Document_and_Entity_Informatio
Document and Entity Information | 6 Months Ended | |
Jun. 30, 2014 | Aug. 01, 2014 | |
Document and Entity Information | ' | ' |
Entity Registrant Name | 'GTX INC /DE/ | ' |
Entity Central Index Key | '0001260990 | ' |
Document Type | '10-Q | ' |
Document Period End Date | 30-Jun-14 | ' |
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 | 'Q2 | ' |
CONDENSED_BALANCE_SHEETS
CONDENSED BALANCE SHEETS (USD $) | Jun. 30, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Current assets: | ' | ' |
Cash and cash equivalents | $11,178 | $14,529 |
Short-term investments | 6,080 | 200 |
Prepaid expenses and other current assets | 1,194 | 442 |
Total current assets | 18,452 | 15,171 |
Property and equipment, net | 58 | 112 |
Intangible and other assets, net | 625 | 322 |
Total assets | 19,135 | 15,605 |
Current liabilities: | ' | ' |
Accounts payable | 992 | 808 |
Accrued expenses and other current liabilities | 2,711 | 3,759 |
Total current liabilities | 3,703 | 4,567 |
Other long-term liabilities | 147 | 354 |
Commitments and contingencies | ' | ' |
Stockholders' equity: | ' | ' |
Common stock, $0.001 par value: 200,000,000 and 120,000,000 shares authorized at both June 30, 2014 and December 31, 2013 respectively; 76,014,531 and 63,185,389 shares issued and outstanding at June 30, 2014 and December 31, 2013, respectively | 76 | 63 |
Additional paid-in capital | 490,500 | 465,981 |
Accumulated deficit | -475,291 | -455,360 |
Total stockholders' equity | 15,285 | 10,684 |
Total liabilities and stockholders' equity | $19,135 | $15,605 |
CONDENSED_BALANCE_SHEETS_Paren
CONDENSED BALANCE SHEETS (Parenthetical) (USD $) | Jun. 30, 2014 | Dec. 31, 2013 |
CONDENSED BALANCE SHEETS | ' | ' |
Common stock, par value (in dollars per share) | $0.00 | $0.00 |
Common stock, shares authorized | 200,000,000 | 120,000,000 |
Common stock, shares issued | 76,014,531 | 63,185,389 |
Common stock, shares outstanding | 76,014,531 | 63,185,389 |
CONDENSED_STATEMENTS_OF_OPERAT
CONDENSED STATEMENTS OF OPERATIONS (USD $) | 3 Months Ended | 6 Months Ended | ||
In Thousands, except Share data, unless otherwise specified | Jun. 30, 2014 | Jun. 30, 2013 | Jun. 30, 2014 | Jun. 30, 2013 |
Expenses: | ' | ' | ' | ' |
Research and development expenses | $7,894 | $10,139 | $14,254 | $19,753 |
General and administrative expenses | 3,052 | 2,684 | 5,681 | 5,707 |
Total expenses | 10,946 | 12,823 | 19,935 | 25,460 |
Loss from operations | -10,946 | -12,823 | -19,935 | -25,460 |
Other income, net | 2 | 21 | 4 | 76 |
Net loss | ($10,944) | ($12,802) | ($19,931) | ($25,384) |
Net loss per share: | ' | ' | ' | ' |
Basic and diluted (in dollars per share) | ($0.15) | ($0.20) | ($0.28) | ($0.40) |
Weighted average shares outstanding: | ' | ' | ' | ' |
Basic and diluted (in shares) | 75,433,302 | 62,994,771 | 70,997,330 | 62,929,816 |
CONDENSED_STATEMENTS_OF_CASH_F
CONDENSED STATEMENTS OF CASH FLOWS (USD $) | 6 Months Ended | |
In Thousands, unless otherwise specified | Jun. 30, 2014 | Jun. 30, 2013 |
Cash flows from operating activities: | ' | ' |
Net loss | ($19,931) | ($25,384) |
Adjustments to reconcile net loss to net cash used in operating activities: | ' | ' |
Depreciation and amortization | 65 | 262 |
Share-based compensation | 3,951 | 1,496 |
Directors' deferred compensation | 63 | 74 |
Changes in assets and liabilities: | ' | ' |
Prepaid expenses and other assets | -1,062 | -394 |
Accounts payable | 184 | 89 |
Accrued expenses and other liabilities | -1,253 | -1,423 |
Net cash used in operating activities | -17,983 | -25,280 |
Cash flows from investing activities: | ' | ' |
Purchase of property and equipment | -4 | -32 |
Purchase of short-term investments, held to maturity | -9,265 | -1,225 |
Proceeds from maturities of short-term investments, held to maturity | 3,385 | 5,880 |
Net cash (used in) provided by investing activities | -5,884 | 4,623 |
Cash flows from financing activities: | ' | ' |
Net proceeds from the issuance of common stock and warrants | 21,135 | ' |
Tax payments related to shares withheld for vested restricted stock units | -617 | ' |
