Cover
Cover - USD ($) | 12 Months Ended | ||
Dec. 31, 2020 | Mar. 08, 2021 | Jun. 30, 2020 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Document Period End Date | Dec. 31, 2020 | ||
Document Fiscal Period Focus | FY | ||
Document Fiscal Year Focus | 2020 | ||
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 | $ 664,542,879 | ||
Entity Common Stock, Shares Outstanding | 124,936,542 | ||
ICFR Auditor Attestation Flag | false |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 |
Current assets: | ||
Cash and cash equivalents | $ 85,433,441 | $ 31,748,686 |
Restricted cash | 350,000 | |
Stock Subscriptions Receivable | 960,033 | |
Prepaid expenses and other current assets | 3,712,861 | 3,724,932 |
Contract asset | 1,618,296 | 2,681,065 |
Total current assets | 92,074,631 | 38,154,683 |
Restricted cash | 669,900 | |
Property and equipment, net | 4,067,837 | 5,083,865 |
Operating lease right of use assets | 5,248,525 | 5,818,983 |
Other assets | 234,038 | 84,968 |
Total assets | 102,294,931 | 49,142,499 |
Current liabilities: | ||
Notes payable | 710,158 | 752,659 |
Accounts payable | 7,381,183 | 11,091,363 |
Accrued expenses | 22,005,432 | 22,447,939 |
Derivative liability | 797,000 | |
Operating lease liabilities, current | 1,004,063 | 595,745 |
Total current liabilities | 31,897,836 | 34,887,706 |
Long-term debt, net of debt discount | 18,029,005 | |
Operating lease liabilities, noncurrent | 7,093,165 | 8,097,228 |
Total liabilities | 57,020,006 | 42,984,934 |
Stockholders’ equity | ||
Preferred stock, $0.0001 par value; 10,000,000 shares authorized, no shares issued and outstanding at December 31, 2020 and 2019 | ||
Common stock, $0.0001 par value; 150,000,000 shares authorized, 98,852,696 and 64,672,893 shares issued and outstanding at December 31, 2020 and 2019, respectively | 9,885 | 6,467 |
Additional paid-in capital | 349,358,378 | 198,975,056 |
Accumulated deficit | (304,093,338) | (192,823,958) |
Total stockholders’ equity | 45,274,925 | 6,157,565 |
Total liabilities and stockholders’ equity | $ 102,294,931 | $ 49,142,499 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2020 | Dec. 31, 2019 |
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 | 150,000,000 | 150,000,000 |
Common stock, shares issued | 98,852,696 | 64,672,893 |
Common stock, shares outstanding | 98,852,696 | 64,672,893 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Income Statement [Abstract] | ||
Revenue from awards and licenses | $ 3,937,230 | $ 36,143,568 |
Operating expenses: | ||
Research and development | 98,267,213 | 89,604,790 |
General and administrative | 28,480,250 | 23,643,357 |
Total operating expenses | 126,747,463 | 113,248,147 |
Operating loss | (122,810,233) | (77,104,579) |
Other income (expense), net: | ||
Other income (expense), net | 13,270,211 | 4,581,838 |
Interest income (expense), net | (1,028,359) | 1,227,643 |
Change in fair value of derivative liability | (251,000) | |
Foreign currency exchange gain (loss) | (449,999) | (158,620) |
Other income, net | 11,540,853 | 5,650,861 |
Net loss | $ (111,269,380) | $ (71,453,718) |
Net loss per share, basic and diluted | $ (1.42) | $ (1.12) |
Weighted average number of common shares outstanding, basic and diluted | 78,133,289 | 63,899,184 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity - USD ($) | Common Stock [Member] | Additional Paid-in Capital [Member] | Retained Earnings [Member] | Total |
Beginning balance, value at Dec. 31, 2018 | $ 5,725 | $ 148,888,635 | $ (121,370,240) | $ 27,524,120 |
Beginning balance, shares at Dec. 31, 2018 | 57,247,496 | |||
Stock-based compensation expense | 11,981,655 | 11,981,655 | ||
Issuance of common stock, net of issuance costs of $6,039,423 | $ 620 | 37,718,078 | 37,718,698 | |
Issuance of common stock, net of issuance costs, shares | 6,198,500 | |||
Issuance of common stock upon exercise of stock options | $ 10 | 386,800 | $ 386,810 | |
Issuance of common stock upon exercise of stock options, shares | 107,029 | 107,029 | ||
Issuance of common stock upon exercise of warrants | $ 112 | (112) | ||
Issuance of common stock upon exercise of warrants, shares | 1,119,868 | |||
Net Loss | (71,453,718) | (71,453,718) | ||
Ending balance, value at Dec. 31, 2019 | $ 6,467 | 198,975,056 | (192,823,958) | 6,157,565 |
Ending balance, shares at Dec. 31, 2019 | 64,672,893 | |||
Stock-based compensation expense | 12,458,229 | 12,458,229 | ||
Issuance of common stock, net of issuance costs of $6,039,423 | $ 3,375 | 136,361,526 | 136,364,901 | |
Issuance of common stock, net of issuance costs, shares | 33,752,192 | |||
Issuance of common stock upon exercise of stock options | $ 43 | 756,418 | $ 756,461 | |
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 | $ 9,885 | $ 349,358,378 | $ (304,093,338) | $ 45,274,925 |
Ending balance, shares at Dec. 31, 2020 | 98,852,696 |
Consolidated Statements of St_2
Consolidated Statements of Stockholders' Equity (Parenthetical) - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Statement of Stockholders' Equity [Abstract] | ||
Stock issuance cost | $ 6,039,423 | $ 2,571,552 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Cash flows from operating activities: | ||
Net loss | $ (111,269,380) | $ (71,453,718) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation expense | 12,458,229 | 11,981,655 |
Depreciation and amortization | 1,123,854 | 739,378 |
Loss on foreign exchange | 93,661 | 45,833 |
Operating lease right of use asset amortization | 570,458 | 490,406 |
Amortization of debt discount | 291,392 | |
Change in fair value of derivative liability | 251,000 | |
Changes in operating assets and liabilities: | ||
Decrease in customer receivable | 5,000,000 | |
Decrease (increase) in prepaid expenses | 346,812 | (1,233,088) |
Decrease (increase) contract asset | 1,062,769 | (2,681,065) |
Increase in other assets | (149,070) | (41,145) |
Increase (decrease) in accounts payable | (3,468,917) | 4,366,439 |
Increase (decrease) in accrued expenses | (400,766) | 12,555,384 |
Decrease in deferred revenue | (6,462,503) | |
Increase (decrease) in operating lease liabilities | (595,745) | 971,696 |
Net cash used in operating activities | (99,685,703) | (45,720,728) |
Cash flows from investing activities: | ||
Purchases of property and equipment | (484,491) | (2,742,541) |
Net cash used in investing activities | (484,491) | (2,742,541) |
Cash flows from financing activities: | ||
Proceeds from issuance of short-term borrowings | 909,375 | 963,514 |
Proceeds from issuance of long-term borrowings | 18,756,021 | |
Repayment of short-term borrowings | (951,876) | (605,160) |
Proceeds from issuance of common stock | 142,200,752 | 40,677,060 |
Issuance costs paid for common stock financings | (6,039,423) | (2,571,552) |
Principal payments under capital lease obligations | (375) | |
Net cash provided by financing activities | 154,874,849 | 38,463,487 |
Net increase (decrease) in cash, cash equivalents, and restricted cash | 54,704,655 | (9,999,782) |
Cash, cash equivalents, and restricted cash at beginning of the year | 31,748,686 | 41,748,468 |
Cash, cash equivalents and restricted cash at end of the year | 86,453,341 | 31,748,686 |
Supplemental disclosure of cash flow information and non cash transactions: | ||
Cash paid during the period for interest | 629,146 | 29,448 |
Fair value of warrants issued in loan agreement | 472,409 | |
Fair value of warrants issued | 334,740 | |
Write-off of fully depreciated property and equipment | 156,645 | |
Purchases of property and equipment included in accounts payable or accrued expenses | 376,664 | |
Right of use assets obtained in exchange for lease obligation upon adoption of ASU 2016-02, net of deferred rent | 2,399,524 | |
Right of use assets obtained in exchange for lease obligation upon entry into lease agreements | $ 3,909,865 | |
Stock subscription receivable | $ 960,033 |
NATURE OF OPERATIONS
NATURE OF OPERATIONS | 12 Months Ended |
Dec. 31, 2020 | |
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 a clinical-stage pharmaceutical company focused on the development and commercialization of novel therapeutics that target the endocannabinoid or immune system. The Company intends to pursue indications for our novel therapeutics that are autoimmune, fibrotic, or metabolic diseases, or cancer. The Company is developing a diverse pipeline of drug candidates and plan to expand our 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. In response to the spread of COVID-19, the Company has taken temporary precautionary measures intended to help minimize the risk of the virus to its employees and community, including temporarily requiring employees to work remotely, implementing remote monitoring procedures for clinical data and suspending all non-essential travel worldwide for its employees. 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, 2020 | |
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, 2020, had an accumulated deficit of $ 304,094,000 85,433,000 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. On February 11, 2020, the Company consummated an underwritten public offering of shares of its common stock (“February 2020 Offering”) (See Note 11). On April 7, 2020, the Company entered into an Open Market Sale Agreement SM 75,000,000 10,539,374 75,000,000 2,250,000 In June 2020, the Company became entitled to receive $ 5,000,000 25,000,000 5,000,000 2.5 On July 28, 2020, the Company entered into the Loan Agreement with its subsidiary, Corbus Pharmaceuticals, Inc., as borrower, the Company, as guarantor, each lender party thereto (the “Lenders”), K2 HealthVentures LLC (“K2HV”), an unrelated third party, as administrative agent for the Lenders, and Ankura Trust Company, LLC, an unrelated third party, as collateral agent for the Lenders, pursuant to which K2HV may provide the Company with term loans in an aggregate principal amount of up to a $ 50,000,000 20,000,000 On August 7, 2020, the Company entered into an Open Market Sale Agreement SM 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 common stock pursuant to the August 2020 Sale Agreement. 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 . The Company has sold an additional 25,391,710 58,861,000 subsequent to December 31, 2020. (See note 11 and 14) |
