Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2018 | Nov. 05, 2018 | |
Document and Entity Information | ||
Entity Registrant Name | GTX INC /DE/ | |
Entity Central Index Key | 1,260,990 | |
Document Type | 10-Q | |
Document Period End Date | Sep. 30, 2018 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Entity Current Reporting Status | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Common Stock, Shares Outstanding | 24,051,844 | |
Document Fiscal Year Focus | 2,018 | |
Document Fiscal Period Focus | Q3 |
CONDENSED BALANCE SHEETS
CONDENSED BALANCE SHEETS - USD ($) $ in Thousands | Sep. 30, 2018 | Dec. 31, 2017 |
Current assets: | ||
Cash and cash equivalents | $ 23,089 | $ 15,816 |
Short-term investments | 14,984 | 28,083 |
Prepaid expenses and other current assets | 2,071 | 2,178 |
Total current assets | 40,144 | 46,077 |
Property and equipment, net | 28 | 51 |
Intangible assets, net | 97 | 108 |
Total assets | 40,269 | 46,236 |
Current liabilities: | ||
Accounts payable | 3,121 | 2,604 |
Accrued expenses and other current liabilities | 6,184 | 5,371 |
Total current liabilities | 9,305 | 7,975 |
Commitments and contingencies | ||
Stockholders' equity: | ||
Common stock, $0.001 par value: 60,000,000 shares authorized at September 30, 2018 and December 31, 2017; 24,051,844 and 21,541,909 shares issued and outstanding at September 30, 2018 and December 31, 2017, respectively | 24 | 22 |
Additional paid-in capital | 625,580 | 599,876 |
Accumulated deficit | (594,640) | (561,637) |
Total stockholders' equity | 30,964 | 38,261 |
Total liabilities and stockholders' equity | $ 40,269 | $ 46,236 |
CONDENSED BALANCE SHEETS (Paren
CONDENSED BALANCE SHEETS (Parenthetical) - $ / shares | Sep. 30, 2018 | Dec. 31, 2017 |
CONDENSED BALANCE SHEETS | ||
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 60,000,000 | 60,000,000 |
Common stock, shares issued | 24,051,844 | 21,541,909 |
Common stock, shares outstanding | 24,051,844 | 21,541,909 |
CONDENSED STATEMENTS OF OPERATI
CONDENSED STATEMENTS OF OPERATIONS - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
Expenses: | ||||
Research and development expenses | $ 7,467 | $ 5,914 | $ 26,429 | $ 14,555 |
General and administrative expenses | 2,160 | 2,617 | 7,044 | 6,701 |
Total expenses | 9,627 | 8,531 | 33,473 | 21,256 |
Loss from operations | (9,627) | (8,531) | (33,473) | (21,256) |
Other income, net | 196 | 27 | 470 | 94 |
Net loss | $ (9,431) | $ (8,504) | $ (33,003) | $ (21,162) |
Net loss per share -- basic and diluted (in dollars per share) | $ (0.39) | $ (0.53) | $ (1.43) | $ (1.32) |
Weighted average shares outstanding: | ||||
Basic and diluted (in shares) | 24,045,992 | 16,115,835 | 23,108,442 | 16,059,383 |
CONDENSED STATEMENTS OF CASH FL
CONDENSED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2018 | Sep. 30, 2017 | |
Cash flows from operating activities: | ||
Net loss | $ (33,003) | $ (21,162) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 34 | 35 |
Share-based compensation | 1,677 | 2,225 |
Directors' deferred compensation | 124 | 124 |
Changes in assets and liabilities: | ||
Prepaid expenses and other assets | 107 | 380 |
Accounts payable | 517 | 1,231 |
Accrued expenses and other liabilities | 813 | 3,437 |
Net cash used in operating activities | (29,731) | (13,730) |
Cash flows from investing activities: | ||
Purchase of short-term investments, held to maturity | (44,155) | (11,400) |
Proceeds from maturities of short-term investments, held to maturity | 57,254 | 24,159 |
Net cash provided by investing activities | 13,099 | 12,759 |
Cash flows from financing activities: | ||
Net proceeds from the issuance of common stock | 24,474 | 45,648 |
Tax payments related to shares withheld for vested restricted stock units | (672) | (156) |
Proceeds from exercise of employee stock options | 103 | |
Net cash provided by financing activities | 23,905 | 45,492 |
Net increase in cash and cash equivalents | 7,273 | 44,521 |
Cash and cash equivalents, beginning of period | 15,816 | 8,910 |
Cash and cash equivalents, end of period | $ 23,089 | $ 53,431 |
Business and Basis of Presentat
Business and Basis of Presentation | 9 Months Ended |
Sep. 30, 2018 | |
Business and Basis of Presentation | |
