes payable or refundable for the current year and deferred tax liabilities and assets are recognized for the future tax consequences of transactions that have been recognized in the Company’s financial statements or tax returns. A valuation allowance is provided when it is more likely than not that some portion or the entire deferred tax asset will not be realized. The Company uses guidance issued by the FASB that clarifies the accounting for uncertainty in income taxes recognized in an enterprise’s financial statements and prescribes a recognition threshold of more likely than not and a measurement process for financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. In making this assessment, a company must determine whether it is more likely than not that a tax position will be sustained upon examination, based solely on the technical merits of the position, and must assume that the tax position will be examined by taxing authorities. As of December 31, 2021, the Company had federal net operating loss carryforwards of approximately $124.3 million, available to reduce future taxable income, of which $76.1 million will begin to expire in 2027. The post December 31, 2017 net operating losses generated of $48.2 million will carryforward indefinitely, but may be subject to an 80% limitation upon utilization. As of December 31, 2021, the Company had state net operating loss carryforwards of approximately $121.1 million, available to reduce future taxable income, which will begin to expire in 2028. Utilization of these net operating losses could be limited under Section 382 of the Internal Revenue Code of 1986, as amended (the “Code”), and similar state laws based on ownership changes and the value of the Company’s stock. Additionally, currently, the Company has approximately $1.4 million of federal research and development credits and approximately $3.4 million of federal orphan drug credits, available to offset future taxable income. These federal research and development and orphan drug credits begin to expire in 2027 and 2035, respectively. Under Section 382 of the Code, the Company’s ability to utilize NOL carryforwards or other tax attributes, such as federal tax credits, in any taxable year may be limited if the Company has experienced an “ownership change.” Generally, a Section 382 ownership change occurs if one or more stockholders or groups of stockholders who owns at least 5% of a corporation’s stock increases its ownership by more than 50 percentage points over its lowest ownership percentage within a specified testing period. Similar rules may apply under state tax laws. We have experienced an ownership change that we believe under Section 382 of the Code will result in limitation in our ability to utilize net operating losses and credits. In addition, the Company may experience future ownership changes as a result of future offerings or other changes in ownership of its stock. As a result, the amount of the NOLs and tax credit carryforward presented in the financial statement could be limited and may expire unutilized. The Company’s net operating loss carryforwards are subject to Internal Revenue Service (“IRS”) examination until they are fully utilized and such tax years are closed. The Company’s policy is to include interest and penalties related to unrecognized tax benefits in income tax expense. The Company incurred no interest or penalties for the years ended December 31, 2021 and 2020. The Company files income tax returns with the IRS and the California Franchise Tax Board. |
Research and Development | Research and Development Costs relating to the design and development of new products are expensed as research and development as incurred in accordance with Financial Accounting Standards Board (“FASB”) ASC 730-10, Research and Development |
Comprehensive Income (Loss) | Comprehensive Income (Loss) Comprehensive income (loss) generally represents all changes in stockholders’ equity during the period except those resulting from investments by, or distributions to, stockholders. The Company’s comprehensive loss was approximately $20.0 million and $13.7 million for the years ended December 31, 2021 and 2020, respectively. The Company’s other comprehensive income (loss) is related to a net unrealized gain (loss) on marketable securities. For the years ended December 31, 2021 and 2020, the Company’s other comprehensive income was zero and $757, respectively. |
