|
Document and Entity Information
|
9 Months Ended | |
|---|---|---|
|
Sep. 30, 2014
|
Nov. 06, 2014
|
|
| Document and Entity Information | ||
| Entity Registrant Name | GTX INC /DE/ | |
| Entity Central Index Key | 0001260990 | |
| Document Type | 10-Q | |
| Document Period End Date | Sep. 30, 2014 | |
| Amendment Flag | false | |
| Current Fiscal Year End Date | --12-31 | |
| Entity Current Reporting Status | Yes | |
| Entity Filer Category | Accelerated Filer | |
| Entity Common Stock, Shares Outstanding | 76,014,531 | |
| Document Fiscal Year Focus | 2014 | |
| Document Fiscal Period Focus | Q3 |
| X | ||||||||||
|
- Definition
If the value is true, then the document is an amendment to previously-filed/accepted document. No definition available.
|
| X | ||||||||||
|
- Definition
End date of current fiscal year in the format --MM-DD. No definition available.
|
| X | ||||||||||
|
- Definition
This is focus fiscal period of the document report. For a first quarter 2006 quarterly report, which may also provide financial information from prior periods, the first fiscal quarter should be given as the fiscal period focus. Values: FY, Q1, Q2, Q3, Q4, H1, H2, M9, T1, T2, T3, M8, CY. No definition available.
|
| X | ||||||||||
|
- Definition
This is focus fiscal year of the document report in CCYY format. For a 2006 annual report, which may also provide financial information from prior periods, fiscal 2006 should be given as the fiscal year focus. Example: 2006. No definition available.
|
| X | ||||||||||
|
- Definition
The end date of the period reflected on the cover page if a periodic report. For all other reports and registration statements containing historical data, it is the date up through which that historical data is presented. If there is no historical data in the report, use the filing date. The format of the date is CCYY-MM-DD. No definition available.
|
| X | ||||||||||
|
- Definition
The type of document being provided (such as 10-K, 10-Q, 485BPOS, etc). The document type is limited to the same value as the supporting SEC submission type, or the word "Other". No definition available.
|
| X | ||||||||||
|
- Definition
A unique 10-digit SEC-issued value to identify entities that have filed disclosures with the SEC. It is commonly abbreviated as CIK. Reference 1: http://www.xbrl.org/2003/role/presentationRef
|
| X | ||||||||||
|
- Definition
Indicate number of shares or other units outstanding of each of registrant's classes of capital or common stock or other ownership interests, if and as stated on cover of related periodic report. Where multiple classes or units exist define each class/interest by adding class of stock items such as Common Class A [Member], Common Class B [Member] or Partnership Interest [Member] onto the Instrument [Domain] of the Entity Listings, Instrument. No definition available.
|
| X | ||||||||||
|
- Definition
Indicate "Yes" or "No" whether registrants (1) have filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that registrants were required to file such reports), and (2) have been subject to such filing requirements for the past 90 days. This information should be based on the registrant's current or most recent filing containing the related disclosure. No definition available.
|
| X | ||||||||||
|
- Definition
Indicate whether the registrant is one of the following: (1) Large Accelerated Filer, (2) Accelerated Filer, (3) Non-accelerated Filer, (4) Smaller Reporting Company (Non-accelerated) or (5) Smaller Reporting Accelerated Filer. Definitions of these categories are stated in Rule 12b-2 of the Exchange Act. This information should be based on the registrant's current or most recent filing containing the related disclosure. No definition available.
|
| X | ||||||||||
|
- Definition
The exact name of the entity filing the report as specified in its charter, which is required by forms filed with the SEC. Reference 1: http://www.xbrl.org/2003/role/presentationRef
|
| X | ||||||||||
|
- Details
|
| X | ||||||||||
|
- Definition
Sum of the carrying value as of the balance sheet date of the current portion of obligations incurred and payable, pertaining to costs that are statutory in nature, are incurred on contractual obligations, or accumulate over time and for which invoices have not yet been received or will not be rendered, and the aggregate carrying amount of other current liabilities not separately disclosed in the balance sheet. No definition available.
|
| X | ||||||||||
|
- Definition
Sum of the carrying amounts of all intangible assets, net of accumulated amortization and impairment, if any, and the aggregate carrying among of other noncurrent assets not separately disclosed in the balance sheet. No definition available.
|
| X | ||||||||||
|
- Definition
Carrying value as of the balance sheet date of liabilities incurred (and for which invoices have typically been received) and payable to vendors for goods and services received that are used in an entity's business. Used to reflect the current portion of the liabilities (due within one year or within the normal operating cycle if longer). Reference 1: http://www.xbrl.org/2003/role/presentationRef
|
| X | ||||||||||
|
- Definition
Value received from shareholders in common stock-related transactions that are in excess of par value or stated value and amounts received from other stock-related transactions. Includes only common stock transactions (excludes preferred stock transactions). May be called contributed capital, capital in excess of par, capital surplus, or paid-in capital. Reference 1: http://www.xbrl.org/2003/role/presentationRef
|
| X | ||||||||||
|
- Definition
Sum of the carrying amounts as of the balance sheet date of all assets that are recognized. Assets are probable future economic benefits obtained or controlled by an entity as a result of past transactions or events. Reference 1: http://www.xbrl.org/2003/role/presentationRef
|
| X | ||||||||||
|
- Definition
Sum of the carrying amounts as of the balance sheet date of all assets that are expected to be realized in cash, sold, or consumed within one year (or the normal operating cycle, if longer). Assets are probable future economic benefits obtained or controlled by an entity as a result of past transactions or events. Reference 1: http://www.xbrl.org/2003/role/presentationRef
|
| X | ||||||||||
|
- Details
|
| X | ||||||||||
|
- Definition
Amount of currency on hand as well as demand deposits with banks or financial institutions. Includes other kinds of accounts that have the general characteristics of demand deposits. Also includes short-term, highly liquid investments that are both readily convertible to known amounts of cash and so near their maturity that they present insignificant risk of changes in value because of changes in interest rates. Excludes cash and cash equivalents within disposal group and discontinued operation. Reference 1: http://www.xbrl.org/2003/role/presentationRef
|
| X | ||||||||||
|
- Definition
Represents the caption on the face of the balance sheet to indicate that the entity has entered into (1) purchase or supply arrangements that will require expending a portion of its resources to meet the terms thereof, and (2) is exposed to potential losses or, less frequently, gains, arising from (a) possible claims against a company's resources due to future performance under contract terms, and (b) possible losses or likely gains from uncertainties that will ultimately be resolved when one or more future events that are deemed likely to occur do occur or fail to occur. Reference 1: http://www.xbrl.org/2003/role/presentationRef
|
| X | ||||||||||
|
- Definition
Aggregate par or stated value of issued nonredeemable common stock (or common stock redeemable solely at the option of the issuer). This item includes treasury stock repurchased by the entity. Note: elements for number of nonredeemable common shares, par value and other disclosure concepts are in another section within stockholders' equity. Reference 1: http://www.xbrl.org/2003/role/presentationRef
|
| X | ||||||||||
|
- Definition
Amount after other than temporary impairment (OTTI) accretion, of investments in debt securities classified as held-to-maturity, expected to be converted to cash, sold or exchanged within one year or the normal operating cycle. Reference 1: http://www.xbrl.org/2003/role/presentationRef
