Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2019 | Aug. 02, 2019 | |
Document And Entity Information | ||
Entity Registrant Name | Corbus Pharmaceuticals Holdings, Inc. | |
Entity Central Index Key | 0001595097 | |
Document Type | 10-Q | |
Document Period End Date | Jun. 30, 2019 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Entity Reporting Status Current | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Accelerated Filer | |
Entity Small Business Flag | true | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | true | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 64,651,593 | |
Document Fiscal Period Focus | Q2 | |
Document Fiscal Year Focus | 2019 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) | Jun. 30, 2019 | Dec. 31, 2018 |
Current assets: | ||
Cash and cash equivalents | $ 73,154,916 | $ 41,748,468 |
Prepaid expenses and other current assets | 2,235,947 | 2,491,844 |
Total current assets | 75,390,863 | 44,240,312 |
Property and equipment, net | 2,912,335 | 2,705,206 |
Operating lease right of use assets | 5,695,689 | |
Other assets | 123,226 | 43,823 |
Total assets | 84,122,113 | 46,989,341 |
Current liabilities: | ||
Notes payable | 99,333 | 394,305 |
Accounts payable | 7,490,561 | 6,345,335 |
Accrued expenses | 19,056,618 | 9,851,191 |
Deferred revenue | 2,482,238 | 1,462,503 |
Operating lease liabilities, current | 312,289 | |
Deferred rent, current | 35,996 | |
Total current liabilities | 29,441,039 | 18,089,330 |
Operating lease liabilities, noncurrent | 7,307,274 | |
Deferred rent, noncurrent | 1,375,891 | |
Total liabilities | 36,748,313 | 19,465,221 |
Commitments and Contingencies | ||
Stockholders' equity | ||
Preferred stock, $0.0001 par value; 10,000,000 shares authorized, no shares issued and outstanding at June 30, 2019 and December 31, 2018 | ||
Common stock, $0.0001 par value; 150,000,000 shares authorized, 64,644,093 and 57,247,496 shares issued and outstanding at June 30, 2019 and December 31, 2018, respectively | 6,465 | 5,725 |
Additional paid-in capital | 192,819,731 | 148,888,635 |
Accumulated deficit | (145,452,396) | (121,370,240) |
Total stockholders' equity | 47,373,800 | 27,524,120 |
Total liabilities and stockholders' equity | $ 84,122,113 | $ 46,989,341 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Jun. 30, 2019 | Dec. 31, 2018 |
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 | ||
Preferred stock, shares outstanding | ||
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 150,000,000 | 150,000,000 |
Common stock, shares issued | 64,644,093 | 57,247,496 |
Common stock, shares outstanding | 64,644,093 | 57,247,496 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Income Statement [Abstract] | ||||
Revenue from awards and licenses | $ 29,094,583 | $ 853,646 | $ 30,980,265 | $ 1,804,088 |
Operating expenses: | ||||
Research and development | 22,181,409 | 10,259,868 | 43,965,113 | 20,025,229 |
General and administrative | 5,207,962 | 2,987,549 | 11,832,709 | 6,037,581 |
Total operating expenses | 27,389,371 | 13,247,417 | 55,797,822 | 26,062,810 |
Operating income (loss) | 1,705,212 | (12,393,771) | (24,817,557) | (24,258,722) |
Other income (expense), net: | ||||
Interest income, net | 448,717 | 266,297 | 783,312 | 469,717 |
Foreign currency exchange gain (loss), net | (1,276) | 58,123 | (47,911) | 24,269 |
Other income, net | 447,441 | 324,420 | 735,401 | 493,986 |
Net income (loss) | $ 2,152,653 | $ (12,069,351) | $ (24,082,156) | $ (23,764,736) |
Net income (loss) per share, basic | $ 0.03 | $ (0.21) | $ (0.38) | $ (0.42) |
Net income (loss) per share, diluted | $ 0.03 | $ (0.21) | $ (0.38) | $ (0.42) |
Weighted average number of common shares outstanding, basic | 64,546,628 | 57,157,955 | 63,119,196 | 56,764,935 |
Weighted average number of common shares outstanding, diluted | 68,511,587 | 57,157,955 | 63,119,196 | 56,764,935 |
Condensed Consolidated Statem_2
Condensed Consolidated Statement of Stockholders' Equity (Unaudited) - USD ($) | Common Stock [Member] | Additional Paid-in Capital [Member] | Accumulated Deficit [Member] | Total |
Balance at Dec. 31, 2017 | $ 5,560 | $ 123,476,102 | $ (65,698,101) | $ 57,783,561 |
Balance, shares at Dec. 31, 2017 | 55,603,427 | |||
Balance at Mar. 31, 2018 | $ 5,714 | $ 142,927,376 | $ (77,393,486) | $ 65,539,604 |
Balance, shares at Mar. 31, 2018 | 57,139,892 | |||
Balance at Dec. 31, 2017 | $ 5,560 | $ 123,476,102 | $ (65,698,101) | $ 57,783,561 |
Balance, shares at Dec. 31, 2017 | 55,603,427 | |||
Issuance of common stock, net of issuance costs | $ 150 | $ 11,246,684 | $ 11,246,834 | |
Issuance of common stock, net of issuance costs, shares | 1,500,000 | |||
Stock-based compensation expense | $ 3,701,010 | $ 3,701,010 | ||
Issuance of common stock upon exercise of stock options | $ 9 | $ 303,257 | $ 303,266 | |
Issuance of common stock upon exercise of stock options, shares | 89,069 | |||
Fair value of warrant issued in connection with Investment Agreement | $ 6,215,225 | $ 6,215,225 | ||
Net income (loss) | (23,764,736) | (23,764,736) | ||
Balance at Jun. 30, 2018 | $ 5,719 | $ 144,942,278 | $ (89,462,837) | $ 55,485,160 |
Balance, shares at Jun. 30, 2018 | 57,192,496 | |||
Balance at Mar. 31, 2018 | $ 5,714 | $ 142,927,376 | $ (77,393,486) | $ 65,539,604 |
Balance, shares at Mar. 31, 2018 | 57,139,892 | |||
Stock issuance costs | $ 52,201 | $ 52,201 | ||
Stock-based compensation expense | 1,816,094 | 1,816,094 | ||
Issuance of common stock upon exercise of stock options | $ 5 | $ 146,607 | $ 146,612 | |
Issuance of common stock upon exercise of stock options, shares | 52,604 | |||
Net income (loss) | $ (12,069,351) | $ (12,069,351) | ||
Balance at Jun. 30, 2018 | $ 5,719 | $ 144,942,278 | $ (89,462,837) | $ 55,485,160 |
Balance, shares at Jun. 30, 2018 | 57,192,496 | |||
Balance at Dec. 31, 2018 | $ 5,725 | $ 148,888,635 | $ (121,370,240) | $ 27,524,120 |
Balance, shares at Dec. 31, 2018 | 57,247,496 | |||
Issuance of common stock, net of issuance costs | $ 620 | $ 37,718,078 | $ 37,718,698 | |
Issuance of common stock, net of issuance costs, shares | 6,198,500 | |||
Stock-based compensation expense | $ 5,906,427 | $ 5,906,427 | ||
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 | 78,229 | ||
Issuance of common stock upon exercise of warrants | $ 112 | $ (112) | ||
Issuance of common stock upon exercise of warrants, shares | 1,119,868 | |||
Net income (loss) | $ (24,082,156) | $ (24,082,156) | ||
Balance at Jun. 30, 2019 | $ 6,465 | $ 192,819,731 | $ (145,452,396) | $ 47,373,800 |
Balance, shares at Jun. 30, 2019 | 64,644,093 | |||
Balance at Mar. 31, 2019 | $ 6,446 | $ 189,899,554 | $ (147,605,049) | $ 42,300,951 |
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 stock options | $ 2 | $ 102,706 | $ 102,708 | |
Issuance of common stock upon exercise of stock options, shares | 16,458 | |||
Issuance of common stock upon exercise of warrants | $ 17 | $ (17) | ||
Issuance of common stock upon exercise of warrants, shares | 172,414 | |||
Net income (loss) | $ 2,152,653 | $ 2,152,653 | ||
Balance at Jun. 30, 2019 | $ 6,465 | $ 192,819,731 | $ (145,452,396) | $ 47,373,800 |
Balance, shares at Jun. 30, 2019 | 64,644,093 |
Condensed Consolidated Statem_3
Condensed Consolidated Statement of Stockholders' Equity (Unaudited) (Parenthetical) - USD ($) | 6 Months Ended | |
Jun. 30, 2019 | Jun. 30, 2018 | |
Statement of Stockholders' Equity [Abstract] | ||
Stock issuance cost | $ 2,571,552 | $ 453,167 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) | 6 Months Ended | |
Jun. 30, 2019 | Jun. 30, 2018 | |
Cash flows from operating activities: | ||
Net loss | $ (24,082,156) | $ (23,764,736) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation expense | 5,906,427 | 3,701,010 |
Depreciation and amortization | 308,331 | 206,314 |
(Gain) loss on foreign exchange | (591) | 40,654 |
Operating lease right of use asset amortization | 232,924 | |
Deferred rent | 363,355 | |
Changes in operating assets and liabilities: | ||
Decrease in customer receivable | 5,000,000 | 12,500,000 |
Decrease (increase) in prepaid expenses | 255,897 | (102,792) |
Increase in other assets | (79,402) | (23,651) |
Increase in accounts payable | 1,097,910 | 628,212 |
Increase in accrued expenses | 8,989,731 | 1,064,995 |
Decrease in deferred revenue | (3,980,265) | (1,769,313) |
Increase in operating lease liabilities | 279,063 | |
Net cash used in operating activities | (6,072,131) | (7,155,952) |
Cash flows from investing activities: | ||
Purchases of property and equipment | (256,898) | (1,944,865) |
Net cash used in investing activities | (256,898) | (1,944,865) |
Cash flows from financing activities: | ||
Principal payments on notes payable | (294,972) | (249,157) |
Proceeds from issuance of common stock | 40,596,961 | 12,003,266 |
Issuance costs paid for common stock financings | (2,566,137) | (671,168) |
Principal payments on capital lease obligation | (375) | (2,072) |
Net cash provided by financing activities | 37,735,477 | 11,080,869 |
Net increase in cash and cash equivalents | 31,406,448 | 1,980,052 |
Cash and cash equivalents at beginning of the period | 41,748,468 | 62,696,486 |
Cash and cash equivalents at end of the period | 73,154,916 | 64,676,538 |
Supplemental disclosure of cash flow information and non-cash transactions: | ||
Cash paid during the period for interest | 6,300 | 2,763 |
Fair value of warrant issued in connection with Investment Agreement | 6,215,225 | |
Stock issuance costs included in accounts payable or accrued expenses | 5,415 | 7,500 |
Purchases of property and equipment included in accounts payable or accrued expenses | 259,731 | 35,148 |
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 | |
Write off of fully amortized leasehold improvements | $ 191,244 |
Nature of Operations
Nature of Operations | 6 Months Ended |
Jun. 30, 2019 | |
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, 2019, the results of its operations and changes in stockholders’ equity for the three months and six months ended June 30, 2019 and 2018 and its cash flows for the six months ended June 30, 2019 and 2018. The December 31, 2018 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, 2018, filed on March 12, 2019. The results of operations for such interim periods are not necessarily indicative of the operating results for the full fiscal year. |
Liquidity
Liquidity | 6 Months Ended |
Jun. 30, 2019 | |
Accounting Policies [Abstract] | |
