Cover
Cover - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Mar. 04, 2022 | |
Cover [Abstract] | ||
Document Type | 10-K | |
Amendment Flag | false | |
Document Annual Report | true | |
Document Transition Report | false | |
Document Period End Date | Dec. 31, 2021 | |
Document Fiscal Period Focus | FY | |
Document Fiscal Year Focus | 2021 | |
Current Fiscal Year End Date | --12-31 | |
Entity File Number | 001-37348 | |
Entity Registrant Name | Corbus Pharmaceuticals Holdings, Inc. | |
Entity Central Index Key | 0001595097 | |
Entity Tax Identification Number | 46-4348039 | |
Entity Incorporation, State or Country Code | DE | |
Entity Address, Address Line One | 500 River Ridge Drive | |
Entity Address, City or Town | Norwood | |
Entity Address, State or Province | MA | |
Entity Address, Postal Zip Code | 02062 | |
City Area Code | 617 | |
Local Phone Number | 963-0100 | |
Title of 12(b) Security | Common Stock, par value $0.0001 per share | |
Trading Symbol | CRBP | |
Security Exchange Name | NASDAQ | |
Entity Well-known Seasoned Issuer | No | |
Entity Voluntary Filers | No | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Public Float | $ 201,863,338 | |
Entity Common Stock, Shares Outstanding | 125,243,381 | |
ICFR Auditor Attestation Flag | false | |
Documents Incorporated by Reference | Portions of the registrant’s proxy statement for the 2022 annual meeting of stockholders to be filed pursuant to Regulation 14A within 120 days after the registrant’s fiscal year ended December 31, 2021 , are incorporated by reference in Part III of this Form 10-K. | |
Auditor Firm ID | 274 | |
Auditor Location | Philadelphia, Pennsylvania | |
Auditor Name | EISNERAMPER LLP |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 25,006,632 | $ 85,433,441 |
Investments | 72,640,520 | |
Restricted cash | 192,475 | 350,000 |
Stock Subscriptions Receivable | 960,033 | |
Prepaid expenses and other current assets | 2,365,010 | 3,712,861 |
Contract asset | 1,618,296 | |
Total current assets | 100,204,637 | 92,074,631 |
Restricted cash | 477,425 | 669,900 |
Property and equipment, net | 2,392,696 | 4,067,837 |
Operating lease right of use assets | 4,609,110 | 5,248,525 |
Other assets | 46,385 | 234,038 |
Total assets | 107,730,253 | 102,294,931 |
Current liabilities: | ||
Notes payable | 767,938 | 710,158 |
Accounts payable | 1,782,277 | 7,381,183 |
Accrued expenses | 10,093,312 | 22,005,432 |
Derivative liability | 133,710 | 797,000 |
Operating lease liabilities, current | 1,136,948 | 1,004,063 |
Current portion of long-term debt | 3,093,344 | |
Total current liabilities | 17,007,529 | 31,897,836 |
Long-term debt, net of debt discount | 15,636,275 | 18,029,005 |
Other long-term liabilities | 22,205 | |
Operating lease liabilities, noncurrent | 5,956,217 | 7,093,165 |
Total liabilities | 38,622,226 | 57,020,006 |
Stockholders' equity | ||
Preferred stock, $0.0001 par value; 10,000,000 shares authorized, no shares issued and outstanding at December 31, 2021 and 2020 | ||
Common stock, $0.0001 par value; 300,000,000 shares authorized, 125,230,881 shares outstanding at December 31, 2021 and 150,000,000 shares authorized, and 98,852,696 shares issued and outstanding at December 31, 2020 | 12,523 | 9,885 |
Additional paid-in capital | 418,891,713 | 349,358,378 |
Retained earnings (accumulated deficit) | (349,733,764) | (304,093,338) |
Accumulated other comprehensive loss | (62,445) | |
Total stockholders’ equity | 69,108,027 | 45,274,925 |
Total liabilities and stockholders’ equity | $ 107,730,253 | $ 102,294,931 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2021 | Dec. 31, 2020 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 300,000,000 | 150,000,000 |
Common stock, shares issued | 125,230,881 | 98,852,696 |
Common stock, shares outstanding | 125,230,881 | 98,852,696 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Income Statement [Abstract] | ||
Revenue from awards and licenses | $ 881,705 | $ 3,937,230 |
Operating expenses: | ||
Research and development | 36,445,285 | 98,267,213 |
General and administrative | 20,425,444 | 28,480,250 |
Total operating expenses | 56,870,729 | 126,747,463 |
Operating loss | (55,989,024) | (122,810,233) |
Other income (expense), net: | ||
Other income (expense), net | 11,899,992 | 13,270,211 |
Interest income (expense), net | (1,830,486) | (1,028,359) |
Change in fair value of derivative liability | 663,290 | (251,000) |
Foreign currency exchange gain (loss) | (384,198) | (449,999) |
Other income (expense), net | 10,348,598 | 11,540,853 |
Net loss | $ (45,640,426) | $ (111,269,380) |
Net loss per share, basic and diluted | $ (0.37) | $ (1.42) |
Weighted average number of common shares outstanding, basic and diluted | 122,990,011 | 78,133,289 |
Comprehensive loss: | ||
Net loss | $ (45,640,426) | $ (111,269,380) |
Other comprehensive income (loss): | ||
Unrealized gain (loss) on marketable debt securities | (62,445) | |
Total other comprehensive income (loss) | (62,445) | |
Total comprehensive loss | $ (45,702,871) | $ (111,269,380) |
Consolidated Statement of Stock
Consolidated Statement of Stockholders' Equity - USD ($) | Total | Common Stock [Member] | Additional Paid-in Capital [Member] | Accumulated Deficit [Member] | AOCI Attributable to Parent [Member] |
Beginning balance, value at Dec. 31, 2019 | $ 6,157,565 | $ 6,467 | $ 198,975,056 | $ 192,823,958 | |
Beginning balance, shares at Dec. 31, 2019 | 64,672,893 | ||||
Issuance of common stock, net of issuance costs | 136,364,901 | $ 3,375 | 136,361,526 | ||
Issuance of common stock, net of issuance costs, shares | 33,752,192 | ||||
Stock-based compensation expense | 12,458,229 | 12,458,229 | |||
Issuance of common stock upon exercise of stock options | $ 756,461 | $ 43 | 756,418 | ||
Issuance of common stock upon exercise of stock options, shares | 427,611 | 427,611 | |||
Fair value of warrants issued | $ 807,149 | 807,149 | |||
Net loss | (111,269,380) | (111,269,380) | |||
Ending balance, value at Dec. 31, 2020 | 45,274,925 | $ 9,885 | 349,358,378 | (304,093,338) | |
Ending balance, shares at Dec. 31, 2020 | 98,852,696 | ||||
Issuance of common stock, net of issuance costs | 59,110,800 | $ 2,554 | 59,108,246 | ||
Issuance of common stock, net of issuance costs, shares | 25,539,585 | ||||
Stock-based compensation expense | $ 9,480,373 | 9,480,373 | |||
Issuance of common stock upon exercise of stock options, shares | 838,600 | ||||
Issuance of common stock upon exercise of warrants | $ 944,800 | $ 84 | 944,716 | ||
Issuance of common stock upon exercise of warrants, shares | 838,600 | ||||
Unrealized gain (loss) on marketable debt securities | (62,445) | $ (62,445) | |||
Net loss | (45,640,426) | (45,640,426) | |||
Ending balance, value at Dec. 31, 2021 | $ 69,108,027 | $ 12,523 | $ 418,891,713 | $ (349,733,764) | $ (62,445) |
Ending balance, shares at Dec. 31, 2021 | 125,230,881 |
Consolidated Statement of Sto_2
Consolidated Statement of Stockholders' Equity (Parenthetical) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Statement of Stockholders' Equity [Abstract] | ||
Stock issuance cost | $ 1,820,437 | $ 6,039,423 |
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 | $ (45,640,426) | $ (111,269,380) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation expense | 9,480,373 | 12,458,229 |
Depreciation and amortization | 999,817 | 1,123,854 |
Loss on impairment of fixed assets | 606,078 | |
Net amortization on premium of investments | 698,254 | |
Stock consideration in connection with PRI License Agreement | 250,000 | |
(Gain) Loss on foreign exchange | 342,424 | 93,661 |
Operating lease right of use asset amortization | 639,415 | 570,458 |
Amortization of debt discount | 700,613 | 291,392 |
Change in fair value of derivative liability | (663,290) | 251,000 |
Loss on sale of property and equipment | 99,520 | |
Changes in operating assets and liabilities: | ||
Decrease in prepaid expenses | 1,347,851 | 346,812 |
Decrease in contract asset | 1,618,296 | 1,062,769 |
Decrease (increase) in other assets | 187,652 | (149,070) |
Increase (decrease) in accounts payable | (5,956,297) | (3,468,917) |
Increase (decrease) in accrued expenses | (11,912,120) | (400,766) |
Increase in other long-term liabilities | 22,205 | |
Decrease in operating lease liabilities | (1,004,062) | (595,745) |
Net cash used in operating activities | (48,183,697) | (99,685,703) |
Cash flows from investing activities: | ||
Purchases of investments | (87,266,596) | |
Proceeds from sales and maturities of investments | 13,880,343 | |
Purchases of property and equipment | (54,172) | (484,491) |
Proceeds from Sale of Property, Plant, and Equipment | 23,900 | |
Net cash used in investing activities | (73,416,525) | (484,491) |
Cash flows from financing activities: | ||
Proceeds from issuance of notes payable | 984,375 | 909,375 |
Proceeds from issuance of long-term borrowings | 18,756,021 | |
Repayment of short-term borrowings | (926,595) | (951,876) |
Proceeds from issuance of common stock | 62,586,070 | 142,200,752 |
Issuance costs paid for common stock financings | (1,820,437) | (6,039,423) |
Net cash provided by financing activities | 60,823,413 | 154,874,849 |
Net increase (decrease) in cash, cash equivalents, and restricted cash | (60,776,809) | 54,704,655 |
Cash, cash equivalents, and restricted cash at beginning of the period | 86,453,341 | 31,748,686 |
Cash, cash equivalents, and restricted cash at end of the period | 25,676,532 | 86,453,341 |
Supplemental disclosure of cash flow information and non cash transactions: | ||
Cash paid during the period for interest | 1,740,878 | 629,146 |
Fair value of warrants issued with K2HV loan agreement | 472,409 | |
Fair value of warrants issued | 334,740 | |
Write-off of fully depreciated property and equipment | 544,752 | 156,645 |
Stock subscription receivable | $ 960,033 |
NATURE OF OPERATIONS
NATURE OF OPERATIONS | 12 Months Ended |
Dec. 31, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
NATURE OF OPERATIONS | 1. NATURE OF OPERATIONS Business Corbus Pharmaceuticals Holdings, Inc. (“the Company” or “Corbus”) is focused on developing new medicines that target inflammation, fibrosis, metabolism and immuno-oncology. Corbus’ current pipeline includes small molecules that activate or inhibit the endocannabinoid system and anti-integrin monoclonal antibodies that block activation of TGFβ. The Company plans to expand its pipeline through internal efforts and business development. Since its inception, the Company has devoted substantially all of its efforts to business planning, research and development, recruiting management and technical staff, acquiring operating assets and raising capital. The Company’s business is subject to significant risks and uncertainties and the Company will be dependent on raising substantial additional capital before it becomes profitable and it may never achieve profitability. The Company is continuing to monitor the impact of the COVID-19 pandemic on its business and operations. |
LIQUIDITY
LIQUIDITY | 12 Months Ended |
Dec. 31, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
LIQUIDITY | 2. LIQUIDITY The accompanying consolidated financial statements have been prepared assuming the Company will continue as a going concern, which contemplates continuity of operations, realization of assets and the satisfaction of liabilities and commitments in the normal course of business. The Company has incurred recurring losses since inception and as of December 31, 2021, had an accumulated deficit of approximately $ 349,734,000 . The Company anticipates operating losses to continue for the foreseeable future due to, among other things, costs related to research funding, development of its product candidates and its preclinical and clinical programs, strategic alliances and the development of its administrative organization. The Company expects the cash, cash equivalents, and investments of approximately $ 97,647,000 at December 31, 2021 will be sufficient to meet its operating and capital requirements at least 12 months from the filing of this 10-K. The source, timing and availability of any future financing will depend principally upon market conditions, and, more specifically, on the progress of the Company’s clinical development programs. Funding may not be available when needed, at all, or on terms acceptable to the Company. Lack of necessary funds may require the Company to, among other things, delay, scale back or eliminate some or all of the Company’s planned clinical or preclinical trials. On August 7, 2020, the Company entered into an Open Market Sale Agreement SM (the “August 2020 Sale Agreement”) with Jefferies LLC (“Jefferies”), as sales agent, pursuant to which the Company may issue and sell, from time to time, through Jefferies, shares of its common stock, and pursuant to which Jefferies may sell its common stock by any method permitted by law deemed to be an “at the market offering” as defined by Rule 415(a)(4) promulgated under the Securities Act of 1933, as amended. The Company will pay Jefferies a commission of 3.0 % of the aggregate gross proceeds from each sale of common stock and have agreed to provide Jefferies with customary indemnification and contribution rights. The Company has also agreed to reimburse Jefferies for certain specified expenses. As of August 7, 2020, the Company is authorized to offer and sell up to $ 150 million of its com mon stock pursuant to the August 2020 Sale Agreement. During the year ended December 31, 2021 , the Company sold 25,391,710 shares of its common stock under the August 2020 Sale Agreement for which the Company received gross proceeds of approximately $ 60,681,238 , less issuance costs incurred of approximately $ 1,820,437 . The Company has sold no additional shares of our common stock under the August 2020 Sale Agreement subsequent to December 31, 2021 (See Note 13). |
SIGNIFICANT ACCOUNTING POLICIES
SIGNIFICANT ACCOUNTING POLICIES | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
SIGNIFICANT ACCOUNTING POLICIES | 3. SIGNIFICANT ACCOUNTING POLICIES A summary of the significant accounting policies followed by the Company in the preparation of the financial statements is as follows: Consolidation The consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All significant intercompany transactions and accounts have been eliminated in consolidation. Use of Estimates The process of preparing financial statements in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”) requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates and changes in estimates may occur. The most significant estimates are related to stock-based compensation expense, the accrual of research, product development and clinical obligations, the recognition of revenue under the Investment Agreement (See Note 11), the valuation of warrants discussed in Note 15 and Note 9, and the derivative liability associated with the K2 Security and Loan agreement (see Note 16). Cash, Cash Equivalents, and Restricted Cash The Company considers only those investments which are highly liquid, readily convertible to cash, and that mature within three months from date of purchase to be cash equivalents. At December 31, 2021 and 2020, cash equivalents were comprised of money market funds. Restricted cash as of December 31, 2021 included security for a stand-by letter of credit issued in favor of a landlord for $ 669,900 of which $ 192,475 was classified in current assets and $ 477,425 was classified in noncurrent assets as of December 31, 2021. Cash and cash equivalents consists of the following: December 31, 2021 2020 Cash $ 6,751,593 $ 1,238,611 Cash Equivalents 18,255,039 84,194,830 Cash and cash equivalents $ 25,006,632 $ 85,433,441 Restricted cash, current 192,475 350,000 Restricted cash, noncurrent 477,425 669,900 Restricted cash $ 669,900 $ 1,019,900 Total cash, cash equivalents, and restricted cash shown in the statement of $ 25,676,532 $ 86,453,341 As of December 31, 2021, all of the Company’s cash and cash equivalents was held in the United States, except for approximately $ 5,752,000 of cash which was held principally in our subsidiary in the United Kingdom. As of December 31, 2020, all of the Company’s cash and cash equivalents was held in the United States, except for approximately $ 1,033,000 of cash which was held principally in our subsidiary in the United Kingdom. Investments Investments consist of investments in debt securities and term deposits with maturities greater than 90 days at their acquisition date. The Company has classified its investments with maturities beyond one year as current, based on their highly liquid nature and because such investments represent the investment of cash that is available for current operations. The Company classifies all of its marketable debt securities as available-for-sale securities. The Company’s marketable debt securities are measured and reported at fair value using quoted prices in active markets for similar securities. Unrealized gains and losses on available-for-sale debt securities are reported as accumulated other comprehensive gain or loss, which is a separate component of stockholders’ equity. The cost of debt securities sold is determined on a specific identification basis, and realized gains and losses are included in other income (expense), net in the consolidated statements of operations and comprehensive loss. The Company evaluates its marketable debt securities with unrealized losses for other-than-temporary impairment. When assessing marketable debt securities for other-than-temporary declines in value, the Company considers such factors as, among other things, how significant the decline in value is as a percentage of the original cost, how long the market value of the investment has been less than its original cost, the Company’s ability and intent to retain the investment for a period of time sufficient to allow for any anticipated recovery in fair value and market conditions in general. If any adjustment to fair value reflects a decline in the value of the investment that the Company considers to be “other than temporary,” the Company reduces the investment to fair value through a charge to the statement of operations and comprehensive loss. No such adjustments were necessary during the periods presented. Financial Instruments The carrying values of the notes payable and debt approximate their fair value due to the fact that they are at market terms. Fair Value Measurements The valuation of the Company’s debt and embedded derivatives are determined primarily by an income approach that considers the present value of net cash flows of the debt with and without prepayment and default features. These embedded debt features, which are determined to be classified as derivative liabilities are marked-to-market each reporting period, with a corresponding non-cash gain or loss charged to the current period. