Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Mar. 06, 2018 | Jun. 30, 2017 | |
Document And Entity Information | |||
Entity Registrant Name | Corbus Pharmaceuticals Holdings, Inc. | ||
Entity Central Index Key | 1,595,097 | ||
Document Type | 10-K | ||
Document Period End Date | Dec. 31, 2017 | ||
Amendment Flag | false | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Filer Category | Accelerated Filer | ||
Entity Public Float | $ 294,882,116 | ||
Entity Common Stock, Shares Outstanding | 57,134,677 | ||
Trading Symbol | CRBP | ||
Document Fiscal Period Focus | FY | ||
Document Fiscal Year Focus | 2,017 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Dec. 31, 2017 | Dec. 31, 2016 |
Current assets: | ||
Cash and cash equivalents | $ 62,537,495 | $ 14,992,257 |
Restricted cash | 158,991 | 150,000 |
Grants receivable | 1,000,000 | |
Stock subscriptions receivable | 330,413 | |
Prepaid expenses and other current assets | 2,808,244 | 930,261 |
Total current assets | 65,504,730 | 17,402,931 |
Restricted cash | 50,000 | |
Property and equipment, net | 1,432,655 | 435,251 |
Other assets | 40,776 | |
Total assets | 66,978,161 | 17,888,182 |
Current liabilities: | ||
Notes payable | 332,861 | 271,757 |
Accounts payable | 3,130,295 | 3,419,921 |
Accrued expenses | 4,741,519 | 3,256,455 |
Deferred revenue, current | 1,940,195 | |
Deferred rent, current | 10,263 | |
Total current liabilities | 8,204,675 | 8,898,591 |
Deferred rent, noncurrent | 989,550 | 65,724 |
Other liabilities | 375 | 4,632 |
Total liabilities | 9,194,600 | 8,968,947 |
Commitments and Contingencies | ||
Stockholders' equity | ||
Preferred Stock $0.0001 par value:10,000,000 shares authorized, no shares issued and outstanding at December 31, 2017 and 2016 | ||
Common stock, $0.0001 par value; 150,000,000 shares authorized at December 31, 2017 and 2016, 55,603,427 and 44,681,745 shares issued and outstanding at December 31, 2017 and 2016, respectively | 5,560 | 4,468 |
Additional paid-in capital | 123,476,102 | 42,191,256 |
Accumulated deficit | (65,698,101) | (33,276,489) |
Total stockholders' equity | 57,783,561 | 8,919,235 |
Total liabilities and stockholders' equity | $ 66,978,161 | $ 17,888,182 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2017 | Dec. 31, 2016 |
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 | 55,603,427 | 44,681,745 |
Common stock, shares outstanding | 55,603,427 | 44,681,745 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2016 | Sep. 30, 2016 | Jun. 30, 2016 | Mar. 31, 2016 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Income Statement [Abstract] | |||||||||||
Revenue from awards | $ 796,312 | $ 350,186 | $ 1,293,697 | $ 375,670 | $ 742,558 | $ 396,598 | $ 396,598 | $ 2,440,195 | $ 1,911,424 | $ 648,382 | |
Operating expenses: | |||||||||||
Research and development | 8,286,682 | 5,622,511 | 5,763,660 | 6,366,112 | 5,380,167 | 4,315,632 | 3,567,003 | 2,173,933 | 26,038,965 | 15,436,735 | 5,888,659 |
General and administrative | 2,575,244 | 2,130,587 | 1,878,090 | 2,380,125 | 2,567,937 | 1,760,696 | 1,021,225 | 1,109,889 | 8,964,046 | 6,459,747 | 3,613,416 |
Total operating expenses | 10,861,926 | 7,753,098 | 7,641,750 | 8,746,237 | 7,948,104 | 6,076,328 | 4,588,228 | 3,283,822 | 35,003,011 | 21,896,482 | 9,502,075 |
Operating loss | (10,861,926) | (6,956,786) | (7,291,564) | (7,452,540) | (7,572,434) | (5,333,770) | (4,191,630) | (2,887,224) | (32,562,816) | (19,985,058) | (8,853,693) |
Other income (expense): | |||||||||||
Interest income, net | 133,073 | 43,402 | 5,271 | 1,366 | 57 | 1,731 | 4,049 | (5,360) | 183,112 | 477 | 977 |
Foreign currency exchange gain (loss) | 35,163 | (52,212) | (10,594) | (14,265) | 2,102 | (14,729) | (1,810) | 343 | (41,908) | (14,094) | 1,977 |
Other income (expense), net | 168,236 | (8,810) | (5,323) | (12,899) | 2,159 | (12,998) | 2,239 | (5,017) | 141,204 | (13,617) | 2,954 |
Net loss | $ (10,693,690) | $ (6,965,596) | $ (7,296,887) | $ (7,465,439) | $ (7,570,275) | $ (5,346,768) | $ (4,189,391) | $ (2,892,241) | $ (32,421,612) | $ (19,998,675) | $ (8,850,739) |
Net loss per share, basic and diluted | $ (0.20) | $ (0.14) | $ (0.15) | $ (0.16) | $ (0.17) | $ (0.12) | $ (0.11) | $ (0.08) | $ (0.65) | $ (0.49) | $ (0.28) |
Weighted average number of common shares outstanding, basic and diluted | 53,828,680 | 50,221,597 | 50,193,726 | 46,381,482 | 44,348,543 | 43,783,504 | 38,748,452 | 37,605,210 | 50,176,953 | 41,137,518 | 31,350,145 |
Statements of Stockholders' Equ
Statements of Stockholders' Equity - USD ($) | Common Stock [Member] | Additional Paid-In Capital [Member] | Accumulated Deficit [Member] | Total |
Balance at Dec. 31, 2014 | $ 2,594 | $ 10,287,214 | $ (4,427,075) | $ 5,862,733 |
Balance, shares at Dec. 31, 2014 | 25,938,332 | |||
Stock-based compensation expense | 1,153,302 | 1,153,302 | ||
Issuance of common stock upon exercise of warrants, net of issuance costs | $ 1,162 | 10,812,963 | 10,814,125 | |
Issuance of common stock upon exercise of warrants, net of issuance costs, shares | 11,615,674 | |||
Issuance of common stock upon exercise of stock options | $ 5 | 5,584 | $ 5,589 | |
Issuance of common stock upon exercise of stock options, shares | 51,128 | 11,666,802 | ||
Net loss | (8,850,739) | $ (8,850,739) | ||
Balance at Dec. 31, 2015 | $ 3,761 | 22,259,063 | (13,277,814) | 8,985,010 |
Balance, shares at Dec. 31, 2015 | 37,605,134 | |||
Stock-based compensation expense | 3,163,534 | 3,163,534 | ||
Issuance of common stock upon exercise of warrants, net of issuance costs | $ 60 | 1,190 | 1,250 | |
Issuance of common stock upon exercise of warrants, net of issuance costs, shares | 601,030 | |||
Issuance of common stock upon exercise of stock options | $ 32 | 467,160 | $ 467,192 | |
Issuance of common stock upon exercise of stock options, shares | 326,886 | 326,886 | ||
Issuance of common stock, net of issuance costs | $ 615 | 16,300,309 | $ 16,300,924 | |
Issuance of common stock, net of issuance costs, shares | 6,148,695 | |||
Net loss | (19,998,675) | (19,998,675) | ||
Balance at Dec. 31, 2016 | $ 4,468 | 42,191,256 | (33,276,489) | 8,919,235 |
Balance, shares at Dec. 31, 2016 | 44,681,745 | |||
Stock-based compensation expense | 5,694,489 | 5,694,489 | ||
Issuance of common stock upon exercise of stock options | $ 27 | 189,463 | $ 189,490 | |
Issuance of common stock upon exercise of stock options, shares | 272,734 | 272,734 | ||
Issuance of common stock, net of issuance costs | $ 1,065 | 75,400,894 | $ 75,401,959 | |
Issuance of common stock, net of issuance costs, shares | 10,648,948 | |||
Net loss | (32,421,612) | (32,421,612) | ||
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 |
Statements of Stockholders' Eq6
Statements of Stockholders' Equity (Parenthetical) - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Statement of Stockholders' Equity [Abstract] | |||
Stock issuance cost | $ 2,969,837 | $ 260,179 | $ 509,215 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Cash flows from operating activities: | |||
Net loss | $ (32,421,612) | $ (19,998,675) | $ (8,850,739) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Stock-based compensation expense | 5,694,489 | 3,163,534 | 1,153,302 |
Depreciation and amortization | 255,652 | 87,664 | 43,943 |
(Gain) loss on foreign exchange | (8,490) | 14,094 | (1,977) |
Deferred rent | 913,563 | 75,987 | |
Changes in operating assets and liabilities: | |||
Decrease (increase) in grants receivable | 1,000,000 | (1,000,000) | |
Increase in prepaid expenses and other current assets | (1,877,983) | (553,745) | (105,959) |
Increase in other assets | (40,776) | ||
(Decrease) increase in accounts payable | (885,797) | 1,890,876 | 972,194 |
Increase in accrued expenses | 1,514,521 | 2,660,461 | 312,788 |
(Decrease) increase in deferred revenue | (1,940,195) | 88,577 | 1,851,618 |
Net cash used in operating activities | (27,796,628) | (13,571,227) | (4,624,830) |
Cash flows from investing activities: | |||
Purchases of property and equipment | (707,429) | (353,032) | (114,037) |
Net cash used in investing activities | (707,429) | (353,032) | (114,037) |
Cash flows from financing activities: | |||
Proceeds from issuance of notes payable | 415,265 | 348,750 | 207,750 |
Principal payments on notes payable | (354,161) | (239,012) | (190,120) |
Proceeds from issuance of common stock | 78,891,699 | 16,699,133 | 11,328,929 |
Issuance costs paid for common stock financings | (2,940,685) | (63,830) | (509,215) |
Principal payments under capital lease obligations | (3,832) | (3,175) | |
Net cash provided by financing activities | 76,008,286 | 16,741,866 | 10,837,344 |
Net increase in cash, cash equivalents, and restricted cash | 47,504,229 | 2,817,607 | 6,098,477 |
Cash, cash equivalents, and restricted cash at beginning of the year | 15,192,257 | 12,374,650 | 6,276,173 |
Cash, cash equivalents, and restricted cash at end of the year | 62,696,486 | 15,192,257 | 12,374,650 |
Supplemental disclosure of cash flow information and non cash transactions: | |||
Cash paid during the period for interest | 12,377 | 5,586 | |
Assets acquired under capital lease obligation | 11,638 | ||
Purchases of property and equipment included in accounts payable or accrued expenses | 579,734 | 34,107 | |
Unpaid stock issuance costs | $ 225,501 | $ 196,349 |
Nature of Operations
Nature of Operations | 12 Months Ended |
Dec. 31, 2017 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Nature of Operations | 1. NATURE OF OPERATIONS Business Corbus Pharmaceuticals Holdings, Inc. (“CPHI” or “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. |
Liquidity
Liquidity | 12 Months Ended |
Dec. 31, 2017 | |
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. The Company has incurred recurring losses since inception and as of December 31, 2017, had an accumulated deficit of $65,698,101. On January 5, 2018, the Company entered into a Controlled Equity Offering SM On January 26, 2018, the Company entered into 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, of which the Company has received $6.25 million to date. 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. (See Note 15). The Company expects the cash on hand of $62,537,495 at December 31, 2017 together with the $11.3 million of net proceeds received from the January 2018 Sales Agreement and the $6.25 million that the Company has received to date under the 2018 CFF Award, to be sufficient to meet its operating and capital requirements at least 12 months from the filing of this 10-K. 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. 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 | 12 Months Ended |
Dec. 31, 2017 | |
