Cover
Cover - shares | 6 Months Ended | |
Jun. 30, 2020 | Jul. 31, 2020 | |
Cover [Abstract] | ||
Document Type | 10-Q/A | |
Amendment Flag | true | |
Amendment Description | Corbus Pharmaceuticals Holdings, Inc. (the “Company”) is filing this amendment (this “Amendment”) to its Quarterly Report on Form 10-Q for the quarter ended June 30, 2020 (the “Quarterly Report”) to revise a clerical error with respect to the status of the Company as a “non-accelerated filer.” The cover page of the Quarterly Report has been revised to indicate that the Company is an “accelerated filer.” In addition, this amendment is being filed to furnish Exhibit 101 (which was previously included in the Quarterly Report) formatted in iXBRL (Inline eXtensible Business Reporting Language), and Exhibit 104 (Cover Page Interactive Data File (formatted in iXBRL and contained in Exhibit 101)), which had been inadvertently omitted from the Quarterly Report. For the convenience of the reader, this report on Form 10-Q/A refiles in its entirety the Quarterly Report. Additionally, this filing includes updated CEO and CFO certifications filed as Exhibits 31.1, 31.2, 32.1, 32.2. No other changes have been made to the Quarterly Report. | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Jun. 30, 2020 | |
Document Fiscal Period Focus | Q2 | |
Document Fiscal Year Focus | 2020 | |
Current Fiscal Year End Date | --12-31 | |
Entity File Number | 001-37348 | |
Entity Registrant Name | Corbus Pharmaceuticals Holdings, Inc. | |
Entity Central Index Key | 0001595097 | |
Entity Tax Identification Number | 46-4348039 | |
Entity Incorporation, State or Country Code | DE | |
Entity Address, Address Line One | 500 River Ridge Drive | |
Entity Address, City or Town | Norwood | |
Entity Address, State or Province | MA | |
Entity Address, Postal Zip Code | 02062 | |
City Area Code | (617) | |
Local Phone Number | 963-0100 | |
Title of 12(b) Security | Common Stock, par value $0.0001 per share | |
Trading Symbol | CRBP | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 81,712,134 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) | Jun. 30, 2020 | Dec. 31, 2019 |
Current assets: | ||
Cash and cash equivalents | $ 63,468,769 | $ 31,748,686 |
Customer receivable | 5,000,000 | |
Stock subscriptions receivable | 16,675,971 | |
Prepaid expenses and other current assets | 2,872,275 | 3,724,932 |
Contract asset | 2,681,065 | |
Total current assets | 88,017,015 | 38,154,683 |
Property and equipment, net | 4,547,303 | 5,083,865 |
Operating lease right of use assets | 5,539,677 | 5,818,983 |
Other assets | 14,085 | 84,968 |
Total assets | 98,118,080 | 49,142,499 |
Current liabilities: | ||
Notes payable | 108,936 | 752,659 |
Accounts payable | 12,697,845 | 11,091,363 |
Accrued expenses | 28,144,144 | 22,447,939 |
Deferred revenue, current | 270,530 | |
Operating lease liabilities, current | 873,525 | 595,745 |
Total current liabilities | 42,094,980 | 34,887,706 |
Operating lease liabilities, noncurrent | 7,609,221 | 8,097,228 |
Total liabilities | 49,704,201 | 42,984,934 |
Commitments and Contingencies | ||
Stockholders’ equity | ||
Preferred stock, $0.0001 par value; 10,000,000 shares authorized, no shares issued and outstanding at June 30, 2020 and December 31, 2019 | ||
Common stock, $0.0001 par value; 150,000,000 shares authorized, 80,655,848 and 64,672,893 shares issued and outstanding at June 30, 2020 and December 31, 2019, respectively | 8,065 | 6,467 |
Additional paid-in capital | 308,991,895 | 198,975,056 |
Accumulated deficit | (260,586,081) | (192,823,958) |
Total stockholders’ equity | 48,413,879 | 6,157,565 |
Total liabilities and stockholders’ equity | $ 98,118,080 | $ 49,142,499 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Jun. 30, 2020 | Dec. 31, 2019 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 150,000,000 | 150,000,000 |
Common stock, shares issued | 80,655,848 | 64,672,893 |
Common stock, shares outstanding | 80,655,848 | 64,672,893 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Income Statement [Abstract] | ||||
Revenue from awards and licenses | $ 286,346 | $ 29,094,583 | $ 2,048,405 | $ 30,980,265 |
Operating expenses: | ||||
Research and development | 30,686,071 | 22,181,409 | 54,633,937 | 43,965,113 |
General and administrative | 7,738,968 | 5,207,962 | 15,438,447 | 11,832,709 |
Total operating expenses | 38,425,039 | 27,389,371 | 70,072,384 | 55,797,822 |
Operating income (loss) | (38,138,693) | 1,705,212 | (68,023,979) | (24,817,557) |
Other income (expense), net: | ||||
Interest income, net | 12,649 | 448,717 | 114,642 | 783,312 |
Foreign currency exchange gain (loss), net | 20,721 | (1,276) | 147,214 | (47,911) |
Other income, net | 33,370 | 447,441 | 261,856 | 735,401 |
Net income (loss) | $ (38,105,323) | $ 2,152,653 | $ (67,762,123) | $ (24,082,156) |
Net income (loss) per share, basic | $ (0.52) | $ 0.03 | $ (0.95) | $ (0.38) |
Net income (loss) per share, diluted | $ (0.52) | $ 0.03 | $ (0.95) | $ (0.38) |
Weighted average number of common shares outstanding, basic | 73,885,548 | 64,546,628 | 71,578,975 | 63,119,196 |
Weighted average number of common shares outstanding, diluted | 73,885,548 | 68,511,587 | 71,578,975 | 63,119,196 |
Condensed Consolidated Statem_2
Condensed Consolidated Statement of Stockholders' Equity (Unaudited) - USD ($) | Common Stock [Member] | Additional Paid-in Capital [Member] | Retained Earnings [Member] | Total |
Beginning balance, value at Dec. 31, 2018 | $ 5,725 | $ 148,888,635 | $ (121,370,240) | $ 27,524,120 |
Beginning balance, shares at Dec. 31, 2018 | 57,247,496 | |||
Stock-based compensation expense | 5,906,427 | 5,906,427 | ||
Issuance of common stock, net of issuance costs of $2,571,552 | $ 620 | 37,718,078 | 37,718,698 | |
Issuance of common stock, net of issuance costs of $2,571,552, shares | 6,198,500 | |||
Issuance of common stock upon exercise of warrants | $ 112 | (112) | ||
Issuance of common stock upon exercise of warrants, shares | 1,119,868 | |||
Issuance of common stock upon exercise of stock options | $ 8 | 306,703 | 306,711 | |
Issuance of common stock upon exercise of stock options, shares | 78,229 | |||
Net loss | (24,082,156) | (24,082,156) | ||
Ending balance, value at Jun. 30, 2019 | $ 6,465 | 192,819,731 | (145,452,396) | 47,373,800 |
Ending balance, shares at Jun. 30, 2019 | 64,644,093 | |||
Beginning balance, value at Mar. 31, 2019 | $ 6,446 | 189,899,554 | (147,605,049) | 42,300,951 |
Beginning balance, shares at Mar. 31, 2019 | 64,455,221 | |||
Stock-based compensation expense | 2,817,488 | 2,817,488 | ||
Issuance of common stock upon exercise of warrants | $ 17 | (17) | ||
Issuance of common stock upon exercise of warrants, shares | 172,414 | |||
Issuance of common stock upon exercise of stock options | $ 2 | 102,706 | 102,708 | |
Issuance of common stock upon exercise of stock options, shares | 16,458 | |||
Net loss | 2,152,653 | 2,152,653 | ||
Ending balance, value at Jun. 30, 2019 | $ 6,465 | 192,819,731 | (145,452,396) | 47,373,800 |
Ending balance, shares at Jun. 30, 2019 | 64,644,093 | |||
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 | 6,485,779 | 6,485,779 | ||
Issuance of common stock, net of issuance costs of $2,571,552 | $ 1,578 | 103,228,775 | 103,230,353 | |
Issuance of common stock, net of issuance costs of $2,571,552, shares | 15,780,461 | |||
Issuance of common stock upon exercise of stock options | $ 20 | 302,285 | $ 302,305 | |
Issuance of common stock upon exercise of stock options, shares | 202,494 | 202,494 | ||
Net loss | (67,762,123) | $ (67,762,123) | ||
Ending balance, value at Jun. 30, 2020 | $ 8,065 | 308,991,895 | (260,586,081) | 48,413,879 |
Ending balance, shares at Jun. 30, 2020 | 80,655,848 | |||
Beginning balance, value at Mar. 31, 2020 | $ 7,249 | 245,164,999 | (222,480,758) | 22,691,490 |
Beginning balance, shares at Mar. 31, 2020 | 72,490,449 | |||
Stock-based compensation expense | 3,348,260 | 3,348,260 | ||
Issuance of common stock, net of issuance costs of $2,571,552 | $ 811 | 60,192,331 | 60,193,142 | |
Issuance of common stock, net of issuance costs of $2,571,552, shares | 8,113,794 | |||
Issuance of common stock upon exercise of warrants, shares | ||||
Issuance of common stock upon exercise of stock options | $ 5 | 286,305 | 286,310 | |
Issuance of common stock upon exercise of stock options, shares | 51,605 | |||
Net loss | (38,105,323) | (38,105,323) | ||
Ending balance, value at Jun. 30, 2020 | $ 8,065 | $ 308,991,895 | $ (260,586,081) | $ 48,413,879 |
Ending balance, shares at Jun. 30, 2020 | 80,655,848 |
Condensed Consolidated Statem_3
Condensed Consolidated Statement of Stockholders' Equity (Unaudited) (Parenthetical) - USD ($) | 3 Months Ended | 6 Months Ended | |
Jun. 30, 2020 | Jun. 30, 2020 | Jun. 30, 2019 | |
Statement of Stockholders' Equity [Abstract] | |||
Stock issuance cost | $ 2,051,853 | $ 5,014,643 | $ 2,571,552 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) | 6 Months Ended | |
Jun. 30, 2020 | Jun. 30, 2019 | |
Cash flows from operating activities: | ||
Net loss | $ (67,762,123) | $ (24,082,156) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation expense | 6,485,779 | 5,906,427 |
Depreciation and amortization | 639,676 | 308,331 |
Gain on foreign exchange | (120,098) | (591) |
Operating lease right of use asset amortization | 279,306 | 232,924 |
Changes in operating assets and liabilities: | ||
Decrease in customer receivable | 5,000,000 | |
Decrease in prepaid expenses | 852,657 | 255,897 |
Decrease in contract asset | 2,681,065 | |
Decrease (increase) in other assets | 70,883 | (79,402) |
Increase in accounts payable | 1,866,324 | 1,097,910 |
Increase in accrued expenses | 5,737,946 | 8,989,731 |
Decrease in deferred revenue | (4,729,470) | (3,980,265) |
(Decrease) increase in operating lease liabilities | (210,227) | 279,063 |
Net cash used in operating activities | (54,208,282) | (6,072,131) |
Cash flows from investing activities: | ||
Purchases of property and equipment | (479,779) | (256,898) |
Net cash used in investing activities | (479,779) | (256,898) |
Cash flows from financing activities: | ||
Principal payments on notes payable | (643,723) | (294,972) |
Proceeds from issuance of common stock | 90,003,980 | 40,596,961 |
Issuance costs paid for common stock financings | (2,952,113) | (2,566,137) |
Principal payments on capital lease obligation | (375) | |