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. As a basis for considering such assumptions, there exists a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value as follows: Level 1 – Unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access as of the measurement date Level 2 – Inputs other than quoted prices included within Level 1 that are directly observable for the asset or liability or indirectly observable through corroboration with observable market data Level 3 – Unobservable inputs for the asset or liability only used when there is little, if any, market activity for the asset or liability at the measurement date The Company’s investments, debt, and its derivative liabilities are carried at fair value determined according to the fair value hierarchy described above. The carrying values of the Company’s prepaid expenses and other current assets, and accrued expenses approximate their fair values due to the short-term nature of these assets and liabilities. To determine the fair value of our embedded derivatives, management evaluates assumptions regarding the probability of certain future events. Other factors used to determine fair value include the discount rate, risk free interest rate and derivative term. The fair value recorded for the derivative liability varies from period to period. This variability may result in the actual derivative liability for a period either above or below the estimates recorded on our consolidated financial statements, resulting in fluctuations in other income (expense) because of the corresponding non-cash gain or loss recorded. Property and Equipment The estimated life for the Company’s property and equipment is as follows: three years for computer hardware and software and three to five years for office furniture and equipment. The Company’s leasehold improvements and assets under capital lease are amortized over the shorter of their useful lives or the respective leases. See Note 7 for details of property and equipment and Note 8 for operating and capital lease commitments. Research and Development Expenses Costs incurred for research and development are expensed as incurred. Nonrefundable advance payments for goods or services that have the characteristics that will be used or rendered for future research and development activities pursuant to executory contractual arrangements with third party research organizations are deferred and recognized as an expense as the related goods are delivered or the related services are performed. Accruals for Research and Development Expenses and Clinical Trials As part of the process of preparing its financial statements, the Company is required to estimate its expenses resulting from its obligations under contracts with vendors, clinical research organizations and consultants and under 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 terms that do not match the periods over which materials or services are provided under such contracts. The Company’s objective is to reflect the appropriate expenses in its financial statements by matching those expenses with the period in which services are performed and efforts are expended. The Company accounts for these expenses according to the timing of various aspects of the expenses. The Company determines the accrual estimates by taking into account discussion with applicable personnel and outside service providers as to the progress of clinical trials, or the services completed. During the course of a clinical trial, the Company adjusts its clinical expense recognition if actual results differ from its estimates. The Company makes estimates of its accrued expenses as of each balance sheet date based on the facts and circumstances known to it at that time. The Company’s clinical trial accruals are dependent upon the timely and accurate reporting of contract research organizations and other third-party vendors. Although the Company does not expect its estimates to be materially different from amounts actually incurred, its 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 it reporting amounts that are too high or too low for any particular period. For the years ended December 31, 2021 and 2020 , there were no material adjustments to the Company’s prior period estimates of accrued expenses for clinical trials. Leases The Company determines if an arrangement is a lease at inception. Operating leases are included in operating lease right-of-use (“ROU”) assets, other current liabilities and operating lease liabilities in the Company’s consolidated balance sheets. ROU assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent its obligation to make lease payments arising from the lease. ROU assets and liabilities are recognized at commencement date based on the present value of lease payments over the lease term. As the Company’s leases do not provide an implicit rate, the Company uses an incremental borrowing rate based on the information available at commencement date in determining the present value of lease payments. This is the rate the Company would have to pay if borrowing on a collateralized basis over a similar term to each lease. The ROU asset also includes any lease payments made and excludes lease incentives. Lease expense for lease payments is recognized on a straight-line basis over the lease term. The Company has subleased a portion of its leased facility under an agreement considered to be an operating lease according to GAAP. The Company has not been legally released from its primary obligations under the original lease and therefore it continues to account for the original lease as it did before commencement of the sublease. The Company will record both fixed and variable payments received from the sublessee in its statement of operations on a straight-line basis as an offset to rent expense. Concentrations of Credit Risk The Company has no significant off-balance-sheet concentration of credit risk such as foreign exchange contracts, option contracts or other hedging arrangements. The Company may from time to time have cash in banks in excess of Federal Deposit Insurance Corporation insurance limits. However, the Company believes the risk of loss is minimal as these banks are large financial institutions. Segment Information Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision maker, or decision-making group, in making decisions regarding resource allocation and assessing performance. To date, the Company has viewed its operations and manages its business as principally one operating segment, which is developing and commercializing therapeutics for autoimmunity, fibrosis, and cancer. As of December 31, 2021, all of the Company’s assets were located in the United States, except for approximately $ 22,504,000 of cash, cash equivalents, and investments, $ 973,000 of prepaid expenses and other assets, and $ 1,000 of property and equipment, net which were held outside of the United States, principally in our subsidiary in the United Kingdom. As of December 31, 2020 , all of the Company’s assets were located in the United States, except for approximately $ 1,033,000 of cash, $ 1,837,000 of prepaid expenses and other assets, and $ 23,000 of property and equipment, net which were held outside of the United States, principally in our subsidiary in the United Kingdom. Income Taxes For federal and state income taxes, deferred tax assets and liabilities are recognized based upon temporary differences between the financial statement and the tax basis of assets and liabilities. Deferred income taxes are based upon prescribed rates and enacted laws applicable to periods in which differences are expected to reverse. A valuation allowance is recorded to reduce a net deferred tax benefit when it is not more likely than not that the tax benefit from the deferred tax assets will be realized. Accordingly, given the cumulative losses since inception, the Company has provided a valuation allowance equal to 100 % of the deferred tax assets in order to eliminate the deferred tax assets amounts. Tax positions taken or expected to be taken in the course of preparing the Company’s tax returns are required to be evaluated to determine whether the tax positions are “more-likely-than-not” of being sustained by the applicable tax authority. Tax positions not deemed to meet a more-likely-than-not threshold, as well as accrued interest and penalties, if any, would be recorded as a tax expense in the current year. There were no uncertain tax positions that require accrual or disclosure to the financial statements as of December 31, 2021 or 2020. Impairment of Long-lived Assets The Company continually monitors events and changes in circumstances that could indicate that carrying amounts of long-lived assets may not be recoverable. An impairment loss is recognized when expected undiscounted cash flows of an asset are less than an asset’s carrying value. Accordingly, when indicators of impairment are present, the Company evaluates the carrying value of such assets in relation to the operating performance and future undiscounted cash flows of the underlying assets. An impairment loss equal to the excess of the fair value of the asset over its carrying amount, is recorded when it is determined that the carrying value of the asset may not be recoverable. The Company recognized an impairment loss of approximately $ 606,000 in the third quarter of 2021 to write down the value of leasehold improvements as a result of entering into a sublease. The Company notes no other impairment charges were taken in 2021. See Note 8 for more details on sublease agreement. Stock-based Payments The Company recognizes compensation costs resulting from the issuance of stock-based awards to employees, non-employees and directors as an expense in the statement of operations over the service period based on a measurement of fair value for each stock-based award. The fair value of each option grant is estimated as of the date of grant using the Black-Scholes option-pricing model, net of estimated forfeitures. The fair value is amortized as compensation cost on a straight-line basis over the requisite service period of the awards, which is generally the vesting period. Foreign Currency Transaction gains and losses arising from currency exchange rate fluctuations on transactions denominated in a currency other than the U.S. Dollar functional currency are recorded in the Company’s statement of operations. Such transaction gains and losses may be realized or unrealized depending upon whether the transaction settled during the period or remains outstanding at the balance sheet date. The functional currency of the Company's foreign subsidiaries is the U.S. dollar. Net Loss Per Common Share Basic and diluted net loss per share of the Company’s common stock has been computed by dividing net loss by the weighted average number of shares outstanding during the period. For years in which there is a net loss, options and warrants are anti-dilutive and therefore excluded from diluted loss per share calculations. The following table sets forth the computation of basic and diluted earnings per share for the years ended December 31, 2021 and 2020: Year Ended December 31, 2021 2020 Net income (loss) $ ( 45,640,426 ) $ ( 111,269,380 ) Weighted average number of common shares-basic 122,990,011 78,133,289 Net income (loss) per share of common stock-basic $ ( 0.37 ) $ ( 1.42 ) * Warrants and options that have not been exercised have been excluded from the diluted calculation as all periods presented have a net loss and the impact of these securities would be anti-dilutive. Recently Adopted Accounting Pronouncements In December 2019, the Financial Accounting Standards Board (the “FASB”) issued ASU 2019-12 , Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes which is intended to simplify various aspects related to accounting for income taxes. The standard is effective for fiscal years, and interim periods within those years, beginning after December 15, 2020, with early adoption permitted. The Company’s adoption of ASU 2019-12 as of January 1, 2021 had no impact on the Company’s financial statements and related disclosures. Recently Issued Accounting Pronouncements In May 2021, the FSB issued ASU 2021-04, Earnings Per Share (Topic 260), Debt—Modifications and Extinguishments (Subtopic 470-50), Compensation—Stock Compensation (Topic 718), and Derivatives and Hedging— Contracts in Entity’s Own Equity (Subtopic 815-40): Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options which is intended to clarify and reduce diversity in an issuer’s accounting for modifications or exchanges of freestanding equity-classified written call options that remain equity classified after modification of exchange. This standard is effective for all entities for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. The standard will be adopted upon the effective date for us beginning January 1, 2022. The Company's adoption of ASU 2021-04 as of January 1, 2022 will not have a material impact on the Company's financial statements and disclosures. In August 2020, the FASB issued ASU 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity which is intended to simplify various aspects of GAAP for certain financial instruments with characteristics of liabilities and equity. The standard is effective for public companies that meet the definition of an SEC filer, excluding entities that are smaller reporting companies as defined by the SEC, for fiscal years, and interim periods within those years, beginning after December 15, 2021. For all other entities, the amendments are effective for fiscal years beginning after December 15, 2023, including interim periods within those fiscal years. Early adoption is permitted, but no earlier than fiscal years beginning after December 15, 2020, including interim periods within those fiscal years. The Company is currently evaluating the timing of the adoption of ASU 2020-06 and the potential impact that this standard may have on its consolidated financial statements and related disclosures. In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”) , which requires the measurement and recognition of expected credit losses for financial assets held at amortized cost. ASU 2016-13 replaces the existing incurred loss impairment model with an expected loss model. It also eliminates the concept of other-than-temporary impairment and requires credit losses related to available-for-sale debt securities to be recorded through an allowance for credit losses rather than as a reduction in the amortized cost basis of the securities. These changes may result in earlier recognition of credit losses. In November 2018, the FASB issued ASU No. 2018-19, Codification Improvements to Topic 326, Financial Instruments—Credit Losses , which narrowed the scope and changed the effective date for non-public entities for ASU 2016-13. The FASB subsequently issued supplemental guidance within ASU No. 2019-05, Financial Instruments—Credit Losses (Topic 326): Targeted Transition Relief (“ASU 2019-05”) . ASU 2019-05 provides an option to irrevocably elect the fair value option for certain financial assets previously measured at amortized cost basis. For public entities that are SEC filers, excluding entities that are eligible to be smaller reporting companies, ASU 2016-13 is effective for annual periods beginning after December 15, 2019, including interim periods within those fiscal years. For all other entities, ASU 2016-13 is effective for annual periods beginning after December 15, 2022, including interim periods within those fiscal years. Early adoption is permitted. This standard will be effective for the Company on January 1, 2023 or when it ceases being eligible to be a smaller reporting company. The Company is currently evaluating the potential impact that this standard may have on its consolidated financial statements and related disclosures. |
INVESTMENTS
INVESTMENTS | 12 Months Ended |
Dec. 31, 2021 | |
Investments, Debt and Equity Securities [Abstract] | |
INVESTMENTS | 4. INVESTMENTS The following table summarizes the Company’s investments as of December 31, 2021 (in thousands): Amortized Cost Gross Gross Fair Value Debt Securities: Commercial paper $ 12,794 $— $— $ 12,794 Corporate debt securities 32,922 — ( 58 ) 32,864 Asset backed securities 10,235 — ( 4 ) 10,231 Other Investments: Term deposits (Maturing 2/10/2022 - 5/5/2022) 16,752 — — 16,752 Total $ 72,703 $— $( 62 ) $ 72,641 The following table summarizes the amortized cost and fair value of the Company’s available-for-sale marketable debt securities by contractual maturity as of December 31, 2021 (in thousands): Amortized Cost Fair Value Maturing in one year or less $ 44,859 $ 44,847 Maturing after one year but less than three years 11,092 11,041 $ 55,951 $ 55,888 As of December 31, 2020, there were no available-for-sale investments. |
FAIR VALUE OF FINANCIAL ASSETS
FAIR VALUE OF FINANCIAL ASSETS AND LIABILITIES | 12 Months Ended |
Dec. 31, 2021 | |
Fair Value Disclosures [Abstract] | |
FAIR VALUE OF FINANCIAL ASSETS AND LIABILITIES | 5. FAIR VALUE OF FINANCIAL ASSETS AND LIABILITIES The following tables present information about the Company’s financial assets and liabilities measured at fair value on a recurring basis and indicate the level of the fair value hierarchy utilized to determine such fair values as of December 31, 2021 (in thousands): Level 1 Level 2 Level 3 Total Assets: Cash Equivalents: Money market funds $ 18,255 $— $— $ 18,255 Investments: Term deposits 16,752 — — 16,752 Commercial paper — 12,794 — 12,794 Corporate debt securities — 32,864 — 32,864 Asset backed securities — 10,231 — 10,231 $ 35,007 $ 55,889 $— $ 90,896 Liabilities: Derivative liabilities $— $— $ 134 $ 134 The following tables present information about the Company’s financial assets and liabilities measured at fair value on a recurring basis and indicate the level of the fair value hierarchy utilized to determine such fair values as of December 31, 2020 (in thousands): Level 1 Level 2 Level 3 Total Assets: Cash Equivalents: Money Market funds $ 84,195 $— $— $ 84,195 84,195 — — 84,195 Liabilities Derivative Liabilities $— $— $ 797 $ 797 |
LICENSE AGREEMENT
LICENSE AGREEMENT | 12 Months Ended |
Dec. 31, 2021 | |
License Agreements | |
LICENSE AGREEMENT | 6. LICENSE AGREEMENTS The Company entered into a license agreement (the “Jenrin Agreement”) with Jenrin Discovery, LLC, a privately-held Delaware limited liability company (“Jenrin”), effective September 20, 2018. Pursuant to the Jenrin Agreement, Jenrin granted the Company exclusive worldwide rights to develop and commercialize the Licensed Products (as defined in the Jenrin Agreement) which includes the Jenrin library of over 600 compounds and multiple issued and pending patent filings. The compounds are designed to treat inflammatory and fibrotic diseases by targeting the endocannabinoid system. In consideration of the license and other rights granted by Jenrin, the Company paid Jenrin a $ 250,000 upfront cash payment and is obligated to pay potential milestone payments to Jenrin totaling up to $ 18,400,000 for each compound it elects to develop based upon the achievement of specified development and regulatory milestones. In addition, Corbus is obligated to pay Jenrin royalties in the mid, single digits based on net sales of any Licensed Products, subject to specified reductions. The Company entered into a license agreement (the “Milky Way License Agreement”) with Milky Way BioPharma, LLC (“Milky Way”), a subsidiary of Panorama Research Inc., effective May 25, 2021. Pursuant to the Milky Way License Agreement, the Company received an exclusive license, under certain patent rights and know-how owned or controlled by Milky Way, to develop, commercialize, and otherwise exploit products containing antibodies against integrin αvβ6 and/or integrin αvβ8 (“Licensed Products”), one of which the Company is referring to as CRB-602. Under the terms of the Milky Way License Agreement, the Company will have sole responsibility for research, development, and commercialization of any Licensed Products, and Company has agreed to use commercially reasonable efforts to perform these activities. The Milky Way Agreement may be terminated earlier in specified situations, including termination for material breach or termination by Corbus with advance notice. In consideration for the license and other rights granted to the Company under the Milky Way License Agreement, the Company paid Milky Way an upfront payment of $ 500,000 and issued to Milky Way 147,875 shares of its common stock. The Company is obligated to pay up to $ 53,000,000 in potential milestone payments for the achievement of certain development, regulatory, and sales milestones. At the Company’s election, the Company may satisfy a portion of certain milestone payments by issuing shares of its common stock. In addition, the Company is obligated to pay royalties in the low, single digits on sales of Licensed Products during the life of the applicable licensed patents on a country-by-county and product-by-product basis, which is subject to a minimum annual royalty obligation, as well as a percentage share of certain payments received by Company from sublicensees. The Company entered into a license agreement (the “UCSF License Agreement”) with the Regents of the University of California (“The Regents”) effective May 26, 2021. Pursuant to the UCSF License Agreement, the Company received an exclusive license to certain patents relating to humanized antibodies against integrin αvβ8, one of which the Company is referring to as CRB-601, along with non-exclusive licenses to certain related know-how and materials. In consideration for the license and other rights granted to the Company under the UCSF License Agreement, the Company paid The Regents a license issue fee of $ 1,500,000 and is obligated to pay an annual license maintenance fee, as well as up to $ 153,000,000 in potential milestone payments for the achievement of certain development, regulatory, and sales milestones. In addition, the Company is obligated to pay royalties in the low, single digits on sales of products falling within the scope of the licensed patents, which is subject to a minimum annual royalty obligation, and a percentage share of certain payments received by Company from sublicensees or in connection with the sale of the licensed program. The Company determined that substantially all of the fair value of the Jenrin Agreement was attributable to a single in-process research and development asset which did not constitute a business. The Company determined that substantially all of the fair value of the Milky Way License Agreement and the UCSF License Agreement was attributable to separate groups of in-process research and development assets which did not constitute a business. The Company concluded that it did no t have any alternative future use for the acquired in-process research and development assets. Thus, the Company recorded the various upfront payment to research and development expenses in the quarter the license deals became effective. The Company will account for the development, regulatory, and sales milestone payments in the period that the relevant milestones are achieved as either research and development expense or as an intangible asset as applicable. |