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 requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates and changes in estimates may occur. The most significant estimates are related to stock based compensation expense, the accrual of research, product development and clinical obligations, and the expected performance period under the 2015 CFFT Award (See Note 8). Prior to the registration of its common stock and the subsequent public listing of the common stock, the Company had granted stock options at exercise prices not less than the fair value of its common stock as determined by the board of directors, with input from management. The Company’s board of directors determined the estimated fair value of the common stock based on a number of objective and subjective factors, including external market conditions affecting the biotechnology industry sector and the historic prices at which the Company sold shares of preferred stock. Cash, Cash Equivalents, and Restricted Cash The Company considers only those investments which are highly liquid, readily convertible to cash, and that mature within three months from date of purchase to be cash equivalents. Marketable investments are those with original maturities in excess of three months. At December 31, 2017 and 2016, cash equivalents were comprised of money market funds. The Company had no marketable investments at December 31, 2017 and 2016. Restricted cash as of December 31, 2017 and 2016 included a collateral account for the Company’s corporate credit cards and is classified in current assets in the amount of $108,991 and $150,000, respectively. Additionally, as of December 31, 2017 and 2016 restricted cash included a stand-by letter of credit issued in favor of a landlord for $50,000 which was classified in current assets as of December 31, 2017 and in noncurrent assets as of December 31, 2016 (See Note 5). Cash, cash equivalents, and restricted cash consists of the following: December 31, 2017 2016 Cash $ 206,510 $ 1,127,530 Money market fund 62,330,985 13,864,727 Cash and cash equivalents 62,537,495 14,992,257 Restricted cash, current 158,991 150,000 Restricted cash, noncurrent — 50,000 Restricted cash 158,991 200,000 Total cash, cash equivalents, and restricted cash shown in the statement of cash flows $ 62,696,486 $ 15,192,257 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 and Development Award Agreements 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. For amounts received under the development award received from the CFFT (See Note 8), the Company recognized those amounts when the triggering event to receive those payments occurred, with those amounts being amortized on a straight-line basis over the expected duration of the remaining performance period of the development program under the award, which concluded in the third quarter of 2017. 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 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 years ended December 31, 2017, 2016 and 2015, there were no material adjustments to the Company’s prior period estimates of accrued expenses for clinical trials. Leases and Deferred Rent The Company leases its office space. Leases are evaluated and classified as operating or capital leases for financial reporting purposes. The Company’s office space leases qualify as operating leases. For operating leases that contain rent escalations and rent holidays, the Company records the total rent payable during the lease term on a straight-line basis over the term of the lease and records the difference between the rents paid and the straight-line rent as deferred rent. Additionally, any tenant improvement allowances received from the lessor are recorded as a reduction to rent expense over the term of the lease. Concentrations of Credit Risk The Company has no significant off-balance-sheet concentration of credit risk such as foreign exchange contracts, option contracts or other hedging arrangements. The Company may from time to time have cash in banks in excess of Federal Deposit Insurance Corporation insurance limits. However, the Company believes the risk of loss is minimal as these banks are large financial institutions. Segment Information Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision maker, or decision making group, in making decisions regarding resource allocation and assessing performance. To date, the Company has viewed its operations and manages its business as principally one operating segment, which is developing and commercializing therapeutics to treat rare life-threatening inflammatory and fibrotic diseases. As of December 31, 2017 and 2016, all of the Company’s assets were located in the United States. 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 asset when it is not more likely than not that the tax benefit from the deferred tax assets will be realized. Accordingly, given the cumulative losses since inception, the Company has provided a valuation allowance equal to 100% of the deferred tax assets in order to eliminate the deferred tax assets amounts. Tax positions taken or expected to be taken in the course of preparing the Company’s tax returns are required to be evaluated to determine whether the tax positions are “more-likely-than-not” of being sustained by the applicable tax authority. Tax positions not deemed to meet a more-likely-than-not threshold, as well as accrued interest and penalties, if any, would be recorded as a tax expense in the current year. There were no uncertain tax positions that require accrual or disclosure to the financial statements as of December 31, 2017 or 2016. 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 for the years ended December 31, 2017, 2016 and 2015. Share-based Payments The Company recognizes compensation costs resulting from the issuance of stock-based awards to employees, non-employees and directors as an expense in the statement of operations over the service period based on a measurement of fair value for each stock-based award. The fair value of each option grant to employees is estimated as of the date of grant using the Black-Scholes option-pricing model. 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. Stock options granted to non-employee consultants are revalued at the end of each reporting period until vested using the Black-Scholes option-pricing model and the changes in their fair value are recorded as adjustments to expense over the related vesting period. On March 30, 2016, the FASB issued ASU No. 2016-09, Compensation—Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting . Net Loss Per Common Share Basic and diluted net loss per share of the Company’s common stock has been computed by dividing net loss by the weighted average number of shares outstanding during the period. For years in which there is a net loss, options and warrants are anti-dilutive and therefore excluded from diluted loss per share calculations. The following table sets forth the computation of basic and diluted earnings per share for the years ended December 31, 2017, 2016 and 2015: Years Ended December 31, 2017 2016 2015 Basic and diluted net loss per share of common stock: Net loss (32,421,612 ) (19,998,675 ) $ (8,850,739 ) Weighted average shares of common stock outstanding 50,176,953 41,137,518 31,350,145 Net loss per share of common stock-basic and diluted $ (0.65 ) $ (0.49 ) $ (0.28 ) The impact of the following potentially dilutive securities for the years ended December 31, 2017, 2016 and 2015 have been excluded from the computation of dilutive weighted average shares outstanding as the inclusion would be antidilutive. December 31, 2017 2016 2015 Warrants 1,288,500 1,288,500 1,969,250 Stock options 7,844,966 6,610,179 3,982,065 9,133,466 7,898,679 5,951,315 Recent Accounting Pronouncements Revenue Recognition In May 2014, the FASB issued guidance codified in Accounting Standards Codification (ASC) 606, Revenue Recognition — Revenue from Contracts with Customers ASC 605, Revenue Recognition Accounting for Leases In February 2016, the FASB issued ASU No . Leases (Topic 842) . |
Property and Equipment
Property and Equipment | 12 Months Ended |
Dec. 31, 2017 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | 4. PROPERTY AND EQUIPMENT Property and Equipment consisted of the following: December 31, 2017 2016 Computer hardware and software $ 136,522 $ 96,131 Office furniture and equipment 287,048 259,138 Leasehold improvements 191,244 188,219 Construction in progress 1,181,730 — Property and equipment, gross 1,796,544 543,488 Less: accumulated depreciation (363,889 ) (108,237 ) Property and equipment, net $ 1,432,655 $ 435,251 Depreciation expense was approximately $256,000, $88,000 and $44,000 for the years ended December 31, 2017, 2016 and 2015, respectively. At December 31, 2017, construction in progress consisted of purchased property and equipment not placed in service until the Company’s relocation into 32,733 square feet of office space in February 2018 (See Note 5). On December 30, 2015, the Company entered into a lease agreement for a copier machine. The cost of the machine was approximately $12,000 and is included in office furniture and equipment category in the table above. The lease payments commenced when the machine was placed in service in January 2016. The machine is being amortized over the life of the lease, which is for a three-year term and includes a bargain purchase option at the end of the term. See Note 5 for details of this capital lease commitment. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2017 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 5. COMMITMENTS AND CONTINGENCIES Operating Lease Commitment In September 2016, the Company amended its commercial lease for office space to expand into an additional 4,088 square feet of office space within the same building for an aggregate total of 10,414 square feet of leased office space (“September 2016 Amendment”). The Company began occupying this space in early November 2016 and the final lease payment was to be due in January 2021. The September 2016 Amendment required an increase in the standby letter of credit to $50,000 (See Note 3). The September 2016 Amendment was terminated upon the commencement date of the August 2017 Lease Agreement discussed below. On August 21, 2017, the Company entered into a lease agreement (“August 2017 Lease Agreement”) with the same landlord, 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 is 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 ranges 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 have been deferred and will 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 may 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 $9,743 in year ended December 31, 2017. The Company records the total rent payable during the lease term on a straight-line basis over the term of the lease and records the difference between the rents paid and the straight-line rent as deferred rent, which is classified in deferred rent, current and deferred rent, noncurrent in the Company’s balance sheet as of December 31, 2017 and 2016. Pursuant to the terms of the Company’s non-cancelable lease agreements in effect at December 31, 2017, the future minimum rent commitments are as follows: 2018 $ 445,333 2019 623,958 2020 784,243 2021 830,600 2022 855,150 Thereafter 1,935,339 Total $ 5,474,623 Total rent expense for the years ended December 31, 2017, 2016 and 2015 was $356,547, $229,705 and $55,496, respectively. Capital Lease Commitment The lease payments commenced when the machine was placed in service in January 2016. The lease is for a three-year term and includes a bargain purchase option at the end of the term. In the accompanying balance sheet as of December 31, 2017 and 2016, the current portion of this capital lease obligation is classified in accrued expenses and the long-term portion of the capital lease obligation is classified in other long-term liabilities. Pursuant to the terms of this capital lease agreement, the future minimum capital lease commitments are as follows as of December 31, 2017: 2018 $ 4,543 2019 379 Total future minimum lease payments 4,922 Less: interest (291 ) Future capital lease obligations 4,631 Less: current portion (4,256 ) Long-term portion $ 375 Interest expense for this capital lease obligation for the years ended December 31, 2017, 2016 and 2015 was $712, $1,286 and $0, respectively. For commitments under the Company’s development award agreements- see Note 8. |
Notes Payable
Notes Payable | 12 Months Ended |
Dec. 31, 2017 | |