Net cash provided by financing activities | 86,408,144 | 37,735,477 |
Net increase in cash and cash equivalents | 31,720,083 | 31,406,448 |
Cash and cash equivalents at beginning of the period | 31,748,686 | 41,748,468 |
Cash and cash equivalents at end of the period | 63,468,769 | 73,154,916 |
Supplemental disclosure of cash flow information and non-cash transactions: | ||
Cash paid during the period for interest | 12,752 | 6,300 |
Stock issuance costs included in accounts payable or accrued expenses | 195,181 | 5,415 |
Stock subscriptions receivable | 16,675,971 | |
Purchases of property and equipment included in accounts payable or accrued expenses | 259,731 | |
Right of use assets obtained in exchange for lease obligation upon adoption of ASU 2016-02 | 2,399,524 | |
Right of use assets obtained in exchange for lease obligation upon entry into February 2019 Lease Agreement | $ 3,529,090 |
NATURE OF OPERATIONS
NATURE OF OPERATIONS | 6 Months Ended |
Jun. 30, 2020 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
NATURE OF OPERATIONS | 1. NATURE OF OPERATIONS Business Corbus Pharmaceuticals Holdings, Inc. (the “Company”) is a clinical stage pharmaceutical company, focused on the development and commercialization of novel therapeutics to treat rare, chronic, and serious inflammatory and fibrotic diseases. 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 June 30, 2020, the results of its operations and changes in stockholders’ equity for the three months and six months ended June 30, 2020 and 2019 and its cash flows for the six months ended June 30, 2020 and 2019. The December 31, 2019 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, 2019, filed on March 16, 2020. The results of operations for such interim periods are not necessarily indicative of the operating results for the full fiscal year. |
LIQUIDITY AND GOING CONCERN
LIQUIDITY AND GOING CONCERN | 6 Months Ended |
Jun. 30, 2020 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
LIQUIDITY AND GOING CONCERN | 2. LIQUIDITY AND GOING CONCERN 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 June 30, 2020, had an accumulated deficit of $ 260,586,081 Should the Company be unable to raise sufficient additional capital, the Company may be required to undertake cost-cutting measures including delaying or discontinuing certain clinical activities. The Company will need to raise significant additional capital to continue to fund the clinical trials for lenabasum and CRB-4001 (see Note 4). The Company may seek to sell common or preferred equity or convertible debt securities, enter into a credit facility or another form of third-party funding, or seek other debt financing. The sale of equity and convertible debt securities may result in dilution to the Company’s stockholders and certain of those securities may have rights senior to those of the Company’s common shares. If the Company raises additional funds through the issuance of preferred stock, convertible debt securities or other debt financing, these securities or other debt could contain covenants that would restrict the Company’s operations. Any other third-party funding arrangement could require the Company to relinquish valuable rights. 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, among other things, to delay, scale back or eliminate some or all of the Company’s planned clinical trials. These factors among others cause management to conclude there is a substantial doubt about the Company’s ability to continue as a going concern. There have been no adjustments made to these consolidated financial statements as a result of these uncertainties. On February 11, 2020, the Company consummated an underwritten public offering of shares of its common stock (“February 2020 Offering”) (See Note 10). On April 7, 2020, the Company entered into an Open Market Sale Agreement SM 75,000,000 In June 2020, the Company became entitled to receive $ 5,000,000 25,000,000 5,000,000 On July 28, 2020, the Company entered into a Loan and Security Agreement (the “Loan Agreement”) with its subsidiary, Corbus Pharmaceuticals, Inc., as borrower, the Company, as guarantor, each lender party thereto (the “Lenders”), K2 HealthVentures LLC (“K2HV”), an unrelated third party, as administrative agent for the Lenders, and Ankura Trust Company, LLC, an unrelated third party, as collateral agent for the Lenders, pursuant to which K2HV may provide the Company with term loans in an aggregate principal amount of up to a $ 50,000,000 |
SIGNIFICANT ACCOUNTING POLICIES
SIGNIFICANT ACCOUNTING POLICIES | 6 Months Ended |
Jun. 30, 2020 | |
Accounting Policies [Abstract] | |
SIGNIFICANT ACCOUNTING POLICIES | 3. SIGNIFICANT ACCOUNTING POLICIES A summary of the significant accounting policies followed by the Company in the preparation of the financial statements is as follows: Use of Estimates The process of preparing financial statements in conformity with accounting principles generally accepted in the United States of America (“GAAP”) requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates and changes in estimates may occur. The most significant estimates are related to stock-based compensation, the accrual of research, product development and clinical obligations, the recognition of revenue under the Investment Agreement (See Note 9), and the valuation of the CFF Warrant discussed in Note 12. Cash and Cash Equivalents The Company considers only those investments which are highly liquid, readily convertible to cash, and that mature within three months from date of purchase to be cash equivalents. Marketable investments are those with original maturities in excess of three months. At June 30, 2020 and December 31, 2019, cash equivalents were comprised of money market funds. The Company had no Cash and cash equivalents consists of the following: Schedule of Cash and Cash Equivalents June 30, December 31, Cash $ 764,791 $ 884,115 Money market fund 62,703,978 30,864,571 Total cash and cash equivalents $ 63,468,769 $ 31,748,686 As of June 30, 2020, all of the Company’s cash and cash equivalents was held in the United States, except for approximately $ 556,000 466,000 Financial Instruments The carrying values of the notes payable approximate their fair value due to the fact that they are at market terms. Property and Equipment The estimated life for the Company's property and equipment is as follows: three years for computer hardware and software and three to five years for office furniture and equipment. Research and Development Expenses Costs incurred for research and development are expensed as incurred. Nonrefundable advance payments for goods or services that have the characteristics that will be used or rendered for future research and development activities pursuant to executory contractual arrangements with third party research organizations are deferred and recognized as an expense as the related goods are delivered or the related services are performed. Accruals for Research and Development Expenses and Clinical Trials As part of the process of preparing its financial statements, the Company is required to estimate its expenses resulting from its obligations under contracts with vendors, clinical research organizations and consultants and under clinical site agreements in connection with conducting clinical trials. The financial terms of these contracts are subject to negotiations, which vary from contract to contract and may result in payment terms that do not match the periods over which materials or services are provided under such contracts. The Company’s objective is to reflect the appropriate expenses in its financial statements by matching those expenses with the period in which services are performed and efforts are expended. The Company accounts for these expenses according to the timing of various aspects of the expenses. The Company determines accrual estimates by taking into account discussion with applicable personnel and outside service providers as to the progress of clinical trials, or the services completed. During the course of a clinical trial, the Company adjusts its clinical expense recognition if actual results differ from its estimates. The Company makes estimates of its accrued expenses as of each balance sheet date based on the facts and circumstances known to it at that time. The Company’s clinical trial accruals are dependent upon the timely and accurate reporting of contract research organizations and other third-party vendors. Although the Company does not expect its estimates to be materially different from amounts actually incurred, its understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and may result in it reporting amounts that are too high or too low for any particular period. For the three and six months ended June 30, 2020 and 2019, there were no material adjustments to the Company’s prior period estimates of accrued expenses for clinical trials. Leases The Company determines if an arrangement is a lease at inception. Operating leases are included in operating lease right-of-use (“ROU”) assets, other current liabilities and operating lease liabilities in the Company’s consolidated balance sheets. ROU assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent its obligation to make lease payments arising from the lease. ROU assets and liabilities are recognized at commencement date based on the present value of lease payments over the lease term. As the Company’s leases do not provide an implicit rate, the Company uses an incremental borrowing rate based on the information available at commencement date in determining the present value of lease payments. This is the rate the Company would have to pay if borrowing on a collateralized basis over a similar term to each lease. The ROU asset also includes any lease payments made and excludes lease incentives. Lease expense for lease payments is recognized on a straight-line basis over the lease term. Concentrations of Credit Risk The Company has no significant off-balance-sheet concentration of credit risk such as foreign exchange contracts, option contracts or other hedging arrangements. The Company may from time to time have cash in banks in excess of Federal Deposit Insurance Corporation insurance limits. However, the Company believes the risk of loss is minimal as