Payments on capital lease and financed equipment obligations | -2 | -4 |
Proceeds from exercise of employee stock options | ' | 869 |
Net cash provided by financing activities | 20,516 | 865 |
Net decrease in cash and cash equivalents | -3,351 | -19,792 |
Cash and cash equivalents, beginning of period | 14,529 | 48,044 |
Cash and cash equivalents, end of period | $11,178 | $28,252 |
Business_and_Basis_of_Presenta
Business and Basis of Presentation | 6 Months Ended |
Jun. 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 with the potential to be used as a novel hormonal therapy for the treatment of metastatic 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, including chronic sarcopenia (age related muscle loss). The Company announced during the second quarter of 2014 positive preliminary results from a Phase 2 proof-of-concept, open-label clinical trial evaluating enobosarm 9 mg for the treatment of patients with androgen receptor (“AR”) positive and estrogen receptor (“ER”) positive metastatic breast cancer who have previously responded to hormonal therapy. Based on the results of this clinical trial, the Company plans to advance clinical development of enobosarm 9 mg in patients with AR positive metastatic breast cancer, subject to the Company’s ability to obtain additional funding. | |
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. Following these meetings, the Company retained experts in both the U.S. and the EU to work with the Company’s internal team to explore the option of submitting a MAA 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 completed the clinical conduct for all additional Phase 1 clinical studies typically required for submission purposes and is now reviewing the pharmacokinetic and safety data necessary to prepare the related clinical study reports. Further, the Company has submitted a pediatric investigational plan to the EMA, which is necessary for the submission of a MAA. Although the Company has performed these prerequisite activities for the submission of 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, the Company is continuing to evaluate the filing of a MAA to the EMA based on the sufficiency of the supporting data and the commercial prospects of the drug candidate in this more narrow indication. In any event, the Company does not currently expect that it will be able to submit a MAA to the EMA prior to the third quarter of 2015, if at all. | |
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 of enobosarm 3 mg would be subject to the Company’s ability to obtain additional funding. | |
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. | |
In April 2014, the Company announced that Mitchell S. Steiner, its 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 at 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 three months ended June 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. | |
The Company has experienced significant recurring operating losses since its inception and has limited funds. The Company estimates that its current cash, cash equivalents and short-term investments, together with interest thereon, will be sufficient to meet its projected operating requirements into the second quarter of 2015. Accordingly, the Company needs to raise substantial additional capital in the near term in order to fund its operations through and beyond the second quarter of 2015 and to continue as a going concern. | |
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, 2013. Operating results for the three and six months ended June 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 June 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 June 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 June 30, 2014 and December 31, 2013, the Company’s accrual for product returns, was $282 and $918, respectively. Of these amounts, $147 and $332 have been included in “Other long-term liabilities” in the condensed balance sheet at June 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 June 30, 2014 up through the date the condensed financial statements were issued. There were no material recognizable or nonrecognizable subsequent events during the period evaluated. | |
