Document_and_Entity_Informatio
Document and Entity Information | 9 Months Ended | |
Sep. 30, 2013 | Nov. 07, 2013 | |
Document and Entity Information | ' | ' |
Entity Registrant Name | 'GTX INC /DE/ | ' |
Entity Central Index Key | '0001260990 | ' |
Document Type | '10-Q | ' |
Document Period End Date | 30-Sep-13 | ' |
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 | ' | 63,185,389 |
Document Fiscal Year Focus | '2013 | ' |
Document Fiscal Period Focus | 'Q3 | ' |
CONDENSED_BALANCE_SHEETS
CONDENSED BALANCE SHEETS (USD $) | Sep. 30, 2013 | Dec. 31, 2012 |
In Thousands, unless otherwise specified | ||
Current assets: | ' | ' |
Cash and cash equivalents | $19,283 | $48,044 |
Short-term investments | 1,675 | 8,045 |
Prepaid expenses and other current assets | 830 | 726 |
Total current assets | 21,788 | 56,815 |
Property and equipment, net | 217 | 507 |
Intangible and other assets, net | 487 | 452 |
Total assets | 22,492 | 57,774 |
Current liabilities: | ' | ' |
Accounts payable | 1,253 | 1,707 |
Accrued expenses and other current liabilities | 3,912 | 7,788 |
Total current liabilities | 5,165 | 9,495 |
Other long-term liabilities | 389 | 578 |
Commitments and contingencies | ' | ' |
Stockholders' equity: | ' | ' |
Common stock, $0.001 par value: 120,000,000 shares authorized at both September 30, 2013 and December 31, 2012; 63,185,389 and 62,818,424 shares issued and outstanding at September 30, 2013 and December 31, 2012, respectively | 63 | 63 |
Additional paid-in capital | 464,445 | 460,887 |
Accumulated deficit | -447,570 | -413,249 |
Total stockholders' equity | 16,938 | 47,701 |
Total liabilities and stockholders' equity | $22,492 | $57,774 |
CONDENSED_BALANCE_SHEETS_Paren
CONDENSED BALANCE SHEETS (Parenthetical) (USD $) | Sep. 30, 2013 | Dec. 31, 2012 |
CONDENSED BALANCE SHEETS | ' | ' |
Common stock, par value (in dollars per share) | $0.00 | $0.00 |
Common stock, shares authorized | 120,000,000 | 120,000,000 |
Common stock, shares issued | 63,185,389 | 62,818,424 |
Common stock, shares outstanding | 63,185,389 | 62,818,424 |
CONDENSED_STATEMENTS_OF_OPERAT
CONDENSED STATEMENTS OF OPERATIONS (USD $) | 3 Months Ended | 9 Months Ended | ||
In Thousands, except Share data, unless otherwise specified | Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 | Sep. 30, 2012 |
Expenses: | ' | ' | ' | ' |
Research and development expenses | $6,477 | $9,764 | $26,230 | $28,836 |
General and administrative expenses | 2,483 | 2,999 | 8,190 | 7,987 |
Total expenses | 8,960 | 12,763 | 34,420 | 36,823 |
Loss from operations | -8,960 | -12,763 | -34,420 | -36,823 |
Other income, net | 23 | -47 | 99 | 14 |
Loss from operations before income taxes | -8,937 | -12,810 | -34,321 | -36,809 |
Income tax benefit | ' | 5,812 | ' | 6,548 |
Net loss from continuing operations | -8,937 | -6,998 | -34,321 | -30,261 |
Income from discontinued operations before income taxes | ' | 20,214 | ' | 22,752 |
Income tax expense | ' | -8,115 | ' | -8,851 |
Net income from discontinued operations | ' | 12,099 | ' | 13,901 |
Net income (loss) | ($8,937) | $5,101 | ($34,321) | ($16,360) |
Net income (loss) per share - basic and diluted: | ' | ' | ' | ' |
Net loss from continuing operations (in dollars per share) | ($0.14) | ($0.11) | ($0.54) | ($0.48) |
Net income from discontinued operations (in dollars per share) | ' | $0.19 | ' | $0.22 |
Net income (loss) per share (in dollars per share) | ($0.14) | $0.08 | ($0.54) | ($0.26) |
Weighted average shares outstanding: | ' | ' | ' | ' |
Basic and diluted (in shares) | 63,179,394 | 62,815,549 | 63,013,923 | 62,806,440 |
CONDENSED_STATEMENTS_OF_CASH_F
CONDENSED STATEMENTS OF CASH FLOWS (USD $) | 9 Months Ended | |
In Thousands, unless otherwise specified | Sep. 30, 2013 | Sep. 30, 2012 |
Cash flows from operating activities: | ' | ' |
Net loss | ($34,321) | ($16,360) |
Adjustments to reconcile net loss to net cash used in operating activities: | ' | ' |
Gain on sale of FARESTON | ' | -18,831 |
Depreciation and amortization | 333 | 596 |
Share-based compensation | 2,227 | 1,878 |
Directors' deferred compensation | 105 | 128 |
Changes in assets and liabilities: | ' | ' |
Prepaid expenses and other assets | -150 | 106 |
Accounts payable | -454 | -12 |
Accrued expenses and other liabilities | -4,060 | 5,451 |
Net cash used in operating activities | -36,320 | -27,044 |
Cash flows from investing activities: | ' | ' |
Purchase of property and equipment | -32 | -125 |
Purchase of short-term investments, held to maturity | -1,225 | -7,815 |
Proceeds from maturities of short-term investments, held to maturity | 7,595 | 9,955 |
