Document and Entity Information
Document and Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2015 | Mar. 04, 2016 | Jun. 30, 2015 | |
Document and Entity Information | |||
Entity Registrant Name | AGILE THERAPEUTICS INC | ||
Entity Central Index Key | 1,261,249 | ||
Document Type | 10-K | ||
Document Period End Date | Dec. 31, 2015 | ||
Amendment Flag | false | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Filer Category | Accelerated Filer | ||
Entity Public Float | $ 94.4 | ||
Entity Common Stock, Shares Outstanding | 28,737,550 | ||
Document Fiscal Year Focus | 2,015 | ||
Document Fiscal Period Focus | FY |
Balance Sheets
Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 |
Current assets: | ||
Cash and cash equivalents | $ 34,395 | $ 40,182 |
Prepaid expenses | 3,690 | 804 |
Total current assets | 38,085 | 40,986 |
Property and equipment, net | 12,318 | 12,046 |
Prepaid expenses, long-term | 1,678 | |
Deferred financing costs, net | 291 | 98 |
Other assets | 18 | 18 |
Total assets | 50,712 | 54,826 |
Current liabilities: | ||
Accounts payable | 2,387 | 2,631 |
Accrued expenses | 2,653 | 1,062 |
Loan payable, current portion | 2,488 | 5,003 |
Warrant liability | 406 | 296 |
Total current liabilities | 7,934 | 8,992 |
Loan payable, long-term | $ 13,035 | $ 9,828 |
Commitments and contingencies (Note 13) | ||
Stockholders' equity: | ||
Common stock, $.0001 par value, authorized 150,000,000 shares; 22,315,612 shares issued and outstanding as of December 31, 2015 and 18,634,872 shares issued and outstanding as of December 31, 2014 | $ 2 | $ 2 |
Additional paid-in capital | 194,468 | 170,396 |
Accumulated deficit | (164,727) | (134,392) |
Total stockholders' equity | 29,743 | 36,006 |
Total liabilities and stockholders' equity | $ 50,712 | $ 54,826 |
Balance Sheets (Parenthetical)
Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2015 | Dec. 31, 2014 |
Balance Sheets | ||
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Common stock, authorized (in shares) | 150,000,000 | 150,000,000 |
Common stock, issued (in shares) | 22,315,612 | 18,634,872 |
Common stock, outstanding (in shares) | 22,315,612 | 18,634,872 |
Statements of Operations
Statements of Operations - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Operating expenses: | |||
Research and development | $ 25,622 | $ 13,365 | $ 9,154 |
General and administrative | 7,467 | 5,150 | 3,574 |
Total operating expenses | 33,089 | 18,515 | 12,728 |
Loss from operations | (33,089) | (18,515) | (12,728) |
Other income (expense) | |||
Interest expense | (2,077) | (1,566) | (1,513) |
Interest income | 5 | 3 | 1 |
Change in fair value of warrants | (110) | 348 | (81) |
Loss on extinguishment of debt | (1,036) | ||
Loss before benefit from income taxes | (36,307) | (19,730) | (14,321) |
Benefit from income taxes | 5,972 | 3,653 | |
Net loss | $ (30,335) | $ (16,077) | $ (14,321) |
Net loss per share (basic and diluted) (in dollars per share) | $ (1.38) | $ (1.41) | $ (289.39) |
Weighted-average shares outstanding (basic and diluted) (in shares) | 22,017,229 | 11,394,971 | 49,486 |
Statements of Convertible Prefe
Statements of Convertible Preferred Stock and Changes in Stockholders' Equity (Deficit), Stockholders' Equity (Deficit) - USD ($) $ in Thousands | Common stockRedeemable Convertible Preferred Stock | Common stockConvertible notesConvertible Promissory Notes, April 2014 | Common stockPrivate Placement | Common stockInitial public offering | Common stock | Additional Paid-in CapitalRedeemable Convertible Preferred Stock | Additional Paid-in CapitalConvertible notesConvertible Promissory Notes, April 2014 | Additional Paid-in CapitalPrivate Placement | Additional Paid-in CapitalInitial public offering | Additional Paid-in Capital | Deficit Accumulated during the Development Stage | Redeemable Convertible Preferred Stock | Convertible notesConvertible Promissory Notes, April 2014 | Private Placement | Initial public offering | Total |
Balance at Dec. 31, 2012 | $ 45,385 | $ (103,994) | $ (58,609) | |||||||||||||
Balance (in shares) at Dec. 31, 2012 | 45,303 | |||||||||||||||
Increase (decrease) in stockholders' equity (deficit) | ||||||||||||||||
Share based compensation-stock options | 1,338 | 1,338 | ||||||||||||||
Issuance of common stock for employee bonuses | 80 | 80 | ||||||||||||||
Issuance of common stock for employee bonuses (in shares) | 11,981 | |||||||||||||||
Exercise of stock options | 70 | 70 | ||||||||||||||
Exercise of stock options (in shares) | 52,037 | |||||||||||||||
Net loss | (14,321) | (14,321) | ||||||||||||||
Balance at Dec. 31, 2013 | 46,873 | (118,315) | (71,442) | |||||||||||||
Balance (in shares) at Dec. 31, 2013 | 109,321 | |||||||||||||||
Increase (decrease) in stockholders' equity (deficit) | ||||||||||||||||
Share based compensation-stock options | 1,381 | 1,381 | ||||||||||||||
Issuance of common stock for employee bonuses | 80 | 80 | ||||||||||||||
Issuance of common stock for employee bonuses (in shares) | 9,983 | |||||||||||||||
Conversion to common stock | $ 1 | $ 69,232 | $ 3,020 | $ 69,233 | $ 3,020 | |||||||||||
Conversion to common stock (in shares) | 8,803,547 | 503,450 | ||||||||||||||
Common stock issued, net of expenses | $ 1 | $ 49,743 | $ 49,744 | |||||||||||||
Common stock issued (in shares) | 9,166,667 | |||||||||||||||
Exercise of stock options | 67 | 67 | ||||||||||||||
Exercise of stock options (in shares) | 41,904 | |||||||||||||||
Net loss | (16,077) | (16,077) | ||||||||||||||
Balance at Dec. 31, 2014 | $ 2 | 170,396 | (134,392) | 36,006 | ||||||||||||
Balance (in shares) at Dec. 31, 2014 | 18,634,872 | |||||||||||||||
Increase (decrease) in stockholders' equity (deficit) | ||||||||||||||||
Share based compensation-stock options | 2,965 | 2,965 | ||||||||||||||
Common stock issued, net of expenses | $ 19,330 | $ 19,330 | ||||||||||||||
Common stock issued (in shares) | 3,418,804 | |||||||||||||||
Fair value of common stock warrant issued with debt financing | 1,184 | 1,184 | ||||||||||||||
Exercise of stock options | 593 | 593 | ||||||||||||||
Exercise of stock options (in shares) | 261,936 | |||||||||||||||
Net loss | (30,335) | (30,335) | ||||||||||||||
Balance at Dec. 31, 2015 | $ 2 | $ 194,468 | $ (164,727) | $ 29,743 | ||||||||||||
Balance (in shares) at Dec. 31, 2015 | 22,315,612 |
Statements of Convertible Pref6
Statements of Convertible Preferred Stock and Changes in Stockholders' Equity (Deficit), Convertible Preferred Stock - USD ($) $ in Thousands | Series A-1 Convertible Preferred Stock | Series A-2 Convertible Preferred Stock | Series B Convertible Preferred Stock | Series C Convertible Preferred Stock |
Balance at Dec. 31, 2012 | $ 898 | $ 544 | $ 44,928 | $ 22,862 |
Balance (in shares) at Dec. 31, 2012 | 137,787 | 66,116 | 4,510,066 | 1,578,400 |
Increase (decrease) in temporary equity | ||||
Change | ||||
Balance at Dec. 31, 2013 | $ 898 | $ 544 | $ 44,928 | $ 22,862 |
Balance (in shares) at Dec. 31, 2013 | 137,787 | 66,116 | 4,510,066 | 1,578,400 |
Increase (decrease) in temporary equity | ||||
Conversion of preferred stock to common stock | $ (898) | $ (544) | $ (44,928) | $ (22,862) |
Conversion of preferred stock to common stock | (137,787) | (66,116) | (4,510,066) | (1,578,400) |
Balance at Dec. 31, 2014 | ||||
Balance (in shares) at Dec. 31, 2014 |
Statements of Cash Flows
Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Cash flows from operating activities | |||
Net loss | $ (30,335) | $ (16,077) | $ (14,321) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Depreciation | 18 | 12 | 12 |
Noncash stock bonus | 80 | 80 | |
Noncash stock based compensation | 2,965 | 1,381 | 1,338 |
Loss on extinguishment of debt | 1,036 | ||
Noncash interest | 590 | 185 | 133 |
Change in fair value of warrants | 110 | (348) | 81 |
Changes in operating assets and liabilities: | |||
Prepaid expenses and other current assets | (1,209) | (2,335) | 107 |
Accounts payable and accrued expenses | 1,347 | 2,599 | (449) |
Net cash used in operating activities | (25,478) | (14,503) | (13,019) |
Cash flows from investing activities | |||
Acquisition of property and equipment | (290) | (96) | (4,945) |
Net cash used in investing activities | (290) | (96) | (4,945) |
Cash flows from financing activities | |||
Proceeds from convertible bridge notes | 3,000 | ||
Proceeds from issuance of term loan | 16,265 | ||
Repayment of term loan | (15,784) | ||
Proceeds from issuance of common stock, in initial public offering, net of offering costs | 49,744 | ||
Proceeds from issuance of common stock in private placement, net of offering costs | 19,330 | ||
Cash paid for financing costs | (423) | (150) | |
Proceeds from exercise of stock options | 593 | 67 | 70 |
Net cash provided by financing activities | 19,981 | 52,661 | 70 |
Net increase (decrease) in cash and cash equivalents | (5,787) | 38,062 | (17,894) |
Cash and cash equivalents, beginning of year | 40,182 | 2,120 | 20,014 |
Cash and cash equivalents, end of year | 34,395 | 40,182 | 2,120 |
Supplemental cash flow information | |||
Interest paid | 1,474 | 1,380 | $ 1,380 |
Supplemental disclosure of noncash financing activities | |||
Fair value of common stock warrants issued | $ 1,184 | ||
Conversion of preferred stock into common stock | 69,233 | ||
Conversion of notes payable and interest into common stock | $ 3,021 |
Organization and Description of
Organization and Description of Business | 12 Months Ended |
Dec. 31, 2015 | |
Organization and Description of Business | |
Organization and Description of Business | 1. Organization and Description of Business Nature of Operations Agile Therapeutics, Inc. (the "Company") was incorporated in Delaware on December 22, 1997. The Company is engaged in research and development of transdermal patch technology for use in contraception. The Company's activities since inception have consisted principally of raising capital and performing research and development. The Company is headquartered in Princeton, New Jersey. The Company is devoting substantially all of its efforts toward research and development of its transdermal patch for use in contraception, and raising capital. The Company has not generated product revenue to date and is subject to a number of risks similar to those of other early stage companies, including dependence on key individuals, the difficulties inherent in the development of commercially usable products, the potential need to obtain additional capital necessary to fund the development of its products, and competition from larger companies. The Company has incurred losses each year since inception. As of December 31, 2015, the Company had an accumulated deficit of approximately $164.7 million. The Company has financed its operations to date primarily through the issuance and sale of its common stock in both public and private offerings of its common stock (see Note 9), private placements of its convertible preferred stock, venture loans, and non-dilutive grant funding. The Company expects to continue to incur net losses into the foreseeable future. As of December 31, 2015, the Company had cash and cash equivalents of $34.4 million. Although the Company has incurred recurring losses in each year since inception, the Company expects its cash and cash equivalents will be sufficient to fund operations for at least the next twelve months. |
Summary of Significant Accounti
Summary of Significant Accounting Polices | 12 Months Ended |
Dec. 31, 2015 | |
Summary of Significant Accounting Polices | |
