Document_and_Entity_Informatio
Document and Entity Information (USD $) | 12 Months Ended | ||
Dec. 31, 2014 | Mar. 09, 2015 | Jun. 30, 2014 | |
Document and Entity Information | |||
Entity Registrant Name | GTX INC /DE/ | ||
Entity Central Index Key | 1260990 | ||
Document Type | 10-K | ||
Document Period End Date | 31-Dec-14 | ||
Amendment Flag | FALSE | ||
Current Fiscal Year End Date | -19 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Filer Category | Accelerated Filer | ||
Entity Public Float | $50,111,518 | ||
Entity Common Stock, Shares Outstanding | 140,325,643 | ||
Document Fiscal Year Focus | 2014 | ||
Document Fiscal Period Focus | FY |
BALANCE_SHEETS
BALANCE SHEETS (USD $) | Dec. 31, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Current assets: | ||
Cash and cash equivalents | $17,880 | $14,529 |
Short-term investments | 31,415 | 200 |
Prepaid expenses and other current assets | 856 | 442 |
Total current assets | 50,151 | 15,171 |
Property and equipment, net | 29 | 112 |
Intangible and other assets, net | 471 | 322 |
Total assets | 50,651 | 15,605 |
Current liabilities: | ||
Accounts payable | 512 | 808 |
Warrant liability | 30,430 | |
Accrued expenses and other current liabilities | 1,850 | 3,759 |
Total current liabilities | 32,792 | 4,567 |
Other long-term liabilities | 30 | 354 |
Commitments and contingencies | ||
Stockholders' equity: | ||
Common stock, $0.001 par value: 200,000,000 and 120,000,000 shares authorized at December 31, 2014 and December 31, 2013, respectively; 140,325,643 and 63,185,389 shares issued and outstanding at December 31, 2014 and December 31, 2013, respectively | 140 | 63 |
Additional paid-in capital | 512,460 | 465,981 |
Accumulated deficit | -494,771 | -455,360 |
Total stockholders' equity | 17,829 | 10,684 |
Total liabilities and stockholders' equity | $50,651 | $15,605 |
BALANCE_SHEETS_Parenthetical
BALANCE SHEETS (Parenthetical) (USD $) | Dec. 31, 2014 | Dec. 31, 2013 |
BALANCE SHEETS | ||
Common stock, par value (in dollars per share) | $0.00 | $0.00 |
Common stock, shares authorized | 200,000,000 | 120,000,000 |
Common stock, shares issued | 140,325,643 | 63,185,389 |
Common stock, shares outstanding | 140,325,643 | 63,185,389 |
STATEMENTS_OF_OPERATIONS
STATEMENTS OF OPERATIONS (USD $) | 12 Months Ended | ||
In Thousands, except Share data, unless otherwise specified | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 |
Expenses: | |||
Research and development expenses | $20,870 | $32,318 | $38,887 |
General and administrative expenses | 9,478 | 11,281 | 10,845 |
Total expenses | 30,348 | 43,599 | 49,732 |
Loss from operations | -30,348 | -43,599 | -49,732 |
Other income (expense), net | -259 | 1,488 | -19 |
Loss on change in fair value of warrant liability | -8,804 | ||
Loss from operations before income taxes | -39,411 | -42,111 | -49,751 |
Income tax benefit | 8,821 | ||
Net loss from continuing operations | -39,411 | -42,111 | -40,930 |
Income from discontinued operations before income taxes | 22,676 | ||
Income tax expense | -8,821 | ||
Net income from discontinued operations | 13,855 | ||
Net loss | ($39,411) | ($42,111) | ($27,075) |
Net (loss) income per share - basic and diluted: | |||
Net loss from continuing operations (in dollars per share) | ($0.48) | ($0.67) | ($0.65) |
Net income from discontinued operations (in dollars per share) | $0.22 | ||
Net loss per share (in dollars per share) | ($0.48) | ($0.67) | ($0.43) |
Weighted average shares outstanding: | |||
Basic and diluted (in shares) | 81,807,706 | 63,057,142 | 62,809,219 |
STATEMENTS_OF_STOCKHOLDERS_EQU
STATEMENTS OF STOCKHOLDERS' EQUITY (USD $) | Common Stock | Common Stock | Common Stock | Additional Paid-in Capital | Additional Paid-in Capital | Additional Paid-in Capital | Retained Earnings | Private Placement, March 2014 | Private Placement, November 2014 | Total |
In Thousands, except Share data, unless otherwise specified | Private Placement, March 2014 | Private Placement, November 2014 | Private Placement, March 2014 | Private Placement, November 2014 | ||||||
Balance at Dec. 31, 2011 | $63 | $457,985 | ($386,174) | $71,874 | ||||||
Balance (in shares) at Dec. 31, 2011 | 62,790,223 | |||||||||
Increase (Decrease) in Stockholders' Equity | ||||||||||
Exercise of employee stock options | 85 | 85 | ||||||||
Exercise of employee stock options (in shares) | 28,201 | 28,201 | ||||||||
Directors' deferred compensation | 169 | 169 | ||||||||
Share-based compensation | 2,648 | 2,648 | ||||||||
Net loss | -27,075 | -27,075 | ||||||||
Balance at Dec. 31, 2012 | 63 | 460,887 | -413,249 | 47,701 | ||||||
Balance (in shares) at Dec. 31, 2012 | 62,818,424 | |||||||||
Increase (Decrease) in Stockholders' Equity | ||||||||||
Issuance of common stock under deferred compensation arrangements (in shares) | 45,667 | |||||||||
Exercise of employee stock options | 1,226 | 1,226 | ||||||||
Exercise of employee stock options (in shares) | 321,298 | 321,298 | ||||||||
Directors' deferred compensation | 135 | 135 | ||||||||
Share-based compensation | 3,733 | 3,733 | ||||||||
Net loss | -42,111 | -42,111 | ||||||||
Balance at Dec. 31, 2013 | 63 | 465,981 | -455,360 | 10,684 | ||||||
Balance (in shares) at Dec. 31, 2013 | 63,185,389 | 63,185,389 | ||||||||
Increase (Decrease) in Stockholders' Equity | ||||||||||
Issuance of common stock and warrants in private placement, net of offering costs | 12 | 64 | 21,123 | 21,420 | 21,135 | 21,484 | ||||
Issuance of common stock in private placement (in shares) | 11,976,048 | 64,311,112 | ||||||||
Exercise of employee stock options (in shares) | 0 | |||||||||
Vesting of restricted stock units, net of shares withheld for tax payments | 1 | -617 | -616 | |||||||
Vesting of restricted stock units, net of shares withheld for tax payments (in shares) | 853,094 | |||||||||
Directors' deferred compensation | 125 | 125 | ||||||||
Share-based compensation | 4,428 | 4,428 | ||||||||
Net loss | -39,411 | -39,411 | ||||||||
Balance at Dec. 31, 2014 | $140 | $512,460 | ($494,771) | $17,829 | ||||||
Balance (in shares) at Dec. 31, 2014 | 140,325,643 | 140,325,643 |
STATEMENTS_OF_CASH_FLOWS
STATEMENTS OF CASH FLOWS (USD $) | 12 Months Ended | ||
In Thousands, unless otherwise specified | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 |
Cash flows from operating activities: | |||
Net loss | ($39,411) | ($42,111) | ($27,075) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Loss on change in fair value of warrant liability | 8,804 | ||
Private placement expenses recorded as other income (expense), net | 297 | ||
Gain on sale of FARESTON | -18,831 | ||
Share-based compensation | 4,428 | 3,733 | 2,648 |
Directors' deferred compensation | 125 | 135 | 169 |
Depreciation and amortization | 102 | 384 | 750 |
Gain on sale of property and equipment | -1,366 | ||
Changes in assets and liabilities: | |||
Prepaid expenses and other assets | -577 | 399 | 1,857 |
Accounts payable | -296 | -899 | 488 |
Accrued expenses and other liabilities | -2,231 | -4,246 | 2,885 |
Net cash used in operating activities | -28,759 | -43,971 | -37,109 |
Cash flows from investing activities: | |||
Purchase of property and equipment | -5 | -32 | -142 |
Proceeds from the sale of property and equipment | 1,424 | ||
Purchase of short-term investments, held to maturity | -41,905 | -1,425 | -11,980 |
Proceeds from maturities of short-term investments, held to maturity | 10,690 | 9,270 | 14,630 |
Proceeds from the sale of FARESTON, net of cash expenses | 18,897 | ||
Net cash (used in) provided by investing activities | -31,220 | 9,237 | 21,405 |
Cash flows from financing activities: | |||
Net proceeds from the issuance of common stock and warrants | 63,949 | ||
Tax payments related to shares withheld for vested restricted stock units | -617 | ||
Proceeds from exercise of employee stock options | 1,226 | 85 | |
Payments on capital lease and financed equipment obligations | -2 | -7 | -82 |
Net cash provided by financing activities | 63,330 | 1,219 | 3 |
Net (decrease) increase in cash and cash equivalents | 3,351 | -33,515 | -15,701 |
Cash and cash equivalents, beginning of period | 14,529 | 48,044 | 63,745 |
Cash and cash equivalents, end of period | $17,880 | $14,529 | $48,044 |
Business
Business | 12 Months Ended |
Dec. 31, 2014 | |
Business | |
Business | 1. Business |
GTx, Inc. ("GTx" or the "Company"), a Delaware corporation incorporated on September 24, 1997 and headquartered in Memphis, Tennessee, is a biopharmaceutical company dedicated to the discovery, development and commercialization of small molecules for the treatment of cancer, including treatments for breast and prostate cancer, and other serious medical conditions. | |
The Company is developing selective androgen receptor modulators ("SARMs"), including its lead product candidate, enobosarm (GTx-024). SARMs are a new class of drugs that the Company believes have the potential to be used as a novel hormonal therapy for the treatment of advanced breast cancer, as well as the potential to prevent and treat muscle wasting in patients with cancer and other musculoskeletal wasting or muscle loss conditions. The Company announced during the second quarter of 2014 positive results from an ongoing Phase 2 proof-of-concept, open-label clinical trial evaluating a 9 mg oral daily dose of enobosarm for the treatment of patients with estrogen receptor ("ER") positive and androgen receptor ("AR") positive metastatic breast cancer who have previously responded to hormonal therapy. The Company's current strategy is focused on further development of enobosarm in two breast cancer indications targeting the androgen receptor. Subject to the receipt of necessary regulatory approvals, the Company plans to initiate a Phase 2 proof-of-concept clinical trial of enobosarm in the second quarter of 2015 that is designed to evaluate the efficacy and safety of enobosarm in patients with advanced AR positive triple-negative breast cancer. Subject to the receipt of necessary regulatory approvals, the Company also plans to initiate a second Phase 2 clinical trial in the third quarter of 2015 evaluating enobosarm in patients with ER positive and AR positive advanced breast cancer. | |
The Company announced in August 2013 that its POWER 1 (platinum plus taxane chemotherapy) and POWER 2 (platinum plus non-taxane chemotherapy) Phase 3 clinical trials evaluating enobosarm 3 mg daily for the prevention and treatment of muscle wasting in patients with advanced non-small cell lung cancer ("NSCLC") failed to meet the statistical criterion for the co-primary endpoints of lean body mass and physical function that were assessed using responder analyses as pre-specified for the United States Food and Drug Administration ("FDA"). Based upon input from representatives from the FDA and from member countries to the European Medicines Agency ("EMA"), the Company believes that the data from the POWER trials is not sufficient to support the filing and approval of a new drug application in the United States or a marketing authorization application in the European Union for enobosarm 3 mg for the prevention and treatment of muscle wasting in patients with advanced NSCLC. The Company's strategy does not currently include further development of enobosarm for this indication in the United States or in the European Union unless such development is part of a third-party collaborative arrangement or strategic partnership. | |
Additionally, the Company is developing GTx-758 (Capesaris®), an oral nonsteroidal selective estrogen receptor alpha agonist, for secondary hormonal therapy in men with castration resistant prostate cancer, and, potentially, as a secondary hormonal treatment for advanced prostate cancer used in combination with androgen deprivation therapy. The Company is presently conducting a Phase 2 clinical trial evaluating GTx-758 as a secondary hormonal therapy in men with metastatic and high risk non-metastatic castration resistant prostate cancer. | |
Significant_Accounting_Policie
Significant Accounting Policies | 12 Months Ended | |||||
Dec. 31, 2014 | ||||||
Significant Accounting Policies | ||||||
Significant Accounting Policies | 2. Significant Accounting Policies | |||||
Basis of Presentation | ||||||
The accompanying financial statements have been prepared in accordance with U.S. generally accepted accounting principles ("U.S. GAAP"). Additionally, GTx operates in one business segment. | ||||||
Use of Estimates | ||||||
The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenues and expenses during the reporting period. Actual amounts and results could differ from those estimates. | ||||||
Cash and Cash Equivalents | ||||||
The Company considers highly liquid investments with initial maturities of three months or less to be cash equivalents. | ||||||
Short-term Investments | ||||||
At December 31, 2014 and 2013, short-term investments consisted of Federal Deposit Insurance Corporation ("FDIC") insured certificates of deposit with original maturities of greater than three months and less than one year. | ||||||
Property and Equipment | ||||||
Property and equipment is stated at cost. Amortization of leasehold improvements is recognized over the shorter of the estimated useful life of the leasehold improvement or the lease term. Depreciation is computed using the straight-line method over the estimated useful lives as follows: | ||||||
Laboratory and office equipment | 3 to 5 years | |||||
Leasehold improvements | 3 to 7 years | |||||
Furniture and fixtures | 5 years | |||||
Computer equipment and software | 3 years | |||||
Warrant Liability | ||||||
On November 14, 2014, the Company issued warrants to purchase 64,311,112 shares of its common stock. The Company classifies the warrants as a liability on its balance sheet since the warrants contain certain terms that could require the Company (or its successor) to purchase the warrants for cash in an amount equal to the value (as calculated utilizing a contractually-agreed Black-Scholes option pricing formula) of the unexercised portion of the warrants in connection with certain change of control transactions occurring on or prior to December 31, 2016, with such cash payment capped at an amount equal to $0.125 per unexercised share underlying each warrant. In addition, each warrant is subject to net cash settlement if, at the time of any exercise, there are then an insufficient number of authorized and reserved shares of common stock to effect a share settlement of the warrant. As of December 31, 2014, the Company did not have a sufficient number of authorized and reserved shares of common stock to effect the share settlement of all of these warrants; however, these warrants were not exercisable at December 31, 2014. | ||||||