Liquidity | 2. LIQUIDITY The Company anticipates operating losses to continue for the foreseeable future due to, among other things, costs related to research funding, development of its product candidates and its preclinical and clinical programs, strategic alliances and the development of its administrative organization. Although the Company had operating income for the second quarter of 2019, the Company has incurred recurring losses since inception and as of June 30, 2019, had an accumulated deficit of $145,452,396. On January 3, 2019, the Company entered into a strategic collaboration with Kaken Pharmaceutical Co., Ltd. (“Kaken”) (See Note 8), pursuant to which, the Company received a $27 million up front payment in the first quarter of 2019. On January 30, 2019, the Company consummated an underwritten public offering of shares of its common stock (“January 2019 Offering”), which resulted in net proceeds to the Company of approximately $37.7 million (See Note 9). In April 2019, the Company became entitled to receive $5 million upon the Company’s achievement of a milestone related to the progress of the Phase 2b Clinical Trial, as set forth in the Cystic Fibrosis Program Related Investment Agreement (“Investment Agreement”) with the Cystic Fibrosis Foundation (“CFF”), a non-profit drug discovery and development corporation, pursuant to which the Company received a development award for up to $25 million in funding (the “2018 CFF Award”) to support a Phase 2b Clinical Trial (the “Phase 2b Clinical Trial”) of lenabasum in patients with cystic fibrosis (See Note 8). The Company received the $5 million payment from the CFF for this milestone achievement in May 2019. Through June 30, 2019, the Company has received $17.5 million of the 2018 CFF Award and the Company expects the remainder of the 2018 CFF Award will be paid to the Company incrementally upon the achievement of the remaining milestones related to the progress of the Phase 2b Clinical Trial, as set forth in the Investment Agreement. Pursuant to the Investment Agreement, 10% of the $27 million upfront payment received from Kaken, or $2.7 million, was paid by the Company to the CFF in May 2019. The Company expects the cash and cash equivalents of $73,154,916 at June 30, 2019 to be sufficient to meet its operating and capital requirements at least 12 months from the filing of this 10-Q. 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. 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. |
Significant Accounting Policies
Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2019 | |
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 8), and the valuation of the CFF Warrant discussed in Note 11. 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, 2019 and December 31, 2018, cash equivalents were comprised of money market funds. The Company had no marketable investments at June 30, 2019 and December 31, 2018. Cash and cash equivalents consists of the following: June 30, 2019 December 31, 2018 Cash $ 1,542,111 $ 808,943 Money market fund 71,612,805 40,939,525 Total cash and cash equivalents $ 73,154,916 $ 41,748,468 As of June 30, 2019, all of the Company’s cash and cash equivalents was held in the United States, except for approximately $1,015,000 of cash which was held in our subsidiary in the United Kingdom and approximately $84,000 which was held in our subsidiary in Australia. As of December 31, 2018, all of the Company’s cash was held in the United States, except for approximately $702,000 of cash which was held in our subsidiary in the United Kingdom. Financial Instruments The carrying amounts reported in the consolidated balance sheet for cash and cash equivalents, receivables, accounts payable and accrued expenses approximate their fair value based on the short-term nature of these 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. The Company’s leasehold improvements and assets under capital lease are amortized over the shorter of their useful lives or the respective leases. See Note 4 for details of property and equipment and Note 5 for operating and capital lease commitments. Research and Development Expenses Costs incurred for research and development are expensed as incurred. Nonrefundable advance payments for goods or services that have the characteristics that will be used or rendered for future research and development activities pursuant to executory contractual arrangements with third party research organizations are deferred and recognized as an expense as the related goods are delivered or the related services are performed. Accruals for Research and Development Expenses and Clinical Trials As part of the process of preparing its financial statements, the Company is required to estimate its expenses resulting from its obligations under contracts with vendors, clinical research organizations and consultants and under clinical site agreements in connection with conducting clinical trials. The financial terms of these contracts are subject to negotiations, which vary from contract to contract and may result in payment terms that do not match the periods over which materials or services are provided under such contracts. The Company’s objective is to reflect the appropriate expenses in its financial statements by matching those expenses with the period in which services are performed and efforts are expended. The Company accounts for these expenses according to the timing of various aspects of the expenses. The Company determines 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, 2019 and 2018, there were no material adjustments to the Company’s prior period estimates of accrued expenses for clinical trials. Leases The Company determines if an arrangement is a lease at inception. Operating leases are included in operating lease right-of-use (“ROU”) assets, other current liabilities and operating lease liabilities in the Company’s consolidated balance sheets. ROU assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent its obligation to make lease payments arising from the lease. ROU assets and liabilities are recognized at commencement date based on the present value of lease payments over the lease term. As the Company’s leases do not provide an implicit rate, the Company uses an incremental borrowing rate based on the information available at commencement date in determining the present value of lease payments. This is the rate the Company would have to pay if borrowing on a collateralized basis over a similar term to each lease. The ROU asset also includes any lease payments made and excludes lease incentives. Lease expense for lease payments is recognized on a straight-line basis over the lease term. Concentrations of Credit Risk The Company has no significant off-balance-sheet concentration of credit risk such as foreign exchange contracts, option contracts or other hedging arrangements. The Company may from time to time have cash in banks in excess of Federal Deposit Insurance Corporation insurance limits. However, the Company believes the risk of loss is minimal as these banks are large financial institutions. Segment Information Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision maker, or decision making group, in making decisions regarding resource allocation and assessing performance. To date, the Company has viewed its operations and manages its business as principally one operating segment, which is developing and commercializing therapeutics to treat rare life-threatening, inflammatory fibrotic diseases. As of June 30, 2019 all of the Company’s assets were located in the United States, except for approximately $1,099,000 of cash, $716,000 of prepaid expenses, $43,000 of other assets, and $66,000 of property and equipment, net which were held outside of the United States, principally in our subsidiary in the United Kingdom. As of December 31, 2018, all of the Company’s assets were located in the United States, except for approximately $702,000 of cash, $1,183,000 of prepaid expenses, $28,000 of other assets, and $54,000 of property and equipment, net which were held in our subsidiary in the United Kingdom. Income Taxes For federal and state income taxes, deferred tax assets and liabilities are recognized based upon temporary differences between the financial statement and the tax basis of assets and liabilities. Deferred income taxes are based upon prescribed rates and enacted laws applicable to periods in which differences are expected to reverse. A valuation allowance is recorded to reduce a net deferred tax benefit when it is not more likely than not that the tax benefit from the deferred tax assets will be realized. Accordingly, given the cumulative losses since inception, the Company has provided a valuation allowance equal to 100% of the deferred tax assets in order to eliminate the deferred tax assets amounts. Tax positions taken or expected to be taken in the course of preparing the Company’s tax returns are required to be evaluated to determine whether the tax positions are “more-likely-than-not” of being sustained by the applicable tax authority. Tax positions not deemed to meet a more-likely-than-not threshold, as well as accrued interest and penalties, if any, would be recorded as a tax expense in the current year. There were no uncertain tax positions that require accrual or disclosure to the financial statements as of June 30, 2019 or December 31, 2018. 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 impairment charges were recorded during the three and six months ended June 30, 2019 and 2018. 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. The fair value is amortized as compensation cost on a straight-line basis over the requisite service period of the awards, which is generally the vesting period. Prior to the Company’s adoption of ASU 2018-07, (see Recent Accounting Pronouncements 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: Three Months Ended June 30 Six Months Ended June 30 2019 2018 2019 2018 Net income (loss) $ 2,152,653 $ (12,069,351 ) $ (24,082,156 ) $ (23,764,736 ) Weighted average number of common shares. basic 64,546,628 57,157,955 63,119,196 56,764,935 Effect of dilutive securities 3,964,959 — — — Weighted average number of common shares-diluted 68,511,587 57,157,955 63,119,196 56,764,935 Net income (loss) per share of common stock-basic $ 0.03 $ (0.21 ) $ (0.38 ) $ (0.42 ) Net income (loss) per share of common stock-diluted $ 0.03 $ (0.21 ) $ (0.38 ) $ (0.42 ) 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, 2018 and the six months ended June 30, 2019 and 2018, the effect of dilutive shares was not included in the computation of net loss per share because we had a net loss. Recent Accounting Pronouncements Accounting for Leases In February 2016, the FASB issued ASU No . Leases (Topic 842), . Nonemployee Share-Based Payment Accounting In June 2018, the FASB issued ASU 2018-07, Compensation-Stock Compensation (Topic 718), Improvements to Nonemployee Share-Based Payment Accounting Collaborative Arrangements In November 2018, the FASB issued ASU 2018-08, Collaborative Arrangements (Topic 808): Clarifying the Interaction between Topic 808 and Topic 606 |
Property and Equipment
Property and Equipment | 6 Months Ended |