Summary of Significant Accounting Polices | 2. Summary of Significant Accounting Polices Basis of Presentation The accompanying financial statements have been prepared in accordance with United States ("U.S.") generally accepted accounting principles ("GAAP") and include all adjustments necessary for the fair presentation of the Company's financial position for the periods presented. Use of Estimates The preparation of the Company's financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. The Company bases its estimates and judgments on historical experience and various other assumptions that it believes are reasonable under the circumstances. The amounts of assets and liabilities reported in the Company's balance sheets and the amounts of expenses reported for each of the periods presented are affected by estimates and assumptions, which are used for, but not limited to, the accounting for common stock warrants, stock-based compensation, income taxes, and accounting for research and development costs. Actual results could differ from those estimates. Stock Split On May 5, 2014, the Company effected a 1.4-for-1 stock split of the Company's common stock. All share and per share amounts of common stock contained in the Company's financial statements have been restated for all periods to give retroactive effect to the stock split. The shares of common stock retained a par value of $0.0001 per share. Accordingly, the stockholders' deficit reflects the stock split by reclassifying from "Additional paid-in Capital" to "Common Stock" in an amount equal to the par value of the increased shares resulting from the stock split. Cash and Cash Equivalents The Company considers all highly-liquid investments with an original maturity of three months or less when purchased to be cash equivalents. All cash and cash equivalents are held in United States financial institutions. Cash and cash equivalents include money market funds that invest primarily in commercial paper and U.S. government and U.S. government agency obligations. The Company maintains balances with financial institutions in excess of the FDIC limit. Fair Value of Financial Instruments In accordance with ASC 825, Financial Instruments , disclosures of fair value information about financial instruments are required, whether or not recognized in the balance sheet, for which it is practicable to estimate that value. Cash and cash equivalents are carried at fair value (see Note 3). Financial instruments, including accounts payable and accrued liabilities, are carried at cost, which approximates fair value given their short-term nature. Property and Equipment Property and equipment, consisting of manufacturing, office and computer equipment, is stated at cost, less accumulated depreciation. Depreciation is computed using the straight-line, method over the estimated useful lives of the assets. Expenditures incurred after the fixed assets have been put into operation, such as repairs and maintenance, are charged to earnings in the period in which costs are incurred. Improvements and additions are capitalized in accordance with Company policy. Long-Lived Assets In accordance with ASC 360, Property, Plant and Equipment , the Company's policy is to review long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Management does not believe that there has been any impairment of the carrying value of any long-lived assets as of December 31, 2015. Research and Development Expense Research and development costs are expensed as incurred. Research and development expense consists primarily of costs related to personnel, including salaries and other personnel-related expenses, expenses related to manufacturing, clinical trial expenses, consulting fees and support services used in drug development. All research and development costs are charged to operations as incurred in accordance with ASC 730, Research and Development . In certain circumstances, the Company is required to make advance payments to vendors for goods or services that will be received in the future for use in research and development activities. In such circumstances, the advance payments are deferred and are expensed when the activity has been performed or when the goods have been received. Deferred Financing Costs Costs directly attributable to the Company's term loan (see Note 8) are deferred and capitalized. These costs represent legal fees and other costs related to the term loan and are being amortized over the term of the loan. Amortization of deferred financing costs charged to interest expense was $211, $59 and $45 for the years ended December 31, 2015, 2014 and 2013, respectively. Concentrations of Credit Risk Financial instruments which potentially subject the Company to credit risk consist principally of cash and cash equivalents. All cash and cash equivalents are held in business checking and money market accounts in United States financial institutions the balances of which exceed federally insured limits. The Company has not recognized any losses from credit risks on such accounts. The Company believes it is not exposed to significant credit risks on cash and cash equivalents. The Company has no financial instruments with off-balance sheet risk of accounting loss. Warrants The Company accounts for its warrants to purchase redeemable convertible stock in accordance with ASC 480, Distinguishing Liabilities from Equity . ASC 480 requires that a financial instrument, other than outstanding share, that, at inception, is indexed to an obligation to repurchase the issuer's equity shares, regardless of the timing or the probability of the redemption feature, and may require the issuer to settle the obligation by transferring assets be classified as a liability. The Company measures the fair value of its warrant liability using an option pricing model with changes in fair value recognized in the statement of operations. In connection with the completion of the Company's initial public offering in May 2014, the warrants to purchase shares of Series A-1 and Series A-2 preferred stock expired unexercised and the warrants to purchase shares of Series C preferred stock automatically converted into warrants to purchase shares of common stock. These common stock warrants with non-standard anti-dilution provisions (referred to as down round protection) are classified as liabilities and re-measured each reporting period. As of December 31, 2015, there were outstanding 62,505 warrants to purchase common stock at $6.00 per share. These warrants expire on December 14, 2019. In connection with the Company's debt financing which was completed in February 2015 (see Note 8), the Company issued warrants to purchase 180,274 shares of common stock. These warrants are classified as a component of stockholders' equity and the value of such warrants was determined using the Black-Scholes option-pricing model. Income Taxes The Company accounts for deferred taxes using the asset and liability method as specified by ASC 740, Income Taxes . Deferred income tax assets and liabilities are determined based on differences between the financial statement reporting and the tax basis of assets and liabilities, operating losses and tax credit carryforwards. Deferred income taxes are measured using the enacted tax rates and laws that are anticipated to be in effect when the differences are expected to reverse. The measurement of deferred income tax assets is reduced, if necessary, by a valuation allowance for any tax benefits which are not expected to be realized. The effect on deferred income tax assets and liabilities of a change in tax rates is recognized in the period that such tax rate changes are enacted. The Company has adopted the authoritative guidance on accounting for and disclosure of uncertainty in tax positions which prescribes a comprehensive model for the financial statement recognition, measurement, presentation and disclosure of uncertain tax positions taken or expected to be taken in income tax returns. The Company has no uncertain tax positions as of December 31, 2015 that qualifies for either recognition or disclosure in the financial statements under this guidance. Stock-Based Compensation The Company accounts for stock-based compensation in accordance with ASC 718, Compensation—Stock Compensation . The Company grants stock options for a fixed number of shares to employees and non-employees with an exercise price equal to the fair value of the shares at grant date. Compensation cost is recognized for all share-based payments granted and is based on the grant-date fair value estimated using the weighted-average assumption of the Black-Scholes option pricing models. The equity instrument is not considered to be issued until the instrument vests. As a result, compensation cost is recognized over the requisite service period with an offsetting credit to additional paid-in capital. Awards for consultants are accounted for under ASC 505-50, Equity Based Payments to Non-Employees . Any compensation expense related to consultants is marked-to-market over the applicable vesting period as they vest. Prior to May 22, 2014, the Company utilized various methodologies in accordance with the framework of the American Institute of Certified Public Accountants Technical Practice Aid, Valuation of Privately-Held Company Equity Securities Issued as Compensation , to estimate the fair value of its stock. The methodologies included an option pricing method and a probability-weighted expected return methodology that determined an estimated value under an initial public offering (IPO) scenario and a sale scenario based upon an assessment of the probability of occurrence of each scenario. Each valuation methodology includes estimates and assumptions that require the Company's judgment. These estimates include assumptions regarding future performance, including the successful completion of clinical trials and the time to completing an IPO or sale of the Company. As with any valuation, significant changes to the key assumptions used in the valuations could result in different fair values of common stock at each valuation date. Segment Information Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision making group, in deciding how to allocate resources and in assessing performance. The Company views its operations and manages its business in one operating and reporting segment, which is the business of developing its transdermal patch for use in contraception. Comprehensive Income Effective January 1, 2012, an update to an accounting standard was issued that requires all non-owner changes in stockholders' equity to be presented either in a single continuous statement of comprehensive income or in two separate but consecutive statements. This update was applied retrospectively. The Company adopted this pronouncement and elected to present a separate statement of comprehensive income. The Company did not incur any components of comprehensive income for the periods presented and therefore, did not include a statement of comprehensive income in the financial statements. Net Loss Per Share Basic net loss per share is calculated by dividing the net loss by the weighted average number of common shares outstanding for the period, without consideration for common stock equivalents. Diluted net loss per share is calculated by dividing the net loss by the weighted-average number of common shares outstanding plus the effect of dilutive potential common shares outstanding during the period determined using the treasury-stock and if-converted methods. For purposes of diluted net loss per share calculation, convertible preferred stock, convertible preferred stock warrants, common stock warrants and stock options are considered to be potentially dilutive securities but are excluded from the calculation of diluted net loss per share because their effect would be anti-dilutive and therefore, basic and diluted net loss per share were the same for all periods presented. The following table sets forth the outstanding potentially dilutive securities that have been excluded from the calculation of diluted net loss per share because to do so would be anti-dilutive (in common equivalent shares): Year Ended December 31, 2015 2014 2013 Convertible preferred stock — — Convertible preferred stock warrants — — Common stock warrants — Common stock options Total Recent Accounting Pronouncements In April 2015, the Financial Accounting Standards Board (FASB) issued an amendment to U.S. GAAP to simplify the balance sheet presentation of the costs for issuing debt. The changes were adopted in Accounting Standards Update (ASU) No. 2015-03, Interest—Imputation of Interest (Subtopic 835-30): Simplifying the Presentation of Debt Issue Costs . Public companies will have to apply the amendments for reporting periods that begin after December 15, 2015. This amendment requires adoption by revising the balance sheets for periods prior to the effective date. The Company is currently evaluating the impact of this ASU and does not believe the adoption of this ASU will have a material impact on the Company's financial position or results of operations. |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2015 | |
Fair Value Measurements | |
