Cover
Cover - shares | 3 Months Ended | |
Mar. 31, 2021 | May 11, 2021 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Mar. 31, 2021 | |
Document Fiscal Period Focus | Q1 | |
Document Fiscal Year Focus | 2021 | |
Current Fiscal Year End Date | --12-31 | |
Entity File Number | 001-37348 | |
Entity Registrant Name | Corbus Pharmaceuticals Holdings, Inc. | |
Entity Central Index Key | 0001595097 | |
Entity Tax Identification Number | 46-4348039 | |
Entity Incorporation, State or Country Code | DE | |
Entity Address, Address Line One | 500 River Ridge Drive | |
Entity Address, City or Town | Norwood | |
Entity Address, State or Province | MA | |
Entity Address, Postal Zip Code | 02062 | |
City Area Code | (617) | |
Local Phone Number | 963-0100 | |
Title of 12(b) Security | Common Stock, par value $0.0001 per share | |
Trading Symbol | CRBP | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 125,033,006 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) | Mar. 31, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 66,613,246 | $ 85,433,441 |
Marketable securities | 57,399,179 | |
Restricted cash | 350,000 | 350,000 |
Stock subscriptions receivable | 960,033 | |
Prepaid expenses and other current assets | 3,658,794 | 3,712,861 |
Contract asset | 2,266,120 | 1,618,296 |
Total current assets | 130,287,339 | 92,074,631 |
Restricted cash | 669,900 | 669,900 |
Property and equipment, net | 3,787,596 | 4,067,837 |
Operating lease right of use assets | 5,096,165 | 5,248,525 |
Other assets | 304,037 | 234,038 |
Total assets | 140,145,037 | 102,294,931 |
Current liabilities: | ||
Notes payable | 408,278 | 710,158 |
Accounts payable | 3,615,366 | 7,381,183 |
Accrued expenses | 17,742,474 | 22,005,432 |
Derivative liability | 803,000 | 797,000 |
Operating lease liabilities, current | 1,036,297 | 1,004,063 |
Total current liabilities | 23,605,415 | 31,897,836 |
Long-term debt, net of debt discount | 18,199,289 | 18,029,005 |
Operating lease liabilities, noncurrent | 6,823,339 | 7,093,165 |
Total liabilities | 48,628,043 | 57,020,006 |
Stockholders’ equity | ||
Preferred stock, $0.0001 par value; 10,000,000 shares authorized, no shares issued and outstanding at March 31, 2021 and December 31, 2020 | ||
Common stock, $0.0001 par value; 150,000,000 shares authorized, 125,033,006 and 98,852,696 shares issued and outstanding at March 31, 2021 and December 31, 2020, respectively | 12,503 | 9,885 |
Additional paid-in capital | 411,691,762 | 349,358,378 |
Accumulated deficit | (320,158,506) | (304,093,338) |
Accumulated other comprehensive loss | (28,765) | |
Total stockholders’ equity | 91,516,994 | 45,274,925 |
Total liabilities and stockholders’ equity | $ 140,145,037 | $ 102,294,931 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Mar. 31, 2021 | Dec. 31, 2020 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 150,000,000 | 150,000,000 |
Common stock, shares issued | 125,033,006 | 98,852,696 |
Common stock, shares outstanding | 125,033,006 | 98,852,696 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($) | 3 Months Ended | ||
Mar. 31, 2021 | Mar. 31, 2020 | ||
Income Statement [Abstract] | |||
Revenue from awards and licenses | $ 647,824 | $ 1,762,059 | |
Operating expenses: | |||
Research and development | 10,720,823 | 23,947,866 | |
General and administrative | 5,341,197 | 7,699,479 | |
Total operating expenses | 16,062,020 | 31,647,345 | |
Operating loss | (15,414,196) | (29,885,286) | |
Other income (expense), net: | |||
Other income (expense), net | (15,094) | ||
Interest income (expense), net | (646,550) | 101,993 | |
Change in fair value of derivative liability | (6,000) | ||
Foreign currency exchange gain (loss), net | 16,672 | 126,493 | |
Other income (expense), net | (650,972) | 228,486 | |
Net loss | $ (16,065,168) | $ (29,656,800) | |
Net loss per share, basic and diluted | [1] | $ (0.14) | $ (0.43) |
Weighted average number of common shares outstanding, basic and diluted | [1] | 116,344,900 | 69,272,402 |
Comprehensive loss: | |||
Net loss | $ (16,065,168) | $ (29,656,800) | |
Other comprehensive loss: | |||
Unrealized loss on marketable debt securities | (28,765) | ||
Total other comprehensive loss | (28,765) | ||
Total comprehensive loss | $ (16,093,933) | $ (29,656,800) | |
[1] | Warrants and options that have not been exercised have been excluded from the diluted calculation as all periods presented have a net loss and the impact of these securities would be anti-dilutive |
Condensed Consolidated Statem_2
Condensed Consolidated Statement of Stockholders' Equity (Unaudited) - USD ($) | Common Stock [Member] | Additional Paid-in Capital [Member] | Retained Earnings [Member] | AOCI Attributable to Parent [Member] | Total |
Beginning balance, value at Dec. 31, 2019 | $ 6,467 | $ 198,975,056 | $ (192,823,958) | $ 6,157,565 | |
Beginning balance, shares at Dec. 31, 2019 | 64,672,893 | ||||
Stock-based compensation expense | 3,137,519 | 3,137,519 | |||
Issuance of common stock, net of issuance costs of $2,962,790 | $ 767 | 43,036,445 | 43,037,212 | ||
Issuance of common stock, net of issuance costs, shares | 7,666,667 | ||||
Issuance of common stock upon exercise of stock options | $ 15 | 15,979 | 15,994 | ||
Issuance of common stock upon exercise of stock options, shares | 150,889 | ||||
Unrealized loss on marketable debt securities | |||||
Net loss | (29,656,800) | (29,656,800) | |||
Ending balance, value at Mar. 31, 2020 | $ 7,249 | 245,164,999 | (222,480,758) | 22,691,490 | |
Ending balance, shares at Mar. 31, 2020 | 72,490,449 | ||||
Beginning balance, value at Dec. 31, 2020 | $ 9,885 | 349,358,378 | (304,093,338) | 45,274,925 | |
Beginning balance, shares at Dec. 31, 2020 | 98,852,696 | ||||
Stock-based compensation expense | 2,580,402 | 2,580,402 | |||
Issuance of common stock, net of issuance costs of $2,962,790 | $ 2,539 | 58,858,262 | 58,860,801 | ||
Issuance of common stock, net of issuance costs, shares | 25,391,710 | ||||
Issuance of common stock upon exercise of stock options | $ 79 | 894,720 | $ 894,799 | ||
Issuance of common stock upon exercise of stock options, shares | 788,600 | 788,600 | |||
Unrealized loss on marketable debt securities | (28,765) | $ (28,765) | |||
Net loss | (16,065,168) | (16,065,168) | |||
Ending balance, value at Mar. 31, 2021 | $ 12,503 | $ 411,691,762 | $ (320,158,506) | $ (28,765) | $ 91,516,994 |
Ending balance, shares at Mar. 31, 2021 | 125,033,006 |
Condensed Consolidated Statem_3
Condensed Consolidated Statement of Stockholders' Equity (Unaudited) (Parenthetical) - USD ($) | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Statement of Stockholders' Equity [Abstract] | ||
Stock issuance cost | $ 1,820,437 | $ 2,962,790 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Cash flows from operating activities: | ||
Net loss | $ (16,065,168) | $ (29,656,800) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation expense | 2,580,402 | 3,137,519 |
Depreciation and amortization | 272,186 | 319,488 |
Net amortization on premium of marketable securities | (901) | |
Gain on foreign exchange | (73,976) | (157,073) |
Operating lease right of use asset amortization | 152,360 | 138,516 |
Amortization of debt discount | 170,284 | |
Change in fair value of derivative liability | 6,000 | |
Loss on sale of property and equipment | 5,456 | |
Changes in operating assets and liabilities: | ||
Decrease in prepaid expenses | 54,067 | 128,024 |
Increase in contract asset | (647,824) | (1,762,059) |
Decrease (increase) in other assets | (70,000) | 70,883 |
Decrease in accounts payable | (3,691,841) | (839,372) |
Increase (decrease) in accrued expenses | (4,262,958) | 1,110,156 |
Decrease in operating lease liabilities | (237,592) | (90,444) |
Net cash used in operating activities | (21,809,505) | (27,601,162) |
Cash flows from investing activities: | ||
Purchases of property and equipment | (463,605) | |
Purchases of marketable securities | (57,427,043) | |
Proceeds from sale of property and equipment | 2,600 | |
Net cash used in investing activities | (57,424,443) | (463,605) |
Cash flows from financing activities: | ||
Repayment of short-term borrowings | (301,880) | (319,754) |
Proceeds from issuance of common stock | 62,536,070 | 46,015,996 |
Issuance costs paid for common stock financings | (1,820,437) | (2,762,240) |
Net cash provided by financing activities | 60,413,753 | 42,934,002 |
Net increase (decrease) in cash, cash equivalents, and restricted cash | (18,820,195) | 14,869,235 |
Cash, cash equivalents, and restricted cash at beginning of the period | 86,453,341 | 31,748,686 |
Cash, cash equivalents, and restricted cash at end of the period | 67,633,146 | 46,617,921 |
Supplemental disclosure of cash flow information and non-cash transactions: | ||
Cash paid during the period for interest | 432,455 | 8,484 |
Stock issuance costs included in accounts payable or accrued expenses | $ 200,550 |
NATURE OF OPERATIONS
NATURE OF OPERATIONS | 3 Months Ended |
Mar. 31, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
NATURE OF OPERATIONS | 1. NATURE OF OPERATIONS Business Corbus Pharmaceuticals Holdings, Inc. (“the Company” or “Corbus”) is 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. The condensed 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. In the opinion of management of the Company, the accompanying unaudited condensed consolidated interim financial statements reflect all adjustments (which include only normal recurring adjustments) necessary to present fairly, in all material respects, the consolidated financial position of the Company as of March 31, 2021 and the results of its operations and cash flows for the three months ended March 31, 2021 and 2020. The December 31, 2020 condensed consolidated balance sheet was derived from audited financial statements. The Company prepared the condensed consolidated financial statements following the requirements of the SEC for interim reporting. Accordingly, certain information and footnote disclosures normally included in financial statements prepared in accordance with generally accepted accounting principles have been condensed or omitted. It is suggested that these condensed consolidated financial statements be read in conjunction with the financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020, filed on March 15, 2021. The results of operations for such interim periods are not necessarily indicative of the operating results for the full fiscal year. 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 | 3 Months Ended |