Net cash provided by investing activities | 6,338 | 2,015 |
Cash flows from financing activities: | ' | ' |
Payments on capital lease and financed equipment obligations | -5 | -67 |
Proceeds from exercise of employee stock options | 1,226 | 82 |
Net cash provided by financing activities | 1,221 | 15 |
Net decrease in cash and cash equivalents | -28,761 | -25,014 |
Cash and cash equivalents, beginning of period | 48,044 | 63,745 |
Cash and cash equivalents, end of period | $19,283 | $38,731 |
Business_and_Basis_of_Presenta
Business and Basis of Presentation | 9 Months Ended |
Sep. 30, 2013 | |
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, 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 with the potential to prevent and treat muscle wasting in patients with cancer and other musculoskeletal wasting or muscle loss conditions, including chronic sarcopenia (age related muscle loss), as well as the potential to be used as a hormonal therapy for the treatment of advanced breast cancer. The Company announced in August 2013 that its two Phase 3 clinical trials evaluating enobosarm 3 mg for the prevention and treatment of muscle wasting in patients with advanced non-small cell lung cancer (“NSCLC”) failed to meet the co-primary endpoints of lean body mass and physical function that were assessed statistically using responder analyses. The Company plans to meet with the United States Food and Drug Administration and representatives of certain member countries of the European Medicines Agency to review and discuss the results of the clinical trials and a feasible regulatory pathway forward to seek marketing approval for enobosarm 3 mg for the prevention and treatment of muscle wasting in patients with advanced NSCLC. | |
The Company is also conducting a Phase 2 open label study evaluating enobosarm 9 mg for the treatment of androgen receptor positive and estrogen receptor positive metastatic breast cancer in women who have previously responded to hormonal therapy for the treatment of their advanced breast cancer. 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 secondary hormonal therapy in men with metastatic castration resistant prostate cancer. | |
The Company has experienced significant recurring operating losses since its inception and has limited funds. The failure of both enobosarm 3 mg Phase 3 clinical trials to meet each of the co-primary endpoints has significantly depressed the Company’s stock price and has severely harmed the Company’s ability to raise additional capital, and, consequently, its prospects as a going concern have been diminished. The Company has implemented a plan to reduce its operating expenses, including significantly reducing its workforce as announced in October 2013, in order to preserve capital while it evaluates feasible regulatory pathways for enobosarm 3 mg, conducts its two Phase 2 clinical trials of enobosarm 9 mg and GTx-758, and pursues discussions with potential partners. However, the expense reduction plan alone will not be sufficient to allow the Company to continue its operations for the next twelve months without raising additional funds. | |
Subsequent Events | |
The Company has evaluated all events or transactions that occurred after September 30, 2013 up through the date the condensed financial statements were issued. | |
In October 2013, the Company announced and 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 estimates that it will record in the fourth quarter of 2013 compensation expense of approximately $1,300 related to cash severance expenses. Additionally, the Company expects to recognize a benefit of approximately $370 resulting from the reversal of share-based compensation expense related to the amendment of certain stock option provisions for the severed employees. | |
There were no other material recognizable or nonrecognizable subsequent events during the period evaluated. | |
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 GTx’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, 2012. Operating results for the three and nine months ended September 30, 2013 are not necessarily indicative of the results that may be expected for the entire fiscal year ending December 31, 2013. | |
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. | |
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, 2013 and December 31, 2012, 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, 2013 and December 31, 2012, net of the valuation allowance, the net deferred tax assets were reduced to zero. Income taxes are described more fully in Note 10 to the Company’s financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2012. | |