PROPERTY AND EQUIPMENT
PROPERTY AND EQUIPMENT | 12 Months Ended |
Dec. 31, 2021 | |
Property, Plant and Equipment [Abstract] | |
PROPERTY AND EQUIPMENT | 7. PROPERTY AND EQUIPMENT Property and Equipment consisted of the following: December 31, 2021 2020 Computer hardware and software $ 248,754 $ 626,328 Office furniture and equipment 1,185,329 1,626,491 Leasehold improvements 3,330,855 4,163,860 Property and equipment, gross 4,764,938 6,416,679 Less: accumulated depreciation ( 2,372,242 ) ( 2,348,842 ) Property and equipment, net $ 2,392,696 $ 4,067,837 Depreciation expense was approximately $ 1,000,000 and $ 1,124,000 for the years ended December 31, 2021 and 2020 , respectively. |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 12 Months Ended |
Dec. 31, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
COMMITMENTS AND CONTINGENCIES | 8. COMMITMENTS AND CONTINGENCIES Operating Lease Commitment On August 21, 2017, the Company entered into a lease agreement (“August 2017 Lease Agreement”) for commercial lease of office space, pursuant to which the Company agreed to lease 32,733 square feet of office space (“Leased Premises”). The initial term of the August 2017 Lease Agreement was for a period of seven year s which began with the Company’s occupancy of the Leased Premises in February 2018. The base rent for the Leased Premises ranged from approximately $ 470,000 for the first year to approximately $ 908,000 for the seventh year. Per the terms of the August 2017 Lease Agreement, the landlord agreed to reimburse the Company for approximately $ 1,080,000 of leasehold improvements. The reimbursements had been deferred and were to be recognized as a reduction of rent expense over the term of the lease. Additionally, the August 2017 Lease Agreement required a standby irrevocable letter of credit of $ 400,000 , which was to be reduced, if the Company is not in default under the August 2017 Lease Agreement, to $ 300,000 and $ 200,000 on the third and fourth anniversary of the commencement date, respectively, The Company entered into an unsecured letter of credit for $ 400,000 in connection with the August 2017 Lease Agreement. The Company adopted ASU 2016-02, Leases (Topic 842), as amended (“ASU 2016-02”) using the effective date method as of January 1, 2019 and recorded a lease liability of approximately $ 3,811,000 , and a right-of-use asset of approximately $ 2,400,000 , with no operations adjustment to the accumulated deficit related to the Leased Premises. Operating leases are included in operating lease right-of-use assets (“ROU”), operating lease liabilities, current and operating lease liabilities, noncurrent in the Company’s consolidated balance sheets. ROU assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent its obligation to make lease payments arising from the lease. ROU assets and liabilities are recognized at the date of adoption based on the present value of lease payments over the lease term. As the Company’s leases do not provide an implicit rate, the Company uses an incremental borrowing rate based on the information available at commencement date in determining the present value of lease payments, which was 9 %. This is the rate the Company would have to pay if borrowing on a collateralized basis over a similar term to each lease. The ROU asset also includes any lease payments made and excludes lease incentives. Lease expense for lease payments is recognized on a straight-line basis over the lease term. On February 26, 2019, the Company amended its lease (“February 2019 Lease Agreement”) pursuant to which an additional 30,023 square feet of office space (“New Premises”) will be leased by the Company in the same building for an aggregate total of 62,756 square feet of leased office space (“Total Premises”). The February 2019 Lease Agreement constitutes a modification as it extends the original lease term and increases the scope of the lease (additional space provided under the amendment), which requires evaluation of the remeasurement of the lease liability and corresponding ROU asset. Accordingly, the Company reassessed the classification of the Leased Premises and remeasured the lease liability on the basis of the extended lease term using the 20 additional monthly rent payments and the incremental borrowing rate at the effective date of the modification of 9%. The remeasurement for the modification resulted in an increase to the lease liability and the ROU asset of approximately $ 855,000 . The Company determined that the New Premises will be treated as a new standalone operating lease and recorded a lease liability and a right-of-use asset of approximately $ 2,700,000 for this lease. Per the terms of the February 2019 Lease Agreement, the landlord agreed to reimburse the Company for approximately $ 991,000 of leasehold improvements. The reimbursements are being recognized as a reduction of rent expense over the term of the lease. Additionally, the February 2019 Lease Agreement required a standby irrevocable letter of credit of $ 369,900 , which may be reduced, if the Company is not in default under the February 2019 Lease Agreement, to $ 277,425 and $ 184,950 on the third and fourth anniversary of the commencement date, respectively. On October 25, 2019, the Company amended its lease (“October 2019 Lease Amendment”) pursuant to which the term of the lease was extended through November 30, 2026 and the existing office space under lease was expanded by 500 square feet for an aggregate total of 63,256 square feet of leased office space (“Amended Total Premises”). The October 2019 Lease Amendment constitutes a modification as it extends the original lease term and increases the scope of the lease (additional space provided under the amendment), which requires evaluation of the remeasurement of the lease liability and corresponding ROU asset. The additional space did not result in a separate contract as the rent increase was determined not to be commensurate with the standalone price for the additional right of use. Accordingly, the Company reassessed the classification of the Amended Total Premises, which resulted in operating classification, and remeasured the lease liability on the basis of the extended lease term using the additional monthly rent payments and the incremental borrowing rate at the effective date of the modification of 8 %. The remeasurement for the modification resulted in an increase to the lease liability and the ROU asset of approximately $ 381,000 that was recorded in the fourth quarter of 2019. The following table contains a summary of the lease costs recognized under ASC 842 and other information pertaining to the Company’s operating leases for the year ended December 31, 2021 and 2020: 2021 2020 Lease cost Operating lease cost $ 1,240,473 $ 1,240,473 Total lease cost $ 1,240,473 $ 1,240,473 Other information Weighted average remaining lease term 4.8 years 5.9 years Weighted average discount rate 8.00 % 8.00 % Total rent expense for the years ended December 31, 2021 and 2020 was $ 1,185,341 and $ 1,240,473 , respectively. Rent expense for the twelve months ended December 31, 2021 was offset by $ 55,133 of sublease income and there was no sublease income for the twelve months ended December 31, 2020. Pursuant to the terms of the Company’s non-cancelable lease agreements in effect at December 31, 2021, the following table summarizes the Company’s maturities of operating lease liabilities as of December 31, 2021: Year ending December 31, 2021: 2022 $ 1,652,563 2023 1,700,005 2024 1,747,447 2025 1,794,889 2026 1,688,145 Total lease payments $ 8,583,049 Less: imputed interest ( 1,489,884 ) Total $ 7,093,165 Sublease Commitment Effective August 26, 2021, the Company entered into a sublease agreement with a third party to sublease 12,112 square feet of the 30,023 square feet currently being leased under one of its two existing lease agreements. The sublease commences on October 1, 2021 and ends October 31, 2026. The Company notes sublease income of $ 55,133 and $ 0 was recognized and offset against rent expense for the years ended December 31, 2021 and 2020, respectively. Undiscounted sublease cash inflows have been summarized in the following table: 2022 $ 104,971 2023 185,717 2024 278,576 2025 290,688 2026 252,333 Total sublease payments $ 1,112,285 For commitments under the Company’s development award agreements- see Note 11. |
NOTES PAYABLE
NOTES PAYABLE | 12 Months Ended |
Dec. 31, 2021 | |
Debt Disclosure [Abstract] | |
NOTES PAYABLE | 9. NOTES PAYABLE D&O Financing In November 2020, the Company entered into a loan agreement with a financing company for $ 909,375 to finance one of the Company’s insurance policies. The terms of the loan stipulate equal monthly payments of principal and interest payments of $ 103,112 over a nine-month period . Interest accrued on this loan at an annual rate of 4.89 %. This loan was fully repaid in July 2021. In November 2021, the Company entered into a loan agreement with a financing company for $ 984,375 to finance one of the Company’s insurance policies. The terms of the loan stipulate equal monthly payments of principal and interest payments of $ 111,041 over a nine-month period . Interest accrues on this loan at an annual rate of 3.64 %. Prepaid expenses as of December 31, 2021, included approximately $ 1,093,750 related to the underlying insurance policy being financed. Loan and Security Agreement with K2 HealthVentures LLC On July 28, 2020, the Company, with its subsidiary, Corbus Pharmaceuticals, Inc., as borrower, entered into a $ 50,000,000 secured Loan and Security Agreement with K2HV, an unrelated third party (the “Loan Agreement”) and received the first $ 20,000,000 tranche upon signing. The second tranche of $ 20,000,000 and the third tranche of $ 10,000,000 will be made available at the Company’s option subject to the achievement of certain clinical and regulatory milestones. The loan matures on August 1, 2024 and the Company is obligated to make interest only payments for the first 24 months and then interest and equal principal payments for the next 24 months. Interest accrues at a variable annual rate equal to the greater of (i) 8.5% and (ii) the rate of interest noted in The Wall Street Journal, Money Rates section, as the “Prime Rate” plus 5.25%, in each case, subject to a step-down of 25 basis points upon the funding of the second tranche. The interest rate used at December 31, 2021 was 8.5 % . K2HV may elect to convert up to $ 5,000,000 of the outstanding loan into common stock at a conversion price of $ 9.40 per share. In connection with the Loan Agreement, on July 28, 2020, the Company issued the Lenders a warrant to purchase up to 86,206 common shares (the “K2 Warrant”) at an exercise price of $ 6.96 (the “Warrant Price”). The K2 Warrant may be exercised either for cash or on a cashless “net exercise” basis and expires on July 28, 2030. The total proceeds attributed to the K2 Warrant was approximately $ 472,000 based on the relative fair value of the K2 Warrant as compared to the sum of the fair values of the K2 Warrant, prepayment feature, default feature, and debt. Total proceeds attributed to the prepayment and default features was approximately $ 546,000 . The Company also incurred approximately $ 1,244,000 of debt issuance costs and is required to make a final payment in excess of the stated principal equal to approximately $ 1,190,000 . See Note 14 for more detail on assumptions used in the valuation of the K2 warrant and see Note 15 for more information on the assumptions used in valuation of the default and prepayment features. The total principal amount of the loan under the Loan Agreement outstanding at December 31, 2021 , including the $ 1,190,000 final payment discussed above, is $ 21,190,000 . Upon the occurrence of an Event of Default (as defined in the Loan Agreement), and during the continuance of an Event of Default, the applicable rate of interest, described above, will be increased by 5.00 % per annum. The secured term loan maturity date is August 1, 2024, and the Loan Agreement includes both financial and non-financial covenants. The Company was in compliance with these covenants as of December 31, 2021. The obligations under the Loan Agreement are secured on a senior basis by a lien on substantially all of the assets of the Company and its subsidiaries. The subsidiaries of the Company are guarantors of the obligations of the Company under the Loan Agreement. The total debt discount related to Lenders of approximately $ 2,262,000 is being charged to interest expense using the effective interest method over the term of the debt. At December 31, 2021, the fair value of our outstanding debt, which is considered Level 3 in the fair value hierarchy, approximates carrying value. Interest expense for the year ended December 31, 2021 was approximately $ 2,709,000 . Interest expense for the year ended December 31, 2020 was approximately $ 1,126,534 . The net carrying amounts of the liability components consists of the following: December 31, 2021 Principal $ 20,000,000 Less: debt discount $ ( 2,262,388 ) Accretion of Debt Discount $ 992,007 Net Carrying amount $ 18,729,619 Less: current portion of long term debt $ ( 3,093,344 ) Total long-term debt, net of discount $ 15,636,275 The following table summarizes the future principal payments due under long-term debt; Principal Payments and final payment on Loan Agreement 2022 $ 3,093,344 2023 9,835,341 2024 8,261,315 Total $ 21,190,000 |
ACCRUED EXPENSES
ACCRUED EXPENSES | 12 Months Ended |
Dec. 31, 2021 | |
Payables and Accruals [Abstract] | |
ACCRUED EXPENSES | 10. ACCRUED EXPENSES Accrued expenses consisted of the following: December 31, 2021 2020 Accrued clinical operations and trials costs $ 5,435,464 $ 14,132,842 Accrued product development costs 203,676 2,189,047 Accrued compensation 2,715,368 4,222,594 Accrued other 1,738,804 1,460,949 Total $ 10,093,312 $ 22,005,432 |
DEVELOPMENT AWARDS AND DEFERRED
DEVELOPMENT AWARDS AND DEFERRED REVENUE | 12 Months Ended |
Dec. 31, 2021 | |
Revenue from Contract with Customer [Abstract] | |
DEVELOPMENT AWARDS AND DEFERRED REVENUE | 11. DEVELOPMENT AWARDS AND DEFERRED REVENUE 2018 CFF Award On January 26, 2018, the Company entered into the Cystic Fibrosis Program Related Investment Agreement with the CFF (“Investment Agreement”), a non-profit drug discovery and development corporation, pursuant to which the Company received an award for up to $ 25 million in funding (the “2018 CFF Award”) to support a Phase 2b Clinical Trial (the “Phase 2b Clinical Trial”) of lenabasum in patients with cystic fibrosis, of which the Company has received $ 25 million in the aggregate through December 31, 2021 upon the Company’s achievement of milestones related to the progress of the Phase 2b Clinical Trial, as set forth in the Investment Agreement. Pursuant to the terms of the Investment Agreement, the Company is obligated to make certain royalty payments to CFF, including a royalty payment of one and one-half times the amount of the 2018 CFF Award, payable in cash within sixty days upon the first receipt of approval of lenabasum in the United States and a second royalty payment of one and one-half times the amount of the 2018 CFF Award upon approval in another major market, as set forth in the Investment Agreement (the “Approval Royalty”). At the Company’s election, the Company may satisfy the first of the two Approval Royalties in registered shares of the Company’s common stock. Additionally, the Company is obligated to make (i) royalty payments to CFF of two and one-half percent of net sales from lenabasum due within sixty days after any quarter in which such net sales occur in the Field, as defined in the Investment Agreement, (ii) royalty payments to CFF of one percent of net sales of Non-Field Products, as defined in the Investment Agreement due within sixty days after any quarter in which such net sales occur, and (iii) royalty payments to CFF of ten percent of any amount the Company and its stockholders receive in connection with the license, sale, or other transfer to a third party of lenabasum, if indicated for the treatment or prevention of CF, or a change of control transaction, except that such payment shall not exceed five times the amount of the 2018 CFF Award, with such payments to be credited against any other net sales royalty payments due. Accordingly, the Company will owe to CFF a royalty payment equal to 10 % of any amounts the Company receives as payment under the collaboration agreement with Kaken, provided that the total royalties that the Company will be required to pay under the Investment Agreement resulting from income from licenses or sales subject to the Investment Agreement are capped at five times the total amount of the 2018 CFF Award, and the Company may credit such royalties against any royalties on net sales otherwise owed to CFF under the Investment Agreement. Accordingly, the Company was required to pay CFF $ 2,700,000 in May 2019 as a result of its receipt of the $ 27,000,000 upfront cash payment from Kaken. Either CFF or the Company may terminate the Investment Agreement for cause, which includes the Company’s material failure to achieve certain commercialization and development milestones. The Company’s payment obligations survive the termination of the Investment Agreement. Pursuant to the terms of the Investment Agreement, the Company issued a warrant to CFF to purchase an aggregate of 1,000,000 shares of the Company’s common stock (the “CFF Warrant”). The CFF Warrant is exercisable at a price equal to $ 13.20 per share and is immediately exercisable for 500,000 shares of the Company’s common stock. Upon completion of the final milestone set forth in the Investment Agreement and receipt of the final payment from CFF to the Company pursuant to the Investment Agreement, the CFF Warrant will be exercisable for the remaining 500,000 shares of the Company’s common stock. The CFF Warrant expires on January 26, 2025 . Any shares of the Company’s common stock issued upon exercise of the CFF Warrant will be unregistered and subject to a one-year