Mar. 31, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
LIQUIDITY | 2. LIQUIDITY The accompanying consolidated financial statements have been prepared assuming the Company will continue as a going concern, which contemplates continuity of operations, realization of assets and the satisfaction of liabilities and commitments in the normal course of business. The Company has incurred recurring losses since inception and as of March 31, 2021, had an accumulated deficit of $ 320,158,506 . The Company anticipates operating losses to continue for the foreseeable future due to, among other things, costs related to research funding, development of its product candidates and its preclinical and clinical programs, strategic alliances and the development of its administrative organization. The Company expects the cash, cash equivalents, and marketable debt securities of $ 124,012,000 at March 31, 2021 and the remaining $ 2,500,000 of proceeds that we expect to receive under the 2018 CFF Award before the end of 2021 will be sufficient to meet its operating and capital requirements at least twelve months from the filing of this 10-Q. The source, timing and availability of any future financing will depend principally upon market conditions, and, more specifically, on the progress of the Company’s clinical development programs. Funding may not be available when needed, at all, or on terms acceptable to the Company. Lack of necessary funds may require the Company to, among other things, delay, scale back or eliminate some or all of the Company’s planned clinical or preclinical trials. On August 7, 2020, the Company entered into an Open Market Sale Agreement SM 3.0 150 25,391,710 60,681,000 1,820,000 |
SIGNIFICANT ACCOUNTING POLICIES
SIGNIFICANT ACCOUNTING POLICIES | 3 Months Ended |
Mar. 31, 2021 | |
Accounting Policies [Abstract] | |
SIGNIFICANT ACCOUNTING POLICIES | 3. SIGNIFICANT ACCOUNTING POLICIES Basis of Presentation The financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the reporting periods. Actual results could differ from those estimates and changes in estimates may occur. The most significant estimates are related to stock-based compensation, the accrual of research, product development and clinical obligations, the recognition of revenue under the Investment Agreement discussed in Note 11, the valuation of warrants discussed in Note 14, and the derivative liability associated with the K2 Security and Loan agreement discussed in Note 9 and 15. Cash, Cash Equivalents, and Restricted Cash The Company considers only those investments which are highly liquid, readily convertible to cash, and that mature within three months from date of purchase to be cash equivalents. At March 31, 2021 and December 31, 2020, cash equivalents were comprised of money market funds. Restricted cash as of at March 31, 2021 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, cash equivalents, and restricted stock consisted of the following: SCHEDULE OF CASH AND CASH EQUIVALENTS AND RESTRICTED CASH March 31, 2021 December 31, 2020 Cash $ 3,384,067 $ 1,238,611 Money market fund 63,229,179 84,194,830 Cash and cash equivalents 66,613,246 $ 85,433,441 Restricted cash, current 350,000 350,000 Restricted cash, noncurrent 669,900 669,900 Restricted cash 1,019,900 1,019,900 Total cash, cash equivalents, and restricted cash shown in the statement of cash flows $ 67,633,146 $ 86,453,341 As of March 31, 2021, all of the Company’s cash and cash equivalents was held in the United States, except for approximately $ 3,144,000 1,033,000 Marketable Securities Marketable securities consist of investments in debt securities with original maturities greater than 90 days at their acquisition date. The Company has classified its investments with maturities beyond one year as current, based on their highly liquid nature and because such marketable securities represent the investment of cash that is available for current operations. The Company classifies all of its marketable securities as available-for-sale securities. The Company’s marketable securities are measured and reported at fair value using quoted prices in active markets for similar securities. Unrealized gains and losses on available-for-sale debt securities are reported as accumulated other comprehensive loss, which is a separate component of stockholders’ equity. The cost of debt securities sold is determined on a specific identification basis, and realized gains and losses are included in other income (expense), net in the consolidated statements of operations and comprehensive loss. The Company evaluates its marketable securities with unrealized losses for other-than-temporary impairment. When assessing marketable securities for other-than-temporary declines in value, the Company considers such factors as, among other things, how significant the decline in value is as a percentage of the original cost, how long the market value of the investment has been less than its original cost, the Company’s ability and intent to retain the investment for a period of time sufficient to allow for any anticipated recovery in fair value and market conditions in general. If any adjustment to fair value reflects a decline in the value of the investment that the Company considers to be “other than temporary,” the Company reduces the investment to fair value through a charge to the statement of operations and comprehensive loss. No such adjustments were necessary during the periods presented. Financial Instruments The carrying values of the notes payable and debt approximate their fair value due to the fact that they are at market terms. Fair Value Measurements Certain assets and liabilities are carried at fair value under GAAP. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three levels of the fair value hierarchy, of which the first two are considered observable and the last is considered unobservable: Level 1 – Unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access as of the measurement date. Level 2 – Inputs other than quoted prices included within Level 1 that are directly observable for the asset or liability or indirectly observable through corroboration with observable market data. Level 3 – Unobservable inputs for the asset or liability only used when there is little, if any, market activity for the asset or liability at the measurement date. The Company’s investments, debt, and its derivative liabilities are carried at fair value determined according to the fair value hierarchy described above. The carrying values of the Company’s prepaid expenses and other current assets, and accrued expenses approximate their fair values due to the short-term nature of these assets and liabilities. 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” 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 three five years The Company’s leasehold improvements and assets under capital lease are amortized over the shorter of their useful lives or the respective leases. 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 accrual estimates by taking into account discussion with applicable internal 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 three months ending March 31, 2021 and 2020, there were no material adjustments to the Company’s prior period estimates of accrued expenses for clinical trials. Leases The Company determines if an arrangement is a lease at inception. Operating leases are included in operating lease right-of-use (“ROU”) assets, other current liabilities and operating lease liabilities in the Company’s consolidated balance sheets. ROU assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent its obligation to make lease payments arising from the lease. ROU assets and liabilities are recognized at commencement date based on the present value of lease payments over the lease term. As the Company’s leases do not provide an implicit rate, the Company uses an incremental borrowing rate based on the information available at commencement date in determining the present value of lease payments. This is the rate the Company would have to pay if borrowing on a collateralized basis over a similar term to each lease. The ROU asset also includes any lease payments made and excludes lease incentives. Lease expense for lease payments is recognized on a straight-line basis over the lease term. Concentrations of Credit Risk The Company has no significant off-balance-sheet concentration of credit risk such as foreign exchange contracts, option contracts or other hedging arrangements. The Company may from time to time have cash in banks in excess of Federal Deposit Insurance Corporation insurance limits. However, the Company believes the risk of loss is minimal as these banks are large financial institutions. Segment Information Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision maker, or decision-making group, in making decisions regarding resource allocation and assessing performance. To date, the Company has viewed its operations and manages its business as principally one operating segment, which is developing and commercializing therapeutics for autoimmunity, fibrosis, and cancer. As of March 31, 2021 all of the Company’s assets were located in the United States, except for approximately $ 3,144,000 of cash, $ 1,706,000 of prepaid expenses and other assets, and $ 16,000 of property and equipment, net which were held outside of the United States, principally in our subsidiary in the United Kingdom. As of December 31, 2020, all of the Company’s assets were located in the United States, except for approximately $ 1,033,000 of cash, $ 1,837,000 of prepaid expenses and other assets, and $ 23,000 of property and equipment, net which were held outside of the United States, principally