Document And Entity Information
Document And Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2016 | Mar. 03, 2017 | Jun. 30, 2016 | |
Document Information [Line Items] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2016 | ||
Document Fiscal Year Focus | 2,016 | ||
Document Fiscal Period Focus | FY | ||
Entity Registrant Name | Lipocine Inc. | ||
Entity Central Index Key | 1,535,955 | ||
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 | $ 51.8 | ||
Trading Symbol | LPCN | ||
Entity Common Stock, Shares Outstanding | 18,594,889 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Dec. 31, 2016 | Dec. 31, 2015 |
Current assets: | ||
Cash and cash equivalents | $ 5,560,716 | $ 20,007,659 |
Marketable investment securities | 21,279,570 | 24,375,168 |
Accrued interest income | 38,943 | 144,536 |
Prepaid and other current assets | 329,548 | 350,160 |
Total current assets | 27,208,777 | 44,877,523 |
Property and equipment, net of accumulated depreciation of $1,092,710 and $1,060,750, respectively | 103,440 | 75,750 |
Long-term marketable investment securities | 0 | 400,252 |
Other assets | 30,753 | 23,753 |
Total assets | 27,342,970 | 45,377,278 |
Current liabilities: | ||
Accounts payable | 245,915 | 507,067 |
Accrued expenses | 1,080,254 | 2,884,794 |
Total current liabilities | 1,326,169 | 3,391,861 |
Total liabilities | 1,326,169 | 3,391,861 |
Commitments and contingencies (notes 8 and 11) | ||
Stockholders' equity: | ||
Preferred stock, par value $0.0001 per share, 10,000,000 shares authorized; zero issued and outstanding | 0 | 0 |
Common stock, par value $0.0001 per share, 100,000,000 shares authorized; 18,462,325 and 18,250,456 issued and 18,456,615 and 18,244,746 outstanding | 1,846 | 1,825 |
Additional paid-in capital | 131,481,123 | 128,502,659 |
Treasury stock at cost, 5,710 shares | (40,712) | (40,712) |
Accumulated other comprehensive loss | (8,493) | (32,900) |
Accumulated deficit | (105,416,963) | (86,445,455) |
Total stockholders' equity | 26,016,801 | 41,985,417 |
Total liabilities and stockholders' equity | $ 27,342,970 | $ 45,377,278 |
Consolidated Balance Sheets _Pa
Consolidated Balance Sheets [Parenthetical] - USD ($) | Dec. 31, 2016 | Dec. 31, 2015 |
Accumulated Depreciation, Depletion and Amortization, Property, Plant, and Equipment (in dollars) | $ 1,092,710 | $ 1,060,750 |
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, issued | 0 | 0 |
Preferred stock, outstanding | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 100,000,000 | 100,000,000 |
Common stock, shares issued | 18,462,325 | 18,250,456 |
Common stock, shares outstanding | 18,456,615 | 18,244,746 |
Treasury Stock, Shares | 5,710 | 5,710 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Operating expenses: | |||
Research and development | $ 8,076,053 | $ 12,580,245 | $ 15,479,446 |
General and administrative | 10,382,146 | 5,801,823 | 5,001,368 |
Restructuring costs | 728,635 | 0 | 0 |
Total operating expenses | 19,186,834 | 18,382,068 | 20,480,814 |
Operating loss | (19,186,834) | (18,382,068) | (20,480,814) |
Other income, net | 216,078 | 173,890 | 108,338 |
Loss before income tax expense | (18,970,756) | (18,208,178) | (20,372,476) |
Income tax expense | (752) | (200) | (200) |
Net loss | $ (18,971,508) | $ (18,208,378) | $ (20,372,676) |
Basic loss per share attributable to common stock (in dollars per share) | $ (1.04) | $ (1.11) | $ (1.60) |
Weighted average common shares outstanding, basic (in shares) | 18,258,149 | 16,470,814 | 12,766,295 |
Diluted loss per share attributable to common stock (in dollars per share) | $ (1.04) | $ (1.11) | $ (1.60) |
Weighted average common shares outstanding, diluted (in shares) | 18,258,149 | 16,470,814 | 12,766,295 |
Comprehensive loss: | |||
Net loss | $ (18,971,508) | $ (18,208,378) | $ (20,372,676) |
Unrealized net gain (loss) on available-for-sale securities | 24,407 | (32,900) | 0 |
Comprehensive loss | $ (18,947,101) | $ (18,241,278) | $ (20,372,676) |
Consolidated Statements of Chan
Consolidated Statements of Changes in Stockholders' Equity - USD ($) | Total | Common Stock [Member] | Treasury Stock [Member] | Additional Paid-in Capital [Member] | Accumulated Other Comprehensive Loss [Member] | Accumulated Deficit [Member] |
Balances at Dec. 31, 2013 | $ 44,823,747 | $ 1,267 | $ 0 | $ 92,686,881 | $ 0 | $ (47,864,401) |
Balances in (shares) at Dec. 31, 2013 | 12,668,393 | |||||
Net loss | (20,372,676) | $ 0 | 0 | 0 | 0 | (20,372,676) |
Unrealized net loss on marketable investment securities | 0 | |||||
Stock-based compensation | 1,892,835 | 0 | 0 | 1,892,835 | 0 | 0 |
Option exercises | 56,776 | $ 2 | 0 | 56,774 | 0 | 0 |
Option exercises in (shares) | 20,205 | |||||
Vesting of restricted stock awards | 0 | $ 10 | 0 | (10) | 0 | 0 |
Vesting of restricted stock awards in (shares) | 96,784 | |||||
Vesting or restricted stock units | 0 | $ 1 | 0 | (1) | 0 | 0 |
Vesting or restricted stock units in (shares) | 15,000 | |||||
Purchase of treasury stock | (40,712) | $ 0 | $ (40,712) | 0 | 0 | 0 |
Purchase of treasury stock in (shares) | (5,710) | 5,710 | ||||
Balances at Dec. 31, 2014 | 26,359,970 | $ 1,280 | $ (40,712) | 94,636,479 | 0 | (68,237,077) |
Balances in (shares) at Dec. 31, 2014 | 12,794,672 | 5,710 | ||||
Net loss | (18,208,378) | $ 0 | $ 0 | 0 | 0 | (18,208,378) |
Unrealized net loss on marketable investment securities | (32,900) | 0 | 0 | 0 | (32,900) | 0 |
Stock-based compensation | 1,150,418 | 0 | 0 | 1,150,418 | 0 | 0 |
Option exercises | 276,994 | $ 10 | 0 | 276,984 | 0 | 0 |
Option exercises in (shares) | 98,574 | |||||
Vesting of restricted stock awards | 0 | $ 0 | 0 | 0 | 0 | 0 |
Vesting of restricted stock awards in (shares) | 4,000 | |||||
Issuance of common stock in offering | 32,439,313 | $ 535 | 0 | 32,438,778 | 0 | 0 |
Issuance of common stock in offering in (shares) | 5,347,500 | |||||
Balances at Dec. 31, 2015 | 41,985,417 | $ 1,825 | $ (40,712) | 128,502,659 | (32,900) | (86,445,455) |
Balances in (shares) at Dec. 31, 2015 | 18,244,746 | 5,710 | ||||
Net loss | (18,971,508) | $ 0 | $ 0 | 0 | 0 | (18,971,508) |
Unrealized net loss on marketable investment securities | 24,407 | 0 | 0 | 0 | 24,407 | 0 |
Stock-based compensation | 2,372,615 | 0 | 0 | 2,372,615 | 0 | 0 |
Option exercises | 605,870 | $ 21 | 0 | 605,849 | 0 | 0 |
Option exercises in (shares) | 208,869 | |||||
Vesting of restricted stock awards | 0 | $ 0 | 0 | 0 | 0 | 0 |
Vesting of restricted stock awards in (shares) | 3,000 | |||||
Balances at Dec. 31, 2016 | $ 26,016,801 | $ 1,846 | $ (40,712) | $ 131,481,123 | $ (8,493) | $ (105,416,963) |
Balances in (shares) at Dec. 31, 2016 | 18,456,615 | 5,710 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Cash flows from operating activities: | |||
Net loss | $ (18,971,508) | $ (18,208,378) | $ (20,372,676) |
Adjustments to reconcile net loss to cash used in operating activities: | |||
Depreciation expense | 31,960 | 26,721 | 14,620 |
Stock-based compensation expense | 2,372,615 | 1,150,418 | 1,892,835 |
Accretion of premium on marketable investment securities | 224,482 | 181,390 | 0 |
Changes in operating assets and liabilities: | |||
Accrued interest income | 105,593 | (144,536) | 0 |
Prepaid and other current assets | 20,612 | (120,248) | 540,118 |
Accounts payable | (261,152) | 200,791 | (449,562) |
Accrued expenses | (1,804,540) | 1,557,538 | 1,070,502 |
Cash used in operating activities | (18,281,938) | (15,356,304) | (17,304,163) |
Cash flows from investing activities: | |||
Refund (payment) of rental deposit | (7,000) | 0 | 21,247 |
Purchases of property and equipment | (59,650) | (28,689) | (59,608) |
Purchases of marketable investment securities | (25,272,225) | (25,789,710) | 0 |
Maturities of marketable investment securities | 28,568,000 | 800,000 | 0 |
Cash provided by (used in) investing activities | 3,229,125 | (25,018,399) | (38,361) |
Cash flows from financing activities: | |||
Proceeds from stock option exercises | 605,870 | 276,994 | 16,064 |
Payment of accrued common stock offering costs | 0 | 0 | (271,183) |
Net proceeds from common stock offering | 0 | 32,439,313 | 0 |
Cash provided by (used in) financing activities | 605,870 | 32,716,307 | (255,119) |
Net decrease in cash and cash equivalents | (14,446,943) | (7,658,396) | (17,597,643) |
Cash and cash equivalents at beginning of period | 20,007,659 | 27,666,055 | 45,263,698 |
Cash and cash equivalents at end of period | 5,560,716 | 20,007,659 | 27,666,055 |
Supplemental disclosure of non-cash investing and financing activities: | |||
Stock received as consideration for stock option exercises and recognized as treasury stock | 0 | 0 | 40,712 |
Unrealized net gain (loss) on marketable investment securities | $ 24,407 | $ (32,900) | $ 0 |
Description of Business
Description of Business | 12 Months Ended |
Dec. 31, 2016 | |
Accounting Policies [Abstract] | |
Organization, Consolidation and Presentation of Financial Statements Disclosure [Text Block] | (1) Description of Business Lipocine Inc. (“Lipocine” or the “Company”) is engaged in research and development for the delivery of drugs using its proprietary delivery technology. The Company’s principal operation is to provide oral delivery solutions for existing drugs. Lipocine develops its own drug candidates or it develops drug candidates on behalf of or in collaboration with corporate partners. The Company has funded operating costs primarily through collaborative license, milestone and research arrangements, through federal grants and through the sale of equity securities. The Company is incorporated under the laws of the State of Delaware. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2016 | |
Accounting Policies [Abstract] | |
Significant Accounting Policies [Text Block] | (2) Summary of Significant Accounting Policies (a) Use of Estimates The preparation of financial statements in conformity with U.S. generally accepted accounting principles requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent 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. Significant items subject to such estimates and assumptions include those related to revenue recognition; stock-based compensation; valuation of deferred taxes; income tax uncertainties; and the useful lives of property and equipment. (b) Cash and Cash Equivalents The Company considers all highly liquid investments with original maturities to the Company of three months or less to be cash equivalents. Although the Company may deposit its cash and cash equivalents with multiple financial institutions, its deposits, at times, may exceed federally insured limits. Cash equivalents were $2,921,000 and $128,000 at December 31, 2016 and 2015. (c) Receivables Accounts receivable are recorded at the invoiced amount and do not bear interest. The Company maintains an allowance for doubtful accounts for estimated losses. In establishing the allowance, management considers historical losses adjusted to take into account current market conditions and their customers’ financial condition, the amount of receivables in dispute, and the current receivables aging and current payment patterns. The Company had no write-offs in 2016, 2015 and 2014 and the Company did not record an allowance for doubtful accounts as of December 31, 2016 and 2015 as there were no accounts receivable outstanding. The Company does not have any off-balance-sheet credit exposure related to its customers. (d) Revenue Recognition Revenue is recognized when there is persuasive evidence that an arrangement exists, delivery has occurred, the price is fixed or determinable, and collectability is reasonably assured. The Company recognizes up-front license fees as earned. Milestone payments are recognized upon successful completion of a performance milestone event. Contract revenues related to collaborative research and development agreements are recognized on a ratable basis as services are performed. Any amounts received in advance of performance are recorded as deferred revenue until earned. The Company enters into arrangements with collaboration partners that sometimes involve multiple deliverables. These arrangements may contain one or more of the following elements: license and other up-front fees, contract research and development services, milestone payments and royalties. Each deliverable in the arrangement is evaluated