these banks are large financial institutions. Segment Information Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision maker, or decision making group, in making decisions regarding resource allocation and assessing performance. To date, the Company has viewed its operations and manages its business as principally one 556,000 1,713,000 13,000 37,000 466,000 1,606,000 23,000 52,000 Income Taxes For federal and state income taxes, deferred tax assets and liabilities are recognized based upon temporary differences between the financial statement and the tax basis of assets and liabilities. Deferred income taxes are based upon prescribed rates and enacted laws applicable to periods in which differences are expected to reverse. A valuation allowance is recorded to reduce a net deferred tax benefit when it is not more likely than not that the tax benefit from the deferred tax assets will be realized. Accordingly, given the cumulative losses since inception, the Company has provided a valuation allowance equal to 100 Tax positions taken or expected to be taken in the course of preparing the Company’s tax returns are required to be evaluated to determine whether the tax positions are “more-likely-than-not” of being sustained by the applicable tax authority. Tax positions not deemed to meet a more-likely-than-not threshold, as well as accrued interest and penalties, if any, would be recorded as a tax expense in the current year. There were no Impairment of Long-lived Assets The Company continually monitors events and changes in circumstances that could indicate that carrying amounts of long-lived assets may not be recoverable. An impairment loss is recognized when expected undiscounted cash flows of an asset are less than an asset’s carrying value. Accordingly, when indicators of impairment are present, the Company evaluates the carrying value of such assets in relation to the operating performance and future undiscounted cash flows of the underlying assets. An impairment loss equal to the excess of the fair value of the asset over its carrying amount, is recorded when it is determined that the carrying value of the asset may not be recoverable. No Stock-based Payments The Company recognizes compensation costs resulting from the issuance of stock-based awards to employees, non-employees and directors as an expense in the statement of operations over the service period based on a measurement of fair value for each stock-based award. The fair value of each option grant 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 Income (Loss) Per Common Share Net income (loss) per share was computed as follows: Schedule of Computation of Net Income (Loss) Per Share Three Months Ended June 30 Six Months Ended June 30 2020 2019 2020 2019 Net income (loss) $ (38,105,323 ) $ 2,152,653 $ (67,762,123 ) $ (24,082,156 ) Weighted average number of common shares-basic 73,885,548 64,546,628 71,578,975 63,119,196 Effect of dilutive securities — 3,964,959 — — Weighted average number of common shares-diluted 73,885,548 68,511,587 71,578,975 63,119,196 Net income (loss) per share of common stock-basic $ (0.52 ) $ 0.03 $ (0.95 ) $ (0.38 ) Net income (loss) per share of common stock-diluted $ (0.52 ) $ 0.03 $ (0.95 ) $ (0.38 ) Antidilutive awards (1) — 281,132 — 317,945 (1) Certain stock-based compensation awards were not included in the calculation of net income per common share for the three months ended June 30, 2019 because their effect would have been antidilutive. For the three months ended June 30, 2020 and the six months ended June 30, 2020 and 2019, the effect of dilutive shares was not included in the computation of net loss per share because the Company had a net loss. Recent Accounting Pronouncements Accounting for Income Taxes In December 2019, the FASB issued ASU 2019-12 , Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes Collaborative Arrangements In November 2018, the FASB issued ASU 2018-18, Collaborative Arrangements (Topic 808): Clarifying the Interaction between Topic 808 and Topic 606 (“ASU 2018-18”) . ASU 2018-18 clarifies the interaction between the accounting guidance for collaborative arrangements and revenue from contracts with customers. . The Company’s as of January 1, 2020 . |
LICENSE AGREEMENT
LICENSE AGREEMENT | 6 Months Ended |
Jun. 30, 2020 | |
License Agreement | |
LICENSE AGREEMENT | 4. LICENSE AGREEMENT The Company entered into a License Agreement (the “Jenrin Agreement”) with Jenrin Discovery, LLC, a privately-held Delaware limited liability company (“Jenrin”), effective September 20, 2018. Pursuant to the Jenrin Agreement, Jenrin granted the Company exclusive worldwide rights to develop and commercialize the Licensed Products (as defined in the Jenrin Agreement) which includes the Jenrin library of over 600 compounds and multiple issued and pending patent filings. The compounds are designed to treat inflammatory and fibrotic diseases by targeting the endocannabinoid system. The lead product candidate is CRB-4001, a peripherally-restricted CB-1 inverse agonist targeting fibrotic liver, lung, heart and kidney diseases. 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 | 6 Months Ended |
Jun. 30, 2020 | |
Property, Plant and Equipment [Abstract] | |
PROPERTY AND EQUIPMENT | 5. PROPERTY AND EQUIPMENT Property and equipment consisted of the following: Summary of Property and Equipment June 30, 2020 December 31, Computer hardware and software $ 794,749 $ 711,442 Office furniture and equipment 1,638,396 1,627,896 Leasehold improvements 4,159,795 4,150,488 Property and equipment, gross 6,592,940 6,489,826 Less: accumulated depreciation (2,045,637 ) (1,405,961 ) Property and equipment, net $ 4,547,303 $ 5,083,865 Depreciation expense was $ 320,188 155,709 639,676 308,331 |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 6 Months Ended |
Jun. 30, 2020 | |
Commitments and Contingencies Disclosure [Abstract] | |
COMMITMENTS AND CONTINGENCIES | 6. COMMITMENTS AND CONTINGENCIES Operating Lease Commitment On August 21, 2017, the Company entered into a lease agreement (“August 2017 Lease Agreement”) for commercial lease of office space, pursuant to which the Company agreed to lease 32,733 seven years 470,000 908,000 1,080,189 400,000 300,000 200,000 400,000 The Company adopted ASU 2016-02, Leases (Topic 842), 3,811,000 2,400,000 ROU assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent its obligation to make lease payments arising from the lease. ROU assets and liabilities are recognized at the date of adoption based on the present value of lease payments over the lease term. As the Company’s leases do not provide an implicit rate, the Company uses an incremental borrowing rate based on the information available at commencement date in determining the present value of lease payments, which was 9 On February 26, 2019, the Company amended its lease (“February 2019 Lease Agreement”) pursuant to which an additional 30,023 62,756 Per ASC 842, the February 2019 Lease Agreement constitutes a modification as it extends the original lease term and increases the scope of the lease (additional space provided under the amendment), which requires evaluation of the remeasurement of the lease liability and corresponding ROU asset. Accordingly, the Company reassessed the classification of the Leased Premises and remeasured the lease liability on the basis of the extended lease term using the 20 additional monthly rent payments and the incremental borrowing rate at the effective date of the modification of 9%. 855,000 2,700,000 On October 25, 2019, the Company amended its lease (“October 2019 Lease Amendment”) pursuant to which the term of the lease was extended through November 30, 2026 and the existing office space under lease was expanded by 500 63,256 The October 2019 Lease Amendment constitutes a modification as it extends the original lease term and increases the scope of the lease (additional space provided under the amendment), which requires evaluation of the remeasurement of the lease liability and corresponding ROU asset. The additional space did not result in a separate contract as the rent increase was determined not to be commensurate with the standalone price for the additional right of use. Accordingly, the Company reassessed the classification of the Amended Total Premises, which resulted in operating classification, and remeasured the lease liability on the basis of the extended lease term using the additional monthly rent payments and the incremental borrowing rate at the effective date of the modification of 8 381,000 The following table contains a summary of the lease costs recognized and other information pertaining to the Company’s operating leases for the year ended December 31, 2019: Schedule of Lease Costs Lease cost Operating lease cost $ 1,025,899 Total lease cost $ 1,025,899 Other information Operating cash flows received for operating leases $ 338,435 Weighted average remaining lease term 6.9 Weighted average discount rate 8.00 % Total lease expense for the three months ended June 30, 2020 and 2019 was $ 310,119 307,182 620,237 507,344 Pursuant to the terms of our non-cancelable lease agreements in effect at June 30, 2020, the following table summarizes our maturities of operating lease liabilities as of June 30, 2020: Schedule of Maturities of Operating Lease Liabilities June 30, 2020 2020 (Remainder of year) $ 714,603 2021 1,605,121 2022 1,652,563 2023 1,700,005 2024 1,747,447 Thereafter 3,483,034 Total lease payments $ 10,902,772 Less: imputed interest (2,420,027 ) Total $ 8,482,746 Capital Lease Commitment The lease payments under the capital lease agreement for the copier machine commenced when the machine was placed in service in January 2016. The lease was for a three-year term that concluded in January 2019 and included a bargain purchase option at the end of the term. For commitments under the Company’s development award agreements see Note 9. COVID-19 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. As a result of the COVID-19 pandemic, the Company may experience disruptions that could adversely impact its business. The COVID-19 pandemic may negatively affect clinical site initiation, patient recruitment and enrollment, patient dosing, distribution of drug to clinical sites and clinical trial monitoring for the Company’s clinical trials. The COVID-19 pandemic may also negatively affect the operations of the third-party contract research organizations that the Company relies upon to assist it in conducting its clinical trials and the contract manufacturers who manufacture the Company’s drug candidates. The Company is continuing to assess the potential impact of the COVID-19 pandemic on its business and operations. |