As a result of the foregoing provisions, the Company is required to account for these warrants as a liability at fair value and the estimated warrant liability is required to be revalued at each balance sheet date until the earlier of the exercise of the warrants or, assuming stockholder approval is obtained for the authorization of additional common stock, the expiration of the provision on December 31, 2016 that could require cash settlement upon certain change of control transactions. Upon the exercise of the warrants or, assuming stockholder approval is obtained for the authorization of additional common stock, the expiration of the provision on December 31, 2016 that could require cash settlement upon certain change of control transactions, the fair value of the warrants will be reclassified from a liability to stockholders' equity on the Company's balance sheets and no further adjustment to the fair value would be made in subsequent periods. See Note 6, Stockholders' Equity, for further information regarding these warrants and the Company's valuation of the warrant liability. | ||||||
Fair Value of Financial Instruments and Warrant Liability | ||||||
The carrying amounts of the Company's financial instruments (which include cash, cash equivalents, short-term investments, and accounts payable) and its warrant liability approximate their fair values. The fair value of the warrant liability is estimated using the Black-Scholes-Merton pricing valuation model. See Note 6, Stockholders' Equity, for additional disclosure on the valuation methodology and significant assumptions. The Company's financial assets and liabilities are classified within a three-level fair value hierarchy that prioritizes the inputs used to measure fair value, which is defined as follows: | ||||||
Level 1 — Quoted prices in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date | ||||||
Level 2 — Inputs other than quoted prices in active markets that are observable for the asset or liability, either directly or indirectly | ||||||
Level 3 — Inputs that are unobservable for the asset or liability | ||||||
Asset and liabilities measured at fair value on a recurring basis as of December 31, 2014 included only the Company's warrant liability of $30,430, which was classified within Level 3 of the hierarchy. As of December 31, 2013, the Company had no assets or liabilities measured at fair value on a recurring basis within Level 3 of the hierarchy. A loss of $8,804 related to the change in the fair value of the warrant liability was recognized during the year ended December 31, 2014 as a non-cash loss in the Company's statement of operations. | ||||||
As the Company has the positive intent and ability to hold its certificates of deposit classified as short-term investments until maturity, these investments have been classified as held to maturity investments and are stated at cost, which approximates fair value. The Company considers these to be Level 2 investments as the fair values of these investments are determined using third-party pricing sources, which generally utilize observable inputs, such as interest rates and maturities of similar assets. | ||||||
Concentration of Risk | ||||||
Financial instruments that potentially subject the Company to a concentration of credit risk consist of cash and cash equivalents and short-term investments. The Company has established guidelines relating to diversification and maturities of its cash equivalents and short-term investments which are designed to manage risk. The Company's cash and cash equivalents consist of bank deposits, certificates of deposit, and money market mutual funds. Bank deposits may at times be in excess of FDIC insurance limits. The Company's short-term investments consist of FDIC insured certificates of deposit with original maturities of greater than three months and less than one year. | ||||||
Research and Development Expenses | ||||||
Research and development expenses include, but are not limited to, the Company's expenses for personnel, supplies, and facilities associated with research activities, screening and identification of product candidates, formulation and synthesis activities, manufacturing, preclinical studies, toxicology studies, clinical trials, regulatory and medical affairs activities, quality assurance activities and license fees. The Company expenses these costs in the period in which they are incurred. The Company estimates its liabilities for research and development expenses in order to match the recognition of expenses to the period in which the actual services are received. As such, accrued liabilities related to third party research and development activities are recognized based upon the Company's estimate of services received and degree of completion of the services in accordance with the specific third party contract. | ||||||
Patent Costs | ||||||
The Company expenses patent costs, including legal expenses, in the period in which they are incurred. Patent expenses are included in general and administrative expenses in the Company's statements of operations. | ||||||
Income Taxes | ||||||
The Company accounts for deferred taxes by recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the financial statements or tax returns. Under this method, deferred tax assets and liabilities are determined based on the difference between the financial statement and tax basis of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. A valuation allowance is provided when it is more likely than not that some portion or all of the deferred tax assets will not be realized. Accordingly, at December 31, 2014 and December 31, 2013, net of the valuation allowance, the net deferred tax assets were reduced to zero. See Note 9, Income Taxes, for further discussion. | ||||||
The Company has recognized the tax effect of discontinued operations in the statement of operations for the year ended December 31, 2012 in accordance with the intra-period accounting rules. An offsetting tax benefit was recorded in continuing operations for the year ended December 31, 2012 in relation to the tax expense that was recognized for discontinued operations. | ||||||
Share-Based Compensation | ||||||
The Company has stock option and equity incentive plans that provide for the purchase or acquisition of the Company's common stock by certain of the Company's employees and non-employees. The Company recognizes compensation expense for its share-based payments based on the fair value of the awards over the period during which an employee or non-employee is required to provide service in exchange for the award. See Note 3, Share-Based Compensation, for further discussion. | ||||||
Other Income (Expense), Net | ||||||
Other income (expense), net consists of foreign currency transaction gains and losses, interest earned on the Company's cash, cash equivalents and short-term investments, interest expense, and other non-operating income or expense. Other income (expense), net for the year ended December 31, 2014 also included expenses related to the private placement of common stock and warrants completed in November 2014 as the warrants issued were accounted for as a liability. Other income (expense), net for the year ended December 31, 2013 also included a gain of $1,366 from the sale of research and development property and equipment sold subsequent to the workforce reduction that occurred in October 2013. See Note 4, Property and Equipment, Net, for further discussion. | ||||||
Basic and Diluted Net Loss Per Share | ||||||
Basic and diluted net loss per share attributable to common stockholders is calculated based on the weighted average number of common shares outstanding during the period. Diluted net loss per share gives effect to the dilutive potential of common stock consisting of stock options, common stock warrants, and unvested restricted stock units ("RSUs"). | ||||||
Weighted average potential shares of common stock of 24,628,775, 6,773,394, and 5,574,915 were excluded from the calculation of diluted net loss per share for the years ended December 31, 2014, 2013 and 2012, respectively, as inclusion of the potential shares would have had an anti-dilutive effect on the net loss per share for the periods. The increase in the weighted average potential shares of common stock excluded from the calculation of diluted net loss per share increased from the prior year due to the issuance of warrants under the two financing transactions that occurred during the year ended December 31, 2014. See Note 6, Stockholders' Equity, for further discussion. At December 31, 2014, the Company had outstanding 140,325,643 shares of common stock. | ||||||
Comprehensive Loss | ||||||
For all periods presented, there were no differences between net loss and comprehensive loss. | ||||||
Discontinued Operations | ||||||
Effective September 30, 2012, the Company entered into an asset purchase agreement (the "FARESTON® Purchase Agreement") with Strakan International S.á r.l., an affiliate of ProStrakan Group plc ("ProStrakan") pursuant to which the Company agreed to transfer, sell and assign to ProStrakan all of the Company's rights and certain assets related to FARESTON® for a total cash purchase price of $21,671. The Company recognized a gain of $18,831 on the sale of FARESTON® for the year ended December 31, 2012. The gain represents the gross proceeds received from the sale reduced by a contract termination fee of $1,000 due to Orion (as discussed further in Note 7, Collaboration and License Agreements), a financial advisory fee related to the transaction of $1,712, and other transaction expenses of approximately $128. The Company has accounted for FARESTON® as a discontinued operation. As a result, revenue of $5,284, cost of goods sold of $784, and operating expenses of $655 related to FARESTON® were excluded from the respective captions in the statement of operations and were included in discontinued operations for the years ended December 31, 2012. Under the FARESTON® Purchase Agreement, the Company remains liable for future product returns relating to sales of FARESTON® made by the Company prior to September 30, 2012. For the year ended December 31, 2014, the Company recorded a benefit of $576 as general and administrative expenses in the statement of operations for adjustments to the Company's accrual for product returns related to the closure of the return period for a portion of the previously sold inventory. | ||||||
FARESTON® Revenue Recognition | ||||||
Revenue from product sales of FARESTON®, which is included in income from discontinued operations before income taxes for the year ended December 31, 2012, was recognized less deductions for estimated sales discounts and sales returns. Revenue from product sales was recognized when persuasive evidence of an arrangement existed, title passed, the price was fixed or determinable, and collectability was reasonably assured. The Company accounted for rebates to certain governmental agencies as a reduction of product sales. The Company allows customers to return product within a specified time period prior to and subsequent to the product's labeled expiration date. Although the Company sold its rights and certain assets related to FARESTON® effective September 30, 2012, the Company retains the liability for future product returns relating to sales of FARESTON® made by the Company prior to September 30, 2012. Therefore, the Company estimates an accrual for product returns based on factors which include historical product returns and estimated product in the distribution channel which is expected to exceed its expiration date. At December 31, 2014 and December 31, 2013, the Company's accrual for product returns, was $141 and $918, respectively. Of these amounts, $30 and $332 have been included in "Other long-term liabilities" in the Company's balance sheet at December 31, 2014 and December 31, 2013, respectively, and represents the portion of the Company's product returns accrual estimated to be payable after one year. | ||||||
Restructuring | ||||||
In October 2013, the Company implemented a reduction in its workforce following the announced results from its two Phase 3 clinical trials evaluating enobosarm 3 mg for the prevention and treatment of muscle wasting in patients with advanced NSCLC. The reduction in force was effective immediately and represented approximately 60% of the Company's total workforce. | ||||||
As a result of the workforce reduction, the Company incurred severance related cash expenses of $1,306, of which $351 was included in general and administrative expenses and $955 was included in research and development expenses for the year ended December 31, 2013. All of these expenses were paid as of December 31, 2013. Additionally, the Company recognized a net benefit of approximately $370 resulting from the reversal of share-based compensation expense related to the modification of certain stock option provisions for the severed employees. Of this amount, $81 was included as a benefit to general and administrative expenses and $289 was included as a benefit to research and development expenses for the year ended December 31, 2013. | ||||||
As a result of the October 2013 reduction in its workforce, the Company is no longer conducting in-house drug discovery activities. During the fourth quarter of 2013, the Company cancelled its sublease for the laboratory facilities and office space utilized for drug discovery. Additionally, the Company sold its related property and equipment for a gain of $1,366, which was included in other income (expense), net for the year ended December 31, 2013. | ||||||
Recent Accounting Pronouncements | ||||||
