Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Mar. 09, 2018 | Jun. 30, 2017 | |
Document And Entity Information [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2017 | ||
Document Fiscal Year Focus | 2,017 | ||
Document Fiscal Period Focus | FY | ||
Trading Symbol | CPRX | ||
Entity Registrant Name | CATALYST PHARMACEUTICALS, INC. | ||
Entity Central Index Key | 1,369,568 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Current Reporting Status | Yes | ||
Entity Voluntary Filers | No | ||
Entity Filer Category | Accelerated Filer | ||
Entity Common Stock, Shares Outstanding | 102,556,164 | ||
Entity Public Float | $ 216,521,603 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Dec. 31, 2017 | Dec. 31, 2016 |
Current Assets: | ||
Cash and cash equivalents | $ 57,496,702 | $ 13,893,064 |
Short-term investments | 26,516,711 | 26,512,753 |
Prepaid expenses and other current assets | 1,173,744 | 1,047,944 |
Total current assets | 85,187,157 | 41,453,761 |
Property and equipment, net | 191,385 | 244,204 |
Deposits | 8,888 | 8,888 |
Total assets | 85,387,430 | 41,706,853 |
Current Liabilities: | ||
Accounts payable | 1,945,575 | 933,176 |
Accrued expenses and other liabilities | 2,320,587 | 1,161,359 |
Total current liabilities | 4,266,162 | 2,094,535 |
Accrued expenses and other liabilities, non-current | 157,456 | 181,162 |
Warrants liability, at fair value | 122,226 | |
Total liabilities | 4,423,618 | 2,397,923 |
Commitments and contingencies | ||
Stockholders' equity: | ||
Preferred stock, $0.001 par value, 5,000,000 shares authorized: none issued and outstanding at December 31, 2017 and 2016 | ||
Common stock, $0.001 par value, 150,000,000 shares authorized; 102,549,498 shares and 82,972,316 shares issued and outstanding at December 31, 2017 and 2016, respectively | 102,549 | 82,972 |
Additional paid-in capital | 207,421,710 | 147,374,028 |
Accumulated deficit | (126,560,447) | (108,148,070) |
Total stockholders' equity | 80,963,812 | 39,308,930 |
Total liabilities and stockholders' equity | $ 85,387,430 | $ 41,706,853 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2017 | Dec. 31, 2016 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 5,000,000 | 5,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 150,000,000 | 150,000,000 |
Common stock, shares issued | 102,549,498 | 82,972,316 |
Common stock, shares outstanding | 102,549,498 | 82,972,316 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Income Statement [Abstract] | |||
Revenues | $ 0 | $ 0 | $ 0 |
Operating costs and expenses: | |||
Research and development | 11,375,237 | 11,369,941 | 11,801,342 |
General and administrative | 7,304,399 | 7,910,260 | 8,597,010 |
Total operating costs and expenses | 18,679,636 | 19,280,201 | 20,398,352 |
Loss from operations | (18,679,636) | (19,280,201) | (20,398,352) |
Other income, net | 454,163 | 321,612 | 100,389 |
Change in fair value of warrants liability | (186,904) | 886,137 | 65,005 |
Loss before income taxes | (18,412,377) | (18,072,452) | (20,232,958) |
Provision for income taxes | 0 | 0 | 0 |
Net loss | $ (18,412,377) | $ (18,072,452) | $ (20,232,958) |
Net loss per share - basic and diluted | $ (0.21) | $ (0.22) | $ (0.25) |
Weighted average shares outstanding - basic and diluted | 85,802,487 | 82,875,281 | 80,858,393 |
Consolidated Statement of Stock
Consolidated Statement of Stockholders' Equity - USD ($) | Total | Common Stock [Member] | Additional Paid-In Capital [Member] | Accumulated Deficit [Member] |
Beginning Balance at Dec. 31, 2014 | $ 35,242,330 | $ 69,119 | $ 105,015,871 | $ (69,842,660) |
Issuance of common stock, net | 34,873,869 | 11,527 | 34,862,342 | |
Issuance of stock options for services | 1,510,018 | 1,510,018 | ||
Amortization of restricted stock for services | 75,440 | 75,440 | ||
Exercise of warrants for common stock | 3,617,261 | 1,178 | 3,616,083 | |
Exercise of stock options for common stock | 390,351 | 1,027 | 389,324 | |
Net loss | (20,232,958) | (20,232,958) | ||
Ending Balance at Dec. 31, 2015 | 55,476,311 | 82,851 | 145,469,078 | (90,075,618) |
Issuance of common stock, net | 27 | (27) | ||
Issuance of stock options for services | 1,760,591 | 1,760,591 | ||
Amortization of restricted stock for services | 75,494 | 75,494 | ||
Exercise of stock options for common stock | 68,986 | 94 | 68,892 | |
Net loss | (18,072,452) | (18,072,452) | ||
Ending Balance at Dec. 31, 2016 | 39,308,930 | 82,972 | 147,374,028 | (108,148,070) |
Issuance of common stock, net | 53,772,560 | 16,455 | 53,756,105 | |
Issuance of stock options for services | 2,342,625 | 2,342,625 | ||
Amortization of restricted stock for services | 65,336 | 65,336 | ||
Exercise of warrants for common stock | 3,518,553 | 2,258 | 3,516,295 | |
Exercise of stock options for common stock | 368,185 | 864 | 367,321 | |
Net loss | (18,412,377) | (18,412,377) | ||
Ending Balance at Dec. 31, 2017 | $ 80,963,812 | $ 102,549 | $ 207,421,710 | $ (126,560,447) |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Operating Activities: | |||
Net loss | $ (18,412,377) | $ (18,072,452) | $ (20,232,958) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Depreciation | 45,689 | 43,406 | 34,468 |
Stock-based compensation | 2,407,961 | 1,836,085 | 1,585,458 |
Change in fair value of warrants liability | 186,904 | (886,137) | (65,005) |
(Increase) decrease in: | |||
Prepaid expenses and other current assets and deposits | (125,800) | 456,794 | (452,040) |
Increase (decrease) in: | |||
Accounts payable | 1,012,399 | (860,951) | (20,083) |
Accrued expenses and other liabilities | 1,142,652 | (480,248) | 1,134,939 |
Net cash used in operating activities | (13,742,572) | (17,963,503) | (18,015,221) |
Investing Activities: | |||
Capital expenditures | (96,061) | (23,465) | |
Proceeds (purchase) of short-term investments | (3,958) | (68,603) | 18,812 |
Proceeds (purchase) of certificates of deposit | 3,717,229 | (1,846) | |
Net cash provided by (used in) investing activities | (3,958) | 3,552,565 | (6,499) |
Financing Activities: | |||
Proceeds from issuance of common stock, net | 53,772,560 | 34,873,869 | |
Payment of employee withholding tax related to stock- based compensation | (11,265) | ||
Proceeds from exercise of warrants | 3,209,423 | 1,895,738 | |
Proceeds from exercise of options | 368,185 | 80,251 | 390,351 |
Net cash provided by financing activities | 57,350,168 | 68,986 | 37,159,958 |
Net increase (decrease) in cash and cash equivalents | 43,603,638 | (14,341,952) | 19,138,238 |
Cash and cash equivalents - beginning of period | 13,893,064 | 28,235,016 | 9,096,778 |
Cash and cash equivalents - end of period | 57,496,702 | $ 13,893,064 | 28,235,016 |
Non-cash investing and financing activities: | |||
Exercise of liability classified warrants for common stock | $ 309,130 | 1,721,523 | |
Non-cash incentive received from lessor | $ 131,175 |
Organization and Description of
Organization and Description of Business | 12 Months Ended |
Dec. 31, 2017 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization and Description of Business | 1. Organization and Description of Business Catalyst Pharmaceuticals, Inc. and subsidiary (collectively, the Company), is a development-stage biopharmaceutical company focused on developing and commercializing innovating therapies for people with rare debilitating, chronic neuromuscular and neurological diseases, including Lambert-Eaton Myasthenic Syndrome (LEMS), Congenital Myasthenic Syndromes (CMS), MuSK antibody positive myasthenia gravis, and infantile spasms. The Company (f/k/a Catalyst Pharmaceutical Partners, Inc.) was incorporated in Delaware in July 2006. It is the successor by merger to Catalyst Pharmaceutical Partners, Inc., a Florida corporation, which commenced operations in January 2002. Since 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 primary focus is on the development and commercialization of its drug candidates. The Company has incurred operating losses in each period from inception through December 31, 2017. The Company has been able to fund its cash needs to date through several public and private offerings of its common stock and warrants, through government grants, and through an investment by a strategic purchaser. See Note 11. Capital Resources While there can be no assurance, based on currently available information, the Company estimates that it currently has sufficient resources to support its operations for at least the next 12 months. The Company may raise required funds in the future through public or private equity offerings, debt financings, corporate collaborations, governmental research grants or other means. The Company may also seek to raise new capital to fund additional product development efforts, even if it has sufficient funds for its planned operations. Any sale by the Company of additional equity or convertible debt securities could result in dilution to the Company’s current stockholders. There can be no assurance that any such required additional funding will be available to the Company at all or available on terms acceptable to the Company. Further, to the extent that the Company raises additional funds through collaborative arrangements, it may be necessary to relinquish some rights to the Company’s drug candidates or grant sublicenses on terms that are not favorable to the Company. If the Company is not able to secure additional funding when needed, the Company may have to delay, reduce the scope of, or eliminate one or more research and development programs, which could have an adverse effect on the Company’s business. |
Basis of Presentation and Signi
Basis of Presentation and Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2017 | |
Accounting Policies [Abstract] | |