lock-up. Under the Investment Agreement, the Company recorded $ 881,705 and $ 3,937,230 of revenue during the years ended December 31, 2021 and 2020, respectively. The Company assessed the 2018 CFF Award for accounting under ASC 606, which it adopted in the first quarter of 2018. To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606, the entity performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company assessed this arrangement in accordance with ASC 606 and concluded that the contract counterparty, CFF, is a customer. The Company identified the following material promise under the arrangement: research and development activities and related services under the Phase 2b Clinical Trial. Based on these assessments, the Company identified one performance obligation at the outset of the Investment Agreement, which consists of: Phase 2b Clinical Trial research and development activities and related services. To determine the transaction price, the Company included the total aggregate payments under the Investment Agreement which amount to $ 25 million and reduced the revenue to be recognized by the payment to the customer of $ 6,215,225 in the form of the CFF Warrant representing its fair value, leaving the remaining $ 18,784,775 as the transaction price as of the outset of the arrangement, which was recognized as revenue over the performance period as discussed below. The $ 6,215,225 fair value of the warrant was also recorded as an increase to additional paid in capital. The Company has invoiced and received $ 25,000,000 in milestone payments, including $ 12,500,000 in 2018, $ 5,000,000 in 2019, $ 5,000,000 in 2020, and $ 2,500,000 in 2021. The Company notes there are no further development milestones under this agreement. The CFF Warrant is accounted for as a payment to the customer. See Note 14 for further information related to the CFF Warrant. The Company notes that the Investment Agreement contains an initial payment that was received upon contract execution and subsequent milestone payments, which are a form of variable consideration that require evaluation for constraint considerations. The Company concluded that the related performance milestones are generally within the Company’s control and as result are considered probable. Revenue associated with the performance obligation is being recognized as revenue as the research and development services are provided using an input method, according to the costs incurred as related to the research and development activities on each program and the costs expected to be incurred in the future to satisfy the performance obligation. The transfer of control occurs over this time period and, in management’s judgment, is the best measure of progress towards satisfying the performance obligation. The research and development services related to this performance obligation were performed over an approximately three-year period and were completed as of December 31, 2021. The amounts recognized as revenue, but not received or invoiced were recognized as a contract asset on the Company’s consolidated balance sheet. |
INCOME TAXES
INCOME TAXES | 12 Months Ended |
Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |
INCOME TAXES | 12. INCOME TAXES No provision or benefit for federal or state income taxes has been recorded, as the Company has incurred a net loss for all of the periods presented, and the Company has provided a full valuation allowance against its deferred tax assets. At December 31, 2021 and 2020, the Company had federal net operating loss carryforwards of approximately $ 186,267,000 and $ 167,399,000 respectively, of which federal carryforwards will expire in varying amounts beginning in 2029 . Of the federal net operating loss carryforwards of $ 186,267,000 , approximately $ 103,686,000 a re from 2019, 2020, and 2021 have no expiration date. Net operating loss carryforwards starting in 2021 are limited to 80 % of taxable income. At December 31, 2021 and 2020, the Company had State net operating loss carryforwards of approximately $ 177,171,000 and $ 161,143,000 , respectively. Utilization of net operating losses may be subject to substantial annual limitations due to the “change in ownership” provisions of the Internal Revenue Code, and similar state provisions. The annual limitations may result in the expiration of net operating losses before utilization. The Company has not yet conducted a study to determine if any such changes have occurred that could limit the Company’s ability to use the net operating losses and tax credit carryforwards. The Company also had research and development tax credit carryforwards at December 31, 2021 and 2020 of approximately $ 8,656,000 and $ 9,233,000 , respectively. In the second half of 2021, the Company received from a foreign taxing authority, an approximate aggregate $ 12.8 million of cash payments for refundable research and development tax credits that were earned on certain research and development expenses. The Company recorded the $ 12.8 million in other income in the accompanying statements of operations for the year ended December 31, 2021. Significant components of the Company’s net deferred tax asset are as follows: December 31, 2021 2020 NOL carryforward $ 50,311,967 $ 45,360,175 Foreign net operating loss carryforward 5,846,372 10,532,490 Tax credits 8,392,989 8,843,792 Stock based compensation 9,102,630 7,354,531 Accrued expenses 559,876 1,202,538 Other temporary differences 1,284,347 1,152,853 Subtotal 75,498,181 74,446,379 Valuation allowance ( 75,498,181 ) ( 74,446,379 ) Net deferred tax asset $ — $ — The Company has maintained a full valuation allowance against its deferred tax assets in all periods presented. A valuation allowance is required to be recorded when it is not more likely than not that some portion or all of the net deferred tax assets will be realized. Since the Company cannot determine that it is more likely than not that it will generate taxable income, and thereby realize the net deferred tax assets, a full valuation allowance has been provided. The valuation allowance increased by $ 1,052,000 and $ 23,324,000 in 2021 and 2020 , respectively, due to the increase in deferred tax assets, primarily due to net operating loss carryforwards. The Company has no uncertain tax positions at December 31, 2021 and 2020 that would affect its effective tax rate. Since the Company is in a loss carryforward position, the Company is generally subject to U.S. federal and state income tax examinations by tax authorities for all years for which a loss carryforward is available. Income tax benefits computed using the federal statutory income tax rate differs from the Company’s effective tax rate primarily due to the following: December 31, 2021 2020 Tax provision at statutory rate 21.00 % 21.00 % State taxes, net of federal benefit 4.98 % 5.83 % Permanent differences ( 3.56 )% ( 1.35 )% Foreign expected tax ( 1.21 )% 7.37 % Tax credits 2.62 % 4.03 % Income tax rate change ( 0.20 )% 0.02 % NOL Adjustments ( 4.10 )% — % Other ( 17.37 )% ( 8.12 )% Decrease in valuation reserve ( 2.16 )% ( 28.78 )% Total — % — % |
STOCK OPTIONS
STOCK OPTIONS | 12 Months Ended |
Dec. 31, 2021 | |
Share-based Payment Arrangement [Abstract] | |
STOCK OPTIONS | 14. STOCK OPTIONS In April 2014, the Company adopted the Corbus Pharmaceuticals Holdings, Inc. 2014 Equity Incentive Plan (the “2014 Plan”). Pursuant to the 2014 Plan, the Company’s Board of Directors may grant incentive and nonqualified stock options and restricted stock to employees, officers, directors, consultants and advisors. Pursuant to the terms of an annual evergreen provision in the 2014 Plan, the number of shares of common stock available for issuance under the 2014 Plan shall automatically increase on January 1 of each year by at least seven percent ( 7 %) of the total number of shares of common stock outstanding on December 31st of the preceding calendar year, or, pursuant to the terms of the 2014 Plan, in any year, the Board of Directors may determine that such increase will provide for a lesser number of shares. On January 1, 2021, pursuant to an annual evergreen provision contained in the 2014 Plan, the number of shares reserved for future grants was increased by 2,500,000 shares , which was less than seven percent ( 7 %) of the outstanding shares of common stock on December 31, 2020. As of January 1, 2021 there was a total of 25,570,842 shares reserved for issuance under the 2014 Plan and there were 9,869,051 shares available for future grants. Options issued under the 2014 Plan generally vest over 4 years from the date of grant in multiple tranches and are exercisable for up to 10 years from the date of issuance. In accordance with the terms of the 2014 Plan, effective as of January 1, 2022, the number of shares of common stock available for issuance under the 2014 Plan increased by 8,766,162 shares, which was seven percent ( 7 %) of t he outstanding shares of common stock on December 31, 2021 (see Note 16). As of January 1, 2022 , the 2014 Plan had a total reserve of 34,337,004 shares and there were 16,760,151 shares available for future grants. Share-based Compensation For stock options issued and outstanding for the years ended December 31, 2021 and 2020, the Company recorded non-cash, stock-based compensation expense of $ 9,480,373 and $ 12,458,229 , respectively, net of estimated forfeitures. Twelve Months Ended December 31, 2021 2020 Research and development expenses $ 2,969,347 $ 5,336,472 General and administrative expenses 6,511,026 7,121,757 Total stock-based compensation $ 9,480,373 $ 12,458,229 The fair value of each option award for employees is estimated on the date of grant and for non-employees is estimated at the end of each reporting period until vested using the Black-Scholes option pricing model that uses the assumptions noted in the following table. The Company uses historical data, as well as subsequent events occurring prior to the issuance of the financial statements, to estimate option exercises and employee terminations in order to estimate its forfeiture rate. The expected term of options granted under the 2014 Plan, all of which qualify as “plain vanilla” per SEC Staff Accounting Bulletin 107, is determined based on the simplified method due to the Company’s limited operating history, and is 6.25 years based on the average between the vesting period and the contractual life of the option. For non-employee options, the expected term is the contractual term. The risk-free rate is based on the yield of a U.S. Treasury security with a term consistent with the option. The weighted average assumptions used principally in determining the fair value of options granted were as follows: 2021 2020 Risk free interest rate 0.76 % 0.59 % Expected dividend yield 0 % 0 % Expected term in years 6.23 6.25 Expected volatility 102.96 % 83.56 % Estimated forfeiture rate 9.12 % 6.02 % A summary of option activity for years ended December 31, 2021 and 2020 is presented below: Options Shares Weighted Weighted Intrinsic Outstanding at December 31, 2019 13,245,366 $ 5.19 Granted 4,536,600 5.00 Exercised ( 427,611 ) 1.77 Forfeited ( 3,064,712 ) 5.60 Outstanding at December 31, 2020 14,289,643 5.15 Granted 7,373,800 2.36 Exercised ( 838,600 ) 1.13 Forfeited ( 5,479,653 ) 5.04 Expired ( 19,085 ) 6.97 Outstanding at December 31, 2021 15,326,105 $ 4.06 6.75 $ 3,529,258 Exercisable at December 31, 2021 9,011,000 $ 4.87 5.22 $ 2,691,592 Vested and expected to vest at December 31, 2021 14,652,110 $ 4.14 6.64 $ 3,340,598 The weighted average grant-date fair value of options granted during the years ended December 31, 2021 and 2020 was $ 1.91 and $ 3.53 per share, respectively. The aggregate intrinsic value of options exercised during the years ended December 31, 2021 and 2020 was approximately $ 1,769,714 and $ 1,235,676 , respectively. As of December 31, 2021, there was approximately $ 10,825,375 of total unrecognized compensation expense, related to non-vested share-based compensation arrangements. The unrecognized compensation expense is estimated to be recognized over a period of 2.47 years at December 31, 2021. As summary of non-vested stock options for the years ended December 31, 2021 and 2020 is presented below: Options Shares Weighted Nonvested December 31, 2019 5,409,272 $ 5.21 Granted 4,536,600 3.53 Vested ( 2,720,493 ) 5.34 Forfeited ( 2,888,085 ) 4.11 Nonvested December 31, 2020 4,337,294 $ 4.14 Granted 7,373,800 1.91 Vested ( 2,241,925 ) 4.02 Forfeited ( 3,154,064 ) 2.80 Non-vested at December 31, 2021 6,315,105 $ 2.26 |
COMMON STOCK
COMMON STOCK | 12 Months Ended |
Dec. 31, 2021 | |
Equity [Abstract] | |
COMMON STOCK | 13. COMMON STOCK The Company has authorized 300,000,000 shares of common stock, $ 0.0001 par value per share, of which 125,230,881 shares were issued and outstanding as of December 31, 2021 . The Company had 150,000,000 shares authorized, and 98,852,696 shares were issued and outstanding as of December 31, 2020. On February 11, 2020, the Company consummated an underwritten public offering of shares of its common stock pursuant to which the Company sold an aggregate of 7,666,667 shares of its common stock, including 1,000,000 shares sold pursuant to the full exercise of the underwriters’ option to purchase additional shares, at a purchase price of $ 6.00 per share with gross proceeds to the Company totaling $ 46,000,000 , less estimated issuance costs incurred of approximately $ 3,147,000 . On April 7, 2020, the Company entered into an Open Market Sale Agreement (the “April 2020 Sale Agreement”) with Jefferies pursuant to which Jefferies served as the Company’s sales agent to sell up to $ 75,000,000 of shares of the Company’s common stock through an “at the market offering”. Sales of common stock under the April 2020 Sale Agreement were made pursuant to an effective registration statement for an aggregate offering of up to $ 75,000,000 . During the year ended December 31, 2021, the Company did not sell any shares of its common stock under the April 2020 Sale Agreement. During the year ended December 31, 2020, the Company sold 10,539,374 shares of its common stock under the April 2020 Sale Agreement for which the Company received gross proceeds of approximately $ 75,000,000 , less issuance costs incurred of approximately $ 2,250,000 through December 31, 2020 . The Company completed sales of the $ 75,000,000 of shares of the Company’s common stock under the April 2020 Sale Agreement prior to beginning to sell shares under the August 2020 Sale Agreement. On August 7, 2020, the Company entered into the August 2020 Sale Agreement with Jefferies pursuant to which Jefferies is serving as the Company’s sales agent to sell shares of the Company’s common stock through an “at the market offering.” As of August 7, 2020, the company was authorized to sell up to $ 150,000,000 of shares of the Company’s common stock pursuant to the August 2020 Sale Agreement. During the year ended December 31, 2021 , the Company sold 25,391,710 shares of its common stock under the August 2020 Sale Agreement for which the Company received gross proceeds of approximately $ 60,681,238 , less issuance costs incurred of approximately $ 1,820,437 throu gh December 31, 2021 . During the year ended December 31, 2020, the Company sold 15,546,151 shares of its common stock under the August 2020 Sale Agreement for which the Company received gross proceeds of approximately $ 21,404,000 , less issuance costs incurred of approximately $ 642,000 through December 31, 2020. During the year ended December 31, 2021 and 2020, the Company issued 838,600 and 427,611 shares of common stock upon the exercise of stock options to purchase common stock and the Company received proceeds of approximately $ 945,000 and $ 756,000 from these exercises, respectively. During the year ended December 31, 2021 , the Company issued 147,875 shares of restricted common stock pursuant to the Milky Way License Agreement. No restricted common shares were issued during the year ended December 31, 2020. No warrants were exercised during the years ended December 31, 2021 and 2020 . |
WARRANTS
WARRANTS | 12 Months Ended |
Dec. 31, 2021 | |
Warrants | |
WARRANTS | 15. WARRANTS No warrants were exercised during the years ended December 31, 2021 and 2020. At December 31, 2021, there were warrants outstanding to purchase 1,506,206 shares of common stock with a weighted average exercise price of $ 9.46 and a weighted average remaining life of 3.60 years, The Company issued a warrant to CFF to purchase an aggregate of 1,000,000 shares of the Company’s common stock (the “CFF Warrant”). The CFF Warrant is exercisable at a price equal to $ 13.20 per share and is immediately exercisable for 500,000 shares of the Company’s common stock. Upon completion of the final milestone set forth in the Investment Agreement and receipt of the final payment from CFF to the Company pursuant to the Investment Agreement, the CFF Warrant will be exercisable for the remaining 500,000 shares of the Company’s common stock. The CFF Warrant expires on January 26, 2025 . Any shares of the Company’s common stock issued upon exercise of the CFF Warrant will be unregistered and subject to a one-year lock-up. The CFF Warrant is classified as equity as it meets all the conditions under U.S. GAAP for equity classification. In accordance with U.S. GAAP, the Company has calculated the fair value of the warrant for initial measurement and will reassess whether equity classification for the warrant is appropriate upon any changes to the warrants or capital structure, at each balance sheet date. The weighted average assumptions used in determining the $ 6,215,225 fair value of the CFF Warrant were as follows: Risk free interest rate 2.60 % Expected dividend yield — % Expected term in years 7.00 Expected volatility 83.5 % On July 28, 2020, the Company entered into the Loan Agreement with K2HV pursuant to which K2HV may provide the Company with term loans in an aggregate principal amount of up to $ 50,000,000 . On July 28, 2020, in connection with the funding of the first $ 20,000,000 tranche, the Company issued a warrant exercisable for 86,206 shares of the Company’s common stock (the “K2 Warrant”) at an exercise price of $ 6.96 per share. The K2 warrant is immediately exercisable for 86,206 shares and expires on July 28, 2030 . Any shares of the Company’s common stock issued upon exercise of the K2 Warrant are permitted to be settled in unregistered shares. The K2 Warrant is classified as equity as it meets all the conditions under U.S. GAAP for equity classification. In accordance with U.S. GAAP, the Company has calculated the fair value of the warrant for initial measurement and will reassess whether equity classification for the warrant is appropriate upon any changes to the warrants or capital structure, at each balance sheet date. The weighted average assumptions used in determining the $ 472,409 fair value of the K2 Warrant were as follows: Risk free interest rate 0.60 % Expected dividend yield — % Expected term in years 10.00 Expected volatility 80.0 % On October 16, 2020, the Company entered into a professional services agreement with an investor relations service provider. Pursuant to the agreement, the Company issued warrants exercisable for a total of 420,000 shares of the Company’s common stock (the “Warrants”) at an exercise price of $ 1.07 per share. The Warrants were fully vested on October 19, 2021. Any shares of the Company’s common stock issued upon exercise of the Warrants are permitted to be settled in unregistered shares. The Warrants are classified as equity as they meet all the conditions under U.S. GAAP for equity classification. In accordance with U.S. GAAP, the Company has calculated the fair value of the warrants for initial measurement and will reassess whether classification for the warrant is appropriate upon any changes to the warrants or capital structure, at each balance sheet date. The weighted average assumptions used in determining the $ 334,740 fair value of the Warrants were as follows: Risk free interest rate 0.90 % Expected dividend yield —% Expected term in years 5.00 Expected volatility 100.6 % |