In August 2014, the Financial Accounting Standards Board issued Accounting Standard Update 2014-15, Disclosure of Uncertainties about an Entity's Ability to Continue as a Going Concern. The new guidance is intended to define management's responsibility to evaluate whether there is substantial doubt about an organization's ability to continue as a going concern within one year of the date the financial statements are issued and to provide related footnote disclosure. This new guidance is effective for the first annual period ending after December 15, 2016 and interim periods thereafter. | ||||||
Subsequent Events | ||||||
The Company has evaluated all events or transactions that occurred after December 31, 2014 up through the date the financial statements were issued. There were no material recognizable or nonrecognizable subsequent events during the period evaluated. | ||||||
ShareBased_Compensation
Share-Based Compensation | 12 Months Ended | ||||||||||||||
Dec. 31, 2014 | |||||||||||||||
Share-Based Compensation | |||||||||||||||
Share-Based Compensation | 3. Share-Based Compensation | ||||||||||||||
Share-based payments include stock option grants and RSUs under the Company's stock option and equity incentive plans and deferred compensation arrangements for the Company's non-employee directors. | |||||||||||||||
The Company has granted and continues to grant to employees and non-employees options to purchase common stock under various plans at prices equal to the fair market value of the stock on the dates the options are granted as determined in accordance with the terms of the applicable plan. The options have a term of ten years from the grant date and generally vest over three years from the grant date for director and non-employee options and over periods of up to five years from the grant date for employee options. Under the terms of the Company's stock option and equity incentive plans, employees generally have three months after the employment relationship ends to exercise all vested options except in the case of voluntary retirement, disability or death, where post-termination exercise periods are generally longer. As described below, however, certain of the Company's outstanding options were modified in 2013 to provide an extended post-termination exercise period. The Company issues new shares of common stock upon the exercise of options. The Company estimates the fair value of stock option awards as of the date of the grant by applying the Black-Scholes-Merton pricing valuation model. The application of this valuation model involves assumptions that are judgmental and highly sensitive in the determination of compensation expense. | |||||||||||||||
The fair value of each stock option is amortized into compensation expense on a straight-line basis between the grant date for the award and each vesting date. The amount of share-based compensation expense recognized is reduced ratably over the vesting period by an estimate of the percentage of options granted that are expected to be forfeited or canceled before becoming fully vested. | |||||||||||||||
As part of the October 2013 workforce reduction, the Company modified stock options of the terminated employees to accelerate the vesting of certain outstanding non-vested stock options and to extend the post-termination exercise period of their vested stock options. The terminated employees' stock options were modified to accelerate the vesting of all outstanding and unvested stock options as if an employee had remained in continuous service as an employee of the Company through January 1, 2014. Further, the Company extended the post-termination exercise period of each terminated employee's outstanding and vested options until the earliest to occur of June 1, 2014 or the expiration of the original term of the particular option. | |||||||||||||||
As part of the Company's efforts to retain the essential employees continuing with the Company following the October 2013 workforce reduction, the Company modified certain stock options held by continuing employees in the fourth quarter of 2013 to accelerate the vesting of certain outstanding non-vested stock options and to extend the post-termination exercise period of vested stock options. For these continuing employees, each of their outstanding stock options was modified to provide that if the employee's service continued through the end of business on May 31, 2014, then: (i) an additional number of shares subject to such option would immediately vest as if the employee's service had continued through January 1, 2015 and (ii) the period during which the vested portion of such options will generally expire would be extended from 90 days to six months after the employee's termination of service, subject in each case to the earlier expiration of the original term of the applicable stock option award. | |||||||||||||||
Additionally, in the fourth quarter of 2013, the Company granted RSUs to certain of the continuing employees, which RSUs vested in full June 1, 2014. The Company estimated the fair value of RSUs using the closing price of its stock on the grant date. The fair value of the RSUs was amortized on a straight-line basis over the requisite service period of the awards. At December 31, 2013, the Company had 1,225,000 unvested RSUs outstanding with a weighted average grant date fair value per share of $1.87. All of the Company's outstanding RSUs vested during the second quarter of 2014 and no RSUs were outstanding as of December 31, 2014. The number of RSUs vested includes 371,906 shares that were withheld on behalf of the Company's employees to satisfy the statutory tax withholding requirements. | |||||||||||||||
The following table summarizes share-based compensation expense included within the statements of operations for each of the three years in the period ended December 31, 2014: | |||||||||||||||
Years Ended December 31, | |||||||||||||||
2014 | 2013 | 2012 | |||||||||||||
Research and development expenses | $ | 2,512 | $ | 1,875 | $ | 1,046 | |||||||||
General and administrative expenses | 2,041 | 1,993 | 1,771 | ||||||||||||
| | | | | | | | | | | |||||
Total share-based compensation | $ | 4,553 | $ | 3,868 | $ | 2,817 | |||||||||
| | | | | | | | | | | |||||
| | | | | | | | | | | |||||
Share-based compensation expense recorded in the statement of operations as general and administrative expense for the years ended December 31, 2014, 2013 and 2012 included share-based compensation expense related to deferred compensation arrangements for the Company's non-employee directors of $125, $135 and $169, respectively. See Note 10, Directors' Deferred Compensation Plan, for further discussion of deferred compensation arrangements for the Company's non-employee directors. | |||||||||||||||
In the second quarter of 2014, in connection with the severance agreement entered into with the Company's then Chief Executive Officer in connection with his resignation, all of the executive's outstanding unvested stock options were vested and became immediately exercisable on April 13, 2014. The Company extended the post-termination exercise period of all of these stock options until the earlier to occur of (i) April 13, 2019 or (ii) the expiration of the term of a particular stock option grant. The Company recorded a one-time, noncash net compensation expense of $215 relating to these stock option modifications. | |||||||||||||||
As a result of the October 2013 modifications of certain stock options held by terminated employees, the Company recognized a net benefit of approximately $370 resulting from the reversal of previously recognized share-based compensation expense that was in excess of the modified fair value of the options. Of this amount, $81 was included as a benefit to general and administrative expenses and $289 was included as a benefit to research and development expenses for the year ended December 31, 2013. The modifications of certain stock options held by the Company's continuing employees during the year ended December 31, 2013 did not have a material impact on share-based compensation expense recognized during the period. | |||||||||||||||
Share-based compensation expense recorded as research and development expenses for the year ended December 31, 2012 was reduced by the reversal of previously recognized share-based compensation expense for non-vested stock options that were canceled in conjunction with the resignation of an executive officer during the year. | |||||||||||||||
For the years ended December 31, 2014, 2013 and 2012, the weighted average grant date fair value per share of stock options granted was $1.04, $2.13 and $2.14, respectively. The weighted average for key assumptions used in determining the grant date fair value of options granted in 2014, 2013 and 2012, and a summary of the methodology applied to develop each assumption is as follows: | |||||||||||||||
Years Ended December 31, | |||||||||||||||
2014 | 2013 | 2012 | |||||||||||||
Expected price volatility | 86.5% | 82.9% | 69.6% | ||||||||||||
Risk-free interest rate | 2.3% | 1.27% | 1.22% | ||||||||||||
Weighted average expected life in years | 6.9 years | 5.9 years | 6.5 years | ||||||||||||
Dividend yield | 0% | 0% | 0% | ||||||||||||
Expected Price Volatility — This is a measure of the amount by which a price has fluctuated or is expected to fluctuate. The Company based its determination of expected volatility on its historical stock price volatility. An increase in the expected price volatility will increase compensation expense. | |||||||||||||||
Risk-Free Interest Rate — This is determined using U.S. Treasury rates where the term is consistent with the expected life of the stock options. An increase in the risk-free interest rate will increase compensation expense. | |||||||||||||||
Expected Life — This is the period of time over which the options granted are expected to remain outstanding and is determined by calculating the average of the vesting term and the contractual term of the options. The Company has utilized this method due to the lack of historical option exercise information related to the Company's stock option and equity incentive plans. Options granted have a maximum term of ten years. An increase in the expected life will increase compensation expense. | |||||||||||||||
Dividend Yield — The Company has not made any dividend payments nor does it have plans to pay dividends in the foreseeable future. An increase in the dividend yield will decrease compensation expense. | |||||||||||||||
The following is a summary of stock option transactions for all of the Company's stock option and equity incentive plans for the three year period ended December 31, 2014: | |||||||||||||||
Number of | Weighted | ||||||||||||||
Shares | Average | ||||||||||||||
Exercise Price | |||||||||||||||
Per Share | |||||||||||||||
Options outstanding at January 1, 2012 | 4,945,565 | $ | 9.12 | ||||||||||||
Options granted | 1,141,250 | 3.35 | |||||||||||||
Options forfeited or expired | (675,755 | ) | 8.82 | ||||||||||||
Options exercised | (28,201 | ) | 3.05 | ||||||||||||
| | | | | | | | ||||||||
Options outstanding at December 31, 2012 | 5,382,859 | 7.96 | |||||||||||||
Options granted | 2,784,200 | 3.12 | |||||||||||||
Options forfeited or expired | (1,400,419 | ) | 5.86 | ||||||||||||
Options exercised | (321,298 | ) | 3.81 | ||||||||||||
| | | | | | | | ||||||||
Options outstanding at December 31, 2013 | 6,445,342 | 6.58 | |||||||||||||
| | | | | | | | ||||||||
Options granted | 3,094,500 | 1.34 | |||||||||||||
Options forfeited or expired | (1,435,408 | ) | 8.5 | ||||||||||||
Options exercised | - | - | |||||||||||||
| | | | | | | | ||||||||
Options outstanding at December 31, 2014 | 8,104,434 | 4.24 | |||||||||||||
| | | | | | | | ||||||||
| | | | | | | | ||||||||
Options vested and expected to vest at December 31, 2014 | 7,795,136 | 4.34 | |||||||||||||
| | | | | | | | ||||||||
| | | | | | | | ||||||||
The following table summarizes information about stock options outstanding at December 31, 2014: | |||||||||||||||
Options Outstanding | Options Exercisable | ||||||||||||||
Exercise Price | Number | Weighted | Weighted | Number | Weighted | ||||||||||
Outstanding | Average | Average | Exercisable | Average | |||||||||||
Remaining | Exercise | Exercise | |||||||||||||
Contractual | Price | Price | |||||||||||||
Life (years) | |||||||||||||||
$0.61 - $1.56 | 3,038,000 | 9.41 | $ | 1.34 | 100 | $ | 1.51 | ||||||||
$1.88 - $4.20 | 3,697,200 | 6.55 | 3.11 | 3,037,803 | 2.97 | ||||||||||
$4.44 - $20.40 | 1,369,234 | 3.05 | 13.72 | 1,314,702 | 14.09 | ||||||||||
| | | | | | | | | | | | | | | |
8,104,434 | 7.03 | 4.24 | 4,352,605 | 6.33 | |||||||||||
| | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | |
At December 31, 2014, the aggregate intrinsic value of all outstanding options was $5 with a weighted average remaining contractual term of 7.03 years. Of the Company's outstanding options, 4,352,605 options were exercisable and had a weighted average remaining contractual term of 5.28 years and no aggregate intrinsic value. Additionally, the Company's vested and expected to vest options had a weighted average remaining contractual term of 6.94 years and an aggregate intrinsic value of $4. | |||||||||||||||
There were no options exercised during the year ended December 31, 2014. The total intrinsic value of options exercised during the years ended December 31, 2013 and 2012 was $688 and $36, respectively. At December 31, 2014, the total compensation cost related to non-vested options not yet recognized was $4,030, with a weighted average expense recognition period of 3.94 years. Shares available for future issuance under the Company's stock option and equity incentive plans were 4,979,673 at December 31, 2014. On January 1, 2015, shares available for future issuance under the 2013 equity incentive plan and 2013 non-employee director equity incentive plan increased by an aggregate of 6,113,026 shares in accordance with the automatic increase provisions of such plans. | |||||||||||||||
Property_and_Equipment_Net
Property and Equipment, Net | 12 Months Ended | |||||||
Dec. 31, 2014 | ||||||||
Property and Equipment, Net | ||||||||
Property and Equipment, Net | 4. Property and Equipment, Net | |||||||
Property and equipment, net consisted of the following: | ||||||||
December 31, | ||||||||
2014 | 2013 | |||||||
Computer equipment and software | $ | 2,128 | $ | 2,130 | ||||
Furniture and fixtures | 1,032 | 1,032 | ||||||
Leasehold improvements | 355 | 355 | ||||||