Clinical Trial Expense | Clinical Trial Expense As part of the process of preparing our consolidated financial statements, we are required to estimate our accrued expenses. Our clinical trial accrual process is designed to account for expenses resulting from our obligations under contracts with vendors, consultants, and contract research organizations (“CROs”), and clinical site agreements in connection with conducting clinical trials. The financial terms of these contracts are subject to negotiations, which vary from contract to contract and may result in payment flows that do not match the periods over which materials or services are provided to us under such contracts. Our objective is to reflect the appropriate clinical trial expenses in our consolidated financial statements by matching the appropriate expenses with the period in which services are provided and efforts are expended. We account for these expenses according to the progress of the trial as measured by patient progression and the timing of various aspects of the trial. We determine accrual estimates through financial models that take into account discussion with applicable personnel and outside service providers as to the progress or state of completion of trials, or the services completed. During the course of a clinical trial, we adjust our clinical expense recognition if actual results differ from our estimates. We make estimates of our accrued expenses as of each balance sheet date in our consolidated financial statements based on the facts and circumstances known to us at that time. Our clinical trial accrual and prepaid assets are dependent, in part, upon the receipt of timely and accurate reporting from CROs and other third-party vendors. Although we do not expect our estimates to be materially different from amounts actually incurred, our understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and may result in us reporting amounts that are too high or too low for any particular period. |
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. December 31, 2021 December 31, 2020 Numerator Net loss $ (20,022,520) $ (13,657,028) Denominator Weighted-average number of shares of common stock outstanding 23,089,323 15,571,056 Dilutive effect of stock options — — Common stock and common stock equivalents used for diluted loss per share 23,089,323 15,571,056 For the years ended December 31, 2021 and 2020, warrants and options to purchase 3,899,606 and 2,488,046 shares of common stock, respectively, have been excluded from the computation of potentially dilutive securities. Potentially dilutive common shares, which primarily consist of stock options issued to employees, consultants, and directors as well as warrants issued, have been excluded from the diluted loss per share calculation because their effect is anti-dilutive. Because the impact of these items is anti-dilutive during periods of net loss, there was no difference between basic and diluted loss per share for the years ended December 31, 2021 and 2020. |
Fair Value Measurements | Fair Value Measurements Assets and liabilities recorded at fair value in the balance sheet are categorized based upon the level of judgment associated with the inputs used to measure their fair value. The categories are as follows: Level Input: Input Definition: Level I Inputs are unadjusted, quoted prices for identical assets or liabilities in active markets at the measurement date. Level II Inputs, other than quoted prices included in Level I, that are observable for the asset or liability through corroboration with market data at the measurement date. Level III Unobservable inputs that reflect management’s best estimate of what market participants would use in pricing the asset or liability at the measurement date. Carrying amounts reported in the balance sheet of cash and cash equivalents, 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. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In October 2019, the FASB issued ASU 2019-12, which affects general principles within Topic 740, Income Taxes. The amendments of ASU 2019-12 are meant to simplify and reduce the cost of accounting for income taxes. For public business entities, the amendments in this Update are effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2020. The Company adopted ASU 2019-12 in the first quarter of 2021. The adoption of this update did not have a material impact on the Company’s financial statements and footnote disclosures. In November 2021, the FASB issued ASU 2021-10, Government Assistance (Topic 832) Other recent accounting pronouncements issued by the FASB, including its Emerging Issues Task Force, the American Institute of Certified Public Accountants, and the SEC, did not or are not believed by management to have a material impact on the Company’s present or future consolidated financial statement presentation or disclosures. |