Business and Basis of Presentation | 1. Business and Basis of Presentation 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 medicines to treat serious and/or significant unmet medical conditions. In 2015, the Company entered into an exclusive license agreement with the University of Tennessee Research Foundation (“UTRF”) to develop UTRF’s proprietary selective androgen receptor degrader (“SARD”) technology which may have the potential to provide compounds that can degrade multiple forms of androgen receptor to treat those patients who do not respond or are resistant to current therapies by inhibiting tumor growth in patients with progressive castration-resistant prostate cancer (“CRPC”). The Company plans to complete ongoing mechanistic preclinical studies by the end of 2018 or early in the first quarter of 2019, select the most appropriate SARD compounds to move forward with those additional preclinical studies required to file an investigational new drug application (“IND”) in 2019, and potentially advance one of its SARD compounds into a first-in-human clinical trial in 2020. While the Company believes that its existing capital resources will be adequate to enable it to conduct and complete planned IND-enabling preclinical studies of SARD compounds during 2019, it will require significant additional financial resources in order to initiate and complete initial human clinical trials and to otherwise further the development of its SARD program. Accordingly, the Company is actively seeking additional funds through potential collaborative, partnering or other strategic arrangements to provide it with the necessary resources for the development of its SARD program. The Company has also been developing selective androgen receptor modulators (“SARMs”), including, enobosarm (GTx-024). Most recently, enobosarm was evaluated in post-menopausal women with SUI compared to placebo. During the third quarter of 2018, the Company announced that the Phase 2 double-blind, placebo-controlled clinical trial of orally-administered enobosarm (3 mg or 1 mg) in post-menopausal women with SUI, did not achieve statistical significance on the primary endpoint for the trial. Enobosarm was generally safe and well tolerated, and reported adverse events were minimal and similar across all treatment groups. The Company is conducting a comprehensive review of all the clinical trial data and is consulting with key experts to fully understand the trial outcomes to determine if there is a rationale for continued SARM development. Even if the Company determines that there is a rationale for continued SARM development, it does not expect to conduct any further development of enobosarm and its other SARMs absent it raising additional funds to do so, whether through potential collaborative, partnering or other strategic arrangements or otherwise. If the Company is unable to determine such a rationale or to raise additional funds for the continued development of enobosarm and its other SARMs, it may determine to discontinue the development of enobosarm and its SARM program altogether, in which case the Company will not receive any return on its investment in enobosarm and its other SARMs. The Company also evaluated enobosarm as a hormonal therapy for women with estrogen receptor positive and androgen receptor positive breast cancer in a Phase 2 clinical trial. The trial met the primary efficacy endpoint in the trial; however, approximately one year ago, the Company determined that treatment paradigms had shifted to immunotherapies and/or combination therapies, and that it was no longer feasible for the Company to conduct further development of enobosarm in breast cancer. 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 filed with the Securities and Exchange Commission on March 13, 2018. Operating results for the three and nine months ended September 30, 2018 are not necessarily indicative of the results that may be expected for the entire fiscal year ending December 31, 2018. 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. Fair Value of Financial Instruments The carrying amounts of the Company’s financial instruments (which include cash, cash equivalents, short-term investments, and accounts payable) approximate their fair values. The Company’s financial assets and liabilities are classified within a three-level fair value hierarchy that prioritizes the inputs used to measure fair value, which is defined as follows: Level 1 — Quoted prices in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date Level 2 — Inputs other than quoted prices in active markets that are observable for the asset or liability, either directly or indirectly Level 3 — Inputs that are unobservable for the asset or liability As the Company has the positive intent and ability to hold its certificates of deposit classified as short-term investments 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. 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, 2018 and December 31, 2017, 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. 