|
| X | ||||||||||
|
- Definition
Amount of liabilities and equity items, including the portion of equity attributable to noncontrolling interests, if any. Reference 1: http://www.xbrl.org/2003/role/presentationRef
|
| X | ||||||||||
|
- Definition
Total obligations incurred as part of normal operations that are expected to be paid during the following twelve months or within one business cycle, if longer. Reference 1: http://www.xbrl.org/2003/role/presentationRef
|
| X | ||||||||||
|
- Details
|
| X | ||||||||||
|
- Definition
Aggregate carrying amount, as of the balance sheet date, of noncurrent obligations not separately disclosed in the balance sheet. Noncurrent liabilities are expected to be paid after one year (or the normal operating cycle, if longer). Reference 1: http://www.xbrl.org/2003/role/presentationRef
|
| X | ||||||||||
|
- Definition
Amount of asset related to consideration paid in advance for costs that provide economic benefits in future periods, and amount of other assets that are expected to be realized or consumed within one year or the normal operating cycle, if longer. Reference 1: http://www.xbrl.org/2003/role/presentationRef
|
| X | ||||||||||
|
- Definition
Amount after accumulated depreciation, depletion and amortization of physical assets used in the normal conduct of business to produce goods and services and not intended for resale. Examples include, but are not limited to, land, buildings, machinery and equipment, office equipment, and furniture and fixtures. Reference 1: http://www.xbrl.org/2003/role/presentationRef
|
| X | ||||||||||
|
- Definition
The cumulative amount of the reporting entity's undistributed earnings or deficit. Reference 1: http://www.xbrl.org/2003/role/presentationRef
|
| X | ||||||||||
|
- Definition
Total of all stockholders' equity (deficit) items, net of receivables from officers, directors, owners, and affiliates of the entity which are attributable to the parent. The amount of the economic entity's stockholders' equity attributable to the parent excludes the amount of stockholders' equity which is allocable to that ownership interest in subsidiary equity which is not attributable to the parent (noncontrolling interest, minority interest). This excludes temporary equity and is sometimes called permanent equity. Reference 1: http://www.xbrl.org/2003/role/presentationRef
|
| X | ||||||||||
|
- Details
|
|
CONDENSED BALANCE SHEETS (Parenthetical) (USD $)
|
Sep. 30, 2014
|
Dec. 31, 2013
|
|---|---|---|
| CONDENSED BALANCE SHEETS | ||
| Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
| Common stock, shares authorized | 200,000,000 | 120,000,000 |
| Common stock, shares issued | 76,014,531 | 63,185,389 |
| Common stock, shares outstanding | 76,014,531 | 63,185,389 |
| X | ||||||||||
|
- Definition
Face amount or stated value per share of common stock. Reference 1: http://www.xbrl.org/2003/role/presentationRef
|
| X | ||||||||||
|
- Definition
The maximum number of common shares permitted to be issued by an entity's charter and bylaws. Reference 1: http://www.xbrl.org/2003/role/presentationRef
|
| X | ||||||||||
|
- Definition
Total number of common shares of an entity that have been sold or granted to shareholders (includes common shares that were issued, repurchased and remain in the treasury). These shares represent capital invested by the firm's shareholders and owners, and may be all or only a portion of the number of shares authorized. Shares issued include shares outstanding and shares held in the treasury. Reference 1: http://www.xbrl.org/2003/role/presentationRef
|
| X | ||||||||||
|
- Definition
Number of shares of common stock outstanding. Common stock represent the ownership interest in a corporation. Reference 1: http://www.xbrl.org/2003/role/presentationRef
|
| X | ||||||||||
|
- Details
|
|
CONDENSED STATEMENTS OF OPERATIONS (USD $)
In Thousands, except Share data, unless otherwise specified |
3 Months Ended | 9 Months Ended | ||
|---|---|---|---|---|
|
Sep. 30, 2014
|
Sep. 30, 2013
|
Sep. 30, 2014
|
Sep. 30, 2013
|
|
| Expenses: | ||||
| Research and development expenses | $ 3,362 | $ 6,477 | $ 17,616 | $ 26,230 |
| General and administrative expenses | 1,594 | 2,483 | 7,275 | 8,190 |
| Total expenses | 4,956 | 8,960 | 24,891 | 34,420 |
| Loss from operations | (4,956) | (8,960) | (24,891) | (34,420) |
| Other income, net | 21 | 23 | 25 | 99 |
| Net loss | $ (4,935) | $ (8,937) | $ (24,866) | $ (34,321) |
| Net loss per share: | ||||
| Basic and diluted (in dollars per share) | $ (0.06) | $ (0.14) | $ (0.34) | $ (0.54) |
| Weighted average shares outstanding: | ||||
| Basic and diluted (in shares) | 76,014,531 | 63,179,394 | 72,688,108 | 63,013,923 |
| X | ||||||||||
|
- Details
|
| X | ||||||||||
|
- Definition
The amount of net income or loss for the period per each share in instances when basic and diluted earnings per share are the same amount and reported as a single line item on the face of the financial statements. Basic earnings per share is the amount of net income or loss for the period per each share of common stock or unit outstanding during the reporting period. Diluted earnings per share includes the amount of net income or loss for the period available to each share of common stock or common unit outstanding during the reporting period and to each share or unit that would have been outstanding assuming the issuance of common shares or units for all dilutive potential common shares or units outstanding during the reporting period. No definition available.
|
| X | ||||||||||
|
- Definition
The aggregate total of expenses of managing and administering the affairs of an entity, including affiliates of the reporting entity, which are not directly or indirectly associated with the manufacture, sale or creation of a product or product line. Reference 1: http://www.xbrl.org/2003/role/presentationRef
|
| X | ||||||||||
|
- Definition
The portion of profit or loss for the period, net of income taxes, which is attributable to the parent. Reference 1: http://www.xbrl.org/2003/role/presentationRef
|
| X | ||||||||||
|
- Definition
Generally recurring costs associated with normal operations except for the portion of these expenses which can be clearly related to production and included in cost of sales or services. Includes selling, general and administrative expense. No definition available.
|
| X | ||||||||||
|
- Details
|
| X | ||||||||||
|
- Definition
The net result for the period of deducting operating expenses from operating revenues. No definition available.
|
| X | ||||||||||
|
- Definition
The net amount of other income and expense amounts, the components of which are not separately disclosed on the income statement, resulting from ancillary business-related activities (that is, excluding major activities considered part of the normal operations of the business) also known as other nonoperating income (expense) recognized for the period. Such amounts may include: (a) dividends, (b) interest on securities, (c) net gains or losses on securities, (d) unusual costs, (e) gains or losses on foreign exchange transactions, and (f) miscellaneous other income and expense items. Reference 1: http://www.xbrl.org/2003/role/presentationRef
|
| X | ||||||||||
|
- Definition
The costs incurred in a planned search or critical investigation aimed at discovery of new knowledge with the hope that such knowledge will be useful in developing a new product or service, a new process or technique, or in bringing about a significant improvement to an existing product or process; or to translate research findings or other knowledge into a plan or design for a new product or process or for a significant improvement to an existing product or process whether intended for sale or the entity's use, during the reporting period charged to research and development projects, excluding in-process research and development acquired in a business combination consummated during the period. Excludes software research and development, which has a separate concept. Reference 1: http://www.xbrl.org/2003/role/presentationRef
|
| X | ||||||||||
|
- Definition
Average number of shares or units issued and outstanding that are used in calculating basic and diluted earnings per share (EPS). No definition available.