Debt Disclosure [Abstract] | |
Notes Payable | 6. NOTES PAYABLE In November 2015, the Company entered into a loan agreement with a financing company for $207,750 to finance one of the Company’s insurance policies. The terms of the loan stipulated equal monthly payments of principal and interest payments of $23,397 over a nine month period. Interest on this loan was accrued at an annual rate of 3.25%. This loan was fully repaid in July 2016. In October 2016, the Company entered into a loan agreement with a financing company for $348,750 to finance one of the Company’s insurance policies. The terms of the loan stipulate equal monthly payments of principal and interest payments of $39,114 over a nine-month period. Interest on this loan was accrued at an annual rate of 2.25%. This loan was fully repaid in July 2017. 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 accrues on this loan at an annual rate of 2.35%. Prepaid expenses and other current assets as of December 31, 2017 and 2016 included $368,976 and $378,750, respectively, related to these insurance policies. Interest expense for notes payable for the years ended December 31, 2017, 2016 and 2015 totaled $3,632, $3,115 and $2,440, respectively. |
Accrued Expenses
Accrued Expenses | 12 Months Ended |
Dec. 31, 2017 | |
Payables and Accruals [Abstract] | |
Accrued Expenses | 7. ACCRUED EXPENSES Accrued expenses consisted of the following: December 31, 2017 2016 Accrued clinical operations and trials costs $ 2,003,799 $ 1,647,490 Accrued product development costs 1,255,439 713,426 Accrued compensation 1,335,672 778,250 Accrued other 146,609 117,289 Total $ 4,741,519 $ 3,256,455 |
Development Award and Deferred
Development Award and Deferred Revenue | 12 Months Ended |
Dec. 31, 2017 | |
Development Award And Deferred Revenue | |
Development Award and Deferred Revenue | 8. DEVELOPMENT AWARD AND DEFERRED REVENUE On April 20, 2015, the Company entered into an award agreement (the “2015 CFFT Award Agreement “) with the CFFT pursuant to which it 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 has received $5.0 million in payments since the inception of the 2015 CFFT Award as outlined below. 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. Upon the execution of the 2015 CFFT Award Agreement, the Company received a payment of $1,250,000 in May 2015. In November 2015, the Company received a second payment of $1,250,000 upon the achievement of a milestone for dosing the first patient. In August 2016, the Company received a third payment from the CFFT in the amount of $1,000,000 for achieving a milestone in July 2016 related to dosing the median clinical trial patient. In January 2017, the Company received a fourth payment from the CFFT in the amount of $1,000,000 for achieving a milestone in December 2016 related to completing the final visit for the final patient, which was billed by the Company to CFFT in December 2016 and was classified in grants receivable as of December 31, 2016. The Company received the final payment from CFFT in the amount of $500,000 in November 2017 for achieving the final milestone in September 2017 related to the issuance to CFFT of the final integrated statistical report for to the Phase 2 CF clinical trial. At that time the Company had completed all its performance obligations under the contract and therefore the performance period had concluded. 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. For the years ended December 31, 2017, 2016 and 2015, in respect of the 2015 CFFT Award Agreement, the Company recognized revenue of $2,440,195, $1,911,424 and $648,382, respectively. Deferred revenue consisted of the following: December 31, 2017 2016 Deferred revenue $ — $ 1,940,195 Less: current portion — (1,940,195 ) Long term portion $ — $ — See Note 15 for the Investment Agreement entered into by the Company after the balance sheet date. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2017 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 9. INCOME TAXES No provision or benefit for federal or state income taxes has been recorded, as the Company has incurred a net loss for all of the periods presented, and the Company has provided a full valuation allowance against its deferred tax assets. At December 31, 2017 and 2016, the Company had federal net operating loss carryforwards of approximately $56,536,000 and $28,644,000, respectively, of which federal carryforwards will expire in varying amounts beginning in 2029. At December 31, 2017 and 2016, the Company had Massachusetts net operating loss carryforwards of approximately $53,110,000 and $26,573,000, respectively. In the first quarter of 2017, the Company adopted ASU 2016-09, which removed the requirement to recognize the deferred tax assets on excess tax benefits in respect of share based payments only when realized. As such, during the year ended December 31, 2017, the Company’s gross deferred tax assets and corresponding valuation allowance each included a one-time increase in respect of an additional federal and state net operating losses of $1,432,000. The adoption of ASU 2016-09 did not have an impact on the Company’s balance sheet, results of operations, cash flows or statement of stockholders’ equity because the Company has a full valuation allowance on its deferred tax assets. Utilization of net operating losses may be subject to substantial annual limitations due to the “change in ownership” provisions of the Internal Revenue Code, and similar state provisions. The annual limitations may result in the expiration of net operating losses before utilization. The Company has not yet conducted a study to determine if any such changes have occurred that could limit the Company’s ability to use the net operating losses and tax credit carryforwards. The Company also had research and development tax credit carryforwards at December 31, 2017 and 2016 of approximately $1,283,000 and $736,000, respectively. Significant components of the Company’s net deferred tax asset are as follows: December 31, 2017 2016 NOL carryforward $ 15,229,127 $ 10,860,828 Tax credits 1,213,347 673,690 Stock based compensation 1,724,248 1,177,650 Accrued expenses 45,654 302,943 Other temporary differences 116,292 225,214 Subtotal 18,328,668 13,240,325 Valuation allowance (18,328,668 ) (13,240,325 ) Net deferred tax asset $ — $ — The Company has maintained a full valuation allowance against its deferred tax assets in all periods presented. A valuation allowance is required to be recorded when it is not more likely than not that some portion or all of the net deferred tax assets will be realized. Since the Company cannot determine that it is more likely than not that it will generate taxable income, and thereby realize the net deferred tax assets, a full valuation allowance has been provided. The valuation allowance increased by $5,088,343 and $7,860,985 in 2017 and 2016, respectively, due to the increase in deferred tax assets, primarily due to net operating loss carryforwards. The Company has no uncertain tax positions at December 31, 2017 and 2016 that would affect its effective tax rate. Since the Company is in a loss carryforward position, the Company is generally subject to U.S. federal and state income tax examinations by tax authorities for all years for which a loss carryforward is available. Income tax benefits computed using the federal statutory income tax rate differs from the Company’s effective tax rate primarily due to the following: December 31, 2017 2016 2015 Tax provision at statutory rate 34.00 % 34.00 % 34.00 % State taxes, net of federal benefit 5.66 % 4.76 % 4.76 % Permanent differences -2.05 % -0.65 % -0.62 % Tax credits 1.59 % 1.33 % 2.67 % Income tax rate change -24.11 % — % — Other 0.60 % -0.13 % 0.04 % Increase in valuation reserve -15.69 % -39.31 % -40.85 % Total 0.00 % 0.00 % 0.00 % The Tax Cut and Jobs Act of 2017 On December 22, 2017, the Tax Cut and Jobs Act (the “Tax Act”) was enacted into law. The Tax Act, among other things, contains significant changes to corporate taxation, including reduction of the corporate tax rate from a top marginal rate of 35% to a flat rate of 21%; limitation of the tax deduction for interest expense to 30% of adjusted earnings (except for certain small businesses); limitation of the deduction of net operating losses generated in tax years beginning after December 31, 2017 to 80% of taxable income, indefinite carryforward of net operating losses generated in tax years after 2018 and elimination of net operating loss carrybacks; changes in the treatment of offshore earnings regardless of whether they are repatriated; current inclusion in U.S. federal taxable income of certain earnings of controlled foreign corporations, mandatory capitalization of research and development expenses beginning in 2022; immediate deductions for certain new investments instead of deductions for depreciation expense over time; further deduction limits on executive compensation; and modifying, repealing and creating many other business deductions and credits, including the reduction in the orphan drug credit from 50% to 25% of qualifying expenditures. As of December 31, 2017, we have made a reasonable estimate of the effects of the Tax Act on our existing deferred taxes and related disclosures by reducing our net federal and state deferred tax assets by $7,815,832 for the reduction in corporate tax rate. This adjustment to our deferred tax assets is offset against the valuation allowance. Additionally, the SEC staff has issued SAB 118, which allows to record provisional amounts during a measurement period not to extend beyond one year of the enactment date. On December 22, 2017, Staff Accounting Bulletin No. 118 (“SAB 118”) was issued to address the application of U.S. GAAP in situations when a registrant does not have the necessary information available, prepared, or analyzed (including computations) in reasonable detail to complete the accounting for certain income tax effects of the Act. Because the Company is still in the process of analyzing certain provisions of the Tax Act, the Company has determined that the adjustment to its deferred taxes was a provisional amount as permitted under SAB 118. |
Common Stock
Common Stock | 12 Months Ended |
Dec. 31, 2017 | |
Equity [Abstract] | |