SIGNIFICANT ACCOUNTING POLICIES
SIGNIFICANT ACCOUNTING POLICIES | 12 Months Ended |
Dec. 31, 2020 | |
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 9), the valuation of the CFF and K2HV warrants discussed in Note 13 and Note 7, and the derivative liability associated with the K2 Security and Loan agreement (see Note 14). Cash and Cash Equivalents 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. Marketable investments are those with original maturities in excess of three months. At December 31, 2020 and 2019, cash equivalents were comprised of money market funds. The Company had no Restricted cash as of December 31, 2020 included a collateral account for the Company’s corporate credit cards and is classified in current assets in the amount of $ 250,000 769,900 100,000 669,900 Cash and cash equivalents consists of the following : SCHEDULE OF CASH AND CASH EQUIVALENTS 2020 2019 December 31, 2020 2019 Cash $ 1,825,784 $ 884,115 Money market fund 83,607,657 30,864,571 Total cash and cash equivalents $ 85,433,441 $ 31,748,686 Restricted cash, current 350,000 — Restricted cash, noncurrent 669,900 — Total restricted cash 1,019,900 — Total cash, cash equivalents, and restricted cash shown in the statement of cash flows $ 86,453,341 $ 31,748,686 As of December 31, 2020, all of the Company’s cash and cash equivalents was held in the United States, except for approximately $ 1,033,000 466,000 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. In accordance with ASC 815 “Accounting for Derivative Instruments and Hedging Activities 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 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. 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, 2020 and 2019, 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. 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 to treat rare life-threatening inflammatory and fibrotic diseases. As of December 31, 2020, all of the Company’s assets were located in the United States, except for approximately $ 1,033,000 1,837,000 23,000 466,000 1,629,000 52,000 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% 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 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. No 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 to employees 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. 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, 2020 and 2019: SCHEDULE OF COMPUTATION OF NET LOSS PER COMMON SHARE Years Ended December 31, 2020 2019 Basic and diluted net loss per share of common stock: Net loss $ (111,269,380 ) $ (71,453,718 ) Weighted average shares of common stock outstanding 78,133,289 63,899,184 Net loss per share of common stock-basic and diluted $ (1.42 ) $ (1.12 ) The impact of the following potentially dilutive securities outstanding as of December 31, 2020 and 2019 have been excluded from the computation of dilutive weighted average shares outstanding as the inclusion would be antidilutive. SCHEDULE OF ANTIDILUTIVE SECURITIES EXCLUDED FROM COMPUTATION OF NET LOSS PER COMMON SHARE December 31, 2020 2019 Warrants 1,506,206 1,000,000 Stock options 14,289,643 13,245,366 15,795,849 14,245,366 Recent Accounting Pronouncements The Company considers applicability and impact of all Accounting Standard Updates (“ASUs”). ASUs not discussed below were assessed and determined to be either not applicable or are expected to have minimal impact on the Company’s balance sheets or statements of operations. Collaborative Arrangements In November 2018, the FASB issued ASU 2018-18, Collaborative Arrangements (Topic 808): Clarifying the Interaction between Topic 808 and Topic 606 Accounting for Income Taxes In December 2019, the FASB issued ASU 2019-12 , Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity 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 |
LICENSE AGREEMENT
LICENSE AGREEMENT | 12 Months Ended |
Dec. 31, 2020 | |
License Agreement | |
LICENSE AGREEMENT | 4. LICENSE AGREEMENT 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 18.4 In January 2017, the FASB issued ASU 2017-01, Business Combinations (Topic 805): Clarifying the Definition of a Business 250,000 18.4 |
PROPERTY AND EQUIPMENT
PROPERTY AND EQUIPMENT | 12 Months Ended |
Dec. 31, 2020 | |
Property, Plant and Equipment [Abstract] | |
PROPERTY AND EQUIPMENT | 5. PROPERTY AND EQUIPMENT Property and Equipment consisted of the following: SUMMARY OF PROPERTY AND EQUIPMENT December 31, 2020 2019 Computer hardware and software $ 626,328 $ 711,442 Office furniture and equipment 1,626,491 1,627,896 Leasehold improvements 4,163,860 4,150,488 Property and equipment, gross 6,416,679 6,489,826 Less: accumulated depreciation (2,348,842 ) (1,405,961 ) Property and equipment, net $ 4,067,837 $ 5,083,865 Depreciation expense was approximately $ 1,124,000 739,000 |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 12 Months Ended |
Dec. 31, 2020 | |
Commitments and Contingencies Disclosure [Abstract] | |
COMMITMENTS AND CONTINGENCIES | 6. 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 seven years 470,000 908,000 1,080,000 400,000 300,000 200,000 400,000 The Company adopted ASU 2016-02, Leases (Topic 842), 3,811,000 2,400,000 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 On February 26, 2019, the Company amended its lease (“February 2019 Lease Agreement”) pursuant to which an additional 30,023 62,756 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%. 855,000 2,700,000 Per the terms of the February 2019 Lease Agreement, the landlord agreed to reimburse the Company for approximately $ 991,000 369,900 277,425 184,950 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 63,256 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 8 381,000 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, 2020 and 2019: SCHEDULE OF LEASE COSTS 2020 2019 Lease cost Operating lease cost $ 1,240,473 1,025,899 Total lease cost $ 1,240,473 1,025,899 Other information Weighted average remaining lease term 5.9 6.9 Weighted average discount rate 8.00 % 8.00 % Total rent expense for the years ended December 31, 2020 and 2019 was $ 1,240,473 1,025,899 Pursuant to the terms of the Company’s non-cancelable lease agreements in effect at December 31, 2020, the following table summarizes the Company’s maturities of operating lease liabilities as of December 31, 2020: Year ending December 31, 2020: SCHEDULE OF MATURITIES OF OPERATING LEASE LIABILITIES December 31, 2020 2021 $ 1,605,121 2022 1,652,563 2023 1,700,005 2024 1,747,447 2025 1,794,889 Thereafter 1,688,145 Total lease payments $ 10,188,170 Less: imputed interest $ (2,090,942 ) Total $ 8,097,228 For commitments under the Company’s development award agreements- see Note 9. |
NOTES PAYABLE
NOTES PAYABLE | 12 Months Ended |
Dec. 31, 2020 | |
Debt Disclosure [Abstract] | |
NOTES PAYABLE | 7. NOTES PAYABLE D&O Financing In November 2019, the Company entered into a loan agreement with a financing company for $ 963,514 109,413 nine-month period 5.25 In November 2020, the Company entered into a loan agreement with a financing company for $ 909,375 103,112 nine-month period 4.89 1,010,000 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 20,000,000 20,000,000 10,000,000 The loan matures on August 1, 2024 8.5 8.5 5,000,000 9.40 In connection with the Loan Agreement, on July 28, 2020, the Company issued the Lenders a warrant to purchase up to 86,206 6.96 472,000 546,000 1,244,000 1,190,000 The total principal amount of the loan under the Loan Agreement outstanding at December 31, 2020, including the $ 1,190,000 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 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, 2020, the fair value of our outstanding debt, which is considered Level 3 in the fair value hierarchy, is estimated to be approximately $ 18,029,005 . Interest expense for the year ended December 31, 2020 was approximately $ 1,126,534 . No interest expense or amortization of debt discount recorded in 2019 related to the Loan Agreement. The net carrying amounts of the liability components consists of the following: SCHEDULE OF NOTES PAYABLE December 31, 2020 Principal $ 20,000,000 Less: debt discount (2,262,388 ) Accretion of Debt Discount 291,393 Net Carrying amount $ 18,029,005 The following table summarizes the future principal payments due under long-term debt; SCHEDULE OF PRINCIPAL MATURITIES ON LONG TERM DEBT December 31, 2020 Principal Payments and final payment on Loan Agreement 2021 $ - 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, 2020 | |
Payables and Accruals [Abstract] | |
ACCRUED EXPENSES | 8. ACCRUED EXPENSES Accrued expenses consisted of the following: SCHEDULE OF ACCRUED EXPENSES 2020 2019 December 31, 2020 2019 Accrued clinical operations and trials costs $ 14,132,842 $ 14,242,669 Accrued product development costs 2,189,047 3,573,231 Accrued compensation 4,222,594 3,673,111 Accrued other 1,460,949 958,928 Total $ 22,005,432 $ 22,447,939 |
DEVELOPMENT AWARDS AND DEFERRED
DEVELOPMENT AWARDS AND DEFERRED REVENUE | 12 Months Ended |
Dec. 31, 2020 | |
Revenue from Contract with Customer [Abstract] | |
