| Business and Basis of Presentation | 3 Months Ended |
| Mar. 31, 2014 |
| 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, including treatments for prostate and breast 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 novel hormonal therapy for the treatment of metastatic 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 for the prevention and treatment of muscle wasting in patients with advanced non-small cell lung cancer (“NSCLC”) failed to meet the primary statistical criterion for the co-primary endpoints of lean body mass and physical function that were assessed statistically using responder analyses as pre-specified for the United States Food and Drug Administration (“FDA”). The Company met with representatives from two member countries to the European Medicines Agency (“EMA”) in January 2014 to review and discuss the results of the POWER trials to determine an appropriate path forward for submitting 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. Based on input from the two member countries, the Company believes data from the POWER 1 trial, as well as supporting data from the POWER 2 trial, may be sufficient to support the submission of a MAA to the EMA seeking marketing authorization for enobosarm 3 mg in the more narrow indication of the prevention and treatment of muscle wasting in patients with advanced NSCLC treated with platinum plus taxane chemotherapy. The Company has initiated seven Phase 1 clinical studies that are typically required for submission purposes and have submitted a pediatric investigational plan, or PIP, to the EMA, which is necessary for submission of a MAA. The Company has retained experts in both the United States and the EU to work with its internal team to explore the option of submitting a MAA for enobosarm 3 mg for the prevention and treatment of muscle wasting in patients with advanced NSCLC treated with platinum plus taxane chemotherapy, after completion of the Phase 1 studies and acceptance of the PIP by the EMA’s Pediatric Committee. 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 primary 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 (“NDA”) for enobosarm 3 mg. The Company is evaluating options for further development of enobosarm 3 mg. Any further development would be subject to the Company’s ability to obtain additional funding and would be required to be successfully completed prior to any NDA submission to the FDA for enobosarm 3 mg. |
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| The Company is 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 metastatic 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 and non-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 Company expects that its current cash resources, together with interest income thereon, will be sufficient to fund the completion of its ongoing Phase 2 clinical trials of enobosarm 9 mg and GTx-758, the completion of its Phase 1 clinical studies of enobosarm 3 mg and the continuation of activities required for the potential submission of a MAA to the EMA for enobosarm 3 mg for the prevention and treatment of muscle wasting in patients with advanced NSCLC treated with platinum plus taxane chemotherapy. However, the Company will need to raise substantial additional capital in the near term to complete the activities that would be required to submit a MAA and to sustain its operations through and beyond the second quarter of 2015. |
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| Basis ofPresentation |
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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, 2013. Operating results for the three months ended March 31, 2014 are not necessarily indicative of the results that may be expected for the entire fiscal year ending December 31, 2014. |
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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. 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. |
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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 March 31, 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. |
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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 March 31, 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. |
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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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| FARESTON® Revenue Recognition |
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| 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 March 31, 2014 and December 31, 2013, the Company’s accrual for product returns, was $454 and $918, respectively. Of these amounts, $189 and $332 have been included in “Other long-term liabilities” in the condensed balance sheet at March 31, 2014 and December 31, 2013, respectively, and represents the portion of the Company’s product returns accrual estimated to be payable after one year. The accrual for product returns decreased during the current period due to the closure of the return period for a portion of the previously sold inventory. |
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| Subsequent Events |
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| The Company has evaluated all events or transactions that occurred after March 31, 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. |
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| In April 2014, the Company announced that Mitchell S. Steiner, M.D., the Company’s Vice Chairman and Chief Executive Officer and a co-founder of the Company, was leaving the Company to pursue other business interests. Dr. Steiner resigned from his roles as Chief Executive Officer and Vice Chairman of the Board of Directors at the Company, and as a member of the Board of Directors, 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 annual meeting of GTx shareholders in 2015. 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 (i) twelve months of base salary continuation payments, which totals $452; (ii) a payout of accrued vacation of $12; and (iii) continued healthcare coverage through the earliest to occur of (a) December 2014, (b) the date he becomes eligible for group health insurance coverage through a new employer or (c) the date Dr. Steiner ceases to be eligible for COBRA continuation coverage, which is estimated to cost the Company $19. As a result of these severance benefits, the Company will recognize cash severance related expenses of $483 during the second quarter of 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. As a result of the modification of Dr. Steiner’s options, the Company will recognize a one-time, noncash net compensation expense of $215 during the second quarter of 2014, which reflects 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. |
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| In connection with Mr. Hanover’s appointment as the Company’s interim Chief Executive Officer, the Board approved the grant of a stock option under its 2013 Equity Incentive Plan (“2013 EIP”) to purchase 500,000 shares of common stock. In accordance with the terms of the 2013 EIP, the option was granted at a price equal to the fair market value of the stock on the date of grant and has a term of ten years from the date of grant and vests in five equal annual installments. All of Mr. Hanover’s previously granted options and a portion of the options granted on April 3, 2014 are subject to accelerated vesting if Mr. Hanover is involuntarily terminated or resigns due to a material demotion, as defined in the amended employment agreement between Mr. Hanover and the Company, within six months of a new Chief Executive Officer becoming employed by the Company. Additionally, if either of these events were to occur, the post-termination exercise period for all of his outstanding vested stock options would be extended until the earlier of (i) five years from his date of termination or resignation on account of a material demotion or (ii) the expiration of the term of a particular stock option grant in accordance with the terms of his amended employment agreement. |
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| On May 7, 2014, the Company filed a Certificate of Amendment to the Company’s Restated Certificate of Incorporation with the Secretary of State of the State of Delaware to increase the number of authorized shares of the Company’s common stock, par value $0.001 per share, from 120,000,000 shares to 200,000,000 shares. The foregoing amendment was approved by the Company’s stockholders at the Company’s 2014 Annual Meeting of Stockholders held on May 6, 2014. |
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