Office and laboratory equipment | 261 | 261 | ||||||
| | | | | | | | |
3,776 | 3,778 | |||||||
Less: accumulated depreciation | (3,747 | ) | (3,666 | ) | ||||
| | | | | | | | |
$ | 29 | $ | 112 | |||||
| | | | | | | | |
| | | | | | | | |
Depreciation and amortization expense for the years ended December 31, 2014, 2013 and 2012 was $88, $369 and $730, respectively. Of these amounts, $1, $169 and $290, respectively, were included in research and development expenses in the statements of operations. | ||||||||
Subsequent to the reduction in workforce implemented in October 2013 and the Company's determination to cease drug discovery activities, the Company sold its related property and equipment and recognized a gain of $1,366 during the year ended December 31, 2013. The carrying value associated with the property and equipment that was sold was $58 and related to laboratory equipment. | ||||||||
Accrued_Expenses_and_Other_Cur
Accrued Expenses and Other Current Liabilities | 12 Months Ended | |||||||
Dec. 31, 2014 | ||||||||
Accrued Expenses and Other Current Liabilities | ||||||||
Accrued Expenses and Other Current Liabilities | 5. Accrued Expenses and Other Current Liabilities | |||||||
Accrued expenses and other current liabilities consisted of the following: | ||||||||
December 31, | ||||||||
2014 | 2013 | |||||||
Clinical trials | $ | 929 | $ | 1,127 | ||||
Net deferred income tax liabilities | 319 | 156 | ||||||
General and administrative | 267 | 497 | ||||||
Employee compensation | 160 | 1,354 | ||||||
Product returns | 112 | 586 | ||||||
Research and development | 63 | 39 | ||||||
| | | | | | | | |
$ | 1,850 | $ | 3,759 | |||||
| | | | | | | | |
| | | | | | | | |
Stockholders_Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2014 | |
Stockholders' Equity | |
Stockholders' Equity | 6. Stockholders' Equity |
Authorized Capital | |
The Company's certificate of incorporation authorizes the Company to issue 200,000,000 shares of common stock, $0.001 par value per share, and 5,000,000 shares of preferred stock, $0.001 par value per share. | |
Common Stock and Associated Warrant Liability | |
On November 14, 2014, the Company completed a private placement of units consisting of an aggregate of 64,311,112 shares of common stock and warrants to purchase an aggregate of 64,311,112 shares of its common stock for net proceeds of $42,814, after deducting offering expenses. The purchasers in the private placement included certain existing GTx stockholders and certain members of the GTx management team and board of directors. The net proceeds from the private placement were allocated to the common stock and warrants based upon the fair value method. Similarly, the offering expenses were allocated between the common stock and the warrants with the portion allocated to common stock offset against the proceeds allocated to stockholders' equity, whereas the portion allocated to the warrants was expensed immediately. The warrants have a per share exercise price of $0.85 and will be exercisable at any time and from time to time from and after the earlier of (i) the date the Company obtains stockholder approval of an amendment to its Restated Certificate of Incorporation to increase its authorized common stock to an amount necessary to effect the share settlement of all of the warrants, which approval the Company has contractually-agreed to seek no later than May 27, 2015, or (ii) the trading day immediately prior to the occurrence of a "fundamental transaction" (as defined in the warrants), but in no event later than June 1, 2015, and will continue to be exercisable for four years thereafter. The Company does not currently have a sufficient number of authorized and unreserved shares of common stock necessary to settle exercises of all of the warrants in full in shares of common stock; accordingly, the warrants will be subject to net cash settlement if, at the time of any exercise, there are then an insufficient number of authorized and reserved shares of common stock to effect a share settlement of the warrants. Assuming stockholder approval of an amendment to the Company's Restated Certificate of Incorporation to increase its authorized common stock to an amount necessary to effect the share settlement of all of the warrants is obtained, warrant exercises would no longer be subject to net cash settlement. The warrants also contain certain terms that could require the Company (or its successor) to purchase the warrants for cash in an amount equal to the value (as calculated utilizing a contractually-agreed Black-Scholes-Merton pricing valuation model) of the unexercised portion of the warrants in connection with certain change of control transactions occurring on or prior to December 31, 2016, with the cash payment capped at an amount equal to $0.125 per unexercised share underlying each warrant. Due to these provisions, the Company is required to account for these warrants as a liability at fair value using the Black-Scholes-Merton pricing valuation model and the estimated warrant liability is required to be revalued at each balance sheet date until the earlier of the exercise of the warrants or, assuming stockholder approval is obtained for the authorization of additional common stock, the expiration of the provision on December 31, 2016 that could require cash settlement upon certain change of control transactions. The Company's warrant liability is influenced by several factors including the price of the Company's common stock as of the balance sheet date. | |
At issuance, the fair value of the warrant liability was estimated to be $21,626. These warrants were revalued at fair value as of December 31, 2014 and the resulting increase in fair value of $8,804 was recorded as a non-cash loss on the change in fair value of warrant liability in the Company's statement of operations. The fair value of the warrants at December 31, 2014 of $30,430 was estimated using the Black-Scholes-Merton pricing valuation model with the following assumptions: expected volatility of 91%, risk-free interest rate of 1.5%, expected life of approximately 4.5 years and no dividends. Significant changes to the Company's market price for its common stock will impact the implied and/or historical volatility used to fair value the warrants. Any significant increases in the Company's stock price will likely create an increase to the fair value of the warrant liability. Similarly, any significant decreases in the Company's stock price will likely create a decrease to the fair value of the warrant liability. | |
On March 6, 2014, the Company completed a private placement of units consisting of an aggregate of 11,976,048 shares of common stock and warrants to purchase an aggregate of 10,179,642 shares of its common stock for net proceeds of $21,135, after deducting offering expenses. The net proceeds from the private placement were allocated to the common stock and warrants based upon their relative fair values. The warrants, which had a one year term that expired on March 6, 2015, carried a per share exercise price of $1.67. The Company assessed whether the warrants require accounting as derivatives. The Company determined that the warrants were indexed to the Company's own stock. As such, the Company has concluded the warrants met the scope exception for determining whether the instruments require accounting as derivatives and are classified in stockholders' equity. The fair value of the warrants on the date of grant was estimated at $4,478 using the Black-Scholes-Merton pricing valuation model with the following assumptions: expected volatility of 67%, risk free interest rate of 0.12%, expected life of one year and no dividends. All of these warrants expired unexercised on March 6, 2015. | |
Collaboration_and_License_Agre
Collaboration and License Agreements | 12 Months Ended |
Dec. 31, 2014 | |
Collaboration and License Agreements | |
Collaboration and License Agreements | 7. Collaboration and License Agreements |
University of Tennessee Research Foundation License Agreement | |
The Company and the University of Tennessee Research Foundation ("UTRF") are parties to a consolidated, amended and restated license agreement (the "SARM License Agreement") pursuant to which the Company has been granted exclusive worldwide rights in all existing SARM technologies owned or controlled by UTRF, including all improvements thereto, and exclusive rights to future SARM technology that may be developed by certain scientists at the University of Tennessee or subsequently licensed to UTRF under certain existing inter-institutional agreements with The Ohio State University. Under the SARM License Agreement, the Company is obligated to pay UTRF annual license maintenance fees, low single-digit royalties on net sales of products and mid single-digit royalties on sublicense revenues. | |
Former Orion Corporation License and Supply Agreement | |
In connection with the Company's sale of its rights and certain assets related to FARESTON® to ProStrakan, the Company and Orion agreed to terminate the Amended and Restated License and Supply Agreement, dated January 1, 2005, as amended, between the Company and Orion (the "Orion Supply Agreement") as well as certain other agreements between the Company and Orion related to the Orion Supply Agreement (collectively, the "Orion Agreements"). Pursuant to the Orion Supply Agreement, the Company obtained an exclusive license from Orion to develop and commercialize toremifene-based products for all human indications worldwide, except breast cancer outside of the United States, and Orion agreed to manufacture and supply all of the Company's needs for clinical trial and commercial grade material for toremifene-based products developed and marketed in the United States and abroad, including toremifene globally and FARESTON® in the United States. The termination of the Orion Agreements was effective September 30, 2012. As consideration for Orion's agreement to terminate the Orion Agreements and to enter into certain agreements with ProStrakan to effect the FARESTON® sale, the Company paid Orion $1,000 in October 2012. | |
Intangible_Assets_Net
Intangible Assets, Net | 12 Months Ended |
Dec. 31, 2014 | |
Intangible Assets, Net | |
Intangible Assets, Net | 8. Intangible Assets, Net |
In accordance with the terms of the former Orion Supply Agreement, the Company paid a license fee to Orion of $4,826. In accordance with the terms of the SARM License Agreement that the Company entered into with UTRF in July 2007, the Company paid a one-time up-front fee of $290. | |
The Company's remaining intangible asset, net at December 31, 2014 and 2013 was $152 and $166, respectively, related to the SARM License Agreement. | |
Income_Taxes
Income Taxes | 12 Months Ended | |||||||
Dec. 31, 2014 | ||||||||
Income Taxes | ||||||||
Income Taxes | 9. Income Taxes | |||||||
Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. The principal components of the Company's net deferred income tax assets and liabilities consisted of the following: | ||||||||
December 31, | ||||||||
2014 | 2013 | |||||||
Deferred income tax assets: | ||||||||
Net federal and state operating loss carryforwards | $ | 139,126 | $ | 127,819 | ||||
Research and development credits | 12,754 | 11,934 | ||||||
Share-based compensation | 6,800 | 8,670 | ||||||
Depreciation and amortization | 89 | 170 | ||||||
Other | 69 | 425 | ||||||
| | | | | | | | |
Total deferred tax assets | 158,838 | 149,018 | ||||||
| | | | | | | | |
Deferred income tax liabilities: | ||||||||
Other | 329 | 157 | ||||||
| | | | | | | | |
Total deferred tax liabilities | 329 | 157 | ||||||
| | | | | | | | |
Net deferred tax assets | 158,509 | 148,861 | ||||||
Valuation allowance | (158,509 | ) | (148,861 | ) | ||||
| | | | | | | | |
$ | - | $ | - | |||||
| | | | | | | | |
| | | | | | | | |
Realization of deferred income tax assets is dependent upon future earnings, if any, the timing and amount of which are uncertain. Accordingly, due to the Company's history of net operating losses, the net deferred tax assets have been fully offset by a valuation allowance. The valuation allowance increased by $9,648, $17,318 and $8,836 in 2014, 2013, and 2012, respectively. | ||||||||
At December 31, 2014, the Company had net federal operating loss carryforwards of approximately $358,702, which expire from 2018 to 2034 if not utilized. The Company had state operating loss carryforwards of approximately $337,735, which expire from 2015 to 2034 if not utilized. The Company also had research and development credits at December 31, 2014 of approximately $12,754, which expire from 2020 to 2034 if not utilized. | ||||||||
Both of the net federal and state operating loss carryforwards include approximately $2,301 of deductions related to the exercise of stock options. This amount represents an excess tax benefit and has not been included in the gross deferred income tax asset reflected for net federal and state operating loss carryforwards. If utilized, the benefits from these deductions will be recorded as an adjustment to additional paid in capital. | ||||||||
The Company will recognize the impact of a tax position in the financial statements if that position is more likely than not of being sustained on audit based on the technical merits of the position. As of December 31, 2014, the Company had no unrecognized tax benefits. Utilization of the Company's net operating loss carryforwards may be subject to a substantial annual limitation due to ownership change limitations provided by Section 382 of the Internal Revenue Code of 1986, as amended, and similar state provisions. The annual limitations may result in the expiration of net operating loss carryforwards before utilization. The Company completed a study of its net operating losses through December 31, 2014 to determine whether such amounts are likely to be limited by Section 382. As a result of this study, the Company does not currently believe any Section 382 limitation exists through December 31, 2014. However, any future ownership changes under Section 382 may limit the Company's ability to fully utilize these tax benefits. The Company has not yet conducted an in-depth study of its research and development credits, although the Company periodically reviews assumptions in its calculations to reflect its best estimate of expected credit. An in-depth study may result in an increase or decrease to the Company's research and development credits and until such study is conducted of the Company's research and development credits, no amounts are being presented as an uncertain tax position. The Company's net deferred income tax assets have been fully offset by a valuation allowance. Therefore, future changes to the Company's unrecognized tax benefits would be offset by an adjustment to the valuation allowance and there would be no impact on the Company's balance sheet, statement of operations, or cash flows. The Company does not expect its unrecognized tax benefits to change significantly over the next 12 months. | ||||||||