DEVELOPMENT AWARDS AND DEFERRED REVENUE | 9. DEVELOPMENT AWARDS AND DEFERRED REVENUE Collaboration with Kaken On January 3, 2019, the Company entered into a Collaboration and License Agreement (the “Agreement”) with Kaken Pharmaceutical Co., Ltd., a company organized under the laws of Japan (“Kaken”). Pursuant to the Agreement, Corbus granted Kaken an exclusive license to commercialize pharmaceutical preparations containing lenabasum (the “Licensed Products”) for the prevention or treatment of dermatomyositis and systemic sclerosis (together, the “Initial Indications”) in Japan (the “Territory”). Pursuant to the terms of the Agreement, Corbus will bear the cost of, and be responsible for, among other things, conducting the clinical studies and other developmental activities for the Licensed Products in the Initial Indications in the Territory, and Kaken will bear the cost of, and be responsible for, among other things, preparing and filing applications for regulatory approval in the Territory and for commercializing Licensed Products in the Territory, and will use commercially reasonable efforts to commercialize Licensed Products and obtain pricing approval for Licensed Products in the Territory. In consideration of the license and other rights granted by Corbus, Kaken paid to Corbus in March 2019 a $ 27,000,000 173,000,000 The Agreement will remain in effect on a Licensed Product-by-Licensed product basis and will expire upon the expiration of the Royalty Term for the final Licensed Product. The “Royalty Term” means the period beginning on the date of the first commercial sale of the Licensed Product in Japan and ends on the latest of (i) the expiration of the last valid claim of the royalty patents covering such Licensed Product in Japan, (ii) the expiration of regulatory exclusivity for such Licensed Product for such Initial Indication in Japan, or (iii) ten (10) years after the first commercial sale of such Licensed Product for such Initial Indication in Japan. The Agreement may be terminated by either party for material breach, upon a party’s insolvency or bankruptcy or upon a challenge by one party of any patents of the other party, and Kaken may terminate in specified situations, including for a safety concern or clinical failure, or at its convenience following the second anniversary of the first commercial sale of a Licensed Product in either of the Initial Indications in the Territory, with 180 days’ notice. Pursuant to the Agreement, the parties agreed to develop a joint steering committee to provide strategic oversight of the parties’ activities under the Agreement, as well as a joint development committee to coordinate the development of Licensed Products in Japan. Additionally, the parties will establish a joint commercialization committee to review and confirm commercialization activities with respect to Licensed Products in Japan upon regulatory approval of such Licensed Product. The Agreement also contains customary representations, warranties and covenants by both parties, as well as customary provisions relating to indemnification, confidentiality and other matters. The Company assessed this arrangement in accordance with U.S. GAAP and concluded that the contract counterparty, Kaken, is a customer. The Company identified the following material promises under the arrangement: (1) the exclusive license to commercialize lenabasum; (2) the product’s initial know-how transfer; (3) election to use the product trademarks; (4) the sharing of data gathered through the execution of the Global Development Plan for the Initial Indications; and (5) Japanese Pharmaceuticals and Medical Devices Agency (“PMDA”)-required supplemental studies. The Company identified two performance obligations; (1) the combined performance obligation of the License, initial know-how transfer and license to the Company’s product trademarks; and (2) the sharing of data gathered through the execution of the Global Development Plan (as defined in the Agreement) for the Initial Indications. The Company determined that the license and initial know-how transfer were not distinct from another in the context of the contract, as initial know-how transfer is highly interrelated to the license and Kaken would incur significant costs to re-create the know-how of the Company. The Company determined that the election to use the product trademarks license contributes to the exclusivity of the license and, therefore, is combined with the license. The PMDA-required supplemental study is a contingent promise although not a performance obligation as the promise does not provide Kaken with a material right. Under the Agreement, in order to evaluate the appropriate transaction price, the Company determined that the upfront amount of $ 27,000,000 The Company estimated the stand-alone selling price of each performance obligation using a market approach and allocated the transaction price on a relative basis. This allocation resulted in a de minimis value attributable to the obligation to sharing of data gathered through the execution of the Global Development Plan for the Initial Indications and effectively all of the value to the combined license, initial know-how transfer and license to product trademarks. Therefore, the full upfront payment of $ 27,000,000 is allocated to the combined performance obligation of the license, initial technology transfer and license to the product trademarks. The Company received the upfront payment of $ 27,000,000 27,000,000 The Company was required to make a $ 2,700,000 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 $ 22.5 million in the aggregate through December 31, 2020 upon the Company’s achievement of milestones related to the progress of the Phase 2b Clinical Trial, as set forth in the Investment Agreement. The Company expects that the $ 2.5 million remainder of the 2018 CFF Award will be paid upon the Company’s achievement of the final milestone related to the progress of the Phase 2b Clinical Trial, as set forth in the Investment Agreement, and the Company expects to receive the remainder before the end of the first half of 2021. 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 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 13.20 500,000 500,000 January 26, 2025 Under the Investment Agreement, the Company recorded $ 3,937,230 9,143,568 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 6,215,225 18,784,775 The Company has invoiced and received $ 22,500,000 so far in milestone payments including $ 12,500,000 in 2018, $ 5,000,000 in 2019 and $ 5,000,000 in 2020. A roll forward of deferred revenue related to the Investment Agreement for the year ended December 31, 2020 is presented below. SCHEDULE OF ROLL FORWARD OF DEFERRED REVENUE December 31, 2020 Beginning balance, December 31, 2019 $ — Invoicing to CFF upon achievement of milestones 5,000,000 Recognition of revenue (3,937,230 ) Reclassification to contract asset (1,062,770 ) Ending balance, December 31, 2020 $ — The CFF Warrant is accounted for as a payment to the customer. See Note 13 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 are expected to be performed over approximately three years and is expected to be completed in the first half of 2021. The amounts received that have not yet been recognized as revenue are recorded in deferred revenue and the amounts recognized as revenue, but not yet received or invoiced are generally recognized as a contract asset on the Company’s condensed consolidated balance sheet. |
INCOME TAXES
INCOME TAXES | 12 Months Ended |
Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | |
INCOME TAXES | 10. 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, 2020 and 2019, the Company had federal net operating loss carryforwards of approximately $ 167,399,000 and $ 99,754,000 , respectively, of which federal carryforwards will expire in varying amounts beginning in 2029 . Of the federal net operating loss carryforwards of $167,399,000, approximately $ 111,047,000 are from 2018, 2019, and 2020 have no expiration date, and are limited to 80 % of taxable income. At December 31, 2020 and 2019, the Company had Massachusetts net operating loss carryforwards of approximately $ 161,143,000 and $ 94,884,000 , 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, 2020 and 2019 of approximately $ 9,233,000 and $ 6,031,000 , respectively. In the second half of 2020, the Company received from a foreign taxing authority, an approximate aggregate $ 13.7 13.7 Significant components of the Company’s net deferred tax asset are as follows: SCHEDULE OF COMPONENTS OF NET DEFERRED TAX ASSET 2020 2019 December 31, 2020 2019 NOL carryforward $ 45,360,175 $ 26,945,090 Foreign net operating loss carryforward 10,532,490 10,875,395 Tax credits 8,843,792 5,844,918 Stock based compensation 7,354,531 5,373,539 Accrued expenses 1,202,538 1,120,196 Other temporary differences 1,152,853 962,981 Subtotal 74,446,379 51,122,119 Valuation allowance (74,446,379 ) (51,122,119 ) 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 $ 23,324,000 and $ 18,210,000 in 2020 and 2019, 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, 2020 and 2019 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: SCHEDULE OF EFFECTIVE INCOME TAX RATE RECONCILIATION 2020 2019 December 31, 2020 2019 Tax provision at statutory rate 21.00 % 21.00 % State taxes, net of federal benefit 5.83 % 5.25 % Permanent differences -1.35 % -2.76 % Foreign expected tax 7.37 % 21.76 % Tax credits 4.03 % 8.82 % Income tax rate change 0.02 % 0.07 % Other -8.12 % 0.45 % Decrease in valuation reserve -28.78 % -54.59 % Total 0.00 % 0.00 % |
COMMON STOCK
COMMON STOCK | 12 Months Ended |
Dec. 31, 2020 | |
Equity [Abstract] | |
COMMON STOCK | 11. COMMON STOCK The Company has authorized 150,000,000 0.0001 98,852,696 64,672,893 On January 30, 2019, the Company consummated an underwritten public offering of shares of its common stock pursuant to which the Company sold an aggregate of 6,198,500 808,500 6.50 40,300,000 2,600,000 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 1,000,000 6.00 46,000,000 3,147,000 On April 7, 2020, the Company entered into 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 75,000,000 10,539,374 75,000,000 2,250,000 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 15,546,151 21,404,000 642,000 During the year ended December 31, 2020 and 2019, the Company issued 427,611 107,029 756,000 387,000 No 1,283,500 1,119,868 |
STOCK OPTIONS
STOCK OPTIONS | 12 Months Ended |