|
| X | ||||||||||
|
- Details
|
| X | ||||||||||
|
- Details
|
| X | ||||||||||
|
- Definition
Amount of currency on hand as well as demand deposits with banks or financial institutions. Includes other kinds of accounts that have the general characteristics of demand deposits. Also includes short-term, highly liquid investments that are both readily convertible to known amounts of cash and so near their maturity that they present insignificant risk of changes in value because of changes in interest rates. Excludes cash and cash equivalents within disposal group and discontinued operation. Reference 1: http://www.xbrl.org/2003/role/presentationRef
|
| X | ||||||||||
|
- Definition
Amount of increase (decrease) in cash and cash equivalents. Cash and cash equivalents are the amount of currency on hand as well as demand deposits with banks or financial institutions. Includes other kinds of accounts that have the general characteristics of demand deposits. Also includes short-term, highly liquid investments that are both readily convertible to known amounts of cash and so near their maturity that they present insignificant risk of changes in value because of changes in interest rates. Includes effect from exchange rate changes. Reference 1: http://www.xbrl.org/2003/role/presentationRef
|
| X | ||||||||||
|
- Definition
The compensation expense recognized during the period pertaining to the deferred compensation arrangement. Reference 1: http://www.xbrl.org/2003/role/presentationRef
|
| X | ||||||||||
|
- Definition
The aggregate expense recognized in the current period that allocates the cost of tangible assets, intangible assets, or depleting assets to periods that benefit from use of the assets. Reference 1: http://www.xbrl.org/2003/role/presentationRef
|
| X | ||||||||||
|
- Definition
The increase (decrease) during the reporting period in the aggregate amount of liabilities incurred (and for which invoices have typically been received) and payable to vendors for goods and services received that are used in an entity's business. Reference 1: http://www.xbrl.org/2003/role/presentationRef
|
| X | ||||||||||
|
- Definition
The increase (decrease) during the reporting period in the aggregate amount of accrued expenses and other operating obligations not separately disclosed in the statement of cash flows. No definition available.
|
| X | ||||||||||
|
- Details
|
| X | ||||||||||
|
- Definition
The increase (decrease) during the reporting period in the value of prepaid expenses and other assets not separately disclosed in the statement of cash flows, for example, deferred expenses, intangible assets, or income taxes. Reference 1: http://www.xbrl.org/2003/role/presentationRef
|
| X | ||||||||||
|
- Definition
Amount of cash inflow (outflow) from financing activities, including discontinued operations. Financing activity cash flows include obtaining resources from owners and providing them with a return on, and a return of, their investment; borrowing money and repaying amounts borrowed, or settling the obligation; and obtaining and paying for other resources obtained from creditors on long-term credit. Reference 1: http://www.xbrl.org/2003/role/presentationRef
|
| X | ||||||||||
|
- Details
|
| X | ||||||||||
|
- Definition
Amount of cash inflow (outflow) from investing activities, including discontinued operations. Investing activity cash flows include making and collecting loans and acquiring and disposing of debt or equity instruments and property, plant, and equipment and other productive assets. Reference 1: http://www.xbrl.org/2003/role/presentationRef
|
| X | ||||||||||
|
- Details
|
| X | ||||||||||
|
- Definition
Amount of cash inflow (outflow) from operating activities, including discontinued operations. Operating activity cash flows include transactions, adjustments, and changes in value not defined as investing or financing activities. Reference 1: http://www.xbrl.org/2003/role/presentationRef
|
| X | ||||||||||
|
- Details
|
| X | ||||||||||
|
- Definition
The portion of profit or loss for the period, net of income taxes, which is attributable to the parent. Reference 1: http://www.xbrl.org/2003/role/presentationRef
|
| X | ||||||||||
|
- Definition
Amount of cash outflow (inflow) through acquisition (sale) of short-term held-to-maturity securities. No definition available.
|
| X | ||||||||||
|
- Definition
Amount of cash outflow to satisfy an employee's income tax withholding obligation as part of a net-share settlement of a share-based award. Reference 1: http://www.xbrl.org/2003/role/presentationRef
|
| X | ||||||||||
|
- Definition
The cash outflow associated with the acquisition of long-lived, physical assets that are used in the normal conduct of business to produce goods and services and not intended for resale; includes cash outflows to pay for construction of self-constructed assets. Reference 1: http://www.xbrl.org/2003/role/presentationRef
|
| X | ||||||||||
|
- Definition
The cash inflow from the issuance of common stock, preferred stock, treasury stock, stock options, and other types of equity. Reference 1: http://www.xbrl.org/2003/role/presentationRef
|
| X | ||||||||||
|
- Definition
The cash inflow associated with the maturity, prepayments and calls (requests for early payments) of debt securities designated as held-to-maturity. Reference 1: http://www.xbrl.org/2003/role/presentationRef
|
| X | ||||||||||
|
- Definition
The cash inflow associated with the amount received from holders exercising their stock options. This item inherently excludes any excess tax benefit, which the entity may have realized and reported separately. Reference 1: http://www.xbrl.org/2003/role/presentationRef
|
| X | ||||||||||
|
- Definition
The cash outflow associated with security instruments that either represent a creditor or an ownership relationship with the holder of the investment security with a maturity of beyond one year or normal operating cycle, if longer. Includes repayments of (a) debt, (b) capital lease obligations, (c) mandatory redeemable capital securities, and (d) any combination of (a), (b), or (c). Reference 1: http://www.xbrl.org/2003/role/presentationRef
|
| X | ||||||||||
|
- Definition
The aggregate amount of noncash, equity-based employee remuneration. This may include the value of stock or unit options, amortization of restricted stock or units, and adjustment for officers' compensation. As noncash, this element is an add back when calculating net cash generated by operating activities using the indirect method. Reference 1: http://www.xbrl.org/2003/role/presentationRef
|
|
Business and Basis of Presentation
|
9 Months Ended |
|---|---|
|
Sep. 30, 2014
|
|
| Business and Basis of Presentation | |
| Business and Basis of Presentation | 1. Business and Basis of Presentation
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, cancer supportive care, including prevention and treatment of cancer-related muscle wasting, 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 preliminary 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 completion of the private placement of its common stock and warrants that the Company announced on November 10, 2014 and the receipt of necessary regulatory approvals, it plans to initiate two Phase 2 clinical trials for these indications in the first half of 2015. One of these Phase 2 clinical trials is designed to enroll patients with ER positive and AR positive metastatic breast cancer, while the other Phase 2 clinical trial is designed to enroll patients with advanced AR positive triple-negative 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”). Enobosarm did, however, demonstrate a statistically significant effect versus placebo on the primary endpoint of physical function in the POWER 1 clinical trial as assessed by continuous variable analysis, as pre-specified in the Company’s statistical analysis plan for the European Medicines Agency (“EMA”). The Company has been evaluating whether data from its two Phase 3 POWER clinical trials is sufficient to support the filing of a marketing authorization application (“MAA”) in the European Union (“EU”) for enobosarm 3 mg for the prevention and treatment of muscle wasting in patients with advanced NSCLC, and has met with representatives from member countries to the EMA to review and discuss the results of the POWER trials. Based upon recent input from these representatives, the Company believes that the data from the POWER trials is not sufficient to support the filing and approval of a MAA in the EU for enobosarm 3 mg for the prevention and treatment of muscle wasting in patients with advanced NSCLC without confirmatory data from another Phase 3 clinical trial of enobosarm in this indication. As a result of the input received from these representatives, the Company currently does not intend to file a MAA and will evaluate whether there is commercial rationale and partner interest to support additional clinical development required for approval. In the Company’s meeting with the FDA in February 2014 to review and discuss the results of the POWER clinical trials, the Company learned that since data from the two POWER trials failed to meet the statistical criterion pre-specified for the co-primary endpoints of lean body mass and physical function, the FDA was not willing to accept a new drug application 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 U.S. or in Europe unless such development is part of a collaborative arrangement or strategic partnership. The Company continues to evaluate other potential indications in the U.S. for enobosarm.