Fair Value Measurements | 3. Fair Value Measurements ASC 820, Fair Value Measurements and Disclosures , describes the fair value hierarchy based on three levels of inputs, of which the first two are considered observable and the last unobservable, that may be used to measure fair value. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants at the measurement date. Assets and liabilities that are measured at fair value are reported using a three-level fair value hierarchy that prioritizes the inputs used to measure fair value. This hierarchy maximizes the use of observable inputs and minimizes the use of unobservable inputs. The three levels of inputs used to measure fair value are as follows: · Level 1—Quotes prices in active markets for identical assets and liabilities. The Company's Level 1 assets and liabilities consist of cash and cash equivalents. · Level 2—Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted market prices for similar assets or liabilities in active markets or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets and liabilities. The Company has no Level 2 assets or liabilities. · Level 3—Unobservable inputs that are supported by little or no market data and which require internal development of assumptions about how market participant price the fair value of the assets or liabilities. The Company's Level 3 liabilities consist of the warrant liability. The Company is required to mark the value of its warrant liability to market and recognize the change in valuation in its statements of operations each reporting period. The following table sets forth the Company's financial instruments measured at fair value by level within the fair value hierarchy as of December 31, 2015 and 2014. Level 1 Level 2 Level 3 2015 Assets: Cash equivalents $ $ — $ — Total assets at fair value $ $ — $ — Liabilities: Common stock warrants — — Total liabilities at fair value $ — $ — $ The significant assumptions used in preparing the option pricing model for valuing the Company's warrants as of December 31, 2015 include (i) volatility (75.0%), (ii) risk free interest rate of 1.54% (estimated using treasury bonds with a 4 year life), (iii) strike price ($6.00) for the common stock warrants, (iv) fair value of common stock ($9.76) and (v) expected life (four years). The following is a rollforward of the fair value of Level 3 warrants: Beginning balance at December 31, 2012 $ Change in fair value Ending balance at December 31, 2013 Expiration of Series A-1 and Series A-2 warrants ) Change in fair value Ending balance at December 31, 2014 Change in fair value Ending balance at December 31, 2015 $ Level 1 Level 2 Level 3 2014 Assets: Cash equivalents $ $ — $ — Total assets at fair value $ $ — $ — Liabilities: Common stock warrants — — Total liabilities at fair value $ — $ — $ The significant assumptions used in preparing the option pricing model for valuing the Company's warrants as of December 31, 2014 include (i) volatility (104.8%), (ii) risk free interest rate of 1.68% (estimated using treasury bonds with a 5 year life), (iii) strike price ($6.00) for the common stock warrants, (iv) fair value of common stock ($6.14) and (v) expected life (five years). There were no transfers between Level 1, 2 or 3 during 2015 or 2014. If the Company's estimates regarding the fair value of its warrants are inaccurate, a future adjustment to these estimated fair values may be required. Additionally, these estimated fair values could change significantly. |
Prepaid Expenses
Prepaid Expenses | 12 Months Ended |
Dec. 31, 2015 | |
Prepaid Expenses | |
Prepaid Expenses | 4. Prepaid Expenses Prepaid expenses consist of the following: December 31 2015 2014 Prepaid clinical trial expense $ $ Prepaid insurance Other Total prepaid expenses $ $ Prepaid expenses, short-term $ $ Prepaid expenses, long-term — Total prepaid expenses $ $ Prepaid expenses, long-term represents non-refundable advances to the Company's clinical research organization which will be applied against final invoices in accordance with the contractual terms of the arrangement. |
Property and Equipment
Property and Equipment | 12 Months Ended |
Dec. 31, 2015 | |
Property and Equipment | |
Property and Equipment | 5. Property and Equipment Property and equipment, consisting of manufacturing, office and computer equipment, is stated at cost, less accumulated depreciation. Depreciation is computed using the straight-line, method over the estimated useful lives of the assets. Property and equipment consist of the following: December 31 2015 2014 Estimated Life Office equipment $ $ 3 - 10 years Computer equipment 3 years Manufacturing equipment 5 years Less: accumulated depreciation ) ) Property and equipment, net $ $ As December 31, 2015 and 2014, manufacturing equipment includes approximately $12.3 million and $12.0 million, respectively, of equipment which is in the process of being constructed and qualified and is not currently being depreciated. |
Accrued Liabilities
Accrued Liabilities | 12 Months Ended |
Dec. 31, 2015 | |
Accrued Liabilities | |
Accrued Liabilities | 6. Accrued Liabilities Accrued liabilities consist of the following: December 31 2015 2014 Employee bonuses $ $ Accrued clinical trial costs Other Total accrued liabilities $ $ |
Convertible Note Financing
Convertible Note Financing | 12 Months Ended |
Dec. 31, 2015 | |
Convertible notes | Convertible Promissory Notes, April 2014 | |
Debt | |
Convertible Note Financing | 7. Convertible Note Financing On April 28, 2014, the Company and certain of the Company's existing preferred stockholders, all of whom qualify as accredited institutional investors, entered into a Convertible Subordinated Note Purchase Agreement pursuant to which such holders agreed to loan the Company an aggregate of $3.0 million. The Company issued Convertible Promissory Notes (the "Notes") to evidence its payment obligations with respect to the $3.0 million. The Notes had an interest rate of 8%, accruing daily and compounding annually. The Notes are convertible into unregistered equity securities of the Company upon the occurrence of events stated therein. The Notes and accrued interest automatically converted into 503,450 shares of common stock at $6.00 per share which was equal to the purchase price at which shares were sold to the public in an underwritten public offering (see Note 9). The Notes were subordinate to the Company's term loan with Oxford Finance LLC. |
Loan and Security Agreements
Loan and Security Agreements | 12 Months Ended |
Dec. 31, 2015 | |
Secured debt | |
Loan and Security Agreements | |
Loan and Security Agreements | 8. Loan and Security Agreements Oxford Finance LLC In December 2012, the Company entered into a Loan and Security Agreement (the "Oxford Loan") with Oxford Finance LLC ("Oxford") pursuant to which the Company borrowed a total of $15.0 million from Oxford. The Oxford Loan accrued interest at a fixed annual rate equal to 9.20% (Three-month U.S. Libor rate of 0.47% plus 8.73%). Interest on the Oxford Loan was payable monthly and principal was due in 30 equal consecutive monthly installments beginning on February 1, 2015 and ending on July 1, 2017. In addition, the Company was required to make a final payment of $675,000 on the maturity date of the Oxford Loan (July 1, 2017). In connection with the Oxford Loan, the Company issued Oxford warrants to purchase 62,505 shares of common stock at $6.00 per share. These warrants expire on December 14, 2019. In February 2015, the Company terminated and repaid all amounts outstanding under the Oxford Loan and recorded a loss on the extinguishment of the Oxford Loan (see further discussion below). Hercules Technology Growth Capital, Inc. In February 2015, the Company entered into a loan and security agreement (the "Hercules Loan") with Hercules Technology Growth Capital, Inc. ("Hercules") for a term loan of up to $25.0 million. A first tranche of $16.5 million was funded upon execution of the Hercules Loan, approximately $15.5 million of which was used to repay the Company's existing term loan with Oxford. The Company is scheduled to make interest-only payments on the loan until July 1, 2016, which period may be extended under certain circumstances. Under the terms of the Hercules Loan, the Company may, but is not obligated to, draw an additional tranche of up to $8.5 million prior to July 1, 2016, subject to the achievement of certain clinical milestones, which may be extended to December 31, 2016 under certain circumstances. The Hercules Loan accrues interest at a rate of the greater of 9.0% or 9.0% plus Prime minus 4.25% and is payable monthly. Principal is due in 30 equal consecutive monthly installments beginning on July 1, 2016 and ending on December 1, 2018. In addition, the Company is required to make a final payment of $610,500 on the maturity date of the Hercules Loan (December 1, 2018). The Company may prepay all, but not less than all, of the Hercules Loan subject to a prepayment premium of 3.0% of the outstanding principal if prepaid during the first year, 2.0% of the outstanding principal if prepaid during the second year and 1.0% of the outstanding principal if prepaid after the second year. The obligations of the Company under the Hercules Loan are secured by a perfected first position lien on all of the assets of the Company, excluding intellectual property assets. In connection with the Hercules Loan, the Company issued Hercules a warrant to purchase 180,274 shares of the Company's common stock at an exercise price of $5.89 per share which expires on February 24, 2020 and granted Hercules the right to participate in future equity financings in an amount up to $2.0 million while the loan and warrant are outstanding. The Company allocated the proceeds of $16.5 million in accordance with ASC 470 based on the relative fair values. The relative fair value of the warrants of approximately $1.2 million at the time of issuance, which was determined using the Black-Scholes option-pricing model, was recorded as additional paid-in capital and reduced the carrying value of the debt. The significant assumptions used in preparing the option pricing model for valuing the Company's warrant issued to Hercules include (i) volatility (75.0%), (ii) risk free interest rate of 1.22% (estimated using treasury bonds with a 4 year life), (iii) strike price ($5.89) for the common stock warrant, (iv) fair value of common stock ($9.82) and (v) expected life (four years). The discount on the debt is being amortized to interest expense over the term of the debt. As a result of the repayment of the Oxford Loan, the Company recorded a loss on the extinguishment of debt of approximately $1.0 million on the Company's statement of operations for the year ended December 31, 2015, representing a prepayment premium, the unamortized discount of the Oxford Loan and the write off of deferred financing costs. Interest expense on the Oxford Loan and the Hercules Loan including the accretion of the value of the related warrants and amortization of the deferred financing costs was approximately $2,077, $1,545 and $1,472, for the years ended December 31, 2015, 2014 and 2013, respectively. The annual maturities of the Hercules Loan, as of December 31, 2015, are as follows: 2016 $ 2017 2018 Total $ |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2015 | |
Stockholders' Equity | |
Stockholders' Equity | 9. Stockholders' Equity Initial Public Offering and Related Transactions On May 29, 2014, the Company completed its initial public offering selling 9,166,667 shares of common stock at $6.00 per share. Proceeds from the Company's initial public offering, net of underwriting discounts and commissions and other offering costs, were $49.7 million. In addition, each of the following occurred in connection with the completion of the Company's IPO on May 29, 2014: • the conversion of all outstanding shares of convertible preferred stock into 8,809,325 shares of the Company's common stock; and • the conversion of the aggregate principal amount of $3.0 million and accrued interest under the Company's outstanding convertible subordinated promissory notes into 503,450 shares of the Company's common stock. On May 7, 2014, the Company filed an amendment to its amended and restated certificate of incorporation which, among other things, revised the automatic conversion provision relating to the Series C Preferred Stock, Series B Preferred Stock, Series A-1 Preferred Stock and Series A-2 Preferred Stock. Following such amendment, the Series C, the Series B, the Series A-1 and A-2 Preferred Stock automatically converted into shares of common stock at the then effective conversion price upon: (i) the closing of an underwritten public offering pursuant to an effective registration statement under the Securities Act of 1933, covering the offer and sale of common stock from which the Company receives gross proceeds of at least $45,000,000 or (ii) the affirmative vote of the holders of at least a majority of the voting power the Series C Preferred Stock, the Series B Preferred Stock and the Series A-1 Preferred Stock, respectively, after first giving effect, if in conjunction with a public offering which does not meet the standards set forth in clause (i) above, to any adjustment of the conversion