in our subsidiary in the United Kingdom. Income Taxes For federal and state income taxes, deferred tax assets and liabilities are recognized based upon temporary differences between the financial statement and the tax basis of assets and liabilities. Deferred income taxes are based upon prescribed rates and enacted laws applicable to periods in which differences are expected to reverse. A valuation allowance is recorded to reduce a net deferred tax benefit when it is not more likely than not that the tax benefit from the deferred tax assets will be realized. Accordingly, given the cumulative losses since inception, the Company has provided a valuation allowance equal to 100 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 is estimated as of the date of grant using the Black-Scholes option-pricing model, net of estimated forfeitures. The fair value of each option grant 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 Net loss per share was computed as follows: SCHEDULE OF COMPUTATION OF NET LOSS PER COMMON SHARE Three Months Ended March 31 2021 2020 Net loss $ (16,065,168 ) $ (29,656,800 ) Weighted average number of common shares-basic and diluted* 116,344,900 69,272,402 Net loss per share of common stock-basic and diluted* $ (0.14 ) $ (0.43 ) * Warrants and options that have not been exercised have been excluded from the diluted calculation as all periods presented have a net loss and the impact of these securities would be anti-dilutive Recently Adopted Accounting Pronouncements In December 2019, the FASB issued ASU 2019-12 , Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes Recently Issued Accounting Pronouncements 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 the potential impact that this standard may have on its consolidated financial statements and related disclosures. In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”) Codification Improvements to Topic 326, Financial Instruments—Credit Losses Financial Instruments—Credit Losses (Topic 326): Targeted Transition Relief (“ASU 2019-05”) This standard will be effective for the Company on January 1, 2023 or when we cease being eligible to be a smaller reporting company. The Company is currently evaluating the potential impact that this standard may have on its consolidated financial statements and related disclosures. |
Marketable Securities
Marketable Securities | 3 Months Ended |
Mar. 31, 2021 | |
Investments, Debt and Equity Securities [Abstract] | |
Marketable Securities | 4. Marketable Securities The following table summarizes the Company’s marketable securities as of March 31, 2021 (in thousands ): Summary of Marketable Securities Amortized Cost Gross Unrealized Gain Gross Unrealized Losses Fair Value Commercial paper $ 22,366 $ $ $ 22,366 Corporate debt securities 28,175 - (28 ) 28,147 Asset Backed Securities “ABS” 6,887 - (1 ) 6,886 $ 57,428 $ - $ (29 ) $ 57,399 The following table summarizes the amortized cost and fair value of the Company’s available-for-sale debt securities by contractual maturity as of March 31, 2021 (in thousands): Schedule of Available for Sale Debt Securities by Contractual Maturity Amortized Cost Fair Value Maturing in one year or less $ 34,441 $ 34,436 Maturing after one year but less than three years 22,987 22,963 $ 57,428 $ 57,399 As of December 31, 2020, there were no |
Fair Value of Financial Assets
Fair Value of Financial Assets and Liabilities | 3 Months Ended |
Mar. 31, 2021 | |
Fair Value Disclosures [Abstract] | |
Fair Value of Financial Assets and Liabilities | 5. Fair Value of Financial Assets and Liabilities The following tables present information about the Company’s financial assets and liabilities measured at fair value on a recurring basis and indicate the level of the fair value hierarchy utilized to determine such fair values as of March 31, 2021 (in thousands): Schedule of Assets and Liabilities Measured at Fair Value on Recurring Basis Level 1 Level 2 Level 3 Total Assets: Cash Equivalents: Money market funds $ 63,229 $ - $ - $ 63,229 Marketable Securities: Commercial paper - 22,366 - 22,366 Corporate debt securities - 28,147 - 28,147 ABS - 6,886 - 6,886 $ 63,229 $ 57,399 $ - $ 120,628 Liabilities: Derivative liabilities $ - $ - $ 803 $ 803 The following tables present information about the Company’s financial assets and liabilities measured at fair value on a recurring basis and indicate the level of the fair value hierarchy utilized to determine such fair values as of December 31, 2020 (in thousands): Level 1 Level 2 Level 3 Total Assets: Cash Equivalents: Money Market funds $ 84,195 $ - $ - $ 84,195 $ 84,195 $ - $ - $ 84,195 Liabilities Derivative Liabilities $ - $ - $ 797 $ 797 |
LICENSE AGREEMENT
LICENSE AGREEMENT | 3 Months Ended |
Mar. 31, 2021 | |
License Agreement | |
LICENSE AGREEMENT | 6. 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 18,400,000 In January 2017, the FASB issued ASU 2017-01, Business Combinations (Topic 805): Clarifying the Definition of a Business 250,000 18,400,000 |
PROPERTY AND EQUIPMENT
PROPERTY AND EQUIPMENT | 3 Months Ended |
Mar. 31, 2021 | |
Property, Plant and Equipment [Abstract] | |
PROPERTY AND EQUIPMENT | 7. PROPERTY AND EQUIPMENT Property and equipment consisted of the following: SUMMARY OF PROPERTY AND EQUIPMENT March 31, 2021 December 31, 2020 Computer hardware and software $ 610,218 $ 626,328 Office furniture and equipment 1,626,491 1,626,491 Leasehold improvements 4,163,860 4,163,860 Property and equipment, gross 6,400,569 6,416,679 Less: accumulated depreciation (2,612,973 ) (2,348,842 ) Property and equipment, net $ 3,787,596 $ 4,067,837 Depreciation expense was $ 272,186 319,488 |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 3 Months Ended |
Mar. 31, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
COMMITMENTS AND CONTINGENCIES | 8. COMMITMENTS AND CONTINGENCIES Operating Lease Commitment See Note 6 to the consolidated financial statements in our 2020 Annual Report for additional information regarding leases. Pursuant to the terms of our non-cancelable lease agreements in effect at March 31, 2021, the following table summarizes our maturities of operating lease liabilities as of March 31, 2021: SCHEDULE OF MATURITIES OF OPERATING LEASE LIABILITIES March 31, 2021 2021 (Remainder of year) $ 1,209,771 2022 1,652,563 2023 1,700,005 2024 1,747,447 2025 1,794,889 Thereafter 1,688,145 Total lease payments $ 9,792,820 Less: imputed interest (1,933,184 ) Total $ 7,859,636 |
NOTES PAYABLE
NOTES PAYABLE | 3 Months Ended |
Mar. 31, 2021 | |
Debt Disclosure [Abstract] | |
NOTES PAYABLE | 9. 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 4.89 707,000 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 K2HV may elect to convert up to $ 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 common shares (the “K2 Warrant”) at an exercise price of $ 6.96 (the “Warrant Price”). The K2 Warrant may be exercised either for cash or on a cashless “net exercise” basis and expires on July 28, 2030. The total proceeds attributed to the K2 Warrant was approximately $ 472,000 based on the relative fair value of the K2 Warrant as compared to the sum of the fair values of the K2 Warrant, prepayment feature, default feature, and debt. Total proceeds attributed to the prepayment and default features was approximately $ 546,000 . The Company also incurred approximately $ 1,244,000 of debt issuance costs and is required to make a final payment equal to approximately $ 1,190,000 . See Note 14 for more detail on assumptions used in the valuation of the K2 warrant and see Note 15 for more information on the assumptions used in valuation of the default and prepayment features. The total principal amount of the loan under the Loan Agreement outstanding at March 31, 2021, 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 18,199,000 18,029,000 658,000 No The net carrying amounts of the liability components consists of the following: SCHEDULE OF NOTES PAYABLE March 31, 2021 December 31, 2020 Principal $ 20,000,000 $ 20,000,000 Less: debt discount (2,262,388 ) (2,262,388 ) Accretion of Debt Discount 461,677 291,393 Net Carrying amount $ 18,199,289 $ 18,029,005 The following table summarizes the future principal payments due under long-term debt; SCHEDULE OF PRINCIPAL MATURITIES ON LONG TERM DEBT Principal Payments and on Loan Agreement Remaining 2021 $ - 2022 3,093,344 2023 9,835,341 2024 8,261,315 Total $ 21,190,000 |
ACCRUED EXPENSES
ACCRUED EXPENSES | 3 Months Ended |
Mar. 31, 2021 | |
Payables and Accruals [Abstract] | |
ACCRUED EXPENSES | 10. ACCRUED EXPENSES Accrued expenses consisted of the following: SCHEDULE OF ACCRUED EXPENSES March 31, 2021 December 31, 2020 Accrued clinical operations and trials costs $ 11,956,892 $ 14,132,842 Accrued product development costs 764,211 2,189,047 Accrued compensation 3,746,283 4,222,594 Accrued other 1,275,088 1,460,949 Total $ 17,742,474 $ 22,005,432 |
DEVELOPMENT AWARDS
DEVELOPMENT AWARDS | 3 Months Ended |
Mar. 31, 2021 | |
Revenue from Contract with Customer [Abstract] | |