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.
In April 2014, the Company announced that Mitchell S. Steiner, its former Chief Executive Officer (“CEO”), Vice Chairman of the Board of Directors and a co-founder of the Company, was leaving the Company to pursue other business interests. Dr. Steiner resigned from his roles as CEO and Vice Chairman of the Board of Directors of the Company effective April 3, 2014. In connection with Dr. Steiner’s resignation, Marc S. Hanover was appointed as the Company’s interim Chief Executive Officer and was elected to the Board to serve the remainder of Dr. Steiner’s term on the Board until the 2015 annual meeting of the Company’s stockholders. Also in connection with Dr. Steiner’s resignation, the Company entered into a severance agreement with Dr. Steiner, pursuant to which Dr. Steiner received severance benefits of twelve months of base salary continuation payments and continued healthcare coverage through the earliest of December 31, 2014 or the date he ceases to be eligible for COBRA continuation coverage. As a result of these severance benefits, the Company recognized cash severance related expenses of $483 during the nine months ended September 30, 2014. Additionally, all of Dr. Steiner’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 his 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. See Note 2, Share-Based Compensation, for further information.
Basis of Presentation
The accompanying unaudited condensed financial statements reflect, in the opinion of management, all adjustments (consisting of normal recurring adjustments) necessary for a fair presentation of the Company’s financial position, results of operations and cash flows for each period presented in accordance with accounting principles generally accepted in the United States for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, information and footnote disclosures normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States have been condensed or omitted from the accompanying condensed financial statements. These interim condensed financial statements should be read in conjunction with the audited financial statements and related notes thereto, which are included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2013. Operating results for the three and nine months ended September 30, 2014 are not necessarily indicative of the results that may be expected for the entire fiscal year ending December 31, 2014.
Use of Estimates
The preparation of condensed financial statements in conformity with accounting principles generally accepted in the United States 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 condensed financial statements, and the reported amounts of revenues and expenses during the reporting period. Actual amounts and results could differ from those estimates.
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. As a result of the October 2013 reduction in its workforce, the Company is no longer conducting drug discovery activities and is focusing its research and development activities on the ongoing clinical development of the Company’s current product candidates.
Cash, Cash Equivalents and Short-term Investments
The Company considers highly liquid investments with initial maturities of three months or less to be cash equivalents.
At September 30, 2014 and December 31, 2013, short-term investments consisted of Federal Deposit Insurance Corporation insured certificates of deposit with original maturities of greater than three months and less than one year. As the Company has the positive intent and ability to hold the certificates of deposit 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.
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 September 30, 2014 and December 31, 2013, net of the valuation allowance, the net deferred tax assets were reduced to zero. Income taxes are described more fully in Note 9 to the Company’s financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2013.
Other Income, net
Other income, net consists of foreign currency transaction gains and losses associated with conducting clinical trials in foreign countries, interest earned on the Company’s cash, cash equivalents and short-term investments, interest expense, and other non-operating income or expense.
FARESTON® Revenue Recognition
Although the Company sold its rights and certain assets related to FARESTON® effective September 30, 2012, the Company retained 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 September 30, 2014 and December 31, 2013, the Company’s accrual for product returns was $141 and $918, respectively. Of these amounts, $82 and $332 have been included in “Other long-term liabilities” in the condensed balance sheet at September 30, 2014 and December 31, 2013, respectively, and represents the portion of the Company’s product returns accrual estimated to be payable after one year.
Subsequent Events
The Company has evaluated all events or transactions that occurred after September 30, 2014 up through the date the condensed financial statements were issued. Other than as set forth below, there were no material recognizable or nonrecognizable subsequent events during the period evaluated.
On November 9, 2014, the Company entered into a definitive securities purchase agreement (the “Purchase Agreement”) with certain purchasers, including members of the Company’s management and Board of Directors (the “Purchasers”), pursuant to which the Company agreed to issue and sell to the Purchasers, subject to customary closing conditions, an aggregate of 64,311,112 immediately separable units, comprised of an aggregate of 64,311,112 shares of common stock and warrants to purchase up to 64,311,112 additional shares of common stock, for an aggregate purchase price of $43,410 (the “Private Placement”). The closing of the Private Placement is subject to the satisfaction of customary closing conditions. The warrants the Company agreed to issue at the closing of the Private Placement, which would have a per share exercise price of $0.85, would 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. The Company does not currently have a sufficient number of authorized and unreserved shares of common stock necessary to settle exercises of the warrants in full in shares of common stock. Under the Purchase Agreement, the Company has agreed to seek stockholder approval, at a special or annual meeting to be held no later than May 27, 2015, of an amendment to the Company’s Certificate of Incorporation to increase the Company’s authorized common stock to an amount necessary to effect the share settlement of all of the warrants the Company agreed to issue at the closing of the Private Placement. Assuming such approval is obtained, warrant exercises would no longer be subject to net cash settlement. The warrants would generally become exercisable on the date such stockholder approval is obtained (but in no event later than June 1, 2015) and would continue to be exercisable for four years thereafter. The Company also agreed to certain registration obligations with respect to the resale by the Purchasers of the common stock issued or underlying the warrants issued in the Private Placement. The Purchase Agreement may be terminated by either the Company or the Purchasers if the closing has not occurred by November 21, 2014 (subject to extension to November 28, 2014 under limited circumstances).
|
| X | ||||||||||
|
- Details
|
| X | ||||||||||
|
- Definition
The entire disclosure for the general note to the financial statements for the reporting entity which may include, descriptions of the basis of presentation, business description, significant accounting policies, consolidations, reclassifications, new pronouncements not yet adopted and changes in accounting principles. No definition available.
|
|
Share-Based Compensation
|
9 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Sep. 30, 2014
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Share-Based Compensation | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Share-Based Compensation | 2. Share-Based Compensation
Share-based payments include stock option grants and restricted stock units (“RSUs”) under the Company’s stock option and equity incentive plans and deferred compensation arrangements for the Company’s non-employee directors. 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. The Company’s share-based compensation plans are described more fully in Note 3 to the financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2013.