Basis of Presentation and Significant Accounting Policies | 2. Basis of Presentation and Significant Accounting Policies a. PRINCIPLES OF CONSOLIDATION b. USE OF ESTIMATES. c. CASH AND CASH EQUIVALENTS. d. SHORT-TERM INVESTMENTS. e. PREPAID EXPENSES AND OTHER CURRENT ASSETS. pre-commercialization f. PROPERTY AND EQUIPMENT. g. OPERATING LEASES. h. FAIR VALUE OF FINANCIAL INSTRUMENTS. i. FAIR VALUE MEASUREMENTS. Level 1 inputs utilize quoted prices (unadjusted) in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date. Level 2 inputs are inputs other than quoted prices included in Level 1 that are observable for the asset or liability, either directly or indirectly. Level 2 inputs may include quoted prices for similar assets and liabilities in active markets, as well as inputs that are observable for the asset or liability (other than quoted prices), such as interest rates, foreign exchange rates, and yield curves that are observable at commonly quoted intervals. Level 3 inputs are unobservable inputs for the asset or liability, which are typically based on an entity’s own assumptions, as there is little, if any, related market activity. In instances where the determination of the fair value measurement is based on inputs from different levels of the fair value hierarchy, the level in the fair value hierarchy within which the entire fair value measurement falls is based on the lowest level input that is significant to the fair value measurement in its entirety. The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires judgment and considers factors specific to the asset or liability. Fair Value Measurements at Reporting Date Using Balances as of Quoted Prices in Significant Significant Money market funds $ 56,820,688 $ 56,820,688 $ — $ — Short-term investments $ 26,516,711 $ 26,516,711 $ — $ — Fair Value Measurements at Reporting Date Using Balances as of Quoted Prices in Significant Significant Money market funds $ 13,395,759 $ 13,395,759 $ — $ — Short-term investments $ 26,512,753 $ 26,512,753 $ — $ — Warrants liability $ 122,226 $ — $ — $ 122,226 j. WARRANTS LIABILITY. k. RESEARCH AND DEVELOPMENT. l. STOCK-BASED COMPENSATION. For the years ended December 31, 2017, 2016 and 2015, the Company recorded stock-based compensation expense as follows: 2017 2016 2015 Research and development $ 785,899 $ 590,857 $ 378,548 General and administrative 1,622,062 1,245,228 1,206,910 Total stock-based compensation $ 2,407,961 $ 1,836,085 $ 1,585,458 m. CONCENTRATION OF CREDIT RISK. n. INCOME TAXES. The Company recognizes the financial statement benefit of a tax position only after determining that the relevant tax authority would more likely than not sustain the position following an audit. For tax positions meeting the more-likely-than-not On December 22, 2017, the U.S. government enacted comprehensive tax legislation commonly referred to as the Tax Cuts and Jobs Act (the “Tax Act”). The Tax Act makes broad and complex changes to the U.S. tax code, including, but not limited to, (1) reducing the U.S. federal corporate tax rate from 35 to 21 percent; (2) requiring companies to pay a one-time o. COMPREHENSIVE INCOME (LOSS). p. NET INCOME (LOSS) PER SHARE. 2017 2016 2015 Stock options to purchase common stock 5,191,666 4,660,000 4,250,000 Warrants to purchase common stock — 2,407,663 2,407,663 Unvested restricted stock — 26,667 53,334 Potential equivalent common stock excluded 5,191,666 7,094,330 6,710,997 Potentially dilutive stock options to purchase common stock as of December 31, 2017, 2016 and 2015 have exercise prices ranging from $0.47 to $4.64. Potentially dilutive warrants to purchase common stock as of December 31, 2016 and 2015 had exercise prices ranging from $1.04 to $2.08 and expired in periods between May 2017 and August 2017. q. SEGMENT INFORMATION. r. RECLASSIFICATIONS. s. RECENTLY ISSUED ACCOUNTING STANDARDS. No. 2016-02, Leases (Topic 842) 2016-02 On March 30, 2016, the FASB issued ASU No. 2016-09, Compensation—Stock Compensation Improvements to Employee Share-Based Payment Accounting In May 2017, the FASB issued ASU No. 2017-09, Compensation – Stock Compensation Scope of Modification Accounting 2017-09 |
Warrants Liability, at Fair Val
Warrants Liability, at Fair Value | 12 Months Ended |
Dec. 31, 2017 | |
Text Block [Abstract] | |
Warrants Liability, at Fair Value | 3. Warrants Liability, at Fair Value The Company allocated approximately $1.3 million of proceeds from its October 2011 registered direct offering to the fair value of common stock purchase warrants issued in connection with the offering that were classified as a liability (the 2011 warrants). The 2011 warrants were classified as a liability because of provisions in such warrants that allowed for the net cash settlement of such warrants in the event of certain fundamental transactions (as defined in the warrant agreement). During periods that the 2011 warrants were outstanding, the valuation of the 2011 warrants was determined using the Black-Scholes Model. This model uses inputs such as the underlying price of the shares issued when the warrant is exercised, volatility, risk free interest rate and expected life of the instrument. The Company has determined that the 2011 warrants liability should be classified within Level 3 of the fair value hierarchy by evaluating each input for the Black-Scholes Model against the fair value hierarchy criteria and using the lowest level of input as the basis for the fair value classification. There are six inputs: closing price of the Company’s common stock on the day of evaluation; the exercise price of the warrants; the remaining term of the warrants; the volatility of the Company’s common stock; annual rate of dividends; and the risk-free rate of return. Of those inputs, the exercise price of the warrants and the remaining term are readily observable in the warrants agreement. The annual rate of dividends is based on the Company’s historical practice of not granting dividends. The closing price of the Company’s common stock would fall under Level 1 of the fair value hierarchy as it is a quoted price in an active market. The risk-free rate of return is a Level 2 input, while the historical volatility is a Level 3 input in accordance with the fair value accounting guidance. Since the lowest level input is a Level 3, the Company determined the 2011 warrants liability was most appropriately classified within Level 3 of the fair value hierarchy. This liability was subject to a fair value mark-to-market The calculated value of the 2011 warrants liability was determined using the Black-Scholes option-pricing model with the following assumptions: December 31, 2016 Risk free interest rate 0.85 % Expected term 0.33 years Expected volatility 100 % Expected dividend yield 0 % Expected forfeiture rate 0 % The following table rolls forward the fair value of the Company’s warrants liability activity for the years ended December 31, 2017, 2016 and 2015: 2017 2016 2015 Fair value, beginning of period $ 122,226 $ 1,008,363 $ 2,794,891 Issuance of warrants — — — Exercise of warrants (309,130 ) — (1,721,523 ) Change in fair value 186,904 (886,137 ) (65,005 ) Fair value, end of period $ — $ 122,226 $ 1,008,363 During 2017, 613,913 of the 2011 warrants were exercised, with proceeds of $798,087 to the Company. On May 2, 2017, the outstanding and unexercised 2011 warrants expired. During 2016, none of the 2011 warrants were exercised. During 2015, 478,261 of the 2011 warrants were exercised, with proceeds to the Company of $621,739. During periods that the 2011 warrants were outstanding, the Company recognized the change in the fair value of the warrants liability as a non-operating |
Prepaid Expenses and Other Curr
Prepaid Expenses and Other Current Assets | 12 Months Ended |
Dec. 31, 2017 | |
Text Block [Abstract] | |
Prepaid Expenses and Other Current Assets | 4. Prepaid Expenses and Other Current Assets Prepaid expenses and other current assets consist of the following as of December 31: 2017 2016 Prepaid research fees $ 388,977 $ 334,565 Prepaid insurance 638,139 598,909 Prepaid pre-commercialization 65,000 35,500 Prepaid subscriptions fees 23,347 22,770 Prepaid rent — 19,756 Other 58,281 36,444 Total prepaid expenses and other current assets $ 1,173,744 $ 1,047,944 |
Property and Equipment, net
Property and Equipment, net | 12 Months Ended |
Dec. 31, 2017 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment, net | 5. Property and Equipment, net Property and equipment, net consists of the following as of December 31: 2017 2016 Computer equipment $ 27,915 $ 27,915 Furniture and equipment 169,931 177,061 Leasehold improvements 152,708 152,708 350,554 357,684 Less: Accumulated depreciation (159,169 ) (113,480 ) Total property and equipment, net $ 191,385 $ 244,204 Depreciation expense was $45,689, $43,406, and $34,468, respectively, for the years ended December 31, 2017, 2016 and 2015. |
Accrued Expenses and Other Liab
Accrued Expenses and Other Liabilities | 12 Months Ended |
Dec. 31, 2017 | |
Payables and Accruals [Abstract] | |
Accrued Expenses and Other Liabilities | 6. Accrued Expenses and Other Liabilities Accrued expenses and other liabilities consist of the following as of December 31: 2017 2016 Accrued preclinical and clinical trial expenses $ 970,649 $ 623,855 Accrued professional fees 227,457 102,673 Accrued compensation and benefits 821,935 264,237 Accrued license fees 252,500 152,500 Deferred rent and lease incentive 24,011 18,094 Other 24,035 — Current accrued expenses and other liabilities 2,320,587 1,161,359 Deferred rent and lease incentive—non-current 157,456 181,162 Non-current 157,456 181,162 Total accrued expenses and other liabilities $ 2,478,043 $ 1,342,521 |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2017 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 7. Commitments and Contingencies The Company has contracted with drug manufacturers and other vendors, including clinical research organizations (CRO) overseeing the clinical trials of the Company’s drug candidates, to assist in the execution of the Company’s preclinical and clinical trials, analysis, and the preparation of material necessary for the submission of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) with the U.S. Food and Drug Administration (FDA). The contracts are cancelable at any time, but obligate the Company to reimburse the providers for any time or costs incurred through the date of termination. The Company has executed a non-cancellable 2018 $ 213,644 2019 220,053 2020 226,655 2021 233,454 2022 220,023 $ 1,113,829 In March 2015, the Company amended the lease to its corporate offices to obtain additional space for its operations. The Company now leases approximately 5,200 square feet and the lease term now expires in 2022. In connection with the expansion, approximately $131,000 of tenant build-out There are no obligations under capital leases. For commitments related to the Company’s license agreements with BioMarin (defined below) and Northwestern (defined below), see Note 8. |
Agreements
Agreements | 12 Months Ended |
Dec. 31, 2017 | |
Text Block [Abstract] | |