Jun. 30, 2019 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | 4. PROPERTY AND EQUIPMENT Property and equipment consisted of the following: June 30, 2019 December 31, 2018 Computer hardware and software $ 514,923 $ 431,637 Office furniture and equipment 953,744 914,742 Leasehold improvements 2,025,410 2,025,410 Construction in progress 393,172 — Property and equipment, gross 3,887,249 3,371,789 Less: accumulated depreciation (974,914 ) (666,583 ) Property and equipment, net $ 2,912,335 $ 2,705,206 Depreciation expense was $155,709 and $124,416 for the three months ended June 30, 2019 and 2018, respectively and $308,331 and $206,314 for the six months ended June 30, 2019 and 2018, respectively. During the second quarter of 2019, the Company incurred construction in progress costs of $393,172 to build out its office space related to the New Premises discussed in Note 5. |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2019 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 5. COMMITMENTS AND CONTINGENCIES Operating Lease Commitment On August 21, 2017, the Company entered into a lease agreement (“August 2017 Lease Agreement”) for commercial lease of office space, pursuant to which the Company agreed to lease 32,733 square feet of office space (“Leased Premises”). The initial term of the August 2017 Lease Agreement was for a period of seven years which began with the Company’s occupancy of the Leased Premises in February 2018. The base rent for the Leased Premises ranged from approximately $470,000 for the first year to approximately $908,000 for the seventh year. Per the terms of the August 2017 Lease Agreement, the landlord agreed to reimburse the Company for $1,080,189 of leasehold improvements. The reimbursements had been deferred and were to be recognized as a reduction of rent expense over the term of the lease. Additionally, the August 2017 Lease Agreement required a standby irrevocable letter of credit of $400,000, which was to be reduced, if the Company is not in default under the August 2017 Lease Agreement, to $300,000 and $200,000 on the third and fourth anniversary of the commencement date, respectively, The Company entered into an unsecured letter of credit for $400,000 in connection with the August 2017 Lease Agreement for which it incurred interest expense of $2,877 and $1,774 for the three months ended June 30, 2019 and 2018, and $4,714 and $3,549 for the six months ended June 30, 2019 and 2018. The Company adopted ASU 2016-02 using the effective date method as of January 1, 2019 and recorded a lease liability of approximately $3.8 million, and a right-of-use asset of approximately $2.4 million, with no operations adjustment to the accumulated deficit related to the Leased Premises. Operating leases are included in operating lease right-of-use assets, operating lease liabilities, current and operating lease liabilities, noncurrent in the Company’s consolidated balance sheets. ROU assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent its obligation to make lease payments arising from the lease. ROU assets and liabilities are recognized at 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, which was 9%. This is the rate the Company would have to pay if borrowing on a collateralized basis over a similar term to each lease. The ROU asset also includes any lease payments made and excludes lease incentives. Lease expense for lease payments is recognized on a straight-line basis over the lease term. On February 26, 2019, the Company amended its lease (“February 2019 Lease Agreement”) pursuant to which an additional 30,023 square feet of office space (“New Premises”) will be leased by the Company in the same building for an aggregate total of 62,756 square feet of leased office space (“Total Premises”). 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. Per ASC 842, an extension of the lease term does not constitute a separate contract. Accordingly, the Company reassessed the classification of the Leased Premises and remeasured the lease liability on the basis of the extended lease term using the 20 additional monthly rent payments and the incremental borrowing rate at the effective date of the modification of 9%. The remeasurement for the modification resulted in an increase to the lease liability and the ROU asset of approximately $855,000. The Company determined that the New Premises will be treated as a new standalone lease under ASC 842 and recorded a lease liability and a right-of-use asset of approximately $2.7 million for the modification. Per the terms of the February 2019 Lease Agreement, the landlord agreed to reimburse the Company for $990,759 of leasehold improvements. The reimbursements have been deferred and will be recognized as a reduction of rent expense over the term of the lease. Additionally, the February 2019 Lease Agreement required a standby irrevocable letter of credit of $369,900, which may be reduced, if the Company is not in default under the February 2019 Lease Agreement, to $277,425 and $184,950 on the third and fourth anniversary of the commencement date, respectively. The following table summarizes the Company’s maturities of operating lease liabilities as of June 30, 2019: 2019 (remainder of year, net of $990,759 reimbursement of leasehold improvements) $ (307,630 ) 2020 1,287,522 2021 1,592,434 2022 1,639,501 2023 1,686,568 Thereafter 5,036,169 Total lease payments $ 10,934,564 Less: present value discount (3,315,001 ) Total $ 7,619,563 Total lease expense for the three months ended June 30, 2019 and 2018 was $307,182 and $147,752, respectively. Total lease expense for the six months ended June 30, 2019 and 2018 was $507,344 and $294,743, respectively. 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. Jenrin 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. The Company plans to commence a Phase 1 clinical trial of CRB-4001 in 2019. In consideration of the license and other rights granted by Jenrin, the Company paid Jenrin a $250,000 upfront cash payment and is obligated to pay potential milestone payments to Jenrin totaling up to $18.4 million for each compound it elects to develop based upon the achievement of specified development and regulatory milestones. In addition, Corbus is obligated to pay Jenrin royalties in the mid, single digits based on net sales of any Licensed Products, subject to specified reductions. As of June 30, 2019, there have been no milestone or royalty payments made to Jenrin. In January 2017, the FASB issued ASU 2017-01, Business Combinations (Topic 805): Clarifying the Definition of a Business |
Notes Payable
Notes Payable | 6 Months Ended |
Jun. 30, 2019 | |
Debt Disclosure [Abstract] | |
Notes Payable | 6. NOTES PAYABLE In November 2017, the Company entered into a loan agreement with a financing company for $415,265 to finance one of the Company’s insurance policies. The terms of the loan stipulate equal monthly payments of principal and interest payments of $41,975 over a ten-month period. Interest accrued on this loan at an annual rate of 2.35%. This loan was fully repaid in August 2018. In November 2018, the Company entered into a loan agreement with a financing company for $491,629 to finance one of the Company’s insurance policies. The terms of the loan stipulate equal monthly payments of principal and interest payments of $49,857 over a ten-month period. Interest accrues on this loan at an annual rate of 3.07%. Prepaid expenses as of June 30, 2019 and December 31, 2018, included $170,625 and $441,875, respectively, related to this insurance policy. Interest expense for notes payable for the three months ended June 30, 2019 and 2018 totaled $1,521 and $904, respectively. Interest expense for notes payable for the six months ended June 30, 2019 and 2018 totaled $3,366 and $2,564, respectively. |
Accrued Expenses
Accrued Expenses | 6 Months Ended |
Jun. 30, 2019 | |
Payables and Accruals [Abstract] | |
Accrued Expenses | 7. ACCRUED EXPENSES Accrued expenses consisted of the following: June 30, 2019 December 31, 2018 Accrued clinical operations and trials costs $ 11,935,501 $ 4,914,881 Accrued product development costs 4,073,377 2,222,093 Accrued compensation 2,100,531 2,253,621 Accrued other 947,209 460,596 Total $ 19,056,618 $ 9,851,191 |
Development Awards and Deferred
Development Awards and Deferred Revenue | 6 Months Ended |
Jun. 30, 2019 | |
Two Thousand Fourteen Equity Incentive Plan [Member] | |
Development Awards and Deferred Revenue | 8. 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 upfront cash payment and is obligated to pay potential milestone payments to Corbus totaling up to approximately $173,000,000 for the achievement of certain development, sales and regulatory milestones, with part of the milestone payments being calculated in Japanese Yen, and therefore subject to change based on the conversion rate to U.S. Dollars in effect at the time of payment. In addition, during the Royalty Term (as defined below), Kaken is obligated to pay Corbus royalties on sales of Licensed Products in the Territory, under certain conditions, in the double digits, which royalty shall be reduced in certain circumstances. In particular, for so long as Corbus supplies Licensed Products to Kaken pursuant to a supply agreement to be entered into by the parties, royalty payments shall be payable for each unit of Licensed Product that Corbus supplies as a percentage of the Japanese National Health Insurance price of the Licensed Product. During any time in which a supply agreement is not in effect, royalty payments shall be changed to a rate to be agreed upon by the parties in good faith. 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 constituted the entirety of the consideration to be included in the transaction price at the outset of the arrangement, which was allocated to the two performance obligations. The potential milestone payments that the Company is eligible to receive were excluded from the transaction price, as all milestone payments are fully constrained based on the probability of achievement. The Company will reevaluate the transaction price at the end of each reporting period and as uncertain events are resolved or other changes in circumstances occur, and, if necessary, adjust its estimate of the transaction price. 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 is allocated to the combined performance obligation of the license, initial technology transfer and license to the product trademarks. The Company received the upfront payment of $27,000,000 in March 2019 and, as the performance obligations were not yet satisfied at that time, the payment was recorded in deferred revenue as of March 31, 2019. The Company satisfied the combined performance obligation by June 30, 2019, upon which the Company recognized the $27,000,000 upfront payment as revenue in the second quarter of 2019. The Company was required to make a $2,700,000 million royalty payment to CFF within 60 days of receipt of the upfront cash payment from Kaken pursuant to the 2018 CFF Award. This obligation was paid by the Company to CFF in May 2019. 