to determine whether it meets the criteria to be accounted for as a separate unit of accounting or whether it should be combined with other deliverables. When deliverables are separable, consideration is allocated to the separate units of accounting based upon the relative selling price method, and appropriate revenue recognition principles are applied to each unit. When the Company determines that the arrangement should be accounted for as a single unit of accounting, revenue is recognized over the period for which performance obligations will be performed. Up-front, nonrefundable fees and milestone payments received by the Company under license and collaboration arrangements that include future obligations, in whatever form, are recognized ratably over the expected performance period under each respective arrangement. Under these arrangements, the Company makes its best estimate of the period over which it expects to fulfill its performance obligations, which may include technology transfer assistance, research activities, clinical development activities, and manufacturing activities from development through the commercialization of the product. Given the uncertainties of these extended collaboration arrangements, significant judgment is required to determine the duration of the performance period. For license and collaboration arrangements where no future performance obligations exist, up-front, nonrefundable fees and milestone payments are recognized when received. Any amounts received in advance of performance are recorded as deferred revenue until recognized. The Company may provide research and development services under collaboration arrangements to advance the development of jointly owned products. The Company records the expenses incurred and reimbursed on a net basis. (e) Property and Equipment Property and equipment are recorded at cost, less accumulated depreciation. Maintenance and repairs that do not extend the life or improve the asset are expensed in the year incurred. Depreciation is computed using the straight-line method over the estimated useful lives of the assets, which are five years for laboratory and office equipment, three years for computer equipment and software, and seven years for furniture and fixtures. (f) Accounting for Impairment of Long-Lived Assets Long-lived assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets held and used is measured by a comparison of the carrying amount of an asset to future net cash flows (undiscounted) expected to be generated by the asset. If such assets are considered to be impaired, the impairment to be recognized is measured as the amount by which the carrying amount of the assets exceeds the fair value of the assets. Assets held for sale are reported at the lower of the carrying amount, or fair value, less costs to sell. (g) Income Taxes Income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. A valuation allowance is provided against net deferred tax assets if, based upon the available evidence, it is more likely than not that some or all of the net deferred tax assets will not be realized. The Company recognizes the effect of income tax positions only if those positions are more likely than not of being sustained. Recognized income tax positions are measured at the largest amount that is greater than 50 percent likely of being realized. Changes in recognition or measurement are reflected in the period in which the change in judgment occurs. The Company records interest and penalties related to unrecognized tax benefits as a component of its income tax expense. (h) Share-Based Payments The Company recognizes stock-based compensation expense for grants of stock option awards, restricted stock units and restricted stock under the Company’s Incentive Plan to employees and nonemployee members of the Company’s board of directors based on the grant-date fair value of those awards. The grant-date fair value of an award is generally recognized as compensation expense over the award’s requisite service period. In addition, the Company has granted performance-based stock option awards and restricted stock grants, which vest based upon the Company satisfying certain performance conditions. Potential compensation cost, measured on the grant date, related to these performance options will be recognized only if, and when, the Company estimates that these options will vest, which is based on whether the Company considers the options’ performance conditions to be probable of attainment. The Company’s estimates of the number of performance-based options that will vest will be revised, if necessary, in subsequent periods. In addition, the Company grants stock options to nonemployee consultants from time to time in exchange for services performed for the Company. Equity instruments granted to nonemployees are subject to periodic revaluation over their vesting terms. During August 2016 and in conjunction with the 2016 Restructuring Plan (see note 5), the Company modified 61,487 existing time-vested options of a terminated employee by extending the exercise period to three years from the date of modification under the terms of the employee’s respective employment and severance agreement. Compensation expense of $51,000 was recorded as a result of the modification and recorded as a restructuring charge. During November 2014, the Company modified 149,498 existing time-vested options of two terminated executives by extending the exercise period to three years from the date of modification under the terms of the executive's respective employment and severance agreements. Compensation expense of $166,000 was recorded as a result of the modification. On January 6, 2014, we modified 366,126 existing time-vested and performance options as well as restricted stock awards of two retiring board of directors by fully vesting all unvested equity awards and extending the exercise period to three years from the date of modification. Compensation expense of $836,000 was recorded as a result of the modification. The Company uses the Black-Scholes model to compute the estimated fair value of stock option awards. Using this model, fair value is calculated based on assumptions with respect to (i) expected volatility of the Company’s Common Stock price, (ii) the periods of time over which employees and members of the board of directors are expected to hold their options prior to exercise (expected term), (iii) expected dividend yield on the Common Stock, and (iv) risk-free interest rates. Stock-based compensation expense also includes an estimate, which is made at the time of grant, of the number of awards that are expected to be forfeited. This estimate is revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. Stock-based compensation cost that has been expensed in the statements of operations amounted to $2.4 million, $1.2 million and $1.9 million for the years ended December 31, 2016, 2015 and 2014, allocated as follows: Year Ended 2016 2015 2014 Research and development $ 629,400 $ 287,491 $ 579,711 General and administrative 1,691,949 862,927 1,313,124 Restructuring costs 51,266 - - $ 2,372,615 $ 1,150,418 $ 1,892,835 The Company issued 990,000 stock options, 301,500 stock options and 337,689 stock options, respectively, during the years ended December 31, 2016, 2015 and 2014. Key assumptions used in the determination of the fair value of stock options granted are as follows: Expected Term : The expected term represents the period that the stock-based awards are expected to be outstanding. Due to limited historical experience of similar awards, the expected term was estimated using the simplified method in accordance with the provisions of Staff Accounting Bulletin (“SAB”) No. 107, Share-Based Payment, Risk-Free Interest Rate : The risk-free interest rate used was based on the implied yield currently available on U.S. Treasury issues with an equivalent remaining term. Expected Dividend : The expected dividend assumption is based on management’s current expectation about the Company’s anticipated dividend policy. The Company does not anticipate declaring dividends in the foreseeable future. Expected Volatility : Since the Company did not have sufficient trading history, the volatility factor was based on the average of similar public companies through August 2014. When selecting similar companies, the Company considered the industry, stage of life cycle, size, and financial leverage. Beginning in August 2014, the volatility factor is based on a combination of the Company's trading history since March 2014 and the average of similar public companies. For options granted in 2016, 2015 and 2014, the Company calculated the fair value of each option grant on the respective dates of grant using the following weighted average assumptions: 2016 2015 2014 Expected term 5.84 years 5.75 years 5.87 years Risk-free interest rate 1.76 % 1.63 % 1.75 % Expected dividend yield Expected volatility 84.26 % 81.39 % 76.30 % Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) 718, Stock Compensation, As of December 31, 2016, there was $3.9 million of total unrecognized compensation cost related to unvested share-based compensation arrangements granted under the Company’s stock option plan. That cost is expected to be recognized over a weighted average period of 2.1 years and will be adjusted for subsequent changes in estimated forfeitures. The weighted average fair value of share-based compensation awards granted during the years ended December 31, 2016, 2015 and 2014 was approximately $6.06 per share, $6.60 per share and $5.45 per share, respectively. (i) Fair Value The Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible. The Company determines fair value based on assumptions that market participants would use in pricing an asset or liability in the principal or most advantageous market. When considering market participant assumptions in fair value measurements, the following fair value hierarchy distinguishes between observable and unobservable inputs, which are categorized in one of the following levels: • Level 1 Inputs: Quoted prices for identical instruments in active markets. • Level 2 Inputs: Quoted prices for similar instruments in active markets, quoted prices for identical or similar instruments in markets that are not active, and model-derived valuation in which all significant inputs and significant value drivers are observable in active markets. • Level 3 Inputs: Valuations derived from valuation techniques in which one or more significant inputs or significant value drivers are unobservable. All of the Company’s financial instruments are valued using quoted prices in active markets or based on other observable inputs. For prepaid and other current assets, accounts payable, and accrued expenses, the carrying amounts approximate fair value because of the short maturity of these instruments. The following table presents the placement in the fair value hierarchy of assets and liabilities that are measured at fair value on a recurring basis at December 31, 2016 and 2015: December 31, Fair value measurements at reporting date using 2016 Level 1 inputs Level 2 inputs Level 3 inputs Assets: Cash equivalents - money market funds $ 2,920,577 $ 2,920,577 $ - $ - Government bonds and notes 7,471,054 3,752,350 3,718,704 - Corporate bonds, notes and commercial paper 13,808,516 - 13,808,516 - $ 24,200,147 $ 6,672,927 $ 17,527,220 $ - December 31, Fair value measurements at reporting date using 2015 Level 1 inputs Level 2 inputs Level 3 inputs Assets: Cash equivalents - money market funds $ 127,905 $ 127,905 $ - $ - Government bonds and notes 802,112 802,112 - - Corporate bonds, notes and commercial paper 23,973,308 - 23,973,308 - $ 24,903,325 $ 930,017 $ 23,973,308 $ - The following methods and assumptions were used to determine the fair value of each class of assets and liabilities recorded at fair value in the balance sheets: Cash equivalents: Cash equivalents primarily consist of highly rated money market funds and commercial paper with original maturities to the Company of three months or less, and are purchased daily at par value with specified yield rates. Cash equivalents related to money market funds are classified within Level 1 of the fair value hierarchy because they are valued using quoted market