Common Stock | 10. COMMON STOCK The Company has authorized 150,000,000 shares of common stock, $0.0001 par value per share, of which 55,603,427 shares, 44,681,745 shares, and 37,605,134 shares were issued and outstanding as of December 31, 2017, 2016, and 2015, respectively. During the year ended December 31, 2015, the Company issued 11,666,802 shares of common stock upon the exercise of warrants and stock options to purchase common stock and the Company received net proceeds of $10,819,714 from these exercises. In June 2016, the Company completed a sale of shares of its common stock pursuant to the terms of a securities purchase agreement under which the Company sold an aggregate of 5,960,000 shares of its common stock in a registered direct offering to investors at a purchase price of $2.50 per share with gross proceeds to the Company totaling approximately $14,900,000 less issuance costs of $25,222. On February 28, 2017, the Company entered in a securities purchase agreement providing for the issuance and sale by the Company of 3,887,815 shares of its common stock in a registered direct offering to institutional and accredited investors at a purchase price of $7.00 per share with gross proceeds to the Company totaling $27,214,705 less issuance costs of $36,291. In November 2016, the Company entered into a sales agreement with Cantor Fitzgerald under which the Company could direct Cantor Fitzgerald as its sales agent to sell common stock under an “At the Market Offering” (“Sales Agreement”). Sales of common stock under the Sales Agreement were made pursuant to an effective registration statement for an aggregate offering of up to $35 million. Under the Sales Agreement, the Company was obligated to pay Cantor a 3% commission on gross proceeds. In 2016, the Company sold 188,695 shares of our common stock under the Sales Agreement at an average selling price of approximately $8.54 per share (net of 3% commission paid to Cantor Fitzgerald) which resulted in proceeds of approximately $1,621,182 and net proceeds of approximately $1,426,145 net of incurred issuance costs. Approximately $330,413 of these proceeds were classified in stock subscriptions receivable as of December 31, 2016 because the Company did not receive these proceeds until January 2017. During the year ended December 31, 2017, in the first quarter, the Company sold 1,413,633 shares of its common stock under the Sales Agreement at an average selling price of approximately $9.71 per share for gross proceeds of $13,724,591 and net proceeds of $13,268,208. The Company did not sell any shares of its common stock under the Sales Agreement in the second or third quarter of 2017 and terminated the Sales Agreement in connection with the October 2017 Offering discussed below. The aggregate amount sold under the Sales Agreement as described above was approximately $15.4 million. See Note 15 for the January 2018 Sales Agreement entered into by the Company and Cantor Fitzgerald after the balance sheet date. On October 26, 2017, the Company consummated an underwritten public offering of shares of its common stock pursuant to which the Company sold an aggregate of 4,650,000 shares of its common stock to institutional investors at a purchase price of $7.00 per share with gross proceeds to the Company totaling $32,550,000, less estimated issuance costs incurred of approximately $2,184,000. The Company also granted the underwriters a 30-day option to purchase up to an additional 697,500 shares of common stock on the same terms as the underwriters were purchasing the base number of shares, which they exercised in November 2017 with net proceeds to us totaling $4,589,550. During the year ended December 31, 2017, the Company issued 272,734 shares of common stock upon the exercise of stock options and warrants to purchase common stock and the Company received net proceeds of $189,490 from these exercises. During the year ended December 31, 2016, the Company issued 927,916 shares of common stock upon the exercise of stock options and warrants to purchase common stock and the Company received net proceeds of $468,442 from these exercises. |
Stock Options
Stock Options | 12 Months Ended |
Dec. 31, 2017 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Stock Options | 11. STOCK OPTIONS In April 2014, the Company adopted the Corbus Pharmaceuticals Holdings, Inc. 2014 Equity Incentive Plan (the “2014 Plan”). Pursuant to the 2014 Plan, the Company’s Board of Directors may grant incentive and nonqualified stock options and restricted stock to employees, officers, directors, consultants and advisors. On January 1, 2017, pursuant to an annual evergreen provision contained in the 2014 Plan, the number of shares reserved for future grants was increased by 3,127,722 shares. As of December 31, 2017, there was a total of 13,043,739 shares reserved for issuance under the 2014 Plan and there were 4,460,334 shares available for future grants. Options issued under the 2014 Plan generally vest over 4 years from the date of grant in multiple tranches and are exercisable for up to 10 years from the date of issuance. 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, which was less than seven percent (7%) of the outstanding shares of common stock on December 31, 2017. As of January 1, 2018, the 2014 Plan had a total reserve of 15,543,739 shares and there were 6,960,334 shares available for future grants. Share-based Compensation For stock options issued and outstanding for the years ended December 31, 2017, 2016 and 2015, the Company recorded non-cash, stock-based compensation expense of $5,694,489 ($4,640,646 for employees and $1,053,843 for non-employees), $3,163,534 ($2,104,939 for employees and $1,058,595 for non-employees) and $1,153,302 ($672,071 for employees and $481,231 for non-employees), respectively, net of estimated forfeitures. The fair value of each option award for employees is estimated on the date of grant and for non-employees is estimated at the end of each reporting period using the Black-Scholes option pricing model that uses the assumptions noted in the following table. Due to its limited operating history, the Company estimated its volatility in consideration of a number of factors, including the volatility of comparable public companies and, commencing in 2015, the Company also included the volatility of 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 based on the average between the vesting period and the contractual life of the options which is 6.25 years. 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: 2017 2016 2015 Risk free interest rate 2.12 % 1.70 % 1.85 % Expected dividend yield 0 % 0 % 0 % Expected term in years 6.25 6.66 6.73 Expected volatility 86.01 % 90.39 % 90.68 % Estimated forfeiture rate 5.00 % 5.00 % 4.83 % For the year ended December 31, 2017, the assumptions used in determining the fair value of options granted to nonemployees included risk free interest rate ranging from 2.12%-2.38%, no expected dividend yield, expected term ranging from 4.91 years to 9.91 years, expected volatility ranging from 85.58% to 89.58%, and estimated forfeiture rate of 5%. A summary of option activity for years ended December 31, 2017 and 2016 is presented below: Options Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Term in Years Intrinsic Value Outstanding at December 31, 2015 3,982,065 $ 1.03 Granted 3,020,000 $ 4.42 Exercised (326,886 ) $ 1.43 Forfeited (65,000 ) $ 2.44 Outstanding at December 31, 2016 6,610,179 $ 2.54 Granted 1,681,500 $ 8.28 Exercised (272,734 ) $ 0.67 Forfeited (173,979 ) $ 6.53 Outstanding at December 31, 2017 7,844,966 $ 3.75 7.72 $ 29,433,877 Vested at December 31, 2017 4,514,977 $ 1.98 7.02 $ 23,444,225 The weighted average grant-date fair value of options granted during the years ended December 31, 2017, 2016 and 2015 was $6.22, $3.81 and $1.41 per share, respectively. The aggregate intrinsic value of options exercised during the years ended December 31, 2017, 2016 and 2015 was approximately $2,092,964. $1,004,321 and $152,531, respectively. As of December 31, 2017 there was approximately $12,542,918 of total unrecognized compensation expense, related to non-vested share-based compensation arrangements. The unrecognized compensation expense is estimated to be recognized over a period of 2.87 years at December 31, 2017. As summary of non-vested stock options for the years ended December 31, 2017 and 2016 is presented below: Options Shares Weighted Average Fair Value Non-vested at December 31, 2015 2,035,254 $ 0.85 Granted 3,020,000 $ 3.69 Vested (1,194,600 ) $ 1.57 Forfeited (34,380 ) $ 1.77 Nonvested at December 31, 2016 3,826,274 $ 2.86 Granted 1,681,500 $ 6.22 Vested (2,003,806 ) $ 2.60 Forfeited (173,979 ) $ 5.03 Non-vested at December 31, 2017 3,329,989 $ 4.61 |
Warrants
Warrants | 12 Months Ended |
Dec. 31, 2017 | |
Derivative Instruments and Hedging Activities Disclosure [Abstract] | |
Warrants | 12. WARRANTS At December 31, 2017, there were warrants outstanding to purchase 1,288,500 shares of common stock with a weighted average exercise price of $1.00 and a weighted average remaining life of 1.41 years. No warrants were exercised during the year ended December 31, 2017. During the year ended December 31, 2016, warrants to purchase 679,500 shares of common stock were exercised on a cashless basis resulting in the issuance of 599,780 shares and 1,250 shares of common stock were exercised on a for cash basis. There were no warrants issued or cancelled during the year ended December 31, 2017 or 2016 For warrant issued to CFF after the balance sheet date – see Note 15. |
Related Party Transactions
Related Party Transactions | 12 Months Ended |
Dec. 31, 2017 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | 13. RELATED PARTY TRANSACTIONS On September 20, 2016, the Company entered into a consulting agreement (the “2016 Consulting Agreement”) with Orchestra Medical Ventures, LLC (“Orchestra”), of which a member of the Company’s Board of Directors, David Hochman, is Managing Partner. Under this agreement, Orchestra rendered a variety of consulting and advisory services relating principally to identifying and evaluating strategic relationships, licensing opportunities, and business strategies. The term of the 2016 Consulting Agreement commenced on September 20, 2016 and expired on March 20, 2017. Pursuant to the terms of the 2016 Consulting Agreement, the Company paid to Orchestra cash compensation in an aggregate amount of $100,000. In connection with this agreement, the Company granted an equity incentive award to Mr. Hochman consisting of options to purchase 50,000 shares (“Option Shares”) of common stock (the “Option Award”) pursuant to the Company’s 2014 Equity Compensation Plan, of which fifty percent (50%) vested on the three (3) month anniversary of the date of grant of the Option Award and the remainder of the Option Shares vested on the six (6) month anniversary of the date of grant of the Option Award. The Option Shares were granted with an exercise price of $7.14 per share. The Company recorded stock-based compensation expense of approximately $222,000 during the year ended December 31, 2016 and $171,000 during the first quarter of 2017 in respect of the Option Award. No stock-based compensation expense was recorded after the first quarter of 2017 related to the Option Shares as they were fully vested in March 2017. |
Quarterly Financial Information
Quarterly Financial Information (Unaudited) | 12 Months Ended |
Dec. 31, 2017 | |
Quarterly Financial Information Disclosure [Abstract] | |
Quarterly Financial Information (Unaudited) | 14. QUARTERLY FINANCIAL INFORMATION (UNAUDITED) Quarters Ended March 31, 2017 June 30, 2017 September 30, 2017 December 31, 2017 Revenue from awards $ 1,293,697 $ 350,186 $ 796,312 $ — Operating expenses: Research and development 6,366,112 5,763,660 5,622,511 8,286,682 General and administrative 2,380,125 1,878,090 2,130,587 2,575,244 Total operating expenses 8,746,237 7,641,750 7,753,098 10,861,926 Operating loss (7,452,540 ) (7,291,564 ) (6,956,786 ) (10,861,926 ) Other income (expense): Interest income (expense), net 1,366 5,271 43,402 133,073 Foreign currency exchange gain (loss) (14,265 ) (10,594 ) (52,212 ) 35,163 Other income (expense), net (12,899 ) (5,323 ) (8,810 ) 168,236 Net loss $ (7,465,439 ) $ (7,296,887 ) $ (6,965,596 ) (10,693,690 ) Net loss per share, basic and diluted $ (0.16 ) $ (0.15 ) $ (0.14 ) (0.20 ) Weighted average number of common shares outstanding, basic and diluted 46,381,482 50,193,726 50,221,597 53,828,680 Quarters Ended March 31, 2016 June 30, 2016 September 30, 2016 December 31, 2016 Revenue from awards $ 396,598 $ 396,598 $ 742,558 $ 375,670 Operating expenses: Research and development 2,173,933 3,567,003 4,315,632 5,380,167 General and administrative 1,109,889 1,021,225 1,760,696 2,567,937 Total operating expenses 3,283,822 4,588,228 6,076,328 7,948,104 Operating loss (2,887,224 ) (4,191,630 ) (5,333,770 ) (7,572,434 ) Other income (expense): Interest income (expense), net (5,360 ) 4,049 1,731 57 Foreign currency exchange gain (loss) 343 (1,810 ) (14,729 ) 2,102 Other income (expense), net (5,017 ) 2,239 (12,998 ) 2,159 Net loss $ (2,892,241 ) $ (4,189,391 ) $ (5,346,768 ) (7,570,275 ) Net loss per share, basic and diluted $ (0.08 ) $ (0.11 ) $ (0.12 ) (0.17 ) Weighted average number of common shares outstanding, basic and diluted 37,605,210 38,748,452 43,783,504 44,348,543 |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2017 | |