NOTES PAYABLE
NOTES PAYABLE | 6 Months Ended |
Jun. 30, 2020 | |
Debt Disclosure [Abstract] | |
NOTES PAYABLE | 7. NOTES PAYABLE In November 2018, the Company entered into a loan agreement with a financing company for $ 491,629 49,857 ten-month period 3.07 This loan was fully repaid in August 2019 In November 2019, the Company entered into a loan agreement with a financing company for $ 963,514 109,413 nine-month period 5.25 356,519 923,292 |
ACCRUED EXPENSES
ACCRUED EXPENSES | 6 Months Ended |
Jun. 30, 2020 | |
Payables and Accruals [Abstract] | |
ACCRUED EXPENSES | 8. ACCRUED EXPENSES Accrued expenses consisted of the following: Schedule of Accrued Expenses June 30, December 31, Accrued clinical operations and trials costs $ 16,901,307 $ 14,242,669 Accrued product development costs 5,695,552 3,573,231 Accrued compensation 3,842,249 3,673,111 Accrued other 1,705,036 958,928 Total $ 28,144,144 $ 22,447,939 |
DEVELOPMENT AWARDS AND DEFERRED
DEVELOPMENT AWARDS AND DEFERRED REVENUE | 6 Months Ended |
Jun. 30, 2020 | |
Revenue from Contract with Customer [Abstract] | |
DEVELOPMENT AWARDS AND DEFERRED REVENUE | 9. DEVELOPMENT AWARDS AND DEFERRED REVENUE Collaboration with Kaken On January 3, 2019, 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 ASC 606 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 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 17,500,000 5,000,000 5,000,000 Pursuant to the terms of the Investment Agreement, the Company is obligated to make certain royalty payments to CFF, including a royalty payment of one and one-half times the amount of the 2018 CFF Award, payable in cash within sixty days upon the first receipt of approval of lenabasum in the United States and a second royalty payment of one and one-half times the amount of the 2018 CFF Award upon approval in another major market, as set forth in the Investment Agreement (the “Approval Royalty”). At the Company’s election, the Company may satisfy the first of the two Approval Royalties in registered shares of the Company’s common stock. Additionally, the Company is obligated to make (i) royalty payments to CFF of two and one-half percent of net sales from lenabasum due within sixty days after any quarter in which such net sales occur in the Field, as defined in the Investment Agreement, (ii) royalty payments to CFF of one percent of net sales of Non-Field Products, as defined in the Investment Agreement due within sixty days after any quarter in which such net sales occur, and (iii) royalty payments to CFF of ten percent of any amount the Company and its stockholders receive in connection with the license, sale, or other transfer to a third party of lenabasum, if indicated for the treatment or prevention of CF, or a change of control transaction, except that such payment shall not exceed five times the amount of the 2018 CFF Award, with such payments to be credited against any other net sales royalty payments due. Accordingly, the Company will owe to CFF a royalty payment equal to 10 Either CFF or the Company may terminate the Investment Agreement for cause, which includes the Company’s material failure to achieve certain commercialization and development milestones. The Company’s payment obligations survive the termination of the Investment Agreement. Pursuant to the terms of the Investment Agreement, the Company issued a warrant to CFF to purchase an aggregate of 1,000,000 13.20 500,000 500,000 January 26, 2025 Under the Investment Agreement, the Company recorded $ 286,346 2,094,583 2,048,405 3,980,265 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 The Company has billed and received $ 22,500,000 12,500,000 5,000,000 5,000,000 Schedule of Roll Forward of Deferred Revenue June 30, 2020 Beginning balance, December 31, 2019 $ — Billing to CFF upon achievement of milestone 5,000,000 Recognition of revenue (2,048,405 ) Reverse to contract asset (unbilled revenue) (2,681,065 ) Ending balance $ 270,530 The CFF Warrant is accounted for as a payment to the customer under ASC 606. See Note 12 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 2.75 |
COMMON STOCK
COMMON STOCK | 6 Months Ended |
Jun. 30, 2020 | |
Equity [Abstract] | |
COMMON STOCK | 10. COMMON STOCK The Company has authorized 150,000,000 0.0001 80,655,848 64,672,893 On January 30, 2019, the Company consummated an underwritten public offering of shares of its common stock pursuant to which the Company sold an aggregate of 6,198,500 808,500 6.50 40,290,250 2,572,000 On February 11, 2020, the Company consummated an underwritten public offering of shares of its common stock pursuant to which the Company sold an aggregate of 7,666,667 1,000,000 6.00 46,000,000 3,147,000 On April 7, 2020, the Company entered into the April 2020 Sale Agreement with Jefferies pursuant to which Jefferies is serving as the Company’s sales agent to sell up to $ 75,000,000 75,000,000 8,113,794 43,702,000 16,676,000 1,053,286 8,148,000 During the three and six months ended June 30, 2020, the Company issued 51,605 202,494 286,310 302,305 16,458 78,229 102,708 306,711 During the three and six months ended June 30, 2019, warrants to purchase 200,000 1,283,500 172,414 1,119,868 No |
STOCK OPTIONS
STOCK OPTIONS | 6 Months Ended |
Jun. 30, 2020 | |
Share-based Payment Arrangement [Abstract] | |
STOCK OPTIONS | 11. 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. Options issued under the 2014 Plan generally vest over 4 10 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, effective as of January 1, 2019, the number of shares of common stock available for issuance under the 2014 Plan increased by 3,000,000 7 18,543,739 8,072,241 5,200,795 In accordance with the terms of 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 8,840,939 5,512,150 Stock-based Compensation For stock options issued and outstanding for the three months ended June 30, 2020 and 2019, respectively, the Company recorded non-cash, stock-based compensation expense of $ 3,348,360 2,817,488 6,485,779 5,906,427 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. Due to its limited operating history, the Company estimates its volatility including the volatility of comparable public companies and its own common stock, taking into account the expected life of the option. 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 to Employees Six Months Ended June 30, 2020 2019 Risk free interest rate 0.62% 2.56% Expected dividend yield 0% 0% Expected term in years 6.25 6.25 Expected volatility 82.89% 87.65% Estimated forfeiture rate 5.98% 4.75% A summary of option activity for the six months ended June 30, 2020 and is presented below: Summary of Option Activity Options Shares Weighted Weighted Contractual Aggregate Outstanding at December 31, 2019 13,245,366 $ 5.19 Granted 3,883,600 4.87 Exercised (202,494 ) 1.49 Forfeited (554,811 ) 5.93 Outstanding at June 30, 2020 16,371,661 $ 5.14 7.27 $ 54,044,121 Vested at June 30, 2020 9,148,866 $ 4.50 5.86 $ 36,271,485 Vested and expected to vest at June 30, 2020 15,775,432 $ 5.13 7.20 $ 52,286,782 The weighted average grant-date fair value of options granted during the six months ended June 30, 2020 and 2019 was $ 3.44 5.41 1,030,994 233,095 31,198,928 19,252,762 26,300,051 2.69 |
WARRANTS
WARRANTS | 6 Months Ended |
Jun. 30, 2020 | |
Warrants | |
WARRANTS | 12. WARRANTS During the three and six months ended June 30, 2019, warrants to purchase 200,000 1,283,500 172,414 1,119,868 No At June 30, 2020, there were warrants outstanding to purchase 1,000,000 13.20 4.58 1,000,000 13.20 500,000 500,000 January 26, 2025 6,215,225 Schedule of Weighted Average Assumption of Warrants Risk free interest rate 2.60 % Expected dividend yield 0 % Expected term in years 7.00 Expected volatility 83.5 % On July 28, 2020, the Company entered into the Loan Agreement with K2HV pursuant to which K2HV may provide the Company with term loans in an aggregate principal amount of up to a $ 50,000,000 20,000,000 86,206 6.96 |
SUSBSEQUENT EVENTS
SUSBSEQUENT EVENTS | 6 Months Ended |
Jun. 30, 2020 | |
Subsequent Events [Abstract] | |
SUSBSEQUENT EVENTS | 13. SUSBSEQUENT EVENTS Loan 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% 5.25% 5,000,000 9.40 86,206 6.96 August 2020 Sale Agreement On August 6, 2020, the Company entered into an Open Market Sale Agreement SM 3.0% 150 |
SIGNIFICANT ACCOUNTING POLICI_2
SIGNIFICANT ACCOUNTING POLICIES (Policies) | 6 Months Ended |
Jun. 30, 2020 | |
Accounting Policies [Abstract] | |
Use of Estimates | Use of Estimates The process of preparing financial statements in conformity with accounting principles generally accepted in the United States of America (“GAAP”) requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates and changes in estimates may occur. The most significant estimates are related to stock-based compensation, the accrual of research, product development and clinical obligations, the recognition of revenue under the Investment Agreement (See Note 9), and the valuation of the CFF Warrant discussed in Note 12. |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers only those investments which are highly liquid, readily convertible to cash, and that mature within three months from date of purchase to be cash equivalents. Marketable investments are those with original maturities in excess of three months. At June 30, 2020 and December 31, 2019, cash equivalents were comprised of money market funds. The Company had no Cash and cash equivalents consists of the following: Schedule of Cash and Cash Equivalents June 30, December 31, Cash $ 764,791 $ 884,115 Money market fund 62,703,978 30,864,571 Total cash and cash equivalents $ 63,468,769 $ 31,748,686 As of June 30, 2020, all of the Company’s cash and cash equivalents was held in the United States, except for approximately $ 556,000 466,000 |
Financial Instruments | Financial Instruments The carrying values of the notes payable approximate their fair value due to the fact that they are at market terms. |