price for each series of preferred stock to which it would otherwise be entitled by virtue of such public offering. On May 29, 2014, the Company filed an amended and restated certificate of incorporation (the "Restated Certificate") with the Secretary of State of the State of Delaware in connection with the closing of the Company's initial public offering of shares of its common stock. The Company's board of directors (the "Board") and stockholders previously approved the Restated Certificate effective as of and contingent upon the closing of the Company's initial public offering. The Restated Certificate amends and restates in its entirety the Company's second amended and restated certificate of incorporation, as amended. The Restated Certificate, among other things: (i) authorizes 150,000,000 shares of common stock; (ii) eliminates all references to the previously existing series of preferred stock; (iii) authorizes 10,000,000 shares of undesignated preferred stock that may be issued from time to time by the Board in one or more series; (iv) provides that the Board be divided into three classes with staggered three-year terms, with one class of directors to be elected at each annual meeting of the Company's stockholders; (v) provides that directors may only be removed with cause and only upon the affirmative vote of holders of at least 75% of the voting power of all then-outstanding shares of capital stock of the Company entitled to vote generally in the election of directors; (vi) provides that only the Board, the chairman of the Board, if one is appointed, or the chief executive officer may call a special meeting of stockholders; and (vii) requires that any action instituted against the Company's officers or directors in connection with their service to the Company be brought in the State of Delaware. Private Placement In January 2015, the Company completed a private placement of approximately 3.4 million shares of common stock at $5.85 per share. Proceeds from the Company's private placement, net of commissions and other offering costs, were approximately $19.3 million. Two of the Company's stockholders, who are also affiliated with members of the Company's Board of Directors, purchased a total of 1,623,932 shares of common stock for approximately $9.5 million in the private placement. Shelf Registration Statement On June 19, 2015, the Company filed a universal shelf registration statement with the SEC for the issuance of common stock, preferred stock, warrants, rights, debt securities and units up to an aggregate amount of $150.0 million (the "2015 Shelf Registration Statement"). On July 1, 2015, the 2015 Shelf Registration Statement was declared effective by the SEC. The Company completed an offering of common stock in January 2016 utilizing the 2015 Shelf Registration Statement (see Note 14). In the future, the Company may also periodically offer one or more of these securities in amounts, prices and terms to be announced when and if the securities are offered. At the time any of the securities covered by the 2015 Shelf Registration Statement are offered for sale, a prospectus supplement will be prepared and filed with the SEC containing specific information about the terms of any such offering. Convertible Preferred Stock (Prior to IPO) Prior to its conversion in the IPO, the Company's convertible preferred stock was classified as temporary equity on its balance sheets instead of stockholders' (deficit) in accordance with authoritative guidance for the classification and measurement or redeemable securities. Upon certain change in control events that were outside of the Company's control, including liquidation, sale or transfer of control of the Company, holders of the convertible preferred stock could cause its redemption. |
Equity Incentive Plans
Equity Incentive Plans | 12 Months Ended |
Dec. 31, 2015 | |
Equity Incentive Plans | |
Equity Incentive Plans | 10. Equity Incentive Plans The Company had granted stock options under an amended and restated 1997 Equity Incentive Plan (the "1997 Plan") and a 2008 Equity Incentive Plan (the "2008 Plan"). The plans provided for the granting of incentive and nonstatutory options and stock awards to consultants, directors, officers and employees. Such options are exercisable for a period of ten years and generally vest over a four-year period. In conjunction with the adoption of the 2008 Plan in April 2008, no additional grants were made from the 1997 Plan and issued options from the 1997 Plan remain outstanding. In 2014, the Company's Board of Directors approved the 2014 Equity Incentive Plan (the "2014 Plan"). The 2014 Plan is the successor to the Company's 2008 Plan and 1997 Plan. In conjunction with the adoption of the 2014 Plan in 2014, no additional grants were made from the 2008 Plan and options from the 1997 Plan and the 2008 Plan remain outstanding. As of December 31, 2015, there were 531,540 shares available for future grant under the 2014 Plan. Through December 31, 2015, the Company granted options to certain employees and nonemployees to purchase shares of common stock at exercise prices ranging from $0.71 to $285.71 per share. The Company recorded non cash stock based compensation expense of $2,965, $1,381 and, $1,338 for the years ended December 31, 2015, 2014 and 2013, respectively, based on the fair market value of the options granted at the grant date as determined using a Black-Scholes option pricing model. Stock-based compensation expense was as follows: Year Ended December 31, 2015 2014 2013 Employee $ $ $ Non-employee Total $ $ $ Stock-based compensation expense related to stock options was allocated as follows: Year Ended December 31, 2015 2014 2013 Research and development $ $ $ General and administrative Total stock-based compensation expense $ $ $ The following assumptions were used to compute employee stock-based compensation under the Black-Scholes option pricing model: 2015 2014 2013 Risk-free interest rate % % % Expected volatility % % % Expected dividend yield % % % Expected life (in years) Risk-free interest rate. The Company bases the risk-free interest rate assumption on observed interest rates appropriate for the expected term of the stock option grants. Expected dividend yield. The Company bases the expected dividend yield assumption on the fact that it has never paid cash dividends and has no present intention to pay cash dividends. Expected volatility. The expected volatility assumption is based on volatilities of a peer group of similar companies whose share prices are publicly available. The peer group was developed based on comparable companies in the biotechnology and pharmaceutical industries. Expected term. The expected term represents the period of time that options are expected to be outstanding. Because the Company does not have historic exercise behavior, management determined the expected life assumption using the simplified method, which is an average of the contractual term of the option and its ordinary vesting period. Forfeitures. The Company reduces stock-based compensation expense for estimated forfeitures. Forfeitures are estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. As of December 31, 2015, the unrecorded deferred stock-based compensation balance related to stock options was approximately $6.2 million and will be recognized over an estimated weighted-average amortization period of 1.79 years. The weighted average grant date fair value of options granted during the year ended December 31, 2015 was $6.31. The following table summarizes the options outstanding, options vested and the options exercisable as of December 31, 2015, 2014 and 2013: Options Weighted- Average Exercise Price Weighted- Average Remaining Contractual Life (Years) Aggregate Intrinsic Value Options outstanding at December 31, 2013 7.9 years Options granted Options exercised ) Options cancelled/forfeited ) Options outstanding at December 31, 2014 7.9 years Options granted Options exercised ) Options cancelled/forfeited ) Options outstanding at December 31, 2015 7.8 years $ Options exercisable at December 31, 2015 6.7 years $ Vested and expected to vest at December 31, 2015 7.8 years Intrinsic value in the above table was calculated as the difference between the Company's estimated stock price at December 31, 2015, of $9.76, and the exercise price, multiplied by the number of options. Intrinsic value for options exercised during 2015 amounts to $1,841. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2015 | |
Income Taxes | |
Income Taxes | 11. Income Taxes As of December 31, 2015, the Company had available net operating loss carryforwards ("NOL") of approximately $151.8 million and $47.2 million for federal and state income tax reporting purposes, respectively, which are available to offset future federal and state taxable income, if any, through 2035. The Company also has research and development tax credit carryforwards of approximately $4.0 million and $0.5 million for federal and state income tax reporting purposes, respectively, which are available to reduce federal income taxes, if any, through 2035 and state income taxes, if any, through 2030. The Internal Revenue Code of 1986, as amended (the "Code") provides for a limitation on the annual use of NOL and other tax attributes (such as research and development tax credit carryforwards) following certain ownership changes, as defined by the Code that could significantly limit the Company's ability to utilize these carryforwards. At this time, the Company has not completed a study to assess whether an ownership change under Section 382 of the Code has occurred, or whether there have been multiple ownership changes since the Company's formation, due to the costs and complexities associated with such a study. The Company may have experienced various ownership changes, as defined by the Code, as a result of past financings. Accordingly, the Company's ability to utilize the aforementioned carryforwards may be limited. Additionally, U.S. tax laws limit the time during which these carryforwards may be applied against future taxes. Therefore, the Company may not be able to take full advantage of these carryforwards for federal and state income tax purposes. The Company does not have any significant unrecognized tax benefits. As of December 31, 2015, the Company has not accrued interest or penalties related to uncertain tax positions. The Company's tax returns for the years ended December 31, 2012 through December 31, 2014 are still subject to examination by major tax jurisdictions. For all years through December 31, 2015, the Company generated research credit but has not conducted a study to document the qualified activities. This study may result in an adjustment to the Company's research and development credit carryforwards; however, until a study is completed and any adjustment in known, no amounts are being presented as an uncertain tax position. A full valuation allowance has been provided against the Company's research and development credits and, if an adjustment is required, this adjustment would be offset by an adjustment to the deferred tax asset established for the research and development credit carryforwards and the valuation allowance. The tax effects of temporary differences that give rise to significant portions of the deferred tax assets are presented below: December 31 2015 2014 Deferred tax assets: Net operating loss carryforwards $ $ Research credit carryforward Stock options and other Total gross deferred tax assets Valuation allowance for deferred tax assets ) ) Net deferred tax assets $ — $ — The gross deferred tax assets and the valuation allowance shown above represent the items which reduce the income tax benefit which would result from applying the federal statutory tax rate to the pretax loss and cause no income tax expense or benefit to be recorded for the years ended December 31, 2015 and 2014. The net change in the valuation allowance for the years ended December 31, 2015 and 2014 was an increase of $8.9 million and $4.7 million, respectively, related primarily to net operating losses incurred by the Company which are not currently deductible. A reconciliation of the U.S. statutory income tax rate to the Company's effective tax rate is as follows: December 31, 2015 2014 2013 Federal income tax at statutory rate % % % State income tax benefit, net of federal benefit % % % Research and development tax credits % % % Other )% — % )% Increase to valuation allowance )% )% )% Effective income tax rate % % % Sale of New Jersey Net Operating Losses The Company received approval to sell a portion of the Company's New Jersey net operating losses (NOLs) as part of the Technology Business Tax Certificate Program sponsored by The New Jersey Economic Development Authority. Under the program, emerging biotechnology companies with unused NOLs and unused research and development credits are allowed to sell these benefits to other companies. On November 30, 2015, the Company completed the sale of NOLs totaling approximately $59.8 million and research and development credits totaling $1.1 million for net proceeds of approximately $6.0 million. Such proceeds are reflected as a tax benefit for the year ended December 31, 2015. On February 27, 2014, the Company completed the sale of NOLs totaling approximately $39.1 million and research and development credits totaling approximately $0.4 million for net proceeds of approximately $3.6 million. Such proceeds are reflected as a tax benefit for year ended December 31, 2014. |