Subsequent Events [Abstract] | |
Subsequent Events | 15. SUBSEQUENT EVENTS Evergreen Provision Pursuant to the terms of an annual evergreen provision in the 2014 Plan, the number of shares of common stock available for issuance under the 2014 Plan shall automatically increase on January 1 of each year by at least seven percent (7%) 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 January 1, 2018, the 2014 Plan had a total reserve of 15,543,739 shares and there were 6,960,334 shares available for future grants. At the Market Offering On January 5, 2018, the Company entered into a sales agreement with Cantor Fitzgerald under which the Company may 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. In February 2018, the Company sold 1,500,000 shares of its common stock to an institutional investor under the January 2018 Sales Agreement for which it received net proceeds of $11,349,000. Cystic Fibrosis Program Related Investment Agreement On January 26, 2018, the Company entered into the Cystic Fibrosis Program Related Investment Agreement with the Cystic Fibrosis Foundation (“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 $6.25 million to date. 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. 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. |
Significant Accounting Polici23
Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2017 | |
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 requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates and changes in estimates may occur. The most significant estimates are related to stock based compensation expense, the accrual of research, product development and clinical obligations, and the expected performance period under the 2015 CFFT Award (See Note 8). Prior to the registration of its common stock and the subsequent public listing of the common stock, the Company had granted stock options at exercise prices not less than the fair value of its common stock as determined by the board of directors, with input from management. The Company’s board of directors determined the estimated fair value of the common stock based on a number of objective and subjective factors, including external market conditions affecting the biotechnology industry sector and the historic prices at which the Company sold shares of preferred stock. |
Cash, Cash Equivalents, and Restricted Cash | Cash, Cash Equivalents, and Restricted Cash The Company considers only those investments which are highly liquid, readily convertible to cash, and that mature within three months from date of purchase to be cash equivalents. Marketable investments are those with original maturities in excess of three months. At December 31, 2017 and 2016, cash equivalents were comprised of money market funds. The Company had no marketable investments at December 31, 2017 and 2016. Restricted cash as of December 31, 2017 and 2016 included a collateral account for the Company’s corporate credit cards and is classified in current assets in the amount of $108,991 and $150,000, respectively. Additionally, as of December 31, 2017 and 2016 restricted cash included a stand-by letter of credit issued in favor of a landlord for $50,000 which was classified in current assets as of December 31, 2017 and in noncurrent assets as of December 31, 2016 (See Note 5). Cash, cash equivalents, and restricted cash consists of the following: December 31, 2017 2016 Cash $ 206,510 $ 1,127,530 Money market fund 62,330,985 13,864,727 Cash and cash equivalents 62,537,495 14,992,257 Restricted cash, current 158,991 150,000 Restricted cash, noncurrent — 50,000 Restricted cash 158,991 200,000 Total cash, cash equivalents, and restricted cash shown in the statement of cash flows $ 62,696,486 $ 15,192,257 |
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 and Development Award Agreements | Research and Development Expenses and Development Award Agreements 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. For amounts received under the development award received from the CFFT (See Note 8), the Company recognized those amounts when the triggering event to receive those payments occurred, with those amounts being amortized on a straight-line basis over the expected duration of the remaining performance period of the development program under the award, which concluded in the third quarter of 2017. |
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 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 years ended December 31, 2017, 2016 and 2015, there were no material adjustments to the Company’s prior period estimates of accrued expenses for clinical trials. |
Leases and Deferred Rent | Leases and Deferred Rent The Company leases its office space. Leases are evaluated and classified as operating or capital leases for financial reporting purposes. The Company’s office space leases qualify as operating leases. For operating leases that contain rent escalations and rent holidays, the Company records the total rent payable during the lease term on a straight-line basis over the term of the lease and records the difference between the rents paid and the straight-line rent as deferred rent. Additionally, any tenant improvement allowances received from the lessor are recorded as a reduction to rent expense over the term of the lease. |
Concentrations of Credit Risk | Concentrations of Credit Risk The Company has no significant off-balance-sheet concentration of credit risk such as foreign exchange contracts, option contracts or other hedging arrangements. The Company may from time to time have cash in banks in excess of Federal Deposit Insurance Corporation insurance limits. However, the Company believes the risk of loss is minimal as these banks are large financial institutions. |
Segment Information | Segment Information Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision maker, or decision making group, in making decisions regarding resource allocation and assessing performance. To date, the Company has viewed its operations and manages its business as principally one operating segment, which is developing and commercializing therapeutics to treat rare life-threatening inflammatory and fibrotic diseases. As of December 31, 2017 and 2016, all of the Company’s assets were located in the United States. |
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 asset when it is not more likely than not that the tax benefit from the deferred tax assets will be realized. Accordingly, given the cumulative losses since inception, the Company has provided a valuation allowance equal to 100% of the deferred tax assets in order to eliminate the deferred tax assets amounts. Tax positions taken or expected to be taken in the course of preparing the Company’s tax returns are required to be evaluated to determine whether the tax positions are “more-likely-than-not” of being sustained by the applicable tax authority. Tax positions not deemed to meet a more-likely-than-not threshold, as well as accrued interest and penalties, if any, would be recorded as a tax expense in the current year. There were no uncertain tax positions that require accrual or disclosure to the financial statements as of December 31, 2017 or 2016. |
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 for the years ended December 31, 2017, 2016 and 2015. |
Share-based Payments | Share-based Payments The Company recognizes compensation costs resulting from the issuance of stock-based awards to employees, non-employees and directors as an expense in the statement of operations over the service period based on a measurement of fair value for each stock-based award. The fair value of each option grant to employees is estimated as of the date of grant using the Black-Scholes option-pricing model. 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. Stock options granted to non-employee consultants are revalued at the end of each reporting period until vested using the Black-Scholes option-pricing model and the changes in their fair value are recorded as adjustments to expense over the related vesting period. On March 30, 2016, the FASB issued ASU No. 2016-09, Compensation—Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting . |
Net Loss Per Common Share | Net Loss Per Common Share Basic and diluted net loss per share of the Company’s common stock has been computed by dividing net loss by the weighted average number of shares outstanding during the period. For years in which there is a net loss, options and warrants are anti-dilutive and therefore excluded from diluted loss per share calculations. The following table sets forth the computation of basic and diluted earnings per share for the years ended December 31, 2017, 2016 and 2015: Years Ended December 31, 2017 2016 2015 Basic and diluted net loss per share of common stock: Net loss (32,421,612 ) (19,998,675 ) $ (8,850,739 ) Weighted average shares of common stock outstanding 50,176,953 41,137,518 31,350,145 Net loss per share of common stock-basic and diluted $ (0.65 ) $ (0.49 ) $ (0.28 ) The impact of the following potentially dilutive securities for the years ended December 31, 2017, 2016 and 2015 have been excluded from the computation of dilutive weighted average shares outstanding as the inclusion would be antidilutive. December 31, 2017 2016 2015 Warrants 1,288,500 1,288,500 1,969,250 Stock options 7,844,966 6,610,179 3,982,065 9,133,466 7,898,679 5,951,315 |
Recent Accounting Pronouncements | Recent Accounting Pronouncements Revenue Recognition In May 2014, the FASB issued guidance codified in Accounting Standards Codification (ASC) 606, Revenue Recognition — Revenue from Contracts with Customers ASC 605, Revenue Recognition Accounting for Leases In February 2016, the FASB issued ASU No . Leases (Topic 842) . |
Significant Accounting Polici24
Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Accounting Policies [Abstract] | |
Schedule of Cash and Cash Equivalents and Restricted Cash | Cash, cash equivalents, and restricted cash consists of the following: December 31, 2017 2016 Cash $ 206,510 $ 1,127,530 Money market fund 62,330,985 13,864,727 Cash and cash equivalents 62,537,495 14,992,257 Restricted cash, current 158,991 150,000 Restricted cash, noncurrent — 50,000 Restricted cash 158,991 200,000 Total cash, cash equivalents, and restricted cash shown in the statement of cash flows $ 62,696,486 $ 15,192,257 |
Computation of Basic and Diluted Earnings Per Share | The following table sets forth the computation of basic and diluted earnings per share for the years ended December 31, 2017, 2016 and 2015: Years Ended December 31, 2017 2016 2015 Basic and diluted net loss per share of common stock: Net loss (32,421,612 ) (19,998,675 ) $ (8,850,739 ) Weighted average shares of common stock outstanding 50,176,953 41,137,518 31,350,145 Net loss per share of common stock-basic and diluted $ (0.65 ) $ (0.49 ) $ (0.28 ) |