Agreements | 8. Agreements a. LICENSE AGREEMENT WITH NORTHWESTERN UNIVERSITY. CPP-115. Under the license agreement with Northwestern, the Company is responsible for continued research and development of any resulting product candidates. As of December 31, 2017, the Company has paid $424,885 in connection with the license and has accrued license fees of $252,500 and $152,500 as of December 31, 2017, and 2016, respectively, in the accompanying consolidated balance sheets for expenses, maintenance fees and milestones. In addition, the Company is obligated to pay certain milestone payments in future years relating to clinical development activities with respect to CPP-115, CPP-115 b. LICENSE AGREEMENT WITH NEW YORK UNIVERSITY AND THE FEINSTEIN INSTITUTE FOR MEDICAL RESEARCH. c LICENSE AGREEMENT WITH BIOMARIN ® Under the License Agreement, the Company has agreed to pay: (i) royalties to BioMarin for seven years from the first commercial sale of Firdapse ® ® Under the Company’s license agreement with BioMarin, the Company has agreed to pay certain milestone payments that BioMarin is obligated to pay to both a third-party licensor of the rights that have been sublicensed to the Company and to the former stockholders of Huxley Pharmaceuticals (“Huxley”) under an earlier stock purchase agreement between BioMarin and the former Huxley stockholders. These milestones aggregate (i) approximately $2.6 million due upon acceptance by the FDA of a filing of an NDA for Firdapse ® ® BioMarin has recently advised the Company that the former Huxley stockholders may take legal action seeking payment of the milestone payments due to them from BioMarin if these milestones are achieved after April 20, 2018, notwithstanding the express termination date in the agreements. BioMarin has also advised the Company that the Company could become involved in any such legal action. While it is too early to determine how this matter will affect the Company, based on currently available information the Company does not believe that this matter will have a material adverse effect on the Company’s financial position or results of operations. The Company also agreed to share in the cost of certain post-marketing studies conducted by BioMarin, and, as of both December 31, 2017, and 2016, the Company had paid BioMarin $3.8 million in the aggregate, related to expenses in connection with Firdapse ® d. AGREEMENTS FOR DRUG DEVELOPMENT, PRECLINICAL AND CLINICAL STUDIES |
Related Party Transactions
Related Party Transactions | 12 Months Ended |
Dec. 31, 2017 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | 9. Related Party Transactions During each of the years ended December 31, 2017, 2016 and 2015, the Company paid approximately $10,000, in consulting fees to members of the Company’s Scientific Advisory Board. During 2015, the Company entered into a consulting agreement with one of its directors to serve as interim chief commercial officer during a period that the Company was seeking to fill that position. The consulting arrangement ended in September 2015 and the director received a total of $45,000 in consulting fees for those services. The Company has an employment agreement with its Chief Executive Officer. Under this agreement, the CEO will receive an annual base salary of approximately $525,000 in 2018. This agreement expires in November 2018. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2017 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 10. Income Taxes Due to the ongoing operating losses and the inability to recognize any income tax benefit, there is no provision for income taxes in any period presented in these financial statements. Since inception, the Company has only generated pretax losses. The reconciliation of income tax expense (benefit) computed at the statutory federal income tax rate of 34% to amounts included in the consolidated statements of operations is as follows: 2017 2016 2015 Statutory rate 34.0 % 34.0 % 34.0 % State tax 3.5 % 3.4 % 3.6 % Valuation allowance 26.5 % (44.7 )% (37.7 )% Federal rate change (73.2 )% 0.0 % 0.0 % Tax credit 6.8 % 6.2 % 0.0 % Other 2.4 % 1.1 % 0.1 % 0.0 % 0.0 % 0.0 % Deferred tax assets and liabilities reflect the net tax effects of net operating loss and tax credit carryovers and the temporary differences between the carrying amounts of assets and liabilities for financial reporting and the amounts used for income tax purposes. Significant components of the Company’s deferred tax assets as of December 31, 2017 and 2016 are as follows: 2017 2016 Net operating loss $ 15,718,570 $ 21,050,217 Start-up 10,508,487 12,823,113 Tax credits 11,582,134 6,960,838 Deferred compensation 1,326,189 1,555,425 Other 72,395 207,133 Gross deferred tax asset 39,207,775 42,596,726 Valuation allowance (39,207,775 ) (42,596,726 ) Net deferred tax assets $ 0 $ 0 The Company’s deferred tax assets have been fully offset by a valuation allowance at December 31, 2017 and 2016 because the Company believes that it is more likely than not that the deferred tax asset will not be realized. The decrease and increase in the valuation allowance on the deferred tax assets was $3,388,951 and $8,287,962 for the years ended December 31, 2017 and 2016, respectively. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in years in which those temporary differences are expected to be recovered or settled. As changes in tax laws or rates are enacted, deferred tax assets and liabilities are adjusted through income tax expense. As a result of the reduction in the U.S. corporate tax rate from 35% to 21% under the Tax Act enacted in December 2017, the Company recorded a reduction of approximately $13.5 million in the fourth quarter of 2017 related to the revaluation of its deferred tax assets. There was no impact to tax expense as a result of the revaluation as the Company’s deferred tax assets have a full valuation allowance. At December 31, 2017 and 2016, respectively, the Company had net operating loss carryforwards of approximately $62.6 million and $56.3 million available to reduce future taxable income, if any. The net operating loss carryforwards will expire at various dates beginning in 2024 and ending in 2037. If an ownership change, as defined under Internal Revenue Code Section 382, occurs, the use of these carry-forwards may be subject to limitation. The effective tax rate of 0% in all periods presented differs from the statutory rate of 34% due to the valuation allowance and because the Company had no taxable income. Beginning in 2010, the Company has received several orphan drug designations by the FDA for products currently under development. The orphan drug designations allow the Company to claim increased federal tax credits for certain research and development activities. No interest or penalties were accrued through December 31, 2017. The Company’s policy is to recognize any related interest or penalties in income tax expense. The Company is not subject to U.S federal, state and local tax examinations by tax authorities for any years before 2014. The Company is not currently under income tax examinations by any tax authorities. |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2017 | |
Equity [Abstract] | |
Stockholders' Equity | 11. Stockholders’ Equity Preferred Stock The Company has 5,000,000 shares of authorized preferred stock, $0.001 par value per share at December 31, 2017 and 2016. No shares of preferred stock were outstanding at December 31, 2017 and 2016. Common Stock During 2015, the Company’s stockholders approved an increase in the Company’s authorized common stock par value $0.001 per share, from 100,000,000 shares to 150,000,000 shares. At December 31, 2017 and 2016, 102,549,498 and 82,972,316 shares, respectively, of common stock were issued and outstanding. Each holder of common stock is entitled to one vote of each share of common stock held of record on all matters on which stockholders generally are entitled to vote. 2016 Shelf Registration Statement On December 23, 2016, the Company filed a shelf Registration Statement on Form S-3 No. 333-215315) 2017 Shelf Registration Statement On July 12, 2017, the Company filed a universal shelf Registration Statement on Form S-3 No. 333-219259) (a) On November 28, 2017, the Company filed a prospectus supplement and offered for sale 16,428,572 shares if its common stock at a price of $3.50 per share in an underwritten public offering. The Company received gross proceeds in the public offering of approximately $57.5 million before underwriting commission and incurred expenses of approximately $3.7 million. As of December 31, 2017, there is approximately $92.5 million available for future sale under the 2017 Shelf Registration Statement. Warrant Exercises For the year ended December 31, 2017, the Company issued 2,257,663 of its authorized but unissued common stock upon the exercise of previously issued common stock purchase warrants, with net proceeds to the Company of $3,209,423. No warrants were exercised during the year ended December 31, 2016. For the year ended December 31, 2015, the Company issued an aggregate of 1,178,261 shares of its authorized but unissued common stock upon the exercise of previously issued common stock purchase warrants, raising net proceeds of $1,895,738. Stockholder Rights Plan On September 20, 2011, the Board of Directors approved the Company’s adoption of a Stockholder Rights Plan. Under the Plan, a dividend of one preferred share purchase right (a Right) was declared for each share of common stock of the Company that was outstanding on October 7, 2011. Each Right entitles the holder to purchase from the Company one one-hundredth The Rights trade automatically with the common stock and will not be exercisable until a person or group has become an “acquiring person” by acquiring 17.5% or more of the Company’s outstanding common stock, or a person or group commences, or publicly announces a tender offer that will result in such a person or group owning 17.5% or more of the Company’s outstanding common stock. Upon announcement that any person or group has become an acquiring person, each Right will entitle all rightholders (other than the acquiring person) to purchase, for the exercise price of $7.80, a number of shares of the Company’s common stock having a market value equal to twice the exercise price. Rightholders would also be entitled to purchase common stock of the acquiring person having a value of twice the exercise price if, after a person had become an acquiring person, the Company were to enter into certain mergers or other transactions. If any person becomes an acquiring person, the Board of Directors may, at its option and subject to certain limitations, exchange one share of common stock for each Right. The Rights have certain anti-takeover effects, in that they would cause substantial dilution to a person or group that attempts to acquire a significant interest in the Company on terms not approved by the Board of Directors. In the event that the Board of Directors determines a transaction to be in the best interests of the Company and its stockholders, the Board of Directors may redeem the Rights for $0.001 per share at any time prior to a person or group becoming an acquiring person. On September 19, 2016, the Board of Directors unanimously approved, and on the same date the Company entered into Amendment No. 1 to the Stockholder Rights Plan (the “Amendment”). Under the terms of the Amendment, the outside expiration date of the rights plan has been extended from September 20, 2016 to September 20, 2019. Additionally, as part of the Amendment, the Board adopted a Certificate of Designation, Preferences and Rights of Series A Junior Participating Preferred Stock of the Company to increase the number of shares of Series A Junior Participating Preferred Stock of the Company available for issuance under the Rights Plan from 500,000 shares to 1.5 million shares. At the Company’s 2017 annual meeting of stockholders, the Company’s stockholders approved the stockholder rights plan, as amended. |