Related Party Transactions
Related Party Transactions | 12 Months Ended |
Dec. 31, 2015 | |
Related Party Transactions | |
Related Party Transactions | 12. Related Party Transactions Effective March 17, 2014, one of the Managing Partners of SmartPharma LLC, or SmartPharma, an entity which provides commercial and business development consulting services to the Company, was appointed Chief Commercial Officer. In connection with the appointment of this individual as Chief Commercial Officer, the Company amended its consulting agreement with SmartPharma to remove this individual from the list of persons providing service under the consulting agreement. SmartPharma invoiced the Company $73 and $126 of fees for the years ended December 31, 2015 and 2014, respectively. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2015 | |
Commitments and Contingencies. | |
Commitments and Contingencies | 13. Commitments and Contingencies Operating Leases The Company leases approximately 7,000 square feet of office space in Princeton, NJ. The current term of the lease is for a five year period ending on November 30, 2020. The Company has the right to terminate the lease after November 30, 2018 under certain circumstances as defined in the lease. Rent expense was $163, $159 and $142 for the years ended December 31, 2015, 2014 and 2013, respectively. Future minimum annual lease commitments under the noncancelable operating lease in effect as of December 31, 2015 are as follows: 2016 $ 2017 $ 2018 $ 2019 $ 2020 $ |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2015 | |
Subsequent Events | |
Subsequent Events | 14. Subsequent Events The following events occurred subsequent to December 31, 2015 through the date the financial statements was available to be issued. Public Offering of Common Stock In January 2016, the Company completed an underwritten public offering of 5,511,812 shares of its common stock at a public offering price of $6.35 per share. In February 2016, the underwriters of the public offering of common stock exercised in full their option to purchase an additional 826,771 shares of common stock at the public offering price of $6.35 per share, less underwriting discounts and commissions. A total of 6,338,583 shares of common stock were sold in the public offering resulting in total estimated net proceeds of approximately $37.3 million. |
Quarterly Data (Unaudited)
Quarterly Data (Unaudited) | 12 Months Ended |
Dec. 31, 2015 | |
Quarterly Data (Unaudited) | |
Quarterly Data (Unaudited) | 15. Quarterly Data (Unaudited) The following tables summarize the quarterly results of operations for each of the quarters in 2015 and 2014. These quarterly results are unaudited, but in the opinion of management, have been prepared on the same basis as our audited financial information and include all adjustments (consisting only of normal recurring adjustments) necessary for a fair presentation of the information set forth herein. March 31, 2015 June 30, 2015 September 30, 2015 December 31, 2015 Total revenue $ — $ — $ — $ — Operating expenses $ $ $ $ Net loss $ ) $ ) $ ) $ ) Basic net loss per common share $ ) $ ) $ ) $ ) Diluted net loss per common share $ ) $ ) $ ) $ ) March 31, 2014 June 30, 2014 September 30, 2014 December 31, 2014 Total revenue $ — $ — $ — $ — Operating expenses $ $ $ $ Net income (loss) $ $ ) $ ) $ ) Basic net income (loss) per common share $ $ ) $ ) $ ) Diluted net income (loss) per common share $ $ ) $ ) $ ) The net loss and basic and diluted net loss per share for the quarter ended December 31, 2015 includes a tax benefit of $5,972 from the sale of New Jersey state net operating losses. Net income and basic and diluted net income per share for the quarter ended March 31, 2014 includes a tax benefit of $3,653 from the sale of New Jersey state net operating losses (see Note 11). |
Summary of Significant Accoun23
Summary of Significant Accounting Polices (Polices) | 12 Months Ended |
Dec. 31, 2015 | |
Summary of Significant Accounting Polices | |
Basis of Presentation | Basis of Presentation The accompanying financial statements have been prepared in accordance with United States ("U.S.") generally accepted accounting principles ("GAAP") and include all adjustments necessary for the fair presentation of the Company's financial position for the periods presented. |
Use of Estimates | Use of Estimates The preparation of the Company's financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. The Company bases its estimates and judgments on historical experience and various other assumptions that it believes are reasonable under the circumstances. The amounts of assets and liabilities reported in the Company's balance sheets and the amounts of expenses reported for each of the periods presented are affected by estimates and assumptions, which are used for, but not limited to, the accounting for common stock warrants, stock-based compensation, income taxes, and accounting for research and development costs. Actual results could differ from those estimates. |
Stock Split | Stock Split On May 5, 2014, the Company effected a 1.4-for-1 stock split of the Company's common stock. All share and per share amounts of common stock contained in the Company's financial statements have been restated for all periods to give retroactive effect to the stock split. The shares of common stock retained a par value of $0.0001 per share. Accordingly, the stockholders' deficit reflects the stock split by reclassifying from "Additional paid-in Capital" to "Common Stock" in an amount equal to the par value of the increased shares resulting from the stock split. |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers all highly-liquid investments with an original maturity of three months or less when purchased to be cash equivalents. All cash and cash equivalents are held in United States financial institutions. Cash and cash equivalents include money market funds that invest primarily in commercial paper and U.S. government and U.S. government agency obligations. The Company maintains balances with financial institutions in excess of the FDIC limit. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments In accordance with ASC 825, Financial Instruments , disclosures of fair value information about financial instruments are required, whether or not recognized in the balance sheet, for which it is practicable to estimate that value. Cash and cash equivalents are carried at fair value (see Note 3). Financial instruments, including accounts payable and accrued liabilities, are carried at cost, which approximates fair value given their short-term nature. |
Property and Equipment | Property and Equipment Property and equipment, consisting of manufacturing, office and computer equipment, is stated at cost, less accumulated depreciation. Depreciation is computed using the straight-line, method over the estimated useful lives of the assets. Expenditures incurred after the fixed assets have been put into operation, such as repairs and maintenance, are charged to earnings in the period in which costs are incurred. Improvements and additions are capitalized in accordance with Company policy. |
Long-Lived Assets | Long-Lived Assets In accordance with ASC 360, Property, Plant and Equipment , the Company's policy is to review long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Management does not believe that there has been any impairment of the carrying value of any long-lived assets as of December 31, 2015. |
Research and Development Expense | Research and Development Expense Research and development costs are expensed as incurred. Research and development expense consists primarily of costs related to personnel, including salaries and other personnel-related expenses, expenses related to manufacturing, clinical trial expenses, consulting fees and support services used in drug development. All research and development costs are charged to operations as incurred in accordance with ASC 730, Research and Development . In certain circumstances, the Company is required to make advance payments to vendors for goods or services that will be received in the future for use in research and development activities. In such circumstances, the advance payments are deferred and are expensed when the activity has been performed or when the goods have been received. |
Deferred Financing Costs | Deferred Financing Costs Costs directly attributable to the Company's term loan (see Note 8) are deferred and capitalized. These costs represent legal fees and other costs related to the term loan and are being amortized over the term of the loan. Amortization of deferred financing costs charged to interest expense was $211, $59 and $45 for the years ended December 31, 2015, 2014 and 2013, respectively. |
Concentrations of Credit Risk | Concentrations of Credit Risk Financial instruments which potentially subject the Company to credit risk consist principally of cash and cash equivalents. All cash and cash equivalents are held in business checking and money market accounts in United States financial institutions the balances of which exceed federally insured limits. The Company has not recognized any losses from credit risks on such accounts. The Company believes it is not exposed to significant credit risks on cash and cash equivalents. The Company has no financial instruments with off-balance sheet risk of accounting loss. |
Warrants | Warrants The Company accounts for its warrants to purchase redeemable convertible stock in accordance with ASC 480, Distinguishing Liabilities from Equity . ASC 480 requires that a financial instrument, other than outstanding share, that, at inception, is indexed to an obligation to repurchase the issuer's equity shares, regardless of the timing or the probability of the redemption feature, and may require the issuer to settle the obligation by transferring assets be classified as a liability. The Company measures the fair value of its warrant liability using an option pricing model with changes in fair value recognized in the statement of operations. In connection with the completion of the Company's initial public offering in May 2014, the warrants to purchase shares of Series A-1 and Series A-2 preferred stock expired unexercised and the warrants to purchase shares of Series C preferred stock automatically converted into warrants to purchase shares of common stock. These common stock warrants with non-standard anti-dilution provisions (referred to as down round protection) are classified as liabilities and re-measured each reporting period. As of December 31, 2015, there were outstanding 62,505 warrants to purchase common stock at $6.00 per share. These warrants expire on December 14, 2019. In connection with the Company's debt financing which was completed in February 2015 (see Note 8), the Company issued warrants to purchase 180,274 shares of common stock. These warrants are classified as a component of stockholders' equity and the value of such warrants was determined using the Black-Scholes option-pricing model. |
Income Taxes | Income Taxes The Company accounts for deferred taxes using the asset and liability method as specified by ASC 740, Income Taxes . Deferred income tax assets and liabilities are determined based on differences between the financial statement reporting and the tax basis of assets and liabilities, operating losses and tax credit carryforwards. Deferred income taxes are measured using the enacted tax rates and laws that are anticipated to be in effect when the differences are expected to reverse. The measurement of deferred income tax assets is reduced, if necessary, by a valuation allowance for any tax benefits which are not expected to be realized. The effect on deferred income tax assets and liabilities of a change in tax rates is recognized in the period that such tax rate changes are enacted. The Company has adopted the authoritative guidance on accounting for and disclosure of uncertainty in tax positions which prescribes a comprehensive model for the financial statement recognition, measurement, presentation and disclosure of uncertain tax positions taken or expected to be taken in income tax returns. The Company has no uncertain tax positions as of December 31, 2015 that qualifies for either recognition or disclosure in the financial statements under this guidance. |