prices or broker or dealer quotations for similar assets. Cash equivalents related to commercial paper are classified within Level 2 of the fair value hierarchy because they are valued using broker/dealer quotes, bids and offers, benchmark yields and credit spreads and other observable inputs. Government bonds and notes: The Company uses a third-party pricing service to value these investments. The pricing service utilizes quoted market prices in active markets for identical assets and reportable trades. Corporate bonds, notes, and commercial paper: The Company uses a third-party pricing service to value these investments. The pricing service utilizes broker/dealer quotes, bids and offers, benchmark yields and credit spreads and other observable inputs. The Company’s accounting policy is to recognize transfers between levels of the fair value hierarchy on the date of the event or change in circumstances that caused the transfer. There were no transfers into or out of Level 1 or Level 2 for the years ended December 31, 2016 and 2015. Earnings (Loss) per Share Basic earnings (loss) per share is calculated by dividing net income (loss) available to common shareholders by the weighted average number of common shares outstanding during the period. Net income (loss) available to common shareholders for the year ended December 31, 2016, 2015 and 2014 was calculated using the two-class method, which is an earnings (loss) allocation method for computing earnings (loss) per share when an entity’s capital structure includes common stock and participating securities. The two-class method determines earnings (losses) per share based on dividends declared on common stock and participating securities (i.e., distributed earnings) and participation rights of participating securities in any undistributed earnings (loss). The application of the two-class method was required since the Company’s unvested restricted stock contains non-forfeitable rights to dividends or dividend equivalents. However, unvested restricted stock grants are not included in computing basic earnings (loss) per share for periods where the Company has losses as these securities are not contractually obligated to share in losses of the Company. Diluted earnings (loss) per share is based on the weighted average number of common shares outstanding plus, where applicable, the additional potential common shares that would have been outstanding related to dilutive options, warrants, and unvested restricted stock to the extent such shares are dilutive. The following table sets forth the computation of basic and diluted earnings (loss) per share of common stock for the years ended December 31, 2016, 2015 and 2014. Year Ended December 31, 2016 2015 2014 Basic loss per share attributable to common stock: Numerator Net loss $ (18,971,508 ) $ (18,208,378 ) $ (20,372,676 ) Denominator Weighted avg. common shares outstanding 18,258,149 16,470,814 12,766,295 Basic loss per share attributable to common stock $ (1.04 ) $ (1.11 ) $ (1.60 ) Diluted loss per share attributable to common stock: Numerator Net loss $ (18,971,508 ) $ (18,208,378 ) $ (20,372,676 ) Denominator Weighted avg. common shares outstanding 18,258,149 16,470,814 12,766,295 Diluted loss per share attributable to common stock $ (1.04 ) $ (1.11 ) $ (1.60 ) December 31, 2016 2015 2014 Stock options 2,225,850 1,722,552 1,528,737 Unvested restricted stock - 3,000 7,000 Warrants - - 20,467 The computation of diluted earnings per share for the years ended December 31, 2016, 2015 and 2014 does not include stock options, unvested restricted stock awards and warrants to purchase shares in the computation of diluted earnings per share because these instruments were antidilutive: (k) Segment Information The Company is a single reportable segment engaged in research and development for the delivery of drugs using its proprietary delivery technology. Operating segments are identified as components of an enterprise for which separate discrete financial information is available for evaluation by the chief operating decision maker in making decisions regarding resource allocation and assessing performance. The chief operating decision maker made such decisions and assessed performance at the company level, as one segment. (l) Principles of Consolidation The consolidated financial statements include the accounts of the Company and all subsidiaries. The Company eliminates all intercompany accounts and transactions in consolidation. |
Marketable Investment Securitie
Marketable Investment Securities | 12 Months Ended |
Dec. 31, 2016 | |
Investments, Debt and Equity Securities [Abstract] | |
Investments in Debt and Marketable Equity Securities (and Certain Trading Assets) Disclosure [Text Block] | (3) Marketable Investment Securities The Company has classified its marketable investment securities as available-for-sale securities. These securities are carried at fair value with unrealized holding gains and losses, net of the related tax effect, included in accumulated other comprehensive loss in stockholders’ equity until realized. Gains and losses on investment security transactions are reported on the specific-identification method. Dividend income is recognized on the ex-dividend date and interest income is recognized on an accrual basis. Gross Gross unrealized unrealized Amortized holding holding Aggregate December 31, 2016 Cost gains losses fair value Government bonds and notes $ 7,473,273 $ - $ (2,219) $ 7,471,054 Corporate bonds, notes and commercial paper 13,814,790 - (6,274) 13,808,516 $ 21,288,063 $ - $ (8,493) $ 21,279,570 Gross Gross unrealized unrealized Amortized holding holding Aggregate December 31, 2015 Cost gains losses fair value Government bonds and notes $ 802,862 $ - $ (750) $ 802,112 Corporate bonds, notes and commercial paper 24,005,458 594 (32,744) 23,973,308 $ 24,808,320 $ 594 $ (33,494) $ 24,775,420 Amortized Aggregate Cost fair value Due within one year $ 21,288,063 $ 21,279,570 $ 21,288,063 $ 21,279,570 There were no sales of marketable investment securities during the years ended December 31, 2016, 2015 and 2014 and therefore no realized gains or losses. Additionally, $ 28.6 800,000 0 |
Contractual Agreements
Contractual Agreements | 12 Months Ended |
Dec. 31, 2016 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Business and Contractual Arrangements for Prepaid Health Care Service Providers [Text Block] | (4) Contractual Agreements (a) Abbott Products, Inc. On March 29, 2012 All obligations under the prior license agreement have been completed except that Lipocine will owe Abbott a perpetual 1% royalty on net sales. 1.0 50 (b) Contract Research and Development The Company has entered into agreements with various contract organizations that conduct preclinical, clinical, analytical and manufacturing development work on behalf of the Company as well as a number of independent contractors, primarily clinical researchers, who serve as advisors to the Company. The Company incurred expenses of $ 5.5 10.0 12.9 |
Restructuring Charges
Restructuring Charges | 12 Months Ended |
Dec. 31, 2016 | |
Restructuring and Related Activities [Abstract] | |
Restructuring and Related Activities Disclosure [Text Block] | (5) Restructuring Charges Restructuring charges relate to our initiative to restructure operations which was approved by the board of directors on July 13, 2016. Under the July 2016 restructuring, the Company reduced its workforce by eight positions, constituting 33 Company’s workforce. The reduction in workforce involved all functional disciplines including general and administrative employees, sales and marketing and research and development personnel. Additionally, the Board approved a further restructuring in October 2016 whereby the Company reduced its workforce by an additional two positions in the sales and marketing functions. The restructurings that occurred in 2016 are jointly referred to as the 2016 Restructuring Plan. The charge related to the 2016 Restructuring Plan during the year ended December 31, 2016 was $ 729,000 678,000 51,000 extending the exercise period of certain options under an existing employee severance agreement. The activity for the year ended December 31, 2016 for restructuring charges is as follows: December 31, 2016 Accrued restructuring charges payable at January 1, 2016 $ - Restructuring expenses during 2016 728,635 Restructuring payments during 2016 (437,796) Non-cash stock option modification (51,266) Accrued restructuring charges payable at December 31, 2016 $ 239,573 The December 31, 2016 accrued restructuring charges will be paid in 2017. |
Property and Equipment
Property and Equipment | 12 Months Ended |
Dec. 31, 2016 | |
Property, Plant and Equipment [Abstract] | |
Property, Plant, and Equipment and Intangible Assets [Text Block] | (6) Property and Equipment December 31, December 31, 2016 2015 Computer equipment and software $ 43,361 $ 43,361 Lab and office equipment 1,048,932 1,041,735 Furniture and fixtures 103,857 51,404 1,196,150 1,136,500 Less accumulated depreciation (1,092,710) (1,060,750) $ 103,440 $ 75,750 Depreciation expense for the years ended December 31, 2016 and 2015 was $ 32,000 27,000 |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2016 | |
Income Tax Disclosure [Abstract] | |
Income Tax Disclosure [Text Block] | (7) Income Taxes (a) Income Tax Expense December 31, 2016 2015 2014 U.S. federal $ - $ - $ - State and local 752 200 200 Deferred - - - Total $ 752 $ 200 $ 200 (b) Tax Rate Reconciliation 752 200 200 34 December 31, 2016 2015 2014 Computed "expected" tax expense (benefit) $ (6,450,075) $ (6,190,781) $ (6,926,642) Increase (reduction) in income taxes resulting from: Change in valuation allowance 6,709,591 6,691,992 7,748,579 Adjustment of tax attributes due to change in ownership - - (127,572) State and local income taxes, net of federal income tax benefit 496 132 132 Stock expense 200,002 102,221 45,097 Research and development tax credits (337,968) (452,609) (743,186) Orphan drug tax credit (127,641) (155,452) - Other, net 6,347 4,697 3,792 $ 752 $ 200 $ 200 (c) Significant Components of Deferred Taxes December 31, 2016 2015 Deferred tax assets: Stock-based compensation $ 1,924,260 $ 1,713,608 Net operating loss carryforwards 30,700,358 23,677,332 Employee benefits 69,112 59,472 Research and development tax credits 2,465,893 2,052,662 Orphan drug tax credits 679,185 485,789 Other deductible tempory differences 70,231 215,638 Total gross deferred tax assets 35,909,039 28,204,501 Less valuation allowance (35,904,927) (28,200,857) Net deferred tax assets 4,112 3,644 Deferred tax liabilities: Plant and equipment (4,112) (3,644) Total gross deferred tax liabilities (4,112) (3,644) Net deferred tax liabilities $ - $ - On December 18, 2015, the Protecting Americans from Tax Hikes Act of 2015 was signed into law. The act made permanent the research and experimentation tax credit for amounts paid or incurred after December 31, 2014, with no substantive changes to the credit. The valuation allowance for deferred tax assets as of December 31, 2016 and 2015 was $ 35.9 28.2 7.7 7.3 During the year ended December 31, 2013, the Company experienced a change in ownership, as defined by the Internal Revenue Code, as amended (the “Code”) under Section 382. A change of ownership occurs when ownership of a company increases by more than 50 percentage points over a three-year testing period of certain stockholders. As a result of this ownership change we determined that our annual limitation on the utilization of our federal net operating loss (“NOL”) and credit carryforwards is approximately $ 1.1 20.2 5.5 carryforwards and $ 1.2 As of December 31, 2016, we had NOL and research and development credit carryforwards for U.S. federal income tax reporting purposes of approximately $ 78.0 1.6 Approximately $25.5 million of the NOL will expire between 2023 and 2033 and $52.5 million of the NOL will expire 2034 through 2036 expire in 2033 through 2036 We also have state NOL and research and development credit carry-forwards of approximately $ 83.9 819,000 Approximately $12.4 million of the Company's state NOL expire in 2018, $19.3 million expires between 2019 and 2028, and $52.2 million will expire in 2029 through 2031 expire in 2023 through 2031 679,000 The Company's federal and state income tax returns for December 31, 2013 through 2016 are open tax years. December 31, 2016 2015 Balance, beginning of year $ - $ - Balance, end of year $ - $ - |