The Company has recognized the tax effect of discontinued operations of FARESTON® (see Note 4, Discontinued Operations) in the condensed statement of operations for the three and nine months ended September 30, 2012 in accordance with the intra-period accounting rules. An offsetting tax benefit was recorded in continuing operations as tax expense was recognized for discontinued operations. | |
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. | |
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®. The Company has accounted for FARESTON® as a discontinued operation. As a result, revenue, cost of goods sold, and operating expenses related to FARESTON® were excluded from the respective captions in the condensed statement of operations and were included in discontinued operations for the three and nine months ended September 30, 2012. See Note 4, Discontinued Operations, for further discussion. | |
FARESTON® Revenue Recognition | |
Revenue from product sales of FARESTON® for the three and nine months ended September 30, 2012, which was included in income from discontinued operations before income taxes, 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 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, 2013 and December 31, 2012, the Company’s accrual for product returns, was $995 and $1,189, respectively. Of these amounts, $332 and $370 have been included in “Other long-term liabilities” in the condensed balance sheet at September 30, 2013 and December 31, 2012, respectively, and represents the portion of the Company’s product returns accrual estimated to be payable after one year. See Note 4, Discontinued Operations, for further discussion. | |
Reclassification | |
Certain prior period results have been reclassified to conform to the current period presentation. | |
Going Concern | |
The accompanying unaudited condensed financial statements have been prepared assuming the Company will continue as a going concern which contemplates the realization of assets and liabilities in the ordinary course of business. The Company has experienced significant recurring operating losses since its inception resulting in an accumulated deficit of $447,570 at September 30, 2013. At September 30, 2013, the Company had cash, cash equivalents and short-term investments of $20,958 compared to $56,089 at December 31, 2012. Currently, the Company has no ongoing collaborations for the development and commercialization of its product candidates and no source of revenue, nor does the Company expect to generate revenue for the foreseeable future. A substantial portion of the Company’s efforts and expenditures have been devoted to enobosarm 3 mg, which was the subject of two Phase 3 clinical trials for the prevention and treatment of muscle wasting in patients with advanced NSCLC, and the Company has been substantially dependent on the successful development, regulatory approval and commercialization of enobosarm 3 mg. The failure of both enobosarm 3 mg Phase 3 clinical trials to meet each of the co-primary endpoints has significantly depressed the Company’s stock price and has severely harmed its ability to raise additional capital, and consequently, the Company’s prospects as a going concern have been diminished. As a result, the Company announced and implemented a plan on October 1, 2013 to reduce its operating expenses, including significantly reducing its workforce, in order to preserve capital. The Company estimates that its current cash and investments will not be sufficient to fund its ongoing operations for the next twelve months. If the Company does not have sufficient funds to continue its operations, it would be required to, among other things, make further reductions in its workforce, eliminate one or both of its ongoing clinical trials, discontinue the development of enobosarm and/or GTx-758, liquidate all or a portion of its assets, and/or seek protection under the provisions of the U.S. Bankruptcy Code. These factors raise substantial doubt about the Company’s ability to continue as a going concern. The Company’s financial statements do not include any adjustments that may result from the outcome of this uncertainty. | |
ShareBased_Compensation
Share-Based Compensation | 9 Months Ended | |||||||||||||
Sep. 30, 2013 | ||||||||||||||
Share-Based Compensation | ' | |||||||||||||
Share-Based Compensation | ' | |||||||||||||
2. Share-Based Compensation | ||||||||||||||
Share-based payments include stock option grants 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 director is required to provide service in exchange for the award. | ||||||||||||||