Stock Compensation Plans
Stock Compensation Plans | 12 Months Ended |
Dec. 31, 2017 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Stock Compensation Plans | 12. Stock Compensation Plans Stock Options The Company may issue stock options, restricted stock, stock appreciation rights and restricted stock units (collectively, the “Awards”) to employees, directors, consultants and scientific advisors of the Company under the 2006 and 2014 Stock Incentive Plans (the 2006 Plan and the 2014 Plan or collectively, the Plans). At December 31, 2017, no shares remain available for future issuance under the 2006 Plan. Under the 2014 Plan, 9,000,000 shares were reserved for issuance and as of December 31, 2017, 3,646,668 shares remain available for future issuance. The Company has granted stock options to employees, officers, directors, scientific advisors and consultants generally at exercise prices equal to the market price of the common stock at grant date. Option awards generally vest over a period of 1 to 3 years of continuous service and have contractual terms from 5 to 7 years. Certain awards provide for accelerated vesting if there is a change in control. The Company issues new shares as shares are required to be delivered upon exercise of outstanding stock options. During the years ended December 31, 2017, 2016, and 2015, options to purchase 780,000, 75,000, and 265,000 shares of the Company’s common stock were exercised with gross proceeds to the Company of $368,185, $80,251, and $390,351, respectively. Further, during the years ended December 31, 2017, 2016, and 2015, options to purchase 100,000, 50,000, and 984,608 shares of the Company’s common stock were exercised on a “cashless” basis, resulting in the issuance of an aggregate of 84,280, 20,030, and 761,600 shares of the Company’s common stock, respectively. During the years ended December 31, 2017, 2016 and 2015 the Company recorded non-cash During the years ended December 31, 2017, 2016 and 2015, the Company granted seven-year options to purchase an aggregate of 1,550,000, 1,285,000 and 1,760,000 shares, respectively, of the Company’s common stock to certain of the Company’s officers, employees, directors, and consultants. Stock option activity under the Company’s Plans for the year ended December 31, 2017 is summarized as follows: Number of Weighted Weighted Aggregate Outstanding at beginning of year 4,660,000 $ 1.94 Granted 1,550,000 1.17 Exercised (880,000 ) 0.47 Forfeited or cancelled (138,334 ) 1.94 Expired — 0.00 Outstanding at end of year 5,191,666 $ 1.96 4.94 $ 10,178,881 Exercisable at end of year 2,908,330 $ 2.44 4.40 $ 4,334,327 Other information pertaining to stock option activity during the years ended December 31, 2017, 2016 and 2015 was as follows: 2017 2016 2015 Weighted–average fair value of granted stock options $ 0.91 $ 0.62 $ 2.13 Total fair value of vested stock options $ 2,016,992 $ 1,634,562 $ 1,307,895 Total intrinsic value of exercised stock options $ 2,296,100 $ 42,000 $ 3,311,599 The following table summarizes information about the Company’s options outstanding at December 31, 2017: Options Outstanding Options Exercisable Range of Exercise Prices Number Weighted Weighted Number Weighted Weighted $0.47 to $0.85 1,085,000 5.15 $ 0.78 550,000 5.09 $ 0.79 $0.86 to $1.14 1,516,666 6.00 $ 1.13 199,999 5.99 $ 1.13 $1.15 to $2.80 1,195,000 4.75 $ 2.48 866,665 4.65 $ 2.51 $2.81 to $3.23 1,020,000 3.67 $ 3.12 1,020,000 3.67 $ 3.12 $3.24 to $4.64 375,000 4.06 $ 3.93 271,666 3.81 $ 3.94 5,191,666 4.94 $ 1.96 2,908,330 4.40 $ 2.44 As of December 31, 2017, there was approximately $1,367,155 of unrecognized compensation expense related to non-vested The Company utilizes the Black-Scholes option-pricing model to determine the fair value of stock options on the date of grant. This model derives the fair value of stock options based on certain assumptions related to the expected stock price volatility, expected option life, risk-free interest rate and dividend yield. Expected volatility is based on reviews of historical volatility of the Company’s common stock. The estimated expected option life is based upon estimated employee exercise patterns and considers whether and the extent to which the options are in-the-money. mid-point Assumptions used during the years were as follows: Year ended December 31, 2017 2016 2015 Risk free interest rate 1.66% to 2.25 % 0.76% to 2.15 % 1.00% to 2.13 % Expected term 4 to 7 years 2 to 6 years 3 to 7 years Expected volatility 104 % 100 % 102 % Expected dividend yield — % — % — % Expected forfeiture rate — % — % — % Restricted Stock Units Under the 2014 Plan, participants may be granted restricted stock units, each of which represents a conditional right to receive shares of common stock in the future. The restricted stock units granted under this plan generally vest ratably over a three to four-year period. Upon vesting, the restricted stock units will convert into an equivalent number of shares of common stock. The amount of expense relating to the restricted stock units is based on the closing market price of the Company’s common stock on the date of grant and is amortized on a straight-line basis over the requisite service period. Restricted stock unit activity during 2017, 2016, and 2015 was as follows: 2017 2016 2015 Number of Weighted Number of Weighted Number of Weighted Date Fair Value Nonvested balance at beginning of year 26,667 $ 2.83 53,334 $ 2.83 80,000 $ 2.83 Granted — — — — — — Vested (26,667 ) 2.83 (26,667 ) 2.83 (26,666 ) 2.83 Forfeited — — — — — — Nonvested balance at end of year $ — $ — 26,667 $ 2.83 53,334 $ 2.83 During the years ended December 31, 2017, 2016 and 2015, the Company recorded non-cash |
Benefit Plan
Benefit Plan | 12 Months Ended |
Dec. 31, 2017 | |
Retirement Benefits [Abstract] | |
Benefit Plan | 13. Benefit Plan The Company maintains an employee savings plan pursuant to Section 401(k) of the Internal Revenue Code covering all eligible employees. Subject to certain dollar limits, eligible employees may contribute up to 15% of their pre-tax |
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) The following table presents unaudited supplemental quarterly financial information for the years ended December 31, 2017 and 2016: Quarter Ended March 31, 2017 June 30, 2017 September 30, December 31, Revenues $ — $ — $ — $ — Loss from operations (4,679,871 ) (4,181,271 ) (4,306,708 ) (5,511,786 ) Change in fair value of warrants liability (397,235 ) 210,331 — — Net loss $ (4,967,129 ) $ (3,879,901 ) $ (4,177,649 ) $ (5,387,698 ) Net loss per share—basic and diluted $ (0.06 ) $ (0.05 ) $ (0.05 ) $ (0.06 ) Quarter Ended March 31, 2016 June 30, 2016 September 30, December 31, 2016 Revenues $ — $ — $ — $ — Loss from operations (6,237,536 ) (4,814,452 ) (3,914,014 ) (4,314,199 ) Change in fair value of warrants liability 733,356 152,783 (106,948 ) 106,946 Net loss $ (5,386,237 ) $ (4,568,914 ) $ (3,953,981 ) $ (4,163,320 ) Net loss per share—basic and diluted $ (0.07 ) $ (0.06 ) $ (0.05 ) $ (0.05 ) Quarterly basic and diluted net loss per common share were computed independently for each quarter and do not necessarily total to the full year basic and diluted net loss per common share. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2017 | |
Subsequent Events [Abstract] | |
Subsequent Events | 15. Subsequent Events Subsequent to year-end, |
Basis of Presentation and Sig22
Basis of Presentation and Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2017 | |
Accounting Policies [Abstract] | |
PRINCIPLES OF CONSOLIDATION | a. PRINCIPLES OF CONSOLIDATION |
USE OF ESTIMATES | b. USE OF ESTIMATES. |
CASH AND CASH EQUIVALENTS | c. CASH AND CASH EQUIVALENTS. |
SHORT-TERM INVESTMENTS | d. SHORT-TERM INVESTMENTS. |
PREPAID EXPENSES AND OTHER CURRENT ASSETS | e. PREPAID EXPENSES AND OTHER CURRENT ASSETS. pre-commercialization |
PROPERTY AND EQUIPMENT | f. PROPERTY AND EQUIPMENT. |
OPERATING LEASES | g. OPERATING LEASES. |
FAIR VALUE OF FINANCIAL INSTRUMENTS | FAIR VALUE OF FINANCIAL INSTRUMENTS. |
FAIR VALUE MEASUREMENTS | i. FAIR VALUE MEASUREMENTS. Level 1 inputs utilize quoted prices (unadjusted) in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date. Level 2 inputs are inputs other than quoted prices included in Level 1 that are observable for the asset or liability, either directly or indirectly. Level 2 inputs may include quoted prices for similar assets and liabilities in active markets, as well as inputs that are observable for the asset or liability (other than quoted prices), such as interest rates, foreign exchange rates, and yield curves that are observable at commonly quoted intervals. Level 3 inputs are unobservable inputs for the asset or liability, which are typically based on an entity’s own assumptions, as there is little, if any, related market activity. In instances where the determination of the fair value measurement is based on inputs from different levels of the fair value hierarchy, the level in the fair value hierarchy within which the entire fair value measurement falls is based on the lowest level input that is significant to the fair value measurement in its entirety. The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires judgment and considers factors specific to the asset or liability. Fair Value Measurements at Reporting Date Using Balances as of Quoted Prices in Significant Significant Money market funds $ 56,820,688 $ 56,820,688 $ — $ — Short-term investments $ 26,516,711 $ 26,516,711 $ — $ — Fair Value Measurements at Reporting Date Using Balances as of Quoted Prices in Significant Significant Money market funds $ 13,395,759 $ 13,395,759 $ — $ — Short-term investments $ 26,512,753 $ 26,512,753 $ — $ — Warrants liability $ 122,226 $ — $ — $ 122,226 |