Leases
Leases | 12 Months Ended |
Dec. 31, 2016 | |
Leases [Abstract] | |
Leases of Lessee Disclosure [Text Block] | (8) Leases On August 6, 2004, the Company assumed a non-cancelable operating lease for office space and laboratory facilities in Salt Lake City, Utah. On May 6, 2014, the Company modified and extended the lease through February 28, 2018. Additionally, on December 28, 2015, the Company entered into an operating lease for office space in Lawrenceville, New Jersey through January 31, 2018. Operating leases Year ending December 31: 2017 387,119 2018 58,903 Total minimum lease payments $ 446,022 The Company’s rent expense was $ 374,000 295,000 327,000 |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2016 | |
Stockholders Equity Note [Abstract] | |
Stockholders Equity Note Disclosure [Text Block] | (9) Stockholders’ Equity (a) Issuance of Common Stock On April 29, 2015, the Company sold 5,347,500 32.4 2.3 (b) Rights Agreement O n November 13, 2015, the Company and American Stock Transfer & Trust Company, LLC, as Rights Agent, entered into a Rights Agreement. Also on November 12, 2015, the Board of Directors of the Company authorized and the Company declared a dividend of one preferred stock purchase right (each a “Right” and collectively, the “Rights”) for each outstanding share of common stock of the Company. The dividend was payable to stockholders of record as of the close of business on November 30, 2015 and entitles the registered holder to purchase from the Company one one-thousandth of a fully paid non-assessable share of Series A Junior Participating Preferred Stock of the Company at a price of $ 63.96 In general, in the event a person becomes an Acquiring Person, then each Right not owned by such Acquiring Person will entitle its holder to purchase from the Company, at the Right’s then current exercise price, in lieu of shares of Series A Junior Participating Preferred Stock, common stock of the Company with a market value of twice the Purchase Price. In addition, if after any person has become an Acquiring Person, (a) the Company is acquired in a merger or other business combination, or (b) 50% or more of the Company’s assets, or assets accounting for 50% or more of its earning power, are sold, leased, exchanged or otherwise transferred (in one or more transactions), proper provision shall be made so that each holder of a Right (other than the Acquiring Person, its affiliates and associates and certain transferees thereof, whose Rights became void) shall thereafter have the right to purchase from the acquiring corporation, for the Purchase Price, that number of shares of common stock of the acquiring corporation which at the time of such transaction would have a market value of twice the Purchase Price. The Company will be entitled to redeem the Rights at $ 0.001 November 12, 2018 (c) Stock Option Plan In April 2014, the board of directors adopted the 2014 Stock and Incentive Plan ("2014 Plan") subject to shareholder approval which was received in June 2014. The 2014 Plan provides for the granting of nonqualified and incentive stock options, stock appreciation rights, restricted stock units, restricted stock and dividend equivalents. An aggregate of 1,000,000 271,906 1,271,906 2,471,906 1,215,520 Outstanding stock options Number of Weighted average shares exercise price Balance at December 31, 2015 1,722,552 $ 5.21 Options granted 990,000 8.65 Options exercised (208,869) 2.90 Options forfeited (269,471) 12.03 Options cancelled (8,362) 7.61 Balance at December 31, 2016 2,225,850 6.12 Options exercisable at December 31, 2016 1,282,660 4.71 Options outstanding Options exercisable Number Weighted Weighted Aggregate intrinsic Number Weighted Weighted Aggregate 2,225,850 7.07 $ 6.12 $ 733,713 1,282,660 5.43 $ 4.71 $ 706,552 The intrinsic value for stock options is defined as the difference between the current market value and the exercise price. The total intrinsic value of stock options exercised during the years ended December 31, 2016, 2015 and 2014 was $ 216,000 658,000 87,000 208,869 98,574 20,205 (d) Restricted Common Stock Number of unvested restricted shares Balance at December 31, 2015 3,000 Granted - Vested (3,000) Cancelled - Balance at December 31, 2016 - (e) Warrants For charitable purposes, on December 23, 2003, the Company granted warrants to a local university for 20,467 12.21 |
401(k) Plan
401(k) Plan | 12 Months Ended |
Dec. 31, 2016 | |
Compensation and Retirement Disclosure [Abstract] | |
Compensation and Employee Benefit Plans [Text Block] | (10) 401(k) Plan On January 1, 2002, the Company adopted a tax qualified employee savings and retirement plan (the “401(k) Plan”) covering eligible employees. Pursuant to the 401(k) Plan, employees may elect to reduce current compensation by a percentage of eligible compensation, not to exceed legal limits, and contribute the amount of such reduction to the 401(k) Plan. Beginning April 1, 2014, the 401(k) Plan was amended to require matching contributions to the 401(k) Plan by the Company on behalf of the participants of 100 128,000 74,000 48,000 |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2016 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies Disclosure [Text Block] | (11) Commitments and Contingencies Litigation The Company is involved in various lawsuits, claims and other legal matters from time to time that arise in the ordinary course of conducting business. The Company records a liability when a particular contingency is probable and estimable. The Company has not accrued for any contingency at December 31, 2016 as the Company does not consider any contingency to be probable nor estimable. While complete assurance cannot be given to the outcome of these proceedings, management does not currently believe that any of these matters, individually or in the aggregate, will have a material adverse effect on our financial condition, liquidity or results of operations. Guarantees and Indemnifications In the ordinary course of business, the Company enters into agreements, such as lease agreements, licensing agreements, clinical trial agreements, and certain services agreements, containing standard guarantee and / or indemnifications provisions. Additionally, the Company has indemnified its directors and officers to the maximum extent permitted under the laws of the State of Delaware. |
Agreement with Spriaso, LLC
Agreement with Spriaso, LLC | 12 Months Ended |
Dec. 31, 2016 | |
Agreement With Spriaso LLC [Abstract] | |
Agreement With Spriaso LLC [Text Block] | (12) Agreement with Spriaso, LLC On July 23, 2013, the Company entered into an assignment/license and a services agreement with Spriaso, a related-party that is majority-owned by certain current and former directors of Lipocine Inc. and their affiliates. Under the license agreement, the Company assigned and transferred to Spriaso all of the Company’s rights, title and interest in its intellectual property to develop products for the cough and cold field. In addition, Spriaso received all rights and obligations under the Company’s product development agreement with a third-party. In exchange, the Company will receive a royalty of 20 10.0 Under the service agreement, the Company provided facilities and up to 10 percent of the services of certain employees to Spriaso for a period of 18 months which expired 230 3,000 61,000 0 Consolidations |
Accounting Pronouncements Issue
Accounting Pronouncements Issued Not Yet Adopted | 12 Months Ended |
Dec. 31, 2016 | |
New Accounting Pronouncements and Changes in Accounting Principles [Abstract] | |
New Accounting Pronouncements and Changes in Accounting Principles [Text Block] | (13) Accounting Pronouncements Issued Not Yet Adopted In August 2016, the FASB issued Accounting Standards Update (“ASU”) 2016-15, Statement of Cash Flows (Topic 230): Classification of Certain Cash Receipts and Cash Payments In June 2016, the FASB issued ASU 2016-13, Financial Instruments - Credit Losses In, March 2016, the FASB issued ASU 2016-09, Improvements to Employee Share-Based Payment Accounting Stock Compensation The standard becomes effective for the Company beginning in the first quarter of our fiscal year ended December 31, 2017 operations. In February 2016, FASB issued ASU 2016-02 , Leases, which provides new guidance for lease accounting including recognizing most leases on-balance sheet. The standard becomes effective for annual and interim periods in fiscal years beginning after December 15, 2018. ASU 2016-02 mandates a modified retrospective transition method for all entities. The Company currently does not have any lease that extends beyond December 31, 2018 but will continue to evaluate the effect that ASU 2016-02 will have on our consolidated financial statements and related disclosures if we enter into new leases that extend beyond December 31, 2018. The Company plans to adopt this pronouncement effective January 1, 2019 and does not believe it will have a material effect on the Company's financial position or results of operations In January 2016, FASB issued ASU 2 016-01, Financial Instruments, Recognition and Measurement of Financial Assets and Financial Liabilities In November 2015, the FASB issued ASU 2015-17, Balance Sheet Classification of Deferred Taxes In May 2014, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606) . . |
Selected Quarterly Financial In
Selected Quarterly Financial Information (Unaudited) | 12 Months Ended |
Dec. 31, 2016 | |
Quarterly Financial Information Disclosure [Abstract] | |
Quarterly Financial Information [Text Block] | (14) Selected Quarterly Financial Information (Unaudited) 2016 First Second Third Fourth Operating loss $ (7,070,404) $ (5,815,120) $ (3,286,220) $ (3,015,090) Net loss (7,009,445) (5,760,111) (3,235,485) (2,966,467) Basic loss per share attributable to common stock (0.38) (0.32) (0.18) (0.16) Diluted loss per share attributable to common stock (0.38) (0.32) (0.18) (0.16) 2015 First Second Third Fourth Operating loss $ (2,974,239) $ (4,277,743) $ (6,433,988) $ (4,696,098) Net loss (2,955,806) (4,246,446) (6,372,428) (4,633,698) Basic loss per share attributable to common stock (0.23) (0.26) (0.35) (0.25) Diluted loss per share attributable to common stock (0.23) (0.26) (0.35) (0.25) |
Summary of Significant Accoun21
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2016 | |
Accounting Policies [Abstract] | |
Use of Estimates, Policy [Policy Text Block] | (a) Use of Estimates The preparation of financial statements in conformity with U.S. generally accepted accounting principles requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent 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. Significant items subject to such estimates and assumptions include those related to revenue recognition; stock-based compensation; valuation of deferred taxes; income tax uncertainties; and the useful lives of property and equipment. |
Cash and Cash Equivalents, Policy [Policy Text Block] | (b) Cash and Cash Equivalents The Company considers all highly liquid investments with original maturities to the Company of three months or less to be cash equivalents. Although the Company may deposit its cash and cash equivalents with multiple financial institutions, its deposits, at times, may exceed federally insured limits. Cash equivalents were $2,921,000 and $128,000 at December 31, 2016 and 2015. |
Receivables, Policy [Policy Text Block] | (c) Receivables Accounts receivable are recorded at the invoiced amount and do not bear interest. The Company maintains an allowance for doubtful accounts for estimated losses. In establishing the allowance, management considers historical losses adjusted to take into account current market conditions and their customers’ financial condition, the amount of receivables in dispute, and the current receivables aging and current payment patterns. The Company had no write-offs in 2016, 2015 and 2014 and the Company did not record an allowance for doubtful accounts as of December 31, 2016 and 2015 as there were no accounts receivable outstanding. The Company does not have any off-balance-sheet credit exposure related to its customers. |