On May 2, 2013, the Company’s stockholders approved the GTx, Inc. 2013 Equity Incentive Plan (the “2013 EIP”) and the GTx, Inc. 2013 Non-Employee Director Equity Incentive Plan (the “2013 NEDEIP”), which became effective on that date. The 2013 EIP is the successor to the Company’s 2004 Equity Incentive Plan (the “2004 EIP”), and the 2013 NEDEIP is the successor to the Company’s Amended and Restated 2004 Non-Employee Directors’ Stock Option Plan (the “2004 NEDSOP”). The total number of shares of the Company’s common stock available for issuance under the 2013 EIP was initially 4,208,157 shares plus up to an additional 6,093,559 shares subject to outstanding awards granted under the 2004 EIP and each of the Genotherapeutics, Inc. Stock Option Plan, the GTx, Inc. 2000 Stock Option Plan, the GTx, Inc. 2001 Stock Option Plan and the GTx, Inc. 2002 Stock Option Plan (collectively, the “Prior Plans”) that, from and after the effective date of the 2013 EIP, expire or terminate for any reason prior to exercise or settlement, are forfeited because of the failure to vest in those shares or are otherwise returned to the 2013 EIP share reserve pursuant to the terms of the plan. In addition, the shares of the Company’s common stock available for issuance under the 2013 EIP will automatically increase on January 1st of each year, for ten years, commencing on January 1, 2014, in an amount equal to 4% of the total number of shares of the Company’s common stock outstanding on December 31 of the preceding calendar year, or such lesser (or no) amount as may be approved by the Company’s Board of Directors. The total number of shares of the Company’s common stock available for issuance under the 2013 NEDEIP was initially 404,000 shares plus up to an additional 449,667 shares subject to outstanding awards granted under the 2004 NEDSOP that, from and after the effective date of the 2013 NEDEIP, expire or terminate for any reason prior to exercise or settlement, are forfeited because of the failure to vest in those shares or are otherwise returned to the 2013 NEDEIP share reserve pursuant to the terms of the plan. In addition, the shares of the Company’s common stock available for issuance under the 2013 NEDEIP will automatically increase on January 1st of each year, for ten years, commencing on January 1, 2014, in an amount equal to the lesser of 1% of the total number of shares of the Company’s common stock outstanding on December 31 of the preceding calendar year and 500,000 shares, or such lesser (or no) amount as may be approved by the Company’s Board of Directors. From and after the effective date of 2013 EIP and the 2013 NEDEIP, no further awards will be made under the Prior Plans and the 2004 NEDSOP. Stock options previously granted under the Prior Plans and the 2004 NEDSOP continue to be governed by the terms of the applicable plan. For more information on the terms of stock options granted to employees and directors, see Note 3 to the Company’s financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2012. | ||||||||||||||
The following table summarizes share-based compensation expense included within the condensed statements of operations for the three and nine months ended September 30, 2013 and 2012: | ||||||||||||||
Three Months Ended | Nine Months Ended | |||||||||||||
September 30, | September 30, | |||||||||||||
2013 | 2012 | 2013 | 2012 | |||||||||||
Research and development expenses | $ | 356 | $ | 335 | $ | 1,051 | $ | 696 | ||||||
General and administrative expenses | 406 | 458 | 1,281 | 1,310 | ||||||||||
Total share-based compensation | $ | 762 | $ | 793 | $ | 2,332 | $ | 2,006 | ||||||
Share-based compensation expense recorded as general and administrative expense for the three months ended September 30, 2013 and 2012 included share-based compensation expense related to deferred compensation arrangements for the Company’s non-employee directors of $31 and $40, respectively. Share-based compensation expense recorded as general and administrative expense for the nine months ended September 30, 2013 and 2012 included share-based compensation expense related to deferred compensation arrangements for the Company’s non-employee directors of $105 and $128, respectively. Share-based compensation expense recorded as research and development expense for the three and nine months ended September 30, 2012 was offset 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 nine months ended September 30, 2012. | ||||||||||||||