DERIVATIVE LIABILITY
DERIVATIVE LIABILITY | 12 Months Ended |
Dec. 31, 2021 | |
Derivative Instruments and Hedging Activities Disclosure [Abstract] | |
DERIVATIVE LIABILITY | 16. DERIVATIVE LIABILITY On July 28, 2020, the Company, with its subsidiary, Corbus Pharmaceuticals, Inc., as borrower, entered into a $ 50,000,000 secured Loan and Security Agreement with K2HV, an unrelated third party (the “Loan Agreement”) and received the first $ 20,000,000 tranche upon signing. The Company has determined that a prepayment feature and default feature needed to be separately valued and mark to market each reporting period after assessing the agreement under ASC 815. The value of these features are determined each reporting period by taking the present value of net cash flows with and without the prepayment features. The significant assumption used to determine the fair value of the debt without any features is the discount rate which has been estimated by using published market rates of triple CCC rated public companies. All other inputs are taken from the Loan Agreement. The additional significant assumptions used when valuing the prepayment feature is the probability of a change of control event. The Company has determined the probability from December 31, 2020 to December 31, 2021 has stayed consistent. The additional significant assumption used when valuing the default feature is the probability of defaulting on the repayment of loan. The Company has determined the probability from December 31, 2020 to December 31, 2021 has remained consistent. The value of these features was determined to be approximately $ 797,000 at December 31, 2020 and $ 133,710 at December 31, 2021 which resulted in $ 663,290 of other income in 2021. The Company considers the fair value of the derivative liability to be Level 3 under the three-tier fair value hierarchy. A roll forward of the fair value of the derivative liability for the year ended December 31, 2021 is presented below. December 31, 2021 Beginning balance, December 31, 2020 $ 797,000 Change in fair value of derivative liabilities ( 663,290 ) Ending balance, December 31, 2021 $ 133,710 |
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS | 12 Months Ended |
Dec. 31, 2021 | |
Subsequent Events [Abstract] | |
SUBSEQUENT EVENTS | 17. SUBSEQUENT EVENTS Evergreen Provision Pursuant to the terms of an annual evergreen provision in the 2014 Plan, the number of shares of common stock available for issuance under the 2014 Plan shall automatically increase on January 1 of each year by at least seven percent ( 7 %) of the total number of shares of common stock outstanding on December 31st of the preceding calendar year, or, pursuant to the terms of the 2014 Plan, in any year, the Board of Directors may determine that such increase will provide for a lesser number of shares. In accordance with the terms of the 2014 Plan, effective as of January 1, 2022, the number of shares of common stock available for issuance under the 2014 Plan increased by 8,766,162 shares, such amount being seven percent ( 7 %) of the outstanding shares of common stock on December 31, 2021. As of January 1, 2022, the 2014 Plan had a total reserve of 34,337,004 shares and there were 16,760,151 shares available for future grants. Venn Litigation On November 18, 2021, Venn Therapeutics, LLC (“Venn”), filed a complaint (the “Complaint”) against us in the U.S. District Court for the Middle District of Florida. The Complaint asserts claims for trade secret misappropriation under federal law and state law, a claim for breach of contract, and state law claims for unfair competition, misrepresentation, unjust enrichment, and intentional interference with advantageous business relations. On November 24, 2021, Venn filed a motion for a preliminary injunction, which requests that the court preliminarily enjoin us from using Venn’s trade secrets and/or confidential information without Venn’s consent, including by conducting any further development work of our immunotherapy program based on CRB-601, until further order of the court. On January 7, 2022, we filed a motion to dismiss the Complaint in its entirety and an opposition to Venn’s motion for a preliminary injunction. We believe that the Complaint and Venn’s preliminary injunction motion are without merit and intend to vigorously defend the Company against these claims; however, there can be no assurance that we will prevail in such proceedings. |
SIGNIFICANT ACCOUNTING POLICI_2
SIGNIFICANT ACCOUNTING POLICIES (Policies) | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Consolidation | Consolidation The consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All significant intercompany transactions and accounts have been eliminated in consolidation. |
Use of Estimates | Use of Estimates The process of preparing financial statements in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”) requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates and changes in estimates may occur. The most significant estimates are related to stock-based compensation expense, the accrual of research, product development and clinical obligations, the recognition of revenue under the Investment Agreement (See Note 11), the valuation of warrants discussed in Note 15 and Note 9, and the derivative liability associated with the K2 Security and Loan agreement (see Note 16). |
Cash, Cash Equivalents, and Restricted Cash | Cash, Cash Equivalents, and Restricted Cash The Company considers only those investments which are highly liquid, readily convertible to cash, and that mature within three months from date of purchase to be cash equivalents. At December 31, 2021 and 2020, cash equivalents were comprised of money market funds. Restricted cash as of December 31, 2021 included security for a stand-by letter of credit issued in favor of a landlord for $ 669,900 of which $ 192,475 was classified in current assets and $ 477,425 was classified in noncurrent assets as of December 31, 2021. Cash and cash equivalents consists of the following: December 31, 2021 2020 Cash $ 6,751,593 $ 1,238,611 Cash Equivalents 18,255,039 84,194,830 Cash and cash equivalents $ 25,006,632 $ 85,433,441 Restricted cash, current 192,475 350,000 Restricted cash, noncurrent 477,425 669,900 Restricted cash $ 669,900 $ 1,019,900 Total cash, cash equivalents, and restricted cash shown in the statement of $ 25,676,532 $ 86,453,341 As of December 31, 2021, all of the Company’s cash and cash equivalents was held in the United States, except for approximately $ 5,752,000 of cash which was held principally in our subsidiary in the United Kingdom. As of December 31, 2020, all of the Company’s cash and cash equivalents was held in the United States, except for approximately $ 1,033,000 of cash which was held principally in our subsidiary in the United Kingdom. |
Investments | Investments consist of investments in debt securities and term deposits with maturities greater than 90 days at their acquisition date. The Company has classified its investments with maturities beyond one year as current, based on their highly liquid nature and because such investments represent the investment of cash that is available for current operations. The Company classifies all of its marketable debt securities as available-for-sale securities. The Company’s marketable debt securities are measured and reported at fair value using quoted prices in active markets for similar securities. Unrealized gains and losses on available-for-sale debt securities are reported as accumulated other comprehensive gain or loss, which is a separate component of stockholders’ equity. The cost of debt securities sold is determined on a specific identification basis, and realized gains and losses are included in other income (expense), net in the consolidated statements of operations and comprehensive loss. The Company evaluates its marketable debt securities with unrealized losses for other-than-temporary impairment. When assessing marketable debt securities for other-than-temporary declines in value, the Company considers such factors as, among other things, how significant the decline in value is as a percentage of the original cost, how long the market value of the investment has been less than its original cost, the Company’s ability and intent to retain the investment for a period of time sufficient to allow for any anticipated recovery in fair value and market conditions in general. If any adjustment to fair value reflects a decline in the value of the investment that the Company considers to be “other than temporary,” the Company reduces the investment to fair value through a charge to the statement of operations and comprehensive loss. No such adjustments were necessary during the periods presented. |
Financial Instruments | Financial Instruments The carrying values of the notes payable and debt approximate their fair value due to the fact that they are at market terms. |
Fair Value Measurements | Fair Value Measurements The valuation of the Company’s debt and embedded derivatives are determined primarily by an income approach that considers the present value of net cash flows of the debt with and without prepayment and default features. These embedded debt features, which are determined to be classified as derivative liabilities are marked-to-market each reporting period, with a corresponding non-cash gain or loss charged to the current period. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. As a basis for considering such assumptions, there exists a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value as follows: Level 1 – Unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access as of the measurement date Level 2 – Inputs other than quoted prices included within Level 1 that are directly observable for the asset or liability or indirectly observable through corroboration with observable market data Level 3 – Unobservable inputs for the asset or liability only used when there is little, if any, market activity for the asset or liability at the measurement date The Company’s investments, debt, and its derivative liabilities are carried at fair value determined according to the fair value hierarchy described above. The carrying values of the Company’s prepaid expenses and other current assets, and accrued expenses approximate their fair values due to the short-term nature of these assets and liabilities. To determine the fair value of our embedded derivatives, management evaluates assumptions regarding the probability of certain future events. Other factors used to determine fair value include the discount rate, risk free interest rate and derivative term. The fair value recorded for the derivative liability varies from period to period. This variability may result in the actual derivative liability for a period either above or below the estimates recorded on our consolidated financial statements, resulting in fluctuations in other income (expense) because of the corresponding non-cash gain or loss recorded. |
Property and Equipment | Property and Equipment The estimated life for the Company’s property and equipment is as follows: three years for computer hardware and software and three to five years for office furniture and equipment. The Company’s leasehold improvements and assets under capital lease are amortized over the shorter of their useful lives or the respective leases. See Note 7 for details of property and equipment and Note 8 for operating and capital lease commitments. |
Research and Development Expenses | Research and Development Expenses Costs incurred for research and development are expensed as incurred. Nonrefundable advance payments for goods or services that have the characteristics that will be used or rendered for future research and development activities pursuant to executory contractual arrangements with third party research organizations are deferred and recognized as an expense as the related goods are delivered or the related services are performed. |
Accruals for Research and Development Expenses and Clinical Trials | Accruals for Research and Development Expenses and Clinical Trials As part of the process of preparing its financial statements, the Company is required to estimate its expenses resulting from its obligations under contracts with vendors, clinical research organizations and consultants and under 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 terms that do not match the periods over which materials or services are provided under such contracts. The Company’s objective is to reflect the appropriate expenses in its financial statements by matching those expenses with the period in which services are performed and efforts are expended. The Company accounts for these expenses according to the timing of various aspects of the expenses. The Company determines the accrual estimates by taking into account discussion with applicable personnel and outside service providers as to the progress of clinical trials, or the services completed. During the course of a clinical trial, the Company adjusts its clinical expense recognition if actual results differ from its estimates. The Company makes estimates of its accrued expenses as of each balance sheet date based on the facts and circumstances known to it at that time. The Company’s clinical trial accruals are dependent upon the timely and accurate reporting of contract research organizations and other third-party vendors. Although the Company does not expect its estimates to be materially different from amounts actually incurred, its 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 it reporting amounts that are too high or too low for any particular period. For the years ended December 31, 2021 and 2020 , there were no material adjustments to the Company’s prior period estimates of accrued expenses for clinical trials. |
Leases | Leases The Company determines if an arrangement is a lease at inception. Operating leases are included in operating lease right-of-use (“ROU”) assets, other current liabilities and operating lease liabilities in the Company’s consolidated balance sheets. ROU assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent its obligation to make lease payments arising from the lease. ROU assets and liabilities are recognized at commencement date based on the present value of lease payments over the lease term. As the Company’s leases do not provide an implicit rate, the Company uses an incremental borrowing rate based on the information available at commencement date in determining the present value of lease payments. This is the rate the Company would have to pay if borrowing on a collateralized basis over a similar term to each lease. The ROU asset also includes any lease payments made and excludes lease incentives. Lease expense for lease payments is recognized on a straight-line basis over the lease term. The Company has subleased a portion of its leased facility under an agreement considered to be an operating lease according to GAAP. The Company has not been legally released from its primary obligations under the original lease and therefore it continues to account for the original lease as it did before commencement of the sublease. The Company will record both fixed and variable payments received from the sublessee in its statement of operations on a straight-line basis as an offset to rent expense. |
Concentrations of Credit Risk | Concentrations of Credit Risk The Company has no significant off-balance-sheet concentration of credit risk such as foreign exchange contracts, option contracts or other hedging arrangements. The Company may from time to time have cash in banks in excess of Federal Deposit Insurance Corporation insurance limits. However, the Company believes the risk of loss is minimal as these banks are large financial institutions. |
Segment Information | Segment Information Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision maker, or decision-making group, in making decisions regarding resource allocation and assessing performance. To date, the Company has viewed its operations and manages its business as principally one operating segment, which is developing and commercializing therapeutics for autoimmunity, fibrosis, and cancer. As of December 31, 2021, all of the Company’s assets were located in the United States, except for approximately $ 22,504,000 of cash, cash equivalents, and investments, $ 973,000 of prepaid expenses and other assets, and $ 1,000 of property and equipment, net which were held outside of the United States, principally in our subsidiary in the United Kingdom. As of December 31, 2020 , all of the Company’s assets were located in the United States, except for approximately $ 1,033,000 of cash, $ 1,837,000 of prepaid expenses and other assets, and $ 23,000 of property and equipment, net which were held outside of the United States, principally in our subsidiary in the United Kingdom. |
Income Taxes | Income Taxes For federal and state income taxes, deferred tax assets and liabilities are recognized based upon temporary differences between the financial statement and the tax basis of assets and liabilities. Deferred income taxes are based upon prescribed rates and enacted laws applicable to periods in which differences are expected to reverse. A valuation allowance is recorded to reduce a net deferred tax benefit when it is not more likely than not that the tax benefit from the deferred tax assets will be realized. Accordingly, given the cumulative losses since inception, the Company has provided a valuation allowance equal to 100 % of the deferred tax assets in order to eliminate the deferred tax assets amounts. Tax positions taken or expected to be taken in the course of preparing the Company’s tax returns are required to be evaluated to determine whether the tax positions are “more-likely-than-not” of being sustained by the applicable tax authority. Tax positions not deemed to meet a more-likely-than-not threshold, as well as accrued interest and penalties, if any, would be recorded as a tax expense in the current year. There were no uncertain tax positions that require accrual or disclosure to the financial statements as of December 31, 2021 or 2020. |
Impairment of Long-lived Assets | Impairment of Long-lived Assets The Company continually monitors events and changes in circumstances that could indicate that carrying amounts of long-lived assets may not be recoverable. An impairment loss is recognized when expected undiscounted cash flows of an asset are less than an asset’s carrying value. Accordingly, when indicators of impairment are present, the Company evaluates the carrying value of such assets in relation to the operating performance and future undiscounted cash flows of the underlying assets. An impairment loss equal to the excess of the fair value of the asset over its carrying amount, is recorded when it is determined that the carrying value of the asset may not be recoverable. The Company recognized an impairment loss of approximately $ 606,000 in the third quarter of 2021 to write down the value of leasehold improvements as a result of entering into a sublease. The Company notes no other impairment charges were taken in 2021. See Note 8 for more details on sublease agreement. |
Stock-based Payments | Stock-based Payments The Company recognizes compensation costs resulting from the issuance of stock-based awards to employees, non-employees and directors as an expense in the statement of operations over the service period based on a measurement of fair value for each stock-based award. The fair value of each option grant is estimated as of the date of grant using the Black-Scholes option-pricing model, net of estimated forfeitures. The fair value is amortized as compensation cost on a straight-line basis over the requisite service period of the awards, which is generally the vesting period. |