Revenue Recognition, Policy [Policy Text Block] | (d) Revenue Recognition Revenue is recognized when there is persuasive evidence that an arrangement exists, delivery has occurred, the price is fixed or determinable, and collectability is reasonably assured. The Company recognizes up-front license fees as earned. Milestone payments are recognized upon successful completion of a performance milestone event. Contract revenues related to collaborative research and development agreements are recognized on a ratable basis as services are performed. Any amounts received in advance of performance are recorded as deferred revenue until earned. The Company enters into arrangements with collaboration partners that sometimes involve multiple deliverables. These arrangements may contain one or more of the following elements: license and other up-front fees, contract research and development services, milestone payments and royalties. Each deliverable in the arrangement is evaluated to determine whether it meets the criteria to be accounted for as a separate unit of accounting or whether it should be combined with other deliverables. When deliverables are separable, consideration is allocated to the separate units of accounting based upon the relative selling price method, and appropriate revenue recognition principles are applied to each unit. When the Company determines that the arrangement should be accounted for as a single unit of accounting, revenue is recognized over the period for which performance obligations will be performed. Up-front, nonrefundable fees and milestone payments received by the Company under license and collaboration arrangements that include future obligations, in whatever form, are recognized ratably over the expected performance period under each respective arrangement. Under these arrangements, the Company makes its best estimate of the period over which it expects to fulfill its performance obligations, which may include technology transfer assistance, research activities, clinical development activities, and manufacturing activities from development through the commercialization of the product. Given the uncertainties of these extended collaboration arrangements, significant judgment is required to determine the duration of the performance period. For license and collaboration arrangements where no future performance obligations exist, up-front, nonrefundable fees and milestone payments are recognized when received. Any amounts received in advance of performance are recorded as deferred revenue until recognized. The Company may provide research and development services under collaboration arrangements to advance the development of jointly owned products. The Company records the expenses incurred and reimbursed on a net basis. |
Property, Plant and Equipment, Policy [Policy Text Block] | (e) Property and Equipment Property and equipment are recorded at cost, less accumulated depreciation. Maintenance and repairs that do not extend the life or improve the asset are expensed in the year incurred. Depreciation is computed using the straight-line method over the estimated useful lives of the assets, which are five years for laboratory and office equipment, three years for computer equipment and software, and seven years for furniture and fixtures. |
Impairment or Disposal of Long-Lived Assets, Policy [Policy Text Block] | (f) Accounting for Impairment of Long-Lived Assets Long-lived assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets held and used is measured by a comparison of the carrying amount of an asset to future net cash flows (undiscounted) expected to be generated by the asset. If such assets are considered to be impaired, the impairment to be recognized is measured as the amount by which the carrying amount of the assets exceeds the fair value of the assets. Assets held for sale are reported at the lower of the carrying amount, or fair value, less costs to sell. |
Income Tax, Policy [Policy Text Block] | (g) Income Taxes Income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. A valuation allowance is provided against net deferred tax assets if, based upon the available evidence, it is more likely than not that some or all of the net deferred tax assets will not be realized. The Company recognizes the effect of income tax positions only if those positions are more likely than not of being sustained. Recognized income tax positions are measured at the largest amount that is greater than 50 percent likely of being realized. Changes in recognition or measurement are reflected in the period in which the change in judgment occurs. The Company records interest and penalties related to unrecognized tax benefits as a component of its income tax expense. |
Compensation Related Costs, Policy [Policy Text Block] | (h) Share-Based Payments The Company recognizes stock-based compensation expense for grants of stock option awards, restricted stock units and restricted stock under the Company’s Incentive Plan to employees and nonemployee members of the Company’s board of directors based on the grant-date fair value of those awards. The grant-date fair value of an award is generally recognized as compensation expense over the award’s requisite service period. In addition, the Company has granted performance-based stock option awards and restricted stock grants, which vest based upon the Company satisfying certain performance conditions. Potential compensation cost, measured on the grant date, related to these performance options will be recognized only if, and when, the Company estimates that these options will vest, which is based on whether the Company considers the options’ performance conditions to be probable of attainment. The Company’s estimates of the number of performance-based options that will vest will be revised, if necessary, in subsequent periods. In addition, the Company grants stock options to nonemployee consultants from time to time in exchange for services performed for the Company. Equity instruments granted to nonemployees are subject to periodic revaluation over their vesting terms. During August 2016 and in conjunction with the 2016 Restructuring Plan (see note 5), the Company modified 61,487 existing time-vested options of a terminated employee by extending the exercise period to three years from the date of modification under the terms of the employee’s respective employment and severance agreement. Compensation expense of $51,000 was recorded as a result of the modification and recorded as a restructuring charge. During November 2014, the Company modified 149,498 existing time-vested options of two terminated executives by extending the exercise period to three years from the date of modification under the terms of the executive's respective employment and severance agreements. Compensation expense of $166,000 was recorded as a result of the modification. On January 6, 2014, we modified 366,126 existing time-vested and performance options as well as restricted stock awards of two retiring board of directors by fully vesting all unvested equity awards and extending the exercise period to three years from the date of modification. Compensation expense of $836,000 was recorded as a result of the modification. The Company uses the Black-Scholes model to compute the estimated fair value of stock option awards. Using this model, fair value is calculated based on assumptions with respect to (i) expected volatility of the Company’s Common Stock price, (ii) the periods of time over which employees and members of the board of directors are expected to hold their options prior to exercise (expected term), (iii) expected dividend yield on the Common Stock, and (iv) risk-free interest rates. Stock-based compensation expense also includes an estimate, which is made at the time of grant, of the number of awards that are expected to be forfeited. This estimate is revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. Stock-based compensation cost that has been expensed in the statements of operations amounted to $2.4 million, $1.2 million and $1.9 million for the years ended December 31, 2016, 2015 and 2014, allocated as follows: Year Ended 2016 2015 2014 Research and development $ 629,400 $ 287,491 $ 579,711 General and administrative 1,691,949 862,927 1,313,124 Restructuring costs 51,266 - - $ 2,372,615 $ 1,150,418 $ 1,892,835 The Company issued 990,000 stock options, 301,500 stock options and 337,689 stock options, respectively, during the years ended December 31, 2016, 2015 and 2014. Key assumptions used in the determination of the fair value of stock options granted are as follows: Expected Term : The expected term represents the period that the stock-based awards are expected to be outstanding. Due to limited historical experience of similar awards, the expected term was estimated using the simplified method in accordance with the provisions of Staff Accounting Bulletin (“SAB”) No. 107, Share-Based Payment, Risk-Free Interest Rate : The risk-free interest rate used was based on the implied yield currently available on U.S. Treasury issues with an equivalent remaining term. Expected Dividend : The expected dividend assumption is based on management’s current expectation about the Company’s anticipated dividend policy. The Company does not anticipate declaring dividends in the foreseeable future. Expected Volatility : Since the Company did not have sufficient trading history, the volatility factor was based on the average of similar public companies through August 2014. When selecting similar companies, the Company considered the industry, stage of life cycle, size, and financial leverage. Beginning in August 2014, the volatility factor is based on a combination of the Company's trading history since March 2014 and the average of similar public companies. For options granted in 2016, 2015 and 2014, the Company calculated the fair value of each option grant on the respective dates of grant using the following weighted average assumptions: 2016 2015 2014 Expected term 5.84 years 5.75 years 5.87 years Risk-free interest rate 1.76 % 1.63 % 1.75 % Expected dividend yield Expected volatility 84.26 % 81.39 % 76.30 % Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) 718, Stock Compensation, As of December 31, 2016, there was $3.9 million of total unrecognized compensation cost related to unvested share-based compensation arrangements granted under the Company’s stock option plan. That cost is expected to be recognized over a weighted average period of 2.1 years and will be adjusted for subsequent changes in estimated forfeitures. The weighted average fair value of share-based compensation awards granted during the years ended December 31, 2016, 2015 and 2014 was approximately $6.06 per share, $6.60 per share and $5.45 per share, respectively. |