The Company uses the Black-Scholes-Merton option pricing valuation 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 fair value of options granted was estimated using the following assumptions for the periods presented: | ||||||||||||||
Three Months Ended | Nine Months Ended | |||||||||||||
September 30, | September 30, | |||||||||||||
2013 | 2012 | 2013 | 2012 | |||||||||||
Expected price volatility | 74.8 | % | 73.8 | % | 74.5 | % | 69.6 | % | ||||||
Risk-free interest rate | 1.8 | % | 1.1 | % | 1.1 | % | 1.2 | % | ||||||
Weighted average expected life in years | 6.5 years | 6.5 years | 6.5 years | 6.5 years | ||||||||||
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: | ||||||||||||||
Number of Shares | Weighted Average | |||||||||||||
Exercise Price Per | ||||||||||||||
Share | ||||||||||||||
Options outstanding at December 31, 2012 | 5,382,859 | $ | 7.96 | |||||||||||
Options granted | 1,459,200 | 4.24 | ||||||||||||
Options forfeited or expired | (531,076 | ) | 8.69 | |||||||||||
Options exercised | (321,298 | ) | 3.81 | |||||||||||
Options outstanding at September 30, 2013 | 5,989,685 | 7.21 | ||||||||||||
Basic_and_Diluted_Net_Income_L
Basic and Diluted Net Income (Loss) Per Share | 9 Months Ended |
Sep. 30, 2013 | |
Basic and Diluted Net Income (Loss) Per Share | ' |
Basic and Diluted Net Income (Loss) Per Share | ' |
3. Basic and Diluted NetIncome (Loss) Per Share | |
Basic and diluted net income (loss) per share attributable to common stockholders is calculated based on the weighted average number of common shares outstanding during the period. Diluted net income (loss) per share gives effect to the dilutive potential of common stock consisting of stock options. | |
Weighted average options outstanding to purchase shares of common stock of 6,136,483 and 5,408,065 for the three months ended September 30, 2013 and 2012, respectively, and 6,432,994 and 5,639,672 for the nine months ended September 30, 2013 and 2012, respectively, were excluded from the calculations of diluted income (loss) per share as inclusion of the options would have had an anti-dilutive effect on the net income (loss) per share for these periods. |
Discontinued_Operations
Discontinued Operations | 9 Months Ended |
Sep. 30, 2013 | |
Discontinued Operations | ' |
Discontinued Operations | ' |
4. Discontinued Operations | |
On September 28, 2012, the Company entered into the FARESTON® Purchase Agreement with ProStrakan pursuant to which the Company agreed to transfer, sell and assign to ProStrakan all of the Company’s rights to FARESTON® and certain assets related thereto. Effective September 30, 2012, the Company completed the sale of FARESTON® pursuant to the FARESTON® Purchase Agreement for a total cash purchase price of $21,671, including payment for purchased inventory. The Company accounted for FARESTON® as a discontinued operation. The FARESTON® operating income of $20,214 and $22,752 for the three and nine months ended September 30, 2012, respectively, was reported as income from discontinued operations in the condensed statement of operations and both periods included the gain of $18,831 recognized on the sale of FARESTON®. For the three months ended September 30, 2012, income from discontinued operations consisted of net product sales of $1,826 reduced by cost of product sales of $263 and FARESTON® operating expenses of $180. For the nine months ended September 30, 2012, income from discontinued operations consisted of net product sales of $5,294 reduced by cost of product sales of $782 and FARESTON® operating expenses of $591. The Company remains liable for product returns related to sales of FARESTON® made by the Company prior to September 30, 2012. At September 30, 2013 and December 31, 2012, the Company’s accrual for product returns, was $995 and $1,189, respectively. | |
University_of_Tennessee_Resear
University of Tennessee Research Foundation License Agreement | 9 Months Ended |
Sep. 30, 2013 | |
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. | |
Business_and_Basis_of_Presenta1
Business and Basis of Presentation (Policies) | 9 Months Ended |
Sep. 30, 2013 | |
Business and Basis of Presentation | ' |
Subsequent Events | ' |
Subsequent Events | |
The Company has evaluated all events or transactions that occurred after September 30, 2013 up through the date the condensed financial statements were issued. | |
In October 2013, the Company announced and 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 estimates that it will record in the fourth quarter of 2013 compensation expense of approximately $1,300 related to cash severance expenses. Additionally, the Company expects to recognize a benefit of approximately $370 resulting from the reversal of share-based compensation expense related to the amendment of certain stock option provisions for the severed employees. | |