The Company is currently open to audit under the statute of limitations by the Internal Revenue Service and the appropriate state income taxing authorities for all years due to the net loss carryforwards from those years. The Company is currently not under examination by the Internal Revenue Service or any other taxing authorities. The Company has not recorded any interest and penalties on any unrecognized tax benefits since its inception. | ||||||||
Directors_Deferred_Compensatio
Directors' Deferred Compensation Plan | 12 Months Ended |
Dec. 31, 2014 | |
Directors' Deferred Compensation Plan | |
Directors' Deferred Compensation Plan | 10. Directors' Deferred Compensation Plan |
Non-employee directors may defer all or a portion of their fees under the Company's Directors' Deferred Compensation Plan until termination of their status as directors. Deferrals can be made into a cash account, a stock account, or a combination of both. Stock accounts will be paid out in the form of Company common stock, except that any fractional shares will be paid out in cash valued at the then current market price of the Company's common stock. Cash accounts and stock accounts under the Directors' Deferred Compensation Plan are credited with interest or the value of any cash and stock dividends, respectively. Non-employee directors are fully vested in any amounts that they elect to defer under the Directors' Deferred Compensation Plan. | |
For the years ended December 31, 2014, 2013 and 2012, the Company incurred non-employee director fee expense of $247, $259 and $237, respectively, of which $125, $135 and $169 was deferred into stock accounts and will be paid in common stock following separation from service as a director. At December 31, 2014, 237,100 shares of the Company's common stock had been credited to individual director stock accounts under the Directors' Deferred Compensation Plan, and no amounts had been credited to individual director cash accounts under the Directors' Deferred Compensation Plan. | |
401k_Plan
401(k) Plan | 12 Months Ended |
Dec. 31, 2014 | |
401(k) Plan | |
401(k) Plan | 11. 401(k) Plan |
The Company sponsors a 401(k) retirement savings plan that is available to all eligible employees. The plan is intended to qualify under Section 401(k) of the Internal Revenue Code of 1986, as amended. The plan provides that each participant may contribute up to a statutory limit of their pre-tax compensation which was $17.5 for employees under age 50 and $23 for employees 50 and older in calendar year 2014. Employee contributions are held in the employees' name and invested by the plan's trustee. The plan also permits the Company to make matching contributions, subject to established limits. The Company elected to match a portion of employee's contributions to the plan in the amount of $200, $338 and $363 in 2014, 2013 and 2012, respectively. | |
Commitments_and_Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2014 | |
Commitments and Contingencies | |
Commitments and Contingencies | 12. Commitments and Contingencies |
Operating Lease Commitments | |
The Company previously leased laboratory facilities and office space pursuant to a sublease, which had been accounted for as an operating lease. Subsequent to the reduction in force implemented in October 2013, this lease was cancelled effective December 31, 2013. The Company subleases office space under a sublease that is accounted for as an operating lease. This sublease has escalating rent payments and expires on April 30, 2015. Total rent expense under the operating leases was approximately $513, $674 and $963 for the years ended December 31, 2014, 2013 and 2012, respectively. As of December 31, 2014, future annual minimum payments under operating lease arrangements were $184 for the year ended December 31, 2015. | |
Quarterly_Financial_Data_Unaud
Quarterly Financial Data (Unaudited) | 12 Months Ended | |||||||||||||
Dec. 31, 2014 | ||||||||||||||
Quarterly Financial Data (Unaudited) | ||||||||||||||
Quarterly Financial Data (Unaudited) | 13. Quarterly Financial Data (Unaudited) | |||||||||||||
The following is a summary of the quarterly results of operations for the years ended December 31, 2014 and 2013: | ||||||||||||||
2014 Quarters Ended | ||||||||||||||
March 31 | June 30 | September 30 | December 31 | |||||||||||
Expenses: | ||||||||||||||
Research and development expenses | $ | 6,360 | $ | 7,894 | $ | 3,362 | $ | 3,254 | ||||||
General and administrative expenses | 2,629 | 3,052 | 1,594 | 2,203 | ||||||||||
| | | | | | | | | | | | | | |
Total expenses | 8,989 | 10,946 | 4,956 | 5,457 | ||||||||||
| | | | | | | | | | | | | | |
Loss from operations | (8,989 | ) | (10,946 | ) | (4,956 | ) | (5,457 | ) | ||||||
Other income (expense), net | 2 | 2 | 21 | (284 | ) | |||||||||
Loss on change in fair value of warrant liability (a) | - | - | - | (8,804 | ) | |||||||||
| | | | | | | | | | | | | | |
Net loss | $ | (8,987 | ) | $ | (10,944 | ) | $ | (4,935 | ) | $ | (14,545 | ) | ||
| | | | | | | | | | | | | | |
| | | | | | | | | | | | | | |
Net loss per share — basic and diluted | $ | (0.14 | ) | $ | (0.15 | ) | $ | (0.06 | ) | $ | (0.13 | ) | ||
| | | | | | | | | | | | | | |
| | | | | | | | | | | | | | |
Weighted average shares outstanding: | ||||||||||||||
Basic and diluted | 66,512,069 | 75,433,302 | 76,014,531 | 108,869,121 | ||||||||||
| | | | | | | | | | | | | | |
| | | | | | | | | | | | | | |
(a) | The loss on change in fair value of warrant liability is related to the private placement of warrants completed in November 2014. See Note 6, Stockholders' Equity, for further information. | |||||||||||||
2013 Quarters Ended | ||||||||||||||
March 31 | June 30 | September 30 | December 31 | |||||||||||
Expenses: | ||||||||||||||
Research and development expenses | $ | 9,614 | $ | 10,139 | $ | 6,477 | $ | 6,088 | ||||||
General and administrative expenses | 3,023 | 2,684 | 2,483 | 3,091 | ||||||||||
| | | | | | | | | | | | | | |
Total expenses | 12,637 | 12,823 | 8,960 | 9,179 | ||||||||||
| | | | | | | | | | | | | | |
Loss from operations | (12,637 | ) | (12,823 | ) | (8,960 | ) | (9,179 | ) | ||||||
Other income, net | 55 | 21 | 23 | 1,389 | ||||||||||
| | | | | | | | | | | | | | |
Net loss | $ | (12,582 | ) | $ | (12,802 | ) | $ | (8,937 | ) | $ | (7,790 | ) | ||
| | | | | | | | | | | | | | |
| | | | | | | | | | | | | | |
Net loss per share — basic and diluted | $ | (0.20 | ) | $ | (0.20 | ) | $ | (0.14 | ) | $ | (0.12 | ) | ||
| | | | | | | | | | | | | | |
| | | | | | | | | | | | | | |
Weighted average shares outstanding: | ||||||||||||||
Basic and diluted | 62,864,140 | 62,994,771 | 63,179,394 | 63,185,389 | ||||||||||
| | | | | | | | | | | | | | |
| | | | | | | | | | | | | | |
Significant_Accounting_Policie1
Significant Accounting Policies (Policies) | 12 Months Ended | |||||
Dec. 31, 2014 | ||||||
Significant Accounting Policies | ||||||
Basis of Presentation | Basis of Presentation | |||||
The accompanying financial statements have been prepared in accordance with U.S. generally accepted accounting principles ("U.S. GAAP"). Additionally, GTx operates in one business segment. | ||||||
Use of Estimates | Use of Estimates | |||||
The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenues and expenses during the reporting period. Actual amounts and results could differ from those estimates. | ||||||
Cash and Cash Equivalents | Cash and Cash Equivalents | |||||
The Company considers highly liquid investments with initial maturities of three months or less to be cash equivalents. | ||||||
Short-term Investments | Short-term Investments | |||||
At December 31, 2014 and 2013, short-term investments consisted of Federal Deposit Insurance Corporation ("FDIC") insured certificates of deposit with original maturities of greater than three months and less than one year. | ||||||
Property and Equipment | Property and Equipment | |||||
Property and equipment is stated at cost. Amortization of leasehold improvements is recognized over the shorter of the estimated useful life of the leasehold improvement or the lease term. Depreciation is computed using the straight-line method over the estimated useful lives as follows: | ||||||
Laboratory and office equipment | 3 to 5 years | |||||
Leasehold improvements | 3 to 7 years | |||||
Furniture and fixtures | 5 years | |||||
Computer equipment and software | 3 years | |||||
Warrant Liability | Warrant Liability | |||||
On November 14, 2014, the Company issued warrants to purchase 64,311,112 shares of its common stock. The Company classifies the warrants as a liability on its balance sheet since the warrants contain certain terms that could require the Company (or its successor) to purchase the warrants for cash in an amount equal to the value (as calculated utilizing a contractually-agreed Black-Scholes option pricing formula) of the unexercised portion of the warrants in connection with certain change of control transactions occurring on or prior to December 31, 2016, with such cash payment capped at an amount equal to $0.125 per unexercised share underlying each warrant. In addition, each warrant is subject to net cash settlement if, at the time of any exercise, there are then an insufficient number of authorized and reserved shares of common stock to effect a share settlement of the warrant. As of December 31, 2014, the Company did not have a sufficient number of authorized and reserved shares of common stock to effect the share settlement of all of these warrants; however, these warrants were not exercisable at December 31, 2014. | ||||||
As a result of the foregoing provisions, the Company is required to account for these warrants as a liability at fair value and the estimated warrant liability is required to be revalued at each balance sheet date until the earlier of the exercise of the warrants or, assuming stockholder approval is obtained for the authorization of additional common stock, the expiration of the provision on December 31, 2016 that could require cash settlement upon certain change of control transactions. Upon the exercise of the warrants or, assuming stockholder approval is obtained for the authorization of additional common stock, the expiration of the provision on December 31, 2016 that could require cash settlement upon certain change of control transactions, the fair value of the warrants will be reclassified from a liability to stockholders' equity on the Company's balance sheets and no further adjustment to the fair value would be made in subsequent periods. See Note 6, Stockholders' Equity, for further information regarding these warrants and the Company's valuation of the warrant liability. | ||||||
Fair Value of Financial Instruments and Warrant Liability | Fair Value of Financial Instruments and Warrant Liability | |||||
The carrying amounts of the Company's financial instruments (which include cash, cash equivalents, short-term investments, and accounts payable) and its warrant liability approximate their fair values. The fair value of the warrant liability is estimated using the Black-Scholes-Merton pricing valuation model. See Note 6, Stockholders' Equity, for additional disclosure on the valuation methodology and significant assumptions. The Company's financial assets and liabilities are classified within a three-level fair value hierarchy that prioritizes the inputs used to measure fair value, which is defined as follows: | ||||||
Level 1 — Quoted prices in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date | ||||||
Level 2 — Inputs other than quoted prices in active markets that are observable for the asset or liability, either directly or indirectly | ||||||
Level 3 — Inputs that are unobservable for the asset or liability | ||||||
Asset and liabilities measured at fair value on a recurring basis as of December 31, 2014 included only the Company's warrant liability of $30,430, which was classified within Level 3 of the hierarchy. As of December 31, 2013, the Company had no assets or liabilities measured at fair value on a recurring basis within Level 3 of the hierarchy. A loss of $8,804 related to the change in the fair value of the warrant liability was recognized during the year ended December 31, 2014 as a non-cash loss in the Company's statement of operations. | ||||||
As the Company has the positive intent and ability to hold its certificates of deposit classified as short-term investments until maturity, these investments have been classified as held to maturity investments and are stated at cost, which approximates fair value. The Company considers these to be Level 2 investments as the fair values of these investments are determined using third-party pricing sources, which generally utilize observable inputs, such as interest rates and maturities of similar assets. | ||||||
Concentration of Risk | Concentration of Risk | |||||
Financial instruments that potentially subject the Company to a concentration of credit risk consist of cash and cash equivalents and short-term investments. The Company has established guidelines relating to diversification and maturities of its cash equivalents and short-term investments which are designed to manage risk. The Company's cash and cash equivalents consist of bank deposits, certificates of deposit, and money market mutual funds. Bank deposits may at times be in excess of FDIC insurance limits. The Company's short-term investments consist of FDIC insured certificates of deposit with original maturities of greater than three months and less than one year. | ||||||
Research and Development Expenses | Research and Development Expenses | |||||