2018 CFF Award On January 26, 2018, the Company entered into the Cystic Fibrosis Program Related Investment Agreement with the CFF (“Investment Agreement”), a non-profit drug discovery and development corporation, pursuant to which the Company received an award for up to $25 million in funding (the “2018 CFF Award”) to support a Phase 2b Clinical Trial (the “Phase 2b Clinical Trial”) of lenabasum in patients with cystic fibrosis, of which the Company has received $17.5 million in the aggregate through June 30, 2019 upon the Company’s achievement of milestones related to the progress of the Phase 2b Clinical Trial, as set forth in the Investment Agreement. In April 2019, the Company became entitled to receive $5 million upon its achievement of a milestone related to the progress of the Phase 2b Clinical Trial, as set forth in the Investment Agreement. The Company received payment from the CFF for this milestone achievement in May 2019. The Company expects that the remainder of the 2018 CFF Award will be paid incrementally upon the Company’s achievement of the remaining milestones related to the progress of the Phase 2b Clinical Trial, as set forth in the Investment Agreement. Pursuant to the terms of the Investment Agreement, the Company is obligated to make certain royalty payments to CFF, including a royalty payment of one and one-half times the amount of the 2018 CFF Award, payable in cash within sixty days upon the first receipt of approval of lenabasum in the United States and a second royalty payment of one and one-half times the amount of the 2018 CFF Award upon approval in another major market, as set forth in the Investment Agreement (the “Approval Royalty”). At the Company’s election, the Company may satisfy the first of the two Approval Royalties in registered shares of the Company’s common stock. Additionally, the Company is obligated to make (i) royalty payments to CFF of two and one-half percent of net sales from lenabasum due within sixty days after any quarter in which such net sales occur in the Field, as defined in the Investment Agreement, (ii) royalty payments to CFF of one percent of net sales of Non-Field Products, as defined in the Investment Agreement due within sixty days after any quarter in which such net sales occur, and (iii) royalty payments to CFF of ten percent of any amount the Company and its stockholders receive in connection with the license, sale, or other transfer to a third party of lenabasum, if indicated for the treatment or prevention of CF, or a change of control transaction, except that such payment shall not exceed five times the amount of the 2018 CFF Award, with such payments to be credited against any other net sales royalty payments due. Accordingly, the Company will owe to CFF a royalty payment equal to 10% of any amounts the Company receives as payment under the collaboration agreement with Kaken, provided that the total royalties that the Company will be required to pay under the Investment Agreement resulting from income from licenses or sales subject to the Investment Agreement are capped at five times the total amount of the 2018 CFF Award, and the Company may credit such royalties against any royalties on net sales otherwise owed to CFF under the Investment Agreement. Accordingly, the Company was required to pay CFF $2,700,000 in May 2019 as a result of its receipt of the $27,000,000 upfront cash payment from Kaken. Either CFF or the Company may terminate the Investment Agreement for cause, which includes the Company’s material failure to achieve certain commercialization and development milestones. The Company’s payment obligations survive the termination of the Investment Agreement. Pursuant to the terms of the Investment Agreement, the Company issued a warrant to CFF to purchase an aggregate of 1,000,000 shares of the Company’s common stock (the “CFF Warrant”). The CFF Warrant is exercisable at a price equal to $13.20 per share and is immediately exercisable for 500,000 shares of the Company’s common stock. Upon completion of the final milestone set forth in the Investment Agreement and receipt of the final payment from CFF to the Company pursuant to the Investment Agreement, the CFF Warrant will be exercisable for the remaining 500,000 shares of the Company’s common stock. The CFF Warrant expires on January 26, 2025. Any shares of the Company’s common stock issued upon exercise of the CFF Warrant will be unregistered and subject to a one-year lock-up. Under the Investment Agreement, the Company recorded $2,094,583 and $853,646 of revenue during the three months ended June 30, 2019 and 2018 and $3,980,265 and $1,804,088 of revenue during the six months ended June 30, 2019 and 2018. The Company assessed the 2018 CFF Award for accounting under ASC 606, which it adopted in the first quarter of 2018 (Note 3). To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606, the entity performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company assessed this arrangement in accordance with ASC 606 and concluded that the contract counterparty, CFF, is a customer. The Company identified the following material promise under the arrangement: research and development activities and related services under the Phase 2b Clinical Trial. Based on these assessments, the Company identified one performance obligation at the outset of the Investment Agreement, which consists of: Phase 2b Clinical Trial research and development activities and related services. To determine the transaction price, the Company included the total aggregate payments under the Investment Agreement which amount to $25 million and reduced the revenue to be recognized by the payment to the customer of $6,215,225 in the form of the CFF Warrant representing its fair value, leaving the remaining $18,784,775 as the transaction price as of the outset of the arrangement, which will be recognized as revenue over the performance period as discussed below. The $6,215,225 fair value of the warrant was also recorded as an increase to additional paid in capital. The Company billed and collected $17,500,000 in milestone payments during the year ended December 31, 2018 which was recorded as an increase to deferred revenue. A roll forward of deferred revenue related to the Investment Agreement for the six months ended June 30, 2019 is presented below. June 30, 2019 Beginning balance, December 31, 2018 $ 1,462,503 Billing to CFF upon achievement of milestones 5,000,000 Recognition of revenue (3,980,265 ) Ending balance, June 30, 2019 $ 2,482,238 The CFF Warrant is accounted for as a payment to the customer under ASC 606. See Note 11 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 an approximately two and a half year period expected to be completed in the second quarter of 2020. The amounts received that have not yet been recognized as revenue are recorded in deferred revenue and the amounts recognized as revenue, but not yet received or invoiced are generally recognized as contract assets on the Company’s condensed consolidated balance sheet. 2015 CFFT Award On April 20, 2015, the Company entered into an award agreement (the “2015 CFFT Award Agreement “) with the Cystic Fibrosis Foundation Therapeutics, Inc (“CFFT”), a non-profit drug discovery and development affiliate of the Cystic Fibrosis Foundation (“CFF”) pursuant to which the Company received a development award (the “2015 CFFT Award”) for up to $5 million in funding. The funding from the 2015 CFFT Award supported a first-in-patient Phase 2 clinical trial of the Company’s oral anti-inflammatory drug lenabasum in adults with cystic fibrosis (“CF”). The Company received $5.0 million in payments under the 2015 CFFT Award. The payments received under the 2015 CFFT Award were recorded as deferred revenue when the triggering event to receive those amounts had occurred and were amortized on a straight-line basis over the expected duration of the remaining performance period under the 2015 CFFT Award which concluded in the third quarter of 2017. In accordance with ASC 605, the Company recorded $2,440,195 of revenue during the year ended December 31, 2017 under the 2015 CFFT Award Agreement. No revenue was recorded under the 2015 CFFT Award Agreement during the year ended December 31, 2018 as the final performance period concluded in the third quarter of 2017. Under ASC 605, milestone payments were initially recognized only in the period that the payment-triggering event occurred or was achieved. Effective January 1, 2018, ASC 605 was superseded by Accounting Standards Codification 606 Revenue Recognition — Revenue from Contracts with Customers Pursuant to the terms of the 2015 CFFT Award Agreement, the Company is obligated to make royalty payments to CFFT contingent upon commercialization of lenabasum in the Field of Use (as defined in the 2015 CFFT Award Agreement) as follows: (i) a royalty payment equal to five times the amount the Company receives under the 2015 CFFT Award Agreement, up to $25 million, payable in three equal annual installments following the first commercial sale of lenabasum, the first of which is due within 90 days following the first commercial sale of lenabasum, (ii) a royalty payment to CFFT equal to the amount the Company receives under the 2015 CFFT Award Agreement, up to $5 million, due in the first calendar year in which the aggregate cumulative net sales of lenabasum in the Field of Use exceed $500 million, and (iii) royalty payment(s) to CFFT of up to approximately $15 million if the Company transfers, sells or licenses lenabasum in the Field of Use other than for certain clinical or development purposes, or if the Company enters into a change of control transaction, with such payment(s) to be credited against the royalty payments due upon commercialization. The Field of Use is defined in the 2015 CFFT Award as the treatment in humans of CF, asbestosis, bronchiectasis, byssinosis, chronic bronchitis/COPD hypersensitivity pneumonitis, pneumoconiosis, primary ciliary dyskinesis, sarcoidosis and silicosis. Either CFFT or the Company may terminate the agreement for cause, which includes the Company’s material failure to achieve certain commercialization and development milestones. The Company’s payment obligations, if any, would survive the termination of the 2015 CFFT Award Agreement. |
Common Stock
Common Stock | 6 Months Ended |
Jun. 30, 2019 | |
Equity [Abstract] | |
Common Stock | 9. COMMON STOCK On January 5, 2018, the Company entered into a sales agreement with Cantor Fitzgerald under which the Company had the ability to direct Cantor Fitzgerald as its sales agent to sell common stock up to an aggregate offering of up to $50 million under an “At the Market Offering” (“January 2018 Sales Agreement”). Sales of common stock under the January 2018 Sales Agreement were made pursuant to an effective registration statement for an aggregate offering of up to $50 million. During the first quarter of 2018, the Company sold 1,500,000 shares of its common stock to an institutional investor under the January 2018 Sales Agreement for which the Company received net proceeds of approximately $11.2 million. The Company did not sell any shares under the January 2018 Sales Agreement in the remainder of 2018 and through February 8, 2019, the effective date of the Company’s termination of the January 2018 Sales Agreement. 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 shares of its common stock, including 808,500 shares sold pursuant to the full exercise of the underwriters’ option to purchase additional shares, at a purchase price of $6.50 per share with gross proceeds to the Company totaling approximately $40.3 million, less issuance costs incurred of approximately $2.6 million. During the three and six months ended June 30, 2019, the Company issued 16,458 and 78,229 shares of common stock upon the exercise of stock options to purchase common stock and the Company received proceeds of $102,708 and $306,711 from these exercises, respectively. During the three and six months ended June 30, 2018, the Company issued 52,604 and 89,069 shares of common stock upon the exercise of stock options to purchase common stock and the Company received proceeds of $146,612 and $303,266 from these exercises, respectively. During the three and six months ended June 30, 2019, warrants to purchase 200,000 shares and 1,283,500 shares of common stock were exercised on a cashless basis resulting in the issuance of 172,414 and 1,119,868 shares of common stock, respectively. No warrants were exercised during the three and six months ended June 30, 2018. |