Fair Value Measurement, Policy [Policy Text Block] | (i) Fair Value The Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible. The Company determines fair value based on assumptions that market participants would use in pricing an asset or liability in the principal or most advantageous market. When considering market participant assumptions in fair value measurements, the following fair value hierarchy distinguishes between observable and unobservable inputs, which are categorized in one of the following levels: • Level 1 Inputs: Quoted prices for identical instruments in active markets. • Level 2 Inputs: Quoted prices for similar instruments in active markets, quoted prices for identical or similar instruments in markets that are not active, and model-derived valuation in which all significant inputs and significant value drivers are observable in active markets. • Level 3 Inputs: Valuations derived from valuation techniques in which one or more significant inputs or significant value drivers are unobservable. All of the Company’s financial instruments are valued using quoted prices in active markets or based on other observable inputs. For prepaid and other current assets, accounts payable, and accrued expenses, the carrying amounts approximate fair value because of the short maturity of these instruments. The following table presents the placement in the fair value hierarchy of assets and liabilities that are measured at fair value on a recurring basis at December 31, 2016 and 2015: December 31, Fair value measurements at reporting date using 2016 Level 1 inputs Level 2 inputs Level 3 inputs Assets: Cash equivalents - money market funds $ 2,920,577 $ 2,920,577 $ - $ - Government bonds and notes 7,471,054 3,752,350 3,718,704 - Corporate bonds, notes and commercial paper 13,808,516 - 13,808,516 - $ 24,200,147 $ 6,672,927 $ 17,527,220 $ - December 31, Fair value measurements at reporting date using 2015 Level 1 inputs Level 2 inputs Level 3 inputs Assets: Cash equivalents - money market funds $ 127,905 $ 127,905 $ - $ - Government bonds and notes 802,112 802,112 - - Corporate bonds, notes and commercial paper 23,973,308 - 23,973,308 - $ 24,903,325 $ 930,017 $ 23,973,308 $ - The following methods and assumptions were used to determine the fair value of each class of assets and liabilities recorded at fair value in the balance sheets: Cash equivalents: Cash equivalents primarily consist of highly rated money market funds and commercial paper with original maturities to the Company of three months or less, and are purchased daily at par value with specified yield rates. Cash equivalents related to money market funds are classified within Level 1 of the fair value hierarchy because they are valued using quoted market prices or broker or dealer quotations for similar assets. Cash equivalents related to commercial paper are classified within Level 2 of the fair value hierarchy because they are valued using broker/dealer quotes, bids and offers, benchmark yields and credit spreads and other observable inputs. Government bonds and notes: The Company uses a third-party pricing service to value these investments. The pricing service utilizes quoted market prices in active markets for identical assets and reportable trades. Corporate bonds, notes, and commercial paper: The Company uses a third-party pricing service to value these investments. The pricing service utilizes broker/dealer quotes, bids and offers, benchmark yields and credit spreads and other observable inputs. The Company’s accounting policy is to recognize transfers between levels of the fair value hierarchy on the date of the event or change in circumstances that caused the transfer. There were no transfers into or out of Level 1 or Level 2 for the years ended December 31, 2016 and 2015. |
Earnings Per Share, Policy [Policy Text Block] | Earnings (Loss) per Share Basic earnings (loss) per share is calculated by dividing net income (loss) available to common shareholders by the weighted average number of common shares outstanding during the period. Net income (loss) available to common shareholders for the year ended December 31, 2016, 2015 and 2014 was calculated using the two-class method, which is an earnings (loss) allocation method for computing earnings (loss) per share when an entity’s capital structure includes common stock and participating securities. The two-class method determines earnings (losses) per share based on dividends declared on common stock and participating securities (i.e., distributed earnings) and participation rights of participating securities in any undistributed earnings (loss). The application of the two-class method was required since the Company’s unvested restricted stock contains non-forfeitable rights to dividends or dividend equivalents. However, unvested restricted stock grants are not included in computing basic earnings (loss) per share for periods where the Company has losses as these securities are not contractually obligated to share in losses of the Company. Diluted earnings (loss) per share is based on the weighted average number of common shares outstanding plus, where applicable, the additional potential common shares that would have been outstanding related to dilutive options, warrants, and unvested restricted stock to the extent such shares are dilutive. The following table sets forth the computation of basic and diluted earnings (loss) per share of common stock for the years ended December 31, 2016, 2015 and 2014. Year Ended December 31, 2016 2015 2014 Basic loss per share attributable to common stock: Numerator Net loss $ (18,971,508 ) $ (18,208,378 ) $ (20,372,676 ) Denominator Weighted avg. common shares outstanding 18,258,149 16,470,814 12,766,295 Basic loss per share attributable to common stock $ (1.04 ) $ (1.11 ) $ (1.60 ) Diluted loss per share attributable to common stock: Numerator Net loss $ (18,971,508 ) $ (18,208,378 ) $ (20,372,676 ) Denominator Weighted avg. common shares outstanding 18,258,149 16,470,814 12,766,295 Diluted loss per share attributable to common stock $ (1.04 ) $ (1.11 ) $ (1.60 ) December 31, 2016 2015 2014 Stock options 2,225,850 1,722,552 1,528,737 Unvested restricted stock - 3,000 7,000 Warrants - - 20,467 The computation of diluted earnings per share for the years ended December 31, 2016, 2015 and 2014 does not include stock options, unvested restricted stock awards and warrants to purchase shares in the computation of diluted earnings per share because these instruments were antidilutive: |
Segment Reporting, Policy [Policy Text Block] | (k) Segment Information The Company is a single reportable segment engaged in research and development for the delivery of drugs using its proprietary delivery technology. Operating segments are identified as components of an enterprise for which separate discrete financial information is available for evaluation by the chief operating decision maker in making decisions regarding resource allocation and assessing performance. The chief operating decision maker made such decisions and assessed performance at the company level, as one segment. |
Consolidation, Policy [Policy Text Block] | (l) Principles of Consolidation The consolidated financial statements include the accounts of the Company and all subsidiaries. The Company eliminates all intercompany accounts and transactions in consolidation. |
Summary of Significant Accoun22
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Accounting Policies [Abstract] | |
Schedule of Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Table Text Block] | Stock-based compensation cost that has been expensed in the statements of operations amounted to $2.4 million, $1.2 million and $1.9 million for the years ended December 31, 2016, 2015 and 2014, allocated as follows: Year Ended 2016 2015 2014 Research and development $ 629,400 $ 287,491 $ 579,711 General and administrative 1,691,949 862,927 1,313,124 Restructuring costs 51,266 - - $ 2,372,615 $ 1,150,418 $ 1,892,835 |
Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions [Table Text Block] | For options granted in 2016, 2015 and 2014, the Company calculated the fair value of each option grant on the respective dates of grant using the following weighted average assumptions: 2016 2015 2014 Expected term 5.84 years 5.75 years 5.87 years Risk-free interest rate 1.76 % 1.63 % 1.75 % Expected dividend yield Expected volatility 84.26 % 81.39 % 76.30 % |
Fair Value Measurements, Nonrecurring [Table Text Block] | The following table presents the placement in the fair value hierarchy of assets and liabilities that are measured at fair value on a recurring basis at December 31, 2016 and 2015: December 31, Fair value measurements at reporting date using 2016 Level 1 inputs Level 2 inputs Level 3 inputs Assets: Cash equivalents - money market funds $ 2,920,577 $ 2,920,577 $ - $ - Government bonds and notes 7,471,054 3,752,350 3,718,704 - Corporate bonds, notes and commercial paper 13,808,516 - 13,808,516 - $ 24,200,147 $ 6,672,927 $ 17,527,220 $ - December 31, Fair value measurements at reporting date using 2015 Level 1 inputs Level 2 inputs Level 3 inputs Assets: Cash equivalents - money market funds $ 127,905 $ 127,905 $ - $ - Government bonds and notes 802,112 802,112 - - Corporate bonds, notes and commercial paper 23,973,308 - 23,973,308 - $ 24,903,325 $ 930,017 $ 23,973,308 $ - |
Schedule of Earnings Per Share, Basic and Diluted [Table Text Block] | The following table sets forth the computation of basic and diluted earnings (loss) per share of common stock for the years ended December 31, 2016, 2015 and 2014. Year Ended December 31, 2016 2015 2014 Basic loss per share attributable to common stock: Numerator Net loss $ (18,971,508) $ (18,208,378) $ (20,372,676) Denominator Weighted avg. common shares outstanding 18,258,149 16,470,814 12,766,295 Basic loss per share attributable to common stock $ (1.04) $ (1.11) $ (1.60) Diluted loss per share attributable to common stock: Numerator Net loss $ (18,971,508) $ (18,208,378) $ (20,372,676) Denominator Weighted avg. common shares outstanding 18,258,149 16,470,814 12,766,295 Diluted loss per share attributable to common stock $ (1.04) $ (1.11) $ (1.60) |
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share [Table Text Block] | The computation of diluted earnings per share for the years ended December 31, 2016, 2015 and 2014 does not include stock options, unvested restricted stock awards and warrants to purchase shares in the computation of diluted earnings per share because these instruments were antidilutive: December 31, 2016 2015 2014 Stock options 2,225,850 1,722,552 1,528,737 Unvested restricted stock - 3,000 7,000 Warrants - - 20,467 |
Marketable Investment Securit23
Marketable Investment Securities (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Investments, Debt and Equity Securities [Abstract] | |
Available-for-sale Securities [Table Text Block] | Gross Gross unrealized unrealized Amortized holding holding Aggregate December 31, 2016 Cost gains losses fair value Government bonds and notes $ 7,473,273 $ - $ (2,219) $ 7,471,054 Corporate bonds, notes and commercial paper 13,814,790 - (6,274) 13,808,516 $ 21,288,063 $ - $ (8,493) $ 21,279,570 Gross Gross unrealized unrealized Amortized holding holding Aggregate December 31, 2015 Cost gains losses fair value Government bonds and notes $ 802,862 $ - $ (750) $ 802,112 Corporate bonds, notes and commercial paper 24,005,458 594 (32,744) 23,973,308 $ 24,808,320 $ 594 $ (33,494) $ 24,775,420 |
Schedule Of Available For Sale Securities Debt Maturities [Table Text Block] | Maturities of debt securities classified as available-for-sale securities at December 31, 2016 are as follows: Amortized Aggregate Cost fair value Due within one year $ 21,288,063 $ 21,279,570 $ 21,288,063 $ 21,279,570 |
Restructuring Charges (Tables)
Restructuring Charges (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Restructuring and Related Activities [Abstract] | |
Schedule of Restructuring Reserve by Type of Cost [Table Text Block] | The activity for the year ended December 31, 2016 for restructuring charges is as follows: December 31, 2016 Accrued restructuring charges payable at January 1, 2016 $ - Restructuring expenses during 2016 728,635 Restructuring payments during 2016 (437,796) Non-cash stock option modification (51,266) Accrued restructuring charges payable at December 31, 2016 $ 239,573 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Property, Plant and Equipment [Abstract] | |
Property, Plant and Equipment [Table Text Block] | Property and equipment consisted of the following: December 31, December 31, 2016 2015 Computer equipment and software $ 43,361 $ 43,361 Lab and office equipment 1,048,932 1,041,735 Furniture and fixtures 103,857 51,404 1,196,150 1,136,500 Less accumulated depreciation (1,092,710) (1,060,750) $ 103,440 $ 75,750 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Income Tax Disclosure [Abstract] | |
Schedule of Components of Income Tax Expense (Benefit) [Table Text Block] | Income tax expense consists of: December 31, 2016 2015 2014 U.S. federal $ - $ - $ - State and local 752 200 200 Deferred - - - Total $ 752 $ 200 $ 200 |
Schedule of Effective Income Tax Rate Reconciliation [Table Text Block] | Income tax expense was $ 752 200 200 34 December 31, 2016 2015 2014 Computed "expected" tax expense (benefit) $ (6,450,075) $ (6,190,781) $ (6,926,642) Increase (reduction) in income taxes resulting from: Change in valuation allowance 6,709,591 6,691,992 7,748,579 Adjustment of tax attributes due to change in ownership - - (127,572) State and local income taxes, net of federal income tax benefit 496 132 132 Stock expense 200,002 102,221 45,097 Research and development tax credits (337,968) (452,609) (743,186) Orphan drug tax credit (127,641) (155,452) - Other, net 6,347 4,697 3,792 $ 752 $ 200 $ 200 |