The following table summarizes share-based compensation expense included within the condensed statements of operations for the three and nine months ended September 30, 2014 and 2013:
Share-based compensation expense recorded as general and administrative expense for both the three months ended September 30, 2014 and 2013 included share-based compensation expense related to deferred compensation arrangements for the Company’s non-employee directors of $31. Share-based compensation expense recorded as general and administrative expense for the nine months ended September 30, 2014 and 2013 included share-based compensation expense related to deferred compensation arrangements for the Company’s non-employee directors of $94 and $105, respectively. As a result of the modification of Dr. Steiner’s options upon his resignation in April 2014, the Company recognized a one-time, noncash net compensation expense of $215, which was included in general and administrative expenses for the nine months ended September 30, 2014. This amount reflects the net of the aggregate incremental fair value associated with the modifications of $359, partially offset by the reversal of $144 of previously recognized share-based compensation expense for Dr. Steiner’s unvested options.
The Company uses the Black-Scholes-Merton option pricing valuation model (“Black-Scholes Model”) to value stock options. The expected life of options is determined by calculating the average of the vesting term and the contractual term of the options. The expected price volatility is based on the Company’s historical stock price volatility. The risk-free interest rate is determined using U.S. Treasury rates where the term is consistent with the expected life of the stock options. Expected dividend yield is not considered as the Company has not made any dividend payments and has no plans of doing so in the foreseeable future. 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.
The Company estimated the fair value of RSUs using the closing price of its stock on the grant date. The fair value of 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 at September 30, 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 fair value of options granted to employees and non-employee directors was estimated using the following assumptions for the periods presented:
The following is a summary of stock option transactions for all of the Company’s stock option and equity incentive plans since the Company’s most recent fiscal year end:
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| X | ||||||||||
|
- Details
|
| X | ||||||||||
|
- Definition
The entire disclosure for compensation-related costs for equity-based compensation, which may include disclosure of policies, compensation plan details, allocation of equity compensation, incentive distributions, equity-based arrangements to obtain goods and services, deferred compensation arrangements, employee stock ownership plan details and employee stock purchase plan details. Reference 1: http://www.xbrl.org/2003/role/presentationRef
|
|
Basic and Diluted Net Loss Per Share
|
9 Months Ended |
|---|---|
|
Sep. 30, 2014
|
|
| Basic and Diluted Net Loss Per Share | |
| Basic and Diluted Net Loss Per Share | 3.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, unvested restricted stock units and common stock warrants.
Weighted average potential shares of common stock of 18,395,096 and 6,136,483 for the three months ended September 30, 2014 and 2013, respectively, and 15,658,766 and 6,432,994 for the nine months ended September 30, 2014 and 2013, respectively, were excluded from the calculations of diluted loss per share as inclusion of the potential shares would have had an anti-dilutive effect on the net loss per share for these periods.
|
| X | ||||||||||
|
- Details
|
| X | ||||||||||
|
- Definition
The entire disclosure for earnings per share. Reference 1: http://www.xbrl.org/2003/role/presentationRef
|
|
Common Stock
|
9 Months Ended |
|---|---|
|
Sep. 30, 2014
|
|
| Common Stock | |
| Common Stock | 4.Common Stock
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 gross proceeds of $21,272. No underwriting discounts or commissions or similar fees were payable in connection with the issuance.
The warrants, which have a one year term expiring on March 6, 2015, have a per share exercise price of $1.67 that is payable only in cash. 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 meet the scope exception for determining whether the instruments require accounting as derivatives and are classified in stockholders’ equity. The fair value of the warrants was estimated at $4,478 using the Black-Scholes Model with the following assumptions: expected volatility of 67%, risk free interest rate of 0.12%, expected life of one year and no dividends. The net proceeds from the private placement were allocated to the common stock and warrants based upon their relative fair values.
|
| X | ||||||||||
|
- Details
|
| X | ||||||||||
|
- Definition
The entire disclosure for shareholders' equity comprised of portions attributable to the parent entity and noncontrolling interest, including other comprehensive income. Includes, but is not limited to, balances of common stock, preferred stock, additional paid-in capital, other capital and retained earnings, accumulated balance for each classification of other comprehensive income and amount of comprehensive income. Reference 1: http://www.xbrl.org/2003/role/presentationRef
|
|
University of Tennessee Research Foundation License Agreement
|
9 Months Ended |
|---|---|
|
Sep. 30, 2014
|
|
| University of Tennessee Research Foundation License Agreement | |
| University of Tennessee Research Foundation License Agreement | 5.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 was 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.
|
| X | ||||||||||
|
- Details
|
| X | ||||||||||
|
- Definition
The entire disclosure for collaborative arrangements in which the entity is a participant, including a) information about the nature and purpose of such arrangements; b) its rights and obligations thereunder; c) the accounting policy for collaborative arrangements; and d) the income statement classification and amounts attributable to transactions arising from the collaborative arrangement between participants. Reference 1: http://www.xbrl.org/2003/role/presentationRef
|
|
Business and Basis of Presentation (Policies)
|
9 Months Ended |
|---|---|
|
Sep. 30, 2014
|
|
| Business and Basis of Presentation | |
| Basis of Presentation | Basis of Presentation
The accompanying unaudited condensed financial statements reflect, in the opinion of management, all adjustments (consisting of normal recurring adjustments) necessary for a fair presentation of the Company’s financial position, results of operations and cash flows for each period presented in accordance with accounting principles generally accepted in the United States for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, information and footnote disclosures normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States have been condensed or omitted from the accompanying condensed financial statements. These interim condensed financial statements should be read in conjunction with the audited financial statements and related notes thereto, which are included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2013. Operating results for the three and nine months ended September 30, 2014 are not necessarily indicative of the results that may be expected for the entire fiscal year ending December 31, 2014.
|
| Use of Estimates | Use of Estimates
The preparation of condensed financial statements in conformity with accounting principles generally accepted in the United States 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 condensed financial statements, and the reported amounts of revenues and expenses during the reporting period. Actual amounts and results could differ from those estimates.
|
| 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. As a result of the October 2013 reduction in its workforce, the Company is no longer conducting drug discovery activities and is focusing its research and development activities on the ongoing clinical development of the Company’s current product candidates.
|
| Cash, Cash Equivalents and Short-term Investments | Cash, Cash Equivalents and Short-term Investments
The Company considers highly liquid investments with initial maturities of three months or less to be cash equivalents.
At September 30, 2014 and December 31, 2013, short-term investments consisted of Federal Deposit Insurance Corporation insured certificates of deposit with original maturities of greater than three months and less than one year. As the Company has the positive intent and ability to hold the certificates of deposit 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.
|
| 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 September 30, 2014 and December 31, 2013, net of the valuation allowance, the net deferred tax assets were reduced to zero. Income taxes are described more fully in Note 9 to the Company’s financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2013.
|
| Other Income, net | Other Income, net
Other income, net consists of foreign currency transaction gains and losses associated with conducting clinical trials in foreign countries, interest earned on the Company’s cash, cash equivalents and short-term investments, interest expense, and other non-operating income or expense.
|
| FARESTON Revenue Recognition | FARESTON® Revenue Recognition
Although the Company sold its rights and certain assets related to FARESTON® effective September 30, 2012, the Company retained 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 September 30, 2014 and December 31, 2013, the Company’s accrual for product returns was $141 and $918, respectively. Of these amounts, $82 and $332 have been included in “Other long-term liabilities” in the condensed balance sheet at September 30, 2014 and December 31, 2013, respectively, and represents the portion of the Company’s product returns accrual estimated to be payable after one year.
|
| Subsequent Events | Subsequent Events
The Company has evaluated all events or transactions that occurred after September 30, 2014 up through the date the condensed financial statements were issued. Other than as set forth below, there were no material recognizable or nonrecognizable subsequent events during the period evaluated.