DEVELOPMENT AWARDS | 11. DEVELOPMENT AWARDS Collaboration with Kaken On January 3, 2019, Corbus Pharmaceuticals Holdings, Inc. 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 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 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 The Company received the upfront payment of $ 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 $ 25,000,000 22,500,000 2.5 Pursuant to the terms of the Investment Agreement, the Company is obligated to make certain royalty payments to CFF, including a royalty payment of one and one-half times the amount of the 2018 CFF Award, payable in cash within sixty days upon the first receipt of approval of lenabasum in the United States and a second royalty payment of one and one-half times the amount of the 2018 CFF Award upon approval in another major market, as set forth in the Investment Agreement (the “Approval Royalty”). At the Company’s election, the Company may satisfy the first of the two Approval Royalties in registered shares of the Company’s common stock. Additionally, the Company is obligated to make (i) royalty payments to CFF of two and one-half percent of net sales from lenabasum due within sixty days after any quarter in which such net sales occur in the Field, as defined in the Investment Agreement, (ii) royalty payments to CFF of one percent of net sales of Non-Field Products, as defined in the Investment Agreement due within sixty days after any quarter in which such net sales occur, and (iii) royalty payments to CFF of ten percent of any amount the Company and its stockholders receive in connection with the license, sale, or other transfer to a third party of lenabasum, if indicated for the treatment or prevention of CF, or a change of control transaction, except that such payment shall not exceed five times the amount of the 2018 CFF Award, with such payments to be credited against any other net sales royalty payments due. Accordingly, the Company will owe to CFF a royalty payment equal to 10% of any amounts the Company receives as payment under the collaboration agreement with Kaken, provided that the total royalties that the Company will be required to pay under the Investment Agreement resulting from income from licenses or sales subject to the Investment Agreement are capped at five times the total amount of the 2018 CFF Award, and the Company may credit such royalties against any royalties on net sales otherwise owed to CFF under the Investment Agreement. Accordingly, the Company was required to pay CFF $ 2,700,000 27,000,000 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 $ 647,824 1,762,059 To determine the transaction price, the Company included the total aggregate payments under the Investment Agreement which amount to $ 25,000,000 6,215,225 18,784,775 6,215,225 The Company has billed and received $ 22,500,000 12,500,000 5,000,000 5,000,000 No 1,618,000 2,266,000 The CFF Warrant is accounted for as a payment to the customer under GAAP. See Note 14 for further information related to the CFF Warrant. The Company notes that the Investment Agreement contains an initial payment that was received upon contract execution and subsequent milestone payments, which are a form of variable consideration that require evaluation for constraint considerations. The Company concluded that the related performance milestones are generally within the Company’s control and as result are considered probable. Revenue associated with the performance obligation is being recognized as revenue as the research and development services are provided using an input method, according to the costs incurred as related to the research and development activities on each program and the costs expected to be incurred in the future to satisfy the performance obligation. The transfer of control occurs over this time period and, in management’s judgment, is the best measure of progress towards satisfying the performance obligation. The research and development services related to this performance obligation are expected to be performed over approximately three years and is expected to be completed in the second half of 2021. The amounts received that have not yet been recognized as revenue are recorded as contract liabilities and the amounts recognized as revenue, but not yet received or invoiced are generally recognized as contract assets on the Company’s condensed consolidated balance sheet. |
COMMON STOCK
COMMON STOCK | 3 Months Ended |
Mar. 31, 2021 | |
Equity [Abstract] | |
COMMON STOCK | 12. COMMON STOCK The Company has authorized 150,000,000 0.0001 125,033,006 98,852,696 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 of shares of the Company’s common stock through an “at the market offering”. Sales of common stock under the April 2020 Sale Agreement were made pursuant to an effective registration statement for an aggregate offering of up to $75,000,000 . During the three months ended March 31, 2021 and 2020, the Company did not sell any shares of its common stock under the April 2020 Sale Agreement. 75,000,000 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 25,391,710 60,681,238 1,820,437 During the three months ended March 31, 2021 and 2020, the Company issued 788,600 150,889 894,800 15,994 No |
STOCK OPTIONS
STOCK OPTIONS | 3 Months Ended |
Mar. 31, 2021 | |
Share-based Payment Arrangement [Abstract] | |
STOCK OPTIONS | 13. 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 In accordance with the terms of the 2014 Plan, and pursuant to the annual evergreen provision contained in the 2014 plan, effective as of January 1, 2020, the number of shares of common stock available for issuance under the 2014 Plan increased by 4,527,103 7 23,070,842 8,540,939 5,621,910 In accordance with the terms of the 2014 Plan, and pursuant to the annual evergreen provision contained in 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 4,941,899 Stock-based Compensation For stock options issued and outstanding for the three months ended March 31, 2021 and 2020, respectively, the Company recorded non-cash, stock-based compensation expense of $ 2,580,402 3,137,519 Stock-based compensation expense was classified in the consolidated statements of operations and comprehensive loss as follows: SCHEDULE OF STOCK-BASED COMPENSATION EXPENSE Three Months Ended March 31, 2021 2020 Research and development expenses $ 887,077 $ 1,364,890 General and administrative expenses 1,693,325 1,772,629 Total stock-based compensation $ 2,580,402 $ 3,137,519 The fair value of each option award for employees is estimated on the date of grant using the Black-Scholes option pricing model that uses the assumptions noted in the following table. Our expected stock price volatility assumptions are based on the historical volatility of our stock over periods that are similar to the expected terms of the grants. 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 to employees were as follows: SUMMARY OF FAIR VALUE OF OPTIONS GRANTED Three Months Ended March 31, 2021 2020 Risk free interest rate 0.66 % 0.65 % Expected dividend yield 0 % 0 % Expected term in years 6.25 6.25 Estimated Forfeiture Rate 9.00 % 6.37 % Expected volatility 103.85 % 82.9 % A summary of option activity for the three months ended March 31, 2021 and is presented below: SUMMARY OF OPTION ACTIVITY Options Shares Weighted Average Weighted Average Remaining Contractual Term in Years Aggregate Outstanding at December 31, 2020 14,289,643 $ 5.15 Granted 5,996,800 2.58 Exercised (788,600 ) 1.13 Forfeited (1,069,648 ) 5.57 Outstanding at March 31, 2021 18,428,195 $ 4.46 7.48 $ 2,841,774 Vested at March 31, 2021 9,412,878 $ 5.16 5.68 $ 2,758,524 Vested and expected to vest at March 31, 2021 17,222,580 $ 4.56 7.33 $ 2,830,060 The weighted average grant-date fair value of options granted during the three months ended March 31, 2021 and 2020 was $ 2.09 3.20 1,735,214 936,115 36,311,140 28,661,461 21,384,572 2.95 |
WARRANTS
WARRANTS | 3 Months Ended |
Mar. 31, 2021 | |
Warrants | |
WARRANTS | 14. WARRANTS No At March 31, 2021, there were warrants outstanding to purchase 1,506,206 shares of common stock with a weighted average exercise price of $ 9.46 and a weighted average remaining life of 4.36 years The Company issued a warrant to CFF to purchase an aggregate of 1,000,000 13.20 500,000 500,000 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 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 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 Expected volatility 100.6 % |
DERIVATIVE LIABILITY
DERIVATIVE LIABILITY | 3 Months Ended |
Mar. 31, 2021 | |
Derivative Instruments and Hedging Activities Disclosure [Abstract] | |
DERIVATIVE LIABILITY | 15. 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 Company has determined that a prepayment feature and default feature needed to be separately valued and mark to market each reporting period after assessing the agreement under GAAP. The value of these features are determined each reporting period by taking the present value of net cash flows with and without the prepayment features. The significant assumption used to determine the fair value of the debt without any features is the discount rate which has been estimated by using published market rates of triple CCC rated public companies. All other inputs are taken from the Loan Agreement. The additional significant assumptions used when valuing the prepayment feature is the probability of a change of control event. The Company has determined the probability from December 31, 2020 to March 31, 2021 has stayed consistent. The additional significant assumption used when valuing the default feature is the probability of defaulting on the repayment of loan. The Company has determined the probability decreased from December 31, 2020 to March 31, 2021 as a result of the additional cash the Company was able to raise in the first quarter of 2021. The value of these features was determined to be approximately $ 797,000 803,000 6,000 three-tier fair value hierarchy. A roll forward of the fair value of the derivative liabilities for the quarter ended March 31, 2021 is presented below. SCHEDULE OF FAIR VALUE OF DERIVATIVE LIABILITY March 31, 2021 Beginning balance, December 31, 2020 $ 797,000 Change in fair value of derivative liabilities 6,000 Ending balance, March 31, 2021 $ 803,000 |
SIGNIFICANT ACCOUNTING POLICI_2
SIGNIFICANT ACCOUNTING POLICIES (Policies) | 3 Months Ended |
Mar. 31, 2021 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the reporting periods. Actual results could differ from those estimates and changes in estimates may occur. The most significant estimates are related to stock-based compensation, the accrual of research, product development and clinical obligations, the recognition of revenue under the Investment Agreement discussed in Note 11, the valuation of warrants discussed in Note 14, and the derivative liability associated with the K2 Security and Loan agreement discussed in Note 9 and 15. |