Foreign Currency | Foreign Currency Transaction gains and losses arising from currency exchange rate fluctuations on transactions denominated in a currency other than the U.S. Dollar functional currency are recorded in the Company’s statement of operations. Such transaction gains and losses may be realized or unrealized depending upon whether the transaction settled during the period or remains outstanding at the balance sheet date. The functional currency of the Company's foreign subsidiaries is the U.S. dollar. |
Net Loss Per Common Share | Net Loss Per Common Share Basic and diluted net loss per share of the Company’s common stock has been computed by dividing net loss by the weighted average number of shares outstanding during the period. For years in which there is a net loss, options and warrants are anti-dilutive and therefore excluded from diluted loss per share calculations. The following table sets forth the computation of basic and diluted earnings per share for the years ended December 31, 2021 and 2020: Year Ended December 31, 2021 2020 Net income (loss) $ ( 45,640,426 ) $ ( 111,269,380 ) Weighted average number of common shares-basic 122,990,011 78,133,289 Net income (loss) per share of common stock-basic $ ( 0.37 ) $ ( 1.42 ) * Warrants and options that have not been exercised have been excluded from the diluted calculation as all periods presented have a net loss and the impact of these securities would be anti-dilutive. |
Recent Accounting Pronouncements | Recently Adopted Accounting Pronouncements In December 2019, the Financial Accounting Standards Board (the “FASB”) issued ASU 2019-12 , Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes which is intended to simplify various aspects related to accounting for income taxes. The standard is effective for fiscal years, and interim periods within those years, beginning after December 15, 2020, with early adoption permitted. The Company’s adoption of ASU 2019-12 as of January 1, 2021 had no impact on the Company’s financial statements and related disclosures. Recently Issued Accounting Pronouncements In May 2021, the FSB issued ASU 2021-04, Earnings Per Share (Topic 260), Debt—Modifications and Extinguishments (Subtopic 470-50), Compensation—Stock Compensation (Topic 718), and Derivatives and Hedging— Contracts in Entity’s Own Equity (Subtopic 815-40): Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options which is intended to clarify and reduce diversity in an issuer’s accounting for modifications or exchanges of freestanding equity-classified written call options that remain equity classified after modification of exchange. This standard is effective for all entities for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. The standard will be adopted upon the effective date for us beginning January 1, 2022. The Company's adoption of ASU 2021-04 as of January 1, 2022 will not have a material impact on the Company's financial statements and disclosures. In August 2020, the FASB issued ASU 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity which is intended to simplify various aspects of GAAP for certain financial instruments with characteristics of liabilities and equity. The standard is effective for public companies that meet the definition of an SEC filer, excluding entities that are smaller reporting companies as defined by the SEC, for fiscal years, and interim periods within those years, beginning after December 15, 2021. For all other entities, the amendments are effective for fiscal years beginning after December 15, 2023, including interim periods within those fiscal years. Early adoption is permitted, but no earlier than fiscal years beginning after December 15, 2020, including interim periods within those fiscal years. The Company is currently evaluating the timing of the adoption of ASU 2020-06 and the potential impact that this standard may have on its consolidated financial statements and related disclosures. In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”) , which requires the measurement and recognition of expected credit losses for financial assets held at amortized cost. ASU 2016-13 replaces the existing incurred loss impairment model with an expected loss model. It also eliminates the concept of other-than-temporary impairment and requires credit losses related to available-for-sale debt securities to be recorded through an allowance for credit losses rather than as a reduction in the amortized cost basis of the securities. These changes may result in earlier recognition of credit losses. In November 2018, the FASB issued ASU No. 2018-19, Codification Improvements to Topic 326, Financial Instruments—Credit Losses , which narrowed the scope and changed the effective date for non-public entities for ASU 2016-13. The FASB subsequently issued supplemental guidance within ASU No. 2019-05, Financial Instruments—Credit Losses (Topic 326): Targeted Transition Relief (“ASU 2019-05”) . ASU 2019-05 provides an option to irrevocably elect the fair value option for certain financial assets previously measured at amortized cost basis. For public entities that are SEC filers, excluding entities that are eligible to be smaller reporting companies, ASU 2016-13 is effective for annual periods beginning after December 15, 2019, including interim periods within those fiscal years. For all other entities, ASU 2016-13 is effective for annual periods beginning after December 15, 2022, including interim periods within those fiscal years. Early adoption is permitted. This standard will be effective for the Company on January 1, 2023 or when it ceases being eligible to be a smaller reporting company. The Company is currently evaluating the potential impact that this standard may have on its consolidated financial statements and related disclosures. |
SIGNIFICANT ACCOUNTING POLICI_3
SIGNIFICANT ACCOUNTING POLICIES (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
SCHEDULE OF CASH AND CASH EQUIVALENTS | Cash and cash equivalents consists of the following: December 31, 2021 2020 Cash $ 6,751,593 $ 1,238,611 Cash Equivalents 18,255,039 84,194,830 Cash and cash equivalents $ 25,006,632 $ 85,433,441 Restricted cash, current 192,475 350,000 Restricted cash, noncurrent 477,425 669,900 Restricted cash $ 669,900 $ 1,019,900 Total cash, cash equivalents, and restricted cash shown in the statement of $ 25,676,532 $ 86,453,341 |
SCHEDULE OF COMPUTATION OF NET LOSS PER COMMON SHARE | The following table sets forth the computation of basic and diluted earnings per share for the years ended December 31, 2021 and 2020: Year Ended December 31, 2021 2020 Net income (loss) $ ( 45,640,426 ) $ ( 111,269,380 ) Weighted average number of common shares-basic 122,990,011 78,133,289 Net income (loss) per share of common stock-basic $ ( 0.37 ) $ ( 1.42 ) |
PROPERTY AND EQUIPMENT (Tables)
PROPERTY AND EQUIPMENT (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Property, Plant and Equipment [Abstract] | |
SUMMARY OF PROPERTY AND EQUIPMENT | Property and Equipment consisted of the following: December 31, 2021 2020 Computer hardware and software $ 248,754 $ 626,328 Office furniture and equipment 1,185,329 1,626,491 Leasehold improvements 3,330,855 4,163,860 Property and equipment, gross 4,764,938 6,416,679 Less: accumulated depreciation ( 2,372,242 ) ( 2,348,842 ) Property and equipment, net $ 2,392,696 $ 4,067,837 |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
SCHEDULE OF LEASE COSTS | The following table contains a summary of the lease costs recognized under ASC 842 and other information pertaining to the Company’s operating leases for the year ended December 31, 2021 and 2020: 2021 2020 Lease cost Operating lease cost $ 1,240,473 $ 1,240,473 Total lease cost $ 1,240,473 $ 1,240,473 Other information Weighted average remaining lease term 4.8 years 5.9 years Weighted average discount rate 8.00 % 8.00 % |
SCHEDULE OF MATURITIES OF OPERATING LEASE LIABILITIES | Pursuant to the terms of the Company’s non-cancelable lease agreements in effect at December 31, 2021, the following table summarizes the Company’s maturities of operating lease liabilities as of December 31, 2021: Year ending December 31, 2021: 2022 $ 1,652,563 2023 1,700,005 2024 1,747,447 2025 1,794,889 2026 1,688,145 Total lease payments $ 8,583,049 Less: imputed interest ( 1,489,884 ) Total $ 7,093,165 |
SUMMARY OF UNDISCOUNTED SUBLEASE CASH INFLOWS | Undiscounted sublease cash inflows have been summarized in the following table: 2022 $ 104,971 2023 185,717 2024 278,576 2025 290,688 2026 252,333 Total sublease payments $ 1,112,285 |
INVESTMENTS (Tables)
INVESTMENTS (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Investments, Debt and Equity Securities [Abstract] | |
SUMMARY OF Investments | The following table summarizes the Company’s investments as of December 31, 2021 (in thousands): Amortized Cost Gross Gross Fair Value Debt Securities: Commercial paper $ 12,794 $— $— $ 12,794 Corporate debt securities 32,922 — ( 58 ) 32,864 Asset backed securities 10,235 — ( 4 ) 10,231 Other Investments: Term deposits (Maturing 2/10/2022 - 5/5/2022) 16,752 — — 16,752 Total $ 72,703 $— $( 62 ) $ 72,641 |
SCHEDULE OF AVAILABLE FOR SALE DEBT SECURITIES BY CONTRACTUAL MATURITY | The following table summarizes the amortized cost and fair value of the Company’s available-for-sale marketable debt securities by contractual maturity as of December 31, 2021 (in thousands): Amortized Cost Fair Value Maturing in one year or less $ 44,859 $ 44,847 Maturing after one year but less than three years 11,092 11,041 $ 55,951 $ 55,888 |
FAIR VALUE OF FINANCIAL ASSET_2
FAIR VALUE OF FINANCIAL ASSETS AND LIABILITIES (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Fair Value Disclosures [Abstract] | |
SCHEDULE OF ASSETS AND LIABILITIES MEASURED AT FAIR VALUE ON RECURRING BASIS | The following tables present information about the Company’s financial assets and liabilities measured at fair value on a recurring basis and indicate the level of the fair value hierarchy utilized to determine such fair values as of December 31, 2021 (in thousands): Level 1 Level 2 Level 3 Total Assets: Cash Equivalents: Money market funds $ 18,255 $— $— $ 18,255 Investments: Term deposits 16,752 — — 16,752 Commercial paper — 12,794 — 12,794 Corporate debt securities — 32,864 — 32,864 Asset backed securities — 10,231 — 10,231 $ 35,007 $ 55,889 $— $ 90,896 Liabilities: Derivative liabilities $— $— $ 134 $ 134 The following tables present information about the Company’s financial assets and liabilities measured at fair value on a recurring basis and indicate the level of the fair value hierarchy utilized to determine such fair values as of December 31, 2020 (in thousands): Level 1 Level 2 Level 3 Total Assets: Cash Equivalents: Money Market funds $ 84,195 $— $— $ 84,195 84,195 — — 84,195 Liabilities Derivative Liabilities $— $— $ 797 $ 797 |
NOTES PAYABLE (Tables)
NOTES PAYABLE (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Debt Disclosure [Abstract] | |
SCHEDULE OF NOTES PAYABLE | The net carrying amounts of the liability components consists of the following: December 31, 2021 Principal $ 20,000,000 Less: debt discount $ ( 2,262,388 ) Accretion of Debt Discount $ 992,007 Net Carrying amount $ 18,729,619 Less: current portion of long term debt $ ( 3,093,344 ) Total long-term debt, net of discount $ 15,636,275 |
SCHEDULE OF PRINCIPAL MATURITIES ON LONG TERM DEBT | The following table summarizes the future principal payments due under long-term debt; Principal Payments and final payment on Loan Agreement 2022 $ 3,093,344 2023 9,835,341 2024 8,261,315 Total $ 21,190,000 |
ACCRUED EXPENSES (Tables)
ACCRUED EXPENSES (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Payables and Accruals [Abstract] | |
SCHEDULE OF ACCRUED EXPENSES | Accrued expenses consisted of the following: December 31, 2021 2020 Accrued clinical operations and trials costs $ 5,435,464 $ 14,132,842 Accrued product development costs 203,676 2,189,047 Accrued compensation 2,715,368 4,222,594 Accrued other 1,738,804 1,460,949 Total $ 10,093,312 $ 22,005,432 |
STOCK OPTIONS (Tables)
STOCK OPTIONS (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Share-based Payment Arrangement [Abstract] | |
SCHEDULE OF STOCK-BASED COMPENSATION EXPENSE | For stock options issued and outstanding for the years ended December 31, 2021 and 2020, the Company recorded non-cash, stock-based compensation expense of $ 9,480,373 and $ 12,458,229 , respectively, net of estimated forfeitures. Twelve Months Ended December 31, 2021 2020 Research and development expenses $ 2,969,347 $ 5,336,472 General and administrative expenses 6,511,026 7,121,757 Total stock-based compensation $ 9,480,373 $ 12,458,229 |
SUMMARY OF FAIR VALUE OF OPTIONS GRANTED | The weighted average assumptions used principally in determining the fair value of options granted were as follows: 2021 2020 Risk free interest rate 0.76 % 0.59 % Expected dividend yield 0 % 0 % Expected term in years 6.23 6.25 Expected volatility 102.96 % 83.56 % Estimated forfeiture rate 9.12 % 6.02 % |
SUMMARY OF OPTION ACTIVITY | A summary of option activity for years ended December 31, 2021 and 2020 is presented below: Options Shares Weighted Weighted Intrinsic Outstanding at December 31, 2019 13,245,366 $ 5.19 Granted 4,536,600 5.00 Exercised ( 427,611 ) 1.77 Forfeited ( 3,064,712 ) 5.60 Outstanding at December 31, 2020 14,289,643 5.15 Granted 7,373,800 2.36 Exercised ( 838,600 ) 1.13 Forfeited ( 5,479,653 ) 5.04 Expired ( 19,085 ) 6.97 Outstanding at December 31, 2021 15,326,105 $ 4.06 6.75 $ 3,529,258 Exercisable at December 31, 2021 9,011,000 $ 4.87 5.22 $ 2,691,592 Vested and expected to vest at December 31, 2021 14,652,110 $ 4.14 6.64 $ 3,340,598 |
SUMMARY OF NON-VESTED STOCK OPTIONS | As summary of non-vested stock options for the years ended December 31, 2021 and 2020 is presented below: Options Shares Weighted Nonvested December 31, 2019 5,409,272 $ 5.21 Granted 4,536,600 3.53 Vested ( 2,720,493 ) 5.34 Forfeited ( 2,888,085 ) 4.11 Nonvested December 31, 2020 4,337,294 $ 4.14 Granted 7,373,800 1.91 Vested ( 2,241,925 ) 4.02 Forfeited ( 3,154,064 ) 2.80 Non-vested at December 31, 2021 6,315,105 $ 2.26 |
INCOME TAXES (Tables)
INCOME TAXES (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |
SCHEDULE OF COMPONENTS OF NET DEFERRED TAX ASSET | Significant components of the Company’s net deferred tax asset are as follows: December 31, 2021 2020 NOL carryforward $ 50,311,967 $ 45,360,175 Foreign net operating loss carryforward 5,846,372 10,532,490 Tax credits 8,392,989 8,843,792 Stock based compensation 9,102,630 7,354,531 Accrued expenses 559,876 1,202,538 Other temporary differences 1,284,347 1,152,853 Subtotal 75,498,181 74,446,379 Valuation allowance ( 75,498,181 ) ( 74,446,379 ) Net deferred tax asset $ — $ — |
SCHEDULE OF EFFECTIVE INCOME TAX RATE RECONCILIATION | Income tax benefits computed using the federal statutory income tax rate differs from the Company’s effective tax rate primarily due to the following: December 31, 2021 2020 Tax provision at statutory rate 21.00 % 21.00 % State taxes, net of federal benefit 4.98 % 5.83 % Permanent differences ( 3.56 )% ( 1.35 )% Foreign expected tax ( 1.21 )% 7.37 % Tax credits 2.62 % 4.03 % Income tax rate change ( 0.20 )% 0.02 % NOL Adjustments ( 4.10 )% — % Other ( 17.37 )% ( 8.12 )% Decrease in valuation reserve ( 2.16 )% ( 28.78 )% Total — % — % |
DERIVATIVE LIABILITY (Tables)
DERIVATIVE LIABILITY (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Derivative Instruments and Hedging Activities Disclosure [Abstract] | |
SCHEDULE OF FAIR VALUE OF DERIVATIVE LIABILITY | A roll forward of the fair value of the derivative liability for the year ended December 31, 2021 is presented below. December 31, 2021 Beginning balance, December 31, 2020 $ 797,000 Change in fair value of derivative liabilities ( 663,290 ) Ending balance, December 31, 2021 $ 133,710 |
LIQUIDITY (Details Narrative)
LIQUIDITY (Details Narrative) - USD ($) | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Aug. 07, 2020 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Retained earnings (accumulated deficit) | $ (349,733,764) | $ (304,093,338) | |
Cash, cash equivalents and investments | 97,647,000 | ||
Proceeds from issuance of common stock | 62,586,070 | 142,200,752 | |
Stock issuance cost | $ 1,820,437 | $ 6,039,423 | |
August 2020 Sale Agreement [Member] | |||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Shares issued | 25,391,710 | ||
Proceeds from issuance of common stock | $ 60,681,238 | ||
Stock issuance cost | $ 1,820,437 | ||
August 2020 Sale Agreement [Member] | Jefferies LLC [Member] | |||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Commission percentage | 3.00% | ||
Authorized to offer and sell up of common stock | $ 150,000,000 |
SIGNIFICANT ACCOUNTING POLICI_4
SIGNIFICANT ACCOUNTING POLICIES - SCHEDULE OF CASH AND CASH EQUIVALENTS (Details) - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 |
Accounting Policies [Abstract] | ||
Cash | $ 6,751,593 | $ 1,238,611 |
Cash Equivalents | 18,255,039 | 84,194,830 |
Cash and cash equivalents | 25,006,632 | 85,433,441 |
Restricted cash, current | 192,475 | 350,000 |
Restricted cash, noncurrent | 477,425 | 669,900 |
Restricted cash | 669,900 | 1,019,900 |
Total cash, cash equivalents, and restricted cash shown in the statement of cash flows | $ 25,676,532 | $ 86,453,341 |
SIGNIFICANT ACCOUNTING POLICI_5
SIGNIFICANT ACCOUNTING POLICIES - SCHEDULE OF COMPUTATION OF NET LOSS PER COMMON SHARE (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Accounting Policies [Abstract] | ||
Net loss | $ (45,640,426) | $ (111,269,380) |
Weighted average number of common shares-basic | 122,990,011 | 78,133,289 |
Net income (loss) per share of common stock-basic | $ (0.37) | $ (1.42) |
SIGNIFICANT ACCOUNTING POLICI_6
SIGNIFICANT ACCOUNTING POLICIES (Details Narrative) - USD ($) | 3 Months Ended | 12 Months Ended | |
Sep. 30, 2021 | Dec. 31, 2021 | Dec. 31, 2020 | |
Property, Plant and Equipment [Line Items] | |||
Restricted cash | $ 669,900 | $ 1,019,900 | |
Restricted cash, current | 192,475 | 350,000 | |
Restricted cash, noncurrent | 477,425 | 669,900 | |
Cash, cash equivalents and investments | 97,647,000 | ||
Prepaid Expense and Other Assets, Current | 2,365,010 | 3,712,861 | |
Property, Plant and Equipment, Net | $ 2,392,696 | $ 4,067,837 | |
Decrease in valuation reserve | (2.16%) | (28.78%) | |
Unrecognized Tax Benefits | $ 0 | $ 0 | |
Impairment charges | $ 606,000 | $ 0 | |
Computer Hardware and Software [Member] | |||
Property, Plant and Equipment [Line Items] | |||
Property and equipment, estimated useful life | 3 years | ||
Office Furniture and Equipment [Member] | Minimum [Member] | |||
Property, Plant and Equipment [Line Items] | |||
Property and equipment, estimated useful life | 3 years | ||
Office Furniture and Equipment [Member] | Maximum [Member] | |||
Property, Plant and Equipment [Line Items] | |||
Property and equipment, estimated useful life | 5 years | ||
Leaseholds and Leasehold Improvements [Member] | |||
Property, Plant and Equipment [Line Items] | |||
Property, Plant and Equipment, Estimated Useful Lives | The Company’s leasehold improvements and assets under capital lease are amortized over the shorter of their useful lives or the respective leases. See Note 7 for details of property and equipment and Note 8 for operating and capital lease commitments. | ||
Deferred Tax Assets [Member] | |||
Property, Plant and Equipment [Line Items] | |||
Decrease in valuation reserve | 100.00% | ||
UNITED KINGDOM | |||
Property, Plant and Equipment [Line Items] | |||
Cash held in subsidiary | $ 5,752,000 | 1,033,000 | |
Cash, cash equivalents and investments | 22,504,000 | 1,033,000 | |
Prepaid Expense and Other Assets, Current | 973,000 | 1,837,000 | |
Property, Plant and Equipment, Net | 1,000 | $ 23,000 | |
Letter of Credit [Member] | |||
Property, Plant and Equipment [Line Items] | |||
Restricted cash | 669,900 | ||
Restricted cash, current | 192,475 | ||
Restricted cash, noncurrent | $ 477,425 |
SUMMARY OF INVESTMENTS (Details
SUMMARY OF INVESTMENTS (Details) - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 |
Net Investment Income [Line Items] | ||
Debt Securities, Available-for-sale, Amortized Cost | $ 55,951 | |