On November 9, 2014, the Company entered into a definitive securities purchase agreement (the “Purchase Agreement”) with certain purchasers, including members of the Company’s management and Board of Directors (the “Purchasers”), pursuant to which the Company agreed to issue and sell to the Purchasers, subject to customary closing conditions, an aggregate of 64,311,112 immediately separable units, comprised of an aggregate of 64,311,112 shares of common stock and warrants to purchase up to 64,311,112 additional shares of common stock, for an aggregate purchase price of $43,410 (the “Private Placement”). The closing of the Private Placement is subject to the satisfaction of customary closing conditions. The warrants the Company agreed to issue at the closing of the Private Placement, which would have a per share exercise price of $0.85, would 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. The Company does not currently have a sufficient number of authorized and unreserved shares of common stock necessary to settle exercises of the warrants in full in shares of common stock. Under the Purchase Agreement, the Company has agreed to seek stockholder approval, at a special or annual meeting to be held no later than May 27, 2015, of an amendment to the Company’s Certificate of Incorporation to increase the Company’s authorized common stock to an amount necessary to effect the share settlement of all of the warrants the Company agreed to issue at the closing of the Private Placement. Assuming such approval is obtained, warrant exercises would no longer be subject to net cash settlement. The warrants would generally become exercisable on the date such stockholder approval is obtained (but in no event later than June 1, 2015) and would continue to be exercisable for four years thereafter. The Company also agreed to certain registration obligations with respect to the resale by the Purchasers of the common stock issued or underlying the warrants issued in the Private Placement. The Purchase Agreement may be terminated by either the Company or the Purchasers if the closing has not occurred by November 21, 2014 (subject to extension to November 28, 2014 under limited circumstances).
|
| X | ||||||||||
|
- Definition
Disclosure of accounting policy for cash, cash equivalents and short-term investments. No definition available.
|
| X | ||||||||||
|
- Definition
Disclosure of the components of Other (Expense) Income, Net. No definition available.
|
| X | ||||||||||
|
- Definition
Disclosure of accounting policy for basis of accounting, or basis of presentation, used to prepare the financial statements (for example, US Generally Accepted Accounting Principles, Other Comprehensive Basis of Accounting, IFRS). No definition available.
|
| X | ||||||||||
|
- Definition
Disclosure of accounting policy for income taxes, which may include its accounting policies for recognizing and measuring deferred tax assets and liabilities and related valuation allowances, recognizing investment tax credits, operating loss carryforwards, tax credit carryforwards, and other carryforwards, methodologies for determining its effective income tax rate and the characterization of interest and penalties in the financial statements. Reference 1: http://www.xbrl.org/2003/role/presentationRef
|
| X | ||||||||||
|
- Details
|
| X | ||||||||||
|
- Definition
Disclosure of accounting policy for costs it has incurred (1) in a planned search or critical investigation aimed at discovery of new knowledge with the hope that such knowledge will be useful in developing a new product or service, a new process or technique, or in bringing about a significant improvement to an existing product or process; or (2) to translate research findings or other knowledge into a plan or design for a new product or process or for a significant improvement to an existing product or process. Reference 1: http://www.xbrl.org/2003/role/presentationRef
|
| X | ||||||||||
|
- Definition
Disclosure of accounting policy for revenue recognition for the sale of goods, which is a transaction between an entity delivering a tangible good to a purchaser. The entity also may disclose its treatment of any unearned or deferred revenue that arises from the transaction. Reference 1: http://www.xbrl.org/2003/role/presentationRef
|
| X | ||||||||||
|
- Definition
Disclosure of accounting policy for reporting subsequent events. Reference 1: http://www.xbrl.org/2003/role/presentationRef
|
| X | ||||||||||
|
- Definition
Disclosure of accounting policy for the use of estimates in the preparation of financial statements in conformity with generally accepted accounting principles. Reference 1: http://www.xbrl.org/2003/role/presentationRef
|
|
Share-Based Compensation (Tables)
|
9 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Sep. 30, 2014
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Share-Based Compensation | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Summary of share-based compensation expense |
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of assumptions used to estimate fair value of options |
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Summary of stock option transactions |
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| X | ||||||||||
|
- Details
|
| X | ||||||||||
|
- Definition
Tabular disclosure of the allocation of equity-based compensation costs to a given line item on the balance sheet and income statement for the period. This may include the reporting line for the costs and the amount capitalized and expensed. Reference 1: http://www.xbrl.org/2003/role/presentationRef
|
| X | ||||||||||
|
- Definition
Tabular disclosure of the number and weighted-average exercise prices (or conversion ratios) for share options (or share units) that were outstanding at the beginning and end of the year, vested and expected to vest, exercisable or convertible at the end of the year, and the number of share options or share units that were granted, exercised or converted, forfeited, and expired during the year. Reference 1: http://www.xbrl.org/2003/role/presentationRef
|
| X | ||||||||||
|
- Definition
Tabular disclosure of the significant assumptions used during the year to estimate the fair value of stock options, including, but not limited to: (a) expected term of share options and similar instruments, (b) expected volatility of the entity's shares, (c) expected dividends, (d) risk-free rate(s), and (e) discount for post-vesting restrictions. Reference 1: http://www.xbrl.org/2003/role/presentationRef
|
|
Business and Basis of Presentation (Details) (USD $)
In Thousands, unless otherwise specified |
1 Months Ended | 3 Months Ended | 9 Months Ended | ||
|---|---|---|---|---|---|
|
Sep. 30, 2014
|
Dec. 31, 2013
|
Apr. 30, 2014
Former Chief Executive Officer
|
Jun. 30, 2014
Former Chief Executive Officer
|
Sep. 30, 2014
Former Chief Executive Officer
|
|
| Income Taxes | |||||
| Net deferred tax assets | $ 0 | $ 0 | |||
| FARESTON Revenue Recognition | |||||
| Accrual for product returns | 141 | 918 | |||
| Accrual for product returns included in other long term liabilities | 82 | 332 | |||
| Severance costs | |||||
| Number of months of base salary paid in the form of severance benefits | 12 months | ||||
| Total cash severance related expenses | 483 | ||||
| One-time, noncash net compensation expense related to the modification of stock options | $ 215 |
| X | ||||||||||
|
- Definition
The estimated liability for future product returns of product sold. No definition available.
|
| X | ||||||||||
|
- Definition
Portion of the entity's product returns accrual estimated to be payable after one year. No definition available.
|
| X | ||||||||||
|
- Details
|
| X | ||||||||||
|
- Definition
Represents the total employee severance related cash expenses recognized by the entity in accordance with a severance agreement. No definition available.
|
| X | ||||||||||
|
- Definition
Represents the number of months of base salary paid in accordance with a severance agreement. No definition available.