Research and development expenses include, but are not limited to, the Company's expenses for personnel, supplies, and facilities associated with research activities, screening and identification of product candidates, formulation and synthesis activities, manufacturing, preclinical studies, toxicology studies, clinical trials, regulatory and medical affairs activities, quality assurance activities and license fees. The Company expenses these costs in the period in which they are incurred. The Company estimates its liabilities for research and development expenses in order to match the recognition of expenses to the period in which the actual services are received. As such, accrued liabilities related to third party research and development activities are recognized based upon the Company's estimate of services received and degree of completion of the services in accordance with the specific third party contract. | ||||||
Patent Costs | Patent Costs | |||||
The Company expenses patent costs, including legal expenses, in the period in which they are incurred. Patent expenses are included in general and administrative expenses in the Company's statements of operations. | ||||||
Income Taxes | Income Taxes | |||||
The Company accounts for deferred taxes by recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the financial statements or tax returns. Under this method, deferred tax assets and liabilities are determined based on the difference between the financial statement and tax basis of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. A valuation allowance is provided when it is more likely than not that some portion or all of the deferred tax assets will not be realized. Accordingly, at December 31, 2014 and December 31, 2013, net of the valuation allowance, the net deferred tax assets were reduced to zero. See Note 9, Income Taxes, for further discussion. | ||||||
The Company has recognized the tax effect of discontinued operations in the statement of operations for the year ended December 31, 2012 in accordance with the intra-period accounting rules. An offsetting tax benefit was recorded in continuing operations for the year ended December 31, 2012 in relation to the tax expense that was recognized for discontinued operations. | ||||||
Share-Based Compensation | Share-Based Compensation | |||||
The Company has stock option and equity incentive plans that provide for the purchase or acquisition of the Company's common stock by certain of the Company's employees and non-employees. The Company recognizes compensation expense for its share-based payments based on the fair value of the awards over the period during which an employee or non-employee is required to provide service in exchange for the award. See Note 3, Share-Based Compensation, for further discussion. | ||||||
Other Income (Expense), Net | Other Income (Expense), Net | |||||
Other income (expense), net consists of foreign currency transaction gains and losses, interest earned on the Company's cash, cash equivalents and short-term investments, interest expense, and other non-operating income or expense. Other income (expense), net for the year ended December 31, 2014 also included expenses related to the private placement of common stock and warrants completed in November 2014 as the warrants issued were accounted for as a liability. Other income (expense), net for the year ended December 31, 2013 also included a gain of $1,366 from the sale of research and development property and equipment sold subsequent to the workforce reduction that occurred in October 2013. See Note 4, Property and Equipment, Net, for further discussion. | ||||||
Basic and Diluted Net Loss Per Share | Basic and Diluted Net Loss Per Share | |||||
Basic and diluted net loss per share attributable to common stockholders is calculated based on the weighted average number of common shares outstanding during the period. Diluted net loss per share gives effect to the dilutive potential of common stock consisting of stock options, common stock warrants, and unvested restricted stock units ("RSUs"). | ||||||
Weighted average potential shares of common stock of 24,628,775, 6,773,394, and 5,574,915 were excluded from the calculation of diluted net loss per share for the years ended December 31, 2014, 2013 and 2012, respectively, as inclusion of the potential shares would have had an anti-dilutive effect on the net loss per share for the periods. The increase in the weighted average potential shares of common stock excluded from the calculation of diluted net loss per share increased from the prior year due to the issuance of warrants under the two financing transactions that occurred during the year ended December 31, 2014. See Note 6, Stockholders' Equity, for further discussion. At December 31, 2014, the Company had outstanding 140,325,643 shares of common stock. | ||||||
Comprehensive Loss | Comprehensive Loss | |||||
For all periods presented, there were no differences between net loss and comprehensive loss. | ||||||
Discontinued Operations | Discontinued Operations | |||||
Effective September 30, 2012, the Company entered into an asset purchase agreement (the "FARESTON® Purchase Agreement") with Strakan International S.á r.l., an affiliate of ProStrakan Group plc ("ProStrakan") pursuant to which the Company agreed to transfer, sell and assign to ProStrakan all of the Company's rights and certain assets related to FARESTON® for a total cash purchase price of $21,671. The Company recognized a gain of $18,831 on the sale of FARESTON® for the year ended December 31, 2012. The gain represents the gross proceeds received from the sale reduced by a contract termination fee of $1,000 due to Orion (as discussed further in Note 7, Collaboration and License Agreements), a financial advisory fee related to the transaction of $1,712, and other transaction expenses of approximately $128. The Company has accounted for FARESTON® as a discontinued operation. As a result, revenue of $5,284, cost of goods sold of $784, and operating expenses of $655 related to FARESTON® were excluded from the respective captions in the statement of operations and were included in discontinued operations for the years ended December 31, 2012. Under the FARESTON® Purchase Agreement, the Company remains liable for future product returns relating to sales of FARESTON® made by the Company prior to September 30, 2012. For the year ended December 31, 2014, the Company recorded a benefit of $576 as general and administrative expenses in the statement of operations for adjustments to the Company's accrual for product returns related to the closure of the return period for a portion of the previously sold inventory. | ||||||
FARESTON Revenue Recognition | FARESTON® Revenue Recognition | |||||
Revenue from product sales of FARESTON®, which is included in income from discontinued operations before income taxes for the year ended December 31, 2012, was recognized less deductions for estimated sales discounts and sales returns. Revenue from product sales was recognized when persuasive evidence of an arrangement existed, title passed, the price was fixed or determinable, and collectability was reasonably assured. The Company accounted for rebates to certain governmental agencies as a reduction of product sales. The Company allows customers to return product within a specified time period prior to and subsequent to the product's labeled expiration date. Although the Company sold its rights and certain assets related to FARESTON® effective September 30, 2012, the Company retains the liability for future product returns relating to sales of FARESTON® made by the Company prior to September 30, 2012. Therefore, the Company estimates an accrual for product returns based on factors which include historical product returns and estimated product in the distribution channel which is expected to exceed its expiration date. At December 31, 2014 and December 31, 2013, the Company's accrual for product returns, was $141 and $918, respectively. Of these amounts, $30 and $332 have been included in "Other long-term liabilities" in the Company's balance sheet at December 31, 2014 and December 31, 2013, respectively, and represents the portion of the Company's product returns accrual estimated to be payable after one year. | ||||||
Restructuring | Restructuring | |||||
In October 2013, the Company implemented a reduction in its workforce following the announced results from its two Phase 3 clinical trials evaluating enobosarm 3 mg for the prevention and treatment of muscle wasting in patients with advanced NSCLC. The reduction in force was effective immediately and represented approximately 60% of the Company's total workforce. | ||||||
As a result of the workforce reduction, the Company incurred severance related cash expenses of $1,306, of which $351 was included in general and administrative expenses and $955 was included in research and development expenses for the year ended December 31, 2013. All of these expenses were paid as of December 31, 2013. Additionally, the Company recognized a net benefit of approximately $370 resulting from the reversal of share-based compensation expense related to the modification of certain stock option provisions for the severed employees. Of this amount, $81 was included as a benefit to general and administrative expenses and $289 was included as a benefit to research and development expenses for the year ended December 31, 2013. | ||||||
As a result of the October 2013 reduction in its workforce, the Company is no longer conducting in-house drug discovery activities. During the fourth quarter of 2013, the Company cancelled its sublease for the laboratory facilities and office space utilized for drug discovery. Additionally, the Company sold its related property and equipment for a gain of $1,366, which was included in other income (expense), net for the year ended December 31, 2013. | ||||||
Recent Accounting Pronouncements | Recent Accounting Pronouncements | |||||
In August 2014, the Financial Accounting Standards Board issued Accounting Standard Update 2014-15, Disclosure of Uncertainties about an Entity's Ability to Continue as a Going Concern. The new guidance is intended to define management's responsibility to evaluate whether there is substantial doubt about an organization's ability to continue as a going concern within one year of the date the financial statements are issued and to provide related footnote disclosure. This new guidance is effective for the first annual period ending after December 15, 2016 and interim periods thereafter. | ||||||
Subsequent Events | Subsequent Events | |||||
The Company has evaluated all events or transactions that occurred after December 31, 2014 up through the date the financial statements were issued. There were no material recognizable or nonrecognizable subsequent events during the period evaluated. | ||||||
Significant_Accounting_Policie2
Significant Accounting Policies (Tables) | 12 Months Ended | |||||
Dec. 31, 2014 | ||||||
Significant Accounting Policies | ||||||
Schedule of estimated useful lives of property and equipment | ||||||
Laboratory and office equipment | 3 to 5 years | |||||
Leasehold improvements | 3 to 7 years | |||||
Furniture and fixtures | 5 years | |||||
Computer equipment and software | 3 years | |||||
ShareBased_Compensation_Tables
Share-Based Compensation (Tables) | 12 Months Ended | ||||||||||||||
Dec. 31, 2014 | |||||||||||||||
Share-Based Compensation | |||||||||||||||
Summary of share-based compensation expense | |||||||||||||||
Years Ended December 31, | |||||||||||||||
2014 | 2013 | 2012 | |||||||||||||
Research and development expenses | $ | 2,512 | $ | 1,875 | $ | 1,046 | |||||||||
General and administrative expenses | 2,041 | 1,993 | 1,771 | ||||||||||||
| | | | | | | | | | | |||||
Total share-based compensation | $ | 4,553 | $ | 3,868 | $ | 2,817 | |||||||||
| | | | | | | | | | | |||||
| | | | | | | | | | | |||||
Schedule of assumptions used to estimate fair value of options | |||||||||||||||
Years Ended December 31, | |||||||||||||||
2014 | 2013 | 2012 | |||||||||||||
Expected price volatility | 86.5% | 82.9% | 69.6% | ||||||||||||
Risk-free interest rate | 2.3% | 1.27% | 1.22% | ||||||||||||
Weighted average expected life in years | 6.9 years | 5.9 years | 6.5 years | ||||||||||||
Dividend yield | 0% | 0% | 0% | ||||||||||||
Summary of stock option transactions | |||||||||||||||
Number of | Weighted | ||||||||||||||
Shares | Average | ||||||||||||||
Exercise Price | |||||||||||||||
Per Share | |||||||||||||||
Options outstanding at January 1, 2012 | 4,945,565 | $ | 9.12 | ||||||||||||
Options granted | 1,141,250 | 3.35 | |||||||||||||
Options forfeited or expired | (675,755 | ) | 8.82 | ||||||||||||
Options exercised | (28,201 | ) | 3.05 | ||||||||||||
| | | | | | | | ||||||||
Options outstanding at December 31, 2012 | 5,382,859 | 7.96 | |||||||||||||
Options granted | 2,784,200 | 3.12 | |||||||||||||
Options forfeited or expired | (1,400,419 | ) | 5.86 | ||||||||||||
Options exercised | (321,298 | ) | 3.81 | ||||||||||||
| | | | | | | | ||||||||
Options outstanding at December 31, 2013 | 6,445,342 | 6.58 | |||||||||||||
| | | | | | | | ||||||||
Options granted | 3,094,500 | 1.34 | |||||||||||||
Options forfeited or expired | (1,435,408 | ) | 8.5 | ||||||||||||
Options exercised | - | - | |||||||||||||
| | | | | | | | ||||||||
Options outstanding at December 31, 2014 | 8,104,434 | 4.24 | |||||||||||||
| | | | | | | | ||||||||
| | | | | | | | ||||||||
Options vested and expected to vest at December 31, 2014 | 7,795,136 | 4.34 | |||||||||||||
| | | | | | | | ||||||||
| | | | | | | | ||||||||
Schedule of stock option activity by exercise price range | : | ||||||||||||||
Options Outstanding | Options Exercisable | ||||||||||||||
Exercise Price | Number | Weighted | Weighted | Number | Weighted | ||||||||||
Outstanding | Average | Average | Exercisable | Average | |||||||||||
Remaining | Exercise | Exercise | |||||||||||||
Contractual | Price | Price | |||||||||||||
Life (years) | |||||||||||||||
$0.61 - $1.56 | 3,038,000 | 9.41 | $ | 1.34 | 100 | $ | 1.51 | ||||||||
$1.88 - $4.20 | 3,697,200 | 6.55 | 3.11 | 3,037,803 | 2.97 | ||||||||||
$4.44 - $20.40 | 1,369,234 | 3.05 | 13.72 | 1,314,702 | 14.09 | ||||||||||