Debt Securities, Available-for-sale | 55,888 | $ 0 |
Other investments and Debt Securities, Amortized Cost Basic | 72,703 | |
Other Investments and Debt Securities, Available-for-sale, Accumulated Gross Unrealized Gain, before Tax | ||
Other Investments and Debt Securities, Available-for-sale, Accumulated Gross Unrealized Loss, before Tax | (62) | |
Other Investments and Debt Securities, Available-for-sale | 72,641 | |
Corporate Debt Securities [Member] | ||
Net Investment Income [Line Items] | ||
Debt Securities, Available-for-sale, Amortized Cost | 32,922 | |
Debt Securities, Available-for-sale, Accumulated Gross Unrealized Gain, before Tax | ||
Debt Securities, Available-for-sale, Accumulated Gross Unrealized Loss, before Tax | (58) | |
Debt Securities, Available-for-sale | 32,864 | |
Asset-backed Securities [Member] | ||
Net Investment Income [Line Items] | ||
Debt Securities, Available-for-sale, Amortized Cost | 10,235 | |
Debt Securities, Available-for-sale, Accumulated Gross Unrealized Gain, before Tax | ||
Debt Securities, Available-for-sale, Accumulated Gross Unrealized Loss, before Tax | (4) | |
Debt Securities, Available-for-sale | 10,231 | |
Commercial Paper [Member] | ||
Net Investment Income [Line Items] | ||
Debt Securities, Available-for-sale, Amortized Cost | 12,794 | |
Debt Securities, Available-for-sale, Accumulated Gross Unrealized Gain, before Tax | ||
Debt Securities, Available-for-sale, Accumulated Gross Unrealized Loss, before Tax | ||
Debt Securities, Available-for-sale | 12,794 | |
Term Deposits (Maturing 2/10/2022 - 5/5/2022) [Member] | ||
Net Investment Income [Line Items] | ||
Other Investments, Available-for-sale, Amortized Cost | 16,752 | |
Other Investments, Available-for-sale, Accumulated Gross Unrealized Gain, before Tax | ||
Other Investments, Available-for-sale, Accumulated Gross Unrealized Loss, before Tax | ||
Other Investments, Available-for-sale | $ 16,752 |
INVESTMENTS - summarizes the am
INVESTMENTS - summarizes the amortized cost and fair value (Details) - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 |
Investments, Debt and Equity Securities [Abstract] | ||
Amortized Cost, Maturing in one year or less | $ 44,859 | |
Amortized Cost, Maturing after one year but less than three years | 11,092 | |
Debt Securities, Available-for-sale, Amortized Cost | 55,951 | |
Fair Value, Maturing in one year or less | 44,847 | |
Fair Value, Maturing after one year but less than three years | 11,041 | |
Debt Securities, Available-for-sale, Fair Value | $ 55,888 | $ 0 |
SCHEDULE OF AVAILABLE FOR SALE
SCHEDULE OF AVAILABLE FOR SALE DEBT SECURITIES BY CONTRACTUAL MATURITY (Details) - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 |
Investments, Debt and Equity Securities [Abstract] | ||
Amortized Cost, Maturing in one year or less | $ 44,859 | |
Fair Value, Maturing in one year or less | 44,847 | |
Amortized Cost, Maturing after one year but less than three years | 11,092 | |
Fair Value, Maturing after one year but less than three years | 11,041 | |
Amortized Cost | 55,951 | |
Fair Value | $ 55,888 | $ 0 |
INVESTMENTS (Details Narrative)
INVESTMENTS (Details Narrative) - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 |
Investments, Debt and Equity Securities [Abstract] | ||
Debt Securities, Available-for-sale | $ 55,888 | $ 0 |
SCHEDULE OF ASSETS AND LIABILIT
SCHEDULE OF ASSETS AND LIABILITIES MEASURED AT FAIR VALUE ON RECURRING BASIS (Details) - Fair Value, Recurring [Member] - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets, Fair Value, Total | $ 90,896 | $ 84,195 |
Liabilities, Fair Value | 134 | 797 |
Short term Deposits [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable Securities, Fair Value | 16,752 | |
Money Market Funds [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash Equivalents, Fair Value | 18,255 | 84,195 |
Commercial Paper [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable Securities, Fair Value | 12,794 | |
Corporate Debt Securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable Securities, Fair Value | 32,864 | |
Asset-backed Securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable Securities, Fair Value | 10,231 | |
Fair Value, Inputs, Level 1 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets, Fair Value, Total | 35,007 | 84,195 |
Liabilities, Fair Value | ||
Fair Value, Inputs, Level 1 [Member] | Short term Deposits [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable Securities, Fair Value | 16,752 | |
Fair Value, Inputs, Level 1 [Member] | Money Market Funds [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash Equivalents, Fair Value | 18,255 | 84,195 |
Fair Value, Inputs, Level 1 [Member] | Commercial Paper [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable Securities, Fair Value | ||
Fair Value, Inputs, Level 1 [Member] | Corporate Debt Securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable Securities, Fair Value | ||
Fair Value, Inputs, Level 1 [Member] | Asset-backed Securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable Securities, Fair Value | ||
Fair Value, Inputs, Level 2 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets, Fair Value, Total | 55,889 | |
Liabilities, Fair Value | ||
Fair Value, Inputs, Level 2 [Member] | Short term Deposits [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable Securities, Fair Value | ||
Fair Value, Inputs, Level 2 [Member] | Money Market Funds [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash Equivalents, Fair Value | ||
Fair Value, Inputs, Level 2 [Member] | Commercial Paper [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable Securities, Fair Value | 12,794 | |
Fair Value, Inputs, Level 2 [Member] | Corporate Debt Securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable Securities, Fair Value | 32,864 | |
Fair Value, Inputs, Level 2 [Member] | Asset-backed Securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable Securities, Fair Value | 10,231 | |
Fair Value, Inputs, Level 3 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets, Fair Value, Total | ||
Liabilities, Fair Value | 134 | 797 |
Fair Value, Inputs, Level 3 [Member] | Short term Deposits [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable Securities, Fair Value | ||
Fair Value, Inputs, Level 3 [Member] | Money Market Funds [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash Equivalents, Fair Value | ||
Fair Value, Inputs, Level 3 [Member] | Commercial Paper [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable Securities, Fair Value | ||
Fair Value, Inputs, Level 3 [Member] | Corporate Debt Securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable Securities, Fair Value | ||
Fair Value, Inputs, Level 3 [Member] | Asset-backed Securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable Securities, Fair Value |
LICENSE AGREEMENT (Details Narr
LICENSE AGREEMENT (Details Narrative) - USD ($) | May 26, 2021 | May 25, 2021 | Sep. 20, 2018 | Dec. 31, 2021 |
Research and Development Expense [Member] | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Upfront cash payment | $ 0 | |||
Jenrin Agreement [Member] | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Upfront cash payment | $ 250,000 | |||
Jenrin Agreement [Member] | Maximum [Member] | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Potential milestone payments | $ 18,400,000 | |||
Milky Way License Agreement Member | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Upfront cash payment | $ 500,000 | |||
Stock Issued During Period, Shares, Acquisitions | 147,875 | |||
Milky Way License Agreement Member | Maximum [Member] | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Potential milestone payments | $ 53,000,000 | |||
UCSF Lincense Agreement [Member] | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
License issuance fee | $ 1,500,000 | |||
UCSF Lincense Agreement [Member] | Maximum [Member] | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Potential milestone payments | $ 153,000,000 |
SUMMARY OF PROPERTY AND EQUIPME
SUMMARY OF PROPERTY AND EQUIPMENT (Details) - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 |
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 4,764,938 | $ 6,416,679 |
Less: accumulated depreciation | (2,372,242) | (2,348,842) |
Property and equipment, net | 2,392,696 | 4,067,837 |
Computer Hardware and Software [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 248,754 | 626,328 |
Office Furniture and Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 1,185,329 | 1,626,491 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 3,330,855 | $ 4,163,860 |
PROPERTY AND EQUIPMENT (Details
PROPERTY AND EQUIPMENT (Details Narrative) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Property, Plant and Equipment [Abstract] | ||
Depreciation | $ 1,000,000 | $ 1,124,000 |
COMMITMENTS AND CONTINGENCIES_2
COMMITMENTS AND CONTINGENCIES (Details Narrative) | Oct. 25, 2019ft² | Feb. 26, 2019USD ($)ft² | Aug. 21, 2017USD ($)ft² | Dec. 31, 2019USD ($) | Dec. 31, 2021USD ($) | Dec. 31, 2020USD ($) | Jan. 02, 2019USD ($) |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Operating lease liability | $ 7,093,165 | ||||||
Operating lease, right of use asset | 4,609,110 | $ 5,248,525 | |||||
Sublease income | 55,133 | 0 | |||||
Lease expenses | $ 1,185,341 | $ 1,240,473 | |||||
Sublease Agreement Description | Effective August 26, 2021, the Company entered into a sublease agreement with a third party to sublease 12,112 square feet of the 30,023 square feet currently being leased under one of its two existing lease agreements. The sublease commences on October 1, 2021 and ends October 31, 2026. | ||||||
Accounting Standards Update 2016-02 [Member] | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Operating lease liability | $ 3,811,000 | ||||||
Operating lease, right of use asset | $ 2,400,000 | ||||||
August 2017 Lease Agreement [Member] | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Area of office space | ft² | 32,733 | ||||||
Operating lease, initial term | 7 years | ||||||
Leasehold improvements | $ 1,080,000 | ||||||
Irrevocable letter of credit | 400,000 | ||||||
Unsecured letter of credit | 400,000 | ||||||
August 2017 Lease Agreement [Member] | First Year [Member] | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Rent expense | 470,000 | ||||||
August 2017 Lease Agreement [Member] | Seventh Year [Member] | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Rent expense | 908,000 | ||||||
August 2017 Lease Agreement [Member] | Third Anniversary [Member] | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Irrevocable letter of credit | 300,000 | ||||||
August 2017 Lease Agreement [Member] | Fourth Anniversary [Member] | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Irrevocable letter of credit | $ 200,000 | ||||||
February 2019 Lease Agreement [Member] | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Leasehold improvements | $ 991,000 | ||||||
Irrevocable letter of credit | 369,900 | ||||||
Operating lease, right of use asset | $ 855,000 | ||||||
Percentage of incremental borrowing rate from present value of lease | 9.00% | ||||||
Operating lease, option to extend | The February 2019 Lease Agreement constitutes a modification as it extends the original lease term and increases the scope of the lease (additional space provided under the amendment), which requires evaluation of the remeasurement of the lease liability and corresponding ROU asset. Accordingly, the Company reassessed the classification of the Leased Premises and remeasured the lease liability on the basis of the extended lease term using the 20 additional monthly rent payments and the incremental borrowing rate at the effective date of the modification of 9%. | ||||||
February 2019 Lease Agreement [Member] | New Premises [Member] | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Area of office space | ft² | 30,023 | ||||||
Operating lease, right of use asset | $ 2,700,000 | ||||||
February 2019 Lease Agreement [Member] | Not In Default On Third Anniversary [Member] | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Irrevocable letter of credit | 277,425 | ||||||
February 2019 Lease Agreement [Member] | Not In Default On Fourth Anniversary [Member] | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Irrevocable letter of credit | $ 184,950 | ||||||
October 2019 Lease Amendment [Member] | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Percentage of incremental borrowing rate from present value of lease | 8.00% | ||||||
Operating lease, option to extend | The October 2019 Lease Amendment constitutes a modification as it extends the original lease term and increases the scope of the lease (additional space provided under the amendment), which requires evaluation of the remeasurement of the lease liability and corresponding ROU asset. The additional space did not result in a separate contract as the rent increase was determined not to be commensurate with the standalone price for the additional right of use. Accordingly, the Company reassessed the classification of the Amended Total Premises, which resulted in operating classification, and remeasured the lease liability on the basis of the extended lease term using the additional monthly rent payments and the incremental borrowing rate at the effective date of the modification of 8%. | ||||||
Increase in right of use assets | $ 381,000 | ||||||
October 2019 Lease Amendment [Member] | Amended Premises [Member] | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Area of office space | ft² | 500 | ||||||
October 2019 Lease Amendment [Member] | Total Premises [Member] | |||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||
Area of office space | ft² | 63,256 |
COMMITMENTS AND CONTINGENCIES -
COMMITMENTS AND CONTINGENCIES - SCHEDULE OF MATURITIES OF OPERATING LEASE LIABILITIES (Details) | Dec. 31, 2021USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
2022 | $ 1,652,563 |
2023 | 1,700,005 |
2024 | 1,747,447 |
2025 | 1,794,889 |
2026 | 1,688,145 |
Total lease payments | 8,583,049 |
Less: imputed interest | (1,489,884) |
Total | $ 7,093,165 |
COMMITMENTS AND CONTINGENCIES_3
COMMITMENTS AND CONTINGENCIES - SCHEDULE OF LEASE COSTS (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Commitments and Contingencies Disclosure [Abstract] | ||
Operating lease cost | $ 1,240,473 | $ 1,240,473 |
Lease, Cost, Total | $ 1,240,473 | $ 1,240,473 |
Weighted average remaining lease term | 4 years 9 months 18 days | 5 years 10 months 24 days |
Weighted average discount rate | 8.00% | 8.00% |
COMMITMENTS AND CONTINGENCIES_4
COMMITMENTS AND CONTINGENCIES - SUMMARY OF UNDISCOUNTED SUBLEASE CASH INFLOWS (Details) | Dec. 31, 2021USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
2022 | $ 104,971 |
2023 | 185,717 |
2024 | 278,576 |
2025 | 290,688 |
2026 | 252,333 |
Total sublease payments | $ 1,112,285 |
SCHEDULE OF NOTES PAYABLE (Deta
SCHEDULE OF NOTES PAYABLE (Details) - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 |
Debt Disclosure [Abstract] | ||
Principal | $ 20,000,000 | |
Less: debt discount | (2,262,388) | |
Accretion of Debt Discount | 992,007 | |
Net Carrying amount | 18,729,619 | |
Current portion of long-term debt | 3,093,344 | |
Total long-term debt, net of discount | $ 15,636,275 | $ 18,029,005 |
SCHEDULE OF PRINCIPAL MATURITIE
SCHEDULE OF PRINCIPAL MATURITIES ON LONG TERM DEBT (Details) | Dec. 31, 2021USD ($) |
Debt Disclosure [Abstract] | |
2022 | $ 3,093,344 |
2023 | 9,835,341 |
2024 | 8,261,315 |
Total long-term debt, net of discount | $ 21,190,000 |
NOTES PAYABLE (Details Narrativ
NOTES PAYABLE (Details Narrative) - USD ($) | Jul. 28, 2020 | Nov. 30, 2021 | Nov. 30, 2020 | Dec. 31, 2021 | Dec. 31, 2020 |
SEC Schedule, 12-17, Insurance Companies, Reinsurance [Line Items] | |||||
Debt Instrument, Unamortized Discount | $ 2,262,388 | ||||
Interest Expense, Debt | 2,709,000 | $ 1,126,534 | |||
Lenders [Member] | |||||
SEC Schedule, 12-17, Insurance Companies, Reinsurance [Line Items] | |||||
Debt Instrument, Unamortized Discount | 2,262,000 | ||||
Insurance Policy [Member] | |||||
SEC Schedule, 12-17, Insurance Companies, Reinsurance [Line Items] | |||||
Prepaid expenses | $ 1,093,750 | ||||
Loan Agreement [Member] | |||||
SEC Schedule, 12-17, Insurance Companies, Reinsurance [Line Items] | |||||
Notes payable | $ 984,375 | $ 909,375 | |||
Monthly principal and interest payments | $ 111,041 | $ 103,112 | |||
Monthly loan payments term | nine-month period | nine-month period | |||
Annual interest rate | 3.64% | 4.89% | |||
Loan Agreement [Member] | K2 HealthVentures LLC [Member] | |||||
SEC Schedule, 12-17, Insurance Companies, Reinsurance [Line Items] | |||||
Annual interest rate | 8.50% | ||||
Secured debt | $ 50,000,000 | $ 21,190,000 | |||
Debt description | The loan matures on August 1, 2024 and the Company is obligated to make interest only payments for the first 24 months and then interest and equal principal payments for the next 24 months. Interest accrues at a variable annual rate equal to the greater of (i) 8.5% and (ii) the rate of interest noted in The Wall Street Journal, Money Rates section, as the “Prime Rate” plus 5.25%, in each case, subject to a step-down of 25 basis points upon the funding of the second tranche. | ||||
Debt maturity date | Aug. 1, 2024 | ||||
Debt conversion amount | $ 5,000,000 | ||||
Debt conversion per share | $ 9.40 | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Non-Option Equity Instruments, Exercised | 86,206 | ||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 6.96 | ||||
Proceeds from Warrant Exercises | $ 472,000 | ||||
Proceeds from prepayment and default features | 546,000 | ||||
Debt issuance cost | 1,244,000 | ||||
Final payment | 1,190,000 | $ 1,190,000 | |||
Loan Agreement [Member] | K2 HealthVentures LLC [Member] | Share-based Payment Arrangement, Tranche One [Member] | |||||
SEC Schedule, 12-17, Insurance Companies, Reinsurance [Line Items] | |||||
Secured debt | 20,000,000 | ||||
Loan Agreement [Member] | K2 HealthVentures LLC [Member] | Share-based Payment Arrangement, Tranche Two [Member] | |||||
SEC Schedule, 12-17, Insurance Companies, Reinsurance [Line Items] | |||||
Secured debt | 20,000,000 | ||||
Loan Agreement [Member] | K2 HealthVentures LLC [Member] | Share-based Payment Arrangement, Tranche Three [Member] | |||||
SEC Schedule, 12-17, Insurance Companies, Reinsurance [Line Items] | |||||
Secured debt | $ 10,000,000 | ||||
Event of Default - Loan Agreement [Member] | K2 HealthVentures LLC [Member] | |||||
SEC Schedule, 12-17, Insurance Companies, Reinsurance [Line Items] | |||||
Annual interest rate | 5.00% |
SCHEDULE OF ACCRUED EXPENSES (D
SCHEDULE OF ACCRUED EXPENSES (Details) - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 |
Payables and Accruals [Abstract] | ||
Accrued clinical operations and trials costs | $ 5,435,464 | $ 14,132,842 |
Accrued product development costs | 203,676 | 2,189,047 |
Accrued compensation | 2,715,368 | 4,222,594 |
Accrued other | 1,738,804 | 1,460,949 |
Total | $ 10,093,312 | $ 22,005,432 |
DEVELOPMENT AWARDS AND DEFERR_2
DEVELOPMENT AWARDS AND DEFERRED REVENUE (Details Narrative) - USD ($) | Jul. 31, 2020 | Jan. 26, 2018 | May 31, 2019 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 |
Entity Listings [Line Items] | |||||||
Revenue | $ 881,705 | $ 3,937,230 | |||||
Additional paid in capital, fair value of warrant issued | 807,149 | ||||||
CFF Warrant [Member] | |||||||
Entity Listings [Line Items] | |||||||
Warrant exercisable price per share | $ 13.20 | ||||||
Cystic Fibrosis Program Related Investment Agreement [Member] | Phase 2b Clinical Trial [Member] | |||||||
Entity Listings [Line Items] | |||||||
Royalty payable | $ 2,700,000 | ||||||
Payments for royalty | $ 27,000,000 | ||||||
Proceeds from investments on achieving milestones | $ 25,000,000 | ||||||
Cystic Fibrosis Program Related Investment Agreement [Member] | Maximum [Member] | |||||||
Entity Listings [Line Items] | |||||||
Gain Contingency, Unrecorded Amount | $ 25,000,000 | ||||||
Investment Agreement [Member] | 2018 CFF Award [Member] | |||||||
Entity Listings [Line Items] | |||||||