Stock Options
Stock Options | 6 Months Ended |
Jun. 30, 2019 | |
Share-based Payment Arrangement [Abstract] | |
Stock Options | 10. 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 years from the date of grant in multiple tranches and are exercisable for up to 10 years from the date of issuance. Pursuant to the terms of an annual evergreen provision in the 2014 Plan, the number of shares of common stock available for issuance under the 2014 Plan shall automatically increase on January 1 of each year by at least seven percent (7%) of the total number of shares of common stock outstanding on December 31st of the preceding calendar year, or, pursuant to the terms of the 2014 Plan, in any year, the Board of Directors may determine that such increase will provide for a lesser number of shares. In accordance with the terms of the 2014 Plan, effective as of January 1, 2018, the number of shares of common stock available for issuance under the 2014 Plan increased by 2,500,000 shares, such amount being less than seven percent (7%) of the outstanding shares of common stock on December 31, 2017. As of December 31, 2018, the 2014 Plan had a total reserve of 15,543,739 shares and there were 5,072,241 shares available for future grants. 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 shares, which was less than seven percent (7%) of the outstanding shares of common stock on December 31, 2018. As of January 1, 2019, the 2014 Plan had a total reserve of 18,543,739 shares and there were 8,072,241 shares available for future grants. As of June 30, 2019, there were 5,200,795 shares available for future grants. Stock-based Compensation For stock options issued and outstanding for the three months ended June 30, 2019 and 2018, respectively, the Company recorded non-cash, stock-based compensation expense of $2,817,488 and $1,816,094, net of estimated forfeitures. For stock options issued and outstanding for the six months ended June 30, 2019 and 2018, respectively, the Company recorded non-cash, stock-based compensation expense of $5,906,427 and $3,701,010, respectively, net of estimated forfeitures. 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 years based on the average between the vesting period and the contractual life of the option. For non-employee options, the expected term is the contractual term. The risk-free rate is based on the yield of a U.S. Treasury security with a term consistent with the option. The weighted average assumptions used principally in determining the fair value of options granted to employees were as follows: Six Months Ended June 30, 2019 2018 Risk free interest rate 2.56 % 2.40 % Expected dividend yield 0 % 0 % Expected term in years 6.25 6.25 Expected volatility 87.7 % 87.9 % A summary of option activity for the six months ended June 30, 2019 and is presented below: Options Shares Weighted Weighted Contractual Aggregate Outstanding at December 31, 2018 9,593,990 $ 4.51 Granted 3,080,800 7.43 Exercised (78,229 ) 3.92 Forfeited (209,354 ) 7.26 Outstanding at June 30, 2019 12,387,207 $ 5.19 7.31 $ 28,315,753 Vested at June 30, 2019 7,048,991 $ 3.51 6.08 $ 26,768,267 The weighted average grant-date fair value of options granted during the six months ended June 30, 2019 and 2018 was $5.41 and $5.82 per share, respectively. The aggregate intrinsic value of options exercised during the six months ended June 30, 2019 and 2018 was approximately $233,095 and $320,541, respectively. The total fair value of options that were vested as of June 30, 2019 and 2018 was $19,252,762 and $11,075,357, respectively. As of June 30, 2019, there was approximately $24,389,674 of total unrecognized compensation expense, related to non-vested share-based option compensation arrangements. The unrecognized compensation expense is estimated to be recognized over a period of 2.78 years as of June 30, 2019. |
Warrants
Warrants | 6 Months Ended |
Jun. 30, 2019 | |
Warrants and Rights Note Disclosure [Abstract] | |
Warrants | 11. WARRANTS During the three and six months ended June 30, 2019, warrants to purchase 200,000 shares and 1,283,500 shares of common stock were exercised on a cashless basis resulting in the issuance of 172,414 shares and 1,119,868 shares of common stock, respectively. No warrants were exercised during the three and six months ended June 30, 2018. At June 30, 2019, there were warrants outstanding to purchase 1,000,000 shares of common stock with a weighted average exercise price of $13.20 and a weighted average remaining life of 5.58 years, related only to the warrant issued to CFF pursuant to the terms of the Investment Agreement (Note 8). The Company issued a warrant to CFF to purchase an aggregate of 1,000,000 shares of the Company’s common stock (the “CFF Warrant”). The CFF Warrant is exercisable at a price equal to $13.20 per share and is immediately exercisable for 500,000 shares of the Company’s common stock. Upon completion of the final milestone set forth in the Investment Agreement and receipt of the final payment from CFF to the Company pursuant to the Investment Agreement, the CFF Warrant will be exercisable for the remaining 500,000 shares of the Company’s common stock. The CFF Warrant expires on January 26, 2025. Any shares of the Company’s common stock issued upon exercise of the CFF Warrant will be unregistered and subject to a one-year lock-up. The CFF Warrant is classified as equity as it meets all the conditions under GAAP for equity classification. In accordance with GAAP, the Company has calculated the fair value of the warrant for initial measurement and will reassess whether equity classification for the warrant is appropriate upon any changes to the warrants or capital structure, at each balance sheet date. The weighted average assumptions used in determining the $6,215,225 fair value of the CFF Warrant were as follows: Risk free interest rate 2.60 % Expected dividend yield 0 % Expected term in years 7.00 Expected volatility 83.5 % |
Significant Accounting Polici_2
Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2019 | |
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 8), and the valuation of the CFF Warrant discussed in Note 11. |
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, 2019 and December 31, 2018, cash equivalents were comprised of money market funds. The Company had no marketable investments at June 30, 2019 and December 31, 2018. Cash and cash equivalents consists of the following: June 30, 2019 December 31, 2018 Cash $ 1,542,111 $ 808,943 Money market fund 71,612,805 40,939,525 Total cash and cash equivalents $ 73,154,916 $ 41,748,468 As of June 30, 2019, all of the Company’s cash and cash equivalents was held in the United States, except for approximately $1,015,000 of cash which was held in our subsidiary in the United Kingdom and approximately $84,000 which was held in our subsidiary in Australia. As of December 31, 2018, all of the Company’s cash was held in the United States, except for approximately $702,000 of cash which was held in our subsidiary in the United Kingdom. |
Financial Instruments | Financial Instruments The carrying amounts reported in the consolidated balance sheet for cash and cash equivalents, receivables, accounts payable and accrued expenses approximate their fair value based on the short-term nature of these 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. The Company’s leasehold improvements and assets under capital lease are amortized over the shorter of their useful lives or the respective leases. See Note 4 for details of property and equipment and Note 5 for operating and capital lease commitments. |
Research and Development Expenses | Research and Development Expenses Costs incurred for research and development are expensed as incurred. Nonrefundable advance payments for goods or services that have the characteristics that will be used or rendered for future research and development activities pursuant to executory contractual arrangements with third party research organizations are deferred and recognized as an expense as the related goods are delivered or the related services are performed. |
Accruals for Research and Development Expenses and Clinical Trials | Accruals for Research and Development Expenses and Clinical Trials As part of the process of preparing its financial statements, the Company is required to estimate its expenses resulting from its obligations under contracts with vendors, clinical research organizations and consultants and under clinical site agreements in connection with conducting clinical trials. The financial terms of these contracts are subject to negotiations, which vary from contract to contract and may result in payment terms that do not match the periods over which materials or services are provided under such contracts. The Company’s objective is to reflect the appropriate expenses in its financial statements by matching those expenses with the period in which services are performed and efforts are expended. The Company accounts for these expenses according to the timing of various aspects of the expenses. The Company determines 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, 2019 and 2018, there were no material adjustments to the Company’s prior period estimates of accrued expenses for clinical trials. |
Leases | Leases The Company determines if an arrangement is a lease at inception. Operating leases are included in operating lease right-of-use (“ROU”) assets, other current liabilities and operating lease liabilities in the Company’s consolidated balance sheets. ROU assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent its obligation to make lease payments arising from the lease. ROU assets and liabilities are recognized at commencement date based on the present value of lease payments over the lease term. As the Company’s leases do not provide an implicit rate, the Company uses an incremental borrowing rate based on the information available at commencement date in determining the present value of lease payments. This is the rate the Company would have to pay if borrowing on a collateralized basis over a similar term to each lease. The ROU asset also includes any lease payments made and excludes lease incentives. Lease expense for lease payments is recognized on a straight-line basis over the lease term. |