Schedule of Deferred Tax Assets and Liabilities [Table Text Block] | The tax effects of temporary differences that give rise to significant portions of the deferred tax assets and deferred tax liabilities at December 31, 2016 and 2015 are presented below. December 31, 2016 2015 Deferred tax assets: Stock-based compensation $ 1,924,260 $ 1,713,608 Net operating loss carryforwards 30,700,358 23,677,332 Employee benefits 69,112 59,472 Research and development tax credits 2,465,893 2,052,662 Orphan drug tax credits 679,185 485,789 Other deductible tempory differences 70,231 215,638 Total gross deferred tax assets 35,909,039 28,204,501 Less valuation allowance (35,904,927) (28,200,857) Net deferred tax assets 4,112 3,644 Deferred tax liabilities: Plant and equipment (4,112) (3,644) Total gross deferred tax liabilities (4,112) (3,644) Net deferred tax liabilities $ - $ - |
Schedule of Unrecognized Tax Benefits Roll Forward [Table Text Block] | A reconciliation of the beginning and ending amount of total unrecognized tax contingencies, excluding interest and penalties, for the years ended December 31, 2016 and 2015 are as follows: December 31, 2016 2015 Balance, beginning of year $ - $ - Balance, end of year $ - $ - |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Leases [Abstract] | |
Schedule of Future Minimum Rental Payments for Operating Leases [Table Text Block] | Future minimum lease payments under the non-cancelable operating leases as of December 31, 2016 are: Operating leases Year ending December 31: 2017 387,119 2018 58,903 Total minimum lease payments $ 446,022 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Stockholders Equity Note [Abstract] | |
Schedule of Stock Options Roll Forward [Table Text Block] | A summary of stock option activity is as follows: Outstanding stock options Number of Weighted average shares exercise price Balance at December 31, 2015 1,722,552 $ 5.21 Options granted 990,000 8.65 Options exercised (208,869) 2.90 Options forfeited (269,471) 12.03 Options cancelled (8,362) 7.61 Balance at December 31, 2016 2,225,850 6.12 Options exercisable at December 31, 2016 1,282,660 4.71 |
Schedule of Stock Options Outstanding and Exercisable [Table Text Block] | The following table summarizes information about stock options outstanding and exercisable at December 31, 2016: Options outstanding Options exercisable Number Weighted Weighted Aggregate intrinsic Number Weighted Weighted Aggregate 2,225,850 7.07 $ 6.12 $ 733,713 1,282,660 5.43 $ 4.71 $ 706,552 |
Schedule of Nonvested Restricted Stock Units Activity [Table Text Block] | A summary of restricted common stock activity is as follows: Number of unvested restricted shares Balance at December 31, 2015 3,000 Granted - Vested (3,000) Cancelled - Balance at December 31, 2016 - |
Selected Quarterly Financial 29
Selected Quarterly Financial Information (Unaudited) (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Quarterly Financial Information Disclosure [Abstract] | |
Quarterly Financial Information [Table Text Block] | 2016 First Second Third Fourth Operating loss $ (7,070,404) $ (5,815,120) $ (3,286,220) $ (3,015,090) Net loss (7,009,445) (5,760,111) (3,235,485) (2,966,467) Basic loss per share attributable to common stock (0.38) (0.32) (0.18) (0.16) Diluted loss per share attributable to common stock (0.38) (0.32) (0.18) (0.16) 2015 First Second Third Fourth Operating loss $ (2,974,239) $ (4,277,743) $ (6,433,988) $ (4,696,098) Net loss (2,955,806) (4,246,446) (6,372,428) (4,633,698) Basic loss per share attributable to common stock (0.23) (0.26) (0.35) (0.25) Diluted loss per share attributable to common stock (0.23) (0.26) (0.35) (0.25) |
Summary of Significant Accoun30
Summary of Significant Accounting Policies (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Allocated Share-based Compensation Expense | $ 2,372,615 | $ 1,150,418 | $ 1,892,835 |
Research and Development Expense [Member] | |||
Allocated Share-based Compensation Expense | 629,400 | 287,491 | 579,711 |
General and Administrative Expense [Member] | |||
Allocated Share-based Compensation Expense | 1,691,949 | 862,927 | 1,313,124 |
Restructuring Costs [Member] | |||
Allocated Share-based Compensation Expense | $ 51,266 | $ 0 | $ 0 |
Summary of Significant Accoun31
Summary of Significant Accounting Policies (Details 1) | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Expected term | 5 years 10 months 2 days | 5 years 9 months | 5 years 10 months 13 days |
Risk-free interest rate | 1.76% | 1.63% | 1.75% |
Expected dividend yield | 0.00% | 0.00% | 0.00% |
Expected volatility | 84.26% | 81.39% | 76.30% |
Summary of Significant Accoun32
Summary of Significant Accounting Policies (Details 2) - USD ($) | Dec. 31, 2016 | Dec. 31, 2015 |
Assets: | ||
Marketable Investment Securities | $ 21,279,570 | $ 24,775,420 |
Assets, Fair Value | 24,200,147 | 24,903,325 |
Money Market Funds [Member] | ||
Assets: | ||
Cash equivalents-money market funds | 2,920,577 | 127,905 |
Government Bonds and Notes [Member] | ||
Assets: | ||
Marketable Investment Securities | 7,471,054 | 802,112 |
Corporate Bonds, Notes and Commercial Paper [Member] | ||
Assets: | ||
Marketable Investment Securities | 13,808,516 | 23,973,308 |
Fair Value, Inputs, Level 1 [Member] | ||
Assets: | ||
Assets, Fair Value | 6,672,927 | 930,017 |
Fair Value, Inputs, Level 1 [Member] | Money Market Funds [Member] | ||
Assets: | ||
Cash equivalents-money market funds | 2,920,577 | 127,905 |
Fair Value, Inputs, Level 1 [Member] | Government Bonds and Notes [Member] | ||
Assets: | ||
Marketable Investment Securities | 3,752,350 | 802,112 |
Fair Value, Inputs, Level 1 [Member] | Corporate Bonds, Notes and Commercial Paper [Member] | ||
Assets: | ||
Marketable Investment Securities | 0 | 0 |
Fair Value, Inputs, Level 2 [Member] | ||
Assets: | ||
Assets, Fair Value | 17,527,220 | 23,973,308 |
Fair Value, Inputs, Level 2 [Member] | Money Market Funds [Member] | ||
Assets: | ||
Cash equivalents-money market funds | 0 | 0 |
Fair Value, Inputs, Level 2 [Member] | Government Bonds and Notes [Member] | ||
Assets: | ||
Marketable Investment Securities | 3,718,704 | 0 |
Fair Value, Inputs, Level 2 [Member] | Corporate Bonds, Notes and Commercial Paper [Member] | ||
Assets: | ||
Marketable Investment Securities | 13,808,516 | 23,973,308 |
Fair Value, Inputs, Level 3 [Member] | ||
Assets: | ||
Assets, Fair Value | 0 | 0 |
Fair Value, Inputs, Level 3 [Member] | Money Market Funds [Member] | ||
Assets: | ||
Cash equivalents-money market funds | 0 | 0 |
Fair Value, Inputs, Level 3 [Member] | Government Bonds and Notes [Member] | ||
Assets: | ||
Marketable Investment Securities | 0 | 0 |
Fair Value, Inputs, Level 3 [Member] | Corporate Bonds, Notes and Commercial Paper [Member] | ||
Assets: | ||
Marketable Investment Securities | $ 0 | $ 0 |
Summary of Significant Accoun33
Summary of Significant Accounting Policies (Details 3) - USD ($) | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2016 | Sep. 30, 2016 | Jun. 30, 2016 | Mar. 31, 2016 | Dec. 31, 2015 | Sep. 30, 2015 | Jun. 30, 2015 | Mar. 31, 2015 | Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Basic loss per share attributable to common stock: Numerator | |||||||||||
Net loss | $ (18,971,508) | $ (18,208,378) | $ (20,372,676) | ||||||||
Denominator | |||||||||||
Weighted avg. common shares outstanding | 18,258,149 | 16,470,814 | 12,766,295 | ||||||||
Basic loss per share attributable to common stock (in dollars per share) | $ (0.16) | $ (0.18) | $ (0.32) | $ (0.38) | $ (0.25) | $ (0.35) | $ (0.26) | $ (0.23) | $ (1.04) | $ (1.11) | $ (1.60) |
Diluted loss per share attributable to common stock: Numerator | |||||||||||
Net loss | $ (18,971,508) | $ (18,208,378) | $ (20,372,676) | ||||||||
Denominator | |||||||||||
Weighted avg. common shares outstanding | 18,258,149 | 16,470,814 | 12,766,295 | ||||||||
Diluted loss per share attributable to common stock (in dollars per share) | $ (0.16) | $ (0.18) | $ (0.32) | $ (0.38) | $ (0.25) | $ (0.35) | $ (0.26) | $ (0.23) | $ (1.04) | $ (1.11) | $ (1.60) |
Summary of Significant Accoun34
Summary of Significant Accounting Policies (Details 4) - shares | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Warrants [Member] | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 0 | 0 | 20,467 |
Unvested Restricted Stock [Member] | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 0 | 3,000 | 7,000 |
Stock Options [Member] | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 2,225,850 | 1,722,552 | 1,528,737 |
Summary of Significant Accoun35
Summary of Significant Accounting Policies (Details Textual) - USD ($) | Jan. 06, 2014 | Aug. 31, 2016 | Nov. 30, 2014 | Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 |
Allocated Share-based Compensation Expense | $ 2,372,615 | $ 1,150,418 | $ 1,892,835 | |||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized | $ 3,900,000 | |||||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized, Period for Recognition | 2 years 1 month 6 days | |||||
Cash Equivalents, at Carrying Value | $ 2,921,000 | $ 128,000 | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Weighted Average Grant Date Fair Value | $ 6.06 | $ 6.60 | $ 5.45 | |||
2016 Restructuring Plan [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Nonvested, Number of Shares | 61,487 | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Plan Modification, Incremental Compensation Cost | $ 51,000 | |||||
Employee Stock Option [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross | 990,000 | 301,500 | 337,689 | |||
Performance Shares [Member] | ||||||
Allocated Share-based Compensation Expense | $ 836,000 | $ 166,000 | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Nonvested, Number of Shares | 366,126 | 149,498 |
Marketable Investment Securit36
Marketable Investment Securities (Details) - USD ($) | Dec. 31, 2016 | Dec. 31, 2015 |
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | $ 21,288,063 | $ 24,808,320 |
Gross unrealized holding gains | 0 | 594 |
Gross unrealized holding losses | (8,493) | (33,494) |
Aggregate fair value | 21,279,570 | 24,775,420 |
Government bonds and notes [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 7,473,273 | 802,862 |
Gross unrealized holding gains | 0 | 0 |
Gross unrealized holding losses | (2,219) | (750) |
Aggregate fair value | 7,471,054 | 802,112 |
Corporate bonds, notes and commercial paper [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 13,814,790 | 24,005,458 |
Gross unrealized holding gains | 0 | 594 |
Gross unrealized holding losses | (6,274) | (32,744) |
Aggregate fair value | $ 13,808,516 | $ 23,973,308 |
Marketable Investment Securit37
Marketable Investment Securities (Details 1) | Dec. 31, 2016USD ($) |
Amortized Cost | |
Due within one year | $ 21,288,063 |
Amortized Cost, Total | 21,288,063 |
Aggregate fair value | |
Due within one year | 21,279,570 |
Aggregate fair value, Total | $ 21,279,570 |
Marketable Investment Securit38
Marketable Investment Securities (Details Textual) - USD ($) | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Proceeds from Sale and Maturity of Marketable Securities, Total | $ 28,600,000 | $ 800,000 | $ 0 |
Contractual Agreements (Details
Contractual Agreements (Details Textual) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Contract Research And Development [Member] | |||
Schedule of Contractual Agreements [Line Items] | |||
Other Research and Development Expense | $ 5.5 | $ 10 | $ 12.9 |
Abbott Products, Inc. [Member] | Collaborative Arrangement [Member] | |||
Schedule of Contractual Agreements [Line Items] | |||
Collaborative Arrangement, Termination Date | Mar. 29, 2012 | ||
Collaborative Arrangement, Rights and Obligations | All obligations under the prior license agreement have been completed except that Lipocine will owe Abbott a perpetual 1% royalty on net sales. | ||
Collaborative Arrangement, Royalties, Maximum Amount | $ 1 | ||
Collaborative Arrangement, Royalties, Percentage of Reduction | 50.00% |
Restructuring Charges (Details)
Restructuring Charges (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Restructuring Cost and Reserve [Line Items] | |||
Accrued restructuring charges payable at January 1, 2016 | $ 0 | ||