Stock-Based Compensation | Stock-Based Compensation The Company accounts for stock-based compensation in accordance with ASC 718, Compensation—Stock Compensation . The Company grants stock options for a fixed number of shares to employees and non-employees with an exercise price equal to the fair value of the shares at grant date. Compensation cost is recognized for all share-based payments granted and is based on the grant-date fair value estimated using the weighted-average assumption of the Black-Scholes option pricing models. The equity instrument is not considered to be issued until the instrument vests. As a result, compensation cost is recognized over the requisite service period with an offsetting credit to additional paid-in capital. Awards for consultants are accounted for under ASC 505-50, Equity Based Payments to Non-Employees . Any compensation expense related to consultants is marked-to-market over the applicable vesting period as they vest. Prior to May 22, 2014, the Company utilized various methodologies in accordance with the framework of the American Institute of Certified Public Accountants Technical Practice Aid, Valuation of Privately-Held Company Equity Securities Issued as Compensation , to estimate the fair value of its stock. The methodologies included an option pricing method and a probability-weighted expected return methodology that determined an estimated value under an initial public offering (IPO) scenario and a sale scenario based upon an assessment of the probability of occurrence of each scenario. Each valuation methodology includes estimates and assumptions that require the Company's judgment. These estimates include assumptions regarding future performance, including the successful completion of clinical trials and the time to completing an IPO or sale of the Company. As with any valuation, significant changes to the key assumptions used in the valuations could result in different fair values of common stock at each valuation date. |
Segment Information | Segment Information Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision making group, in deciding how to allocate resources and in assessing performance. The Company views its operations and manages its business in one operating and reporting segment, which is the business of developing its transdermal patch for use in contraception. |
Comprehensive Income | Comprehensive Income Effective January 1, 2012, an update to an accounting standard was issued that requires all non-owner changes in stockholders' equity to be presented either in a single continuous statement of comprehensive income or in two separate but consecutive statements. This update was applied retrospectively. The Company adopted this pronouncement and elected to present a separate statement of comprehensive income. The Company did not incur any components of comprehensive income for the periods presented and therefore, did not include a statement of comprehensive income in the financial statements. |
Net Loss Per Share | Net Loss Per Share Basic net loss per share is calculated by dividing the net loss by the weighted average number of common shares outstanding for the period, without consideration for common stock equivalents. Diluted net loss per share is calculated by dividing the net loss by the weighted-average number of common shares outstanding plus the effect of dilutive potential common shares outstanding during the period determined using the treasury-stock and if-converted methods. For purposes of diluted net loss per share calculation, convertible preferred stock, convertible preferred stock warrants, common stock warrants and stock options are considered to be potentially dilutive securities but are excluded from the calculation of diluted net loss per share because their effect would be anti-dilutive and therefore, basic and diluted net loss per share were the same for all periods presented. The following table sets forth the outstanding potentially dilutive securities that have been excluded from the calculation of diluted net loss per share because to do so would be anti-dilutive (in common equivalent shares): Year Ended December 31, 2015 2014 2013 Convertible preferred stock — — Convertible preferred stock warrants — — Common stock warrants — Common stock options Total |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In April 2015, the Financial Accounting Standards Board (FASB) issued an amendment to U.S. GAAP to simplify the balance sheet presentation of the costs for issuing debt. The changes were adopted in Accounting Standards Update (ASU) No. 2015-03, Interest—Imputation of Interest (Subtopic 835-30): Simplifying the Presentation of Debt Issue Costs . Public companies will have to apply the amendments for reporting periods that begin after December 15, 2015. This amendment requires adoption by revising the balance sheets for periods prior to the effective date. The Company is currently evaluating the impact of this ASU and does not believe the adoption of this ASU will have a material impact on the Company's financial position or results of operations. |
Summary of Significant Accoun24
Summary of Significant Accounting Polices (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Summary of Significant Accounting Polices | |
Schedule of potentially dilutive securities excluded from calculation of diluted net loss per share | The following table sets forth the outstanding potentially dilutive securities that have been excluded from the calculation of diluted net loss per share because to do so would be anti-dilutive (in common equivalent shares): Year Ended December 31, 2015 2014 2013 Convertible preferred stock — — Convertible preferred stock warrants — — Common stock warrants — Common stock options Total |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Fair Value Measurements | |
Schedule of financial instruments measured at fair value by level within fair value hierarchy | Level 1 Level 2 Level 3 2015 Assets: Cash equivalents $ $ — $ — Total assets at fair value $ $ — $ — Liabilities: Common stock warrants — — Total liabilities at fair value $ — $ — $ Level 1 Level 2 Level 3 2014 Assets: Cash equivalents $ $ — $ — Total assets at fair value $ $ — $ — Liabilities: Common stock warrants — — Total liabilities at fair value $ — $ — $ |
Rollforward of fair value of Level 3 warrants | Beginning balance at December 31, 2012 $ Change in fair value Ending balance at December 31, 2013 Expiration of Series A-1 and Series A-2 warrants ) Change in fair value Ending balance at December 31, 2014 Change in fair value Ending balance at December 31, 2015 $ |
Prepaid Expenses (Tables)
Prepaid Expenses (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Prepaid Expenses | |
Schedule of prepaid expenses by component and classification | December 31 2015 2014 Prepaid clinical trial expense $ $ Prepaid insurance Other Total prepaid expenses $ $ Prepaid expenses, short-term $ $ Prepaid expenses, long-term — Total prepaid expenses $ $ |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Property and Equipment | |
Schedule of components of property and equipment | December 31 2015 2014 Estimated Life Office equipment $ $ 3 - 10 years Computer equipment 3 years Manufacturing equipment 5 years Less: accumulated depreciation ) ) Property and equipment, net $ $ |
Accrued Liabilities (Tables)
Accrued Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Accrued Liabilities | |
Schedule of components of accrued liabilities | December 31 2015 2014 Employee bonuses $ $ Accrued clinical trial costs Other Total accrued liabilities $ $ |
Loan and Security Agreements (T
Loan and Security Agreements (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Loan and Security Agreements | |
Schedule of annual maturities of Hercules Loan | 2016 $ 2017 2018 Total $ |
Equity Incentive Plans (Tables)
Equity Incentive Plans (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Equity Incentive Plans | |
Schedule of stock-based compensation expense and allocation | Year Ended December 31, 2015 2014 2013 Employee $ $ $ Non-employee Total $ $ $ Year Ended December 31, 2015 2014 2013 Research and development $ $ $ General and administrative Total stock-based compensation expense $ $ $ |
Schedule of assumptions used to compute employee stock-based compensation | 2015 2014 2013 Risk-free interest rate % % % Expected volatility % % % Expected dividend yield % % % Expected life (in years) |
Summary of options outstanding, vested and exercisable | Options Weighted- Average Exercise Price Weighted- Average Remaining Contractual Life (Years) Aggregate Intrinsic Value Options outstanding at December 31, 2013 7.9 years Options granted Options exercised ) Options cancelled/forfeited ) Options outstanding at December 31, 2014 7.9 years Options granted Options exercised ) Options cancelled/forfeited ) Options outstanding at December 31, 2015 7.8 years $ Options exercisable at December 31, 2015 6.7 years $ Vested and expected to vest at December 31, 2015 7.8 years |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Income Taxes | |
Schedule of tax effects of temporary differences that give rise to significant portions of deferred tax assets | December 31 2015 2014 Deferred tax assets: Net operating loss carryforwards $ $ Research credit carryforward Stock options and other Total gross deferred tax assets Valuation allowance for deferred tax assets ) ) Net deferred tax assets $ — $ — |
Schedule of reconciliation of U.S. statutory income tax rate to effective tax rate | December 31, 2015 2014 2013 Federal income tax at statutory rate % % % State income tax benefit, net of federal benefit % % % Research and development tax credits % % % Other )% — % )% Increase to valuation allowance )% )% )% Effective income tax rate % % % |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Commitments and Contingencies. | |
Schedule of future minimum annual lease commitments under noncancelable operating lease | 2016 $ 2017 $ 2018 $ 2019 $ 2020 $ |
Quarterly Data (Unaudited) (Tab
Quarterly Data (Unaudited) (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Quarterly Data (Unaudited) | |
Summary of quarterly results of operations | March 31, 2015 June 30, 2015 September 30, 2015 December 31, 2015 Total revenue $ — $ — $ — $ — Operating expenses $ $ $ $ Net loss $ ) $ ) $ ) $ ) Basic net loss per common share $ ) $ ) $ ) $ ) Diluted net loss per common share $ ) $ ) $ ) $ ) March 31, 2014 June 30, 2014 September 30, 2014 December 31, 2014 Total revenue $ — $ — $ — $ — Operating expenses $ $ $ $ Net income (loss) $ $ ) $ ) $ ) Basic net income (loss) per common share $ $ ) $ ) $ ) Diluted net income (loss) per common share $ $ ) $ ) $ ) |
Organization and Description 34
Organization and Description of Business (Details) - USD ($) $ in Thousands | 12 Months Ended | |||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | |
Organization and Description of Business | ||||
Product revenue | $ 0 | |||
Accumulated deficit | (164,727) | $ (134,392) | ||
Cash and cash equivalents | $ 34,395 | $ 40,182 | $ 2,120 | $ 20,014 |
Summary of Significant Accoun35
Summary of Significant Accounting Polices - Stock Split (Details) | May. 05, 2014$ / shares | Dec. 31, 2015$ / shares | Dec. 31, 2014$ / shares |
Stock split | |||
Par value of common stock (in dollars per share) | $ 0.0001 | $ 0.0001 | $ 0.0001 |
Common stock | |||
Stock split | |||
Stock split conversion ratio | 1.4 |
Summary of Significant Accoun36
Summary of Significant Accounting Polices - Deferred Financing Costs (Details 2) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Interest expense | |||
Deferred Financing Costs | |||
Amortization of deferred financing costs | $ 211 | $ 59 | $ 45 |
Summary of Significant Accoun37
Summary of Significant Accounting Polices - Concentration of Credit Risk (Details 3) $ in Thousands | Dec. 31, 2015USD ($) |
Concentration of risk, financial assets | |
Financial instruments with off-balance sheet risk of accounting loss, assets | $ 0 |
Concentration risk, financial liabilities | |
Financial instruments with off-balance sheet risk of accounting loss, liabilities | $ 0 |