Concentrations of Credit Risk | Concentrations of Credit Risk The Company has no significant off-balance-sheet concentration of credit risk such as foreign exchange contracts, option contracts or other hedging arrangements. The Company may from time to time have cash in banks in excess of Federal Deposit Insurance Corporation insurance limits. However, the Company believes the risk of loss is minimal as these banks are large financial institutions. |
Segment Information | Segment Information Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision maker, or decision making group, in making decisions regarding resource allocation and assessing performance. To date, the Company has viewed its operations and manages its business as principally one operating segment, which is developing and commercializing therapeutics to treat rare life-threatening, inflammatory fibrotic diseases. As of June 30, 2019 all of the Company’s assets were located in the United States, except for approximately $1,099,000 of cash, $716,000 of prepaid expenses, $43,000 of other assets, and $66,000 of property and equipment, net which were held outside of the United States, principally in our subsidiary in the United Kingdom. As of December 31, 2018, all of the Company’s assets were located in the United States, except for approximately $702,000 of cash, $1,183,000 of prepaid expenses, $28,000 of other assets, and $54,000 of property and equipment, net which were held in our subsidiary in the United Kingdom. |
Income Taxes | Income Taxes For federal and state income taxes, deferred tax assets and liabilities are recognized based upon temporary differences between the financial statement and the tax basis of assets and liabilities. Deferred income taxes are based upon prescribed rates and enacted laws applicable to periods in which differences are expected to reverse. A valuation allowance is recorded to reduce a net deferred tax benefit when it is not more likely than not that the tax benefit from the deferred tax assets will be realized. Accordingly, given the cumulative losses since inception, the Company has provided a valuation allowance equal to 100% of the deferred tax assets in order to eliminate the deferred tax assets amounts. Tax positions taken or expected to be taken in the course of preparing the Company’s tax returns are required to be evaluated to determine whether the tax positions are “more-likely-than-not” of being sustained by the applicable tax authority. Tax positions not deemed to meet a more-likely-than-not threshold, as well as accrued interest and penalties, if any, would be recorded as a tax expense in the current year. There were no uncertain tax positions that require accrual or disclosure to the financial statements as of June 30, 2019 or December 31, 2018. |
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 impairment charges were recorded during the three and six months ended June 30, 2019 and 2018. |
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. The fair value is amortized as compensation cost on a straight-line basis over the requisite service period of the awards, which is generally the vesting period. Prior to the Company’s adoption of ASU 2018-07, (see Recent Accounting Pronouncements |
Foreign Currency | Foreign Currency Transaction gains and losses arising from currency exchange rate fluctuations on transactions denominated in a currency other than the U.S. Dollar functional currency are recorded in the Company’s statement of operations. Such transaction gains and losses may be realized or unrealized depending upon whether the transaction settled during the period or remains outstanding at the balance sheet date. |
Net Loss Per Common Share | Net income (loss) per share was computed as follows: Three Months Ended June 30 Six Months Ended June 30 2019 2018 2019 2018 Net income (loss) $ 2,152,653 $ (12,069,351 ) $ (24,082,156 ) $ (23,764,736 ) Weighted average number of common shares. basic 64,546,628 57,157,955 63,119,196 56,764,935 Effect of dilutive securities 3,964,959 — — — Weighted average number of common shares-diluted 68,511,587 57,157,955 63,119,196 56,764,935 Net income (loss) per share of common stock-basic $ 0.03 $ (0.21 ) $ (0.38 ) $ (0.42 ) Net income (loss) per share of common stock-diluted $ 0.03 $ (0.21 ) $ (0.38 ) $ (0.42 ) 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, 2018 and the six months ended June 30, 2019 and 2018, the effect of dilutive shares was not included in the computation of net loss per share because we had a net loss. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements Accounting for Leases In February 2016, the FASB issued ASU No . Leases (Topic 842), . Nonemployee Share-Based Payment Accounting In June 2018, the FASB issued ASU 2018-07, Compensation-Stock Compensation (Topic 718), Improvements to Nonemployee Share-Based Payment Accounting Collaborative Arrangements In November 2018, the FASB issued ASU 2018-08, Collaborative Arrangements (Topic 808): Clarifying the Interaction between Topic 808 and Topic 606 (“ASU 2018-08”) . ASU 2018-08 clarifies the interaction between the accounting guidance for collaborative arrangements and revenue from contracts with customers. . Early adoption, including adoption in any interim period, is permitted. The Company is currently . |
Significant Accounting Polici_3
Significant Accounting Policies (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Accounting Policies [Abstract] | |
Schedule of Cash and Cash Equivalents | Cash and cash equivalents consists of the following: June 30, 2019 December 31, 2018 Cash $ 1,542,111 $ 808,943 Money market fund 71,612,805 40,939,525 Total cash and cash equivalents $ 73,154,916 $ 41,748,468 |
Schedule of Computation of Basic and Diluted Earnings Per Share | Net income (loss) per share was computed as follows: Three Months Ended June 30 Six Months Ended June 30 2019 2018 2019 2018 Net income (loss) $ 2,152,653 $ (12,069,351 ) $ (24,082,156 ) $ (23,764,736 ) Weighted average number of common shares. basic 64,546,628 57,157,955 63,119,196 56,764,935 Effect of dilutive securities 3,964,959 — — — Weighted average number of common shares-diluted 68,511,587 57,157,955 63,119,196 56,764,935 Net income (loss) per share of common stock-basic $ 0.03 $ (0.21 ) $ (0.38 ) $ (0.42 ) Net income (loss) per share of common stock-diluted $ 0.03 $ (0.21 ) $ (0.38 ) $ (0.42 ) 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, 2018 and the six months ended June 30, 2019 and 2018, the effect of dilutive shares was not included in the computation of net loss per share because we had a net loss. |
Property and Equipment (Tables)
Property and Equipment (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Property, Plant and Equipment [Abstract] | |
Summary of Property and Equipment | Property and equipment consisted of the following: June 30, 2019 December 31, 2018 Computer hardware and software $ 514,923 $ 431,637 Office furniture and equipment 953,744 914,742 Leasehold improvements 2,025,410 2,025,410 Construction in progress 393,172 — Property and equipment, gross 3,887,249 3,371,789 Less: accumulated depreciation (974,914 ) (666,583 ) Property and equipment, net $ 2,912,335 $ 2,705,206 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of Future Minimum Rent Commitments | The following table summarizes the Company’s maturities of operating lease liabilities as of June 30, 2019: 2019 (remainder of year, net of $990,759 reimbursement of leasehold improvements) $ (307,630 ) 2020 1,287,522 2021 1,592,434 2022 1,639,501 2023 1,686,568 Thereafter 5,036,169 Total lease payments $ 10,934,564 Less: present value discount (3,315,001 ) Total $ 7,619,563 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Expenses | Accrued expenses consisted of the following: June 30, 2019 December 31, 2018 Accrued clinical operations and trials costs $ 11,935,501 $ 4,914,881 Accrued product development costs 4,073,377 2,222,093 Accrued compensation 2,100,531 2,253,621 Accrued other 947,209 460,596 Total $ 19,056,618 $ 9,851,191 |
Development Awards and Deferr_2
Development Awards and Deferred Revenue (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Two Thousand Fourteen Equity Incentive Plan [Member] | |
Schedule of Roll Forward Deferred Revenue | A roll forward of deferred revenue related to the Investment Agreement for the six months ended June 30, 2019 is presented below. June 30, 2019 Beginning balance, December 31, 2018 $ 1,462,503 Billing to CFF upon achievement of milestones 5,000,000 Recognition of revenue (3,980,265 ) Ending balance, June 30, 2019 $ 2,482,238 |
Stock Options (Tables)
Stock Options (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Share-based Payment Arrangement [Abstract] | |
Summary of Assumptions Used Principally in Determining Fair Value of Options Granted | The weighted average assumptions used principally in determining the fair value of options granted to employees were as follows: Six Months Ended June 30, 2019 2018 Risk free interest rate 2.56 % 2.40 % Expected dividend yield 0 % 0 % Expected term in years 6.25 6.25 Expected volatility 87.7 % 87.9 % |
Summary of Option Activity | A summary of option activity for the six months ended June 30, 2019 and is presented below: Options Shares Weighted Weighted Contractual Aggregate Outstanding at December 31, 2018 9,593,990 $ 4.51 Granted 3,080,800 7.43 Exercised (78,229 ) 3.92 Forfeited (209,354 ) 7.26 Outstanding at June 30, 2019 12,387,207 $ 5.19 7.31 $ 28,315,753 Vested at June 30, 2019 7,048,991 $ 3.51 6.08 $ 26,768,267 |
Warrants (Tables)
Warrants (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Warrants and Rights Note Disclosure [Abstract] | |
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 (Details Narrative)
Liquidity (Details Narrative) - USD ($) | Jan. 30, 2019 | Jan. 03, 2019 | Apr. 30, 2019 | Jun. 30, 2019 | May 31, 2019 | Dec. 31, 2018 |
Accumulated deficit | $ (145,452,396) | $ (121,370,240) | ||||
Accounts payable | 7,490,561 | 6,345,335 | ||||
Cash and cash equivalents | 73,154,916 | $ 41,748,468 | ||||
Cystic Fibrosis Program Related Investment Agreement [Member] | ||||||
Percentage of payment from the upfront payment received | 10.00% | |||||
Accounts payable | $ 2,700,000 | |||||
Cystic Fibrosis Program Related Investment Agreement [Member] | 2018 CFF Award [Member] | ||||||
Milestone received on achievement on clinical trial | $ 17,500,000 | $ 5,000,000 | ||||
Maximum amount received as development award as funding | $ 25,000,000 | |||||
Cystic Fibrosis Program Related Investment Agreement [Member] | Cystic Fibrosis Foundation [Member] | ||||||
Milestone received on achievement on clinical trial | $ 5,000,000 | |||||
Kaken Pharmaceutical Co., Ltd. [Member] | ||||||
Upfront payment received from strategic collaboration | $ 27,000,000 | |||||
Underwritten Public Offering [Member] | ||||||
Net proceeds | $ 37,700,000 |
Significant Accounting Polici_4
Significant Accounting Policies (Details Narrative) | 6 Months Ended | |||