Dec. 31, 2020 | |
Share-based Payment Arrangement [Abstract] | |
STOCK OPTIONS | 12. 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 4,527,103 7 23,070,842 7,369,051 4 10 In accordance with the terms of the 2014 Plan, effective as of January 1, 2021, the number of shares of common stock available for issuance under the 2014 Plan increased by 2,500,000 7 25,570,842 9,869,051 Share-based Compensation For stock options issued and outstanding for the years ended December 31, 2020 and 2019, the Company recorded non-cash, stock-based compensation expense of $ 12,458,229 11,981,655 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 The weighted average assumptions used principally in determining the fair value of options granted were as follows: SUMMARY OF FAIR VALUE OF OPTIONS GRANTED 2020 2019 Risk free interest rate 0.59 % 2.33 % Expected dividend yield 0 % 0 % Expected term in years 6.25 6.25 Expected volatility 83.56 % 86.98 % Estimated forfeiture rate 6.02 % 4.85 % A summary of option activity for years ended December 31, 2020 and 2019 is presented below: SUMMARY OF OPTION ACTIVITY Options Shares Weighted Weighted Intrinsic Outstanding at December 31, 2018 9,593,990 $ 4.51 Granted 4,125,800 $ 6.91 Exercised (107,029 ) $ 3.61 Forfeited (367,395 ) $ 7.10 Outstanding at December 31, 2019 13,245,366 $ 5.19 Outstanding at December 31, 2020 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 6.59 $ 3,500,516 Exercisable at December 31, 2020 9,952,349 $ 4.86 5.67 $ 3,417,266 Vested and expected to vest at December 31, 2020 13,984,246 $ 5.15 6.54 $ 3,487,159 The weighted average grant-date fair value of options granted during the years ended December 31, 2020 and 2019 was $ 3.53 5.03 1,235,676 324,567 14,664,483 2.35 As summary of non-vested stock options for the years ended December 31, 2020 and 2019 is presented below: SUMMARY OF NON-VESTED STOCK OPTIONS Options Shares Weighted Non-vested at December 31, 2018 3,626,289 $ 5.32 Granted 4,125,800 $ 5.03 Vested (2,038,128 ) $ 4.95 Forfeited (304,689 ) $ 5.22 Nonvested at December 31, 2019 5,409,272 $ 5.21 Non-vested at 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 Non-vested at December 31, 2020 4,337,294 $ 4.14 |
WARRANTS
WARRANTS | 12 Months Ended |
Dec. 31, 2020 | |
Warrants | |
WARRANTS | 13. WARRANTS No 1,283,500 1,119,868 At December 31, 2020, 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 4.6 years, related to the warrants issued to CFF pursuant to the terms of the Investment Agreement (Note 9) warrants issued to a consultant for investor relations services and the warrants issued pursuant to the K2 Loan and Security Agreement (Note 7). The Company issued a warrant to CFF to purchase an aggregate of 1,000,000 13.20 500,000 January 26, 2025 6,215,225 SCHEDULE OF WEIGHTED AVERAGE ASSUMPTION OF WARRANTS Risk free interest rate 2.60 % Expected dividend yield 0 % 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 20,000,000 86,206 6.96 July 28, 2030 472,409 SCHEDULE OF WEIGHTED AVERAGE ASSUMPTION OF WARRANTS Risk free interest rate 0.60 % Expected dividend yield 0 % 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 1.07 334,740 SCHEDULE OF WEIGHTED AVERAGE ASSUMPTION OF WARRANTS Risk free interest rate 0.90 % Expected dividend yield 0 % Expected term in years 5.00 Expected volatility 100.6 % |
DERIVATIVE LIABILITY
DERIVATIVE LIABILITY | 12 Months Ended |
Dec. 31, 2020 | |
Derivative Instruments and Hedging Activities Disclosure [Abstract] | |
DERIVATIVE LIABILITY | 14. DERIVATIVE LIABILITY On July 28, 2020, the Company, with its subsidiary, Corbus Pharmaceuticals, Inc., as borrower, entered into a $ 50,000,000 20,000,000 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 increased from July 28, 2020 to December 31, 2020 as a result of SSc-002 phase 3 and CF-002 phase 2 trial results. 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 increased from July 28, 2020 to December 30, 2020. As the probability of both features increased the fair value of the derivative liability has increased at December 31, 2020. The value of these features was determined to be approximately $ 546,000 797,000 251,000 A roll forward of the fair value of the derivative liability for the year ended December 31, 2020 is presented below. SCHEDULE OF FAIR VALUE OF DERIVATIVE LIABILITY December 31, 2020 Beginning balance, December 31, 2019 $ — Initial measurement of fair value 546,000 Change in fair value of derivative liability 251,000 Ending balance, December 31, 2020 $ 797,000 |
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS | 12 Months Ended |
Dec. 31, 2020 | |
Subsequent Events [Abstract] | |
SUBSEQUENT EVENTS | 15. 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 2,500,000 7 25,570,842 9,869,051 Sales of Stock The Company has sold an additional 25,391,710 shares of our common stock under the August 2020 Sale Agreement for net proceeds of approximately $ 58,861,000 subsequent to December 31, 2020. |
SIGNIFICANT ACCOUNTING POLICI_2
SIGNIFICANT ACCOUNTING POLICIES (Policies) | 12 Months Ended |
Dec. 31, 2020 | |
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 9), the valuation of the CFF and K2HV warrants discussed in Note 13 and Note 7, and the derivative liability associated with the K2 Security and Loan agreement (see Note 14). |
Cash and Cash Equivalents | Cash and Cash Equivalents 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. Marketable investments are those with original maturities in excess of three months. At December 31, 2020 and 2019, cash equivalents were comprised of money market funds. The Company had no Restricted cash as of December 31, 2020 included a collateral account for the Company’s corporate credit cards and is classified in current assets in the amount of $ 250,000 769,900 100,000 669,900 Cash and cash equivalents consists of the following : SCHEDULE OF CASH AND CASH EQUIVALENTS 2020 2019 December 31, 2020 2019 Cash $ 1,825,784 $ 884,115 Money market fund 83,607,657 30,864,571 Total cash and cash equivalents $ 85,433,441 $ 31,748,686 Restricted cash, current 350,000 — Restricted cash, noncurrent 669,900 — Total restricted cash 1,019,900 — Total cash, cash equivalents, and restricted cash shown in the statement of cash flows $ 86,453,341 $ 31,748,686 As of December 31, 2020, all of the Company’s cash and cash equivalents was held in the United States, except for approximately $ 1,033,000 466,000 |
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. In accordance with ASC 815 “Accounting for Derivative Instruments and Hedging Activities 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 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. |
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, 2020 and 2019, 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. |
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 to treat rare life-threatening inflammatory and fibrotic diseases. As of December 31, 2020, all of the Company’s assets were located in the United States, except for approximately $ 1,033,000 1,837,000 23,000 466,000 1,629,000 52,000 |
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% 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 |
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. No |
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 to employees 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. |
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, 2020 and 2019: SCHEDULE OF COMPUTATION OF NET LOSS PER COMMON SHARE Years Ended December 31, 2020 2019 Basic and diluted net loss per share of common stock: Net loss $ (111,269,380 ) $ (71,453,718 ) Weighted average shares of common stock outstanding 78,133,289 63,899,184 Net loss per share of common stock-basic and diluted $ (1.42 ) $ (1.12 ) The impact of the following potentially dilutive securities outstanding as of December 31, 2020 and 2019 have been excluded from the computation of dilutive weighted average shares outstanding as the inclusion would be antidilutive. SCHEDULE OF ANTIDILUTIVE SECURITIES EXCLUDED FROM COMPUTATION OF NET LOSS PER COMMON SHARE December 31, 2020 2019 Warrants 1,506,206 1,000,000 Stock options 14,289,643 13,245,366 15,795,849 14,245,366 |
Recent Accounting Pronouncements | Recent Accounting Pronouncements The Company considers applicability and impact of all Accounting Standard Updates (“ASUs”). ASUs not discussed below were assessed and determined to be either not applicable or are expected to have minimal impact on the Company’s balance sheets or statements of operations. Collaborative Arrangements In November 2018, the FASB issued ASU 2018-18, Collaborative Arrangements (Topic 808): Clarifying the Interaction between Topic 808 and Topic 606 Accounting for Income Taxes In December 2019, the FASB issued ASU 2019-12 , Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity 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 |
SIGNIFICANT ACCOUNTING POLICI_3
SIGNIFICANT ACCOUNTING POLICIES (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Accounting Policies [Abstract] | |
SCHEDULE OF CASH AND CASH EQUIVALENTS | Cash and cash equivalents consists of the following : SCHEDULE OF CASH AND CASH EQUIVALENTS 2020 2019 December 31, 2020 2019 Cash $ 1,825,784 $ 884,115 Money market fund 83,607,657 30,864,571 Total cash and cash equivalents $ 85,433,441 $ 31,748,686 Restricted cash, current 350,000 — Restricted cash, noncurrent 669,900 — Total restricted cash 1,019,900 — Total cash, cash equivalents, and restricted cash shown in the statement of cash flows $ 86,453,341 $ 31,748,686 |
SCHEDULE OF COMPUTATION OF NET LOSS PER COMMON SHARE | SCHEDULE OF COMPUTATION OF NET LOSS PER COMMON SHARE Years Ended December 31, 2020 2019 Basic and diluted net loss per share of common stock: Net loss $ (111,269,380 ) $ (71,453,718 ) Weighted average shares of common stock outstanding 78,133,289 63,899,184 Net loss per share of common stock-basic and diluted $ (1.42 ) $ (1.12 ) |