ORGANIZATION AND SUMMARY OF S_3
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
Schedule of property, plant and equipment | December 31, December 31, 2021 2020 Furniture and fixtures $ 43,123 $ 48,676 Laboratory equipment 2,475,543 1,473,708 Leasehold improvements 33,742 47,043 2,552,408 1,569,427 Less accumulated depreciation (756,712) (718,580) Property and equipment, net $ 1,795,696 $ 850,847 |
Schedule of basic and diluted earnings (loss) per share | December 31, 2021 December 31, 2020 Numerator Net loss $ (20,022,520) $ (13,657,028) Denominator Weighted-average number of shares of common stock outstanding 23,089,323 15,571,056 Dilutive effect of stock options — — Common stock and common stock equivalents used for diluted loss per share 23,089,323 15,571,056 |
Schedule of fair value measurements | 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. |
STOCK AWARDS, WARRANTS AND OP_2
STOCK AWARDS, WARRANTS AND OPTIONS (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Schedule of employee and non-employee stock based compensation expense | 2021 2020 General and administrative $ 2,566,883 $ 1,705,477 Research and development 398,809 247,202 Total $ 2,965,692 $ 1,952,679 |
Summary of Stock Option Outstanding And Exercisable | Options Outstanding Weighted Average Weighted Average Range of Ex. Prices Options Outstanding Term (yrs.) Exercise Price $1.18 - $1.39 2,006,916 6.50 $ 1.39 $2.54 - $3.74 1,291,158 8.95 $ 3.73 $4.37 - $6.30 495,750 9.18 $ 5.22 3,793,824 $ 2.68 Options Exercisable Weighted Average Weighted Average Range of Ex. Prices Options Exercisable Term (yrs.) Exercise Price $1.18 - $1.39 1,250,375 5.54 $ 1.38 $2.54 - $3.74 310,007 8.74 $ 3.70 $4.37 - $6.30 65,673 8.39 $ 5.79 1,626,055 $ 2.00 |
Warrant [Member] | |
Summary of warrant activity | Weighted Average Warrants Exercise Price Outstanding at January 1, 2020 7,501,696 $ 0.65 Granted 4,200,000 1.28 Exercised (11,575,523) 0.87 Outstanding at December 31, 2020 126,173 $ 1.32 Exercised (20,391) 1.10 Outstanding at December 31, 2021 105,782 $ 1.37 |
Schedule of outstanding warrants | Warrants Outstanding December 31, December 31, Exercise Price Expiration Type Grant Date 2021 2020 per Share Date Common Warrants 12/19/2019 40,782 61,173 $ 1.10 12/19/2024 Common Warrants 3/27/2020 65,000 65,000 $ 1.5313 3/27/2025 105,782 126,173 |
Stock Option [Member] | |
Schedule of fair value of option using Black-Scholes option | December 31, 2021 December 31, 2020 Expected volatility 123% - 124 % 104% - 124 % Expected term 6 years 5 - 6 years Dividend yield 0 % 0 % Risk-free interest rates 0.5 - 1.1 % 0.4 - 1.5 % |
Schedule of employee and non-employee stock option | Number of Weighted Average Aggregate Options Exercise Price Intrinsic Value Outstanding at January 1, 2020 754,913 $ 12.63 $ — Granted 1,878,058 2.14 Exercised (63,774) 3.19 $ 329,035 Expired/Cancelled (207,324) 5.73 Outstanding at December 31, 2020 2,361,873 $ 1.89 $ 4,236,737 Granted 1,636,324 3.95 Exercised (21,338) 1.39 $ 51,044 Expired/Cancelled (183,035) 3.84 Outstanding at December 31, 2021 3,793,824 $ 2.68 $ 3,104,631 Exercisable at December 31, 2021 1,626,055 $ 2.00 $ 1,938,298 |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
COMMITMENTS AND CONTINGENCIES | |
Schedule of Future Minimum Rental Payments | The table below excludes short-term operating leases. The following table summarizes maturities of lease liabilities and the reconciliation of lease liabilities as of December 31, 2021: 2022 $ 492,380 2023 656,678 2024 674,931 2025 693,732 2026 562,627 Total minimum lease payments 3,080,348 Less: imputed interest (210,009) Total operating lease liabilities $ 2,870,339 Included in the consolidated balance sheet: Current portion of lease liabilities $ 417,632 Lease liabilities, net of current 2,452,707 Total operating lease liabilities $ 2,870,339 Other Information: Weighted average remaining lease term 4.79 years Weighted average discount rate 2.75% |
ORGANIZATION AND SUMMARY OF S_4
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Property and Equipment (Details) - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 |