Property and Equipment | Property and Equipment The estimated life for the Company's property and equipment is as follows: three years for computer hardware and software and three to five years for office furniture and equipment. |
Research and Development Expenses | Research and Development Expenses Costs incurred for research and development are expensed as incurred. Nonrefundable advance payments for goods or services that have the characteristics that will be used or rendered for future research and development activities pursuant to executory contractual arrangements with third party research organizations are deferred and recognized as an expense as the related goods are delivered or the related services are performed. |
Accruals for Research and Development Expenses and Clinical Trials | Accruals for Research and Development Expenses and Clinical Trials As part of the process of preparing its financial statements, the Company is required to estimate its expenses resulting from its obligations under contracts with vendors, clinical research organizations and consultants and under clinical site agreements in connection with conducting clinical trials. The financial terms of these contracts are subject to negotiations, which vary from contract to contract and may result in payment terms that do not match the periods over which materials or services are provided under such contracts. The Company’s objective is to reflect the appropriate expenses in its financial statements by matching those expenses with the period in which services are performed and efforts are expended. The Company accounts for these expenses according to the timing of various aspects of the expenses. The Company determines accrual estimates by taking into account discussion with applicable personnel and outside service providers as to the progress of clinical trials, or the services completed. During the course of a clinical trial, the Company adjusts its clinical expense recognition if actual results differ from its estimates. The Company makes estimates of its accrued expenses as of each balance sheet date based on the facts and circumstances known to it at that time. The Company’s clinical trial accruals are dependent upon the timely and accurate reporting of contract research organizations and other third-party vendors. Although the Company does not expect its estimates to be materially different from amounts actually incurred, its understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and may result in it reporting amounts that are too high or too low for any particular period. For the three and six months ended June 30, 2020 and 2019, there were no material adjustments to the Company’s prior period estimates of accrued expenses for clinical trials. |
Leases | Leases The Company determines if an arrangement is a lease at inception. Operating leases are included in operating lease right-of-use (“ROU”) assets, other current liabilities and operating lease liabilities in the Company’s consolidated balance sheets. ROU assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent its obligation to make lease payments arising from the lease. ROU assets and liabilities are recognized at commencement date based on the present value of lease payments over the lease term. As the Company’s leases do not provide an implicit rate, the Company uses an incremental borrowing rate based on the information available at commencement date in determining the present value of lease payments. This is the rate the Company would have to pay if borrowing on a collateralized basis over a similar term to each lease. The ROU asset also includes any lease payments made and excludes lease incentives. Lease expense for lease payments is recognized on a straight-line basis over the lease term. |
Concentrations of Credit Risk | Concentrations of Credit Risk The Company has no significant off-balance-sheet concentration of credit risk such as foreign exchange contracts, option contracts or other hedging arrangements. The Company may from time to time have cash in banks in excess of Federal Deposit Insurance Corporation insurance limits. However, the Company believes the risk of loss is minimal as these banks are large financial institutions. |
Segment Information | Segment Information Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision maker, or decision making group, in making decisions regarding resource allocation and assessing performance. To date, the Company has viewed its operations and manages its business as principally one 556,000 1,713,000 13,000 37,000 466,000 1,606,000 23,000 52,000 |
Income Taxes | Income Taxes For federal and state income taxes, deferred tax assets and liabilities are recognized based upon temporary differences between the financial statement and the tax basis of assets and liabilities. Deferred income taxes are based upon prescribed rates and enacted laws applicable to periods in which differences are expected to reverse. A valuation allowance is recorded to reduce a net deferred tax benefit when it is not more likely than not that the tax benefit from the deferred tax assets will be realized. Accordingly, given the cumulative losses since inception, the Company has provided a valuation allowance equal to 100 Tax positions taken or expected to be taken in the course of preparing the Company’s tax returns are required to be evaluated to determine whether the tax positions are “more-likely-than-not” of being sustained by the applicable tax authority. Tax positions not deemed to meet a more-likely-than-not threshold, as well as accrued interest and penalties, if any, would be recorded as a tax expense in the current year. There were no |
Impairment of Long-lived Assets | Impairment of Long-lived Assets The Company continually monitors events and changes in circumstances that could indicate that carrying amounts of long-lived assets may not be recoverable. An impairment loss is recognized when expected undiscounted cash flows of an asset are less than an asset’s carrying value. Accordingly, when indicators of impairment are present, the Company evaluates the carrying value of such assets in relation to the operating performance and future undiscounted cash flows of the underlying assets. An impairment loss equal to the excess of the fair value of the asset over its carrying amount, is recorded when it is determined that the carrying value of the asset may not be recoverable. No |
Stock-based Payments | Stock-based Payments The Company recognizes compensation costs resulting from the issuance of stock-based awards to employees, non-employees and directors as an expense in the statement of operations over the service period based on a measurement of fair value for each stock-based award. The fair value of each option grant 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 Income (Loss) Per Common Share | Net Income (Loss) Per Common Share Net income (loss) per share was computed as follows: Schedule of Computation of Net Income (Loss) Per Share Three Months Ended June 30 Six Months Ended June 30 2020 2019 2020 2019 Net income (loss) $ (38,105,323 ) $ 2,152,653 $ (67,762,123 ) $ (24,082,156 ) Weighted average number of common shares-basic 73,885,548 64,546,628 71,578,975 63,119,196 Effect of dilutive securities — 3,964,959 — — Weighted average number of common shares-diluted 73,885,548 68,511,587 71,578,975 63,119,196 Net income (loss) per share of common stock-basic $ (0.52 ) $ 0.03 $ (0.95 ) $ (0.38 ) Net income (loss) per share of common stock-diluted $ (0.52 ) $ 0.03 $ (0.95 ) $ (0.38 ) Antidilutive awards (1) — 281,132 — 317,945 (1) Certain stock-based compensation awards were not included in the calculation of net income per common share for the three months ended June 30, 2019 because their effect would have been antidilutive. For the three months ended June 30, 2020 and the six months ended June 30, 2020 and 2019, the effect of dilutive shares was not included in the computation of net loss per share because the Company had a net loss. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements Accounting for Income Taxes In December 2019, the FASB issued ASU 2019-12 , Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes Collaborative Arrangements In November 2018, the FASB issued ASU 2018-18, Collaborative Arrangements (Topic 808): Clarifying the Interaction between Topic 808 and Topic 606 (“ASU 2018-18”) . ASU 2018-18 clarifies the interaction between the accounting guidance for collaborative arrangements and revenue from contracts with customers. . The Company’s as of January 1, 2020 . |
SIGNIFICANT ACCOUNTING POLICI_3
SIGNIFICANT ACCOUNTING POLICIES (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Accounting Policies [Abstract] | |
Schedule of Cash and Cash Equivalents | Cash and cash equivalents consists of the following: Schedule of Cash and Cash Equivalents June 30, December 31, Cash $ 764,791 $ 884,115 Money market fund 62,703,978 30,864,571 Total cash and cash equivalents $ 63,468,769 $ 31,748,686 |
Schedule of Computation of Net Income (Loss) Per Share | Net income (loss) per share was computed as follows: Schedule of Computation of Net Income (Loss) Per Share Three Months Ended June 30 Six Months Ended June 30 2020 2019 2020 2019 Net income (loss) $ (38,105,323 ) $ 2,152,653 $ (67,762,123 ) $ (24,082,156 ) Weighted average number of common shares-basic 73,885,548 64,546,628 71,578,975 63,119,196 Effect of dilutive securities — 3,964,959 — — Weighted average number of common shares-diluted 73,885,548 68,511,587 71,578,975 63,119,196 Net income (loss) per share of common stock-basic $ (0.52 ) $ 0.03 $ (0.95 ) $ (0.38 ) Net income (loss) per share of common stock-diluted $ (0.52 ) $ 0.03 $ (0.95 ) $ (0.38 ) Antidilutive awards (1) — 281,132 — 317,945 (1) Certain stock-based compensation awards were not included in the calculation of net income per common share for the three months ended June 30, 2019 because their effect would have been antidilutive. For the three months ended June 30, 2020 and the six months ended June 30, 2020 and 2019, the effect of dilutive shares was not included in the computation of net loss per share because the Company had a net loss. |
PROPERTY AND EQUIPMENT (Tables)
PROPERTY AND EQUIPMENT (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Property, Plant and Equipment [Abstract] | |