Cash, Cash Equivalents, and Restricted Cash | Cash, Cash Equivalents, and Restricted Cash The Company considers only those investments which are highly liquid, readily convertible to cash, and that mature within three months from date of purchase to be cash equivalents. At March 31, 2021 and December 31, 2020, cash equivalents were comprised of money market funds. Restricted cash as of at March 31, 2021 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, cash equivalents, and restricted stock consisted of the following: SCHEDULE OF CASH AND CASH EQUIVALENTS AND RESTRICTED CASH March 31, 2021 December 31, 2020 Cash $ 3,384,067 $ 1,238,611 Money market fund 63,229,179 84,194,830 Cash and cash equivalents 66,613,246 $ 85,433,441 Restricted cash, current 350,000 350,000 Restricted cash, noncurrent 669,900 669,900 Restricted cash 1,019,900 1,019,900 Total cash, cash equivalents, and restricted cash shown in the statement of cash flows $ 67,633,146 $ 86,453,341 As of March 31, 2021, all of the Company’s cash and cash equivalents was held in the United States, except for approximately $ 3,144,000 1,033,000 |
Marketable Securities | Marketable Securities Marketable securities consist of investments in debt securities with original maturities greater than 90 days at their acquisition date. The Company has classified its investments with maturities beyond one year as current, based on their highly liquid nature and because such marketable securities represent the investment of cash that is available for current operations. The Company classifies all of its marketable securities as available-for-sale securities. The Company’s marketable securities are measured and reported at fair value using quoted prices in active markets for similar securities. Unrealized gains and losses on available-for-sale debt securities are reported as accumulated other comprehensive loss, which is a separate component of stockholders’ equity. The cost of debt securities sold is determined on a specific identification basis, and realized gains and losses are included in other income (expense), net in the consolidated statements of operations and comprehensive loss. The Company evaluates its marketable securities with unrealized losses for other-than-temporary impairment. When assessing marketable securities for other-than-temporary declines in value, the Company considers such factors as, among other things, how significant the decline in value is as a percentage of the original cost, how long the market value of the investment has been less than its original cost, the Company’s ability and intent to retain the investment for a period of time sufficient to allow for any anticipated recovery in fair value and market conditions in general. If any adjustment to fair value reflects a decline in the value of the investment that the Company considers to be “other than temporary,” the Company reduces the investment to fair value through a charge to the statement of operations and comprehensive loss. No such adjustments were necessary during the periods presented. |
Financial Instruments | Financial Instruments The carrying values of the notes payable and debt approximate their fair value due to the fact that they are at market terms. |
Fair Value Measurements | Fair Value Measurements Certain assets and liabilities are carried at fair value under GAAP. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three levels of the fair value hierarchy, of which the first two are considered observable and the last is considered unobservable: Level 1 – Unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access as of the measurement date. Level 2 – Inputs other than quoted prices included within Level 1 that are directly observable for the asset or liability or indirectly observable through corroboration with observable market data. Level 3 – Unobservable inputs for the asset or liability only used when there is little, if any, market activity for the asset or liability at the measurement date. The Company’s investments, debt, and its derivative liabilities are carried at fair value determined according to the fair value hierarchy described above. The carrying values of the Company’s prepaid expenses and other current assets, and accrued expenses approximate their fair values due to the short-term nature of these assets and liabilities. 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” 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 three five years The Company’s leasehold improvements and assets under capital lease are amortized over the shorter of their useful lives or the respective leases. |
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 accrual estimates by taking into account discussion with applicable internal 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 three months ending March 31, 2021 and 2020, there were no material adjustments to the Company’s prior period estimates of accrued expenses for clinical trials. |
Leases | Leases The Company determines if an arrangement is a lease at inception. Operating leases are included in operating lease right-of-use (“ROU”) assets, other current liabilities and operating lease liabilities in the Company’s consolidated balance sheets. ROU assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent its obligation to make lease payments arising from the lease. ROU assets and liabilities are recognized at commencement date based on the present value of lease payments over the lease term. As the Company’s leases do not provide an implicit rate, the Company uses an incremental borrowing rate based on the information available at commencement date in determining the present value of lease payments. This is the rate the Company would have to pay if borrowing on a collateralized basis over a similar term to each lease. The ROU asset also includes any lease payments made and excludes lease incentives. Lease expense for lease payments is recognized on a straight-line basis over the lease term. |
Concentrations of Credit Risk | Concentrations of Credit Risk The Company has no significant off-balance-sheet concentration of credit risk such as foreign exchange contracts, option contracts or other hedging arrangements. The Company may from time to time have cash in banks in excess of Federal Deposit Insurance Corporation insurance limits. However, the Company believes the risk of loss is minimal as these banks are large financial institutions. |
Segment Information | Segment Information Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision maker, or decision-making group, in making decisions regarding resource allocation and assessing performance. To date, the Company has viewed its operations and manages its business as principally one operating segment, which is developing and commercializing therapeutics for autoimmunity, fibrosis, and cancer. As of March 31, 2021 all of the Company’s assets were located in the United States, except for approximately $ 3,144,000 of cash, $ 1,706,000 of prepaid expenses and other assets, and $ 16,000 of property and equipment, net which were held outside of the United States, principally in our subsidiary in the United Kingdom. As of December 31, 2020, all of the Company’s assets were located in the United States, except for approximately $ 1,033,000 of cash, $ 1,837,000 of prepaid expenses and other assets, and $ 23,000 of property and equipment, net which were held outside of the United States, principally in our subsidiary in the United Kingdom. |
Income Taxes | Income Taxes For federal and state income taxes, deferred tax assets and liabilities are recognized based upon temporary differences between the financial statement and the tax basis of assets and liabilities. Deferred income taxes are based upon prescribed rates and enacted laws applicable to periods in which differences are expected to reverse. A valuation allowance is recorded to reduce a net deferred tax benefit when it is not more likely than not that the tax benefit from the deferred tax assets will be realized. Accordingly, given the cumulative losses since inception, the Company has provided a valuation allowance equal to 100 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 is estimated as of the date of grant using the Black-Scholes option-pricing model, net of estimated forfeitures. The fair value of each option grant 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 Net loss per share was computed as follows: SCHEDULE OF COMPUTATION OF NET LOSS PER COMMON SHARE Three Months Ended March 31 2021 2020 Net loss $ (16,065,168 ) $ (29,656,800 ) Weighted average number of common shares-basic and diluted* 116,344,900 69,272,402 Net loss per share of common stock-basic and diluted* $ (0.14 ) $ (0.43 ) * Warrants and options that have not been exercised have been excluded from the diluted calculation as all periods presented have a net loss and the impact of these securities would be anti-dilutive |
Recently Adopted Accounting Pronouncements | Recently Adopted Accounting Pronouncements In December 2019, the FASB issued ASU 2019-12 , Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes |
Recently Issued Accounting Pronouncements | Recently Issued Accounting Pronouncements 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 the potential impact that this standard may have on its consolidated financial statements and related disclosures. In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”) Codification Improvements to Topic 326, Financial Instruments—Credit Losses Financial Instruments—Credit Losses (Topic 326): Targeted Transition Relief (“ASU 2019-05”) This standard will be effective for the Company on January 1, 2023 or when we cease being eligible to be a smaller reporting company. The Company is currently evaluating the potential impact that this standard may have on its consolidated financial statements and related disclosures. |
SIGNIFICANT ACCOUNTING POLICI_3
SIGNIFICANT ACCOUNTING POLICIES (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Accounting Policies [Abstract] | |
SCHEDULE OF CASH AND CASH EQUIVALENTS AND RESTRICTED CASH | Cash, cash equivalents, and restricted stock consisted of the following: SCHEDULE OF CASH AND CASH EQUIVALENTS AND RESTRICTED CASH March 31, 2021 December 31, 2020 Cash $ 3,384,067 $ 1,238,611 Money market fund 63,229,179 84,194,830 Cash and cash equivalents 66,613,246 $ 85,433,441 Restricted cash, current 350,000 350,000 Restricted cash, noncurrent 669,900 669,900 Restricted cash 1,019,900 1,019,900 Total cash, cash equivalents, and restricted cash shown in the statement of cash flows $ 67,633,146 $ 86,453,341 |