Property, Plant and Equipment, Gross | $ 2,552,408 | $ 1,569,427 |
Less accumulated depreciation | (756,712) | (718,580) |
Property and equipment, net | 1,795,696 | 850,847 |
Furniture and fixtures | ||
Property, Plant and Equipment, Gross | 43,123 | 48,676 |
Laboratory equipment | ||
Property, Plant and Equipment, Gross | 2,475,543 | 1,473,708 |
Leasehold improvements | ||
Property, Plant and Equipment, Gross | $ 33,742 | $ 47,043 |
ORGANIZATION AND SUMMARY OF S_5
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Earnings (Loss) per share (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Numerator | ||
Net loss | $ (20,022,520) | $ (13,657,028) |
Denominator | ||
Weighted-average number of shares of common stock outstanding basic | 23,089,323 | 15,571,056 |
Dilutive effect of stock options | 0 | 0 |
Weighted-average number of shares of common stock outstanding diluted | 23,089,323 | 15,571,056 |
ORGANIZATION AND SUMMARY OF S_6
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Additional Information (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Apr. 29, 2020 | |
Accounting Policies [Line Items] | |||
Cash and cash equivalents | $ 34,885,274 | $ 32,665,874 | |
Common Stock, par value (in dollars per share) | $ 0.001 | $ 0.001 | |
Depreciation | $ 243,532 | $ 139,560 | |
Amortization of intangible assets | 2,165 | 4,330 | |
Long-lived assets impairment | 0 | 0 | |
Goodwill and intangible asset impairment | 0 | 0 | |
Research and development | 13,571,045 | 8,457,000 | |
Tax credit carryforward amount | 76,100,000 | ||
Net unrealized gain on marketable securities | 0 | 757 | |
Comprehensive loss | 20,022,520 | 13,656,271 | |
Receivables under "ERC" | 356,997 | ||
Interest and penalties related to unrecognized tax benefits | 0 | $ 0 | |
Other income | |||
Accounting Policies [Line Items] | |||
Revenue recognized under "ERC" | $ 548,207 | ||
Paycheck Protection Program Loan | |||
Accounting Policies [Line Items] | |||
Loan amount | $ 318,160 | ||
Warrant | |||
Accounting Policies [Line Items] | |||
Antidilutive securities | 3,899,606 | 2,488,046 | |
General Business Tax Credit Carryforward [Member] | |||
Accounting Policies [Line Items] | |||
Tax credit carryforward amount | $ 3,400,000 | ||
Operating loss carryforwards expiration year | 2035 | ||
Research Tax Credit Carryforward [Member] | |||
Accounting Policies [Line Items] | |||
Tax credit carryforward amount | $ 1,400,000 | ||
Tax credit carry forwards Expiration Year | 2027 | ||
Domestic Tax Authority [Member] | |||
Accounting Policies [Line Items] | |||
Operating loss carry forwards indefinitely | $ 48,200,000 | ||
Tax credit carryforward limitations on use | The post December 31, 2017 net operating losses generated of $48.2 million will carryforward indefinitely, but may be subject to an 80% limitation upon utilization. | ||
Operating Loss Carryforwards | $ 124,300,000 | ||
Operating loss carryforwards expiration year | 2027 | ||
State and Local Jurisdiction [Member] | |||
Accounting Policies [Line Items] | |||
Operating Loss Carryforwards | $ 121,100,000 | ||
Operating loss carryforwards expiration year | 2028 | ||
Minimum | |||
Accounting Policies [Line Items] | |||
Estimated useful lives (in years) | 5 years | ||
Intangible assets, useful lives (in years) | 5 years | ||
Maximum | |||
Accounting Policies [Line Items] | |||
Estimated useful lives (in years) | 7 years | ||
Intangible assets, useful lives (in years) | 15 years |
NOTE PAYABLE (Details)
NOTE PAYABLE (Details) - Paycheck Protection Program Loan | Apr. 29, 2020USD ($) |
Debt Instrument [Line Items] | |
Amount of loan applied | $ 318,160 |
Debt term | 2 years |
Bears interest rate, percentage | 1.00% |
STOCKHOLDER'S EQUITY (Details)
STOCKHOLDER'S EQUITY (Details) - USD ($) | Jun. 21, 2021 | May 04, 2020 | Mar. 25, 2020 | Dec. 31, 2021 | Dec. 31, 2021 | Dec. 31, 2020 | Jun. 21, 2021 | Dec. 31, 2021 | Dec. 31, 2019 |
Class of Stock [Line Items] | |||||||||
Commission rate on sale price per share | 3.00% | ||||||||
Gross proceeds from sale of common stock | $ 20,174,448 | $ 27,343,069 | |||||||
Number of warrants issued | 105,782 | 105,782 | 126,173 | 105,782 | 7,501,696 | ||||
Beneficial ownership limitation | 4.99% | ||||||||
Warrants Outstanding | 105,782 | 105,782 | 126,173 | 105,782 | 7,501,696 | ||||
Common stock, shares issued | 24,185,001 | 24,185,001 | 20,577,123 | 24,185,001 | |||||