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 $475,291 at June 30, 2014. At June 30, 2014, the Company had cash, cash equivalents and short-term investments of $17,258 compared to $14,729 at December 31, 2013. 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 has 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 the enobosarm 3 mg Phase 3 clinical trials to meet the primary statistical criterion for the co-primary endpoints agreed upon with the FDA has significantly depressed the Company’s stock price and has harmed its future prospects and ability to raise additional capital, and consequently, the Company’s prospects as a going concern have been diminished. The Company estimates that its current cash, cash equivalents and short-term investments, together with interest thereon, will be sufficient to meet its projected operating requirements only into the second quarter of 2015. 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 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 | 6 Months Ended | |||||||||||||
Jun. 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 director 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 Company’s 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 six months ended June 30, 2014 and 2013: | ||||||||||||||
Three Months Ended | Six Months Ended | |||||||||||||
June 30, | June 30, | |||||||||||||
2014 | 2013 | 2014 | 2013 | |||||||||||
Research and development expenses | $ | 950 | $ | 353 | $ | 2,330 | $ | 695 | ||||||
General and administrative expenses | 817 | 361 | 1,684 | 875 | ||||||||||
Total share-based compensation | $ | 1,767 | $ | 714 | $ | 4,014 | $ | 1,570 | ||||||
Share-based compensation expense recorded as general and administrative expense for the three months ended June 30, 2014 and 2013 included share-based compensation expense related to deferred compensation arrangements for the Company’s non-employee directors of $31 and $32, respectively. Share-based compensation expense recorded as general and administrative expense for the six months ended June 30, 2014 and 2013 included share-based compensation expense related to deferred compensation arrangements for the Company’s non-employee directors of $63 and $74, 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 three and six months ended June 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 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 June 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 was estimated using the following assumptions for the periods presented: | ||||||||||||||
Three Months Ended | Six Months Ended | |||||||||||||
June 30, | June 30, | |||||||||||||
2014 | 2013 | 2014 | 2013 | |||||||||||
Expected price volatility | 86.5 | % | 75.7 | % | 86.5 | % | 74.5 | % | ||||||
Risk-free interest rate | 2.3 | % | 1.0 | % | 2.3 | % | 1.1 | % | ||||||
Weighted average expected life in years | 6.9 years | 6.0 years | 6.9 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, 2013 | 6,445,342 | $ | 6.58 | |||||||||||
Options granted | 2,912,500 | 1.37 | ||||||||||||
Options forfeited or expired | (1,134,874 | ) | 9.39 | |||||||||||
Options exercised | — | — | ||||||||||||
Options outstanding at June 30, 2014 | 8,222,968 | 4.35 | ||||||||||||
Basic_and_Diluted_Net_Loss_Per
Basic and Diluted Net Loss Per Share | 6 Months Ended |
Jun. 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 17,695,578 and 6,488,055 for the three months ended June 30, 2014 and 2013, respectively, and 14,267,924 and 6,583,708 for the six months ended June 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. | |
Common_Stock
Common Stock | 6 Months Ended |
Jun. 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 per unit for gross proceeds of $21,272. Pursuant to the terms of a registration rights agreement dated March 6, 2014 that the Company entered into with the investors, the Company agreed to file a registration statement under the Securities Act registering the resale of all 22,155,690 shares held by or issuable to the investors. 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 proceeds of the sale of the private placement were allocated to the common stock and warrants based upon their relative fair values. | |