SCHEDULE OF COMPUTATION OF NET LOSS PER COMMON SHARE | Net loss per share was computed as follows: SCHEDULE OF COMPUTATION OF NET LOSS PER COMMON SHARE Three Months Ended March 31 2021 2020 Net loss $ (16,065,168 ) $ (29,656,800 ) Weighted average number of common shares-basic and diluted* 116,344,900 69,272,402 Net loss per share of common stock-basic and diluted* $ (0.14 ) $ (0.43 ) * Warrants and options that have not been exercised have been excluded from the diluted calculation as all periods presented have a net loss and the impact of these securities would be anti-dilutive |
Marketable Securities (Tables)
Marketable Securities (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Investments, Debt and Equity Securities [Abstract] | |
Summary of Marketable Securities | The following table summarizes the Company’s marketable securities as of March 31, 2021 (in thousands ): Summary of Marketable Securities Amortized Cost Gross Unrealized Gain Gross Unrealized Losses Fair Value Commercial paper $ 22,366 $ $ $ 22,366 Corporate debt securities 28,175 - (28 ) 28,147 Asset Backed Securities “ABS” 6,887 - (1 ) 6,886 $ 57,428 $ - $ (29 ) $ 57,399 |
Schedule of Available for Sale Debt Securities by Contractual Maturity | The following table summarizes the amortized cost and fair value of the Company’s available-for-sale debt securities by contractual maturity as of March 31, 2021 (in thousands): Schedule of Available for Sale Debt Securities by Contractual Maturity Amortized Cost Fair Value Maturing in one year or less $ 34,441 $ 34,436 Maturing after one year but less than three years 22,987 22,963 $ 57,428 $ 57,399 |
Fair Value of Financial Asset_2
Fair Value of Financial Assets and Liabilities (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Fair Value Disclosures [Abstract] | |
Schedule of Assets and Liabilities Measured at Fair Value on Recurring Basis | The following tables present information about the Company’s financial assets and liabilities measured at fair value on a recurring basis and indicate the level of the fair value hierarchy utilized to determine such fair values as of March 31, 2021 (in thousands): Schedule of Assets and Liabilities Measured at Fair Value on Recurring Basis Level 1 Level 2 Level 3 Total Assets: Cash Equivalents: Money market funds $ 63,229 $ - $ - $ 63,229 Marketable Securities: Commercial paper - 22,366 - 22,366 Corporate debt securities - 28,147 - 28,147 ABS - 6,886 - 6,886 $ 63,229 $ 57,399 $ - $ 120,628 Liabilities: Derivative liabilities $ - $ - $ 803 $ 803 The following tables present information about the Company’s financial assets and liabilities measured at fair value on a recurring basis and indicate the level of the fair value hierarchy utilized to determine such fair values as of December 31, 2020 (in thousands): Level 1 Level 2 Level 3 Total Assets: Cash Equivalents: Money Market funds $ 84,195 $ - $ - $ 84,195 $ 84,195 $ - $ - $ 84,195 Liabilities Derivative Liabilities $ - $ - $ 797 $ 797 |
PROPERTY AND EQUIPMENT (Tables)
PROPERTY AND EQUIPMENT (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Property, Plant and Equipment [Abstract] | |
SUMMARY OF PROPERTY AND EQUIPMENT | Property and equipment consisted of the following: SUMMARY OF PROPERTY AND EQUIPMENT March 31, 2021 December 31, 2020 Computer hardware and software $ 610,218 $ 626,328 Office furniture and equipment 1,626,491 1,626,491 Leasehold improvements 4,163,860 4,163,860 Property and equipment, gross 6,400,569 6,416,679 Less: accumulated depreciation (2,612,973 ) (2,348,842 ) Property and equipment, net $ 3,787,596 $ 4,067,837 |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
SCHEDULE OF MATURITIES OF OPERATING LEASE LIABILITIES | Pursuant to the terms of our non-cancelable lease agreements in effect at March 31, 2021, the following table summarizes our maturities of operating lease liabilities as of March 31, 2021: SCHEDULE OF MATURITIES OF OPERATING LEASE LIABILITIES March 31, 2021 2021 (Remainder of year) $ 1,209,771 2022 1,652,563 2023 1,700,005 2024 1,747,447 2025 1,794,889 Thereafter 1,688,145 Total lease payments $ 9,792,820 Less: imputed interest (1,933,184 ) Total $ 7,859,636 |
NOTES PAYABLE (Tables)
NOTES PAYABLE (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Debt Disclosure [Abstract] | |
SCHEDULE OF NOTES PAYABLE | The net carrying amounts of the liability components consists of the following: SCHEDULE OF NOTES PAYABLE March 31, 2021 December 31, 2020 Principal $ 20,000,000 $ 20,000,000 Less: debt discount (2,262,388 ) (2,262,388 ) Accretion of Debt Discount 461,677 291,393 Net Carrying amount $ 18,199,289 $ 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 Principal Payments and on Loan Agreement Remaining 2021 $ - 2022 3,093,344 2023 9,835,341 2024 8,261,315 Total $ 21,190,000 |
ACCRUED EXPENSES (Tables)
ACCRUED EXPENSES (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Payables and Accruals [Abstract] | |
SCHEDULE OF ACCRUED EXPENSES | Accrued expenses consisted of the following: SCHEDULE OF ACCRUED EXPENSES March 31, 2021 December 31, 2020 Accrued clinical operations and trials costs $ 11,956,892 $ 14,132,842 Accrued product development costs 764,211 2,189,047 Accrued compensation 3,746,283 4,222,594 Accrued other 1,275,088 1,460,949 Total $ 17,742,474 $ 22,005,432 |
STOCK OPTIONS (Tables)
STOCK OPTIONS (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Share-based Payment Arrangement [Abstract] | |
SCHEDULE OF STOCK-BASED COMPENSATION EXPENSE | Stock-based compensation expense was classified in the consolidated statements of operations and comprehensive loss as follows: SCHEDULE OF STOCK-BASED COMPENSATION EXPENSE Three Months Ended March 31, 2021 2020 Research and development expenses $ 887,077 $ 1,364,890 General and administrative expenses 1,693,325 1,772,629 Total stock-based compensation $ 2,580,402 $ 3,137,519 |
SUMMARY OF FAIR VALUE OF OPTIONS GRANTED | The weighted average assumptions used principally in determining the fair value of options granted to employees were as follows: SUMMARY OF FAIR VALUE OF OPTIONS GRANTED Three Months Ended March 31, 2021 2020 Risk free interest rate 0.66 % 0.65 % Expected dividend yield 0 % 0 % Expected term in years 6.25 6.25 Estimated Forfeiture Rate 9.00 % 6.37 % Expected volatility 103.85 % 82.9 % |
SUMMARY OF OPTION ACTIVITY | A summary of option activity for the three months ended March 31, 2021 and is presented below: SUMMARY OF OPTION ACTIVITY Options Shares Weighted Average Weighted Average Remaining Contractual Term in Years Aggregate Outstanding at December 31, 2020 14,289,643 $ 5.15 Granted 5,996,800 2.58 Exercised (788,600 ) 1.13 Forfeited (1,069,648 ) 5.57 Outstanding at March 31, 2021 18,428,195 $ 4.46 7.48 $ 2,841,774 Vested at March 31, 2021 9,412,878 $ 5.16 5.68 $ 2,758,524 Vested and expected to vest at March 31, 2021 17,222,580 $ 4.56 7.33 $ 2,830,060 |
WARRANTS (Tables)
WARRANTS (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
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 Expected volatility 83.5 % |
K Two 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 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 Expected volatility 100.6 % |
DERIVATIVE LIABILITY (Tables)
DERIVATIVE LIABILITY (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Derivative Instruments and Hedging Activities Disclosure [Abstract] | |
SCHEDULE OF FAIR VALUE OF DERIVATIVE LIABILITY | A roll forward of the fair value of the derivative liabilities for the quarter ended March 31, 2021 is presented below. SCHEDULE OF FAIR VALUE OF DERIVATIVE LIABILITY March 31, 2021 Beginning balance, December 31, 2020 $ 797,000 Change in fair value of derivative liabilities 6,000 Ending balance, March 31, 2021 $ 803,000 |
LIQUIDITY (Details Narrative)
LIQUIDITY (Details Narrative) - USD ($) | 3 Months Ended | |||
Mar. 31, 2021 | Mar. 31, 2020 | Dec. 31, 2020 | Aug. 07, 2020 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Retained Earnings (Accumulated Deficit) | $ 320,158,506 | $ 304,093,338 | ||
Cash, cash equivalents and marketable debt securities | 124,012,000 | |||
Proceeds from issuance of common stock | 62,536,070 | $ 46,015,996 | ||
Issuance costs incurred | $ 1,820,437 | $ 2,962,790 | ||
August 2020 Sale Agreement [Member] | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Issuance of common stock, net of issuance costs | 25,391,710 | |||
Proceeds from issuance of common stock | $ 60,681,000 | |||
Issuance costs incurred | 1,820,000 | |||
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 | |||
2018 CFF Award [Member] | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Accounts Receivable, after Allowance for Credit Loss | $ 2,500,000 |
SCHEDULE OF CASH AND CASH EQUIV
SCHEDULE OF CASH AND CASH EQUIVALENTS AND RESTRICTED CASH (Details) - USD ($) | Mar. 31, 2021 | Dec. 31, 2020 |
Accounting Policies [Abstract] | ||
Cash | $ 3,384,067 | $ 1,238,611 |
Money market fund | 63,229,179 | 84,194,830 |
Cash and cash equivalents | 66,613,246 | 85,433,441 |
Restricted cash, current | 350,000 | 350,000 |
Restricted cash, noncurrent | 669,900 | 669,900 |
Restricted cash | 1,019,900 | 1,019,900 |
Total cash, cash equivalents, and restricted cash shown in the statement of cash flows | $ 67,633,146 | $ 86,453,341 |
SCHEDULE OF COMPUTATION OF NET
SCHEDULE OF COMPUTATION OF NET LOSS PER COMMON SHARE (Details) - USD ($) | 3 Months Ended | ||
Mar. 31, 2021 | Mar. 31, 2020 | ||
Accounting Policies [Abstract] | |||
Net loss | $ (16,065,168) | $ (29,656,800) | |
Weighted average number of common shares - basic and diluted | [1] | 116,344,900 | 69,272,402 |
loss per share of common stock-basic and diluted | [1] | $ (0.14) | $ (0.43) |
[1] | Warrants and options that have not been exercised have been excluded from the diluted calculation as all periods presented have a net loss and the impact of these securities would be anti-dilutive |