Common stock, shares outstanding | 24,185,001 | 24,185,001 | 20,577,123 | 24,185,001 | |||||
Placement Agent Warrants | |||||||||
Class of Stock [Line Items] | |||||||||
Number of warrants issued | 200,000 | 65,000 | 65,000 | 65,000 | |||||
Exercise price of warrant | $ 1.5313 | ||||||||
Effective warrant terms | 6 months | ||||||||
Warrants Outstanding | 200,000 | 65,000 | 65,000 | 65,000 | |||||
Exercising Holder [Member] | |||||||||
Class of Stock [Line Items] | |||||||||
Number of shares issued to the exercising holders | 724,500 | ||||||||
Number of shares being held in abeyance | 3,275,500 | ||||||||
New Warrants [Member] | |||||||||
Class of Stock [Line Items] | |||||||||
Number of warrants issued | 0 | 0 | 0 | ||||||
Exercise price of warrant | $ 1.27 | ||||||||
Effective warrant terms | 5 years 6 months | ||||||||
Warrants Outstanding | 0 | 0 | 0 | ||||||
December 2019 Financing | Exercising Holder [Member] | |||||||||
Class of Stock [Line Items] | |||||||||
Issuance costs | $ 400,000 | ||||||||
Proceeds from issuance of warrants | $ 4,900,000 | ||||||||
May 2020 ATM Program | |||||||||
Class of Stock [Line Items] | |||||||||
Number of common stock shares issued | 6,027,852 | ||||||||
Gross proceeds from sale of common stock | $ 37,100,000 | ||||||||
Issuance costs | $ 1,200,000 | ||||||||
Maximum aggregate offering price | $ 40,000,000 | ||||||||
Average price | $ 6.15 | $ 6.15 | |||||||
June 2021 ATM Program | |||||||||
Class of Stock [Line Items] | |||||||||
Number of common stock shares issued | 1,267,475 | ||||||||
Gross proceeds from sale of common stock | $ 7,500,000 | ||||||||
Issuance costs | $ 300,000 | ||||||||
Maximum aggregate offering price | $ 75,000,000 | ||||||||
Average price | $ 5.89 | $ 5.89 | $ 5.89 | ||||||
Exercise Agreement | |||||||||
Class of Stock [Line Items] | |||||||||
Exercise price of warrant | $ 1.10 | ||||||||
Exercise Agreement | Exercising Holder [Member] | |||||||||
Class of Stock [Line Items] | |||||||||
Exercise price of warrant | $ 1.225 | ||||||||
Warrant issued exercised | 4,000,000 | ||||||||
Exercise Agreement | New Warrants [Member] | |||||||||
Class of Stock [Line Items] | |||||||||
Exercise price of warrant | $ 0.125 | ||||||||
Warrant issued exercised | 4,000,000 |
STOCK AWARDS, WARRANTS AND OP_3
STOCK AWARDS, WARRANTS AND OPTIONS - Warrants (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
STOCK AWARDS, WARRANTS AND OPTIONS | ||
Warrants Outstanding at Beginning | 126,173 | 7,501,696 |
Warrants Granted | 4,200,000 | |
Warrants Exercised | (20,391) | (11,575,523) |
Warrants Outstanding at Ending | 105,782 | 126,173 |
Weighted Average Exercise Price Outstanding at Beginning | $ 1.32 | $ 0.65 |
Weighted Average Exercise Price Granted | 1.28 | |
Weighted Average Exercise Price Exercised | 1.10 | 0.87 |
Weighted Average Exercise Price Outstanding at Ending | $ 1.37 | $ 1.32 |
STOCK AWARDS, WARRANTS AND OP_4
STOCK AWARDS, WARRANTS AND OPTIONS - Outstanding Warrants (Details) - $ / shares | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Class of Warrant or Right [Line Items] | |||
Warrants Outstanding | 105,782 | 126,173 | 7,501,696 |
Common Warrants with Expiration on December 2024 One | |||
Class of Warrant or Right [Line Items] | |||
Grant Date | Dec. 19, 2019 | ||
Warrants Outstanding | 40,782 | 61,173 | |
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) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected volatility, Minimum | 123.00% | 104.00% |
Expected volatility, Maximum | 124.00% | 124.00% |
Expected term | 6 years | |
Dividend yield | 0.00% | 0.00% |
Risk-free interest rates, Minimum | 0.50% | 0.40% |
Risk-free interest rates, Maximum | 1.10% | 1.50% |
Minimum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected term | 5 years | |
Maximum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected term | 6 years |
STOCK AWARDS, WARRANTS AND OP_6
STOCK AWARDS, WARRANTS AND OPTIONS - Stock-based Compensation Expense (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||
Stock-based compensation cost | $ 2,965,692 | $ 1,952,679 |
General and administrative | ||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||
Stock-based compensation cost | 2,566,883 | 1,705,477 |
Research and development | ||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||
Stock-based compensation cost | $ 398,809 | $ 247,202 |
STOCK AWARDS, WARRANTS AND OP_7
STOCK AWARDS, WARRANTS AND OPTIONS - Stock options outstanding and exercisable (Details) | 12 Months Ended |