Summary of Property and Equipment | Property and equipment consisted of the following: Summary of Property and Equipment June 30, 2020 December 31, Computer hardware and software $ 794,749 $ 711,442 Office furniture and equipment 1,638,396 1,627,896 Leasehold improvements 4,159,795 4,150,488 Property and equipment, gross 6,592,940 6,489,826 Less: accumulated depreciation (2,045,637 ) (1,405,961 ) Property and equipment, net $ 4,547,303 $ 5,083,865 |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of Lease Costs | The following table contains a summary of the lease costs recognized and other information pertaining to the Company’s operating leases for the year ended December 31, 2019: Schedule of Lease Costs Lease cost Operating lease cost $ 1,025,899 Total lease cost $ 1,025,899 Other information Operating cash flows received for operating leases $ 338,435 Weighted average remaining lease term 6.9 Weighted average discount rate 8.00 % |
Schedule of Maturities of Operating Lease Liabilities | Pursuant to the terms of our non-cancelable lease agreements in effect at June 30, 2020, the following table summarizes our maturities of operating lease liabilities as of June 30, 2020: Schedule of Maturities of Operating Lease Liabilities June 30, 2020 2020 (Remainder of year) $ 714,603 2021 1,605,121 2022 1,652,563 2023 1,700,005 2024 1,747,447 Thereafter 3,483,034 Total lease payments $ 10,902,772 Less: imputed interest (2,420,027 ) Total $ 8,482,746 |
ACCRUED EXPENSES (Tables)
ACCRUED EXPENSES (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Expenses | Accrued expenses consisted of the following: Schedule of Accrued Expenses June 30, December 31, Accrued clinical operations and trials costs $ 16,901,307 $ 14,242,669 Accrued product development costs 5,695,552 3,573,231 Accrued compensation 3,842,249 3,673,111 Accrued other 1,705,036 958,928 Total $ 28,144,144 $ 22,447,939 |
DEVELOPMENT AWARDS AND DEFERR_2
DEVELOPMENT AWARDS AND DEFERRED REVENUE (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Revenue from Contract with Customer [Abstract] | |
Schedule of Roll Forward of Deferred Revenue | Schedule of Roll Forward of Deferred Revenue June 30, 2020 Beginning balance, December 31, 2019 $ — Billing to CFF upon achievement of milestone 5,000,000 Recognition of revenue (2,048,405 ) Reverse to contract asset (unbilled revenue) (2,681,065 ) Ending balance $ 270,530 |
STOCK OPTIONS (Tables)
STOCK OPTIONS (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Share-based Payment Arrangement [Abstract] | |
Summary of Fair Value of Options Granted to Employees | 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 to Employees Six Months Ended June 30, 2020 2019 Risk free interest rate 0.62% 2.56% Expected dividend yield 0% 0% Expected term in years 6.25 6.25 Expected volatility 82.89% 87.65% Estimated forfeiture rate 5.98% 4.75% |
Summary of Option Activity | A summary of option activity for the six months ended June 30, 2020 and is presented below: Summary of Option Activity Options Shares Weighted Weighted Contractual Aggregate Outstanding at December 31, 2019 13,245,366 $ 5.19 Granted 3,883,600 4.87 Exercised (202,494 ) 1.49 Forfeited (554,811 ) 5.93 Outstanding at June 30, 2020 16,371,661 $ 5.14 7.27 $ 54,044,121 Vested at June 30, 2020 9,148,866 $ 4.50 5.86 $ 36,271,485 Vested and expected to vest at June 30, 2020 15,775,432 $ 5.13 7.20 $ 52,286,782 |
WARRANTS (Tables)
WARRANTS (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Warrants | |
Schedule of Weighted Average Assumption of Warrants | Schedule of Weighted Average Assumption of Warrants Risk free interest rate 2.60 % Expected dividend yield 0 % Expected term in years 7.00 Expected volatility 83.5 % |
LIQUIDITY AND GOING CONCERN (De
LIQUIDITY AND GOING CONCERN (Details Narrative) - USD ($) | Jul. 31, 2020 | Apr. 07, 2020 | Jun. 30, 2020 | Jul. 28, 2020 | Dec. 31, 2019 |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Accumulated deficit | $ 260,586,081 | $ 192,823,958 | |||
Cystic Fibrosis Program Related Investment Agreement [Member] | Phase 2 b Clinical trial [Member] | |||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Consideration payment milestone received | 5,000,000 | ||||
Proceeds from investments on achieving milestones | $ 25,000,000 | ||||
Cystic Fibrosis Program Related Investment Agreement [Member] | Phase 2 b Clinical trial [Member] | Subsequent Event [Member] | |||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Consideration payment milestone received | $ 5,000,000 | ||||
K2 HealthVentures LLC And Ankura Trust Company, LLC [Member] | Loan Agreement [Member] | Subsequent Event [Member] | |||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Debt face amount | $ 50,000,000 | ||||
Market Offering [Member] | Jefferies LLC [Member] | Maximum [Member] | |||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Number of common stock shares sold | 75,000,000 |
Schedule of Cash and Cash Equiv
Schedule of Cash and Cash Equivalents (Details) - USD ($) | Jun. 30, 2020 | Dec. 31, 2019 |
Accounting Policies [Abstract] | ||
Cash | $ 764,791 | $ 884,115 |
Money market fund | 62,703,978 | 30,864,571 |
Total cash and cash equivalents | $ 63,468,769 | $ 31,748,686 |
Schedule of Computation of Net
Schedule of Computation of Net Income (Loss) Per Share (Details) - USD ($) | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | ||
Accounting Policies [Abstract] | |||||
Net income (loss) | $ (38,105,323) | $ 2,152,653 | $ (67,762,123) | $ (24,082,156) | |
Weighted average number of common shares-basic | 73,885,548 | 64,546,628 | 71,578,975 | 63,119,196 | |
Effect of dilutive securities | 3,964,959 | ||||
Weighted average number of common shares-diluted | 73,885,548 | 68,511,587 | 71,578,975 | 63,119,196 | |
Net income (loss) per share of common stock-basic | $ (0.52) | $ 0.03 | $ (0.95) | $ (0.38) | |
Net income (loss) per share of common stock-diluted | $ (0.52) | $ 0.03 | $ (0.95) | $ (0.38) | |
Antidilutive awards (1) | [1] | 281,132 | 317,945 | ||
[1] | Certain stock-based compensation awards were not included in the calculation of net income per common share for the three months ended June 30, 2019 because their effect would have been antidilutive. For the three months ended June 30, 2020 and the six months ended June 30, 2020 and 2019, the effect of dilutive shares was not included in the computation of net loss per share because the Company had a net loss. |
SIGNIFICANT ACCOUNTING POLICI_4
SIGNIFICANT ACCOUNTING POLICIES (Details Narrative) - USD ($) | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Dec. 31, 2019 | |
SEC Schedule, 12-29, Real Estate Companies, Investment in Mortgage Loans on Real Estate [Line Items] | |||
Marketable investments | $ 0 | $ 0 | |
Property and equipment, estimated useful lives | The estimated life for the Company's property and equipment is as follows: three years for computer hardware and software and three to five years for office furniture and equipment. | ||
Number of operating segment | one | ||
Cash | $ 764,791 | 884,115 | |
Prepaid expenses and other current assets | 2,872,275 | 3,724,932 | |
Property and equipment, net | 4,547,303 | 5,083,865 | |
Uncertain tax positions | 0 | 0 | |
Impairment charges | $ 0 | $ 0 | |
Deferred Tax Assets [Member] | |||
SEC Schedule, 12-29, Real Estate Companies, Investment in Mortgage Loans on Real Estate [Line Items] | |||
Valuation allowance | 100.00% | ||
United Kingdom and Australia [Member] | |||
SEC Schedule, 12-29, Real Estate Companies, Investment in Mortgage Loans on Real Estate [Line Items] | |||
Cash held in subsidiary | $ 556,000 | 466,000 | |
UNITED KINGDOM | |||
SEC Schedule, 12-29, Real Estate Companies, Investment in Mortgage Loans on Real Estate [Line Items] | |||
Cash | 556,000 | 466,000 | |
Prepaid expenses and other current assets | 1,713,000 | 1,606,000 | |
Other assets | 13,000 | 23,000 | |
Property and equipment, net | $ 37,000 | $ 52,000 |
LICENSE AGREEMENT (Details Narr
LICENSE AGREEMENT (Details Narrative) - USD ($) | Sep. 20, 2018 | Sep. 30, 2018 | Jun. 30, 2020 |
Research and Development Expense [Member] | |||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Upfront cash payment | $ 250,000 | ||
Potential milestone payments | $ 18,400,000 | ||
Jenrin Agreement [Member] | |||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Upfront cash payment | $ 250,000 | ||
Potential milestone payments | $ 18,400,000 |
Summary of Property and Equipme
Summary of Property and Equipment (Details) - USD ($) | Jun. 30, 2020 | Dec. 31, 2019 |
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 6,592,940 | $ 6,489,826 |
Less: accumulated depreciation | (2,045,637) | (1,405,961) |
Property and equipment, net | 4,547,303 | 5,083,865 |
Computer Hardware and Software [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 794,749 | 711,442 |
Office Furniture and Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 1,638,396 | 1,627,896 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 4,159,795 | $ 4,150,488 |
PROPERTY AND EQUIPMENT (Details
PROPERTY AND EQUIPMENT (Details Narrative) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Property, Plant and Equipment [Abstract] | ||||
Depreciation expense | $ 320,188 | $ 155,709 | $ 639,676 | $ 308,331 |
Schedule of Lease Costs (Detail
Schedule of Lease Costs (Details) | 12 Months Ended |
Dec. 31, 2019USD ($) | |
Commitments and Contingencies Disclosure [Abstract] | |
Operating lease cost | $ 1,025,899 |
Total lease cost | 1,025,899 |
Operating cash flows received for operating leases | $ 338,435 |
Weighted average remaining lease term | 6 years 10 months 24 days |
Weighted average discount rate | 8.00% |
Schedule of Maturities of Opera
Schedule of Maturities of Operating Lease Liabilities (Details) | Jun. 30, 2020USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
2020 (Remainder of year) | $ 714,603 |
2021 | 1,605,121 |
2022 | 1,652,563 |
2023 | 1,700,005 |
2024 | 1,747,447 |
Thereafter | 3,483,034 |
Total lease payments | 10,902,772 |
Less: imputed interest | (2,420,027) |
Total | $ 8,482,746 |
COMMITMENTS AND CONTINGENCIES_2
COMMITMENTS AND CONTINGENCIES (Details Narrative) | Oct. 25, 2019ft² | Feb. 26, 2019USD ($)ft² | Aug. 21, 2017USD ($)ft² | Jun. 30, 2020USD ($) | Dec. 31, 2019USD ($) | Jun. 30, 2019USD ($) | Jun. 30, 2020USD ($) | Jun. 30, 2019USD ($) | Jan. 02, 2019USD ($) |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||||||