WARRANTS LIABILITY | j. WARRANTS LIABILITY. |
RESEARCH AND DEVELOPMENT | k. RESEARCH AND DEVELOPMENT. |
STOCK-BASED COMPENSATION | l. STOCK-BASED COMPENSATION. For the years ended December 31, 2017, 2016 and 2015, the Company recorded stock-based compensation expense as follows: 2017 2016 2015 Research and development $ 785,899 $ 590,857 $ 378,548 General and administrative 1,622,062 1,245,228 1,206,910 Total stock-based compensation $ 2,407,961 $ 1,836,085 $ 1,585,458 |
CONCENTRATION OF CREDIT RISK | m. CONCENTRATION OF CREDIT RISK. |
INCOME TAXES | n. INCOME TAXES. The Company recognizes the financial statement benefit of a tax position only after determining that the relevant tax authority would more likely than not sustain the position following an audit. For tax positions meeting the more-likely-than-not On December 22, 2017, the U.S. government enacted comprehensive tax legislation commonly referred to as the Tax Cuts and Jobs Act (the “Tax Act”). The Tax Act makes broad and complex changes to the U.S. tax code, including, but not limited to, (1) reducing the U.S. federal corporate tax rate from 35 to 21 percent; (2) requiring companies to pay a one-time |
COMPREHENSIVE INCOME (LOSS) | o. COMPREHENSIVE INCOME (LOSS). |
NET INCOME (LOSS) PER SHARE | p. NET INCOME (LOSS) PER SHARE. 2017 2016 2015 Stock options to purchase common stock 5,191,666 4,660,000 4,250,000 Warrants to purchase common stock — 2,407,663 2,407,663 Unvested restricted stock — 26,667 53,334 Potential equivalent common stock excluded 5,191,666 7,094,330 6,710,997 Potentially dilutive stock options to purchase common stock as of December 31, 2017, 2016 and 2015 have exercise prices ranging from $0.47 to $4.64. Potentially dilutive warrants to purchase common stock as of December 31, 2016 and 2015 had exercise prices ranging from $1.04 to $2.08 and expired in periods between May 2017 and August 2017. |
SEGMENT INFORMATION | q. SEGMENT INFORMATION. |
RECLASSIFICATIONS | r. RECLASSIFICATIONS. |
RECENTLY ISSUED ACCOUNTING STANDARDS | s. RECENTLY ISSUED ACCOUNTING STANDARDS. No. 2016-02, Leases (Topic 842) 2016-02 On March 30, 2016, the FASB issued ASU No. 2016-09, Compensation—Stock Compensation Improvements to Employee Share-Based Payment Accounting In May 2017, the FASB issued ASU No. 2017-09, Compensation – Stock Compensation Scope of Modification Accounting 2017-09 |
Basis of Presentation and Sig23
Basis of Presentation and Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Accounting Policies [Abstract] | |
Fair Value Measurement Specific to Assets or Liability | The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires judgment and considers factors specific to the asset or liability. Fair Value Measurements at Reporting Date Using Balances as of Quoted Prices in Significant Significant Money market funds $ 56,820,688 $ 56,820,688 $ — $ — Short-term investments $ 26,516,711 $ 26,516,711 $ — $ — Fair Value Measurements at Reporting Date Using Balances as of Quoted Prices in Significant Significant Money market funds $ 13,395,759 $ 13,395,759 $ — $ — Short-term investments $ 26,512,753 $ 26,512,753 $ — $ — Warrants liability $ 122,226 $ — $ — $ 122,226 |
Stock-Based Compensation Expense | For the years ended December 31, 2017, 2016 and 2015, the Company recorded stock-based compensation expense as follows: 2017 2016 2015 Research and development $ 785,899 $ 590,857 $ 378,548 General and administrative 1,622,062 1,245,228 1,206,910 Total stock-based compensation $ 2,407,961 $ 1,836,085 $ 1,585,458 |
Potential Shares Excluded from Determination of Basic and Diluted Net Loss Per Share | The potential shares, which are excluded from the determination of basic and diluted net loss per share as their effect is anti-dilutive, for the years ended December 31, 2017, 2016 and 2015, are as follows: 2017 2016 2015 Stock options to purchase common stock 5,191,666 4,660,000 4,250,000 Warrants to purchase common stock — 2,407,663 2,407,663 Unvested restricted stock — 26,667 53,334 Potential equivalent common stock excluded 5,191,666 7,094,330 6,710,997 |
Warrants Liability, at Fair V24
Warrants Liability, at Fair Value (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Summary of Company's Warrants Liability Activity | The following table rolls forward the fair value of the Company’s warrants liability activity for the years ended December 31, 2017, 2016 and 2015: 2017 2016 2015 Fair value, beginning of period $ 122,226 $ 1,008,363 $ 2,794,891 Issuance of warrants — — — Exercise of warrants (309,130 ) — (1,721,523 ) Change in fair value 186,904 (886,137 ) (65,005 ) Fair value, end of period $ — $ 122,226 $ 1,008,363 |
Warrants Liability, at Fair Value [Member] | |
Summary of Assumptions Used in Black-Scholes Model to Calculate Fair Value of Warrants Liability | The calculated value of the 2011 warrants liability was determined using the Black-Scholes option-pricing model with the following assumptions: December 31, 2016 Risk free interest rate 0.85 % Expected term 0.33 years Expected volatility 100 % Expected dividend yield 0 % Expected forfeiture rate 0 % |
Prepaid Expenses and Other Cu25
Prepaid Expenses and Other Current Assets (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Text Block [Abstract] | |
Prepaid Expenses and Other Current Assets | Prepaid expenses and other current assets consist of the following as of December 31: 2017 2016 Prepaid research fees $ 388,977 $ 334,565 Prepaid insurance 638,139 598,909 Prepaid pre-commercialization 65,000 35,500 Prepaid subscriptions fees 23,347 22,770 Prepaid rent — 19,756 Other 58,281 36,444 Total prepaid expenses and other current assets $ 1,173,744 $ 1,047,944 |
Property and Equipment, net (Ta
Property and Equipment, net (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment, net | Property and equipment, net consists of the following as of December 31: 2017 2016 Computer equipment $ 27,915 $ 27,915 Furniture and equipment 169,931 177,061 Leasehold improvements 152,708 152,708 350,554 357,684 Less: Accumulated depreciation (159,169 ) (113,480 ) Total property and equipment, net $ 191,385 $ 244,204 |
Accrued Expenses and Other Li27
Accrued Expenses and Other Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Expenses and Other Liabilities | Accrued expenses and other liabilities consist of the following as of December 31: 2017 2016 Accrued preclinical and clinical trial expenses $ 970,649 $ 623,855 Accrued professional fees 227,457 102,673 Accrued compensation and benefits 821,935 264,237 Accrued license fees 252,500 152,500 Deferred rent and lease incentive 24,011 18,094 Other 24,035 — Current accrued expenses and other liabilities 2,320,587 1,161,359 Deferred rent and lease incentive—non-current 157,456 181,162 Non-current 157,456 181,162 Total accrued expenses and other liabilities $ 2,478,043 $ 1,342,521 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Commitments and Contingencies Disclosure [Abstract] | |
Future Minimum Lease Payments under Operating Lease Agreement | As of December 31, 2017, future minimum lease payments under the operating lease agreement are as follows: 2018 $ 213,644 2019 220,053 2020 226,655 2021 233,454 2022 220,023 $ 1,113,829 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Income Tax Disclosure [Abstract] | |
Reconciliation of Income Tax Expense (Benefit) Computed at Statutory Federal Income Tax Rate | The reconciliation of income tax expense (benefit) computed at the statutory federal income tax rate of 34% to amounts included in the consolidated statements of operations is as follows: 2017 2016 2015 Statutory rate 34.0 % 34.0 % 34.0 % State tax 3.5 % 3.4 % 3.6 % Valuation allowance 26.5 % (44.7 )% (37.7 )% Federal rate change (73.2 )% 0.0 % 0.0 % Tax credit 6.8 % 6.2 % 0.0 % Other 2.4 % 1.1 % 0.1 % 0.0 % 0.0 % 0.0 % |
Components of Deferred Tax Assets | Significant components of the Company’s deferred tax assets as of December 31, 2017 and 2016 are as follows: 2017 2016 Net operating loss $ 15,718,570 $ 21,050,217 Start-up 10,508,487 12,823,113 Tax credits 11,582,134 6,960,838 Deferred compensation 1,326,189 1,555,425 Other 72,395 207,133 Gross deferred tax asset 39,207,775 42,596,726 Valuation allowance (39,207,775 ) (42,596,726 ) Net deferred tax assets $ 0 $ 0 |
Stock Compensation Plans (Table
Stock Compensation Plans (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Stock option activity under the Company's Plans | Stock option activity under the Company’s Plans for the year ended December 31, 2017 is summarized as follows: Number of Weighted Weighted Aggregate Outstanding at beginning of year 4,660,000 $ 1.94 Granted 1,550,000 1.17 Exercised (880,000 ) 0.47 Forfeited or cancelled (138,334 ) 1.94 Expired — 0.00 Outstanding at end of year 5,191,666 $ 1.96 4.94 $ 10,178,881 Exercisable at end of year 2,908,330 $ 2.44 4.40 $ 4,334,327 |
Schedule of Other Information Pertaining to Stock Option Activity | Other information pertaining to stock option activity during the years ended December 31, 2017, 2016 and 2015 was as follows: 2017 2016 2015 Weighted–average fair value of granted stock options $ 0.91 $ 0.62 $ 2.13 Total fair value of vested stock options $ 2,016,992 $ 1,634,562 $ 1,307,895 Total intrinsic value of exercised stock options $ 2,296,100 $ 42,000 $ 3,311,599 |
Summary of Company's Stock Options Outstanding | The following table summarizes information about the Company’s options outstanding at December 31, 2017: Options Outstanding Options Exercisable Range of Exercise Prices Number Weighted Weighted Number Weighted Weighted $0.47 to $0.85 1,085,000 5.15 $ 0.78 550,000 5.09 $ 0.79 $0.86 to $1.14 1,516,666 6.00 $ 1.13 199,999 5.99 $ 1.13 $1.15 to $2.80 1,195,000 4.75 $ 2.48 866,665 4.65 $ 2.51 $2.81 to $3.23 1,020,000 3.67 $ 3.12 1,020,000 3.67 $ 3.12 $3.24 to $4.64 375,000 4.06 $ 3.93 271,666 3.81 $ 3.94 5,191,666 4.94 $ 1.96 2,908,330 4.40 $ 2.44 |
Summary of Stock Options Awards Based on Certain Assumptions | Assumptions used during the years were as follows: Year ended December 31, 2017 2016 2015 Risk free interest rate 1.66% to 2.25 % 0.76% to 2.15 % 1.00% to 2.13 % Expected term 4 to 7 years 2 to 6 years 3 to 7 years Expected volatility 104 % 100 % 102 % Expected dividend yield — % — % — % Expected forfeiture rate — % — % — % |