|
| X | ||||||||||
|
- Definition
Represents the amount of one-time noncash compensation expense for modified awards, net off previously recognized share-based compensation expense for the nonvested awards. No definition available.
|
| X | ||||||||||
|
- Definition
Amount after allocation of valuation allowances of deferred tax asset attributable to deductible temporary differences and carryforwards, net of deferred tax liability attributable to taxable temporary differences. Reference 1: http://www.xbrl.org/2003/role/presentationRef
|
| X | ||||||||||
|
- Details
|
| X | ||||||||||
|
- Details
|
|
Business and Basis of Presentation (Details 2) (Private Placement, USD $)
In Thousands, except Share data, unless otherwise specified |
0 Months Ended | 0 Months Ended | ||
|---|---|---|---|---|
|
Mar. 06, 2014
|
Mar. 06, 2014
|
Nov. 09, 2014
Projected
Subsequent Event
|
Nov. 09, 2014
Projected
Subsequent Event
|
|
| Common Stock | ||||
| Immediately separable units issued under private placement | 64,311,112 | |||
| Stock issued under private placement (in shares) | 11,976,048 | 64,311,112 | ||
| Warrants issued to purchase shares under private placement | 10,179,642 | 64,311,112 | ||
| Aggregate purchase price (in dollars) | $ 21,272 | $ 43,410 | ||
| Per share exercise price payable in cash (in dollars per share) | $ 1.67 | $ 0.85 | ||
| Warrant term | 1 year | 4 years |
| X | ||||||||||
|
- Definition
Represents the term of warrant, in PnYnMnDTnHnMnS' format, for example, 'P1Y5M13D' represents the reported fact of one year, five months, and thirteen days. No definition available.
|
| X | ||||||||||
|
- Definition
Number of immediately separable units, consisting of common stock share and attached warrant, issued during the period. No definition available.
|
| X | ||||||||||
|
- Definition
Exercise price per share or per unit of warrants or rights outstanding. Reference 1: http://www.xbrl.org/2003/role/presentationRef
|
| X | ||||||||||
|
- Definition
Number of securities into which the class of warrant or right may be converted. For example, but not limited to, 500,000 warrants may be converted into 1,000,000 shares. Reference 1: http://www.xbrl.org/2003/role/presentationRef
|
| X | ||||||||||
|
- Definition
The cash inflow associated with the amount received from entity's raising of capital via private rather than public placement. Reference 1: http://www.xbrl.org/2003/role/presentationRef
|
| X | ||||||||||
|
- Definition
Number of new stock issued during the period. Reference 1: http://www.xbrl.org/2003/role/presentationRef
|
| X | ||||||||||
|
- Details
|
|
Share-Based Compensation (Details) (USD $)
In Thousands, unless otherwise specified |
3 Months Ended | 9 Months Ended | 3 Months Ended | 9 Months Ended | 3 Months Ended | 9 Months Ended | 3 Months Ended | 9 Months Ended | 3 Months Ended | 9 Months Ended | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Sep. 30, 2014
|
Sep. 30, 2013
|
Sep. 30, 2014
|
Sep. 30, 2013
|
Sep. 30, 2014
Research and Development Expenses
|
Sep. 30, 2013
Research and Development Expenses
|
Sep. 30, 2014
Research and Development Expenses
|
Sep. 30, 2013
Research and Development Expenses
|
Sep. 30, 2014
General and Administrative Expenses
|
Sep. 30, 2013
General and Administrative Expenses
|
Sep. 30, 2014
General and Administrative Expenses
|
Sep. 30, 2013
General and Administrative Expenses
|
Sep. 30, 2014
Director
General and Administrative Expenses
|
Sep. 30, 2013
Director
General and Administrative Expenses
|
Sep. 30, 2014
Director
General and Administrative Expenses
|
Sep. 30, 2013
Director
General and Administrative Expenses
|
Jun. 30, 2014
Former Chief Executive Officer
|
Sep. 30, 2014
Former Chief Executive Officer
|
Sep. 30, 2014
Former Chief Executive Officer
General and Administrative Expenses
|
|
| Share-based compensation expense | |||||||||||||||||||
| Total share-based compensation | $ 266 | $ 762 | $ 4,280 | $ 2,332 | $ 89 | $ 356 | $ 2,419 | $ 1,051 | $ 177 | $ 406 | $ 1,861 | $ 1,281 | |||||||
| Share-based compensation expense related to deferred compensation arrangements for non-employee directors | 94 | 105 | 31 | 31 | 94 | 105 | |||||||||||||
| One-time, noncash net compensation expense related to the modification of stock options | 215 | 215 | |||||||||||||||||
| Aggregate incremental fair value associated with the modifications of stock options | 359 | ||||||||||||||||||
| Amount of previously recognized share-based compensation expense for unvested options reversed | $ 144 | ||||||||||||||||||
| X | ||||||||||
|
- Definition
Represents the amount of one-time noncash compensation expense for modified awards, net off previously recognized share-based compensation expense for the nonvested awards. No definition available.
|
| X | ||||||||||
|
- Definition
Represents the reversal of previously recognized share-based compensation expense for non-vested stock options cancelled in conjunction with the total workforce reduction. No definition available.
|
| X | ||||||||||
|
- Definition
Represents the expense recognized during the period arising from equity-based compensation arrangements (for example, shares of stock, unit, stock options or other equity instruments) with employees, directors and certain consultants qualifying for treatment as employees. Reference 1: http://www.xbrl.org/2003/role/presentationRef
|
| X | ||||||||||
|
- Definition
The compensation expense recognized during the period pertaining to the deferred compensation arrangement. Reference 1: http://www.xbrl.org/2003/role/presentationRef
|
| X | ||||||||||
|
- Details
|
| X | ||||||||||
|
- Definition
An excess of the fair value of the modified award over the fair value of the award immediately before the modification. Reference 1: http://www.xbrl.org/2003/role/presentationRef
|
|
Share-Based Compensation (Details 2) (Restricted Stock Units (RSUs), USD $)
|
3 Months Ended | ||
|---|---|---|---|
|
Jun. 30, 2014
|
Sep. 30, 2014
|
Dec. 31, 2013
|
|
|
Restricted Stock Units (RSUs)
|
|||
| Number of Shares | |||
| Unvested awards (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 |
| X | ||||||||||
|
- Definition
The number of non-vested equity-based payment instruments, excluding stock (or unit) options, that validly exist and are outstanding as of the balance sheet date. Reference 1: http://www.xbrl.org/2003/role/presentationRef
|
| X | ||||||||||
|
- Details
|
| X | ||||||||||
|
- Definition
The weighted average fair value of nonvested awards on equity-based plans excluding option plans (for example, phantom stock or unit plan, stock or unit appreciation rights plan, revenue or profit achievement stock award plan) for which the employer is contingently obligated to issue equity instruments or transfer assets to an employee who has not yet satisfied service or performance criteria necessary to gain title to proceeds from the sale of the award or underlying shares or units. Reference 1: http://www.xbrl.org/2003/role/presentationRef
|
| X | ||||||||||
|
- Details
|
| X | ||||||||||
|
- Definition
For net-share settlement of share-based awards when the employer settles employees' income tax withholding obligations, this element represents the number of shares the employees use to repay the employer. No definition available.
