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 |
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Business |
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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. |
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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. |
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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. |
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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. |
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Subsequent Events |
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The Company has evaluated all events or transactions that occurred after September 30, 2013 up through the date the condensed financial statements were issued. |
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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. |
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There were no other material recognizable or nonrecognizable subsequent events during the period evaluated. |
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Basis of Presentation |
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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. |
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Use of Estimates |
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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. |
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Research and Development Expenses |
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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. |
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Cash, Cash Equivalents and Short-term Investments |
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The Company considers highly liquid investments with initial maturities of three months or less to be cash equivalents. |
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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. |
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Income Taxes |
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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. |
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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. |
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Other Income, net |
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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. |
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Discontinued Operations |
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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. |
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FARESTON® Revenue Recognition |
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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. |
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Reclassification |
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Certain prior period results have been reclassified to conform to the current period presentation. |
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Going Concern |
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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. |
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