Potentially Dilutive Securities Excluded from Computation of Dilutive Weighted Average Shares Outstanding | The impact of the following potentially dilutive securities for the years ended December 31, 2017, 2016 and 2015 have been excluded from the computation of dilutive weighted average shares outstanding as the inclusion would be antidilutive. December 31, 2017 2016 2015 Warrants 1,288,500 1,288,500 1,969,250 Stock options 7,844,966 6,610,179 3,982,065 9,133,466 7,898,679 5,951,315 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Property, Plant and Equipment [Abstract] | |
Summary of Property and Equipment | Property and Equipment consisted of the following: December 31, 2017 2016 Computer hardware and software $ 136,522 $ 96,131 Office furniture and equipment 287,048 259,138 Leasehold improvements 191,244 188,219 Construction in progress 1,181,730 — Property and equipment, gross 1,796,544 543,488 Less: accumulated depreciation (363,889 ) (108,237 ) Property and equipment, net $ 1,432,655 $ 435,251 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of Future Minimum Rent Commitments | Pursuant to the terms of the Company’s non-cancelable lease agreements in effect at December 31, 2017, the future minimum rent commitments are as follows: 2018 $ 445,333 2019 623,958 2020 784,243 2021 830,600 2022 855,150 Thereafter 1,935,339 Total $ 5,474,623 |
Schedule of Future Minimum Capital Lease Commitments | Pursuant to the terms of this capital lease agreement, the future minimum capital lease commitments are as follows as of December 31, 2017: 2018 $ 4,543 2019 379 Total future minimum lease payments 4,922 Less: interest (291 ) Future capital lease obligations 4,631 Less: current portion (4,256 ) Long-term portion $ 375 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Expenses | Accrued expenses consisted of the following: December 31, 2017 2016 Accrued clinical operations and trials costs $ 2,003,799 $ 1,647,490 Accrued product development costs 1,255,439 713,426 Accrued compensation 1,335,672 778,250 Accrued other 146,609 117,289 Total $ 4,741,519 $ 3,256,455 |
Development Award and Deferre28
Development Award and Deferred Revenue (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Deferred Revenue Disclosure [Abstract] | |
Schedule of Deferred Revenue | Deferred revenue consisted of the following: December 31, 2017 2016 Deferred revenue $ — $ 1,940,195 Less: current portion — (1,940,195 ) Long term portion $ — $ — |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Income Tax Disclosure [Abstract] | |
Components of Net Deferred Tax Asset | Significant components of the Company’s net deferred tax asset are as follows: December 31, 2017 2016 NOL carryforward $ 15,229,127 $ 10,860,828 Tax credits 1,213,347 673,690 Stock based compensation 1,724,248 1,177,650 Accrued expenses 45,654 302,943 Other temporary differences 116,292 225,214 Subtotal 18,328,668 13,240,325 Valuation allowance (18,328,668 ) (13,240,325 ) Net deferred tax asset $ — $ — |
Schedule of Effective Income Tax Rate Reconciliation | Income tax benefits computed using the federal statutory income tax rate differs from the Company’s effective tax rate primarily due to the following: December 31, 2017 2016 2015 Tax provision at statutory rate 34.00 % 34.00 % 34.00 % State taxes, net of federal benefit 5.66 % 4.76 % 4.76 % Permanent differences -2.05 % -0.65 % -0.62 % Tax credits 1.59 % 1.33 % 2.67 % Income tax rate change -24.11 % — % — Other 0.60 % -0.13 % 0.04 % Increase in valuation reserve -15.69 % -39.31 % -40.85 % Total 0.00 % 0.00 % 0.00 % |
Stock Options (Tables)
Stock Options (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Disclosure of Compensation Related Costs, Share-based Payments [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: 2017 2016 2015 Risk free interest rate 2.12 % 1.70 % 1.85 % Expected dividend yield 0 % 0 % 0 % Expected term in years 6.25 6.66 6.73 Expected volatility 86.01 % 90.39 % 90.68 % Estimated forfeiture rate 5.00 % 5.00 % 4.83 % |
Summary of Option Activity | A summary of option activity for years ended December 31, 2017 and 2016 is presented below: Options Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Term in Years Intrinsic Value Outstanding at December 31, 2015 3,982,065 $ 1.03 Granted 3,020,000 $ 4.42 Exercised (326,886 ) $ 1.43 Forfeited (65,000 ) $ 2.44 Outstanding at December 31, 2016 6,610,179 $ 2.54 Granted 1,681,500 $ 8.28 Exercised (272,734 ) $ 0.67 Forfeited (173,979 ) $ 6.53 Outstanding at December 31, 2017 7,844,966 $ 3.75 7.72 $ 29,433,877 Vested at December 31, 2017 4,514,977 $ 1.98 7.02 $ 23,444,225 |
Summary of Non-Vested Stock Options | As summary of non-vested stock options for the years ended December 31, 2017 and 2016 is presented below: Options Shares Weighted Average Fair Value Non-vested at December 31, 2015 2,035,254 $ 0.85 Granted 3,020,000 $ 3.69 Vested (1,194,600 ) $ 1.57 Forfeited (34,380 ) $ 1.77 Nonvested at December 31, 2016 3,826,274 $ 2.86 Granted 1,681,500 $ 6.22 Vested (2,003,806 ) $ 2.60 Forfeited (173,979 ) $ 5.03 Non-vested at December 31, 2017 3,329,989 $ 4.61 |
Quarterly Financial Informati31
Quarterly Financial Information (Unaudited) (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Quarterly Financial Information Disclosure [Abstract] | |
Schedule of Quarterly Financial Information | Quarters Ended March 31, 2017 June 30, 2017 September 30, 2017 December 31, 2017 Revenue from awards $ 1,293,697 $ 350,186 $ 796,312 $ — Operating expenses: Research and development 6,366,112 5,763,660 5,622,511 8,286,682 General and administrative 2,380,125 1,878,090 2,130,587 2,575,244 Total operating expenses 8,746,237 7,641,750 7,753,098 10,861,926 Operating loss (7,452,540 ) (7,291,564 ) (6,956,786 ) (10,861,926 ) Other income (expense): Interest income (expense), net 1,366 5,271 43,402 133,073 Foreign currency exchange gain (loss) (14,265 ) (10,594 ) (52,212 ) 35,163 Other income (expense), net (12,899 ) (5,323 ) (8,810 ) 168,236 Net loss $ (7,465,439 ) $ (7,296,887 ) $ (6,965,596 ) (10,693,690 ) Net loss per share, basic and diluted $ (0.16 ) $ (0.15 ) $ (0.14 ) (0.20 ) Weighted average number of common shares outstanding, basic and diluted 46,381,482 50,193,726 50,221,597 53,828,680 Quarters Ended March 31, 2016 June 30, 2016 September 30, 2016 December 31, 2016 Revenue from awards $ 396,598 $ 396,598 $ 742,558 $ 375,670 Operating expenses: Research and development 2,173,933 3,567,003 4,315,632 5,380,167 General and administrative 1,109,889 1,021,225 1,760,696 2,567,937 Total operating expenses 3,283,822 4,588,228 6,076,328 7,948,104 Operating loss (2,887,224 ) (4,191,630 ) (5,333,770 ) (7,572,434 ) Other income (expense): Interest income (expense), net (5,360 ) 4,049 1,731 57 Foreign currency exchange gain (loss) 343 (1,810 ) (14,729 ) 2,102 Other income (expense), net (5,017 ) 2,239 (12,998 ) 2,159 Net loss $ (2,892,241 ) $ (4,189,391 ) $ (5,346,768 ) (7,570,275 ) Net loss per share, basic and diluted $ (0.08 ) $ (0.11 ) $ (0.12 ) (0.17 ) Weighted average number of common shares outstanding, basic and diluted 37,605,210 38,748,452 43,783,504 44,348,543 |
Liquidity (Details Narrative)
Liquidity (Details Narrative) - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Accumulated deficit | $ 65,698,101 | $ 33,276,489 | |
Proceeds from sale of stock | 78,891,699 | 16,699,133 | $ 11,328,929 |
Cash on hand | 62,537,495 | $ 14,992,257 | |
2018 CFF Award [Member] | |||
Amount received for development award | 6,250,000 | ||
Sales Agreement [Member] | |||
Proceeds from sale of stock | 13,724,591 | ||
Sales Agreement [Member] | January 2018 [Member] | |||
Proceeds from sale of stock | 11,300,000 | ||
Investment Agreement [Member] | January 26, 2018 [Member] | Phase 2b Clinical Trial [Member] | |||
Amount received for development award | 6,250,000 | ||
Cantor Fitzgerald & Co. [Member] | Sales Agreement [Member] | January 5, 2018 [Member] | |||
Number of common stock value sold | $ 50,000,000 | ||
Number of common stock share sold | 1,500,000 | ||
Proceeds from sale of stock | $ 11,300,000 |
Significant Accounting Polici33
Significant Accounting Policies (Details Narrative) | 12 Months Ended | |
Dec. 31, 2017USD ($)Segment | Dec. 31, 2016USD ($) | |
Significant Accounting Policies [Line Items] | ||
Marketable investments | $ 0 | $ 0 |
Restricted cash | $ 158,991 | 200,000 |
Operating segments | Segment | 1 | |
Valuation allowance | 100.00% | |
Uncertain tax position | $ 0 | 0 |
Impairment charges | 0 | 0 |
Operating lease future non-cancelable lease payments amount | $ 5,474,623 | |
Computer Hardware and Software [Member] | ||
Significant Accounting Policies [Line Items] | ||
Estimated useful life of all property and equipment | 3 years | |
Corporate Credit Cards [Member] | ||
Significant Accounting Policies [Line Items] | ||
Restricted cash | $ 108,991 | 150,000 |
Stand-by Letter of Credit [Member] | ||
Significant Accounting Policies [Line Items] | ||
Restricted cash | $ 50,000 | $ 50,000 |
Maximum [Member] | ||
Significant Accounting Policies [Line Items] | ||
Cash equivalents and restricted cash maturity period | 3 months | |
Maximum [Member] | Office Furniture and Equipment [Member] | ||
Significant Accounting Policies [Line Items] | ||
Estimated useful life of all property and equipment | 5 years | |
Minimum [Member] | ||
Significant Accounting Policies [Line Items] | ||
Marketable investments maturity period | 3 months | |
Minimum [Member] | Office Furniture and Equipment [Member] | ||
Significant Accounting Policies [Line Items] | ||
Estimated useful life of all property and equipment | 3 years |
Significant Accounting Polici34
Significant Accounting Policies - Schedule of Cash and Cash Equivalents and Restricted Cash (Details) - USD ($) | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 |
Cash and Cash Equivalents [Abstract] | ||||
Cash | $ 206,510 | $ 1,127,530 | ||
Money market fund | 62,330,985 | 13,864,727 | ||
Cash and cash equivalents | 62,537,495 | 14,992,257 | ||
Restricted cash, current | 158,991 | 150,000 | ||
Restricted cash, noncurrent | 50,000 | |||
Restricted cash | 158,991 | 200,000 | ||
Total cash, cash equivalents, and restricted cash shown in the statement of cash flows | $ 62,696,486 | $ 15,192,257 | $ 12,374,650 | $ 6,276,173 |
Significant Accounting Polici35
Significant Accounting Policies - Computation of Basic and Diluted Earnings Per Share (Details) - USD ($) | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2016 | Sep. 30, 2016 | Jun. 30, 2016 | Mar. 31, 2016 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Earnings Per Share [Abstract] | |||||||||||
Net loss | $ (10,693,690) | $ (6,965,596) | $ (7,296,887) | $ (7,465,439) | $ (7,570,275) | $ (5,346,768) | $ (4,189,391) | $ (2,892,241) | $ (32,421,612) | $ (19,998,675) | $ (8,850,739) |
Weighted average shares of common stock outstanding | 53,828,680 | 50,221,597 | 50,193,726 | 46,381,482 | 44,348,543 | 43,783,504 | 38,748,452 | 37,605,210 | 50,176,953 | 41,137,518 | 31,350,145 |
Net loss per share of common stock-basic and diluted | $ (0.20) | $ (0.14) | $ (0.15) | $ (0.16) | $ (0.17) | $ (0.12) | $ (0.11) | $ (0.08) | $ (0.65) | $ (0.49) | $ (0.28) |
Significant Accounting Polici36
Significant Accounting Policies - Potential Dilutive Securities Excluded from Computation of Dilutive Weighted Average Shares Outstanding (Details) - shares | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Potential dilutive securities excluded from computation of dilutive weighted average shares outstanding | 9,133,466 | 7,898,679 | 5,951,315 |
Warrants [Member] | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Potential dilutive securities excluded from computation of dilutive weighted average shares outstanding | 1,288,500 | 1,288,500 | 1,969,250 |