University_of_Tennessee_Resear
University of Tennessee Research Foundation License Agreement | 6 Months Ended |
Jun. 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. | |
Business_and_Basis_of_Presenta1
Business and Basis of Presentation (Policies) | 6 Months Ended |
Jun. 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 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 and six months ended June 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 June 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 June 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 June 30, 2014 and December 31, 2013, the Company’s accrual for product returns, was $282 and $918, respectively. Of these amounts, $147 and $332 have been included in “Other long-term liabilities” in the condensed balance sheet at June 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 June 30, 2014 up through the date the condensed financial statements were issued. There were no material recognizable or nonrecognizable subsequent events during the period evaluated. | |
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 $475,291 at June 30, 2014. At June 30, 2014, the Company had cash, cash equivalents and short-term investments of $17,258 compared to $14,729 at December 31, 2013. 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 has 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 the enobosarm 3 mg Phase 3 clinical trials to meet the primary statistical criterion for the co-primary endpoints agreed upon with the FDA has significantly depressed the Company’s stock price and has harmed its future prospects and ability to raise additional capital, and consequently, the Company’s prospects as a going concern have been diminished. The Company estimates that its current cash, cash equivalents and short-term investments, together with interest thereon, will be sufficient to meet its projected operating requirements only into the second quarter of 2015. 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 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) | 6 Months Ended | |||||||||||||
Jun. 30, 2014 | ||||||||||||||
Share-Based Compensation | ' | |||||||||||||
Summary of share-based compensation expense | ' | |||||||||||||
Three Months Ended | Six Months Ended | |||||||||||||
June 30, | June 30, | |||||||||||||
2014 | 2013 | 2014 | 2013 | |||||||||||
Research and development expenses | $ | 950 | $ | 353 | $ | 2,330 | $ | 695 | ||||||
General and administrative expenses | 817 | 361 | 1,684 | 875 | ||||||||||
Total share-based compensation | $ | 1,767 | $ | 714 | $ | 4,014 | $ | 1,570 | ||||||
Schedule of assumptions used to estimate fair value of options | ' | |||||||||||||
Three Months Ended | Six Months Ended | |||||||||||||
June 30, | June 30, | |||||||||||||
2014 | 2013 | 2014 | 2013 | |||||||||||
Expected price volatility | 86.5 | % | 75.7 | % | 86.5 | % | 74.5 | % | ||||||
Risk-free interest rate | 2.3 | % | 1.0 | % | 2.3 | % | 1.1 | % | ||||||
Weighted average expected life in years | 6.9 years | 6.0 years | 6.9 years | 6.5 years | ||||||||||
Summary of stock option transactions | ' | |||||||||||||
Number of Shares | Weighted Average | |||||||||||||
Exercise Price Per | ||||||||||||||
Share | ||||||||||||||
Options outstanding at December 31, 2013 | 6,445,342 | $ | 6.58 | |||||||||||
Options granted | 2,912,500 | 1.37 | ||||||||||||
Options forfeited or expired | (1,134,874 | ) | 9.39 | |||||||||||
Options exercised | — | — | ||||||||||||
Options outstanding at June 30, 2014 | 8,222,968 | 4.35 | ||||||||||||
Business_and_Basis_of_Presenta2
Business and Basis of Presentation (Details) (USD $) | Jun. 30, 2014 | Dec. 31, 2013 | Apr. 30, 2014 | Jun. 30, 2014 |
In Thousands, unless otherwise specified | Former Chief Executive Officer [Member] | Former Chief Executive Officer [Member] | ||
Income Taxes | ' | ' | ' | ' |
Net deferred tax assets | $0 | $0 | ' | ' |
FARESTON Revenue Recognition | ' | ' | ' | ' |
Accrual for product returns | 282 | 918 | ' | ' |