Operating lease liability | $ 8,482,746 | $ 8,482,746 | |||||||
Operating lease, right of use asset | 5,539,677 | $ 5,818,983 | 5,539,677 | ||||||
Increase in operating lease liabilities | (210,227) | $ 279,063 | |||||||
Lease expenses | $ 310,119 | $ 307,182 | $ 620,237 | $ 507,344 | |||||
Accounting Standards Update 2016-02 [Member] | |||||||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||||||
Operating lease liability | $ 3,811,000 | ||||||||
Operating lease, right of use asset | $ 2,400,000 | ||||||||
August 2017 Lease Agreement [Member] | |||||||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||||||
Area of office space | ft² | 32,733 | ||||||||
Operating lease, term | seven years | ||||||||
Leasehold improvements | $ 1,080,189 | ||||||||
Irrevocable letter of credit | 400,000 | ||||||||
Unsecured letter of credit | 400,000 | ||||||||
August 2017 Lease Agreement [Member] | First Year [Member] | |||||||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||||||
Rent expense | 470,000 | ||||||||
August 2017 Lease Agreement [Member] | Seventh Year [Member] | |||||||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||||||
Rent expense | 908,000 | ||||||||
August 2017 Lease Agreement [Member] | Third Anniversary [Member] | |||||||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||||||
Irrevocable letter of credit | 300,000 | ||||||||
August 2017 Lease Agreement [Member] | Fourth Anniversary [Member] | |||||||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||||||
Irrevocable letter of credit | $ 200,000 | ||||||||
February 2019 Lease Agreement [Member] | |||||||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||||||
Operating lease liability | $ 855,000 | ||||||||
Operating lease, right of use asset | $ 855,000 | ||||||||
Percentage of incremental borrowing rate from present value of lease | 9.00% | ||||||||
Operating lease, option to extend | Per ASC 842, the February 2019 Lease Agreement constitutes a modification as it extends the original lease term and increases the scope of the lease (additional space provided under the amendment), which requires evaluation of the remeasurement of the lease liability and corresponding ROU asset. Accordingly, the Company reassessed the classification of the Leased Premises and remeasured the lease liability on the basis of the extended lease term using the 20 additional monthly rent payments and the incremental borrowing rate at the effective date of the modification of 9%. | ||||||||
February 2019 Lease Agreement [Member] | New Premises [Member] | |||||||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||||||
Area of office space | ft² | 30,023 | ||||||||
Operating lease liability | $ 2,700,000 | ||||||||
Operating lease, right of use asset | $ 2,700,000 | ||||||||
February 2019 Lease Agreement [Member] | Total Premises [Member] | |||||||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||||||
Area of office space | ft² | 62,756 | ||||||||
October 2019 Lease Amendment [Member] | |||||||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||||||
Percentage of incremental borrowing rate from present value of lease | 8.00% | ||||||||
Operating lease, option to extend | The October 2019 Lease Amendment constitutes a modification as it extends the original lease term and increases the scope of the lease (additional space provided under the amendment), which requires evaluation of the remeasurement of the lease liability and corresponding ROU asset. The additional space did not result in a separate contract as the rent increase was determined not to be commensurate with the standalone price for the additional right of use. Accordingly, the Company reassessed the classification of the Amended Total Premises, which resulted in operating classification, and remeasured the lease liability on the basis of the extended lease term using the additional monthly rent payments and the incremental borrowing rate at the effective date of the modification of 8%. | ||||||||
Increase in operating lease liabilities | $ 381,000 | ||||||||
October 2019 Lease Amendment [Member] | Total Premises [Member] | |||||||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||||||
Area of office space | ft² | 63,256 | ||||||||
October 2019 Lease Amendment [Member] | Amended Premises [Member] | |||||||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||||||
Area of office space | ft² | 500 |
NOTES PAYABLE (Details Narrativ
NOTES PAYABLE (Details Narrative) - USD ($) | 1 Months Ended | |||
Nov. 30, 2019 | Nov. 30, 2018 | Jun. 30, 2020 | Dec. 31, 2019 | |
Insurance Policy [Member] | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Prepaid expenses | $ 356,519 | $ 923,292 | ||
Loan Agreement [Member] | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Notes payable | $ 963,514 | $ 491,629 | ||
Monthly principal and interest payments | $ 109,413 | $ 49,857 | ||
Monthly loan payments term | nine-month period | ten-month period | ||
Annual interest rate | 5.25% | 3.07% | ||
Loan repayment term description | This loan was fully repaid in August 2019 |
Schedule of Accrued Expenses (D
Schedule of Accrued Expenses (Details) - USD ($) | Jun. 30, 2020 | Dec. 31, 2019 |
Payables and Accruals [Abstract] | ||
Accrued clinical operations and trials costs | $ 16,901,307 | $ 14,242,669 |
Accrued product development costs | 5,695,552 | 3,573,231 |
Accrued compensation | 3,842,249 | 3,673,111 |
Accrued other | 1,705,036 | 958,928 |
Total | $ 28,144,144 | $ 22,447,939 |
Schedule of Roll Forward of Def
Schedule of Roll Forward of Deferred Revenue (Details) | 6 Months Ended |
Jun. 30, 2020USD ($) | |
Revenue from Contract with Customer [Abstract] | |
Beginning balance | |
Billing to CFF upon achievement of milestone | 5,000,000 |
Recognition of revenue | (2,048,405) |
Reverse to contract asset (unbilled revenue) | (2,681,065) |
Ending balance | $ 270,530 |
DEVELOPMENT AWARDS AND DEFERR_3
DEVELOPMENT AWARDS AND DEFERRED REVENUE (Details Narrative) - USD ($) | Jan. 26, 2018 | Jul. 31, 2020 | Jun. 30, 2020 | May 31, 2019 | Mar. 31, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | Dec. 31, 2019 | Dec. 31, 2018 |
Entity Listings [Line Items] | |||||||||||
Revenue recognized | $ (2,048,405) | ||||||||||
Revenue | $ 286,346 | $ 29,094,583 | $ 2,048,405 | $ 30,980,265 | |||||||
CFF Warrant [Member] | |||||||||||
Entity Listings [Line Items] | |||||||||||
Warrant exercisable price per share | $ 13.20 | $ 13.20 | $ 13.20 | ||||||||
Cystic Fibrosis Foundation [Member] | |||||||||||
Entity Listings [Line Items] | |||||||||||
Payments for royalty | $ 2,700,000 | ||||||||||
Cystic Fibrosis Foundation [Member] | Subsequent Event [Member] | |||||||||||
Entity Listings [Line Items] | |||||||||||
Payments for milestone achievement | $ 5,000,000 | ||||||||||
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 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 | ||||||||||
Revenue recognized | $ 27,000,000 | ||||||||||
Royalty payable | $ 27,000,000 | 27,000,000 | 27,000,000 | ||||||||
Cystic Fibrosis Program Related Investment Agreement [Member] | Phase 2b Clinical Trial [Member] | |||||||||||
Entity Listings [Line Items] | |||||||||||
Proceeds from investments on achieving milestones | 17,500,000 | ||||||||||
Cystic Fibrosis Program Related Investment Agreement [Member] | Maximum [Member] | |||||||||||
Entity Listings [Line Items] | |||||||||||
Development award received | $ 25,000,000 | ||||||||||
Investment Agreement [Member] | |||||||||||
Entity Listings [Line Items] | |||||||||||
Payment of milestone related received | $ 5,000,000 | ||||||||||
Revenue | $ 5,000,000 | $ 5,000,000 | $ 12,500,000 | ||||||||
Investment Agreement [Member] | Subsequent Event [Member] | |||||||||||
Entity Listings [Line Items] | |||||||||||
Revenue | $ 22,500,000 | ||||||||||
Investment Agreement [Member] | Cystic Fibrosis Foundation Warrants [Member] | |||||||||||
Entity Listings [Line Items] | |||||||||||
Revenue | 25,000,000 | ||||||||||
Additional paid in capital, fair value of warrant issued | 6,215,225 | ||||||||||
Revenue to be recognized | $ 18,784,775 | 18,784,775 | $ 18,784,775 | ||||||||
Research and development period | 2 years 9 months | ||||||||||
Collaboration Agreement [Member] | Cystic Fibrosis Foundation [Member] | |||||||||||
Entity Listings [Line Items] | |||||||||||
Royalty payment percentage | 10.00% | ||||||||||
Investment Agreement [Member] | 2018 CFF Award [Member] | |||||||||||
Entity Listings [Line Items] | |||||||||||
Revenue | $ 286,346 | $ 2,094,583 | $ 2,048,405 | $ 3,980,265 | |||||||
Investment Agreement [Member] | CFF Warrant [Member] | |||||||||||
Entity Listings [Line Items] | |||||||||||
Warrant to purchase of common stock | 1,000,000 | 1,000,000 | 1,000,000 | ||||||||
Warrant exercisable price per share | $ 13.20 | $ 13.20 | $ 13.20 | ||||||||
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 | 500,000 | 500,000 | ||||||||
Investment Agreement [Member] | CFF Warrant [Member] | Warrants Exercisable On Completion Of Final Milestone [Member] | |||||||||||
Entity Listings [Line Items] | |||||||||||
Warrant to purchase of common stock | 500,000 | 500,000 | 500,000 |
COMMON STOCK (Details Narrative
COMMON STOCK (Details Narrative) - USD ($) | Apr. 07, 2020 | Feb. 11, 2020 | Jan. 30, 2019 | Jul. 31, 2020 | Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | Dec. 31, 2019 |
Subsidiary, Sale of Stock [Line Items] | |||||||||
Common stock, shares authorized | 150,000,000 | 150,000,000 | 150,000,000 | ||||||
Common stock, par value | $ 0.0001 | $ 0.0001 | $ 0.0001 | ||||||
Common stock, shares issued | 80,655,848 | 80,655,848 | 64,672,893 | ||||||
Common stock, shares outstanding | 80,655,848 | 80,655,848 | 64,672,893 | ||||||
Gross proceeds from sale of stock | $ 90,003,980 | $ 40,596,961 | |||||||
Stock issuance cost | $ 2,051,853 | $ 5,014,643 | $ 2,571,552 | ||||||
Issuance of common stock upon exercise of stock options, shares | 202,494 | ||||||||
Warrant [Member] | |||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||
Issuance of common stock upon exercise of stock options, shares | 0 | 172,414 | 0 | 1,119,868 | |||||
Warrants to purchase shares of common stock, exercised | 200,000 | 1,283,500 | |||||||