Stock Options [Member] | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Potential dilutive securities excluded from computation of dilutive weighted average shares outstanding | 7,844,966 | 6,610,179 | 3,982,065 |
Property and Equipment (Details
Property and Equipment (Details Narrative) | 12 Months Ended | |||
Dec. 31, 2017USD ($)ft² | Dec. 31, 2016USD ($) | Dec. 31, 2015USD ($) | Dec. 30, 2015USD ($) | |
Property, Plant and Equipment [Line Items] | ||||
Depreciation expense | $ 255,652 | $ 87,664 | $ 43,943 | |
Cost of machine | $ 1,796,544 | $ 543,488 | ||
Copier Machine [Member] | ||||
Property, Plant and Equipment [Line Items] | ||||
Cost of machine | $ 12,000 | |||
Lease term | 3 years | |||
February 2018 [Member] | ||||
Property, Plant and Equipment [Line Items] | ||||
Area of land | ft² | 32,733 |
Property and Equipment - Summar
Property and Equipment - Summary of Property and Equipment (Details) - USD ($) | Dec. 31, 2017 | Dec. 31, 2016 |
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 1,796,544 | $ 543,488 |
Less: accumulated depreciation | (363,889) | (108,237) |
Property and equipment, net | 1,432,655 | 435,251 |
Computer Hardware and Software [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 136,522 | 96,131 |
Office Furniture and Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 287,048 | 259,138 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 191,244 | 188,219 |
Construction in Progress [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 1,181,730 |
Commitments and Contingencies39
Commitments and Contingencies (Details Narrative) | Aug. 21, 2017USD ($)ft² | Sep. 30, 2016USD ($)ft² | Dec. 31, 2017USD ($) | Dec. 31, 2016USD ($) | Dec. 31, 2015USD ($) |
Commitment And Contingencies [Line Items] | |||||
Area of office space | ft² | 4,088 | ||||
Rent expense | $ 356,547 | $ 229,705 | $ 55,496 | ||
Terms of lease | 3 years | ||||
Interest expense | $ 712 | $ 1,286 | $ 0 | ||
August 2017 Lease Agreement [Member] | |||||
Commitment And Contingencies [Line Items] | |||||
Area of office space | ft² | 32,733 | ||||
Leasehold improvements | $ 1,080,189 | ||||
Irrevocable letter of credit | 400,000 | ||||
Incurred interest expense | $ 9,743 | ||||
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 | ||||
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 | ||||
September 2016 Amendment [Member] | |||||
Commitment And Contingencies [Line Items] | |||||
Area of office space | ft² | 10,414 | ||||
Operating lease expiration date | Jan. 31, 2021 | ||||
Standby letters of credit | $ 50,000 |
Commitments and Contingencies -
Commitments and Contingencies - Schedule of Future Minimum Rent Commitments (Details) | Dec. 31, 2017USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
2,018 | $ 445,333 |
2,019 | 623,958 |
2,020 | 784,243 |
2,021 | 830,600 |
2,022 | 855,150 |
Thereafter | 1,935,339 |
Total | $ 5,474,623 |
Commitments and Contingencies41
Commitments and Contingencies - Schedule of Future Minimum Capital Lease Commitments (Details) - Copier Machine [Member] | Dec. 31, 2017USD ($) |
Commitment And Contingencies [Line Items] | |
2,018 | $ 4,543 |
2,019 | 379 |
Total future minimum lease payments | 4,922 |
Less: interest | (291) |
Future capital lease obligations | 4,631 |
Less: current portion | (4,256) |
Long-term portion | $ 375 |
Notes Payable (Details Narrativ
Notes Payable (Details Narrative) - USD ($) | 1 Months Ended | 12 Months Ended | ||||
Nov. 30, 2017 | Oct. 31, 2016 | Nov. 30, 2015 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Debt Instrument [Line Items] | ||||||
Proceeds from issuance of notes payable | $ 415,265 | $ 348,750 | $ 207,750 | |||
Prepaid expenses and other current assets | 2,808,244 | 930,261 | ||||
Interest expense for notes payable | 3,632 | 3,115 | $ 2,440 | |||
Insurance Policies [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Prepaid expenses and other current assets | $ 368,976 | $ 378,750 | ||||
Notes Payable Other Payables [Member] | Three Point Two Five Percent Notes Payable [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Proceeds from issuance of notes payable | $ 207,750 | |||||
Principal and interest payable | $ 23,397 | |||||
Monthly loan payments term | 9 months | |||||
Annual interest rate | 3.25% | |||||
Notes Payable Other Payables [Member] | Two Point Two Five Percent Notes Payable [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Proceeds from issuance of notes payable | $ 348,750 | |||||
Principal and interest payable | $ 39,114 | |||||
Monthly loan payments term | 9 months | |||||
Annual interest rate | 2.25% | |||||
Notes Payable Other Payables [Member] | Two Point Three Five Percent Notes Payable [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Proceeds from issuance of notes payable | $ 415,265 | |||||
Principal and interest payable | $ 41,975 | |||||
Monthly loan payments term | 10 months | |||||
Annual interest rate | 2.35% |
Accrued Expenses - Schedule of
Accrued Expenses - Schedule of Accrued Expenses (Details) - USD ($) | Dec. 31, 2017 | Dec. 31, 2016 |
Payables and Accruals [Abstract] | ||
Accrued clinical operations and trials costs | $ 2,003,799 | $ 1,647,490 |
Accrued product development costs | 1,255,439 | 713,426 |
Accrued compensation | 1,335,672 | 778,250 |
Accrued other | 146,609 | 117,289 |
Total | $ 4,741,519 | $ 3,256,455 |
Development Award and Deferre44
Development Award and Deferred Revenue (Details Narrative) | Jan. 31, 2017USD ($) | Aug. 31, 2016USD ($) | Apr. 20, 2015USD ($)Installments | Nov. 30, 2017USD ($) | Nov. 30, 2015USD ($) | May 31, 2015USD ($) | Dec. 31, 2017USD ($) | Sep. 30, 2017USD ($) | Jun. 30, 2017USD ($) | Mar. 31, 2017USD ($) | Dec. 31, 2016USD ($) | Sep. 30, 2016USD ($) | Jun. 30, 2016USD ($) | Mar. 31, 2016USD ($) | Dec. 31, 2017USD ($) | Dec. 31, 2016USD ($) | Dec. 31, 2015USD ($) |
Development Award [Line Items] | |||||||||||||||||
Revenue | $ 796,312 | $ 350,186 | $ 1,293,697 | $ 375,670 | $ 742,558 | $ 396,598 | $ 396,598 | $ 2,440,195 | $ 1,911,424 | $ 648,382 | |||||||
2015 CFFT Award Agreement [Member] | |||||||||||||||||
Development Award [Line Items] | |||||||||||||||||
Amount received upon execution of award agreement | $ 1,000,000 | $ 1,000,000 | $ 500,000 | $ 1,250,000 | $ 1,250,000 | ||||||||||||
2015 CFFT Award Agreement [Member] | Oral Anti-inflammatory Drug [Member] | |||||||||||||||||
Development Award [Line Items] | |||||||||||||||||
Amount received upon execution of award agreement | $ 5,000,000 | ||||||||||||||||
2015 CFFT Award Agreement [Member] | Lenabasum [Member] | |||||||||||||||||
Development Award [Line Items] | |||||||||||||||||
Number of installments | Installments | 3 | ||||||||||||||||
Payment due period after the first commercial sale | 90 days | ||||||||||||||||
Royalty payment, sales target | $ 500,000,000 | ||||||||||||||||
2015 CFFT Award Agreement [Member] | Lenabasum [Member] | Upon Transfer Sale or Licensing [Member] | |||||||||||||||||
Development Award [Line Items] | |||||||||||||||||
Royalty payable | 15,000,000 | ||||||||||||||||
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 |
Development Award and Deferre45
Development Award and Deferred Revenue - Schedule of Deferred Revenue (Details) - USD ($) | Dec. 31, 2017 | Dec. 31, 2016 |
Deferred Revenue Disclosure [Abstract] | ||
Deferred revenue | $ 1,940,195 | |
Less: current portion | (1,940,195) | |
Long-term portion |
Income Taxes (Details Narrative
Income Taxes (Details Narrative) - USD ($) | Dec. 22, 2017 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 |
Income Taxes [Line Items] | ||||
Net operating loss carryforwards | $ 56,536,000 | $ 28,644,000 | ||
Net operating loss carryforwards excess stock-based compensation | 1,432,000 | |||
Deferred tax assets valuation allowance increase | 5,088,343 | 7,860,985 | ||
Uncertain tax position | $ 0 | $ 0 | ||
Taxable income percentage | 0.00% | 0.00% | 0.00% | |
Massachusett [Member] | ||||
Income Taxes [Line Items] | ||||
Net operating loss carryforwards | $ 53,110,000 | $ 26,573,000 | ||
Research [Member] | ||||
Income Taxes [Line Items] | ||||
Tax credit carryforwards | $ 1,283,000 | $ 736,000 | ||
Federal [Member] | ||||
Income Taxes [Line Items] | ||||
Operating loss carryforwards expiration year | 2,029 | |||
State And Local Jurisdiction [Member] | ||||
Income Taxes [Line Items] | ||||
Operating loss carryforwards expiration year | 2,014 | |||
The Tax Cut and Jobs Act of 2017 [Member] | ||||
Income Taxes [Line Items] | ||||
Taxable income percentage | 80.00% | |||
Deferred tax asset | $ 7,815,832 | |||
The Tax Cut and Jobs Act of 2017 [Member] | Interest Expense [Member] | ||||
Income Taxes [Line Items] | ||||
Reduction of corporate tax rate percentage | 30.00% | |||
The Tax Cut and Jobs Act of 2017 [Member] | Maximum [Member] | ||||
Income Taxes [Line Items] | ||||
Reduction of corporate tax rate percentage | 35.00% | |||
The Tax Cut and Jobs Act of 2017 [Member] | Minimum [Member] | ||||
Income Taxes [Line Items] | ||||
Reduction of corporate tax rate percentage | 21.00% | |||
The Tax Cut and Jobs Act of 2017 [Member] | Orphan Drug Credit [Member] | Maximum [Member] | ||||
Income Taxes [Line Items] | ||||
Reduction of corporate tax rate percentage | 50.00% | |||
The Tax Cut and Jobs Act of 2017 [Member] | Orphan Drug Credit [Member] | Minimum [Member] | ||||
Income Taxes [Line Items] | ||||
Reduction of corporate tax rate percentage | 25.00% |
Income Taxes - Components of Ne
Income Taxes - Components of Net Deferred Tax Asset (Details) - USD ($) | Dec. 31, 2017 | Dec. 31, 2016 |
Deferred Tax Assets, Net [Abstract] | ||
NOL carryforward | $ 15,229,127 | $ 10,860,828 |
Tax credits | 1,213,347 | 673,690 |
Stock based compensation | 1,724,248 | 1,177,650 |
Accrued expenses | 45,654 | 302,943 |
Other temporary differences | 116,292 | 225,214 |
Subtotal | 18,328,668 | 13,240,325 |
Valuation allowance | (18,328,668) | (13,240,325) |
Net deferred tax asset |
Income Taxes - Schedule of Effe
Income Taxes - Schedule of Effective Income Tax Rate Reconciliation (Details) | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Income Tax Disclosure [Abstract] | |||
Tax provision at statutory rate | 34.00% | 34.00% | 34.00% |
State taxes, net of federal benefit | 5.66% | 4.76% | 4.76% |
Permanent differences | (2.05%) | (0.65%) | (0.62%) |
Tax credits | 1.59% | 1.33% | 2.67% |
Income tax rate change | (24.11%) | ||
Other | 0.60% | (0.13%) | 0.04% |
Increase in valuation reserve | (15.69%) | (39.31%) | (40.85%) |
Total | 0.00% | 0.00% | 0.00% |
Common Stock (Details Narrative
Common Stock (Details Narrative) - USD ($) | Oct. 26, 2017 | Feb. 28, 2017 | Nov. 30, 2017 | Nov. 30, 2016 | Jun. 30, 2016 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 |
Common stock, shares authorized | 150,000,000 | 150,000,000 | 150,000,000 | |||||
Common stock, par value | $ 0.0001 | $ 0.0001 | $ 0.0001 | |||||
Common stock, shares issued | 55,603,427 | 44,681,745 | 37,605,134 | |||||
Common stock, shares outstanding | 55,603,427 | 44,681,745 | 37,605,134 | |||||
Issuance of common stock upon exercise of stock options, shares | 272,734 | 326,886 | 11,666,802 | |||||
Proceeds from exercise of stock options | $ 189,490 | $ 468,442 | $ 10,819,714 | |||||
Gross proceeds from sale of stock | 78,891,699 | 16,699,133 | 11,328,929 | |||||
Stock issuance cost | 2,969,837 | 260,179 | $ 509,215 | |||||
Stock subscriptions receivable | 330,413 | |||||||
Aggregate common stock sold, value | $ 75,401,959 | $ 16,300,924 | ||||||
Institutional Investors [Member] | ||||||||
Aggregate common stock sold, shares | 4,650,000 | |||||||