SCHEDULE OF ANTIDILUTIVE SECURITIES EXCLUDED FROM COMPUTATION OF NET LOSS PER COMMON SHARE | The impact of the following potentially dilutive securities outstanding as of December 31, 2020 and 2019 have been excluded from the computation of dilutive weighted average shares outstanding as the inclusion would be antidilutive. SCHEDULE OF ANTIDILUTIVE SECURITIES EXCLUDED FROM COMPUTATION OF NET LOSS PER COMMON SHARE December 31, 2020 2019 Warrants 1,506,206 1,000,000 Stock options 14,289,643 13,245,366 15,795,849 14,245,366 |
PROPERTY AND EQUIPMENT (Tables)
PROPERTY AND EQUIPMENT (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Property, Plant and Equipment [Abstract] | |
SUMMARY OF PROPERTY AND EQUIPMENT | Property and Equipment consisted of the following: SUMMARY OF PROPERTY AND EQUIPMENT December 31, 2020 2019 Computer hardware and software $ 626,328 $ 711,442 Office furniture and equipment 1,626,491 1,627,896 Leasehold improvements 4,163,860 4,150,488 Property and equipment, gross 6,416,679 6,489,826 Less: accumulated depreciation (2,348,842 ) (1,405,961 ) Property and equipment, net $ 4,067,837 $ 5,083,865 |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
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, 2020 and 2019: SCHEDULE OF LEASE COSTS 2020 2019 Lease cost Operating lease cost $ 1,240,473 1,025,899 Total lease cost $ 1,240,473 1,025,899 Other information Weighted average remaining lease term 5.9 6.9 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, 2020, the following table summarizes the Company’s maturities of operating lease liabilities as of December 31, 2020: Year ending December 31, 2020: SCHEDULE OF MATURITIES OF OPERATING LEASE LIABILITIES December 31, 2020 2021 $ 1,605,121 2022 1,652,563 2023 1,700,005 2024 1,747,447 2025 1,794,889 Thereafter 1,688,145 Total lease payments $ 10,188,170 Less: imputed interest $ (2,090,942 ) Total $ 8,097,228 |
NOTES PAYABLE (Tables)
NOTES PAYABLE (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Debt Disclosure [Abstract] | |
SCHEDULE OF NOTES PAYABLE | The net carrying amounts of the liability components consists of the following: SCHEDULE OF NOTES PAYABLE December 31, 2020 Principal $ 20,000,000 Less: debt discount (2,262,388 ) Accretion of Debt Discount 291,393 Net Carrying amount $ 18,029,005 |
SCHEDULE OF PRINCIPAL MATURITIES ON LONG TERM DEBT | The following table summarizes the future principal payments due under long-term debt; SCHEDULE OF PRINCIPAL MATURITIES ON LONG TERM DEBT December 31, 2020 Principal Payments and final payment on Loan Agreement 2021 $ - 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, 2020 | |
Payables and Accruals [Abstract] | |
SCHEDULE OF ACCRUED EXPENSES | Accrued expenses consisted of the following: SCHEDULE OF ACCRUED EXPENSES 2020 2019 December 31, 2020 2019 Accrued clinical operations and trials costs $ 14,132,842 $ 14,242,669 Accrued product development costs 2,189,047 3,573,231 Accrued compensation 4,222,594 3,673,111 Accrued other 1,460,949 958,928 Total $ 22,005,432 $ 22,447,939 |
DEVELOPMENT AWARDS AND DEFERR_2
DEVELOPMENT AWARDS AND DEFERRED REVENUE (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Revenue from Contract with Customer [Abstract] | |
SCHEDULE OF ROLL FORWARD OF DEFERRED REVENUE | SCHEDULE OF ROLL FORWARD OF DEFERRED REVENUE December 31, 2020 Beginning balance, December 31, 2019 $ — Invoicing to CFF upon achievement of milestones 5,000,000 Recognition of revenue (3,937,230 ) Reclassification to contract asset (1,062,770 ) Ending balance, December 31, 2020 $ — |
INCOME TAXES (Tables)
INCOME TAXES (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
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: SCHEDULE OF COMPONENTS OF NET DEFERRED TAX ASSET 2020 2019 December 31, 2020 2019 NOL carryforward $ 45,360,175 $ 26,945,090 Foreign net operating loss carryforward 10,532,490 10,875,395 Tax credits 8,843,792 5,844,918 Stock based compensation 7,354,531 5,373,539 Accrued expenses 1,202,538 1,120,196 Other temporary differences 1,152,853 962,981 Subtotal 74,446,379 51,122,119 Valuation allowance (74,446,379 ) (51,122,119 ) 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: SCHEDULE OF EFFECTIVE INCOME TAX RATE RECONCILIATION 2020 2019 December 31, 2020 2019 Tax provision at statutory rate 21.00 % 21.00 % State taxes, net of federal benefit 5.83 % 5.25 % Permanent differences -1.35 % -2.76 % Foreign expected tax 7.37 % 21.76 % Tax credits 4.03 % 8.82 % Income tax rate change 0.02 % 0.07 % Other -8.12 % 0.45 % Decrease in valuation reserve -28.78 % -54.59 % Total 0.00 % 0.00 % |
STOCK OPTIONS (Tables)
STOCK OPTIONS (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Share-based Payment Arrangement [Abstract] | |
SUMMARY OF FAIR VALUE OF OPTIONS GRANTED | The weighted average assumptions used principally in determining the fair value of options granted were as follows: SUMMARY OF FAIR VALUE OF OPTIONS GRANTED 2020 2019 Risk free interest rate 0.59 % 2.33 % Expected dividend yield 0 % 0 % Expected term in years 6.25 6.25 Expected volatility 83.56 % 86.98 % Estimated forfeiture rate 6.02 % 4.85 % |
SUMMARY OF OPTION ACTIVITY | A summary of option activity for years ended December 31, 2020 and 2019 is presented below: SUMMARY OF OPTION ACTIVITY Options Shares Weighted Weighted Intrinsic Outstanding at December 31, 2018 9,593,990 $ 4.51 Granted 4,125,800 $ 6.91 Exercised (107,029 ) $ 3.61 Forfeited (367,395 ) $ 7.10 Outstanding at December 31, 2019 13,245,366 $ 5.19 Outstanding at December 31, 2020 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 6.59 $ 3,500,516 Exercisable at December 31, 2020 9,952,349 $ 4.86 5.67 $ 3,417,266 Vested and expected to vest at December 31, 2020 13,984,246 $ 5.15 6.54 $ 3,487,159 |
SUMMARY OF NON-VESTED STOCK OPTIONS | As summary of non-vested stock options for the years ended December 31, 2020 and 2019 is presented below: SUMMARY OF NON-VESTED STOCK OPTIONS Options Shares Weighted Non-vested at December 31, 2018 3,626,289 $ 5.32 Granted 4,125,800 $ 5.03 Vested (2,038,128 ) $ 4.95 Forfeited (304,689 ) $ 5.22 Nonvested at December 31, 2019 5,409,272 $ 5.21 Non-vested at 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 Non-vested at December 31, 2020 4,337,294 $ 4.14 |
WARRANTS (Tables)
WARRANTS (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
CFF Warrant [Member] | |
Class of Warrant or Right [Line Items] | |
SCHEDULE OF WEIGHTED AVERAGE ASSUMPTION OF WARRANTS | SCHEDULE OF WEIGHTED AVERAGE ASSUMPTION OF WARRANTS Risk free interest rate 2.60 % Expected dividend yield 0 % Expected term in years 7.00 Expected volatility 83.5 % |
K2 Warrant [Member] | |
Class of Warrant or Right [Line Items] | |
SCHEDULE OF WEIGHTED AVERAGE ASSUMPTION OF WARRANTS | SCHEDULE OF WEIGHTED AVERAGE ASSUMPTION OF WARRANTS Risk free interest rate 0.60 % Expected dividend yield 0 % Expected term in years 10.00 Expected volatility 80.0 % |
Glenridge Warrant [Member] | |
Class of Warrant or Right [Line Items] | |
SCHEDULE OF WEIGHTED AVERAGE ASSUMPTION OF WARRANTS | SCHEDULE OF WEIGHTED AVERAGE ASSUMPTION OF WARRANTS Risk free interest rate 0.90 % Expected dividend yield 0 % Expected term in years 5.00 Expected volatility 100.6 % |
DERIVATIVE LIABILITY (Tables)
DERIVATIVE LIABILITY (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
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, 2020 is presented below. SCHEDULE OF FAIR VALUE OF DERIVATIVE LIABILITY December 31, 2020 Beginning balance, December 31, 2019 $ — Initial measurement of fair value 546,000 Change in fair value of derivative liability 251,000 Ending balance, December 31, 2020 $ 797,000 |
LIQUIDITY (Details Narrative)
LIQUIDITY (Details Narrative) - USD ($) | Jul. 31, 2020 | Apr. 07, 2020 | Jun. 30, 2020 | Mar. 15, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Aug. 07, 2020 | Jul. 28, 2020 |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Accumulated deficit | $ 304,094,000 | |||||||
Cash and cash equivalents | 85,433,000 | |||||||
Proceeds from issuance of common stock | 142,200,752 | $ 40,677,060 | ||||||
Issuance costs incurred | 6,039,423 | $ 2,571,552 | ||||||
Debt face amount | $ 20,000,000 | |||||||
April 2020 Sale Agreement [Member] | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Shares issued | 10,539,374 | |||||||
Proceeds from issuance of common stock | $ 75,000,000 | |||||||
Issuance costs incurred | $ 2,250,000 | |||||||
April 2020 Sale Agreement [Member] | Jefferies LLC [Member] | Maximum [Member] | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Number of common stock shares sold | 75,000,000 | |||||||
Cystic Fibrosis Program Related Investment Agreement [Member] | Phase 2b Clinical trial [Member] | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Consideration payment milestone received | $ 5,000,000 | $ 5,000,000 | ||||||
Proceeds from investments on achieving milestones | $ 25,000,000 | |||||||
Remainder payable upon the achievement of the last remaining milestone | $ 2,500,000 | |||||||
Loan Agreement [Member] | K2 HealthVentures LLC And Ankura Trust Company, LLC [Member] | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Debt face amount | $ 50,000,000 | |||||||
Loan Agreement [Member] | K2 HealthVentures LLC And Ankura Trust Company, LLC [Member] | Tranche One [Member] | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Debt face amount | $ 20,000,000 | |||||||
August 2020 Sale Agreement [Member] | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Shares issued | 15,546,151 | |||||||
Proceeds from issuance of common stock | $ 21,404,000 | |||||||
Issuance costs incurred | $ 642,000 | |||||||
August 2020 Sale Agreement [Member] | Subsequent Event [Member] | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Shares issued | 25,391,710 | |||||||
Proceeds from issuance of common stock | $ 58,861,000 | |||||||
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 |
SCHEDULE OF CASH AND CASH EQUIV
SCHEDULE OF CASH AND CASH EQUIVALENTS (Details) - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 |