Summary of Restricted Stock Unit Activity | Restricted stock unit activity during 2017, 2016, and 2015 was as follows: 2017 2016 2015 Number of Weighted Number of Weighted Number of Weighted Date Fair Value Nonvested balance at beginning of year 26,667 $ 2.83 53,334 $ 2.83 80,000 $ 2.83 Granted — — — — — — Vested (26,667 ) 2.83 (26,667 ) 2.83 (26,666 ) 2.83 Forfeited — — — — — — Nonvested balance at end of year $ — $ — 26,667 $ 2.83 53,334 $ 2.83 |
Quarterly Financial Informati31
Quarterly Financial Information (unaudited) (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Quarterly Financial Information Disclosure [Abstract] | |
Schedule of Quarterly Financial Information | The following table presents unaudited supplemental quarterly financial information for the years ended December 31, 2017 and 2016: Quarter Ended March 31, 2017 June 30, 2017 September 30, December 31, Revenues $ — $ — $ — $ — Loss from operations (4,679,871 ) (4,181,271 ) (4,306,708 ) (5,511,786 ) Change in fair value of warrants liability (397,235 ) 210,331 — — Net loss $ (4,967,129 ) $ (3,879,901 ) $ (4,177,649 ) $ (5,387,698 ) Net loss per share—basic and diluted $ (0.06 ) $ (0.05 ) $ (0.05 ) $ (0.06 ) Quarter Ended March 31, 2016 June 30, 2016 September 30, December 31, 2016 Revenues $ — $ — $ — $ — Loss from operations (6,237,536 ) (4,814,452 ) (3,914,014 ) (4,314,199 ) Change in fair value of warrants liability 733,356 152,783 (106,948 ) 106,946 Net loss $ (5,386,237 ) $ (4,568,914 ) $ (3,953,981 ) $ (4,163,320 ) Net loss per share—basic and diluted $ (0.07 ) $ (0.06 ) $ (0.05 ) $ (0.05 ) |
Basis of Presentation and Sig32
Basis of Presentation and Significant Accounting Policies - Additional Information (Detail) | 1 Months Ended | 12 Months Ended | |||
Oct. 31, 2011shares | Dec. 31, 2018 | Dec. 31, 2017USD ($)Segment$ / sharesshares | Dec. 31, 2016USD ($)$ / sharesshares | Dec. 31, 2015USD ($)$ / shares | |
Summary Of Basis Of Presentation And Significant Accounting Policies [Line Items] | |||||
Maximum maturity period of cash and cash equivalent | Three months | ||||
Deferred rent and lease incentive in accrued expenses and other liabilities | $ | $ 181,467 | $ 199,256 | |||
Statutory rate | 34.00% | 34.00% | 34.00% | ||
Stock option exercise price range, Minimum | $ 0.47 | $ 0.47 | $ 0.47 | ||
Stock option exercise price range, Maximum | $ 4.64 | $ 4.64 | $ 4.64 | ||
Number of reportable segment | Segment | 1 | ||||
October 28, 2011 Warrants [Member] | |||||
Summary Of Basis Of Presentation And Significant Accounting Policies [Line Items] | |||||
Warrants issued in offering | shares | 1,523,370 | ||||
Warrants outstanding | shares | 0 | 763,913 | |||
October 28, 2011 Warrants [Member] | Warrants Liability, at Fair Value [Member] | |||||
Summary Of Basis Of Presentation And Significant Accounting Policies [Line Items] | |||||
Warrants expiration date | May 2, 2017 | ||||
Trading Securities [Member] | Other Income, Net [Member] | |||||
Summary Of Basis Of Presentation And Significant Accounting Policies [Line Items] | |||||
Unrealized gain (loss) | $ | $ 29,430 | $ 58,861 | $ (29,430) | ||
Scenario, Plan [Member] | |||||
Summary Of Basis Of Presentation And Significant Accounting Policies [Line Items] | |||||
Statutory rate | 21.00% | ||||
U.S. federal corporate tax rate [Member] | |||||
Summary Of Basis Of Presentation And Significant Accounting Policies [Line Items] | |||||
Statutory rate | 35.00% | ||||
Computer Equipment [Member] | |||||
Summary Of Basis Of Presentation And Significant Accounting Policies [Line Items] | |||||
Useful life of assets | 3 years | ||||
Minimum [Member] | |||||
Summary Of Basis Of Presentation And Significant Accounting Policies [Line Items] | |||||
Minimum amortization period of compensation cost on straight line basis | 1 year | ||||
Potentially dilutive warrants to purchase common stock | $ 1.04 | $ 1.04 | |||
Minimum [Member] | Leasehold Improvements [Member] | |||||
Summary Of Basis Of Presentation And Significant Accounting Policies [Line Items] | |||||
Useful life of assets | 5 years | ||||
Minimum [Member] | Furniture and Equipment [Member] | |||||
Summary Of Basis Of Presentation And Significant Accounting Policies [Line Items] | |||||
Useful life of assets | 3 years | ||||
Maximum [Member] | |||||
Summary Of Basis Of Presentation And Significant Accounting Policies [Line Items] | |||||
Minimum amortization period of compensation cost on straight line basis | 3 years | ||||
Potentially dilutive warrants to purchase common stock | $ 2.08 | $ 2.08 | |||
Maximum [Member] | Leasehold Improvements [Member] | |||||
Summary Of Basis Of Presentation And Significant Accounting Policies [Line Items] | |||||
Useful life of assets | 7 years | ||||
Maximum [Member] | Furniture and Equipment [Member] | |||||
Summary Of Basis Of Presentation And Significant Accounting Policies [Line Items] | |||||
Useful life of assets | 6 years |
Basis of Presentation and Sig33
Basis of Presentation and Significant Accounting Policies - Fair Value Measurement Specific to Assets or Liability (Detail) - USD ($) | Dec. 31, 2017 | Dec. 31, 2016 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Short-term investments | $ 26,516,711 | $ 26,512,753 |
Warrants liability | 122,226 | |
Money Market Funds [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Money market funds | 56,820,688 | 13,395,759 |
Quoted Prices in Active Markets for Identical Assets/Liabilities (Level 1) [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Short-term investments | 26,516,711 | 26,512,753 |
Quoted Prices in Active Markets for Identical Assets/Liabilities (Level 1) [Member] | Money Market Funds [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Money market funds | $ 56,820,688 | 13,395,759 |
Significant Unobservable Inputs (Level 3) [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Warrants liability | $ 122,226 |
Basis of Presentation and Sig34
Basis of Presentation and Significant Accounting Policies - Stock-Based Compensation Expense (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||
Total stock-based compensation | $ 2,407,961 | $ 1,836,085 | $ 1,585,458 |
Research and Development [Member] | |||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||
Total stock-based compensation | 785,899 | 590,857 | 378,548 |
General and Administrative [Member] | |||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||
Total stock-based compensation | $ 1,622,062 | $ 1,245,228 | $ 1,206,910 |
Basis of Presentation and Sig35
Basis of Presentation and Significant Accounting Policies - Potential Shares Excluded from Determination of Basic and Diluted Net Loss Per Share (Detail) - 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 equivalent common stock excluded | 5,191,666 | 7,094,330 | 6,710,997 |
Options to Purchase Common Stock [Member] | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Potential equivalent common stock excluded | 5,191,666 | 4,660,000 | 4,250,000 |
Warrants Liability, at Fair Value [Member] | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Potential equivalent common stock excluded | 2,407,663 | 2,407,663 | |
Unvested Restricted Stock [Member] | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Potential equivalent common stock excluded | 26,667 | 53,334 |
Warrants Liability, at Fair V36
Warrants Liability, at Fair Value - Additional Information (Detail) - USD ($) | 1 Months Ended | 12 Months Ended | ||
Oct. 31, 2011 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Class of Warrant or Right [Line Items] | ||||
Recognition of warrants fair value at date of issuance | $ 0 | $ 0 | $ 0 | |
Number of warrants exercised during the period | 2,257,663 | 0 | 1,178,261 | |
Proceeds of Warrants | $ 3,209,423 | $ 1,895,738 | ||
October 28, 2011 Warrants [Member] | Warrants Liability, at Fair Value [Member] | ||||
Class of Warrant or Right [Line Items] | ||||
Recognition of warrants fair value at date of issuance | $ 1,300,000 | |||
Number of warrants exercised during the period | 613,913 | 0 | 478,261 | |
Proceeds of Warrants | $ 798,087 | $ 621,739 | ||
Warrants expiration date | May 2, 2017 |
Warrants Liability, at Fair V37
Warrants Liability, at Fair Value - Summary of Assumptions Used in Black-Scholes Model to Calculate Fair Value of Warrants Liability (Detail) - Warrants Liability, at Fair Value [Member] | 12 Months Ended |
Dec. 31, 2016 | |
Fair Value Inputs, Liabilities, Quantitative Information [Line Items] | |
Risk free interest rate | 0.85% |
Expected term | 3 months 29 days |
Expected volatility | 100.00% |
Expected dividend yield | 0.00% |
Expected forfeiture rate | 0.00% |
Warrants Liability, at Fair V38
Warrants Liability, at Fair Value - Summary of Company's Warrants Liability Activity (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Fair Value Disclosures [Abstract] | |||
Fair value, beginning of period | $ 122,226 | $ 1,008,363 | $ 2,794,891 |
Issuance of warrants | 0 | 0 | 0 |
Exercise of warrants | (309,130) | (1,721,523) | |
Change in fair value | $ 186,904 | (886,137) | (65,005) |
Fair value, end of period | $ 122,226 | $ 1,008,363 |
Prepaid Expenses and Other Cu39
Prepaid Expenses and Other Current Assets - Prepaid Expenses and Other Current Assets (Detail) - USD ($) | Dec. 31, 2017 | Dec. 31, 2016 |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | ||
Prepaid research fees | $ 388,977 | $ 334,565 |
Prepaid insurance | 638,139 | 598,909 |
Prepaid pre-commercialization fees | 65,000 | 35,500 |
Prepaid subscriptions fees | 23,347 | 22,770 |
Prepaid rent | 19,756 | |
Other | 58,281 | 36,444 |
Total prepaid expenses and other current assets | $ 1,173,744 | $ 1,047,944 |
Property and Equipment, net - P
Property and Equipment, net - Property and Equipment, net (Detail) - USD ($) | Dec. 31, 2017 | Dec. 31, 2016 |
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 350,554 | $ 357,684 |
Less: Accumulated depreciation | (159,169) | (113,480) |
Total property and equipment, net | 191,385 | 244,204 |
Computer Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 27,915 | 27,915 |
Furniture and Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 169,931 | 177,061 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 152,708 | $ 152,708 |
Property and Equipment, net - A
Property and Equipment, net - Additional Information (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Property, Plant and Equipment [Abstract] | |||
Depreciation expenses | $ 45,689 | $ 43,406 | $ 34,468 |
Accrued Expenses and Other Li42
Accrued Expenses and Other Liabilities - Schedule of Accrued Expenses and Other Liabilities (Detail) - USD ($) | Dec. 31, 2017 | Dec. 31, 2016 |
Payables and Accruals [Abstract] | ||
Accrued preclinical and clinical trial expenses | $ 970,649 | $ 623,855 |
Accrued professional fees | 227,457 | 102,673 |