There were no other material recognizable or nonrecognizable subsequent events during the period evaluated. | |
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 GTx’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, 2012. Operating results for the three and nine months ended September 30, 2013 are not necessarily indicative of the results that may be expected for the entire fiscal year ending December 31, 2013. | |
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. | |
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, 2013 and December 31, 2012, 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, 2013 and December 31, 2012, net of the valuation allowance, the net deferred tax assets were reduced to zero. Income taxes are described more fully in Note 10 to the Company’s financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2012. | |
The Company has recognized the tax effect of discontinued operations of FARESTON® (see Note 4, Discontinued Operations) in the condensed statement of operations for the three and nine months ended September 30, 2012 in accordance with the intra-period accounting rules. An offsetting tax benefit was recorded in continuing operations as tax expense was recognized for discontinued operations. | |
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. | |
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®. The Company has accounted for FARESTON® as a discontinued operation. As a result, revenue, cost of goods sold, and operating expenses related to FARESTON® were excluded from the respective captions in the condensed statement of operations and were included in discontinued operations for the three and nine months ended September 30, 2012. See Note 4, Discontinued Operations, for further discussion. | |
FARESTON Revenue Recognition | ' |
FARESTON® Revenue Recognition | |
Revenue from product sales of FARESTON® for the three and nine months ended September 30, 2012, which was included in income from discontinued operations before income taxes, 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 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, 2013 and December 31, 2012, the Company’s accrual for product returns, was $995 and $1,189, respectively. Of these amounts, $332 and $370 have been included in “Other long-term liabilities” in the condensed balance sheet at September 30, 2013 and December 31, 2012, respectively, and represents the portion of the Company’s product returns accrual estimated to be payable after one year. See Note 4, Discontinued Operations, for further discussion. | |
Reclassification | ' |
Reclassification | |
Certain prior period results have been reclassified to conform to the current period presentation. | |
Going Concern | ' |
Going Concern | |
The accompanying unaudited condensed financial statements have been prepared assuming the Company will continue as a going concern which contemplates the realization of assets and liabilities in the ordinary course of business. The Company has experienced significant recurring operating losses since its inception resulting in an accumulated deficit of $447,570 at September 30, 2013. At September 30, 2013, the Company had cash, cash equivalents and short-term investments of $20,958 compared to $56,089 at December 31, 2012. Currently, the Company has no ongoing collaborations for the development and commercialization of its product candidates and no source of revenue, nor does the Company expect to generate revenue for the foreseeable future. A substantial portion of the Company’s efforts and expenditures have been devoted to enobosarm 3 mg, which was the subject of two Phase 3 clinical trials for the prevention and treatment of muscle wasting in patients with advanced NSCLC, and the Company has been substantially dependent on the successful development, regulatory approval and commercialization of enobosarm 3 mg. The failure of both enobosarm 3 mg Phase 3 clinical trials to meet each of the co-primary endpoints has significantly depressed the Company’s stock price and has severely harmed its ability to raise additional capital, and consequently, the Company’s prospects as a going concern have been diminished. As a result, the Company announced and implemented a plan on October 1, 2013 to reduce its operating expenses, including significantly reducing its workforce, in order to preserve capital. The Company estimates that its current cash and investments will not be sufficient to fund its ongoing operations for the next twelve months. If the Company does not have sufficient funds to continue its operations, it would be required to, among other things, make further reductions in its workforce, eliminate one or both of its ongoing clinical trials, discontinue the development of enobosarm and/or GTx-758, liquidate all or a portion of its assets, and/or seek protection under the provisions of the U.S. Bankruptcy Code. These factors raise substantial doubt about the Company’s ability to continue as a going concern. The Company’s financial statements do not include any adjustments that may result from the outcome of this uncertainty. | |