Equity Option [Member] | |||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||
Issuance of common stock upon exercise of stock options, shares | 51,605 | 16,458 | 202,494 | 78,229 | |||||
Proceeds from exercise of stock options | $ 286,310 | $ 102,708 | $ 302,305 | $ 306,711 | |||||
April 2020 Sale Agreement [Member] | |||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||
Aggregate common stock sold, shares | 8,113,794 | ||||||||
Gross proceeds from sale of stock | $ 43,702,000 | ||||||||
Stock subscriptions receivable | $ 16,676,000 | $ 16,676,000 | |||||||
April 2020 Sale Agreement [Member] | Subsequent Event [Member] | |||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||
Aggregate common stock sold, shares | 1,053,286 | ||||||||
Gross proceeds from sale of stock | $ 8,148,000 | ||||||||
April 2020 Sale Agreement [Member] | Maximum [Member] | |||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||
Value of common stock to be sold | $ 75,000,000 | ||||||||
April 2020 Sale Agreement [Member] | Jefferies LLC [Member] | Maximum [Member] | |||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||
Value of common stock to be sold | $ 75,000,000 | ||||||||
IPO [Member] | |||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||
Aggregate common stock sold, shares | 7,666,667 | 6,198,500 | |||||||
Purchase price per share | $ 6 | $ 6.50 | |||||||
Gross proceeds from sale of stock | $ 46,000,000 | $ 40,290,250 | |||||||
Stock issuance cost | $ 3,147,000 | $ 2,572,000 | |||||||
IPO [Member] | Underwriters [Member] | |||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||
Aggregate common stock sold, shares | 1,000,000 | 808,500 |
Summary of Fair Value of Option
Summary of Fair Value of Options Granted to Employees (Details) | 6 Months Ended | |
Jun. 30, 2020 | Jun. 30, 2019 | |
Option Indexed to Issuer's Equity [Line Items] | ||
Expected term in years | 6 years 3 months | |
Share-based Payment Arrangement, Option [Member] | ||
Option Indexed to Issuer's Equity [Line Items] | ||
Risk free interest rate | 0.62% | 2.56% |
Expected dividend yield | 0.00% | 0.00% |
Expected term in years | 6 years 3 months | 6 years 3 months |
Expected volatility | 82.89% | 87.65% |
Estimated forfeiture rate | 5.98% | 4.75% |
Summary of Option Activity (Det
Summary of Option Activity (Details) | 6 Months Ended |
Jun. 30, 2020USD ($)$ / sharesshares | |
Share-based Payment Arrangement [Abstract] | |
Shares, Outstanding, Beginning balance | shares | 13,245,366 |
Weighted Average Exercise Price, Outstanding, Beginning balance | $ / shares | $ 5.19 |
Shares, Granted | shares | 3,883,600 |
Weighted Average Exercise Price, Granted | $ / shares | $ 4.87 |
Shares, Exercised | shares | (202,494) |
Weighted Average Exercise Price, Exercised | $ / shares | $ 1.49 |
Shares, Forfeited | shares | (554,811) |
Weighted Average Exercise Price, Forfeited | $ / shares | $ 5.93 |
Shares, Outstanding, Ending balance | shares | 16,371,661 |
Weighted Average Exercise Price, Outstanding, Ending balance | $ / shares | $ 5.14 |
Weighted Average Remaining Contractual Term in Years, Outstanding | 7 years 3 months 7 days |
Average Intrinsic Value, Outstanding | $ | $ 54,044,121 |
Shares, Vested | shares | 9,148,866 |
Weighted Average Exercise Price, Vested | $ / shares | $ 4.50 |
Weighted Average Remaining Contractual Term in Years, Vested | 5 years 10 months 9 days |
Average Intrinsic Value, Vested | $ | $ 36,271,485 |
Shares, Vested and expected to vest | shares | 15,775,432 |
Weighted Average Exercise Price, Vested and expected to vest | $ / shares | $ 5.13 |
Weighted Average Remaining Contractual Term in Years, Vested and expected to vest | 7 years 2 months 12 days |
Average Intrinsic Value, Vested and expected to vest | $ | $ 52,286,782 |
STOCK OPTIONS (Details Narrativ
STOCK OPTIONS (Details Narrative) - USD ($) | Jan. 02, 2020 | Apr. 30, 2014 | Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | Dec. 31, 2018 | Jan. 02, 2019 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Stock-based compensation expense | $ 3,348,360 | $ 2,817,488 | $ 6,485,779 | $ 5,906,427 | ||||
Option granted expected term | 6 years 3 months | |||||||
Total fair value of options vested | 54,044,121 | $ 54,044,121 | ||||||
Equity Option [Member] | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Weighted average grant-date fair value, options granted | $ 3.44 | $ 5.41 | ||||||
Average intrinsic value of options exercised | $ 1,030,994 | $ 233,095 | ||||||
Total fair value of options vested | 31,198,928 | $ 19,252,762 | 31,198,928 | $ 19,252,762 | ||||
Total unrecognized compensation expense | $ 26,300,051 | $ 26,300,051 | ||||||
Share-based compensation expense, not yet recognized period of recognition | 2 years 8 months 8 days | |||||||
Share-based Payment Arrangement, Option [Member] | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Option granted expected term | 6 years 3 months | 6 years 3 months | ||||||
2014 Equity Incentive Plan [Member] | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Stock option vesting term | 4 years | |||||||
Stock option expiration period | 10 years | |||||||
Percentage of outstanding common shares | 7.00% | 7.00% | ||||||
Increase in number of shares of common stock available for issuance | 3,000,000 | |||||||
2014 Equity Incentive Plan [Member] | Evergreen Provision [Member] | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Percentage of outstanding common shares | 7.00% | |||||||
Increase in number of shares of common stock available for issuance | 4,527,103 | |||||||
Aggregate common stock available for stock options granted, shares | 23,070,842 | |||||||
Shares available for grant | 8,840,939 | 5,512,150 | 5,512,150 | |||||
2014 Equity Incentive Plan [Member] | Share-based Payment Arrangement, Option [Member] | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Shares available for grant | 5,200,795 | 5,200,795 | 8,072,241 | |||||
2014 Equity Incentive Plan [Member] | Share-based Payment Arrangement, Option [Member] | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Aggregate common stock available for stock options granted, shares | 18,543,739 |
Schedule of Weighted Average As
Schedule of Weighted Average Assumption of Warrants (Details) - Warrant [Member] | Jun. 30, 2020ft² |
Measurement Input, Risk Free Interest Rate [Member] | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |
Warrants outstanding measurement input, percentage | 2.60 |
Measurement Input, Expected Dividend Rate [Member] | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |
Warrants outstanding measurement input, percentage | 0 |
Measurement Input, Expected Term [Member] | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |
Warrants outstanding measurement input, term | 7 years |
Measurement Input, Price Volatility [Member] | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |
Warrants outstanding measurement input, percentage | 83.5 |
WARRANTS (Details Narrative)
WARRANTS (Details Narrative) - USD ($) | Jul. 28, 2020 | Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | Jun. 28, 2020 |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||||
Issuance of common stock upon exercise of stock options, shares | 202,494 | |||||
Fair value of warrants issued | $ 6,215,225 | |||||
Subsequent Event [Member] | 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] | Subsequent Event [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 | 200,000 | 1,283,500 | ||||
Issuance of common stock upon exercise of stock options, shares | 0 | 172,414 | 0 | 1,119,868 | ||
Warrant [Member] | Loan Agreement [Member] | K2 HealthVentures LLC [Member] | Subsequent Event [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 | |||||
CFF Warrant [Member] | ||||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||||
Warrants outstanding to purchase of common stock shares | 1,000,000 | 1,000,000 | ||||
Exercise price of warrants | $ 13.20 | $ 13.20 | ||||
Number of warrants exercisable for common stock | 500,000 | |||||
CFF Warrant [Member] | Investment Agreement [Member] | ||||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||||
Warrants outstanding to purchase of common stock shares | 1,000,000 | 1,000,000 | ||||
Exercise price of warrants | $ 13.20 | $ 13.20 | ||||
Weighted average remaining life of warrants | 4 years 6 months 29 days | |||||
Number of warrants exercisable for common stock | 500,000 | |||||
Warrants expiration term | Jan. 26, 2025 | Jan. 26, 2025 |
SUSBSEQUENT EVENTS (Details Nar
SUSBSEQUENT EVENTS (Details Narrative) - USD ($) | Jul. 28, 2020 | Aug. 06, 2020 | Nov. 30, 2019 | Nov. 30, 2018 |
Loan Agreement [Member] | ||||
Subsequent Event [Line Items] | ||||
Interest rate | 5.25% | 3.07% | ||
Subsequent Event [Member] | Loan Agreement [Member] | K2 HealthVentures LLC [Member] | ||||
Subsequent Event [Line Items] | ||||
Secured debt | $ 50,000,000 | |||
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 | |||
Interest rate | 8.50% | |||
Debt conversion per share | $ 9.40 | |||
Warrants to purchase shares of common stock, exercised | 86,206 | |||
Exercise price of warrants | $ 6.96 | |||
Subsequent Event [Member] | Loan Agreement [Member] | K2 HealthVentures LLC [Member] | Maximum [Member] | ||||
Subsequent Event [Line Items] | ||||
Debt conversion amount | $ 5,000,000 | |||
Subsequent Event [Member] | Loan Agreement [Member] | K2 HealthVentures LLC [Member] | Prime Rate [Member] | ||||
Subsequent Event [Line Items] | ||||
Interest rate | 5.25% | |||
Subsequent Event [Member] | Loan Agreement [Member] | K2 HealthVentures LLC [Member] | Share-based Payment Arrangement, Tranche One [Member] | ||||
Subsequent Event [Line Items] | ||||
Secured debt | $ 20,000,000 | |||
Subsequent Event [Member] | Loan Agreement [Member] | K2 HealthVentures LLC [Member] | Share-based Payment Arrangement, Tranche Two [Member] | ||||
Subsequent Event [Line Items] | ||||
Secured debt | 20,000,000 | |||
Subsequent Event [Member] | Loan Agreement [Member] | K2 HealthVentures LLC [Member] | Share-based Payment Arrangement, Tranche Three [Member] | ||||
Subsequent Event [Line Items] | ||||
Secured debt | $ 10,000,000 | |||
Subsequent Event [Member] | August 2020 Sale Agreement [Member] | Jefferies LLC [Member] | ||||
Subsequent Event [Line Items] | ||||
Commission percentage | 3.00% | |||
Authorized to offer and sell up of common stock | $ 150,000,000 |