Accrued compensation and benefits | 821,935 | 264,237 |
Accrued license fees | 252,500 | 152,500 |
Deferred rent and lease incentive | 24,011 | 18,094 |
Other | 24,035 | |
Current accrued expenses and other liabilities | 2,320,587 | 1,161,359 |
Deferred rent and lease incentive-non-current | 157,456 | 181,162 |
Non-current accrued expenses and other liabilities | 157,456 | 181,162 |
Total accrued expenses and other liabilities | $ 2,478,043 | $ 1,342,521 |
Commitments and Contingencies -
Commitments and Contingencies - Future Minimum Lease Payments under Operating Lease Agreement (Detail) | Dec. 31, 2017USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
2,018 | $ 213,644 |
2,019 | 220,053 |
2,020 | 226,655 |
2,021 | 233,454 |
2,022 | 220,023 |
Total | $ 1,113,829 |
Commitments and Contingencies44
Commitments and Contingencies - Additional Information (Detail) | 1 Months Ended | 12 Months Ended | ||
Mar. 31, 2015USD ($)ft² | Dec. 31, 2017USD ($) | Dec. 31, 2016USD ($) | Dec. 31, 2015USD ($) | |
Commitments and Contingencies Disclosure [Abstract] | ||||
Area of leased property | ft² | 5,200 | |||
Lease expiration year | 2,022 | |||
Tenant build-out costs | $ 131,000 | |||
Rent expense | $ 204,170 | $ 201,920 | $ 129,727 | |
Obligations under capital leases | $ 0 |
Agreements - Northwestern Unive
Agreements - Northwestern University - Additional Information (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
License Agreement [Line Items] | ||
Accrued license fees | $ 252,500 | $ 152,500 |
Northwestern License Agreement [Member] | ||
License Agreement [Line Items] | ||
License fee paid | 424,885 | |
Accrued license fees | 252,500 | $ 152,500 |
Future milestone payment | $ 300,000 |
Agreements - BioMarin - Additio
Agreements - BioMarin - Additional Information (Detail) - License Agreement with BioMarin [Member] - USD ($) | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
License Agreement [Line Items] | ||
Date on which strategic collaboration is entered into | Oct. 26, 2012 | |
Royalty agreement period | 7 years | |
Net sales royalty threshold | $ 100,000,000 | |
Milestone payment due upon NDA acceptance | 2,600,000 | |
Milestone payment due upon NDA approval | 7,200,000 | |
Costs paid for Firdapse joint studies | $ 3,800,000 | $ 3,800,000 |
Milestone Payment Description | BioMarin’s obligation to pay the milestone payments due to the former Huxley stockholders (and the Company’s corresponding obligation to pay such milestone payments expressly expires if these milestones have not been not satisfied by April 20, 2018 | |
Huxley Pharmaceuticals [Member] | ||
License Agreement [Line Items] | ||
Milestone payment due upon NDA acceptance | $ 2,425,000 | |
Milestone payment due upon NDA approval | 4,200,000 | |
Third Party Licensor [Member] | ||
License Agreement [Line Items] | ||
Milestone payment due upon NDA acceptance | 150,000 | |
Milestone payment due upon NDA approval | $ 3,000,000 | |
Minimum [Member] | ||
License Agreement [Line Items] | ||
Percentage of royalty on net sales | 7.00% | |
Maximum [Member] | ||
License Agreement [Line Items] | ||
Percentage of royalty on net sales | 10.00% |
Related Party Transactions - Ad
Related Party Transactions - Additional Information (Detail) - USD ($) | 1 Months Ended | 12 Months Ended | ||
Sep. 30, 2015 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Related Party Transaction [Line Items] | ||||
Consulting fees to Company officer and members of the Scientific Advisory Board | $ 10,000 | $ 10,000 | $ 10,000 | |
CEO Employment Agreement [Member] | ||||
Related Party Transaction [Line Items] | ||||
Annual base salary of CEO | $ 525,000 | |||
Expiration date of employment agreement | 2018-11 | |||
Consulting Agreements [Member] | ||||
Related Party Transaction [Line Items] | ||||
Consulting fees to Company officer and members of the Scientific Advisory Board | $ 45,000 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) | 3 Months Ended | 12 Months Ended | |||
Dec. 31, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Income Taxes [Line Items] | |||||
Statutory rate | 34.00% | 34.00% | 34.00% | ||
Increase (decrease) in valuation allowance on deferred tax assets | $ (3,388,951) | $ 8,287,962 | |||
Reduction in net deferred tax assets | $ 13,500,000 | ||||
Net operating loss carryforwards | 62,600,000 | $ 62,600,000 | $ 56,300,000 | ||
Net operating loss carryforwards expiration date | Beginning in 2024 and ending in 2037. | ||||
Effective tax rate | 0.00% | 0.00% | 0.00% | ||
Interest or penalties accrued | $ 0 | $ 0 | |||
Scenario, Plan [Member] | |||||
Income Taxes [Line Items] | |||||
Statutory rate | 21.00% | ||||
U.S. federal corporate tax rate [Member] | |||||
Income Taxes [Line Items] | |||||
Statutory rate | 35.00% |
Income Taxes - Schedule of Reco
Income Taxes - Schedule of Reconciliation of Income Tax Expense (Benefit) Computed at Statutory Federal Income Tax Rate (Detail) | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Income Tax Disclosure [Abstract] | |||
Statutory rate | 34.00% | 34.00% | 34.00% |
State tax | 3.50% | 3.40% | 3.60% |
Valuation allowance | 26.50% | (44.70%) | (37.70%) |
Federal rate change | (73.20%) | 0.00% | 0.00% |
Tax credit | 6.80% | 6.20% | 0.00% |
Other | 2.40% | 1.10% | 0.10% |
Reconciliation of income tax expense (benefit) | 0.00% | 0.00% | 0.00% |
Income Taxes - Components of De
Income Taxes - Components of Deferred Tax Assets (Detail) - USD ($) | Dec. 31, 2017 | Dec. 31, 2016 |
Components of Deferred Tax Assets [Abstract] | ||
Net operating loss | $ 15,718,570 | $ 21,050,217 |
Start-up cost | 10,508,487 | 12,823,113 |
Tax credits | 11,582,134 | 6,960,838 |
Deferred compensation | 1,326,189 | 1,555,425 |
Other | 72,395 | 207,133 |
Gross deferred tax asset | 39,207,775 | 42,596,726 |
Valuation allowance | (39,207,775) | (42,596,726) |
Net deferred tax assets | $ 0 | $ 0 |
Stockholders' Equity (Preferred
Stockholders' Equity (Preferred Stock and Common Stock) - Additional Information (Detail) | Dec. 31, 2017Vote$ / sharesshares | Dec. 31, 2016$ / sharesshares | Dec. 31, 2015$ / sharesshares | Dec. 31, 2014shares |
Equity [Abstract] | ||||
Preferred stock, shares authorized | 5,000,000 | 5,000,000 | ||
Preferred stock, par value | $ / shares | $ 0.001 | $ 0.001 | ||
Preferred stock, shares outstanding | 0 | 0 | ||
Common stock, shares authorized | 150,000,000 | 150,000,000 | 150,000,000 | 100,000,000 |
Common stock, par value | $ / shares | $ 0.001 | $ 0.001 | $ 0.001 | |
Common stock, shares issued | 102,549,498 | 82,972,316 | ||
Common stock, shares outstanding | 102,549,498 | 82,972,316 | ||
Number of votes entitled for each share of common stock | Vote | 1 |
Stockholders' Equity (2016 Shel
Stockholders' Equity (2016 Shelf Registration Statement) - Additional Information (Detail) | Dec. 23, 2016USD ($) |
2016 Shelf Registration Statement [Member] | |
Stockholders' Equity [Line Items] | |
Maximum dollar amount of common stock to be issued under shelf registration statement | $ 33,800,000 |
Stockholders' Equity (2017 Shel
Stockholders' Equity (2017 Shelf Registration Statement) - Additional Information (Detail) - USD ($) | Nov. 28, 2017 | Dec. 31, 2017 | Jul. 12, 2017 |
Underwritten Public Offering [Member] | |||
Stockholders' Equity [Line Items] | |||
Number of common stock sold in offering | 16,428,572 | ||
Common stock issued, price per share | $ 3.50 | ||
Gross proceeds from issuance of common stock | $ 57,500,000 | ||
Offering expenses | $ 3,700,000 | ||
2017 Shelf Registration Statement [Member] | |||
Stockholders' Equity [Line Items] | |||
Maximum dollar amount of securities to be issued under shelf registration statement | $ 150,000,000 | ||
Value of common stock available for future sale | $ 92,500,000 |
Stockholders' Equity (Warrant E
Stockholders' Equity (Warrant Exercises) - Additional Information (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Equity [Abstract] | |||
Issuance of common stock for warrant exercises | 2,257,663 | 1,178,261 | |
Proceeds from exercise of warrants | $ 3,209,423 | $ 1,895,738 | |
Number of warrants exercised during the period | 2,257,663 | 0 | 1,178,261 |
Stockholders' Equity (Stockhold
Stockholders' Equity (Stockholder Rights Plan) - Additional Information (Detail) - $ / shares | Sep. 19, 2016 | Sep. 20, 2011 | Dec. 31, 2017 |
Series A Preferred Stock [Member] | |||
Stockholders' Equity [Line Items] | |||
Preferred share purchase right price | $ 7.80 | ||
Series A Preferred Stock [Member] | Certificate of Designation [Member] | |||
Stockholders' Equity [Line Items] | |||
Junior participating preferred stock shares issued available for issuance under rights agreement, initial | 500,000 | ||
Junior participating preferred stock shares issued available for issuance under rights agreement, amended | 1,500,000 | ||
Stockholder Rights Plan [Member] | |||
Stockholders' Equity [Line Items] | |||
Warrants exercise price | $ 7.80 | ||
Minimum percentage of outstanding stock acquired by a person or group to trigger Shareholder Rights Plan | 17.50% | ||
Stockholders Rights Plan redemption price of right | $ 0.001 | ||
Class of warrant or right expiration date | Sep. 20, 2016 | ||
Class of warrant or right expiration date, Extended | Sep. 20, 2019 |
Stock Compensation Plans - Addi
Stock Compensation Plans - Additional Information (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Stock option contractual term | 4 years 4 months 24 days | ||
Number of stock options exercised | 880,000 | ||
Proceeds from exercise of stock options | $ 368,185 | $ 80,251 | $ 390,351 |
Stock options granted | 1,550,000 | ||
Expected dividend rate | 0.00% | 0.00% | 0.00% |
Stock Option [Member] | Minimum [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share based compensation, vesting period | 1 year | ||
Stock option contractual term | 5 years | ||
Stock Option [Member] | Maximum [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share based compensation, vesting period | 3 years | ||
Stock option contractual term | 7 years | ||
Restricted Stock Units (RSUs) [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Non-cash stock-based compensation expense | $ 65,336 | $ 75,494 | $ 75,440 |
2014 Stock Incentive Plan [Member] | Common Stock [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Common stock shares reserved for issuance under the Plan | 9,000,000 | ||
Common stock shares available for future issuance under the Plan | 3,646,668 | ||
2006 Stock Incentive Plan [Member] | Common Stock [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Common stock shares available for future issuance under the Plan | 0 | ||