| | | | | | | | | | | | | | | |
8,104,434 | 7.03 | 4.24 | 4,352,605 | 6.33 | |||||||||||
| | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | |
Property_and_Equipment_Net_Tab
Property and Equipment, Net (Tables) | 12 Months Ended | |||||||
Dec. 31, 2014 | ||||||||
Property and Equipment, Net | ||||||||
Schedule of property and equipment, net | ||||||||
December 31, | ||||||||
2014 | 2013 | |||||||
Computer equipment and software | $ | 2,128 | $ | 2,130 | ||||
Furniture and fixtures | 1,032 | 1,032 | ||||||
Leasehold improvements | 355 | 355 | ||||||
Office and laboratory equipment | 261 | 261 | ||||||
| | | | | | | | |
3,776 | 3,778 | |||||||
Less: accumulated depreciation | (3,747 | ) | (3,666 | ) | ||||
| | | | | | | | |
$ | 29 | $ | 112 | |||||
| | | | | | | | |
| | | | | | | | |
Accrued_Expenses_and_Other_Cur1
Accrued Expenses and Other Current Liabilities (Tables) | 12 Months Ended | |||||||
Dec. 31, 2014 | ||||||||
Accrued Expenses and Other Current Liabilities | ||||||||
Schedule of accrued expenses and other current liabilities | ||||||||
December 31, | ||||||||
2014 | 2013 | |||||||
Clinical trials | $ | 929 | $ | 1,127 | ||||
Net deferred income tax liabilities | 319 | 156 | ||||||
General and administrative | 267 | 497 | ||||||
Employee compensation | 160 | 1,354 | ||||||
Product returns | 112 | 586 | ||||||
Research and development | 63 | 39 | ||||||
| | | | | | | | |
$ | 1,850 | $ | 3,759 | |||||
| | | | | | | | |
| | | | | | | | |
Income_Taxes_Tables
Income Taxes (Tables) | 12 Months Ended | |||||||
Dec. 31, 2014 | ||||||||
Income Taxes | ||||||||
Schedule of principal components of the Company's net deferred income tax assets and liabilities | ||||||||
December 31, | ||||||||
2014 | 2013 | |||||||
Deferred income tax assets: | ||||||||
Net federal and state operating loss carryforwards | $ | 139,126 | $ | 127,819 | ||||
Research and development credits | 12,754 | 11,934 | ||||||
Share-based compensation | 6,800 | 8,670 | ||||||
Depreciation and amortization | 89 | 170 | ||||||
Other | 69 | 425 | ||||||
| | | | | | | | |
Total deferred tax assets | 158,838 | 149,018 | ||||||
| | | | | | | | |
Deferred income tax liabilities: | ||||||||
Other | 329 | 157 | ||||||
| | | | | | | | |
Total deferred tax liabilities | 329 | 157 | ||||||
| | | | | | | | |
Net deferred tax assets | 158,509 | 148,861 | ||||||
Valuation allowance | (158,509 | ) | (148,861 | ) | ||||
| | | | | | | | |
$ | - | $ | - | |||||
| | | | | | | | |
| | | | | | | | |
Quarterly_Financial_Data_Unaud1
Quarterly Financial Data (Unaudited) (Tables) | 12 Months Ended | |||||||||||||
Dec. 31, 2014 | ||||||||||||||
Quarterly Financial Data (Unaudited) | ||||||||||||||
Summary of the quarterly results of operations | ||||||||||||||
2014 Quarters Ended | ||||||||||||||
March 31 | June 30 | September 30 | December 31 | |||||||||||
Expenses: | ||||||||||||||
Research and development expenses | $ | 6,360 | $ | 7,894 | $ | 3,362 | $ | 3,254 | ||||||
General and administrative expenses | 2,629 | 3,052 | 1,594 | 2,203 | ||||||||||
| | | | | | | | | | | | | | |
Total expenses | 8,989 | 10,946 | 4,956 | 5,457 | ||||||||||
| | | | | | | | | | | | | | |
Loss from operations | (8,989 | ) | (10,946 | ) | (4,956 | ) | (5,457 | ) | ||||||
Other income (expense), net | 2 | 2 | 21 | (284 | ) | |||||||||
Loss on change in fair value of warrant liability (a) | - | - | - | (8,804 | ) | |||||||||
| | | | | | | | | | | | | | |
Net loss | $ | (8,987 | ) | $ | (10,944 | ) | $ | (4,935 | ) | $ | (14,545 | ) | ||
| | | | | | | | | | | | | | |
| | | | | | | | | | | | | | |
Net loss per share — basic and diluted | $ | (0.14 | ) | $ | (0.15 | ) | $ | (0.06 | ) | $ | (0.13 | ) | ||
| | | | | | | | | | | | | | |
| | | | | | | | | | | | | | |
Weighted average shares outstanding: | ||||||||||||||
Basic and diluted | 66,512,069 | 75,433,302 | 76,014,531 | 108,869,121 | ||||||||||
| | | | | | | | | | | | | | |
| | | | | | | | | | | | | | |
(a) | The loss on change in fair value of warrant liability is related to the private placement of warrants completed in November 2014. See Note 6, Stockholders' Equity, for further information. | |||||||||||||
2013 Quarters Ended | ||||||||||||||
March 31 | June 30 | September 30 | December 31 | |||||||||||
Expenses: | ||||||||||||||
Research and development expenses | $ | 9,614 | $ | 10,139 | $ | 6,477 | $ | 6,088 | ||||||
General and administrative expenses | 3,023 | 2,684 | 2,483 | 3,091 | ||||||||||
| | | | | | | | | | | | | | |
Total expenses | 12,637 | 12,823 | 8,960 | 9,179 | ||||||||||
| | | | | | | | | | | | | | |
Loss from operations | (12,637 | ) | (12,823 | ) | (8,960 | ) | (9,179 | ) | ||||||
Other income, net | 55 | 21 | 23 | 1,389 | ||||||||||
| | | | | | | | | | | | | | |
Net loss | $ | (12,582 | ) | $ | (12,802 | ) | $ | (8,937 | ) | $ | (7,790 | ) | ||
| | | | | | | | | | | | | | |
| | | | | | | | | | | | | | |
Net loss per share — basic and diluted | $ | (0.20 | ) | $ | (0.20 | ) | $ | (0.14 | ) | $ | (0.12 | ) | ||
| | | | | | | | | | | | | | |
| | | | | | | | | | | | | | |
Weighted average shares outstanding: | ||||||||||||||
Basic and diluted | 62,864,140 | 62,994,771 | 63,179,394 | 63,185,389 | ||||||||||
| | | | | | | | | | | | | | |
| | | | | | | | | | | | | | |
Significant_Accounting_Policie3
Significant Accounting Policies (Details) | 12 Months Ended |
Dec. 31, 2014 | |
item | |
Significant Accounting Policies | |
Number of business segments | 1 |
Laboratory and Office Equipment | Minimum | |
Property and equipment | |
Estimated useful lives | 3 years |
Laboratory and Office Equipment | Maximum | |
Property and equipment | |
Estimated useful lives | 5 years |
Leasehold Improvements | Minimum | |
Property and equipment | |
Estimated useful lives | 3 years |
Leasehold Improvements | Maximum | |
Property and equipment | |
Estimated useful lives | 7 years |
Furniture and Fixtures | |
Property and equipment | |
Estimated useful lives | 5 years |
Computer Equipment and Software | |
Property and equipment | |
Estimated useful lives | 3 years |
Significant_Accounting_Policie4
Significant Accounting Policies (Details 2) (USD $) | 3 Months Ended | 12 Months Ended | ||
In Thousands, except Share data, unless otherwise specified | Dec. 31, 2014 | Dec. 31, 2014 | Nov. 14, 2014 | Dec. 31, 2013 |
Fair Value of Financial Instruments | ||||
Warrant liability | $30,430 | $30,430 | ||
Loss on change in fair value of warrant liability | 8,804 | 8,804 | ||
Warrant Liability | ||||
Warrants issued to purchase shares under private placement | 64,311,112 | |||
Maximum contingent per share cash settlement price (in dollars per share) | $0.13 | |||
Fair Value Measurements, Recurring | Level 3 | ||||
Fair Value of Financial Instruments | ||||
Warrant liability | 30,430 | 30,430 | ||
Assets at fair value | 0 | |||
Liabilities at fair value | $0 |
Significant_Accounting_Policie5
Significant Accounting Policies (Details 3) (USD $) | 12 Months Ended | ||
In Thousands, except Share data, unless otherwise specified | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 |
Income Taxes | |||
Net deferred tax assets | $0 | $0 | |
Other Income (Expense), Net | |||
Gain on sale of property and equipment | $1,366 | ||
Basic and Diluted Net Loss Per Share | |||
Weighted average potential shares of common stock excluded from calculation of diluted net loss per share | 24,628,775 | 6,773,394 | 5,574,915 |
Common stock, shares outstanding | 140,325,643 | 63,185,389 |
Significant_Accounting_Policie6
Significant Accounting Policies (Details 4) (USD $) | 3 Months Ended | 12 Months Ended | 1 Months Ended | 0 Months Ended | |||||||||
In Thousands, unless otherwise specified | Dec. 31, 2014 | Sep. 30, 2014 | Jun. 30, 2014 | Mar. 31, 2014 | Dec. 31, 2013 | Sep. 30, 2013 | Jun. 30, 2013 | Mar. 31, 2013 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | Oct. 31, 2012 | Sep. 30, 2012 |
Discontinued Operations disclosures | |||||||||||||
Gain on sale of FARESTON | $18,831 | ||||||||||||
Operating income disclosures related to discontinued operations | |||||||||||||
General and administrative expense (benefit) | 2,203 | 1,594 | 3,052 | 2,629 | 3,091 | 2,483 | 2,684 | 3,023 | 9,478 | 11,281 | 10,845 | ||
Former Orion Corporation License and Supply Agreement | |||||||||||||
Discontinued Operations disclosures | |||||||||||||
Contract termination fee | 1,000 | ||||||||||||
Fareston | |||||||||||||
Discontinued Operations disclosures | |||||||||||||
Proceeds from the sale of rights and certain assets related to FARESTON | 21,671 | ||||||||||||
Gain on sale of FARESTON | 18,831 | ||||||||||||
Financial advisory fee | 1,712 | ||||||||||||
Other transaction expenses | 128 | ||||||||||||
Operating income disclosures related to discontinued operations | |||||||||||||
Product sales, net | 5,284 | ||||||||||||
Cost of product sales | 784 | ||||||||||||
Operating expenses | 655 | ||||||||||||
General and administrative expense (benefit) | -576 | ||||||||||||
FARESTON Revenue Recognition | |||||||||||||
Accrual for product returns | 141 | 918 | 141 | 918 | |||||||||
Accrual for product returns included in other long term liabilities | 30 | 332 | 30 | 332 | |||||||||
Fareston | Former Orion Corporation License and Supply Agreement | |||||||||||||
Discontinued Operations disclosures | |||||||||||||
Contract termination fee | $1,000 |
Significant_Accounting_Policie7
Significant Accounting Policies (Details 5) (USD $) | 1 Months Ended | 12 Months Ended |
In Thousands, unless otherwise specified | Oct. 31, 2013 | Dec. 31, 2013 |
Restructuring | ||
Reduction in workforce (as a percent) | 60.00% | |
Gain on sale of property and equipment | $1,366 | |
One-time compensation expense related to cash severance | ||
Restructuring | ||
Expense (benefit) related to workforce reduction | 1,306 | |
One-time compensation expense related to cash severance | General and Administrative Expenses | ||
Restructuring | ||
Expense (benefit) related to workforce reduction | 351 | |
One-time compensation expense related to cash severance | Research and Development Expenses | ||
Restructuring | ||
Expense (benefit) related to workforce reduction | 955 | |
One-time share based compensation benefit related to amendment of stock option provisions | ||
Restructuring | ||
Expense (benefit) related to workforce reduction | -370 | |
One-time share based compensation benefit related to amendment of stock option provisions | General and Administrative Expenses | ||
Restructuring | ||
Expense (benefit) related to workforce reduction | -81 | |
One-time share based compensation benefit related to amendment of stock option provisions | Research and Development Expenses | ||
Restructuring | ||
Expense (benefit) related to workforce reduction | ($289) |
ShareBased_Compensation_Detail
Share-Based Compensation (Details) (USD $) | 12 Months Ended | 3 Months Ended | ||
In Thousands, unless otherwise specified | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | Jun. 30, 2014 |
Share-based compensation expense | ||||
Term of options from the grant date | 10 years | |||
Total share-based compensation | $4,553 | $3,868 | $2,817 | |
Share-based compensation expense related to deferred compensation arrangements for non-employee directors | 125 | 135 | 169 | |
One-time share based compensation benefit related to amendment of stock option provisions | ||||
Share-based compensation expense | ||||
Expense (benefit) related to workforce reduction | -370 | |||
Research and Development Expenses | ||||
Share-based compensation expense | ||||
Total share-based compensation | 2,512 | 1,875 | 1,046 | |
Research and Development Expenses | One-time share based compensation benefit related to amendment of stock option provisions | ||||
Share-based compensation expense | ||||
Expense (benefit) related to workforce reduction | -289 | |||
General and Administrative Expenses | ||||
Share-based compensation expense | ||||
Total share-based compensation | 2,041 | 1,993 | 1,771 | |
General and Administrative Expenses | One-time share based compensation benefit related to amendment of stock option provisions | ||||
Share-based compensation expense | ||||
Expense (benefit) related to workforce reduction | -81 | |||
Maximum | ||||
Share-based compensation expense | ||||
Term of options from the grant date | 10 years | |||
Director | ||||
Share-based compensation expense | ||||
Option vesting period | 3 years | |||
Share-based compensation expense related to deferred compensation arrangements for non-employee directors | 125 | 135 | 169 | |
Director | General and Administrative Expenses | ||||
Share-based compensation expense | ||||
Share-based compensation expense related to deferred compensation arrangements for non-employee directors | 125 | 135 | 169 | |
Former Chief Executive Officer | ||||
Share-based compensation expense | ||||
One-time, noncash net compensation expense related to the modification of stock options | $215 | |||
Employees | ||||
Share-based compensation expense | ||||
Period available to exercise all vested options after end of employment relationship | 3 months | |||
Option vesting period after employee's termination of service before modification | 90 days | |||
Modified option vesting period after employee's termination of service | 6 months | |||
Employees | Maximum | ||||
Share-based compensation expense | ||||
Option vesting period | 5 years |
ShareBased_Compensation_Detail1
Share-Based Compensation (Details 2) (Restricted Stock Units (RSUs), USD $) | 12 Months Ended | |
Dec. 31, 2014 | Dec. 31, 2013 | |
Restricted Stock Units (RSUs) | ||
Number of Shares | ||
Unvested awards outstanding (in shares) | 0 | 1,225,000 |
Vested shares withheld to satisfy statutory tax withholding requirements | 371,906 | |
Weighted Average Grant Date Fair Value Per Share | ||
Weighted average grant date fair value per share (in dollars per share) | $1.87 |
ShareBased_Compensation_Detail2
Share-Based Compensation (Details 3) (USD $) | 12 Months Ended | ||
Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | |
Share-based compensation | |||
Weighted average grant date fair value (in dollars per share) | $1.04 | $2.13 | $2.14 |
Fair value of options granted | |||
Expected price volatility (as a percent) | 86.50% | 82.90% | 69.60% |
Risk-free interest rate (as a percent) | 2.30% | 1.27% | 1.22% |