Summary of Significant Accoun38
Summary of Significant Accounting Polices - Warrants (Details 4) - Common stock warrants - $ / shares | Dec. 31, 2015 | Feb. 28, 2015 | Dec. 31, 2012 |
Warrants | |||
Warrants | |||
Common stock that can be purchased with warrants (in shares) | 180,274 | ||
Exercise price of warrants (in dollars per share) | $ 5.89 | ||
Warrants | |||
Warrants | |||
Common stock that can be purchased with warrants (in shares) | 62,505 | 62,505 | |
Exercise price of warrants (in dollars per share) | $ 6 | $ 6 |
Summary of Significant Accoun39
Summary of Significant Accounting Polices - Uncertain Tax Positions and Segment Information (Details 5) $ in Thousands | 12 Months Ended |
Dec. 31, 2015USD ($)segment | |
Uncertainty in tax positions | |
Unrecognized Tax Benefits | $ | $ 0 |
Segment Information | |
Number of operating segments | segment | 1 |
Summary of Significant Accoun40
Summary of Significant Accounting Polices - Outstanding Potentially Dilutive Securities that are Anti-Dilutive (Details 6) - shares | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Anti-dilutive securities | |||
Anti-dilutive securities excluded from the calculation of diluted net loss per share (in shares) | 2,407,844 | 1,880,053 | 7,661,010 |
Redeemable Convertible Preferred Stock | |||
Anti-dilutive securities | |||
Anti-dilutive securities excluded from the calculation of diluted net loss per share (in shares) | 6,292,369 | ||
Convertible preferred stock warrants | |||
Anti-dilutive securities | |||
Anti-dilutive securities excluded from the calculation of diluted net loss per share (in shares) | 205,020 | ||
Common stock warrants | |||
Anti-dilutive securities | |||
Anti-dilutive securities excluded from the calculation of diluted net loss per share (in shares) | 242,779 | 62,505 | |
Stock options | |||
Anti-dilutive securities | |||
Anti-dilutive securities excluded from the calculation of diluted net loss per share (in shares) | 2,165,065 | 1,817,548 | 1,163,621 |
Fair Value Measurements - Finan
Fair Value Measurements - Financial Instruments Measured at Fair Value by Hierarchy Level and Significant Assumptions Used for Warrants (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Liabilities: | ||
Common stock warrants | $ 406 | $ 296 |
Significant assumptions used in preparing the option pricing model for valuing the Company's warrants | ||
Fair value of stock (in dollars per share) | $ 9.76 | |
Recurring | Level 1 | ||
Assets: | ||
Total assets at fair value | $ 34,324 | 40,135 |
Recurring | Level 1 | Cash equivalents | ||
Assets: | ||
Cash and cash equivalents | 34,324 | 40,135 |
Recurring | Level 3 | ||
Liabilities: | ||
Total liabilities at fair value | 406 | 296 |
Recurring | Level 3 | Warrants | Common stock warrants | ||
Liabilities: | ||
Common stock warrants | $ 406 | $ 296 |
Recurring | Level 3 | Warrants | Common stock warrants | Option pricing model | ||
Significant assumptions used in preparing the option pricing model for valuing the Company's warrants | ||
Volatility (as a percent) | 75.00% | 104.80% |
Risk free interest rate (as a percent) | 1.54% | 1.68% |
Life of treasury bonds | 4 years | 5 years |
Strike price (in dollars per share) | $ 6 | $ 6 |
Fair value of stock (in dollars per share) | $ 9.76 | $ 6.14 |
Expected life | 4 years | 5 years |
Fair Value Measurements - Rollf
Fair Value Measurements - Rollforward of Fair Value of Level 3 Warrants and Transfers Between Levels (Details 2) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Fair value measurements | |||
Asset transfers out of Level 1 into Level 2 | $ 0 | $ 0 | |
Asset transfers out of Level 2 into Level 1 | 0 | 0 | |
Asset transfers into (out of) Level 3 | 0 | 0 | |
Liability transfers out of Level 1 into Level 2 | 0 | 0 | |
Liability transfers out of Level 2 into Level 1 | 0 | 0 | |
Liability transfers into (out of) Level 3 | 0 | 0 | |
Liabilities | Warrants | |||
Rollforward of the fair value of Level 3 warrants | |||
Beginning balance | 296 | 644 | $ 563 |
Expiration of Series A-1 and Series A-2 warrants | (493) | ||
Change in fair value | 110 | 145 | 81 |
Ending balance | $ 406 | $ 296 | $ 644 |
Prepaid Expenses (Details)
Prepaid Expenses (Details) - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 |
Prepaid Expenses | ||
Prepaid clinical trial expense | $ 2,803 | $ 1,678 |
Prepaid insurance | 780 | 762 |
Other | 107 | 42 |
Total prepaid expenses | 3,690 | 2,482 |
Prepaid expenses, short-term and long-term | ||
Prepaid expenses, short-term | 3,690 | 804 |
Prepaid expenses, long-term | 1,678 | |
Total prepaid expenses | $ 3,690 | $ 2,482 |
Property and Equipment (Details
Property and Equipment (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Property and Equipment | ||
Property and equipment, gross | $ 12,622 | $ 12,332 |
Less: accumulated depreciation | (304) | (286) |
Property and equipment, net | 12,318 | 12,046 |
Office equipment | ||
Property and Equipment | ||
Property and equipment, gross | $ 55 | 55 |
Office equipment | Minimum | ||
Property and Equipment | ||
Estimated Life | 3 years | |
Office equipment | Maximum | ||
Property and Equipment | ||
Estimated Life | 10 years | |
Computer equipment | ||
Property and Equipment | ||
Property and equipment, gross | $ 106 | 95 |
Estimated Life | 3 years | |
Manufacturing equipment | ||
Property and Equipment | ||
Property and equipment, gross | $ 12,461 | 12,182 |
Estimated Life | 5 years | |
Manufacturing equipment in process of being constructed and qualified | ||
Property and Equipment | ||
Property and equipment, gross | $ 12,300 | $ 12,000 |
Accrued Liabilities (Details)
Accrued Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 |
Accrued Liabilities | ||
Employee bonuses | $ 938 | $ 665 |
Accrued clinical trial costs | 1,507 | 254 |
Other | 208 | 143 |
Total accrued liabilities | $ 2,653 | $ 1,062 |
Convertible Note Financing (Det
Convertible Note Financing (Details) - Convertible notes - Convertible Promissory Notes, April 2014 - USD ($) $ / shares in Units, $ in Millions | May. 29, 2014 | Dec. 31, 2014 | Apr. 28, 2014 |
Convertible note financing | |||
Aggregate amount of loan borrowed | $ 3 | ||
Interest rate (as a percent) | 8.00% | ||
Conversion price (in dollars per share) | $ 6 | ||
Common stock | |||
Convertible note financing | |||
Conversion to common stock (in shares) | 503,450 | 503,450 |
Loan and Security Agreements -
Loan and Security Agreements - Oxford Loan and Hercules Loan (Details) | 1 Months Ended | 12 Months Ended | ||||
Feb. 28, 2015USD ($)$ / sharesshares | Dec. 31, 2012USD ($)$ / sharesshares | Dec. 31, 2015USD ($)installment$ / sharesshares | Dec. 31, 2014USD ($)installment | Dec. 31, 2013USD ($) | Dec. 31, 2012$ / sharesshares | |
Loan and Security Agreements | ||||||
Fair value of common stock warrant issued with debt financing | $ 1,184,000 | |||||
Significant assumptions used in preparing the option pricing model for valuing the Company's warrants | ||||||
Fair value of stock (in dollars per share) | $ / shares | $ 9.76 | |||||
Loss on extinguishment of debt | $ 1,036,000 | |||||
Warrants | Common stock warrants | ||||||
Loan and Security Agreements | ||||||
Common stock that can be purchased with warrants (in shares) | shares | 180,274 | |||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 5.89 | |||||
Significant assumptions used in preparing the option pricing model for valuing the Company's warrants | ||||||
Volatility (as a percent) | 75.00% | |||||
Risk free interest rate (as a percent) | 1.22% | |||||
Life of treasury bonds | 4 years | |||||
Strike price (in dollars per share) | $ / shares | $ 5.89 | |||||
Fair value of stock (in dollars per share) | $ / shares | $ 9.82 | |||||
Expected life | 4 years | |||||
Additional Paid-in Capital | ||||||
Loan and Security Agreements | ||||||
Fair value of common stock warrant issued with debt financing | $ 1,200,000 | $ 1,184,000 | ||||
Warrants | Common stock warrants | ||||||
Loan and Security Agreements | ||||||
Common stock that can be purchased with warrants (in shares) | shares | 62,505 | 62,505 | 62,505 | |||
Exercise price of warrants (in dollars per share) | $ / shares | $ 6 | $ 6 | $ 6 | |||
Secured debt | ||||||
Significant assumptions used in preparing the option pricing model for valuing the Company's warrants | ||||||
Interest expense, including accretion of value of related warrants and amortization of deferred financing costs | $ 2,077,000 | $ 1,545,000 | $ 1,472,000 | |||
Secured debt | Oxford Loan | ||||||
Loan and Security Agreements | ||||||
Amount borrowed | $ 15,000,000 | |||||
Repayment of existing debt | 15,500,000 | |||||
Number of consecutive monthly principal installments | installment | 30 | |||||
Final payment | $ 675,000 | |||||
Secured debt | Hercules Loan | ||||||
Loan and Security Agreements | ||||||
Maximum borrowing capacity | 25,000,000 | |||||
Amount borrowed | 16,500,000 | |||||
Additional amount available | 8,500,000 | |||||
Interest rate (as a percent) | 9.00% | |||||
Variable rate basis | Prime minus 4.25% | |||||
Number of consecutive monthly principal installments | installment | 30 | |||||
Final payment | $ 610,500 | |||||
Discount on debt | 1,200,000 | |||||
Secured debt | LIBOR | Oxford Loan | ||||||
Loan and Security Agreements | ||||||
Interest rate (as a percent) | 9.20% | |||||
Variable rate basis | Three-month U.S. Libor | |||||
Variable rate base (as a percent) | 0.47% | |||||
Variable interest rate margin (as a percent) | 8.73% | |||||
Secured debt | Prime | Hercules Loan | ||||||
Loan and Security Agreements | ||||||
Variable rate basis | Prime minus 4.25% | |||||
Variable interest rate margin (as a percent) | 9.00% | |||||
Variable rate adjustment (as a percent) | 4.25% | |||||
Secured debt | First year | Hercules Loan | ||||||
Loan and Security Agreements | ||||||
Prepayment premium as percentage of outstanding principal | 3.00% | |||||
Secured debt | Second year | Hercules Loan | ||||||
Loan and Security Agreements | ||||||
Prepayment premium as percentage of outstanding principal | 2.00% | |||||
Secured debt | After the second year | Hercules Loan | ||||||
Loan and Security Agreements | ||||||
Prepayment premium as percentage of outstanding principal | 1.00% | |||||
Equity financings | Right to participate in future equity financings | Secured debt | Hercules Loan | Hercules | Maximum | ||||||
Loan and Security Agreements | ||||||
Equity financings amount | $ 2,000,000 | |||||
Secured debt | Oxford Loan | ||||||
Significant assumptions used in preparing the option pricing model for valuing the Company's warrants | ||||||
Loss on extinguishment of debt | $ 1,000,000 |
Loan and Security Agreements 48
Loan and Security Agreements - Annual Maturities of Hercules Loan (Details 2) $ in Thousands | Dec. 31, 2015USD ($) |
Maturities of Loan | |
2,016 | $ 2,999 |
2,017 | 6,428 |
2,018 | 7,073 |
Total | $ 16,500 |
Stockholders' Equity - Initial
Stockholders' Equity - Initial Public Offering and Related Transactions (Details) - USD ($) $ / shares in Units, $ in Thousands | May. 29, 2014 | Dec. 31, 2014 |
Convertible notes | Convertible Promissory Notes, April 2014 | ||
Stockholders' equity | ||
Conversion to common stock | $ 3,000 | $ 3,020 |
Redeemable Convertible Preferred Stock | ||
Stockholders' equity | ||
Conversion to common stock | $ 69,233 | |
Common stock | Convertible notes | Convertible Promissory Notes, April 2014 | ||
Stockholders' equity | ||
Conversion to common stock (in shares) | 503,450 | 503,450 |
Common stock | Redeemable Convertible Preferred Stock | ||
Stockholders' equity | ||
Conversion to common stock | $ 1 | |
Conversion to common stock (in shares) | 8,809,325 | 8,803,547 |
Initial public offering | ||
Stockholders' equity | ||
Proceeds from the issuance of common stock, net | $ 49,700 | |
Initial public offering | Common stock | ||
Stockholders' equity | ||
Common stock issued (in shares) | 9,166,667 | 9,166,667 |
Share price (in dollars per share) | $ 6 |
Stockholders' Equity - Amended
Stockholders' Equity - Amended and Restated Certificate of Incorporation (Details 2) | May. 29, 2014classshares | May. 29, 2014seriesclassshares | May. 07, 2014USD ($) | Dec. 31, 2015shares | Dec. 31, 2014shares |
Sale of stock | |||||
Number of shares of common stock authorized | shares | 150,000,000 | 150,000,000 | 150,000,000 | 150,000,000 | |
Authorized shares of preferred stock | shares | 10,000,000 | 10,000,000 | |||
Number of classes of Board | class | 3 | ||||
Term of Board member | 3 years | ||||
Number of classes elected at each annual meeting | class | 1 | ||||
Minimum | |||||
Sale of stock | |||||
Number of series of preferred stock that may be issued | series | 1 | ||||