SIGNIFICANT ACCOUNTING POLICI_4
SIGNIFICANT ACCOUNTING POLICIES (Details Narrative) - USD ($) | 3 Months Ended | |
Mar. 31, 2021 | Dec. 31, 2020 | |
Property, Plant and Equipment [Line Items] | ||
Restricted cash, current | $ 350,000 | $ 350,000 |
Restricted cash | 1,019,900 | 1,019,900 |
Restricted cash, noncurrent | 669,900 | 669,900 |
Cash | 3,384,067 | 1,238,611 |
Prepaid expenses and other assets | 3,658,794 | 3,712,861 |
Property, Plant and Equipment, Net | 3,787,596 | 4,067,837 |
Uncertain tax positions | 0 | 0 |
Impairment charges | $ 0 | |
Deferred Tax Assets [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Valuation allowance | 100.00% | |
Computer Hardware and Software [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, estimated useful life | 3 years | |
Office Furniture and Equipment [Member] | Minimum [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, estimated useful life | 3 years | |
Office Furniture and Equipment [Member] | Maximum [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, estimated useful life | 5 years | |
Leaseholds and Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, estimated useful lives | The Company’s leasehold improvements and assets under capital lease are amortized over the shorter of their useful lives or the respective leases. | |
UNITED KINGDOM | ||
Property, Plant and Equipment [Line Items] | ||
Cash held in subsidiary | $ 3,144,000 | 1,033,000 |
Cash | 3,144,000 | 1,033,000 |
Prepaid expenses and other assets | 1,706,000 | 1,837,000 |
Property, Plant and Equipment, Net | 16,000 | $ 23,000 |
Letter of Credit [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Restricted cash, current | 100,000 | |
Restricted cash | 769,900 | |
Restricted cash, noncurrent | 669,900 | |
Company's Corporate Credit Cards [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Restricted cash, current | $ 250,000 |
Summary of Marketable Securitie
Summary of Marketable Securities (Details) - USD ($) | Mar. 31, 2021 | Dec. 31, 2020 |
Net Investment Income [Line Items] | ||
Marketable securities, Amortized Cost | $ 57,428,000 | |
Marketable securities, Gross Unrealized Gain | ||
Marketable securities, Gross Unrealized Losses | (29,000) | |
Marketable securities, Fair Value | 57,399,000 | $ 0 |
Corporate Debt Securities [Member] | ||
Net Investment Income [Line Items] | ||
Marketable securities, Amortized Cost | 28,175,000 | |
Marketable securities, Gross Unrealized Gain | ||
Marketable securities, Gross Unrealized Losses | (28,000) | |
Marketable securities, Fair Value | 28,147,000 | |
Asset-backed Securities [Member] | ||
Net Investment Income [Line Items] | ||
Marketable securities, Amortized Cost | 6,887,000 | |
Marketable securities, Gross Unrealized Gain | ||
Marketable securities, Gross Unrealized Losses | (1,000) | |
Marketable securities, Fair Value | 6,886,000 | |
Commercial Paper [Member] | ||
Net Investment Income [Line Items] | ||
Marketable securities, Amortized Cost | 22,366,000 | |
Marketable securities, Gross Unrealized Gain | ||
Marketable securities, Gross Unrealized Losses | ||
Marketable securities, Fair Value | $ 22,366,000 |
Schedule of Available for Sale
Schedule of Available for Sale Debt Securities by Contractual Maturity (Details) - USD ($) | Mar. 31, 2021 | Dec. 31, 2020 |
Investments, Debt and Equity Securities [Abstract] | ||
Amortized Cost, Maturing in one year or less | $ 34,441,000 | |
Fair Value, Maturing in one year or less | 34,436,000 | |
Amortized Cost, Maturing after one year but less than three years | 22,987,000 | |
Fair Value, Maturing after one year but less than three years | 22,963,000 | |
Amortized Cost | 57,428,000 | |
Fair Value | $ 57,399,000 | $ 0 |
Marketable Securities (Details
Marketable Securities (Details Narrative) - USD ($) | Mar. 31, 2021 | Dec. 31, 2020 |
Investments, Debt and Equity Securities [Abstract] | ||
Debt Securities, Available-for-sale | $ 57,399,000 | $ 0 |
Schedule of Assets and Liabilit
Schedule of Assets and Liabilities Measured at Fair Value on Recurring Basis (Details) - Fair Value, Recurring [Member] - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets, Fair Value | $ 120,628 | $ 84,195 |
Liabilities, Fair Value | 803 | 797 |
Money Market Funds [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash Equivalents, Fair Value | 63,229 | 84,195 |
Commercial Paper [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable Securities, Fair Value | 22,366 | |
Corporate Debt Securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable Securities, Fair Value | 28,147 | |
Asset-backed Securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable Securities, Fair Value | 6,886 | |
Fair Value, Inputs, Level 1 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets, Fair Value | 63,229 | 84,195 |
Liabilities, Fair Value | ||
Fair Value, Inputs, Level 1 [Member] | Money Market Funds [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash Equivalents, Fair Value | 63,229 | 84,195 |
Fair Value, Inputs, Level 1 [Member] | Commercial Paper [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable Securities, Fair Value | ||
Fair Value, Inputs, Level 1 [Member] | Corporate Debt Securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable Securities, Fair Value | ||
Fair Value, Inputs, Level 1 [Member] | Asset-backed Securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable Securities, Fair Value | ||
Fair Value, Inputs, Level 2 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets, Fair Value | 57,399 | |
Liabilities, Fair Value | ||
Fair Value, Inputs, Level 2 [Member] | Money Market Funds [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash Equivalents, Fair Value | ||
Fair Value, Inputs, Level 2 [Member] | Commercial Paper [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable Securities, Fair Value | 22,366 | |
Fair Value, Inputs, Level 2 [Member] | Corporate Debt Securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable Securities, Fair Value | 28,147 | |
Fair Value, Inputs, Level 2 [Member] | Asset-backed Securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable Securities, Fair Value | 6,886 | |
Fair Value, Inputs, Level 3 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Assets, Fair Value | ||
Liabilities, Fair Value | 803 | 797 |
Fair Value, Inputs, Level 3 [Member] | Money Market Funds [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash Equivalents, Fair Value | ||
Fair Value, Inputs, Level 3 [Member] | Commercial Paper [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable Securities, Fair Value | ||
Fair Value, Inputs, Level 3 [Member] | Corporate Debt Securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable Securities, Fair Value | ||
Fair Value, Inputs, Level 3 [Member] | Asset-backed Securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable Securities, Fair Value |
LICENSE AGREEMENT (Details Narr
LICENSE AGREEMENT (Details Narrative) - USD ($) | Sep. 20, 2018 | Mar. 31, 2021 | Sep. 30, 2018 |
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 ($) | Mar. 31, 2021 | Dec. 31, 2020 |
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 6,400,569 | $ 6,416,679 |
Less: accumulated depreciation | (2,612,973) | (2,348,842) |
Property and equipment, net | 3,787,596 | 4,067,837 |
Computer Hardware and Software [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 610,218 | 626,328 |
Office Furniture and Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 1,626,491 | 1,626,491 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 4,163,860 | $ 4,163,860 |
PROPERTY AND EQUIPMENT (Details
PROPERTY AND EQUIPMENT (Details Narrative) - USD ($) | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Property, Plant and Equipment [Abstract] | ||
Depreciation | $ 272,186 | $ 319,488 |
SCHEDULE OF MATURITIES OF OPERA
SCHEDULE OF MATURITIES OF OPERATING LEASE LIABILITIES (Details) | Mar. 31, 2021USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
2021 (Remainder of year) | $ 1,209,771 |
2022 | 1,652,563 |
2023 | 1,700,005 |
2024 | 1,747,447 |
2025 | 1,794,889 |
Thereafter | 1,688,145 |
Total lease payments | 9,792,820 |
Less: imputed interest | (1,933,184) |
Total | $ 7,859,636 |
SCHEDULE OF NOTES PAYABLE (Deta
SCHEDULE OF NOTES PAYABLE (Details) - USD ($) | Mar. 31, 2021 | Dec. 31, 2020 |
Debt Disclosure [Abstract] | ||
Principal | $ 20,000,000 | $ 20,000,000 |
Less: debt discount | (2,262,388) | (2,262,388) |
Accretion of Debt Discount | 461,677 | 291,393 |
Net Carrying amount | $ 18,199,289 | $ 18,029,005 |
SCHEDULE OF PRINCIPAL MATURITIE
SCHEDULE OF PRINCIPAL MATURITIES ON LONG TERM DEBT (Details) | Mar. 31, 2021USD ($) |
Debt Disclosure [Abstract] | |
Remaining 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 | Mar. 31, 2021 | Mar. 31, 2020 | Dec. 31, 2020 |
SEC Schedule, 12-17, Insurance Companies, Reinsurance [Line Items] | ||||||
Debt Instrument, Unamortized Discount | $ 2,262,388 | $ 2,262,388 | ||||
Interest Expense, Debt | 658,000 | $ 0 | ||||
Fair Value, Inputs, Level 3 [Member] | ||||||
SEC Schedule, 12-17, Insurance Companies, Reinsurance [Line Items] | ||||||
Secured debt | 18,199,000 | 18,029,000 | ||||
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 | $ 707,000 | $ 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 | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Non-Option Equity Instruments, Exercised | 86,206 | |||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 6.96 | |||||
Proceeds from Warrant Exercises | $ 472,000 | |||||
Proceeds from prepayment and default features. | 546,000 | |||||
Debt issuance cost. | 1,244,000 | |||||
Final payment | 1,190,000 | |||||
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 ($) | Mar. 31, 2021 | Dec. 31, 2020 |
Payables and Accruals [Abstract] | ||
Accrued clinical operations and trials costs | $ 11,956,892 | $ 14,132,842 |
Accrued product development costs | 764,211 | 2,189,047 |
Accrued compensation | 3,746,283 | 4,222,594 |
Accrued other | 1,275,088 | 1,460,949 |
Total | $ 17,742,474 | $ 22,005,432 |
DEVELOPMENT AWARDS (Details Nar
DEVELOPMENT AWARDS (Details Narrative) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | 36 Months Ended | ||||||