Accounting Policies [Abstract] | ||
Cash | $ 1,825,784 | $ 884,115 |
Money market fund | 83,607,657 | 30,864,571 |
Total cash and cash equivalents | 85,433,441 | 31,748,686 |
Restricted cash, current | 350,000 | |
Restricted cash, noncurrent | 669,900 | |
Total restricted cash | 1,019,900 | |
Total cash, cash equivalents, and restricted cash shown in the statement of cash flows | $ 86,453,341 | $ 31,748,686 |
SCHEDULE OF COMPUTATION OF NET
SCHEDULE OF COMPUTATION OF NET LOSS PER COMMON SHARE (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Accounting Policies [Abstract] | ||
Net loss | $ (111,269,380) | $ (71,453,718) |
Weighted average shares of common stock outstanding | 78,133,289 | 63,899,184 |
loss per share of common stock-basic and diluted | $ (1.42) | $ (1.12) |
SCHEDULE OF ANTIDILUTIVE SECURI
SCHEDULE OF ANTIDILUTIVE SECURITIES EXCLUDED FROM COMPUTATION OF NET LOSS PER COMMON SHARE (Details) - shares | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Potential dilutive securities excluded from computation of dilutive weighted average shares outstanding | 15,795,849 | 14,245,366 |
Warrant [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Potential dilutive securities excluded from computation of dilutive weighted average shares outstanding | 1,506,206 | 1,000,000 |
Share-based Payment Arrangement, Option [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Potential dilutive securities excluded from computation of dilutive weighted average shares outstanding | 14,289,643 | 13,245,366 |
SIGNIFICANT ACCOUNTING POLICI_4
SIGNIFICANT ACCOUNTING POLICIES (Details Narrative) - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Marketable investments | $ 0 | $ 0 |
Restricted cash current | 350,000 | |
Restricted cash | 1,019,900 | |
Restricted cash non current | $ 669,900 | |
Property and equipment, estimated useful lives | 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. | |
Cash | $ 1,825,784 | 884,115 |
Prepaid expenses and other current assets | 3,712,861 | 3,724,932 |
Property and equipment, net | $ 4,067,837 | $ 5,083,865 |
Valuation allowance | (28.78%) | (54.59%) |
Uncertain tax positions | $ 0 | $ 0 |
Impairment charges | $ 0 | 0 |
Deferred Tax Assets [Member] | ||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Valuation allowance | 100.00% | |
UNITED KINGDOM | ||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Cash held in subsidiary | $ 1,033,000 | 466,000 |
Cash | 1,033,000 | 466,000 |
Prepaid expenses and other current assets | 1,837,000 | 1,629,000 |
Property and equipment, net | 23,000 | $ 52,000 |
Letter of Credit [Member] | ||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Restricted cash current | 100,000 | |
Restricted cash | 769,900 | |
Restricted cash non current | 669,900 | |
Company's Corporate Credit Cards [Member] | ||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Restricted cash current | $ 250,000 |
LICENSE AGREEMENT (Details Narr
LICENSE AGREEMENT (Details Narrative) - USD ($) | Sep. 20, 2018 | Sep. 30, 2018 | Dec. 31, 2020 |
Research and Development Expense [Member] | |||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Upfront cash payment | $ 250,000 | ||
Potential milestone payments | $ 18,400,000 | ||
Jenrin Agreement [Member] | |||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Upfront cash payment | $ 250,000 | ||
Potential milestone payments | $ 18,400,000 |
SUMMARY OF PROPERTY AND EQUIPME
SUMMARY OF PROPERTY AND EQUIPMENT (Details) - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 |
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 6,416,679 | $ 6,489,826 |
Less: accumulated depreciation | (2,348,842) | (1,405,961) |
Property and equipment, net | 4,067,837 | 5,083,865 |
Computer Hardware and Software [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 626,328 | 711,442 |
Office Furniture and Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 1,626,491 | 1,627,896 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 4,163,860 | $ 4,150,488 |
PROPERTY AND EQUIPMENT (Details
PROPERTY AND EQUIPMENT (Details Narrative) - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Property, Plant and Equipment [Abstract] | ||
Depreciation | $ 1,124,000 | $ 739,000 |
SCHEDULE OF LEASE COSTS (Detail
SCHEDULE OF LEASE COSTS (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Commitments and Contingencies Disclosure [Abstract] | ||
Operating lease cost | $ 1,240,473 | $ 1,025,899 |
Total lease cost | $ 1,240,473 | $ 1,025,899 |
Weighted average remaining lease term | 5 years 10 months 24 days | 6 years 10 months 24 days |
Weighted average discount rate | 8.00% | 8.00% |
SCHEDULE OF MATURITIES OF OPERA
SCHEDULE OF MATURITIES OF OPERATING LEASE LIABILITIES (Details) | Dec. 31, 2020USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
2021 | $ 1,605,121 |
2022 | 1,652,563 |
2023 | 1,700,005 |
2024 | 1,747,447 |
2025 | 1,794,889 |
Thereafter | 1,688,145 |
Total lease payments | 10,188,170 |
Less: imputed interest | (2,090,942) |
Total | $ 8,097,228 |
COMMITMENTS AND CONTINGENCIES_2
COMMITMENTS AND CONTINGENCIES (Details Narrative) | Oct. 25, 2019ft² | Feb. 26, 2019USD ($)ft² | Aug. 21, 2017USD ($)ft² | Dec. 31, 2019USD ($) | Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($) | Jan. 02, 2019USD ($) |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||||
Operating lease liability | $ 8,097,228 | ||||||
Operating lease, right of use asset | $ 5,818,983 | 5,248,525 | $ 5,818,983 | ||||
Increase in operating lease liabilities | (595,745) | 971,696 | |||||
Lease expenses | $ 1,240,473 | $ 1,025,899 | |||||
Accounting Standards Update 2016-02 [Member] | |||||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||||
Operating lease liability | $ 3,811,000 | ||||||
Operating lease, right of use asset | $ 2,400,000 | ||||||
August 2017 Lease Agreement [Member] | |||||||
New Accounting Pronouncements or Change in Accounting Principle [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] | |||||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||||
Rent expense | 470,000 | ||||||
August 2017 Lease Agreement [Member] | Seventh Year [Member] | |||||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||||
Rent expense | 908,000 | ||||||
August 2017 Lease Agreement [Member] | Third Anniversary [Member] | |||||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||||
Irrevocable letter of credit | 300,000 | ||||||
August 2017 Lease Agreement [Member] | Fourth Anniversary [Member] | |||||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||||
Irrevocable letter of credit | $ 200,000 | ||||||
February 2019 Lease Agreement [Member] | |||||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||||
Leasehold improvements | $ 991,000 | ||||||
Irrevocable letter of credit | 369,900 | ||||||
Operating lease liability | 855,000 | ||||||
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] | |||||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||||
Area of office space | ft² | 30,023 | ||||||
Operating lease liability | $ 2,700,000 | ||||||
Operating lease, right of use asset | $ 2,700,000 | ||||||
February 2019 Lease Agreement [Member] | Total Premises [Member] | |||||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||||
Area of office space | ft² | 62,756 | ||||||
February 2019 Lease Agreement [Member] | Not In Default On Third Anniversary [Member] | |||||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||||
Irrevocable letter of credit | $ 277,425 | ||||||
February 2019 Lease Agreement [Member] | Not In Default On Fourth Anniversary [Member] | |||||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||||
Irrevocable letter of credit | $ 184,950 | ||||||
October 2019 Lease Amendment [Member] | |||||||
New Accounting Pronouncements or Change in Accounting Principle [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 operating lease liabilities | 381,000 | ||||||
Increase in right of use assets | $ 381,000 | ||||||
October 2019 Lease Amendment [Member] | Total Premises [Member] | |||||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||||
Area of office space | ft² | 63,256 | ||||||
October 2019 Lease Amendment [Member] | Amended Premises [Member] | |||||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||||
Area of office space | ft² | 500 |
SCHEDULE OF NOTES PAYABLE (Deta
SCHEDULE OF NOTES PAYABLE (Details) | Dec. 31, 2020USD ($) |
Debt Disclosure [Abstract] | |
Principal | $ 20,000,000 |
Less: debt discount | (2,262,388) |
Accretion of Debt Discount | 291,393 |
Net Carrying amount | $ 18,029,005 |
SCHEDULE OF PRINCIPAL MATURITIE
SCHEDULE OF PRINCIPAL MATURITIES ON LONG TERM DEBT (Details) | Dec. 31, 2020USD ($) |
Debt Disclosure [Abstract] | |
2021 | |
2022 | 3,093,344 |
2023 | 9,835,341 |
2024 | 8,261,315 |
Total | $ 21,190,000 |
NOTES PAYABLE (Details Narrativ
NOTES PAYABLE (Details Narrative) - USD ($) | Jul. 28, 2020 | Nov. 30, 2020 | Nov. 30, 2019 | Dec. 31, 2020 | Dec. 31, 2019 |
SEC Schedule, 12-17, Insurance Companies, Reinsurance [Line Items] | |||||
Debt Instrument, Unamortized Discount | $ 2,262,388 | ||||
Interest Expense, Debt | 1,126,534 | $ 0 | |||
Fair Value, Inputs, Level 3 [Member] | |||||
SEC Schedule, 12-17, Insurance Companies, Reinsurance [Line Items] | |||||
Secured debt | 18,029,005 | ||||
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 | $ 1,010,000 | ||||
Loan Agreement [Member] | |||||
SEC Schedule, 12-17, Insurance Companies, Reinsurance [Line Items] | |||||
Notes payable | $ 909,375 | $ 963,514 | |||
Monthly principal and interest payments | $ 103,112 | $ 109,413 | |||
Monthly loan payments term | nine-month period | nine-month period | |||
Annual interest rate | 4.89% | 5.25% | |||
Loan Agreement [Member] | K2 HealthVentures LLC [Member] | |||||
SEC Schedule, 12-17, Insurance Companies, Reinsurance [Line Items] | |||||
Annual interest rate | 8.50% | 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 | ||||
Warrants to purchase shares of common stock, exercised | 86,206 | ||||