|
|
Share-Based Compensation (Details 3) (USD $)
|
3 Months Ended | 9 Months Ended | ||
|---|---|---|---|---|
|
Sep. 30, 2014
|
Sep. 30, 2013
|
Sep. 30, 2014
|
Sep. 30, 2013
|
|
| Fair value of options granted | ||||
| Expected price volatility (as a percent) | 86.60% | 74.80% | 86.50% | 74.50% |
| Risk-free interest rate (as a percent) | 2.10% | 1.80% | 2.30% | 1.10% |
| Weighted average expected life in years | 7 years | 6 years 6 months | 6 years 10 months 24 days | 6 years 6 months |
| Number of Shares | ||||
| Options outstanding at the beginning of the period (in shares) | 6,445,342 | |||
| Options granted (in shares) | 3,042,500 | |||
| Options forfeited or expired (in shares) | (1,242,108) | |||
| Options outstanding at the end of the period (in shares) | 8,245,734 | 8,245,734 | ||
| Weighted Average Exercise Price Per Share | ||||
| Options outstanding at the beginning of the period (in dollars per share) | $ 6.58 | |||
| Options granted (in dollars per share) | $ 1.36 | |||
| Options forfeited or expired (in dollars per share) | $ 9.03 | |||
| Options outstanding at the end of the period (in dollars per share) | $ 4.28 | $ 4.28 | ||
| X | ||||||||||
|
- Details
|
| X | ||||||||||
|
- Definition
Expected term of share-based compensation awards, in 'PnYnMnDTnHnMnS' format, for example, 'P1Y5M13D' represents the reported fact of one year, five months, and thirteen days. Reference 1: http://www.xbrl.org/2003/role/presentationRef
|
| X | ||||||||||
|
- Definition
The estimated measure of the percentage by which a share price is expected to fluctuate during a period. Volatility also may be defined as a probability-weighted measure of the dispersion of returns about the mean. The volatility of a share price is the standard deviation of the continuously compounded rates of return on the share over a specified period. That is the same as the standard deviation of the differences in the natural logarithms of the stock prices plus dividends, if any, over the period. Reference 1: http://www.xbrl.org/2003/role/presentationRef
|
| X | ||||||||||
|
- Definition
The risk-free interest rate assumption that is used in valuing an option on its own shares. Reference 1: http://www.xbrl.org/2003/role/presentationRef
|
| X | ||||||||||
|
- Definition
For presentations that combine terminations, the number of shares under options that were cancelled during the reporting period as a result of occurrence of a terminating event specified in contractual agreements pertaining to the stock option plan or that expired. Reference 1: http://www.xbrl.org/2003/role/presentationRef
|
| X | ||||||||||
|
- Definition
Weighted average price of options that were either forfeited or expired. Reference 1: http://www.xbrl.org/2003/role/presentationRef
|
| X | ||||||||||
|
- Definition
Net number of share options (or share units) granted during the period. Reference 1: http://www.xbrl.org/2003/role/presentationRef
|
| X | ||||||||||
|
- Definition
Number of options outstanding, including both vested and non-vested options. Reference 1: http://www.xbrl.org/2003/role/presentationRef
|
| X | ||||||||||
|
- Details
|
| X | ||||||||||
|
- Definition
Weighted average price at which grantees can acquire the shares reserved for issuance under the stock option plan. Reference 1: http://www.xbrl.org/2003/role/presentationRef
|
| X | ||||||||||
|
- Details
|
| X | ||||||||||
|
- Definition
Weighted average per share amount at which grantees can acquire shares of common stock by exercise of options. No definition available.
|
|
Basic and Diluted Net Loss Per Share (Details)
|
3 Months Ended | 9 Months Ended | ||
|---|---|---|---|---|
|
Sep. 30, 2014
|
Sep. 30, 2013
|
Sep. 30, 2014
|
Sep. 30, 2013
|
|
| Basic and Diluted Net Loss Per Share | ||||
| Weighted average potential shares of common stock excluded from calculation of diluted net income (loss) per share | 18,395,096 | 6,136,483 | 15,658,766 | 6,432,994 |
| X | ||||||||||
|
- Definition
Securities (including those issuable pursuant to contingent stock agreements) that could potentially dilute basic earnings per share (EPS) or earnings per unit (EPU) in the future that were not included in the computation of diluted EPS or EPU because to do so would increase EPS or EPU amounts or decrease loss per share or unit amounts for the period presented. Reference 1: http://www.xbrl.org/2003/role/presentationRef
|
| X | ||||||||||
|
- Details
|
|
Common Stock (Details) (Private Placement, USD $)
In Thousands, except Share data, unless otherwise specified |
0 Months Ended | |
|---|---|---|
|
Mar. 06, 2014
|
Mar. 06, 2014
|
|
|
Private Placement
|
||
| Common Stock | ||
| Stock issued under private placement (in shares) | 11,976,048 | |
| Warrants issued to purchase shares under private placement | 10,179,642 | |
| Aggregate purchase price (in dollars) | $ 21,272 | |
| Warrant term | 1 year | |
| Per share exercise price payable in cash (in dollars per share) | $ 1.67 | |
| 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 | |
| Dividend rate of warrants (as a percent) | 0.00% |
| X | ||||||||||
|
- Definition
Represents the term of warrant, in PnYnMnDTnHnMnS' format, for example, 'P1Y5M13D' represents the reported fact of one year, five months, and thirteen days. No definition available.
|
| X | ||||||||||
|
- Definition
Exercise price per share or per unit of warrants or rights outstanding. Reference 1: http://www.xbrl.org/2003/role/presentationRef
|
| X | ||||||||||
|
- Definition
Number of securities into which the class of warrant or right may be converted. For example, but not limited to, 500,000 warrants may be converted into 1,000,000 shares. Reference 1: http://www.xbrl.org/2003/role/presentationRef
|
| X | ||||||||||
|
- Definition
Expected dividends to be paid to holders of the underlying shares or financial instruments (expressed as a percentage of the share or instrument's price). Reference 1: http://www.xbrl.org/2003/role/presentationRef
|
| X | ||||||||||
|
- Definition
Period the instrument, asset or liability is expected to be outstanding, in 'PnYnMnDTnHnMnS' format, for example, 'P1Y5M13D' represents the reported fact of one year, five months, and thirteen days. Reference 1: http://www.xbrl.org/2003/role/presentationRef
|
| X | ||||||||||
|
- Definition
Measure of dispersion, in percentage terms (for instance, the standard deviation or variance), for a given stock price. Reference 1: http://www.xbrl.org/2003/role/presentationRef
|
| X | ||||||||||
|
- Definition
Risk-free interest rate assumption used in valuing an instrument. Reference 1: http://www.xbrl.org/2003/role/presentationRef
|
| X | ||||||||||
|
- Definition
The cash inflow associated with the amount received from entity's raising of capital via private rather than public placement. Reference 1: http://www.xbrl.org/2003/role/presentationRef
|
| X | ||||||||||
|
- Details
|
| X | ||||||||||
|
- Definition
Number of new stock issued during the period. Reference 1: http://www.xbrl.org/2003/role/presentationRef
|
| X | ||||||||||
|
- Definition
Fair value portion of warrants not settleable in cash classified as equity. Reference 1: http://www.xbrl.org/2003/role/presentationRef
|