Jun. 30, 2019USD ($)Segment | Jun. 30, 2018USD ($) | Jan. 02, 2019USD ($) | Dec. 31, 2018USD ($) | |
Significant Accounting Policies [Line Items] | ||||
Cash equivalents maturity period | 3 months | |||
Marketable investments maturity period | 3 months | |||
Marketable investments | ||||
Operating segments | Segment | 1 | |||
Cash | $ 1,542,111 | 808,943 | ||
Property and equipment, net | $ 2,912,335 | 2,705,206 | ||
Valuation allowance | 100.00% | |||
Uncertain tax position | ||||
Impairment charges | ||||
Operating lease liability | 7,619,563 | |||
Operating lease, right of use asset | $ 5,695,689 | |||
ASU 2016-02 [Member] | ||||
Significant Accounting Policies [Line Items] | ||||
Operating lease liability | $ 3,800,000 | |||
Operating lease, right of use asset | $ 2,400,000 | |||
Computer Hardware and Software [Member] | ||||
Significant Accounting Policies [Line Items] | ||||
Estimated useful life of all property and equipment | 3 years | |||
United Kingdom [Member] | ||||
Significant Accounting Policies [Line Items] | ||||
Cash held in subsidiary | $ 1,015,000 | 702,000 | ||
Cash | 1,099,000 | 702,000 | ||
Prepaid expenses | 716,000 | 1,183,000 | ||
Other assets | 43,000 | 28,000 | ||
Property and equipment, net | 66,000 | $ 54,000 | ||
Australia [Member] | ||||
Significant Accounting Policies [Line Items] | ||||
Cash held in subsidiary | $ 84,000 | |||
Minimum [Member] | Office Furniture and Equipment [Member] | ||||
Significant Accounting Policies [Line Items] | ||||
Estimated useful life of all property and equipment | 3 years | |||
Maximum [Member] | Office Furniture and Equipment [Member] | ||||
Significant Accounting Policies [Line Items] | ||||
Estimated useful life of all property and equipment | 5 years |
Significant Accounting Polici_5
Significant Accounting Policies - Schedule of Cash and Cash Equivalents (Details) - USD ($) | Jun. 30, 2019 | Dec. 31, 2018 |
Accounting Policies [Abstract] | ||
Cash | $ 1,542,111 | $ 808,943 |
Money market fund | 71,612,805 | 40,939,525 |
Total cash and cash equivalents | $ 73,154,916 | $ 41,748,468 |
Significant Accounting Polici_6
Significant Accounting Policies - Schedule of Computation of Basic and Diluted Earnings Per Share (Details) - USD ($) | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | ||
Accounting Policies [Abstract] | |||||
Net income (loss) | $ 2,152,653 | $ (12,069,351) | $ (24,082,156) | $ (23,764,736) | |
Weighted average number of common shares. basic | 64,546,628 | 57,157,955 | 63,119,196 | 56,764,935 | |
Effect of dilutive securities | 3,964,959 | ||||
Weighted average number of common shares-diluted | 68,511,587 | 57,157,955 | 63,119,196 | 56,764,935 | |
Net income (loss) per share of common stock-basic | $ 0.03 | $ (0.21) | $ (0.38) | $ (0.42) | |
Net income (loss) per share of common stock-diluted | $ 0.03 | $ (0.21) | $ (0.38) | $ (0.42) | |
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, 2018 and the six months ended June 30, 2019 and 2018, the effect of dilutive shares was not included in the computation of net loss per share because we had a net loss. |
Property and Equipment (Details
Property and Equipment (Details Narrative) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Property, Plant and Equipment [Abstract] | ||||
Depreciation expense | $ 155,709 | $ 124,416 | $ 308,331 | $ 206,314 |
Construction in progress costs | $ 393,172 | $ 393,172 |
Property and Equipment - Summar
Property and Equipment - Summary of Property and Equipment (Details) - USD ($) | Jun. 30, 2019 | Dec. 31, 2018 |
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 3,887,249 | $ 3,371,789 |
Less: accumulated depreciation | (974,914) | (666,583) |
Property and equipment, net | 2,912,335 | 2,705,206 |
Computer Hardware and Software [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 514,923 | 431,637 |
Office Furniture and Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 953,744 | 914,742 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 2,025,410 | 2,025,410 |
Construction in Progress [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 393,172 |
Commitments and Contingencies_2
Commitments and Contingencies (Details Narrative) | Feb. 26, 2019USD ($)ft² | Sep. 20, 2018USD ($) | Aug. 21, 2017USD ($)ft² | Jun. 30, 2019USD ($) | Sep. 30, 2018USD ($) | Jun. 30, 2018USD ($) | Jun. 30, 2019USD ($) | Jun. 30, 2018USD ($) | Jan. 02, 2019USD ($) | Dec. 31, 2018USD ($) |
Commitment And Contingencies [Line Items] | ||||||||||
Operating lease liability | $ 7,619,563 | $ 7,619,563 | ||||||||
Operating lease, right of use asset | 5,695,689 | 5,695,689 | ||||||||
Leasehold improvements reimbursement | 990,759 | |||||||||
Total lease expense | 307,182 | $ 147,752 | 507,344 | $ 294,743 | ||||||
Research and Development Expense [Member] | ||||||||||
Commitment And Contingencies [Line Items] | ||||||||||
Upfront cash payment | $ 250,000 | |||||||||
Potential milestone payments | 18,400,000 | |||||||||
ASU 2016-02 [Member] | ||||||||||
Commitment And Contingencies [Line Items] | ||||||||||
Operating lease liability | $ 3,800,000 | |||||||||
Operating lease, right of use asset | $ 2,400,000 | |||||||||
August 2017 Lease Agreement [Member] | ||||||||||
Commitment And Contingencies [Line Items] | ||||||||||
Area of office space | ft² | 32,733 | |||||||||
Operating lease, term | 7 years | |||||||||
Leasehold improvements | $ 1,080,189 | |||||||||
Irrevocable letter of credit | 400,000 | |||||||||
Unsecured letter of credit | $ 400,000 | |||||||||
Incurred interest expense | $ 2,877 | $ 1,774 | $ 4,714 | $ 3,549 | ||||||
Percentage of incremental borrowing rate from present value of lease | 9.00% | |||||||||
August 2017 Lease Agreement [Member] | First Year [Member] | ||||||||||
Commitment And Contingencies [Line Items] | ||||||||||
Rent expense | $ 470,000 | |||||||||
August 2017 Lease Agreement [Member] | Seventh Year [Member] | ||||||||||
Commitment And Contingencies [Line Items] | ||||||||||
Rent expense | 908,000 | |||||||||
August 2017 Lease Agreement [Member] | Third Anniversary [Member] | ||||||||||
Commitment And Contingencies [Line Items] | ||||||||||
Irrevocable letter of credit | 300,000 | |||||||||
August 2017 Lease Agreement [Member] | Fourth Anniversary [Member] | ||||||||||
Commitment And Contingencies [Line Items] | ||||||||||
Irrevocable letter of credit | $ 200,000 | |||||||||
February 2019 Lease Agreement [Member] | ||||||||||
Commitment And Contingencies [Line Items] | ||||||||||
Irrevocable letter of credit | $ 369,900 | |||||||||
Operating lease liability | 855,000 | |||||||||
Operating lease, right of use asset | $ 855,000 | |||||||||
Percentage of incremental borrowing rate from present value of lease | 9.00% | |||||||||
Operating lease, extended term | 20 months | |||||||||
Leasehold improvements reimbursement | $ 990,759 | |||||||||
February 2019 Lease Agreement [Member] | New Premises [Member] | ||||||||||
Commitment And Contingencies [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] | ||||||||||
Commitment And Contingencies [Line Items] | ||||||||||
Area of office space | ft² | 62,756 | |||||||||
February 2019 Lease Agreement [Member] | Third Anniversary [Member] | ||||||||||
Commitment And Contingencies [Line Items] | ||||||||||
Irrevocable letter of credit | $ 277,425 | |||||||||
February 2019 Lease Agreement [Member] | Fourth Anniversary [Member] | ||||||||||
Commitment And Contingencies [Line Items] | ||||||||||
Irrevocable letter of credit | $ 184,950 | |||||||||
Jenrin Agreement [Member] | ||||||||||
Commitment And Contingencies [Line Items] | ||||||||||
Upfront cash payment | $ 250,000 | |||||||||
Potential milestone payments | $ 18,400,000 |
Commitments and Contingencies -
Commitments and Contingencies - Schedule of Future Minimum Rent Commitments (Details) | Jun. 30, 2019USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
2019 (remainder of year, net of $990,759 reimbursement of leasehold improvements) | $ (307,630) |
2020 | 1,287,522 |
2021 | 1,592,434 |
2022 | 1,639,501 |
2023 | 1,686,568 |
Thereafter | 5,036,169 |
Total lease payments | 10,934,564 |
Less: present value discount | (3,315,001) |
Total | $ 7,619,563 |
Commitments and Contingencies_3
Commitments and Contingencies - Schedule of Future Minimum Rent Commitments (Details) (Parenthetical) | 6 Months Ended |
Jun. 30, 2019USD ($) | |
Commitments and Contingencies Disclosure [Abstract] | |
Leasehold improvements reimbursement | $ 990,759 |
Notes Payable (Details Narrativ
Notes Payable (Details Narrative) - USD ($) | 1 Months Ended | 3 Months Ended | 6 Months Ended | ||||
Nov. 30, 2018 | Nov. 30, 2017 | Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | Dec. 31, 2018 | |
Debt Instrument [Line Items] | |||||||
Prepaid expenses and other current assets | $ 2,235,947 | $ 2,235,947 | $ 2,491,844 | ||||
Interest expense for notes payable | 1,521 | $ 904 | 3,366 | $ 2,564 | |||
Insurance Policy [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Prepaid expenses and other current assets | $ 170,625 | $ 170,625 | $ 441,875 | ||||
Loan Agreement [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Proceeds from issuance of notes payable | $ 491,629 | $ 415,265 | |||||
Monthly principal and interest payments | $ 49,857 | $ 41,975 | |||||
Monthly loan payments term | 10 months | 10 months | |||||
Annual interest rate | 3.07% | 2.35% |
Accrued Expenses - Schedule of
Accrued Expenses - Schedule of Accrued Expenses (Details) - USD ($) | Jun. 30, 2019 | Dec. 31, 2018 |
Payables and Accruals [Abstract] | ||
Accrued clinical operations and trials costs | $ 11,935,501 | $ 4,914,881 |
Accrued product development costs | 4,073,377 | 2,222,093 |
Accrued compensation | 2,100,531 | 2,253,621 |
Accrued other | 947,209 | 460,596 |
Total | $ 19,056,618 | $ 9,851,191 |
Development Awards and Deferr_3
Development Awards and Deferred Revenue (Details Narrative) - USD ($) | Jan. 26, 2018 | Apr. 20, 2015 | May 31, 2019 | Apr. 30, 2019 | Mar. 31, 2019 | Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | Dec. 31, 2018 | Dec. 31, 2017 |
Development Award [Line Items] | |||||||||||
Additional paid in capital, fair value of warrant issued | $ 6,215,225 | ||||||||||
Amount received upon achievement | $ 2,482,238 | $ 2,482,238 | $ 1,462,503 | ||||||||
Cystic Fibrosis Foundation Warrants [Member] | |||||||||||
Development Award [Line Items] | |||||||||||
Warrant to purchase of common stock | 1,000,000 | ||||||||||
Warrant exercisable price per share | $ 13.20 | ||||||||||
Warrant exercisable shares of common stock | 500,000 | ||||||||||
Warrant expires date | Jan. 26, 2025 | ||||||||||
Collaboration and License Agreement [Member] | Kaken Pharmaceutical Co., Ltd. [Member] | |||||||||||
Development Award [Line Items] | |||||||||||
Upfront payment, received from related party | $ 27,000,000 | 27,000,000 | |||||||||
Consideration received on milestone payments | $ 173,000,000 | ||||||||||
Royalty term description | 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. | ||||||||||
Collaboration and License Agreement [Member] | Kaken Pharmaceutical Co., Ltd. [Member] | 2018 CFF Award [Member] | |||||||||||