Exercise price of warrants | $ 6.96 | ||||
Proceeds from warrant | $ 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, 2020 | Dec. 31, 2019 |
Payables and Accruals [Abstract] | ||
Accrued clinical operations and trials costs | $ 14,132,842 | $ 14,242,669 |
Accrued product development costs | 2,189,047 | 3,573,231 |
Accrued compensation | 4,222,594 | 3,673,111 |
Accrued other | 1,460,949 | 958,928 |
Total | $ 22,005,432 | $ 22,447,939 |
SCHEDULE OF ROLL FORWARD OF DEF
SCHEDULE OF ROLL FORWARD OF DEFERRED REVENUE (Details) | 12 Months Ended |
Dec. 31, 2020USD ($) | |
Revenue from Contract with Customer [Abstract] | |
Beginning balance, December 31, 2019 | |
Invoicing to CFF upon achievement of milestones | 5,000,000 |
Recognition of revenue | (3,937,230) |
Reclassification to contract asset | (1,062,770) |
Ending balance, December 31, 2020 |
DEVELOPMENT AWARDS AND DEFERR_3
DEVELOPMENT AWARDS AND DEFERRED REVENUE (Details Narrative) - USD ($) | Jan. 26, 2018 | Jul. 31, 2020 | May 31, 2019 | Mar. 31, 2019 | Dec. 31, 2020 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | Jun. 30, 2019 |
Entity Listings [Line Items] | |||||||||
Contract with Customer, Liability, Revenue Recognized | $ (3,937,230) | ||||||||
Revenue | 3,937,230 | $ 36,143,568 | |||||||
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 | $ 13.20 | |||||||
Cystic Fibrosis Foundation [Member] | |||||||||
Entity Listings [Line Items] | |||||||||
Payments for royalty | $ 2,700,000 | ||||||||
Collaboration and License Agreement [Member] | Kaken Pharmaceutical Co., Ltd. [Member] | |||||||||
Entity Listings [Line Items] | |||||||||
Upfront payment, received from related party | $ 27,000,000 | ||||||||
Consideration receivable on milestone payments | $ 173,000,000 | ||||||||
Royalty term description | The “Royalty Term” means the period beginning on the date of the first commercial sale of the Licensed Product in Japan and ends on the latest of (i) the expiration of the last valid claim of the royalty patents covering such Licensed Product in Japan, (ii) the expiration of regulatory exclusivity for such Licensed Product for such Initial Indication in Japan, or (iii) ten (10) years after the first commercial sale of such Licensed Product for such Initial Indication in Japan. The Agreement may be terminated by either party for material breach, upon a party’s insolvency or bankruptcy or upon a challenge by one party of any patents of the other party, and Kaken may terminate in specified situations, including for a safety concern or clinical failure, or at its convenience following the second anniversary of the first commercial sale of a Licensed Product in either of the Initial Indications in the Territory, with 180 days’ notice. | ||||||||
Revenue from related parties, recorded as deferred revenue | $ 27,000,000 | ||||||||
Contract with Customer, Liability, Revenue Recognized | $ 27,000,000 | ||||||||
Royalty payable | $ 27,000,000 | $ 27,000,000 | |||||||
Cystic Fibrosis Program Related Investment Agreement [Member] | Phase 2b Clinical Trial [Member] | |||||||||
Entity Listings [Line Items] | |||||||||
Warrants [Text Block] | $ 22,500,000 | ||||||||
Loans Payable | $ 2,500,000 | 2,500,000 | |||||||
Cystic Fibrosis Program Related Investment Agreement [Member] | Maximum [Member] | |||||||||
Entity Listings [Line Items] | |||||||||
Gain Contingency, Unrecorded Amount | $ 25,000,000 | ||||||||
Collaboration Agreement [Member] | Cystic Fibrosis Foundation [Member] | |||||||||
Entity Listings [Line Items] | |||||||||
Royalty payment percentage | 10.00% | ||||||||
Investment Agreement [Member] | 2018 CFF Award [Member] | |||||||||
Entity Listings [Line Items] | |||||||||
Revenue | $ 3,937,230 | 9,143,568 | |||||||
Investment Agreement [Member] | CFF Warrant [Member] | |||||||||
Entity Listings [Line Items] | |||||||||
Warrant to purchase of common stock | 1,000,000 | 1,000,000 | |||||||
Warrant exercisable price per share | $ 9.46 | $ 9.46 | |||||||
Warrants expiration term | Jan. 26, 2025 | 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 | 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 | 500,000 | |||||||
Investment Agreement [Member] | |||||||||
Entity Listings [Line Items] | |||||||||
Revenue | $ 22,500,000 | $ 5,000,000 | $ 5,000,000 | $ 12,500,000 | |||||
Investment Agreement [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 | $ 18,784,775 | |||||||
Research and development period | 3 years |
SCHEDULE OF COMPONENTS OF NET D
SCHEDULE OF COMPONENTS OF NET DEFERRED TAX ASSET (Details) - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 |
Income Tax Disclosure [Abstract] | ||
NOL carryforward | $ 45,360,175 | $ 26,945,090 |
Foreign net operating loss carryforward | 10,532,490 | 10,875,395 |
Tax credits | 8,843,792 | 5,844,918 |
Stock based compensation | 7,354,531 | 5,373,539 |
Accrued expenses | 1,202,538 | 1,120,196 |
Other temporary differences | 1,152,853 | 962,981 |
Subtotal | 74,446,379 | 51,122,119 |
Valuation allowance | (74,446,379) | (51,122,119) |
Net deferred tax asset |
SCHEDULE OF EFFECTIVE INCOME TA
SCHEDULE OF EFFECTIVE INCOME TAX RATE RECONCILIATION (Details) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | ||
Tax provision at statutory rate | 21.00% | 21.00% |
State taxes, net of federal benefit | 5.83% | 5.25% |
Permanent differences | (1.35%) | (2.76%) |
Foreign expected tax | 7.37% | 21.76% |
Tax credits | 4.03% | 8.82% |
Income tax rate change | 0.02% | 0.07% |
Other | (8.12%) | 0.45% |
Decrease in valuation reserve | (28.78%) | (54.59%) |
Total | 0.00% | 0.00% |
INCOME TAXES (Details Narrative
INCOME TAXES (Details Narrative) - USD ($) | 6 Months Ended | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2020 | Dec. 31, 2019 | |
Operating Loss Carryforwards [Line Items] | |||
Research and development tax credit carryforwards | $ 9,233,000 | $ 9,233,000 | $ 6,031,000 |
Deferred tax assets valuation allowance increase | 23,324,000 | 18,210,000 | |
Uncertain tax position | 0 | 0 | 0 |
Federal [Member] | |||
Operating Loss Carryforwards [Line Items] | |||
Net operating loss carryforwards | 167,399,000 | $ 167,399,000 | 99,754,000 |
Operating loss carryforwards expiration year | 2029 | ||
Net operating loss carryforwards no expiration | 111,047,000 | $ 111,047,000 | |
Net operating loss carryforwards limitation percentage on taxable income | 80.00% | ||
Massachusetts [Member] | |||
Operating Loss Carryforwards [Line Items] | |||
Net operating loss carryforwards | 161,143,000 | $ 161,143,000 | $ 94,884,000 |
Foreign Tax Authority [Member] | Other Income [Member] | |||
Operating Loss Carryforwards [Line Items] | |||
Proceeds form income tax refund | $ 13,700,000 | $ 13,700,000 |
COMMON STOCK (Details Narrative
COMMON STOCK (Details Narrative) - USD ($) | Apr. 07, 2020 | Feb. 11, 2020 | Jan. 30, 2019 | Dec. 31, 2020 | Dec. 31, 2019 |
Subsidiary, Sale of Stock [Line Items] | |||||
Common stock, shares authorized | 150,000,000 | 150,000,000 | |||
Common stock, par value | $ 0.0001 | $ 0.0001 | |||
Common stock, shares issued | 98,852,696 | 64,672,893 | |||
Common stock, shares outstanding | 98,852,696 | 64,672,893 | |||
Gross proceeds from sale of stock | $ 142,200,752 | $ 40,677,060 | |||
Stock issuance cost | $ 6,039,423 | $ 2,571,552 | |||
Issuance of common stock upon exercise of stock options, shares | 427,611 | 107,029 | |||
Warrant [Member] | |||||
Subsidiary, Sale of Stock [Line Items] | |||||
Issuance of common stock upon exercise of stock options, shares | 1,119,868 | ||||
Warrants to purchase shares of common stock, exercised | 0 | 1,283,500 | |||
Equity Option [Member] | |||||
Subsidiary, Sale of Stock [Line Items] | |||||
Issuance of common stock upon exercise of stock options, shares | 427,611 | 107,029 | |||
Proceeds from exercise of stock options | $ 756,000 | $ 387,000 | |||
April 2020 Sale Agreement [Member] | |||||
Subsidiary, Sale of Stock [Line Items] | |||||
Gross proceeds from sale of stock | 75,000,000 | ||||
Stock issuance cost | $ 2,250,000 | ||||
Shares issued | 10,539,374 | ||||
April 2020 Sale Agreement [Member] | Jefferies LLC [Member] | Maximum [Member] | |||||
Subsidiary, Sale of Stock [Line Items] | |||||
Aggregate common stock sold, shares | 75,000,000 | ||||
Value of common stock to be sold | $ 75,000,000 | ||||
August 2020 Sale Agreement [Member] | |||||
Subsidiary, Sale of Stock [Line Items] | |||||
Aggregate common stock sold, shares | 15,546,151 | ||||
Gross proceeds from sale of stock | $ 21,404,000 | ||||
Stock issuance cost | $ 642,000 | ||||
August 2020 Sale Agreement [Member] | Jefferies LLC [Member] | Maximum [Member] | |||||
Subsidiary, Sale of Stock [Line Items] | |||||
Aggregate common stock sold, shares | 150,000,000 | ||||
IPO [Member] | |||||
Subsidiary, Sale of Stock [Line Items] | |||||
Aggregate common stock sold, shares | 7,666,667 | 6,198,500 | |||
Purchase price per share | $ 6 | $ 6.50 | |||
Gross proceeds from sale of stock | $ 46,000,000 | $ 40,300,000 | |||
Stock issuance cost | $ 3,147,000 | $ 2,600,000 | |||
IPO [Member] | Underwriters [Member] | |||||
Subsidiary, Sale of Stock [Line Items] | |||||
Aggregate common stock sold, shares | 1,000,000 | 808,500 |
SUMMARY OF FAIR VALUE OF OPTION
SUMMARY OF FAIR VALUE OF OPTIONS GRANTED (Details) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
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 | 0.59% | 233.00% |
Expected dividend yield | 0.00% | 0.00% |
Expected term in years | 6 years 3 months | 6 years 3 months |
Expected volatility | 83.56% | 86.98% |
Estimated Forfeiture Rate | 6.02% | 4.85% |
SUMMARY OF OPTION ACTIVITY (Det
SUMMARY OF OPTION ACTIVITY (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Share-based Payment Arrangement [Abstract] | ||
Shares, Outstanding, Beginning balance | 13,245,366 | 9,593,990 |
Weighted Average Exercise Price, Outstanding, Beginning balance | $ 5.19 | $ 4.51 |
Shares, Granted | 4,536,600 | 4,125,800 |
Weighted Average Exercise Price, Granted | $ 5 | $ 6.91 |