Weighted average expected life in years | 6 years 10 months 24 days | 5 years 10 months 24 days | 6 years 6 months |
Dividend yield (as a percent) | 0.00% | 0.00% | 0.00% |
Option term | 10 years | ||
Number of Shares | |||
Options outstanding at the beginning of the period (in shares) | 6,445,342 | 5,382,859 | 4,945,565 |
Options granted (in shares) | 3,094,500 | 2,784,200 | 1,141,250 |
Options forfeited or expired (in shares) | -1,435,408 | -1,400,419 | -675,755 |
Options exercised (in shares) | 0 | -321,298 | -28,201 |
Options outstanding at the end of the period (in shares) | 8,104,434 | 6,445,342 | 5,382,859 |
Options vested and expected to vest at the end of the period (in shares) | 7,795,136 | ||
Weighted Average Exercise Price Per Share | |||
Options outstanding at the beginning of the period (in dollars per share) | $6.58 | $7.96 | $9.12 |
Options granted (in dollars per share) | $1.34 | $3.12 | $3.35 |
Options forfeited or expired (in dollars per share) | $8.50 | $5.86 | $8.82 |
Options exercised (in dollars per share) | $3.81 | $3.05 | |
Options outstanding at the end of the period (in dollars per share) | $4.24 | $6.58 | $7.96 |
Options vested and expected to vest at the end of the period (in dollars per share) | $4.34 | ||
Maximum | |||
Fair value of options granted | |||
Option term | 10 years |
ShareBased_Compensation_Detail3
Share-Based Compensation (Details 4) (USD $) | 12 Months Ended | ||
In Thousands, except Share data, unless otherwise specified | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 |
Information about stock options outstanding | |||
Options Outstanding, Number Outstanding (in shares) | 8,104,434 | ||
Options Outstanding, Weighted Average Remaining Contractual Life | 7 years 11 days | ||
Options Outstanding, Weighted Average Exercise Price (in dollars per share) | $4.24 | ||
Options Exercisable, Number Exercisable (in shares) | 4,352,605 | ||
Options Exercisable, Weighted Average Exercise Price (in dollars per share) | $6.33 | ||
Additional information | |||
Aggregate intrinsic value of all outstanding options (in dollars) | $5 | ||
Options exercisable, weighted average remaining contractual term | 5 years 3 months 11 days | ||
Options exercisable, aggregate intrinsic value (in dollars) | 0 | ||
Vested and expected to vest options, weighted average remaining contractual term | 6 years 11 months 9 days | ||
Vested and expected to vest options, intrinsic value (in dollars) | 4 | ||
Options exercised (in shares) | 0 | 321,298 | 28,201 |
Intrinsic value of options exercised (in dollars) | 688 | 36 | |
Compensation cost related to non-vested options not yet recognized | $4,030 | ||
Weighted average expense recognition period related to non-vested options not yet recognized | 3 years 11 months 9 days | ||
Shares available for future issuance under the Company's stock option and equity incentive plans | 4,979,673 | ||
Increase to shares available for future issuance in accordance with annual automatic increase provisions | 6,113,026 | ||
$0.61 to $1.56 | |||
Information about stock options outstanding | |||
Low end of range of exercise prices (in dollars per share) | $0.61 | ||
High end of range of exercise prices (in dollars per share) | $1.56 | ||
Options Outstanding, Number Outstanding (in shares) | 3,038,000 | ||
Options Outstanding, Weighted Average Remaining Contractual Life | 9 years 4 months 28 days | ||
Options Outstanding, Weighted Average Exercise Price (in dollars per share) | $1.34 | ||
Options Exercisable, Number Exercisable (in shares) | 100 | ||
Options Exercisable, Weighted Average Exercise Price (in dollars per share) | $1.51 | ||
$1.88 to $4.20 | |||
Information about stock options outstanding | |||
Low end of range of exercise prices (in dollars per share) | $1.88 | ||
High end of range of exercise prices (in dollars per share) | $4.20 | ||
Options Outstanding, Number Outstanding (in shares) | 3,697,200 | ||
Options Outstanding, Weighted Average Remaining Contractual Life | 6 years 6 months 18 days | ||
Options Outstanding, Weighted Average Exercise Price (in dollars per share) | $3.11 | ||
Options Exercisable, Number Exercisable (in shares) | 3,037,803 | ||
Options Exercisable, Weighted Average Exercise Price (in dollars per share) | $2.97 | ||
$4.44 to $20.40 | |||
Information about stock options outstanding | |||
Low end of range of exercise prices (in dollars per share) | $4.44 | ||
High end of range of exercise prices (in dollars per share) | $20.40 | ||
Options Outstanding, Number Outstanding (in shares) | 1,369,234 | ||
Options Outstanding, Weighted Average Remaining Contractual Life | 3 years 18 days | ||
Options Outstanding, Weighted Average Exercise Price (in dollars per share) | $13.72 | ||
Options Exercisable, Number Exercisable (in shares) | 1,314,702 | ||
Options Exercisable, Weighted Average Exercise Price (in dollars per share) | $14.09 |
Property_and_Equipment_Net_Det
Property and Equipment, Net (Details) (USD $) | 12 Months Ended | ||
In Thousands, unless otherwise specified | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 |
Property and equipment | |||
Property and Equipment, gross | $3,776 | $3,778 | |
Less: accumulated depreciation | -3,747 | -3,666 | |
Property and Equipment, Net | 29 | 112 | |
Depreciation and amortization expense | 88 | 369 | 730 |
Gain on sale of property and equipment | 1,366 | ||
Research and Development Expenses | |||
Property and equipment | |||
Depreciation and amortization expense | 1 | 169 | 290 |
Computer Equipment and Software | |||
Property and equipment | |||
Property and Equipment, gross | 2,128 | 2,130 | |
Furniture and Fixtures | |||
Property and equipment | |||
Property and Equipment, gross | 1,032 | 1,032 | |
Leasehold Improvements | |||
Property and equipment | |||
Property and Equipment, gross | 355 | 355 | |
Laboratory and Office Equipment | |||
Property and equipment | |||
Property and Equipment, gross | 261 | 261 | |
Property and equipment sold | $58 |
Accrued_Expenses_and_Other_Cur2
Accrued Expenses and Other Current Liabilities (Details) (USD $) | Dec. 31, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Accrued Expenses and Other Current Liabilities | ||
Clinical trials | $929 | $1,127 |
Net deferred income tax liabilities | 319 | 156 |
General and administrative | 267 | 497 |
Employee compensation | 160 | 1,354 |
Product returns | 112 | 586 |
Research and development | 63 | 39 |
Accrued expenses and other current liabilities | $1,850 | $3,759 |
Stockholders_Equity_Details
Stockholders' Equity (Details) (USD $) | 3 Months Ended | 12 Months Ended | 0 Months Ended | ||
In Thousands, except Share data, unless otherwise specified | Dec. 31, 2014 | Dec. 31, 2014 | Nov. 14, 2014 | Mar. 06, 2014 | Dec. 31, 2013 |
Authorized Capital | |||||
Common stock shares authorized | 200,000,000 | 200,000,000 | 120,000,000 | ||
Par value per share (in dollars per share) | $0.00 | $0.00 | $0.00 | ||
Preferred stock shares authorized | 5,000,000 | 5,000,000 | |||
Par value per share (in dollars per share) | $0.00 | $0.00 | |||
Common Stock and Associated Warrant Liability | |||||
Warrants issued to purchase shares under private placement | 64,311,112 | ||||
Maximum contingent per share cash settlement price (in dollars per share) | $0.13 | ||||
Fair value of warrant liability | $30,430 | $30,430 | |||
Loss on change in fair value of warrant liability | 8,804 | 8,804 | |||
Private Placement, November 2014 | |||||
Common Stock and Associated Warrant Liability | |||||
Shares issued | 64,311,112 | ||||
Warrants issued to purchase shares under private placement | 64,311,112 | ||||
Net cash proceeds from public offering after deducting underwriting discounts and commissions and other offering expenses | 42,814 | ||||
Exercise price (in dollars per share) | $0.85 | ||||
Warrant term | 4 years | ||||
Maximum contingent per share cash settlement price (in dollars per share) | $0.13 | ||||
Fair value of warrant liability | 30,430 | 30,430 | 21,626 | ||
Loss on change in fair value of warrant liability | 8,804 | ||||
Expected volatility of warrants (as a percent) | 91.00% | ||||
Risk free interest rate of warrants (as a percent) | 1.50% | ||||
Expected life of warrants | 4 years 6 months | ||||
Expected dividends on warrants | $0 | ||||
Private Placement, March 2014 | |||||
Common Stock and Associated Warrant Liability | |||||
Shares issued | 11,976,048 | ||||
Warrants issued to purchase shares under private placement | 10,179,642 | ||||
Net cash proceeds from public offering after deducting underwriting discounts and commissions and other offering expenses | 21,135 | ||||
Exercise price (in dollars per share) | $1.67 | ||||
Warrant term | 1 year | ||||
Estimated fair value of warrants | $4,478 | ||||
Expected volatility of warrants (as a percent) | 67.00% | ||||
Risk free interest rate of warrants (as a percent) | 0.12% | ||||
Expected life of warrants | 1 year | ||||
Expected dividends on warrants | $0 |
Collaboration_and_License_Agre1
Collaboration and License Agreements (Details) (Former Orion Corporation License and Supply Agreement, USD $) | 1 Months Ended |
In Thousands, unless otherwise specified | Oct. 31, 2012 |
Former Orion Corporation License and Supply Agreement | |
Collaboration and license agreements disclosures | |
Contract termination fee | $1,000 |
Intangible_Assets_Net_Details
Intangible Assets, Net (Details) (USD $) | 0 Months Ended | |||
In Thousands, unless otherwise specified | Jan. 01, 2005 | Dec. 31, 2014 | Dec. 31, 2013 | Jul. 31, 2007 |
Former Orion Corporation License and Supply Agreement | ||||
Intangible assets, net | ||||
License fee | $4,826 | |||
SARM License Agreement | ||||
Intangible assets, net | ||||
One-time up-front fee | 290 | |||
Intangible asset, net | $152 | $166 |
Income_Taxes_Details
Income Taxes (Details) (USD $) | 12 Months Ended | ||
In Thousands, unless otherwise specified | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 |
Deferred income tax assets: | |||
Net federal and state operating loss carryforwards | $139,126 | $127,819 | |
Research and development credits | 12,754 | 11,934 | |
Share-based compensation | 6,800 | 8,670 | |
Depreciation and amortization | 89 | 170 | |
Other | 69 | 425 | |
Total deferred tax assets | 158,838 | 149,018 | |
Deferred income tax liabilities: | |||
Other | 329 | 157 | |
Total deferred tax liabilities | 329 | 157 | |
Net deferred tax assets | 158,509 | 148,861 | |
Valuation allowance | -158,509 | -148,861 | |
Net deferred tax assets and liabilities | 0 | 0 | |
Valuation allowance disclosure | |||
Increase in valuation allowance | 9,648 | 17,318 | 8,836 |
Tax credits | |||
Unrecognized tax benefits | 0 | ||
Federal | |||
Operating loss carryforwards | |||
Net operating loss carryforwards | 358,702 | ||
State | |||
Operating loss carryforwards | |||
Net operating loss carryforwards | 337,735 | ||
Federal and State | |||
Operating loss carryforwards | |||
Deductions related to the exercise of stock options | $2,301 |
Directors_Deferred_Compensatio1
Directors' Deferred Compensation Plan (Details) (USD $) | 12 Months Ended | ||
In Thousands, except Share data, unless otherwise specified | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 |
Directors' deferred compensation plan | |||
Non-employee director fee expense which was deferred into stock accounts | $125 | $135 | $169 |
Director | |||
Directors' deferred compensation plan | |||
Non-employee director fee expense | 247 | 259 | 237 |
Non-employee director fee expense which was deferred into stock accounts | 125 | 135 | 169 |
Shares of common stock credited to individual director stock accounts under the Directors' Deferred Compensation Plan | 237,100 | ||
Amount credited to individual director cash accounts under the Directors' Deferred Compensation Plan | $0 |
401k_Plan_Details
401(k) Plan (Details) (USD $) | 12 Months Ended | ||
Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | |
item | |||
401(k) Plan | |||
Maximum annual contribution per employee who is under the specified age in the current calendar year | $17,500 | ||
Age specified for current calendar year to determine employee's contribution | 50 | ||
Maximum annual contribution per employee who is equal to specified age and older in the current calendar year | 23,000 | ||
Company's matching contribution to the plan | $200,000 | $338,000 | $363,000 |
Commitments_and_Contingencies_
Commitments and Contingencies (Details) (USD $) | 12 Months Ended | ||
In Thousands, unless otherwise specified | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 |
Commitments and Contingencies | |||
Rent expense under operating leases | $513 | $674 | $963 |
Operating Lease Commitments | |||
2015 | $184 |
Quarterly_Financial_Data_Unaud2
Quarterly Financial Data (Unaudited) (Details) (USD $) | 3 Months Ended | 12 Months Ended | |||||||||
In Thousands, except Share data, unless otherwise specified | Dec. 31, 2014 | Sep. 30, 2014 | Jun. 30, 2014 | Mar. 31, 2014 | Dec. 31, 2013 | Sep. 30, 2013 | Jun. 30, 2013 | Mar. 31, 2013 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 |
Expenses: | |||||||||||
Research and development expenses | $3,254 | $3,362 | $7,894 | $6,360 | $6,088 | $6,477 | $10,139 | $9,614 | $20,870 | $32,318 | $38,887 |
General and administrative expenses | 2,203 | 1,594 | 3,052 | 2,629 | 3,091 | 2,483 | 2,684 | 3,023 | 9,478 | 11,281 | 10,845 |
Total expenses | 5,457 | 4,956 | 10,946 | 8,989 | 9,179 | 8,960 | 12,823 | 12,637 | 30,348 | 43,599 | 49,732 |
Loss from operations | -5,457 | -4,956 | -10,946 | -8,989 | -9,179 | -8,960 | -12,823 | -12,637 | -30,348 | -43,599 | -49,732 |
Other income (expense), net | -284 | 21 | 2 | 2 | 1,389 | 23 | 21 | 55 | -259 | 1,488 | -19 |
Loss on change in fair value of warrant liability | -8,804 | -8,804 | |||||||||
Loss from operations before income taxes | ($14,545) | ($4,935) | ($10,944) | ($8,987) | ($7,790) | ($8,937) | ($12,802) | ($12,582) | ($39,411) | ($42,111) | ($49,751) |
Net (loss) income per share - basic and diluted: | |||||||||||
Net loss per share (in dollars per share) | ($0.13) | ($0.06) | ($0.15) | ($0.14) | ($0.12) | ($0.14) | ($0.20) | ($0.20) | ($0.48) | ($0.67) | ($0.43) |
Weighted average shares outstanding: | |||||||||||
Basic and diluted (in shares) | 108,869,121 | 76,014,531 | 75,433,302 | 66,512,069 | 63,185,389 | 63,179,394 | 62,994,771 | 62,864,140 | 81,807,706 | 63,057,142 | 62,809,219 |