Dec. 31, 2021$ / sharesshares | |
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Outstanding, Options (shares) | shares | 3,793,824 |
Outstanding, Weighted Average Exercise Price | $ 2.68 |
Exercisable, Option (Shares) | shares | 1,626,055 |
Exercisable, Weighted Average Exercise Price | $ 2 |
Range One [Member] | |
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Range of Exercise Prices, lower range | 1.18 |
Range of Exercise Prices, upper range | $ 1.39 |
Outstanding, Options (shares) | shares | 2,006,916 |
Outstanding, Weighted Average Term | 6 years 6 months |
Outstanding, Weighted Average Exercise Price | $ 1.39 |
Exercisable, Option (Shares) | shares | 1,250,375 |
Exercisable, Weighted Average Term | 5 years 6 months 14 days |
Exercisable, Weighted Average Exercise Price | $ 1.38 |
Range Two [Member] | |
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Range of Exercise Prices, lower range | 2.54 |
Range of Exercise Prices, upper range | $ 3.74 |
Outstanding, Options (shares) | shares | 1,291,158 |
Outstanding, Weighted Average Term | 8 years 11 months 12 days |
Outstanding, Weighted Average Exercise Price | $ 3.73 |
Exercisable, Option (Shares) | shares | 310,007 |
Exercisable, Weighted Average Term | 8 years 8 months 26 days |
Exercisable, Weighted Average Exercise Price | $ 3.70 |
Range Three [Member] | |
Share-based Payment Arrangement, Option, Exercise Price Range [Line Items] | |
Range of Exercise Prices, lower range | 4.37 |
Range of Exercise Prices, upper range | $ 6.30 |
Outstanding, Options (shares) | shares | 495,750 |
Outstanding, Weighted Average Term | 9 years 2 months 4 days |
Outstanding, Weighted Average Exercise Price | $ 5.22 |
Exercisable, Option (Shares) | shares | 65,673 |
Exercisable, Weighted Average Term | 8 years 4 months 20 days |
Exercisable, Weighted Average Exercise Price | $ 5.79 |
STOCK AWARDS, WARRANTS AND OP_8
STOCK AWARDS, WARRANTS AND OPTIONS - Stock Option Activity (Details) - USD ($) | Feb. 12, 2020 | Dec. 31, 2021 | Dec. 31, 2020 |
Number of Options | |||
Outstanding at End of the period | 662,968 | ||
Weighted Average Exercise Price | |||
Granted | $ 1.39 | ||
Stock Option | |||
Number of Options | |||
Outstanding at Beginning of the period | 2,361,873 | 754,913 | |
Granted | 1,636,324 | 1,878,058 | |
Exercised | (21,338) | (63,774) | |
Expired/Cancelled | (183,035) | (207,324) | |
Outstanding at End of the period | 3,793,824 | 2,361,873 | |
Exercisable | 1,626,055 | ||
Weighted Average Exercise Price | |||
Outstanding at Beginning of the period | $ 1.89 | $ 12.63 | |
Granted | 3.95 | 2.14 | |
Exercised | 1.39 | 3.19 | |
Expired/Cancelled | 3.84 | 5.73 | |
Outstanding at Ending of the period | 2.68 | $ 1.89 | |
Exercisable | $ 2 | ||
Aggregate Intrinsic Value | |||
Exercised | $ 51,044 | $ 329,035 | |
Outstanding | 3,104,631 | $ 4,236,737 | |
Exercisable | $ 1,938,298 |
STOCK AWARDS, WARRANTS AND OP_9
STOCK AWARDS, WARRANTS AND OPTIONS - Additional Information (Details) - USD ($) | Jan. 01, 2022 | Jun. 11, 2021 | Jan. 01, 2021 | Feb. 12, 2020 | Jun. 30, 2021 | Dec. 31, 2021 | Dec. 31, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Nov. 30, 2012 | Sep. 30, 2012 |
Disclosure Stockholders Equity, stock Options And Warrants Additional Information [Line Items] | |||||||||||
Number of options available for issuance | 3,869,682 | ||||||||||
Estimated weighted fair value of option granted (in per share) | $ 3.45 | $ 3.93 | |||||||||
Total incremental cost | $ 178,000 | ||||||||||
Total unrecognized fair value compensation cost | $ 7,700,000 | $ 171,000 | |||||||||
Weighted average period | 1 year 4 months 24 days | ||||||||||
Stock Option | Stock Option Plan 2012 | |||||||||||
Disclosure Stockholders Equity, stock Options And Warrants Additional Information [Line Items] | |||||||||||
Maximum number of common stock reserved under the Plan | 710,142 | ||||||||||
Stock Option | Non-Employee Director Plan 2012 | |||||||||||
Disclosure Stockholders Equity, stock Options And Warrants Additional Information [Line Items] | |||||||||||
Maximum number of common stock reserved under the Plan | 269,731 | ||||||||||
Stock Option | Stock Option Plan 2020 | |||||||||||
Disclosure Stockholders Equity, stock Options And Warrants Additional Information [Line Items] | |||||||||||
Maximum number of common stock reserved under the Plan | 2,500,000 | ||||||||||
Number of additional shares authorized | 0 | ||||||||||