Affirmative vote of all then-outstanding shares of capital stock for removal of directors (as a percent) | 75.00% | ||||
Series C Convertible Preferred Stock | Automatic conversion, underwritten public offering | Minimum | |||||
Sale of stock | |||||
Gross proceeds from sale of common stock | $ 45,000,000 | ||||
Series B Convertible Preferred Stock | Automatic conversion, underwritten public offering | Minimum | |||||
Sale of stock | |||||
Gross proceeds from sale of common stock | 45,000,000 | ||||
Series A-1 Convertible Preferred Stock | Automatic conversion, underwritten public offering | Minimum | |||||
Sale of stock | |||||
Gross proceeds from sale of common stock | 45,000,000 | ||||
Series A-2 Convertible Preferred Stock | Automatic conversion, underwritten public offering | Minimum | |||||
Sale of stock | |||||
Gross proceeds from sale of common stock | $ 45,000,000 |
Stockholders' Equity - Private
Stockholders' Equity - Private Placement (Details 3) - Private Placement $ / shares in Units, $ in Millions | 1 Months Ended | 12 Months Ended |
Jan. 31, 2015USD ($)shareholder$ / sharesshares | Dec. 31, 2015shares | |
Sale of stock | ||
Proceeds from the issuance of common stock, net | $ | $ 19.3 | |
Stockholders affiliated with members of Board of Directors | ||
Sale of stock | ||
Proceeds from the issuance of common stock, net | $ | $ 9.5 | |
Common stock | ||
Sale of stock | ||
Common stock issued (in shares) | shares | 3,400,000 | 3,418,804 |
Share price (in dollars per share) | $ / shares | $ 5.85 | |
Common stock | Stockholders affiliated with members of Board of Directors | ||
Sale of stock | ||
Number of stockholders affiliated with members of Board of Directors who purchased shares | shareholder | 2 | |
Common stock issued (in shares) | shares | 1,623,932 |
Stockholders' Equity - Shelf Re
Stockholders' Equity - Shelf Registration Statement (Details 4) $ in Millions | Jun. 19, 2015USD ($) |
2015 Shelf Registration | |
Sale of stock | |
Aggregate amount of securities issuable | $ 150 |
Equity Incentive Plans - Awards
Equity Incentive Plans - Awards Granted, Terms and Employee and Non-employee Stock-Based Compensation Expense (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | Apr. 30, 2008 | |
Amended and restated 1997 Equity Incentive Plan 1997 | ||||
Equity incentive plans | ||||
Shares available for grant | 0 | |||
2008 Equity Incentive Plan | ||||
Equity incentive plans | ||||
Shares available for grant | 0 | |||
2014 Equity Incentive Plan | ||||
Equity incentive plans | ||||
Shares available for grant | 531,540 | |||
Stock options | ||||
Equity incentive plans | ||||
Stock-based compensation expense | $ 2,965 | $ 1,381 | $ 1,338 | |
Stock options | Minimum | ||||
Equity incentive plans | ||||
Exercise prices of options granted through the end of the year (in dollars per share) | $ 0.71 | |||
Stock options | Maximum | ||||
Equity incentive plans | ||||
Exercise prices of options granted through the end of the year (in dollars per share) | $ 285.71 | |||
Employee stock options | ||||
Equity incentive plans | ||||
Expiration period | 10 years | |||
Vesting period | 4 years | |||
Stock-based compensation expense | $ 2,662 | 1,185 | 476 | |
Non-employee stock options | ||||
Equity incentive plans | ||||
Expiration period | 10 years | |||
Vesting period | 4 years | |||
Stock-based compensation expense | $ 303 | $ 196 | $ 862 |
Equity Incentive Plans - Alloca
Equity Incentive Plans - Allocation of Stock-Based Compensation Related to Stock Options (Details 2) - Stock options - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Stock-Based Compensation Expense | |||
Total stock-based compensation expense | $ 2,965 | $ 1,381 | $ 1,338 |
Research and development | |||
Stock-Based Compensation Expense | |||
Total stock-based compensation expense | 1,161 | 617 | 862 |
General and administrative | |||
Stock-Based Compensation Expense | |||
Total stock-based compensation expense | $ 1,804 | $ 764 | $ 476 |
Equity Incentive Plans - Assump
Equity Incentive Plans - Assumptions Used Emplyee Stock Option Grants and Stock-Based Compensation to be Recognized (Details 3) - USD ($) $ / shares in Units, $ in Millions | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Employee stock options | |||
Weighted average of the assumptions used to compute employee stock based compensation | |||
Risk-free interest rate (as a percent) | 1.92% | 1.84% | 1.73% |
Expected volatility (as a percent) | 75.00% | 104.80% | 104.80% |
Expected dividend yield (as a percent) | 0.00% | 0.00% | 0.00% |
Expected life (in years) | 6 years 3 months | 6 years 3 months | 6 years 3 months |
Stock options | |||
Unrecorded deferred stock-based compensation | |||
Unrecorded deferred stock-based compensation balance related to stock options | $ 6.2 | ||
Weighted-average amortization period over which cost is expected to be recognized | 1 year 9 months 15 days | ||
Options granted | |||
Weighted average grant date fair value of options granted (in dollars per share) | $ 6.31 |
Equity Incentive Plans - Summar
Equity Incentive Plans - Summary of Activity for Options Outstanding, Options Exercisable and Intrinsic Value (Details 4) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Aggressive Intrinsic Value | |||
Estimated stock price (in dollars per share) | $ 9.76 | ||
Stock options | |||
Options | |||
Options outstanding at beginning of year (in shares) | 1,817,548 | 1,163,621 | |
Options granted (in shares) | 620,600 | 712,570 | |
Options exercised (in shares) | (261,936) | (41,904) | |
Options cancelled/forfeited (in shares) | (11,147) | (16,739) | |
Options outstanding at end of year (in shares) | 2,165,065 | 1,817,548 | 1,163,621 |
Options exercisable at end of year (in shares) | 1,083,249 | ||
Vested and expected to vest, at end of year (in shares) | 2,165,065 | ||
Weighted-Average Exercise Price | |||
Options outstanding at beginning of year (in dollars per share) | $ 5.56 | $ 3.44 | |
Options granted (in dollars per share) | 9.84 | 8.76 | |
Options exercised (in dollars per share) | 2.26 | 1.61 | |
Options cancelled/forfeited (in dollars per share) | 2.14 | 4.65 | |
Options outstanding at end of year (in dollars per share) | 7.19 | $ 5.56 | $ 3.44 |
Options exercisable at end of year (in dollars per share) | 5.06 | ||
Vested and expected to vest, at end of year (in dollars per share) | $ 7.19 | ||
Weighted-Average Remaining Contractual Life (Years) | |||
Options outstanding at end of year | 7 years 9 months 18 days | 7 years 10 months 24 days | 7 years 10 months 24 days |
Options exercisable at end of year | 6 years 8 months 12 days | ||
Vested and expected to vest, at end of year | 7 years 9 months 18 days | ||
Aggressive Intrinsic Value | |||
Options outstanding at the end of the period (in dollars) | $ 6,459 | ||
Options exercisable at the end of the period (in dollars) | 5,622 | ||
Options exercised for intrinsic value (in dollars) | $ 1,841 |
Income Taxes - Net Operating Lo
Income Taxes - Net Operating Loss Carryforwards (Details) $ in Millions | Dec. 31, 2015USD ($) |
State | |
Net operating loss carryforwards | |
Net operating loss carryforwards | $ 47.2 |
Federal | |
Net operating loss carryforwards | |
Net operating loss carryforwards | $ 151.8 |
Income Taxes - Research and Dev
Income Taxes - Research and Development Tax Credit Carryforwards (Details 2) - Research and Development $ in Millions | Dec. 31, 2015USD ($) |
State | |
Tax credit carryforwards | |
Tax credit carryforwards | $ 0.5 |
Federal | |
Tax credit carryforwards | |
Tax credit carryforwards | $ 4 |
Income Taxes - Tax Effects of T
Income Taxes - Tax Effects of Temporary Differences that Give Rise to Deferred Tax Assets (Details 3) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Deferred tax assets: | ||
Net operating loss carryforwards | $ 54,197 | $ 46,853 |
Research credit carryforward | 4,527 | 3,683 |
Stock options and other | 1,474 | 795 |
Total gross deferred tax assets | 60,198 | 51,331 |
Valuation allowance for deferred tax assets | (60,198) | (51,331) |
Income taxes | ||
Deferred income tax expense or benefit | 0 | 0 |
Valuation allowance | ||
Net change in the valuation allowance, related primarily to net operating losses | $ 8,900 | $ 4,700 |
Income Taxes - Reconciliation o
Income Taxes - Reconciliation of U.S. Statutory Income Tax Rate to Effective Tax Rate (Details 4) | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Reconciliation of the U.S. statutory income tax rate to the Company's effective tax rate | |||
Federal income tax at statutory rate (as a percent) | 34.00% | 34.00% | 34.00% |
State income tax benefit, net of federal benefit (as a percent) | 6.00% | 6.00% | 5.70% |
Research and development tax credits (as a percent) | 2.00% | 3.00% | 2.70% |
Other (as a percent) | (2.00%) | (1.40%) | |
Increase to valuation allowance (as a percent) | (24.00%) | (24.00%) | (41.00%) |
Effective income tax rate (as a percent) | 16.00% | 19.00% | 0.00% |
Income Taxes - Sale of New Jers
Income Taxes - Sale of New Jersey Net Operating Losses (Details 5) - State - USD ($) $ in Millions | Nov. 30, 2015 | Feb. 27, 2014 | Dec. 31, 2015 |
Sale of New Jersey Net Operating Losses | |||
NOLs | $ 47.2 | ||
Research and Development | |||
Sale of New Jersey Net Operating Losses | |||
Tax credits | $ 0.5 | ||
New Jersey | Sale of unused NOLs and research and development credits | |||
Sale of New Jersey Net Operating Losses | |||
NOLs | $ 59.8 | $ 39.1 | |
Net proceeds from sale | 6 | 3.6 | |
New Jersey | Research and Development | Sale of unused NOLs and research and development credits | |||
Sale of New Jersey Net Operating Losses | |||
Tax credits | $ 1.1 | $ 0.4 |
Related Party Transactions (Det
Related Party Transactions (Details) - SmartPharma $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015USD ($) | Dec. 31, 2014USD ($) | Mar. 17, 2014person | |
Related party transactions | |||
Number of Managing Partners appointed to Chief Commercial Officer | person | 1 | ||
Commercial and business development consulting services | |||
Related party transactions | |||
Fees invoiced by the related party | $ | $ 73 | $ 126 |
Commitments and Contingencies63
Commitments and Contingencies (Details) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015USD ($)ft² | Dec. 31, 2014USD ($) | Dec. 31, 2013USD ($) | |
Operating Leases | |||
Area of office space leased (in square feet) | ft² | 7,000 | ||
Lease term | 5 years | ||
Rent expense | $ 163 | $ 159 | $ 142 |
Future minimum annual lease commitments under the noncancelable operating lease | |||
2,016 | 162 | ||
2,017 | 163 | ||
2,018 | 169 | ||
2,019 | 170 | ||
2,020 | $ 162 |
Subsequent Events (Details)
Subsequent Events (Details) - Subsequent Events - USD ($) $ / shares in Units, $ in Millions | 1 Months Ended | 2 Months Ended | |
Feb. 29, 2016 | Jan. 31, 2016 | Feb. 29, 2016 | |
Underwritten public offering | |||
Subsequent Events | |||
Proceeds from the issuance of common stock, net | $ 37.3 | ||
Underwritten public offering | Common stock | |||
Subsequent Events | |||
Common stock issued (in shares) | 5,511,812 | 6,338,583 | |
Share price (in dollars per share) | $ 6.35 | ||
Underwriter purchase option | Common stock | |||
Subsequent Events | |||
Common stock issued (in shares) | 826,771 | ||
Share price (in dollars per share) | $ 6.35 | $ 6.35 |
Quarterly Data (Unaudited) - Qu
Quarterly Data (Unaudited) - Quarterly Results of Operations (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2015 | Sep. 30, 2015 | Jun. 30, 2015 | Mar. 31, 2015 | Dec. 31, 2014 | Sep. 30, 2014 | Jun. 30, 2014 | Mar. 31, 2014 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Summary of quarterly results of operations | |||||||||||
Total revenue | $ 0 | ||||||||||
Operating expenses | $ 9,165 | $ 8,965 | $ 7,982 | $ 6,977 | $ 6,524 | $ 6,049 | $ 3,495 | $ 2,448 | 33,089 | $ 18,515 | $ 12,728 |
Net income (loss) | $ (3,899) | $ (9,411) | $ (8,486) | $ (8,538) | $ (6,845) | $ (6,353) | $ (3,718) | $ 839 | $ (30,335) | $ (16,077) | $ (14,321) |
Basic net income (loss) per common share (in dollars per share) | $ (0.17) | $ (0.42) | $ (0.38) | $ (0.40) | $ (0.37) | $ (0.34) | $ (0.46) | $ 0.10 | |||
Diluted net income (loss) per common share (in dollars per share) | $ (0.17) | $ (0.42) | $ (0.38) | $ (0.40) | $ (0.37) | $ (0.34) | $ (0.46) | $ 0.01 |
Quarterly Data (Unaudited) - Ta
Quarterly Data (Unaudited) - Tax Benefit from Sale of New Jersey State Net Operating Losses (Details 2) - USD ($) $ in Thousands | 3 Months Ended | |
Dec. 31, 2015 | Mar. 31, 2014 | |
New Jersey | Sale of unused NOLs and research and development credits | ||
Sale of New Jersey Net Operating Losses | ||
Tax benefit | $ 5,972 | $ 3,653 |