Shares, Exercised | (427,611) | (107,029) |
Weighted Average Exercise Price, Exercised | $ 1.77 | $ 3.61 |
Shares, Forfeited | (3,064,712) | (367,395) |
Weighted Average Exercise Price, Forfeited | $ 5.60 | $ 7.10 |
Shares, Outstanding, Ending balance | 14,289,643 | 13,245,366 |
Weighted Average Exercise Price, Outstanding, Ending balance | $ 5.15 | $ 5.19 |
Weighted Average Remaining Contractual Term in Years, Outstanding | 6 years 7 months 2 days | |
Average Intrinsic Value, Outstanding | $ 3,500,516 | |
Shares, Exercisable | 9,952,349 | |
Weighted Average Exercise Price, Exercisable | $ 4.86 | |
Weighted Average Remaining Contractual Term in Years, Exercisable | 5 years 8 months 1 day | |
Average Intrinsic Value, Exercisable | $ 3,417,266 | |
Shares, Vested and expected to vest | 13,984,246 | |
Weighted Average Exercise Price, Vested and expected to vest | $ 5.15 | |
Weighted Average Remaining Contractual Term in Years, Vested and expected to vest | 6 years 6 months 14 days | |
Average Intrinsic Value, Vested and expected to vest | $ 3,487,159 |
SUMMARY OF NON-VESTED STOCK OPT
SUMMARY OF NON-VESTED STOCK OPTIONS (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Share-based Payment Arrangement [Abstract] | ||
Shares Non-vested , Beginning balance | 5,409,272 | 3,626,289 |
Weighted Average Fair Value Non Vested, Beginning Balance | $ 5.21 | $ 5.32 |
Shares, Granted | 4,536,600 | 4,125,800 |
Weighted Average Fair Value, Granted | $ 3.53 | $ 5.03 |
Shares, Vested | (2,720,493) | (2,038,128) |
Weighted Average Fair Value, Vested | $ 5.34 | $ 4.95 |
Shares, Forfeited | (2,888,085) | (304,689) |
Weighted Average Fair Value, Forfeited | $ 4.11 | $ 5.22 |
Shares Outstanding, Ending balance | 4,337,294 | 5,409,272 |
Weighted Average Fair Value Non Vested, Ending Balance | $ 4.14 | $ 5.21 |
STOCK OPTIONS (Details Narrativ
STOCK OPTIONS (Details Narrative) - USD ($) | Jan. 02, 2021 | Jan. 02, 2020 | Apr. 30, 2014 | Dec. 31, 2020 | Dec. 31, 2019 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Stock-based compensation expense | $ 12,458,229 | $ 11,981,655 | |||
Option granted expected term | 6 years 3 months | ||||
Weighted average grant-date fair value, options granted | $ 3.53 | $ 5.03 | |||
Equity Option [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Average intrinsic value of options exercised | $ 1,235,676 | $ 324,567 | |||
Total unrecognized compensation expense | $ 14,664,483 | ||||
Share-based compensation expense, not yet recognized period of recognition | 2 years 4 months 6 days | ||||
2014 Equity Incentive Plan [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Percentage of outstanding common shares | 7.00% | ||||
Stock option vesting term | 4 years | ||||
Stock option expiration period | 10 years | ||||
2014 Equity Incentive Plan [Member] | Subsequent Event [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Aggregate common stock available for stock options granted, shares | 25,570,842 | ||||
Shares available for grant | 9,869,051 | ||||
2014 Equity Incentive Plan [Member] | January 1, 2021 [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 | 2,500,000 | ||||
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% | ||||
Increase in number of shares of common stock available for issuance | 4,527,103 | ||||
Aggregate common stock available for stock options granted, shares | 23,070,842 | ||||
Shares available for grant | 7,369,051 | ||||
2014 Equity Incentive Plan [Member] | Evergreen Provision [Member] | Subsequent Event [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Percentage of outstanding common shares | 7.00% | ||||
Aggregate common stock available for stock options granted, shares | 25,570,842 | ||||
Shares available for grant | 9,869,051 |
SCHEDULE OF WEIGHTED AVERAGE AS
SCHEDULE OF WEIGHTED AVERAGE ASSUMPTION OF WARRANTS (Details) | Dec. 31, 2020ft² |
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 | 0.835 |
CFF Warrant [Member] | Glenridge Warrants [Member] | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |
Warrants outstanding measurement input, percentage | 0 |
K 2 Warrant [Member] | Measurement Input, Risk Free Interest Rate [Member] | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |
Warrants outstanding measurement input, percentage | 0.0060 |
K 2 Warrant [Member] | Measurement Input, Expected Dividend Rate [Member] | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |
Warrants outstanding measurement input, percentage | 0 |
K 2 Warrant [Member] | Measurement Input, Expected Term [Member] | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |
Warrants outstanding measurement input, term | 10 years |
K 2 Warrant [Member] | Measurement Input, Price Volatility [Member] | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |
Warrants outstanding measurement input, percentage | 0.800 |
Glenridge Warrants [Member] | Measurement Input, Risk Free Interest Rate [Member] | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |
Warrants outstanding measurement input, percentage | 0.0090 |
Glenridge Warrants [Member] | Measurement Input, Expected Term [Member] | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |
Warrants outstanding measurement input, term | 5 years |
Glenridge Warrants [Member] | Measurement Input, Price Volatility [Member] | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |
Warrants outstanding measurement input, percentage | 1.006 |
WARRANTS (Details Narrative)
WARRANTS (Details Narrative) - USD ($) | Oct. 16, 2020 | Jul. 28, 2020 | Dec. 31, 2020 | Dec. 31, 2019 | Jun. 28, 2020 |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||
Issuance of common stock upon exercise of stock options, shares | 427,611 | 107,029 | |||
Fair value of warrants issued | $ 6,215,225 | ||||
Debt face amount | $ 20,000,000 | ||||
Share-based Payment Arrangement, Tranche One [Member] | |||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||
Debt face amount | $ 20,000,000 | ||||
Loan Agreement [Member] | K2 HealthVentures LLC [Member] | |||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||
Warrants to purchase shares of common stock, exercised | 86,206 | ||||
Exercise price of warrants | $ 6.96 | ||||
Loan Agreement [Member] | K2 HealthVentures LLC [Member] | Maximum [Member] | |||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||
Debt face amount | $ 50,000,000 | ||||
Warrant [Member] | |||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||
Warrants to purchase shares of common stock, exercised | 0 | 1,283,500 | |||
Issuance of common stock upon exercise of stock options, shares | 1,119,868 | ||||
Warrant [Member] | Loan Agreement [Member] | K2 HealthVentures LLC [Member] | |||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||
Warrants to purchase shares of common stock, exercised | 86,206 | ||||
Exercise price of warrants | $ 6.96 | ||||
Warrant expire date | Jul. 28, 2030 | ||||
Fair value of warrants issued | $ 472,409 | ||||
Warrant [Member] | Professional Services Agreement [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 | ||||
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 | ||||
CFF Warrant [Member] | Investment Agreement [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 | 4 years 7 months 6 days | ||||
Number of warrants exercisable for common stock | 500,000 | ||||
Warrant expire date | Jan. 26, 2025 |
SCHEDULE OF FAIR VALUE OF DERIV
SCHEDULE OF FAIR VALUE OF DERIVATIVE LIABILITY (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Derivative Instruments and Hedging Activities Disclosure [Abstract] | ||
Beginning balance | ||
Initial measurement of fair value | 546,000 | |
Change in fair value of derivative liability | 251,000 | |
Ending balance | $ 797,000 |
DERIVATIVE LIABILITY (Details N
DERIVATIVE LIABILITY (Details Narrative) - USD ($) | Jul. 28, 2020 | Dec. 31, 2020 | Dec. 31, 2019 |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Initial measurement of fair value | $ 546,000 | ||
Change in fair value of derivative liability | (251,000) | ||
Loan Agreement [Member] | K2 HealthVentures LLC [Member] | |||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Secured debt | $ 50,000,000 | 21,190,000 | |
Initial measurement of fair value | 546,000 | 797,000 | |
Change in fair value of derivative liability | $ 251,000 | ||
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, 2021 | Jan. 02, 2020 | Apr. 30, 2014 | Mar. 15, 2021 | Dec. 31, 2020 | Dec. 31, 2019 |
Subsequent Event [Line Items] | ||||||
Proceeds from Issuance of Common Stock | $ 142,200,752 | $ 40,677,060 | ||||
August 2020 Sale Agreement [Member] | ||||||
Subsequent Event [Line Items] | ||||||
Stock Issued During Period, Shares, New Issues | 15,546,151 | |||||
Proceeds from Issuance of Common Stock | $ 21,404,000 | |||||
2014 Equity Incentive Plan [Member] | ||||||
Subsequent Event [Line Items] | ||||||
Percentage of outstanding common shares | 7.00% | |||||
Evergreen Provision [Member] | 2014 Equity Incentive Plan [Member] | ||||||
Subsequent Event [Line Items] | ||||||
Percentage of outstanding common shares | 7.00% | |||||
Shares available for future issuance | 23,070,842 | |||||
Shares available for future grants | 7,369,051 | |||||
Subsequent Event [Member] | August 2020 Sale Agreement [Member] | ||||||
Subsequent Event [Line Items] | ||||||
Stock Issued During Period, Shares, New Issues | 25,391,710 | |||||
Proceeds from Issuance of Common Stock | $ 58,861,000 | |||||
Subsequent Event [Member] | 2014 Equity Incentive Plan [Member] | ||||||
Subsequent Event [Line Items] | ||||||
Shares available for future issuance | 25,570,842 | |||||
Shares available for future grants | 9,869,051 | |||||
Subsequent Event [Member] | Evergreen Provision [Member] | 2014 Equity Incentive Plan [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 | 2,500,000 | |||||
Percentage of outstanding common shares | 7.00% | |||||
Shares available for future issuance | 25,570,842 | |||||
Shares available for future grants | 9,869,051 |