Stock Option | Stock Option Plan 2021 | |||||||||||
Disclosure Stockholders Equity, stock Options And Warrants Additional Information [Line Items] | |||||||||||
Percentage of outstanding shares | 5.00% | ||||||||||
Maximum number of common stock reserved under the Plan | 3,500,000 | ||||||||||
Number of additional shares authorized | 1,209,250 | 823,084 | |||||||||
Incentive Stock Option | Stock Option Plan 2012 | |||||||||||
Disclosure Stockholders Equity, stock Options And Warrants Additional Information [Line Items] | |||||||||||
Minimum limit of fair market value to be treated as non-statutory stock | $ 100,000 | ||||||||||
Minimum | |||||||||||
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 | ||||||||||
Terms of stock option plans | 10 years |
CONCENTRATIONS (Details)
CONCENTRATIONS (Details) | Dec. 31, 2021USD ($)item |
CONCENTRATIONS | |
Number of financial institutions | item | 2 |
Cash, FDIC insured amount | $ 250,000 |
Cash, uninsured deposits | $ 34,400,000 |
GOVERNMENT GRANT AWARDS (Detail
GOVERNMENT GRANT AWARDS (Details) | Jun. 16, 2016USD ($)item | Sep. 30, 2016USD ($) | Jun. 16, 2016USD ($) | Dec. 31, 2021USD ($) |
Revenue from Grant | $ 0 | |||
California Institute for Regenerative Medicine | ||||
Grant award liability | $ 3,400,000 | $ 3,400,000 | $ 3,400,000 | |
Minimum expected contribution | $ 2,300,000 | |||
Term of award | 10 years | |||
Number of times, maximum royalty to be paid on total amount of award | item | 9 | |||
Debt term | 5 years | |||
California Institute for Regenerative Medicine | LIBOR | ||||
Interest rate | 1.00% | |||
U.S. Department of Defense Grant Award | ||||
Approved for grant award | $ 2,400,000 | |||
Cost incurred under award | $ 2,300,000 | |||
Disbursement period | 4 years |
COMMITMENTS AND CONTINGENCIES -
COMMITMENTS AND CONTINGENCIES - Future Minimum Rental Payments (Details) - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 |
COMMITMENTS AND CONTINGENCIES | ||
2022 | $ 492,380 | |
2023 | 656,678 | |
2024 | 674,931 | |
2025 | 693,732 | |
2026 | 562,627 | |
Total minimum lease payments | 3,080,348 | |
Less: imputed interest | (210,009) | |
Total operating lease liabilities | 2,870,339 | |
Included in the consolidated balance sheet: | ||
Current portion of lease liabilities | 417,632 | $ 0 |
Lease liabilities, net of current | 2,452,707 | $ 0 |
Total operating lease liabilities | $ 2,870,339 | |
Weighted average remaining lease term | 4 years 9 months 14 days | |
Weighted average discount rate | 2.75% |
COMMITMENTS AND CONTINGENCIES_2
COMMITMENTS AND CONTINGENCIES - Additional Information (Details) | Nov. 01, 2021USD ($) | Jul. 16, 2021USD ($)ft² | Jul. 01, 2013 | Nov. 30, 2021USD ($) | Dec. 31, 2021USD ($) | Dec. 31, 2020USD ($) | Jul. 31, 2021USD ($) | Jun. 01, 2014 |
COMMITMENTS AND CONTINGENCIES | ||||||||
Lease term | 2 years | |||||||
Lease, option to extend | true | |||||||
Lease renewal term | 12 months | |||||||
Reduction in monthly lease payment | $ 5,548 | |||||||
Future minimum rental payments to related parties | $ 3,080,348 | |||||||
Operating lease, ROU asset | 2,821,944 | $ 0 | ||||||
Operating lease, ROU liability | $ 2,870,339 | |||||||
Number of months of base salary | 6 months | |||||||
Restructuring reserve | $ 0 | |||||||
Operating lease costs | 129,726 | |||||||
Operating lease payments | $ 81,331 | |||||||
Vivarium Agreement with Explora BioLabs, Inc [Member] | ||||||||
COMMITMENTS AND CONTINGENCIES | ||||||||
Lease term | 1 year | |||||||
Lease renewal term | 1 year | |||||||
Written Notice Period | 60 days | |||||||
Base rent per month | $ 4,021 | |||||||
Property Located at 10865 Road to Cure in Diego | CALIFORNIA | ||||||||
COMMITMENTS AND CONTINGENCIES | ||||||||
Lease renewal term | 5 years | |||||||
Ground leases | ft² | 9,396 | |||||||
Annual lease rent | $ 600,000 | |||||||
Operating lease percentage | 3.00% | |||||||
Operating lease, ROU asset | $ 2,700,000 | |||||||
Operating lease, ROU liability | $ 2,700,000 | |||||||
Fifth Lease Amendment | ||||||||
COMMITMENTS AND CONTINGENCIES | ||||||||
Written Notice Period | 90 days | |||||||
Monthly lease payment | $ 13,073 | |||||||
Facilities Lease | ||||||||
COMMITMENTS AND CONTINGENCIES | ||||||||
Lease term | 3 years | |||||||
Lease renewal term | 12 months | |||||||
Monthly lease payment | $ 10,707 | |||||||
Unrelated Party | ||||||||
COMMITMENTS AND CONTINGENCIES | ||||||||
Short term lease expenses | 141,923 | 194,748 | ||||||
Related party | ||||||||
COMMITMENTS AND CONTINGENCIES | ||||||||