Development Award [Line Items] | |||||||||||
Royalty payable | 27,000,000 | ||||||||||
Cystic Fibrosis Program Related Investment Agreement [Member] | |||||||||||
Development Award [Line Items] | |||||||||||
Consideration received on milestone payments | 17,500,000 | ||||||||||
Cystic Fibrosis Program Related Investment Agreement [Member] | Phase 2b Clinical Trial [Member] | |||||||||||
Development Award [Line Items] | |||||||||||
Consideration received on milestone payments | $ 5,000,000 | ||||||||||
Cystic Fibrosis Program Related Investment Agreement [Member] | Maximum [Member] | |||||||||||
Development Award [Line Items] | |||||||||||
Development award received | $ 25,000,000 | ||||||||||
Collaboration Agreement [Member] | Cystic Fibrosis Foundation [Member] | |||||||||||
Development Award [Line Items] | |||||||||||
Royalty payment percentage | 10.00% | ||||||||||
Investment Agreement [Member] | Cystic Fibrosis Foundation Warrants [Member] | |||||||||||
Development Award [Line Items] | |||||||||||
Warrant exercisable shares of common stock | 500,000 | ||||||||||
Investment Agreement [Member] | 2018 CFF Award [Member] | |||||||||||
Development Award [Line Items] | |||||||||||
Revenue | $ 2,094,583 | $ 853,646 | 3,980,265 | $ 1,804,088 | |||||||
Investment Agreement [Member] | Kaken Pharmaceutical Co., Ltd. [Member] | 2018 CFF Award [Member] | |||||||||||
Development Award [Line Items] | |||||||||||
Upfront payment, received from related party | $ 27,000,000 | ||||||||||
Proceeds from Royalty | $ 2,700,000 | ||||||||||
Investment Agreement [Member] | Cystic Fibrosis Foundation Warrants [Member] | |||||||||||
Development Award [Line Items] | |||||||||||
Revenue | 18,784,775 | ||||||||||
Reclassified to contract asset and classified in prepaid expenses | 25,000,000 | ||||||||||
Additional paid in capital, fair value of warrant issued | $ 6,215,225 | ||||||||||
Increase in deferred revenue | 17,500,000 | ||||||||||
2015 CFFT Award Agreement [Member] | |||||||||||
Development Award [Line Items] | |||||||||||
Revenue | $ 2,440,195 | ||||||||||
2015 CFFT Award Agreement [Member] | Oral Anti-inflammatory Drug [Member] | |||||||||||
Development Award [Line Items] | |||||||||||
Amount received upon achievement | $ 5,000,000 | ||||||||||
2015 CFFT Award Agreement [Member] | Lenabasum [Member] | Upon Reaching the Sales Target [Member] | |||||||||||
Development Award [Line Items] | |||||||||||
Payment due period after the first commercial sale | 90 days | ||||||||||
Royalty payment, sales target | $ 500,000,000 | ||||||||||
2015 CFFT Award Agreement [Member] | Maximum [Member] | |||||||||||
Development Award [Line Items] | |||||||||||
Development award received | 5,000,000 | ||||||||||
2015 CFFT Award Agreement [Member] | Maximum [Member] | Lenabasum [Member] | Upon Commercialization of the Product [Member] | |||||||||||
Development Award [Line Items] | |||||||||||
Royalty payable | 25,000,000 | ||||||||||
2015 CFFT Award Agreement [Member] | Maximum [Member] | Lenabasum [Member] | Upon Reaching the Sales Target [Member] | |||||||||||
Development Award [Line Items] | |||||||||||
Royalty payable | 5,000,000 | ||||||||||
2015 CFFT Award Agreement [Member] | Maximum [Member] | Lenabasum [Member] | Upon Transfer Sale or Licensing [Member] | |||||||||||
Development Award [Line Items] | |||||||||||
Royalty payable | $ 15,000,000 |
Development Awards and Deferr_4
Development Awards and Deferred Revenue - Schedule of Roll Forward Deferred Revenue (Details) | 6 Months Ended |
Jun. 30, 2019USD ($) | |
Two Thousand Fourteen Equity Incentive Plan [Member] | |
Deferred revenue, beginning balance | $ 1,462,503 |
Billing to CFF upon achievement of milestones | 5,000,000 |
Recognition of revenue | (3,980,265) |
Deferred revenue, ending balance | $ 2,482,238 |
Common Stock (Details Narrative
Common Stock (Details Narrative) - USD ($) | Jan. 30, 2019 | Jan. 05, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | Mar. 31, 2018 | Jun. 30, 2019 | Jun. 30, 2018 |
Aggregate common stock sold, shares | |||||||
Gross proceeds from sale of stock | $ 40,596,961 | $ 12,003,266 | |||||
Stock issuance cost | $ 52,201 | ||||||
Issuance of common stock upon exercise of stock options, shares | 78,229 | ||||||
Warrants [Member] | |||||||
Aggregate common stock sold, shares | 1,119,868 | 172,414 | |||||
Issuance of common stock upon exercise of stock options, shares | 1,283,500 | ||||||
Warrants to purchase common stock | 200,000 | 200,000 | |||||
Stock Option [Member] | |||||||
Issuance of common stock upon exercise of stock options, shares | 16,458 | 52,604 | 78,229 | 89,069 | |||
Proceeds from exercise of stock options | $ 102,708 | $ 146,612 | $ 306,711 | $ 303,266 | |||
Public Offering [Member] | |||||||
Number of common stock value sold | $ 6,198,500 | ||||||
Gross proceeds from sale of stock | $ 40,300,000 | ||||||
Purchase price per share | $ 6.50 | ||||||
Stock issuance cost | $ 2,600,000 | ||||||
Public Offering [Member] | Underwriters [Member] | |||||||
Number of common stock value sold | $ 808,500 | ||||||
January 2018 Sales Agreement [Member] | Institutional Investor [Member] | |||||||
Aggregate common stock sold, shares | 1,500,000 | ||||||
Gross proceeds from sale of stock | $ 11,200,000 | ||||||
January 2018 Sales Agreement [Member] | Maximum [Member] | |||||||
Number of common stock value sold | $ 50,000,000 |
Stock Options (Details Narrativ
Stock Options (Details Narrative) - USD ($) | 1 Months Ended | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||||
Apr. 30, 2014 | Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | Jan. 02, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Stock-based compensation expense | $ 2,817,488 | $ 1,816,094 | $ 5,906,427 | $ 3,701,010 | ||||
Option granted expected term | 6 years 2 months 30 days | |||||||
Weighted average grant-date fair value, options granted | $ 5.41 | $ 5.82 | ||||||
Stock Option [Member] | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Average intrinsic value of options exercised | $ 233,095 | $ 320,541 | ||||||
Fair value of options vested | $ 19,252,762 | $ 11,075,357 | ||||||
Total unrecognized compensation expense | $ 24,389,674 | |||||||
Share-based compensation expense, not yet recognized weighted average period of recognition | 2 years 9 months 11 days | |||||||
2014 Equity Incentive Plan [Member] | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Percentage of outstanding common shares | 7.00% | |||||||
Increase in number of shares of common stock available for issuance | 2,500,000 | |||||||
Aggregate common stock available for stock options granted, shares | 15,543,739 | |||||||
Shares available for grant | 5,200,795 | 5,200,795 | 5,072,241 | |||||
2014 Equity Incentive Plan [Member] | January 1, 2019 [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 | 3,000,000 | |||||||
Aggregate common stock available for stock options granted, shares | 18,543,739 | |||||||
Shares available for grant | 8,072,241 | |||||||
2014 Equity Incentive Plan [Member] | Evergreen Provision [Member] | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Percentage of outstanding common shares | 7.00% | |||||||
2014 Equity Incentive Plan [Member] | Employee Stock Option [Member] | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Stock option vesting term | 4 years | |||||||
Stock option exercisable period | 10 years |
Stock Options - Summary of Assu
Stock Options - Summary of Assumptions Used Principally in Determining Fair Value of Options Granted (Details) | 6 Months Ended | |
Jun. 30, 2019 | Jun. 30, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected term in years | 6 years 2 months 30 days | |
Employee Stock Option [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Risk free interest rate | 2.56% | 2.40% |
Expected dividend yield | 0.00% | 0.00% |
Expected term in years | 6 years 2 months 30 days | 6 years 2 months 30 days |
Expected volatility | 87.70% | 87.90% |
Stock Options - Summary of Opti
Stock Options - Summary of Option Activity (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Share-based Payment Arrangement [Abstract] | ||||
Shares, Outstanding, Beginning balance | 9,593,990 | |||
Shares, Granted | 3,080,800 | |||
Shares, Exercised | (78,229) | |||
Shares, Forfeited | (209,354) | |||
Shares, Outstanding, Ending balance | 12,387,207 | 12,387,207 | ||
Shares, Vested | 7,048,991 | 7,048,991 | ||
Weighted Average Exercise Price, Outstanding, Beginning balance | $ 4.51 | |||
Weighted Average Exercise Price, Granted | 7.43 | |||
Weighted Average Exercise Price, Exercised | 3.92 | |||
Weighted Average Exercise Price, Forfeited | 7.26 | |||
Weighted Average Exercise Price, Outstanding, Ending balance | $ 5.19 | 5.19 | ||
Weighted Average Exercise Price, Vested | $ 3.51 | $ 3.51 | ||
Weighted Average Remaining Contractual Term in Years, Outstanding | 7 years 3 months 22 days | |||
Weighted Average Remaining Contractual Term in Years, Vested | 6 years 29 days | |||
Average Intrinsic Value, Outstanding | $ 28,315,753 | $ 28,315,753 | ||
Average Intrinsic Value, Vested | $ 26,768,267 | $ 26,768,267 |
Warrants (Details Narrative)
Warrants (Details Narrative) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Class of Warrant or Right [Line Items] | ||||
Issuance of common stock upon exercise of stock options, shares | 78,229 | |||
Issuance of common stock | ||||
Fair value of warrants issued | $ 6,215,225 | |||
Warrants [Member] | ||||
Class of Warrant or Right [Line Items] | ||||
Warrant to purchase of common stock | 200,000 | 200,000 | ||
Issuance of common stock upon exercise of stock options, shares | 1,283,500 | |||
Issuance of common stock | 1,119,868 | 172,414 | ||
CFF Warrant [Member] | ||||
Class of Warrant or Right [Line Items] | ||||
Warrant to purchase of common stock | 1,000,000 | 1,000,000 | ||
Weighted average exercise price of warrants | $ 13.20 | $ 13.20 | ||
Number of warrants exercisable for common stock | 500,000 | |||
Warrants expiration term | Jan. 26, 2025 | Jan. 26, 2025 | ||
CFF Warrant [Member] | Investment Agreement [Member] | ||||
Class of Warrant or Right [Line Items] | ||||
Warrant to purchase of common stock | 1,000,000 | 1,000,000 | ||
Weighted average exercise price of warrants | $ 13.20 | $ 13.20 | ||
Weighted average remaining life of warrants | 5 years 6 months 29 days | |||
Number of warrants exercisable for common stock | 500,000 |
Warrants - Schedule of Weighted
Warrants - Schedule of Weighted Average Assumption of Warrants (Details) - Warrants [Member] | 6 Months Ended |
Jun. 30, 2019 | |
Measurement Input, Risk Free Interest Rate [Member] | |
Class of Warrant or Right [Line Items] | |
Warrants outstanding measurement input, percentage | 2.60 |
Measurement Input, Expected Dividend Rate [Member] | |
Class of Warrant or Right [Line Items] | |
Warrants outstanding measurement input, percentage | 0 |
Expected Term [Member] | |
Class of Warrant or Right [Line Items] | |
Warrants outstanding measurement input, term | 7 years |
Measurement Input, Price Volatility [Member] | |
Class of Warrant or Right [Line Items] | |
Warrants outstanding measurement input, percentage | 83.5 |