May 31, 2019 | Mar. 31, 2019 | Mar. 31, 2021 | Dec. 31, 2020 | Mar. 31, 2020 | Sep. 30, 2020 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2020 | Jan. 26, 2018 | |
Entity Listings [Line Items] | |||||||||||
Revenue | $ 647,824 | $ 1,762,059 | |||||||||
CFF Warrant [Member] | |||||||||||
Entity Listings [Line Items] | |||||||||||
Warrant exercisable price per share | $ 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 | ||||||||||
Cystic Fibrosis Program Related Investment Agreement [Member] | Phase 2b Clinical Trial [Member] | |||||||||||
Entity Listings [Line Items] | |||||||||||
Royalty payable | 2,700,000 | ||||||||||
Payments for royalty | $ 27,000,000 | ||||||||||
Proceeds from investments on achieving milestones | $ 22,500,000 | ||||||||||
Loans Payable | $ 2,500,000 | ||||||||||
Cystic Fibrosis Program Related Investment Agreement [Member] | Maximum [Member] | |||||||||||
Entity Listings [Line Items] | |||||||||||
Gain Contingency, Unrecorded Amount | $ 25,000,000 | ||||||||||
Investment Agreement [Member] | 2018 CFF Award [Member] | |||||||||||
Entity Listings [Line Items] | |||||||||||
Revenue | $ 647,824 | $ 1,762,059 | |||||||||
Investment Agreement [Member] | CFF Warrant [Member] | |||||||||||
Entity Listings [Line Items] | |||||||||||
Warrant to purchase of common stock | 1,000,000 | ||||||||||
Warrant exercisable price per share | $ 9.46 | ||||||||||
Warrants expiration term | Jan. 26, 2025 | 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 | ||||||||||
Investment Agreement [Member] | CFF Warrant [Member] | Warrants Exercisable On Completion Of Final Milestone [Member] | |||||||||||
Entity Listings [Line Items] | |||||||||||
Warrant to purchase of common stock | 500,000 | ||||||||||
Investment Agreement [Member] | |||||||||||
Entity Listings [Line Items] | |||||||||||
Revenue | $ 0 | $ 5,000,000 | $ 5,000,000 | $ 12,500,000 | $ 22,500,000 | ||||||
Contract asset | 2,266,000 | $ 1,618,000 | |||||||||
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 |
COMMON STOCK (Details Narrative
COMMON STOCK (Details Narrative) - USD ($) | Apr. 07, 2020 | Feb. 11, 2020 | Mar. 31, 2021 | Mar. 31, 2020 | Dec. 31, 2020 |
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 | 125,033,006 | 98,852,696 | |||
Common stock, shares outstanding | 125,033,006 | 98,852,696 | |||
Gross proceeds from sale of stock | $ 62,536,070 | $ 46,015,996 | |||
Stock issuance cost | $ 1,820,437 | $ 2,962,790 | |||
Issuance of common stock upon exercise of stock options, shares | 788,600 | ||||
Warrant [Member] | |||||
Subsidiary, Sale of Stock [Line Items] | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Non-Option Equity Instruments, Exercised | 0 | 0 | |||
Equity Option [Member] | |||||
Subsidiary, Sale of Stock [Line Items] | |||||
Issuance of common stock upon exercise of stock options, shares | 788,600 | 150,889 | |||
Proceeds from exercise of stock options | $ 894,800 | $ 15,994 | |||
April 2020 Sale Agreement [Member] | |||||
Subsidiary, Sale of Stock [Line Items] | |||||
Sale of common stock shares, value | $ 75,000,000 | ||||
April 2020 Sale Agreement [Member] | Jefferies LLC [Member] | Maximum [Member] | |||||
Subsidiary, Sale of Stock [Line Items] | |||||
Sale of common stock shares, value | $ 75,000,000 | ||||
August 2020 Sale Agreement [Member] | |||||
Subsidiary, Sale of Stock [Line Items] | |||||
Aggregate common stock sold, shares | 25,391,710 | ||||
Gross proceeds from sale of stock | $ 60,681,238 | $ 1,820,437 | |||
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 | ||||
Purchase price per share | $ 6 | ||||
Gross proceeds from sale of stock | $ 46,000,000 | ||||
Stock issuance cost | $ 3,147,000 | ||||
IPO [Member] | Underwriters [Member] | |||||
Subsidiary, Sale of Stock [Line Items] | |||||
Aggregate common stock sold, shares | 1,000,000 |
SCHEDULE OF STOCK-BASED COMPENS
SCHEDULE OF STOCK-BASED COMPENSATION EXPENSE (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total stock-based compensation | $ 2,580,402 | $ 3,137,519 |
Research and Development Expense [Member] | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total stock-based compensation | 887,077 | 1,364,890 |
General and Administrative Expense [Member] | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total stock-based compensation | $ 1,693,325 | $ 1,772,629 |
SUMMARY OF FAIR VALUE OF OPTION
SUMMARY OF FAIR VALUE OF OPTIONS GRANTED (Details) | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Option Indexed to Issuer's Equity [Line Items] | ||
Expected term in years | 6 years 3 months | |
Share-based Payment Arrangement, Option [Member] | ||
Option Indexed to Issuer's Equity [Line Items] | ||
Risk free interest rate | 0.66% | 0.65% |
Expected dividend yield | 0.00% | 0.00% |
Expected term in years | 6 years 3 months | 6 years 3 months |
Estimated Forfeiture Rate | 9.00% | 6.37% |
Expected volatility | 103.85% | 82.90% |
SUMMARY OF OPTION ACTIVITY (Det
SUMMARY OF OPTION ACTIVITY (Details) | 3 Months Ended |
Mar. 31, 2021USD ($)$ / sharesshares | |
Share-based Payment Arrangement [Abstract] | |
Shares, Outstanding, Beginning balance | shares | 14,289,643 |
Weighted Average Exercise Price, Outstanding, Beginning balance | $ / shares | $ 5.15 |
Shares, Granted | shares | 5,996,800 |
Weighted Average Exercise Price, Granted | $ / shares | $ 2.58 |
Shares, Exercised | shares | (788,600) |
Weighted Average Exercise Price, Exercised | $ / shares | $ 1.13 |
Shares, Forfeited | shares | (1,069,648) |
Weighted Average Exercise Price, Forfeited | $ / shares | $ 5.57 |
Shares, Outstanding, Ending balance | shares | 18,428,195 |
Weighted Average Exercise Price, Outstanding, Ending balance | $ / shares | $ 4.46 |
Weighted Average Remaining Contractual Term in Years, Outstanding | 7 years 5 months 23 days |
Average Intrinsic Value, Outstanding | $ | $ 2,841,774 |
Shares, Vested | shares | 9,412,878 |
Weighted Average Exercise Price, Vested | $ / shares | $ 5.16 |
Weighted Average Remaining Contractual Term in Years, Vested | 5 years 8 months 4 days |
Average Intrinsic Value, Vested | $ | $ 2,758,524 |
Shares, Vested and expected to vest | shares | 17,222,580 |
Weighted Average Exercise Price, Vested and expected to vest | $ / shares | $ 4.56 |
Weighted Average Remaining Contractual Term in Years, Vested and expected to vest | 7 years 3 months 29 days |
Aggregate Intrinsic Value, Vested and expected to vest | $ | $ 2,830,060 |
STOCK OPTIONS (Details Narrativ
STOCK OPTIONS (Details Narrative) - USD ($) | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||||
Apr. 30, 2014 | Mar. 31, 2021 | Mar. 31, 2020 | Dec. 31, 2020 | Dec. 31, 2019 | Jan. 02, 2021 | Jan. 02, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Stock-based compensation expense | $ 2,580,402 | $ 3,137,519 | |||||
Option granted expected term | 6 years 3 months | ||||||
Weighted average grant-date fair value, options granted | $ 2.09 | $ 3.20 | |||||
Total fair value of options vested | $ 2,841,774 | ||||||
Equity Option [Member] | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Average intrinsic value of options exercised | 1,735,214 | $ 936,115 | |||||
Total fair value of options vested | 36,311,140 | $ 28,661,461 | |||||
Total unrecognized compensation expense | $ 21,384,572 | ||||||
Share-based compensation expense, not yet recognized period of recognition | 2 years 11 months 12 days | ||||||
2014 Equity Incentive Plan [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 | 23,070,842 | |||||
Shares available for grant | 4,941,899 | 5,621,910 | 9,869,051 | 8,540,939 | |||
2014 Equity Incentive Plan [Member] | January 1, 2020 [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 | ||||||
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 |
SCHEDULE OF WEIGHTED AVERAGE AS
SCHEDULE OF WEIGHTED AVERAGE ASSUMPTION OF WARRANTS (Details) | Mar. 31, 2021ft² |
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 |
K2 Warrant [Member] | Measurement Input, Risk Free Interest Rate [Member] | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |
Warrants outstanding measurement input, percentage | 0.0060 |
K2 Warrant [Member] | Measurement Input, Expected Dividend Rate [Member] | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |
Warrants outstanding measurement input, percentage | 0 |
K2 Warrant [Member] | Measurement Input, Expected Term [Member] | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |
Warrants outstanding measurement input, term | 10 years |
K2 Warrant [Member] | Measurement Input, Price Volatility [Member] | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |
Warrants outstanding measurement input, percentage | 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 | Mar. 31, 2021 | Mar. 31, 2020 | Dec. 31, 2020 | Jun. 28, 2020 |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||||
Fair value of warrants issued | $ 6,215,225 | |||||
Debt face amount | $ 20,000,000 | $ 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 | 0 | ||||
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 | |||||
Fair value of warrants issued | $ 472,409 | |||||
Warrant expire date | Jul. 28, 2030 | |||||
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 4 months 9 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 ($) | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Derivative Instruments and Hedging Activities Disclosure [Abstract] | ||
Beginning balance | $ 797,000 | |
Change in fair value of derivative liability | 6,000 | |
Ending balance | $ 803,000 |
DERIVATIVE LIABILITY (Details N
DERIVATIVE LIABILITY (Details Narrative) - USD ($) | 3 Months Ended | 12 Months Ended | ||
Mar. 31, 2021 | Mar. 31, 2020 | Dec. 31, 2020 | Jul. 28, 2020 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Change in fair value of derivative liability | $ (6,000) | |||
Loan Agreement [Member] | K2 HealthVentures LLC [Member] | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Secured debt | 21,190,000 | $ 50,000,000 | ||
Initial measurement of fair value | 803,000 | $ 797,000 | ||
Change in fair value of derivative liability | $ 6,000 | |||
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 |