Two Thousand Fourteen Plan [Member] | Restricted Stock Units (RSUs) [Member] | Minimum [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share based compensation, vesting period | 3 years | ||
Two Thousand Fourteen Plan [Member] | Restricted Stock Units (RSUs) [Member] | Maximum [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share based compensation, vesting period | 4 years | ||
Options to Purchase Common Stock [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Number of stock options exercised | 780,000 | 75,000 | 265,000 |
Proceeds from exercise of stock options | $ 368,185 | $ 80,251 | $ 390,351 |
Non-cash stock-based compensation expense | $ 2,342,625 | $ 1,760,591 | $ 1,510,018 |
Stock option granted, contractual term | 7 years | 7 years | |
Stock options granted | 1,550,000 | 1,285,000 | 1,760,000 |
Unrecognized compensation expense related to non-vested stock compensation awards granted under the Plan | $ 1,367,155 | ||
Expected remaining weighted average vesting period | 1 year 4 months 20 days | ||
Expected dividend rate | 0.00% | ||
Options to Purchase Common Stock [Member] | Cashless Basis [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Number of stock options exercised | 100,000 | 50,000 | 984,608 |
Shares issued for cashless option exercise | 84,280 | 20,030 | 761,600 |
Stock Compensation Plans - Summ
Stock Compensation Plans - Summary of Stock Option Activity under the Company's Plan (Detail) | 12 Months Ended |
Dec. 31, 2017USD ($)$ / sharesshares | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Number of options, Outstanding at beginning of year | shares | 4,660,000 |
Number of options, Granted | shares | 1,550,000 |
Number of options, Exercised | shares | (880,000) |
Number of options, Forfeited or cancelled | shares | (138,334) |
Number of options, Expired | shares | 0 |
Number of options, Outstanding at end of year | shares | 5,191,666 |
Number of options, Exercisable at end of year | shares | 2,908,330 |
Weighted average exercise price, Outstanding at beginning of year | $ / shares | $ 1.94 |
Weighted average exercise price, Granted | $ / shares | 1.17 |
Weighted average exercise price, Exercised | $ / shares | 0.47 |
Weighted average exercise price, Forfeited or cancelled | $ / shares | 1.94 |
Weighted average exercise price, Expired | $ / shares | 0 |
Weighted average exercise price, Outstanding at end of year | $ / shares | 1.96 |
Weighted average exercise price, Exercisable at end of year | $ / shares | $ 2.44 |
Weighted Average Remaining Contractual Term (Years), Outstanding at end of year | 4 years 11 months 8 days |
Weighted Average Remaining Contractual Term (Years), Exercisable at end of year | 4 years 4 months 24 days |
Aggregate Intrinsic value, Outstanding at end of year | $ | $ 10,178,881 |
Aggregate Intrinsic value, Exercisable at end of year | $ | $ 4,334,327 |
Stock Compensation Plans - Sche
Stock Compensation Plans - Schedule of Other Information Pertaining to Stock Option Activity (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |||
Weighted-average fair value of granted stock options | $ 0.91 | $ 0.62 | $ 2.13 |
Total fair value of vested stock options | $ 2,016,992 | $ 1,634,562 | $ 1,307,895 |
Total intrinsic value of exercised stock options | $ 2,296,100 | $ 42,000 | $ 3,311,599 |
Stock Compensation Plans - Su59
Stock Compensation Plans - Summary of Company's Stock Options Outstanding (Detail) - $ / shares | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Range of Exercise Prices Lower Range | $ 0.47 | $ 0.47 | $ 0.47 |
Range of Exercise Prices Upper Range | $ 4.64 | $ 4.64 | $ 4.64 |
Number Outstanding, Options Outstanding | 5,191,666 | ||
Weighted Average Remaining Contractual Life (Years), Options Outstanding | 4 years 11 months 8 days | ||
Weighted Average Exercise Price, Options Outstanding | $ 1.96 | ||
Number Exercisable Options Exercisable | 2,908,330 | ||
Weighted Average Remaining Contractual Life (Years), Options Exercisable | 4 years 4 months 24 days | ||
Weighted Average Exercise Price, Options Exercisable | $ 2.44 | ||
$0.47 to $0.85 [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Range of Exercise Prices Lower Range | 0.47 | ||
Range of Exercise Prices Upper Range | $ 0.85 | ||
Number Outstanding, Options Outstanding | 1,085,000 | ||
Weighted Average Remaining Contractual Life (Years), Options Outstanding | 5 years 1 month 24 days | ||
Weighted Average Exercise Price, Options Outstanding | $ 0.78 | ||
Number Exercisable Options Exercisable | 550,000 | ||
Weighted Average Remaining Contractual Life (Years), Options Exercisable | 5 years 1 month 2 days | ||
Weighted Average Exercise Price, Options Exercisable | $ 0.79 | ||
$0.86 to $1.14 [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Range of Exercise Prices Lower Range | 0.86 | ||
Range of Exercise Prices Upper Range | $ 1.14 | ||
Number Outstanding, Options Outstanding | 1,516,666 | ||
Weighted Average Remaining Contractual Life (Years), Options Outstanding | 6 years | ||
Weighted Average Exercise Price, Options Outstanding | $ 1.13 | ||
Number Exercisable Options Exercisable | 199,999 | ||
Weighted Average Remaining Contractual Life (Years), Options Exercisable | 5 years 11 months 26 days | ||
Weighted Average Exercise Price, Options Exercisable | $ 1.13 | ||
$1.15 to $2.80 [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Range of Exercise Prices Lower Range | 1.15 | ||
Range of Exercise Prices Upper Range | $ 2.80 | ||
Number Outstanding, Options Outstanding | 1,195,000 | ||
Weighted Average Remaining Contractual Life (Years), Options Outstanding | 4 years 9 months | ||
Weighted Average Exercise Price, Options Outstanding | $ 2.48 | ||
Number Exercisable Options Exercisable | 866,665 | ||
Weighted Average Remaining Contractual Life (Years), Options Exercisable | 4 years 7 months 24 days | ||
Weighted Average Exercise Price, Options Exercisable | $ 2.51 | ||
$2.81 to $3.23 [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Range of Exercise Prices Lower Range | 2.81 | ||
Range of Exercise Prices Upper Range | $ 3.23 | ||
Number Outstanding, Options Outstanding | 1,020,000 | ||
Weighted Average Remaining Contractual Life (Years), Options Outstanding | 3 years 8 months 2 days | ||
Weighted Average Exercise Price, Options Outstanding | $ 3.12 | ||
Number Exercisable Options Exercisable | 1,020,000 | ||
Weighted Average Remaining Contractual Life (Years), Options Exercisable | 3 years 8 months 2 days | ||
Weighted Average Exercise Price, Options Exercisable | $ 3.12 | ||
$3.24 to $4.64 [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Range of Exercise Prices Lower Range | 3.24 | ||
Range of Exercise Prices Upper Range | $ 4.64 | ||
Number Outstanding, Options Outstanding | 375,000 | ||
Weighted Average Remaining Contractual Life (Years), Options Outstanding | 4 years 22 days | ||
Weighted Average Exercise Price, Options Outstanding | $ 3.93 | ||
Number Exercisable Options Exercisable | 271,666 | ||
Weighted Average Remaining Contractual Life (Years), Options Exercisable | 3 years 9 months 22 days | ||
Weighted Average Exercise Price, Options Exercisable | $ 3.94 |
Stock Compensation Plans - Su60
Stock Compensation Plans - Summary of Stock Options Awards Based on Certain Assumptions (Detail) | 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, Minimum | 1.66% | 0.76% | 1.00% |
Risk free interest rate, Maximum | 2.25% | 2.15% | 2.13% |
Expected volatility | 104.00% | 100.00% | 102.00% |
Expected dividend yield | 0.00% | 0.00% | 0.00% |
Expected forfeiture rate | 0.00% | 0.00% | 0.00% |
Minimum [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected term | 4 years | 2 years | 3 years |
Maximum [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected term | 7 years | 6 years | 7 years |
Stock Compensation Plans - Su61
Stock Compensation Plans - Summary of Restricted Stock Unit Activity (Detail) - Restricted Stock Units (RSUs) [Member] - $ / shares | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Schedule Of Restricted Stock Activity [Line Items] | |||
Nonvested balance at beginning of year | 26,667 | 53,334 | 80,000 |
Granted | 0 | 0 | 0 |
Vested | (26,667) | (26,667) | (26,666) |
Forfeited | 0 | 0 | 0 |
Nonvested balance at end of year | 26,667 | 53,334 | |
Nonvested Weighted Average Grant Date Fair Value balance at beginning of year | $ 2.83 | $ 2.83 | $ 2.83 |
Weighted Average Grant Date Fair Value, Granted | 0 | 0 | 0 |
Weighted Average Grant Date Fair Value, Vested | 2.83 | 2.83 | 2.83 |
Weighted Average Grant Date Fair Value, Forfeited | $ 0 | 0 | 0 |
Nonvested Weighted Average Grant Date Fair Value balance at end of year | $ 2.83 | $ 2.83 |
Benefit Plan - Additional Infor
Benefit Plan - Additional Information (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Retirement Benefits [Abstract] | |||
Employees contribution of pre-tax annual compensation | 15.00% | ||
Discretionary matching contributions of employee contributions of an employee's gross salary | 4.00% | ||
Contributions | $ 84,000 | $ 59,000 | $ 69,000 |
Quarterly Financial Informati63
Quarterly Financial Information (Unaudited) - Schedule of Quarterly Financial Information (Detail) - 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] | |||||||||||
Revenues | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 |
Loss from operations | (5,511,786) | (4,306,708) | (4,181,271) | (4,679,871) | (4,314,199) | (3,914,014) | (4,814,452) | (6,237,536) | (18,679,636) | (19,280,201) | (20,398,352) |
Change in fair value of warrants liability | 210,331 | (397,235) | 106,946 | (106,948) | 152,783 | 733,356 | (186,904) | 886,137 | 65,005 | ||
Net loss | $ (5,387,698) | $ (4,177,649) | $ (3,879,901) | $ (4,967,129) | $ (4,163,320) | $ (3,953,981) | $ (4,568,914) | $ (5,386,237) | $ (18,412,377) | $ (18,072,452) | $ (20,232,958) |
Net loss per share - basic and diluted | $ (0.06) | $ (0.05) | $ (0.05) | $ (0.06) | $ (0.05) | $ (0.05) | $ (0.06) | $ (0.07) | $ (0.21) | $ (0.22) | $ (0.25) |
Subsequent Events - Additional
Subsequent Events - Additional Information (Detail) - shares | 1 Months Ended | 12 Months Ended | ||
Jan. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Subsequent Event [Line Items] | ||||
Stock options granted | 1,550,000 | |||
Options to Purchase Common Stock [Member] | ||||
Subsequent Event [Line Items] | ||||
Stock option granted, contractual term | 7 years | 7 years | ||
Stock options granted | 1,550,000 | 1,285,000 | 1,760,000 | |
Options to Purchase Common Stock [Member] | Subsequent Event [Member] | ||||
Subsequent Event [Line Items] | ||||
Stock option granted, contractual term | 7 years | |||
Stock options granted | 1,772,500 |