ShareBased_Compensation_Tables
Share-Based Compensation (Tables) | 9 Months Ended | |||||||||||||
Sep. 30, 2013 | ||||||||||||||
Share-Based Compensation | ' | |||||||||||||
Summary of share-based compensation expense | ' | |||||||||||||
Three Months Ended | Nine Months Ended | |||||||||||||
September 30, | September 30, | |||||||||||||
2013 | 2012 | 2013 | 2012 | |||||||||||
Research and development expenses | $ | 356 | $ | 335 | $ | 1,051 | $ | 696 | ||||||
General and administrative expenses | 406 | 458 | 1,281 | 1,310 | ||||||||||
Total share-based compensation | $ | 762 | $ | 793 | $ | 2,332 | $ | 2,006 | ||||||
Schedule of assumptions used to estimate fair value of options | ' | |||||||||||||
Three Months Ended | Nine Months Ended | |||||||||||||
September 30, | September 30, | |||||||||||||
2013 | 2012 | 2013 | 2012 | |||||||||||
Expected price volatility | 74.8 | % | 73.8 | % | 74.5 | % | 69.6 | % | ||||||
Risk-free interest rate | 1.8 | % | 1.1 | % | 1.1 | % | 1.2 | % | ||||||
Weighted average expected life in years | 6.5 years | 6.5 years | 6.5 years | 6.5 years | ||||||||||
Summary of stock option transactions | ' | |||||||||||||
Number of Shares | Weighted Average | |||||||||||||
Exercise Price Per | ||||||||||||||
Share | ||||||||||||||
Options outstanding at December 31, 2012 | 5,382,859 | $ | 7.96 | |||||||||||
Options granted | 1,459,200 | 4.24 | ||||||||||||
Options forfeited or expired | (531,076 | ) | 8.69 | |||||||||||
Options exercised | (321,298 | ) | 3.81 | |||||||||||
Options outstanding at September 30, 2013 | 5,989,685 | 7.21 | ||||||||||||
Business_and_Basis_of_Presenta2
Business and Basis of Presentation (Details) (USD $) | Sep. 30, 2013 | Dec. 31, 2012 | Oct. 31, 2013 | Dec. 31, 2013 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | Subsequent event | Subsequent event | Subsequent event | ||
One-time compensation expense related to cash severance | One-time share based compensation benefit related to amendment of stock option provisions | ||||
Subsequent events | ' | ' | ' | ' | ' |
Reduction in workforce (as a percent) | ' | ' | 60.00% | ' | ' |
Estimated expense (benefit) related to workforce reduction | ' | ' | ' | $1,300 | ($370) |
Income Taxes | ' | ' | ' | ' | ' |
Net deferred tax assets | 0 | 0 | ' | ' | ' |
FARESTON Revenue Recognition | ' | ' | ' | ' | ' |
Accrual for product returns | 995 | 1,189 | ' | ' | ' |
Accrual for product returns included in other long term liabilities | 332 | 370 | ' | ' | ' |
Going Concern | ' | ' | ' | ' | ' |
Accumulated deficit | -447,570 | -413,249 | ' | ' | ' |
Cash, cash equivalents and short-term investments | $20,958 | $56,089 | ' | ' | ' |
ShareBased_Compensation_Detail
Share-Based Compensation (Details) | 0 Months Ended |
2-May-13 | |
2013 EIP | ' |
Share-based compensation. | ' |
Number of shares initially available for issuance | 4,208,157 |
Period for which common stock available for issuance under the plan will automatically increase on January 1st of each year | '10 years |
2013 EIP | Maximum | ' |
Share-based compensation. | ' |
Additional number of shares available for issuance subject to the expiration or forfeiture of awards granted under prior share-based compensation plans | 6,093,559 |
Annual increase in common stock available for issuance under the plan as a percentage of the total number of shares of the Company's common stock outstanding on December 31 of the preceding calendar year | 4.00% |
2013 EIP | Minimum | ' |
Share-based compensation. | ' |
Increase in common stock available for issuance under the plan as may be approved by the Company's Board of Directors | 0 |
2013 NEDEIP | ' |
Share-based compensation. | ' |
Number of shares initially available for issuance | 404,000 |
Period for which common stock available for issuance under the plan will automatically increase on January 1st of each year | '10 years |