Accrual for product returns included in other long term liabilities | 147 | 332 | ' | ' |
Going Concern | ' | ' | ' | ' |
Accumulated deficit | 475,291 | 455,360 | ' | ' |
Cash, cash equivalents and short-term investments | 17,258 | 14,729 | ' | ' |
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 |
ShareBased_Compensation_Detail
Share-Based Compensation (Details) (USD $) | 3 Months Ended | 6 Months Ended | ||
In Thousands, unless otherwise specified | Jun. 30, 2014 | Jun. 30, 2013 | Jun. 30, 2014 | Jun. 30, 2013 |
Share-based compensation expense | ' | ' | ' | ' |
Total share-based compensation | $1,767 | $714 | $4,014 | $1,570 |
Share-based compensation expense related to deferred compensation arrangements for non-employee directors | ' | ' | 63 | 74 |
Research And Development Expense [Member] | ' | ' | ' | ' |
Share-based compensation expense | ' | ' | ' | ' |
Total share-based compensation | 950 | 353 | 2,330 | 695 |
General And Administrative Expense [Member] | ' | ' | ' | ' |
Share-based compensation expense | ' | ' | ' | ' |
Total share-based compensation | 817 | 361 | 1,684 | 875 |
Director [Member] | General And Administrative Expense [Member] | ' | ' | ' | ' |
Share-based compensation expense | ' | ' | ' | ' |
Share-based compensation expense related to deferred compensation arrangements for non-employee directors | 31 | 32 | 63 | 74 |
Former Chief Executive Officer [Member] | ' | ' | ' | ' |
Share-based compensation expense | ' | ' | ' | ' |
One-time, noncash net compensation expense related to the modification of stock options | 215 | ' | ' | ' |
Aggregate incremental fair value associated with the modifications of stock options | 359 | ' | 359 | ' |
Amount of previously recognized share-based compensation expense for unvested options reversed | 144 | ' | 144 | ' |
Former Chief Executive Officer [Member] | General And Administrative Expense [Member] | ' | ' | ' | ' |
Share-based compensation expense | ' | ' | ' | ' |
One-time, noncash net compensation expense related to the modification of stock options | $215 | ' | $215 | ' |
ShareBased_Compensation_Detail1
Share-Based Compensation (Details 2) (Restricted Stock Units RSU [Member], USD $) | 3 Months Ended | |
Jun. 30, 2014 | Dec. 31, 2013 | |
Restricted Stock Units RSU [Member] | ' | ' |
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 |
ShareBased_Compensation_Detail2
Share-Based Compensation (Details 3) (USD $) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2014 | Jun. 30, 2013 | Jun. 30, 2014 | Jun. 30, 2013 | |
Fair value of options granted | ' | ' | ' | ' |
Expected price volatility (as a percent) | 86.50% | 75.70% | 86.50% | 74.50% |
Risk-free interest rate (as a percent) | 2.30% | 1.00% | 2.30% | 1.10% |
Weighted average expected life in years | '6 years 10 months 24 days | '6 years | '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) | ' | ' | 2,912,500 | ' |
Options forfeited or expired (in shares) | ' | ' | -1,134,874 | ' |
Options outstanding at the end of the period (in shares) | 8,222,968 | ' | 8,222,968 | ' |
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) | ' | ' | $1.37 | ' |
Options forfeited or expired (in dollars per share) | ' | ' | $9.39 | ' |
Options outstanding at the end of the period (in dollars per share) | $4.35 | ' | $4.35 | ' |
Basic_and_Diluted_Net_Loss_Per1
Basic and Diluted Net Loss Per Share (Details) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2014 | Jun. 30, 2013 | Jun. 30, 2014 | Jun. 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 | 17,695,578 | 6,488,055 | 14,267,924 | 6,583,708 |
Common_Stock_Details
Common Stock (Details) (Private Placement [Member], USD $) | 0 Months Ended |
In Thousands, except Share data, unless otherwise specified | Mar. 06, 2014 |
Private Placement [Member] | ' |
Common Stock | ' |
Stock issued under private placement (in shares) | 11,976,048 |
Warrants issued to purchase shares under private placement | 10,179,642 |
Gross proceeds from issuance of stock (in dollars) | $21,272 |
Number of shares to be registered by a registration statement under Securities Act | 22,155,690 |
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% |