Revenue | $ 881,705 | 3,937,230 | |||||
Investment Agreement [Member] | CFF Warrant [Member] | |||||||
Entity Listings [Line Items] | |||||||
Warrant to purchase of common stock | 1,000,000 | ||||||
Warrants expiration term | Jan. 26, 2025 | ||||||
Investment Agreement [Member] | CFF Warrant [Member] | Immediately Exercisable Warrants [Member] | |||||||
Entity Listings [Line Items] | |||||||
Warrant to purchase of common stock | 500,000 | ||||||
Investment Agreement [Member] | CFF Warrant [Member] | Warrants Exercisable On Completion Of Final Milestone [Member] | |||||||
Entity Listings [Line Items] | |||||||
Warrant to purchase of common stock | 500,000 | ||||||
Investment Agreements [Member] | |||||||
Entity Listings [Line Items] | |||||||
Revenue | $ 25,000,000 | $ 2,500,000 | $ 5,000,000 | $ 5,000,000 | $ 12,500,000 | ||
Investment Agreements [Member] | Cystic Fibrosis Foundation Warrants [Member] | |||||||
Entity Listings [Line Items] | |||||||
Revenue | 25,000,000 | ||||||
Additional paid in capital, fair value of warrant issued | 6,215,225 | ||||||
Revenue to be recognized | $ 18,784,775 | ||||||
Collaboration Agreement [Member] | Cystic Fibrosis Foundation [Member] | |||||||
Entity Listings [Line Items] | |||||||
Royalty payment percentage | 10.00% |
COMMON STOCK (Details Narrative
COMMON STOCK (Details Narrative) - USD ($) | Apr. 07, 2020 | Feb. 11, 2020 | Dec. 31, 2021 | Dec. 31, 2020 |
Significant Change in Unrecognized Tax Benefits is Reasonably Possible [Line Items] | ||||
Common stock, shares authorized | 300,000,000 | 150,000,000 | ||
Common stock, par value | $ 0.0001 | $ 0.0001 | ||
Common stock, shares issued | 125,230,881 | 98,852,696 | ||
Common stock, shares outstanding | 125,230,881 | 98,852,696 | ||
Gross proceeds from sale of stock | $ 62,586,070 | $ 142,200,752 | ||
Issuance costs incurred | $ 1,820,437 | $ 6,039,423 | ||
Issuance of common stock upon exercise of stock options, shares | 838,600 | 427,611 | ||
Warrant [Member] | ||||
Significant Change in Unrecognized Tax Benefits is Reasonably Possible [Line Items] | ||||
Warrants to purchase shares of common stock, exercised | 0 | 0 | ||
Equity Option [Member] | ||||
Significant Change in Unrecognized Tax Benefits is Reasonably Possible [Line Items] | ||||
Issuance of common stock upon exercise of stock options, shares | 838,600 | 427,611 | ||
Proceeds from exercise of stock options | $ 945,000 | $ 756,000 | ||
April 2020 Sale Agreement [Member] | ||||
Significant Change in Unrecognized Tax Benefits is Reasonably Possible [Line Items] | ||||
Gross proceeds from sale of stock | $ 75,000,000 | 75,000,000 | ||
Sale of Stock, Consideration Received on Transaction | 10,539,374 | |||
Estimated Issuance Costs Incurred | $ 2,250,000 | |||
April 2020 Sale Agreement [Member] | Maximum [Member] | ||||
Significant Change in Unrecognized Tax Benefits is Reasonably Possible [Line Items] | ||||
Sale of Stock, Consideration Received on Transaction | 75,000,000 | |||
April 2020 Sale Agreement [Member] | Jefferies LLC [Member] | Maximum [Member] | ||||
Significant Change in Unrecognized Tax Benefits is Reasonably Possible [Line Items] | ||||
Sale of Stock, Consideration Received on Transaction | $ 75,000,000 | |||
August 2020 Sale Agreement [Member] | ||||
Significant Change in Unrecognized Tax Benefits is Reasonably Possible [Line Items] | ||||
Aggregate common stock sold, shares | 25,391,710 | 15,546,151 | ||
Gross proceeds from sale of stock | $ 60,681,238 | $ 21,404,000 | ||
Estimated Issuance Costs Incurred | $ 1,820,437 | $ 642,000 | ||
August 2020 Sale Agreement [Member] | Jefferies LLC [Member] | Maximum [Member] | ||||
Significant Change in Unrecognized Tax Benefits is Reasonably Possible [Line Items] | ||||
Aggregate common stock sold, shares | 150,000,000 | |||
Milky Way License Agreement Member | Restricted Stock [Member] | ||||
Significant Change in Unrecognized Tax Benefits is Reasonably Possible [Line Items] | ||||
Shares issued | 147,875 | 0 | ||
IPO [Member] | ||||
Significant Change in Unrecognized Tax Benefits is Reasonably Possible [Line Items] | ||||
Aggregate common stock sold, shares | 7,666,667 | |||
Purchase price per share | $ 6 | |||
Gross proceeds from sale of stock | $ 46,000,000 | |||
Issuance costs incurred | $ 3,147,000 | |||
IPO [Member] | Underwriters [Member] | ||||
Significant Change in Unrecognized Tax Benefits is Reasonably Possible [Line Items] | ||||
Aggregate common stock sold, shares | 1,000,000 |
SCHEDULE OF COMPONENTS OF NET D
SCHEDULE OF COMPONENTS OF NET DEFERRED TAX ASSET (Details) - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 |
Income Tax Disclosure [Abstract] | ||
NOL carryforward | $ 50,311,967 | $ 45,360,175 |
Foreign net operating loss carryforward | 5,846,372 | 10,532,490 |
Tax credits | 8,392,989 | 8,843,792 |
Stock based compensation | 9,102,630 | 7,354,531 |
Accrued expenses | 559,876 | 1,202,538 |
Other temporary differences | 1,284,347 | 1,152,853 |
Subtotal | 75,498,181 | 74,446,379 |
Valuation allowance | (75,498,181) | (74,446,379) |
Net deferred tax asset |
SCHEDULE OF EFFECTIVE INCOME TA
SCHEDULE OF EFFECTIVE INCOME TAX RATE RECONCILIATION - (Details) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | ||
Tax provision at statutory rate | 21.00% | 21.00% |
State taxes, net of federal benefit | 4.98% | 5.83% |
Permanent differences | (3.56%) | (1.35%) |
Foreign expected tax | (1.21%) | 7.37% |
Tax credits | 2.62% | 4.03% |
Income tax rate change | (0.20%) | 0.02% |
NOL Adjustments | (4.10%) | 0.00% |
Other | (17.37%) | (8.12%) |
Decrease in valuation reserve | (2.16%) | (28.78%) |
Effective Income Tax Rate Reconciliation, Percent, Total | 0.00% | 0.00% |
INCOME TAXES (Details Narrative
INCOME TAXES (Details Narrative) - USD ($) | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Operating Loss Carryforwards [Line Items] | |||
Net operating loss carryforwards no expiration | $ 186,267,000 | ||
Research and development tax credit carryforwards | 8,656,000 | $ 9,233,000 | |
Deferred tax assets valuation allowance increase | 1,052,000 | 23,324,000 | |
Uncertain tax position | 0 | 0 | |
Federal [Member] | |||
Operating Loss Carryforwards [Line Items] | |||
Net operating loss carryforwards | $ 186,267,000 | 167,399,000 | |
Operating loss carryforwards expiration year | 2029 | ||
Net operating loss carryforwards no expiration | $ 103,686,000 | 103,686,000 | $ 103,686,000 |
Net operating loss carryforwards limitation percentage on taxable income | 80.00% | ||
MASSACHUSETTS [Member] | |||
Operating Loss Carryforwards [Line Items] | |||
Net operating loss carryforwards | $ 177,171,000 | $ 161,143,000 | |
Foreign Tax Authority [Member] | Other Income [Member] | |||
Operating Loss Carryforwards [Line Items] | |||
Proceeds from Income Tax Refunds | $ 12,800,000 |
STOCK OPTIONS (Details Narrativ
STOCK OPTIONS (Details Narrative) - USD ($) | Jan. 02, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | Jan. 01, 2022 | Jan. 01, 2021 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Stock-based compensation expense | $ 9,480,373 | $ 12,458,229 | |||
Option granted expected term | 6 years 3 months | ||||
Weighted average grant-date fair value, options granted | $ 1.91 | $ 3.53 | |||
Total fair value of options vested | $ 3,529,258 | ||||
Equity Option [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Weighted average grant-date fair value, options granted | $ 1.91 | $ 3.53 | |||
Average intrinsic value of options exercised | $ 1,769,714 | $ 1,235,676 | |||
Total unrecognized compensation expense | $ 10,825,375 | ||||
Share-based compensation expense, not yet recognized period of recognition | 2 years 5 months 19 days | ||||
2014 Equity Incentive Plan [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Percentage of outstanding common shares | 7.00% | ||||
Shares available for future issuance | 25,570,842 | ||||
Shares available for future grants | 9,869,051 | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Period | 4 years | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Expiration Period | 10 years | ||||
2014 Equity Incentive Plan [Member] | January 1, 2021 [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Increase in number of shares of common stock available for issuance | 2,500,000 | ||||
2014 Equity Incentive Plan [Member] | January 1, 2022 [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Percentage of outstanding common shares | 7.00% | ||||
Increase in number of shares of common stock available for issuance | 8,766,162 | ||||
2014 Equity Incentive Plan [Member] | Evergreen Provision [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Percentage of outstanding common shares | 7.00% | ||||
2014 Equity Incentive Plan [Member] | Subsequent Event [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Shares available for future issuance | 34,337,004 | ||||
Shares available for future grants | 16,760,151 | ||||
2014 Equity Incentive Plan [Member] | Subsequent Event [Member] | Evergreen Provision [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Percentage of outstanding common shares | 7.00% | ||||
Shares available for future issuance | 34,337,004 | ||||
Shares available for future grants | 16,760,151 |
STOCK OPTIONS - SCHEDULE OF STO
STOCK OPTIONS - SCHEDULE OF STOCK-BASED COMPENSATION EXPENSE (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Share-based Payment Arrangement, Expense | $ 9,480,373 | $ 12,458,229 |
Research and Development Expense [Member] | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Share-based Payment Arrangement, Expense | 2,969,347 | 5,336,472 |
General And Administrative Expense [Member] | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Share-based Payment Arrangement, Expense | $ 6,511,026 | $ 7,121,757 |
STOCK OPTIONS - SUMMARY OF FAIR
STOCK OPTIONS - SUMMARY OF FAIR VALUE OF OPTIONS GRANTED (Details) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Option Indexed to Issuer's Equity [Line Items] | ||
Expected term in years | 6 years 3 months | |
Share-based Payment Arrangement, Option [Member] | ||
Option Indexed to Issuer's Equity [Line Items] | ||
Risk free interest rate | 0.76% | 0.59% |
Expected dividend yield | 0.00% | 0.00% |
Expected term in years | 6 years 2 months 23 days | 6 years 3 months |
Expected volatility | 102.96% | 83.56% |
Estimated Forfeiture Rate | 9.12% | 6.02% |
STOCK OPTIONS - SUMMARY OF OPTI
STOCK OPTIONS - SUMMARY OF OPTION ACTIVITY (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Share-based Payment Arrangement [Abstract] | ||
Shares, Outstanding, Beginning balance | 14,289,643 | 13,245,366 |
Shares, Granted | 7,373,800 | 4,536,600 |
Shares, Exercised | (838,600) | (427,611) |
Shares, Forfeited | (5,479,653) | (3,064,712) |
Shares, Expired | (19,085) | |
Shares, Outstanding, Ending balance | 15,326,105 | 14,289,643 |
Shares, Exercisable | 9,011,000 | |
Shares, Vested and expected to vest | 14,652,110 | |
Weighted Average Exercise Price, Outstanding, Beginning balance | $ 5.15 | $ 5.19 |
Weighted Average Exercise Price, Granted | 2.36 | 5 |
Weighted Average Exercise Price, Exercised | 1.13 | 1.77 |
Weighted Average Exercise Price, Forfeited | 5.04 | 5.60 |
Weighted Average Exercise Price , Expired | 6.97 | |
Weighted Average Exercise Price, Outstanding, Ending balance | 4.06 | $ 5.15 |
Weighted Average Exercise Price, Exercisable | 4.87 | |
Weighted Average Exercise Price, Vested and expected to vest | $ 4.14 | |
Weighted Average Remaining Contractual Term in Years, Outstanding | 6 years 9 months | |
Weighted Average Remaining Contractual Term in Years, Vested | 5 years 2 months 19 days | |
Weighted Average Remaining Contractual Term in Years, Vested and expected to vest | 6 years 7 months 20 days | |
Average Intrinsic Value, Outstanding | $ 3,529,258 | |
Average Intrinsic Value, Vested | 2,691,592 | |
Aggregate Intrinsic Value, Vested and expected to vest | $ 3,340,598 |
STOCK OPTIONS - SUMMARY OF NON-
STOCK OPTIONS - SUMMARY OF NON-VESTED STOCK OPTION (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Share-based Payment Arrangement [Abstract] | ||
Shares Non-vested , Beginning balance | 4,337,294 | 5,409,272 |
Shares, Granted | 7,373,800 | 4,536,600 |
Shares, Vested | (2,241,925) | (2,720,493) |
Shares, Forfeited | (3,154,064) | (2,888,085) |
Shares Outstanding, Ending balance | 6,315,105 | 4,337,294 |
Weighted Average Fair Value Non Vested, Beginning Balance | $ 4.14 | $ 5.21 |
Weighted average grant-date fair value, options granted | 1.91 | 3.53 |
Weighted Average Fair Value, Vested | 4.02 | 5.34 |
Weighted Average Fair Value, Forfeited | 2.80 | 4.11 |
Weighted Average Fair Value Non Vested, Ending Balance | $ 2.26 | $ 4.14 |
WARRANTS (Details Narrative)
WARRANTS (Details Narrative) - USD ($) | Oct. 16, 2020 | Jul. 28, 2020 | Dec. 31, 2021 | Dec. 31, 2020 |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||
Issuance of common stock upon exercise of stock options, shares | 838,600 | 427,611 | ||
Debt face amount | $ 20,000,000 | |||
Warrant [Member] | ||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||
Warrants to purchase shares of common stock, exercised | 0 | 0 | ||
Share-based Payment Arrangement, Tranche One [Member] | ||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||
Debt face amount | $ 20,000,000 | |||
CFF Warrant [Member] | ||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||
Warrants outstanding to purchase of common stock shares | 1,000,000 | |||
Exercise price of warrants | $ 13.20 | |||
Number of warrants exercisable for common stock | 500,000 | |||
Investment Agreement [Member] | CFF Warrant [Member] | ||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||
Warrants outstanding to purchase of common stock shares | 1,506,206 | |||
Exercise price of warrants | $ 9.46 | |||
Weighted average remaining life of warrants | 3 years 7 months 6 days | |||
Number of warrants exercisable for common stock | 500,000 | |||
Warrant expire date | Jan. 26, 2025 | |||
Fair value of warrants issued | $ 6,215,225 | |||
Loan Agreement [Member] | K2 HealthVentures LLC [Member] | ||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||
Exercise price of warrants | $ 6.96 | |||
Warrants to purchase shares of common stock, exercised | 86,206 | |||
Loan Agreement [Member] | K2 Warrant [Member] | ||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||
Warrants outstanding to purchase of common stock shares | 86,206 | |||
Exercise price of warrants | $ 6.96 | |||
Warrants to purchase shares of common stock, exercised | 86,206 | |||
Warrant expire date | Jul. 28, 2030 | |||
Fair value of warrants issued | $ 472,409 | |||
Loan Agreement [Member] | K2 Warrant [Member] | Maximum [Member] | ||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||
Debt face amount | $ 50,000,000 | |||
Professional Services Agreement [Member] | Warrant [Member] | Investor Relations Service Provider [Member] | ||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||
Warrants outstanding to purchase of common stock shares | 420,000 | |||
Exercise price of warrants | $ 1.07 | |||
Fair value of warrants issued | $ 334,740 |
SCHEDULE OF WEIGHTED AVERAGE AS
SCHEDULE OF WEIGHTED AVERAGE ASSUMPTION OF WARRANTS (Details) | Dec. 31, 2021 |
CFF Warrant [Member] | Measurement Input, Risk Free Interest Rate [Member] | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |
Warrants outstanding measurement input, percentage | 2.60 |
CFF Warrant [Member] | Measurement Input, Expected Dividend Rate [Member] | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |
Warrants outstanding measurement input, percentage | 0 |
CFF Warrant [Member] | Measurement Input, Expected Term [Member] | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |
Warrants outstanding measurement input, term | 7 years |
CFF Warrant [Member] | Measurement Input, Price Volatility [Member] | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |
Warrants outstanding measurement input, percentage | 83.5 |
K2 Warrant [Member] | Measurement Input, Risk Free Interest Rate [Member] | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |
Warrants outstanding measurement input, percentage | 0.60 |
K2 Warrant [Member] | Measurement Input, Expected Dividend Rate [Member] | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |
Warrants outstanding measurement input, percentage | 0 |
K2 Warrant [Member] | Measurement Input, Expected Term [Member] | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |
Warrants outstanding measurement input, term | 10 years |
K2 Warrant [Member] | Measurement Input, Price Volatility [Member] | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |
Warrants outstanding measurement input, percentage | 80 |
Warrants [Member] | Measurement Input, Risk Free Interest Rate [Member] | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |
Warrants outstanding measurement input, percentage | 0.90 |
Warrants [Member] | Measurement Input, Expected Dividend Rate [Member] | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |
Warrants outstanding measurement input, percentage | |
Warrants [Member] | Measurement Input, Expected Term [Member] | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |
Warrants outstanding measurement input, term | 5 years |
Warrants [Member] | Measurement Input, Price Volatility [Member] | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |
Warrants outstanding measurement input, percentage | 100.6 |
SCHEDULE OF FAIR VALUE OF DERIV
SCHEDULE OF FAIR VALUE OF DERIVATIVE LIABILITY (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Derivative Instruments and Hedging Activities Disclosure [Abstract] | ||
Beginning balance, December 31, 2020 | $ 797,000 | |
Change in fair value of derivative liabilities | (663,290) | $ 251,000 |
Ending balance, December 31, 2021 | $ 133,710 | $ 797,000 |
DERIVATIVE LIABILITY (Details N
DERIVATIVE LIABILITY (Details Narrative) - USD ($) | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Jul. 28, 2020 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Gain (Loss) on Sale of Derivatives | $ 663,290 | $ (251,000) | |
Loan Agreement [Member] | K2 HealthVentures LLC [Member] | |||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Secured debt | 21,190,000 | $ 50,000,000 | |
Initial measurement of fair value | 133,710 | $ 797,000 | |
Gain (Loss) on Sale of Derivatives | $ 663,290 | ||
Loan Agreement [Member] | K2 HealthVentures LLC [Member] | Share-based Payment Arrangement, Tranche One [Member] | |||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Secured debt | $ 20,000,000 |
SUBSEQUENT EVENTS (Details Narr
SUBSEQUENT EVENTS (Details Narrative) - USD ($) | Jan. 02, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | Jan. 01, 2022 | Jan. 01, 2021 |
Subsequent Event [Line Items] | |||||
Proceeds from issuance of common stock | $ 62,586,070 | $ 142,200,752 | |||
2014 Equity Incentive Plan [Member] | |||||
Subsequent Event [Line Items] | |||||
Percentage of outstanding common shares | 7.00% | ||||
Shares available for future issuance | 25,570,842 | ||||
Shares available for future grants | 9,869,051 | ||||
2014 Equity Incentive Plan [Member] | Evergreen Provision [Member] | |||||
Subsequent Event [Line Items] | |||||
Percentage of outstanding common shares | 7.00% | ||||
August 2020 Sale Agreement [Member] | |||||
Subsequent Event [Line Items] | |||||
Issuance of common stock, net of issuance costs, shares | 25,391,710 | ||||
Proceeds from issuance of common stock | $ 60,681,238 | ||||
Subsequent Event [Member] | 2014 Equity Incentive Plan [Member] | |||||
Subsequent Event [Line Items] | |||||
Shares available for future issuance | 34,337,004 | ||||
Shares available for future grants | 16,760,151 | ||||
Subsequent Event [Member] | 2014 Equity Incentive Plan [Member] | Evergreen Provision [Member] | |||||
Subsequent Event [Line Items] | |||||
Increases in number of shares of common stock available for issuance, minimum percentage of outstanding common stock | 7.00% | ||||
Number of shares of common stock available for issuance | 8,766,162 | ||||
Percentage of outstanding common shares | 7.00% | ||||
Shares available for future issuance | 34,337,004 | ||||
Shares available for future grants | 16,760,151 |