Purchase price per share | $ 7 | |||||||
Gross proceeds from sale of stock | $ 32,550,000 | $ 4,589,550 | ||||||
Stock issuance cost | $ 2,184,000 | |||||||
Securities Purchase Agreement [Member] | Institutional and Accredited Investors [Member] | ||||||||
Aggregate common stock sold, shares | 3,887,815 | 5,960,000 | ||||||
Purchase price per share | $ 7 | $ 2.50 | ||||||
Gross proceeds from sale of stock | $ 27,214,705 | $ 14,900,000 | ||||||
Stock issuance cost | $ 36,291 | $ 25,222 | ||||||
Sales Agreement [Member] | ||||||||
Aggregate common stock sold, shares | 1,413,633 | |||||||
Purchase price per share | $ 9.71 | |||||||
Gross proceeds from sale of stock | $ 13,724,591 | |||||||
Stock issuance cost | 13,268,208 | |||||||
Sales Agreement [Member] | Cantor Fitzgerald [Member] | ||||||||
Aggregate common stock sold, shares | 188,695 | |||||||
Purchase price per share | $ 8.54 | |||||||
Gross proceeds from sale of stock | $ 1,621,182 | |||||||
Stock issuance cost | 1,426,145 | |||||||
Commission paid percentage | 3.00% | |||||||
Stock subscriptions receivable | $ 330,413 | |||||||
Aggregate common stock sold, value | $ 15,400,000 | |||||||
Sales Agreement [Member] | Cantor Fitzgerald [Member] | Maximum [Member] | ||||||||
Aggregate offering amount | $ 35,000,000 |
Stock Options (Details Narrativ
Stock Options (Details Narrative) - USD ($) | Jan. 02, 2017 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Stock-based compensation expense | $ 5,694,489 | $ 3,163,534 | $ 1,153,302 | |
Average intrinsic value of options exercised | 2,092,964 | $ 1,004,321 | $ 152,531 | |
Total unrecognized compensation expense | $ 12,542,918 | |||
Share-based compensation expense, not yet recognized period of recognition | 2 years 10 months 14 days | |||
Stock Option [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Weighted average grant-date fair value, options granted | $ 6.22 | $ 3.81 | $ 1.41 | |
Employees [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Stock-based compensation expense | $ 4,640,646 | $ 2,104,939 | $ 672,071 | |
Non-Employees [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Stock-based compensation expense | $ 1,053,843 | $ 1,058,595 | $ 481,231 | |
Forfeitures estimated, percentage | 5.00% | |||
Non-Employees [Member] | Minimum [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Option granted expected term | 4 years 10 months 28 days | |||
Option granted risk free interest rate | 2.12% | |||
Non-Employees [Member] | Maximum [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Option granted expected term | 9 years 10 months 28 days | |||
Option granted risk free interest rate | 2.38% | |||
2014 Equity Incentive Plan [Member] | Employee Stock Option [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Aggregate common stock available for stock options granted, shares | 13,043,739 | |||
Shares available for grant | 4,460,334 | |||
Stock option vesting term | 4 years | |||
Stock option expiration period | 10 years | |||
Option granted expected term | 6 years 2 months 30 days | |||
Evergreen Provision [Member] | 2014 Equity Incentive Plan [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Increase in number of shares of common stock available for issuance | 3,127,722 | |||
Evergreen Provision [Member] | 2014 Equity Incentive Plan [Member] | January 1, 2018 [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Increase in number of shares of common stock available for issuance | 2,500,000 | |||
Aggregate common stock available for stock options granted, shares | 15,543,739 | |||
Shares available for grant | 6,960,334 |
Stock Options - Summary of Assu
Stock Options - Summary of Assumptions Used Principally in Determining Fair Value of Options Granted (Details) - Employee Stock Option [Member] | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Risk free interest rate | 2.12% | 1.70% | 1.85% |
Expected dividend yield | 0.00% | 0.00% | 0.00% |
Expected term in years | 6 years 2 months 30 days | 6 years 7 months 28 days | 6 years 8 months 23 days |
Expected volatility | 86.01% | 90.39% | 90.68% |
Estimated forfeiture rate | 5.00% | 5.00% | 4.83% |
Stock Options - Summary of Opti
Stock Options - Summary of Option Activity (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |||
Shares Outstanding, Beginning balance | 6,610,179 | 3,982,065 | |
Shares, Granted | 1,681,500 | 3,020,000 | |
Shares, Exercised | (272,734) | (326,886) | (11,666,802) |
Shares, Forfeited | (173,979) | (65,000) | |
Shares Outstanding, Ending balance | 7,844,966 | 6,610,179 | 3,982,065 |
Shares, Vested | 4,514,977 | ||
Weighted Average Exercise Price Outstanding, Beginning balance | $ 2.54 | $ 1.03 | |
Weighted Average Exercise Price, Granted | 8.28 | 4.42 | |
Weighted Average Exercise Price, Exercised | 0.67 | 1.43 | |
Weighted Average Exercise Price, Forfeited | 6.53 | 2.44 | |
Weighted Average Exercise Price Outstanding, Ending balance | 3.75 | 2.54 | $ 1.03 |
Weighted Average Exercise Price, Vested | $ 1.98 | ||
Weighted Average Remaining Contractual Term in Years, Outstanding | 7 years 8 months 19 days | ||
Weighted Average Remaining Contractual Term in Years, Vested | 7 years 7 days | ||
Average Intrinsic Value, Outstanding | $ 29,433,877 | ||
Average Intrinsic Value, Vested | $ 23,444,225 |
Stock Options - Summary of Non
Stock Options - Summary of Non Vested Stock Options (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | ||
Shares Non-vested , Beginning balance | 3,826,274 | 2,035,254 |
Shares, Granted | 1,681,500 | 3,020,000 |
Shares, vested | (2,003,806) | (1,194,600) |
Shares, Forfeited | (173,979) | (34,380) |
Shares Outstanding, Ending balance | 3,329,989 | 3,826,274 |
Weighted Average fair value non vested, Beginning balance | $ 2.86 | $ 0.85 |
Weighted Average fair value, Forfeited | 5.03 | |
Weighted Average fair value non vested, Ending balance | $ 4.61 | $ 2.86 |
Warrants (Details Narrative)
Warrants (Details Narrative) - $ / shares | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Equity [Abstract] | ||
Warrants outstanding to purchase of common stock shares | 1,288,500 | 679,500 |
Weighted average exercise price of warrants | $ 1 | |
Weighted average remaining life of warrants | 1 year 4 months 28 days | |
Issuance of common stock shares exercised on cashless basis | 599,780 | |
Number of common stock were exercised on a cash basis | 1,250 | |
Number of warrants issued | ||
Number of warrants cancelled |
Related Party Transactions (Det
Related Party Transactions (Details Narrative) - USD ($) | 1 Months Ended | 3 Months Ended | 12 Months Ended | |
Sep. 20, 2016 | Mar. 31, 2017 | Dec. 31, 2017 | Dec. 31, 2016 | |
Related Party Transaction [Line Items] | ||||
Options granted exercise price | $ 8.28 | $ 4.42 | ||
Stock-based compensation expense | $ 171,000 | $ 222,000 | ||
2014 Equity Compensation Plan [Member] | ||||
Related Party Transaction [Line Items] | ||||
Option vested percentage | 50.00% | |||
Options granted exercise price | $ 7.14 | |||
Orchestra Medical Ventures LLC [Member] | 2016 Consulting Agreement [Member] | ||||
Related Party Transaction [Line Items] | ||||
Cash compensation amount | $ 100,000 | |||
Agreement expiry date | Mar. 20, 2017 | |||
Options to purchase, shares | 50,000 |
Quarterly Financial Informati56
Quarterly Financial Information (Unaudited) - Schedule of Quarterly Financial Information (Details) - USD ($) | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2016 | Sep. 30, 2016 | Jun. 30, 2016 | Mar. 31, 2016 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Quarterly Financial Information Disclosure [Abstract] | |||||||||||
Revenue from awards | $ 796,312 | $ 350,186 | $ 1,293,697 | $ 375,670 | $ 742,558 | $ 396,598 | $ 396,598 | $ 2,440,195 | $ 1,911,424 | $ 648,382 | |
Research and development | 8,286,682 | 5,622,511 | 5,763,660 | 6,366,112 | 5,380,167 | 4,315,632 | 3,567,003 | 2,173,933 | 26,038,965 | 15,436,735 | 5,888,659 |
General and administrative | 2,575,244 | 2,130,587 | 1,878,090 | 2,380,125 | 2,567,937 | 1,760,696 | 1,021,225 | 1,109,889 | 8,964,046 | 6,459,747 | 3,613,416 |
Total operating expenses | 10,861,926 | 7,753,098 | 7,641,750 | 8,746,237 | 7,948,104 | 6,076,328 | 4,588,228 | 3,283,822 | 35,003,011 | 21,896,482 | 9,502,075 |
Operating loss | (10,861,926) | (6,956,786) | (7,291,564) | (7,452,540) | (7,572,434) | (5,333,770) | (4,191,630) | (2,887,224) | (32,562,816) | (19,985,058) | (8,853,693) |
Interest income (expense), net | 133,073 | 43,402 | 5,271 | 1,366 | 57 | 1,731 | 4,049 | (5,360) | 183,112 | 477 | 977 |
Foreign currency exchange gain (loss) | 35,163 | (52,212) | (10,594) | (14,265) | 2,102 | (14,729) | (1,810) | 343 | (41,908) | (14,094) | 1,977 |
Other income (expense), net | 168,236 | (8,810) | (5,323) | (12,899) | 2,159 | (12,998) | 2,239 | (5,017) | 141,204 | (13,617) | 2,954 |
Net loss | $ (10,693,690) | $ (6,965,596) | $ (7,296,887) | $ (7,465,439) | $ (7,570,275) | $ (5,346,768) | $ (4,189,391) | $ (2,892,241) | $ (32,421,612) | $ (19,998,675) | $ (8,850,739) |
Net loss per share, basic and diluted | $ (0.20) | $ (0.14) | $ (0.15) | $ (0.16) | $ (0.17) | $ (0.12) | $ (0.11) | $ (0.08) | $ (0.65) | $ (0.49) | $ (0.28) |
Weighted average number of common shares outstanding, basic and diluted | 53,828,680 | 50,221,597 | 50,193,726 | 46,381,482 | 44,348,543 | 43,783,504 | 38,748,452 | 37,605,210 | 50,176,953 | 41,137,518 | 31,350,145 |
Subsequent Events (Details Narr
Subsequent Events (Details Narrative) - USD ($) | Jan. 26, 2018 | Jan. 05, 2018 | Jan. 01, 2018 | Jan. 02, 2017 | Feb. 28, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 |
Proceeds from issuance of common stock | $ 78,891,699 | $ 16,699,133 | $ 11,328,929 | |||||
Warrant exercisable price per sahre | $ 1 | |||||||
Warrant exercisable shares of common stock | 1,288,500 | 679,500 | ||||||
Evergreen Provision [Member] | 2014 Equity Incentive Plan [Member] | ||||||||
Increased number of shares of common stock available for issuance | 3,127,722 | |||||||
Subsequent Event [Member] | Phase 2b Clinical Trial [Member] | ||||||||
Amount received upon execution of award agreement | $ 6,250,000 | |||||||
Subsequent Event [Member] | Cystic Fibrosis Foundation warrants [Member] | ||||||||
Warrant to purchase of common stock | 1,000,000 | |||||||
Warrant exercisable price per sahre | $ 13.20 | |||||||
Warrant exercisable shares of common stock | 500,000 | |||||||
Warrant expires date | Jan. 26, 2025 | |||||||
Subsequent Event [Member] | Cystic Fibrosis Program Related Investment Agreement [Member] | ||||||||
Development award received | $ 25,000,000 | |||||||
Subsequent Event [Member] | Investment Agreement [Member] | Cystic Fibrosis Foundation warrants [Member] | ||||||||
Warrant exercisable shares of common stock | 500,000 | |||||||
Subsequent Event [Member] | At the Market Offering [Member] | ||||||||
Number of common stock value sold | $ 50,000,000 | |||||||
Subsequent Event [Member] | At the Market Offering [Member] | 2018 Sales Agreement [Member] | ||||||||
Number of common stock share sold | 1,500,000 | |||||||
Proceeds from issuance of common stock | $ 11,349,000 | |||||||
Subsequent Event [Member] | Evergreen Provision [Member] | 2014 Equity Incentive Plan [Member] | ||||||||
Increases in number of shares of common stock available for issuance, minimum percentage of outstanding common stock | 7.00% | |||||||
Increased number of shares of common stock available for issuance | 2,500,000 | |||||||
Percentage of outstanding common shares | 7.00% | |||||||
Total reserve under the plan | 15,543,739 | |||||||
Shares available for future grants | 6,960,334 |