Annual increase in common stock available for issuance under the plan as a percentage of the total number of shares of the Company's common stock outstanding on December 31 of the preceding calendar year | 1.00% |
2013 NEDEIP | Maximum | ' |
Share-based compensation. | ' |
Additional number of shares available for issuance subject to the expiration or forfeiture of awards granted under prior share-based compensation plans | 449,667 |
Annual increase in common stock available for issuance under the plan each year (in shares) | 500,000 |
2013 NEDEIP | Minimum | ' |
Share-based compensation. | ' |
Increase in common stock available for issuance under the plan as may be approved by the Company's Board of Directors | 0 |
ShareBased_Compensation_Detail1
Share-Based Compensation (Details 2) (USD $) | 3 Months Ended | 9 Months Ended | ||
In Thousands, unless otherwise specified | Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 | Sep. 30, 2012 |
Share-based compensation expense | ' | ' | ' | ' |
Total share-based compensation | $762 | $793 | $2,332 | $2,006 |
Share-based compensation expense related to deferred compensation arrangements for non-employee directors | ' | ' | 105 | 128 |
Research and development expenses | ' | ' | ' | ' |
Share-based compensation expense | ' | ' | ' | ' |
Total share-based compensation | 356 | 335 | 1,051 | 696 |
General and administrative expenses | ' | ' | ' | ' |
Share-based compensation expense | ' | ' | ' | ' |
Total share-based compensation | 406 | 458 | 1,281 | 1,310 |
Non-employee Directors | General and administrative expenses | ' | ' | ' | ' |
Share-based compensation expense | ' | ' | ' | ' |
Share-based compensation expense related to deferred compensation arrangements for non-employee directors | $31 | $40 | $105 | $128 |
ShareBased_Compensation_Detail2
Share-Based Compensation (Details 3) (USD $) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 | Sep. 30, 2012 | |
Fair value of options granted | ' | ' | ' | ' |
Expected price volatility (as a percent) | 74.80% | 73.80% | 74.50% | 69.60% |
Risk-free interest rate (as a percent) | 1.80% | 1.10% | 1.10% | 1.20% |
Weighted average expected life in years | '6 years 6 months | '6 years 6 months | '6 years 6 months | '6 years 6 months |
Number of Shares | ' | ' | ' | ' |
Options outstanding at the beginning of the period (in shares) | ' | ' | 5,382,859 | ' |
Options granted (in shares) | ' | ' | 1,459,200 | ' |
Options forfeited or expired (in shares) | ' | ' | -531,076 | ' |
Options exercised (in shares) | ' | ' | -321,298 | ' |
Options outstanding at the end of the period (in shares) | 5,989,685 | ' | 5,989,685 | ' |
Weighted Average Exercise Price Per Share | ' | ' | ' | ' |
Options outstanding at the beginning of the period (in dollars per share) | ' | ' | $7.96 | ' |
Options granted (in dollars per share) | ' | ' | $4.24 | ' |
Options forfeited or expired (in dollars per share) | ' | ' | $8.69 | ' |
Options exercised (in dollars per share) | ' | ' | $3.81 | ' |
Options outstanding at the end of the period (in dollars per share) | $7.21 | ' | $7.21 | ' |
Basic_and_Diluted_Net_Income_L1
Basic and Diluted Net Income (Loss) Per Share (Details) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 | Sep. 30, 2012 | |
Basic and Diluted Net Income (Loss) Per Share | ' | ' | ' | ' |
Weighted average options outstanding to purchase shares of common stock excluded from calculation of diluted net income (loss) per share | 6,136,483 | 5,408,065 | 6,432,994 | 5,639,672 |
Discontinued_Operations_Detail
Discontinued Operations (Details) (USD $) | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||
In Thousands, unless otherwise specified | Sep. 30, 2012 | Sep. 30, 2012 | Sep. 30, 2012 | Sep. 30, 2013 | Dec. 31, 2012 |
Operating income disclosures related to discontinued operations | ' | ' | ' | ' | ' |
Gain on sale of FARESTON | ' | ' | $18,831 | ' | ' |
Liabilities related to discontinued operations | ' | ' | ' | ' | ' |
Accrual for product returns | ' | ' | ' | 995 | 1,189 |
FARESTON | ' | ' | ' | ' | ' |
Discontinued Operations disclosures | ' | ' | ' | ' | ' |
Proceeds from the sale of rights and certain assets related to FARESTON | 21,671 | ' | ' | ' | ' |
Operating income disclosures related to discontinued operations | ' | ' | ' | ' | ' |
Gain on sale of FARESTON | ' | 18,831 | 18,831 | ' | ' |
Product sales, net | ' | 1,826 | 5,294 | ' | ' |
Cost of product sales | ' | 263 | 782 | ' | ' |
Operating expenses | ' | 180 | 591 | ' | ' |
FARESTON operating income | ' | 20,214 | 22,752 | ' | ' |
Liabilities related to discontinued operations | ' | ' | ' | ' | ' |
Accrual for product returns | ' | ' | ' | $995 | $1,189 |