Restructuring expenses during 2016 | 728,635 | $ 0 | $ 0 |
Restructuring payments during 2016 | (437,796) | ||
Non-cash stock option modification | (51,266) | ||
Accrued restructuring charges payable at December 31, 2016 | $ 239,573 | $ 0 |
Restructuring Charges (Details
Restructuring Charges (Details Textual) - USD ($) | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Restructuring Cost and Reserve [Line Items] | |||
Restructuring Charges | $ 728,635 | $ 0 | $ 0 |
2016 Restructuring Plan [Member] | |||
Restructuring Cost and Reserve [Line Items] | |||
Restructuring Charges | 729,000 | ||
Severance Costs | 678,000 | ||
Non Cash Cost Extend Exercise Period Vested Options | $ 51,000 | ||
Restructuring and Related Cost, Number of Positions Eliminated, Period Percent | 33.00% |
Property and Equipment (Details
Property and Equipment (Details) - USD ($) | Dec. 31, 2016 | Dec. 31, 2015 |
Property, Plant and Equipment [Line Items] | ||
Computer equipment and software | $ 43,361 | $ 43,361 |
Lab and office equipment | 1,048,932 | 1,041,735 |
Furniture and fixtures | 103,857 | 51,404 |
Property, Plant and Equipment, Gross | 1,196,150 | 1,136,500 |
Less accumulated depreciation | (1,092,710) | (1,060,750) |
Property, Plant and Equipment, Net | $ 103,440 | $ 75,750 |
Property and Equipment (Detai43
Property and Equipment (Details Textual) - USD ($) | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Property, Plant and Equipment [Line Items] | |||
Depreciation, Depletion and Amortization, Nonproduction, Total | $ 31,960 | $ 26,721 | $ 14,620 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Income Taxes [Line Items] | |||
Income Tax Expense (Benefit), U.S. federal | $ 0 | $ 0 | $ 0 |
Income Tax Expense (Benefit), State and local | 752 | 200 | 200 |
Deferred Income Tax Expense (Benefit), Total | 0 | 0 | 0 |
Income Tax Expense (Benefit) | $ 752 | $ 200 | $ 200 |
Income Taxes (Details 1)
Income Taxes (Details 1) - USD ($) | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Income Taxes [Line Items] | |||
Computed "expected" tax expense (benefit) | $ (6,450,075) | $ (6,190,781) | $ (6,926,642) |
Increase (reduction) in income taxes resulting from: | |||
Change in valuation allowance | 6,709,591 | 6,691,992 | 7,748,579 |
Adjustment of tax attributes due to change in ownership | 0 | 0 | (127,572) |
State and local income taxes, net of federal income tax benefit | 496 | 132 | 132 |
Stock expense | 200,002 | 102,221 | 45,097 |
Research and development tax credits | (337,968) | (452,609) | (743,186) |
Orphan drug tax credit | (127,641) | (155,452) | 0 |
Other, net | 6,347 | 4,697 | 3,792 |
Income Tax Expense (Benefit) | $ 752 | $ 200 | $ 200 |
Income Taxes (Details 2)
Income Taxes (Details 2) - USD ($) | Dec. 31, 2016 | Dec. 31, 2015 |
Deferred tax assets: | ||
Stock-based compensation | $ 1,924,260 | $ 1,713,608 |
Net operating loss carryforwards | 30,700,358 | 23,677,332 |
Employee benefits | 69,112 | 59,472 |
Research and development tax credits | 2,465,893 | 2,052,662 |
Orphan drug tax credits | 679,185 | 485,789 |
Other deductible tempory differences | 70,231 | 215,638 |
Total gross deferred tax assets | 35,909,039 | 28,204,501 |
Less valuation allowance | (35,904,927) | (28,200,857) |
Net deferred tax assets | 4,112 | 3,644 |
Deferred tax liabilities: | ||
Plant and equipment | (4,112) | (3,644) |
Total gross deferred tax liabilities | (4,112) | (3,644) |
Net deferred tax liabilities | $ 0 | $ 0 |
Income Taxes (Details 3)
Income Taxes (Details 3) - USD ($) | Dec. 31, 2016 | Dec. 31, 2015 |
Income Taxes [Line Items] | ||
Balance, beginning of year | $ 0 | $ 0 |
Balance, end of year | $ 0 | $ 0 |
Income Taxes (Details Textual)
Income Taxes (Details Textual) - USD ($) | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Income Taxes [Line Items] | |||
Income Tax Expense (Benefit) | $ 752 | $ 200 | $ 200 |
Operating Loss Carryforwards | 78,000,000 | ||
Tax Credit Carryforward, Amount | 1,600,000 | ||
Deferred Tax Assets, Valuation Allowance | 35,904,927 | 28,200,857 | |
Valuation Allowance, Deferred Tax Asset, Increase (Decrease), Amount | 7,700,000 | $ 7,300,000 | |
Operating Loss Carry forwards Limitations On Use Amount | 1,100,000 | ||
Operating Loss Carry forwards Preownership Change Amount | 20,200,000 | ||
Operating Loss Forgive Pre ownership Change Amount | 5,500,000 | ||
Tax Credit Carryforward Preownership Change Amount | 1,200,000 | ||
Orphan Drug Credit [Member] | |||
Income Taxes [Line Items] | |||
Tax Credit Carryforward, Amount | $ 679,000 | ||
U.S. Federal [Member] | |||
Income Taxes [Line Items] | |||
Operating Loss Carry forwards Expiration Date1 | Approximately $25.5 million of the NOL will expire between 2023 and 2033 and $52.5 million of the NOL will expire 2034 through 2036 | ||
Effective Income Tax Rate Reconciliation, at Federal Statutory Income Tax Rate, Percent | 34.00% | ||
U.S. Federal [Member] | Research and Development Expense [Member] | |||
Income Taxes [Line Items] | |||
Tax Credit Carryforward, Description | expire in 2033 through 2036 | ||
State And Local [Member] | |||
Income Taxes [Line Items] | |||
Operating Loss Carryforwards | $ 83,900,000 | ||
Operating Loss Carry forwards Expiration Date1 | Approximately $12.4 million of the Company's state NOL expire in 2018, $19.3 million expires between 2019 and 2028, and $52.2 million will expire in 2029 through 2031 | ||
State And Local [Member] | Research and Development Expense [Member] | |||
Income Taxes [Line Items] | |||
Tax Credit Carryforward, Amount | $ 819,000 | ||
Tax Credit Carryforward, Description | expire in 2023 through 2031 |
Leases (Details)
Leases (Details) | Dec. 31, 2016USD ($) |
Year ending December 31: | |
2,017 | $ 387,119 |
2,018 | 58,903 |
Total minimum lease payments | $ 446,022 |
Leases (Details Textual)
Leases (Details Textual) - USD ($) | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Operating Leased Assets [Line Items] | |||
Operating Leases, Rent Expense | $ 374,000 | $ 295,000 | $ 327,000 |
Stockholders' Equity (Details)
Stockholders' Equity (Details) - Employee Stock Option [Member] - $ / shares | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Number of Shares, Balance at beginning of the period (in shares) | 1,722,552 | ||
Number of Shares, Options granted (in shares) | 990,000 | 301,500 | 337,689 |
Number of Shares, Options exercised (in shares) | (208,869) | ||
Number of Shares, Options forfeited (in shares) | (269,471) | ||
Number of Shares, Options cancelled (in shares) | (8,362) | ||
Number of Shares, Balance at end of the period (in shares) | 2,225,850 | 1,722,552 | |
Number of Shares, Options exercisable (in shares) | 1,282,660 | ||
Weighted average exercise price, Balance at beginning of the period (in dollars per share) | $ 5.21 | ||
Weighted average exercise price, Options granted (in dollars per share) | 8.65 | ||
Weighted average exercise price, Options exercised (in dollars per share) | 2.90 | ||
Weighted average exercise price, Options forfeited (in dollars per share) | 12.03 | ||
Weighted average exercise price, Options cancelled (in dollars per share) | 7.61 | ||
Weighted average exercise price, Balance at end of the period (in dollars per share) | 6.12 | $ 5.21 | |
Weighted average exercise price, Options exercisable (in dollars per share) | $ 4.71 |
Stockholders' Equity (Details 1
Stockholders' Equity (Details 1) - Employee Stock Option [Member] - USD ($) | 12 Months Ended | |
Dec. 31, 2016 | Dec. 31, 2015 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Number of options outstanding | 2,225,850 | 1,722,552 |
Options outstanding, Weighted average remaining contractual life (Years) | 7 years 25 days | |
Options outstanding, Weighted average exercise price (in dollars per share) | $ 6.12 | $ 5.21 |
Options outstanding, Aggregate intrinsic value | $ 733,713 | |
Number of options exerciseable | 1,282,660 | |
Options exercisable, Weighted average remaining contractual life (Years) | 5 years 5 months 5 days | |
Options exercisable, Weighted average exercise price (in dollars per share) | $ 4.71 | |
Options exercisable, Aggregate intrinsic value | $ 706,552 |
Stockholders' Equity (Details 2
Stockholders' Equity (Details 2) - Restricted Stock [Member] | 12 Months Ended |
Dec. 31, 2016shares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Number of shares, Balance at beginning of the period | 3,000 |
Number of shares, Granted | 0 |
Number of shares, Vested | (3,000) |
Number of shares, Cancelled | 0 |
Number of shares, Balance at end of the period | 0 |
Stockholders' Equity (Details T
Stockholders' Equity (Details Textual) - USD ($) | 1 Months Ended | 12 Months Ended | ||||||
Apr. 29, 2015 | Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | Mar. 31, 2016 | Nov. 13, 2015 | Apr. 30, 2014 | Dec. 31, 2010 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period, Intrinsic Value | $ 216,000 | $ 658,000 | $ 87,000 | |||||
Proceeds from Issuance of Common Stock | 0 | 32,439,313 | 0 | |||||
Payments of Stock Issuance Costs | $ 0 | $ 0 | $ 271,183 | |||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 63.96 | |||||||
Class of Warrant or Right, Redemption Price of Warrants or Rights | $ 0.001 | |||||||
Class of Warrant or Right, Date from which Warrants or Rights Exercisable | Nov. 12, 2018 | |||||||
Common Stock [Member] | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period | 208,869 | 98,574 | 20,205 | |||||
Stock Issued During Period, Shares, New Issues | 5,347,500 | 5,347,500 | ||||||
Accredited Investors [Member] | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Proceeds from Issuance of Common Stock | $ 32,400,000 | |||||||
Payments of Stock Issuance Costs | $ 2,300,000 | |||||||
Warrant [Member] | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 12.21 | |||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested and Expected to Vest, Outstanding, Number | 20,467 | |||||||
2014 Equity Incentive Plans [Member] | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized | 1,271,906 | 1,000,000 | ||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant | 1,215,520 | |||||||
2011 Equity Incentive Plan [Member] | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant | 271,906 |
401(k) Plan (Details Textual)
401(k) Plan (Details Textual) - USD ($) | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Defined Benefit Plans and Other Postretirement Benefit Plans Table Text Block [Line Items] | |||
Defined Contribution Plan, Cost Recognized | $ 128,000 | $ 74,000 | $ 48,000 |
Defined Contribution Plan, Employer Matching Contribution, Percent of Match | 100.00% |
Agreement with Spriaso, LLC (De
Agreement with Spriaso, LLC (Details Textual) - USD ($) | 1 Months Ended | 12 Months Ended | ||
Jul. 23, 2013 | Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Related Party Transaction [Line Items] | ||||
Percentage Of Fee To Be Received | 20.00% | |||
Maximum Proceeds From Affiliates Under License Agreement | $ 10,000,000 | |||
Description Of Terms Of Service Agreement | Under the service agreement, the Company provided facilities and up to 10 percent of the services of certain employees to Spriaso for a period of 18 months which expired | |||
Service Fee | $ 230 | |||
Proceeds From Reimbursement | $ 3,000 | $ 61,000 | $ 0 |
Selected Quarterly Financial 57
Selected Quarterly Financial Information (Details) - USD ($) | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2016 | Sep. 30, 2016 | Jun. 30, 2016 | Mar. 31, 2016 | Dec. 31, 2015 | Sep. 30, 2015 | Jun. 30, 2015 | Mar. 31, 2015 | Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Operating loss | $ (3,015,090) | $ (3,286,220) | $ (5,815,120) | $ (7,070,404) | $ (4,696,098) | $ (6,433,988) | $ (4,277,743) | $ (2,974,239) | $ (19,186,834) | $ (18,382,068) | $ (20,480,814) |
Net loss | $ (2,966,467) | $ (3,235,485) | $ (5,760,111) | $ (7,009,445) | $ (4,633,698) | $ (6,372,428) | $ (4,246,446) | $ (2,955,806) | $ (18,971,508) | $ (18,208,378) | $ (20,372,676) |
Basic loss per share attributable to common stock (in dollars per share) | $ (0.16) | $ (0.18) | $ (0.32) | $ (0.38) | $ (0.25) | $ (0.35) | $ (0.26) | $ (0.23) | $ (1.04) | $ (1.11) | $ (1.60) |
Diluted loss per share attributable to common stock (in dollars per share) | $ (0.16) | $ (0.18) | $ (0.32) | $ (0.38) | $ (0.25) | $ (0.35) | $ (0.26) | $ (0.23) | $ (1.04) | $ (1.11) | $ (1.60) |