Short term lease expenses | $ 164,168 | $ 189,660 |
LICENSE AGREEMENTS (Details)
LICENSE AGREEMENTS (Details) | Apr. 28, 2021USD ($) | Dec. 31, 2021EUR (€) | Dec. 31, 2021USD ($) | May 31, 2015USD ($) |
Rome License Agreement | ||||
LICENSE AGREEMENTS | ||||
Notice period | 90 days | |||
JHU License Agreement | ||||
LICENSE AGREEMENTS | ||||
Notice period | 60 days | |||
Threshold period to cure breach | 30 days | |||
CSMC License Agreement | ||||
LICENSE AGREEMENTS | ||||
Notice period | 90 days | |||
Exosomes License Agreement | ||||
LICENSE AGREEMENTS | ||||
Notice period | 90 days | 90 days | ||
Upfront Payment | $ 10,000 | |||
Minimum | Rome License Agreement | ||||
LICENSE AGREEMENTS | ||||
Royalties payment | € | € 20,000 | |||
Maximum | JHU License Agreement | ||||
LICENSE AGREEMENTS | ||||
Potential milestone payments | $ 1,850,000 | |||
Completion of Phase One | Minimum | ||||
LICENSE AGREEMENTS | ||||
Milestone payment range upon completion of certain phases | 100,000 | |||
Obtention of FDA Approval | Maximum | ||||
LICENSE AGREEMENTS | ||||
Milestone payment range upon completion of certain phases | $ 1,000,000 | |||
Completion Of Phase Two Due | JHU License Agreement | ||||
LICENSE AGREEMENTS | ||||
Potential milestone payments | $ 250,000 | |||
Milestone payments to be made upon completion of certain phases | $ 500,000 | |||
Patent rights | JHU License Agreement | ||||
LICENSE AGREEMENTS | ||||
Agreement effective period | 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 | |||
Non Payment of Royalties | Exosomes License Agreement | ||||
LICENSE AGREEMENTS | ||||
Threshold period to cure breach | 30 days | |||
CSMC Agreement Compliance | CSMC License Agreement | ||||
LICENSE AGREEMENTS | ||||
Agreement termination period | 90 days | |||
CSMC Agreement Compliance | Exosomes License Agreement | ||||
LICENSE AGREEMENTS | ||||
Threshold period to cure breach | 90 days | |||
Material Breach Has Not Been Cured | CSMC License Agreement | ||||
LICENSE AGREEMENTS | ||||
Agreement termination period | 90 days | |||
Material Breach Has Not Been Cured | Exosomes License Agreement | ||||
LICENSE AGREEMENTS | ||||
Threshold period to cure breach | 90 days | |||
Fails To Cure Breach after Notice From CSMC | CSMC License Agreement | ||||
LICENSE AGREEMENTS | ||||
Agreement termination period | 90 days | |||
Fails To Cure Breach after Notice From CSMC | Exosomes License Agreement | ||||
LICENSE AGREEMENTS | ||||
Threshold period to cure breach | 60 days | 90 days |
RELATED PARTY TRANSACTIONS (Det
RELATED PARTY TRANSACTIONS (Details) | Apr. 01, 2013USD ($) | Jan. 31, 2022shares | Jul. 31, 2020shares | Dec. 31, 2021USD ($)item | Dec. 31, 2020USD ($) | Dec. 31, 2013USD ($) |
RELATED PARTY TRANSACTIONS | ||||||
Current Account payable and accrued expenses | $ 599,388 | $ 8,972 | ||||
Compensation received for services to be provided | 1,700,000 | |||||
Other revenues from related party | 245,000 | 120,000 | ||||
Prepaid Expenses and Other Current Assets | ||||||
RELATED PARTY TRANSACTIONS | ||||||
Due from Related Parties | 0 | 56,000 | ||||
Advisory Services Agreement | Dr Eduardo Marban | ||||||
RELATED PARTY TRANSACTIONS | ||||||
Granted option | shares | 50,000 | 50,000 | ||||
Board of Directors Chairman | Sublease Agreement with Frank Litvack | ||||||
RELATED PARTY TRANSACTIONS | ||||||
Monthly Sub-lease Income | $ 2,500 | 0 | 20,000 | |||
Board of Directors Chairman | Consulting Agreement with Frank Litvack | ||||||
RELATED PARTY TRANSACTIONS | ||||||
Monthly consulting fees | $ 10,000 | |||||
Notice period for termination of agreement | 30 days | |||||
CSMC | ||||||
RELATED PARTY TRANSACTIONS | ||||||
Payment for reimbursement for research and development, license and patent fees and facilities rent expenses incurred by related party | $ 341,000 | 307,000 | ||||
Number of clinical trial sponsored | item | 2 | |||||
CSMC | Transaction other than Sub-Award Agreement | ||||||
RELATED PARTY TRANSACTIONS | ||||||
Current Account payable and accrued expenses | $ 589,388 | $ 8,972 |
SUBSEQUENT EVENTS (Details)
SUBSEQUENT EVENTS (Details) - Subsequent event - USD ($) $ in Millions | Jan. 24, 2022 | Jan. 31, 2022 |
NS Distribution Agreement | ||
SUBSEQUENT EVENTS | ||
Upfront payment to be received | $ 30 | |
Potential additional sales and development milestone payments | $ 705 | |
Employees Non Employee Consultants And Directors | ||
SUBSEQUENT EVENTS | ||
Granted option | 1,769,370 |