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, 2018 and December 31, 2017, net of the valuation allowance, the net deferred tax assets were reduced to zero. Income taxes are described more fully in Note 8 to the Company’s financial statements included in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 13, 2018. Other Income, net Other income, net consists of foreign currency transaction gains and losses, interest earned on the Company’s cash, cash equivalents and short-term investments, and other non-operating income or expense. Recent Accounting Pronouncements In February 2016, the Financial Accounting Standards Board issued Accounting Standard Update (“ASU”) 2016-02, Leases (Topic 842). This ASU requires that lessees recognize assets and liabilities on the balance sheet for the present value of the rights and obligations created by all leases with terms of more than 12 months. The ASU also will require disclosures designed to give financial statement users information on the amount, timing, and uncertainty of cash flows arising from leases. This new guidance will be effective for the Company as of January 1, 2019. The Company does not expect the adoption of the standard update to have a significant impact on its financial position or results of operations. Subsequent Events The Company has evaluated all events or transactions that occurred after September 30, 2018 up through the date the condensed financial statements were issued. There were no material recognizable or nonrecognizable subsequent events during the period evaluated. |
Share-Based Compensation
Share-Based Compensation | 9 Months Ended |
Sep. 30, 2018 | |
Share-Based Compensation | |
Share-Based Compensation | 2. Share-Based Compensation Share-based payments include stock option grants and 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 filed with the Securities and Exchange Commission on March 13, 2018. The following table summarizes share-based compensation expense included within the condensed statements of operations for the three and nine months ended September 30, 2018 and 2017: Three Months Ended Nine Months Ended 2018 2017 2018 2017 Research and development expenses $ $ $ $ General and administrative expenses Total share-based compensation $ $ $ $ Share-based compensation expense recorded as general and administrative expense for both the three months ended September 30, 2018 and 2017 included share-based compensation expense related to deferred compensation arrangements for the Company’s non-employee directors of $41. Share-based compensation expense recorded as general and administrative expense for both the nine months ended September 30, 2018 and 2017 included share-based compensation expense related to deferred compensation arrangements for the Company’s non-employee directors of $124. The Company uses the 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 fair value of options granted was estimated using the following assumptions: Nine Months Ended 2018 2017 Expected price volatility Risk-free interest rate Weighted average expected life in years 7 years 6.9 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 Options outstanding at December 31, 2017 $ Options granted Options exercised ) Options forfeited or expired ) Options outstanding at September 30, 2018 The Company estimates the fair value of RSUs using the closing price of its stock on the grant date. The fair value of RSUs is amortized on a straight-line basis over the requisite service period of the awards. The following is a summary of the RSU transactions for all of the Company’s equity incentive plans since the Company’s most recent fiscal year end: Number of Shares Nonvested RSUs at December 31, 2017 RSUs granted — RSUs vested ) RSUs forfeited — Nonvested RSUs at September 30, 2018 — |
Basic and Diluted Net Loss Per
Basic and Diluted Net Loss Per Share | 9 Months Ended |
Sep. 30, 2018 | |
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 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, unvested RSUs and common stock warrants. Weighted average potential shares of common stock of 10,971,031 and 8,741,251 for the three months ended September 30, 2018 and 2017, respectively, and 11,265,025 and 8,574,822 for the nine months ended September 30, 2018 and 2017, respectively, were excluded from the calculations of diluted net loss per share as inclusion of the potential shares would have had an anti-dilutive effect on the net loss per share for the periods. |
Stockholders' Equity
Stockholders' Equity | 9 Months Ended |
Sep. 30, 2018 | |
Stockholders' Equity | |
Stockholders' Equity | 4. Stockholders’ Equity On February 9, 2018, the Company entered into an At-the-Market Equity Offering Sales Agreement (the “ATM Sales Agreement”) with Stifel, Nicolaus & Company, Incorporated, as sales agent (“Stifel”), pursuant to which the Company may offer and sell, from time to time, through Stifel, shares of the Company’s common stock, having an aggregate offering price of up to $50,000. On May 16, 2018, the Company sold 1,501,501 shares of common stock under the ATM Sales Agreement for net proceeds of $24,474. As of September 30, 2018, the Company had approximately $25,000 of common stock remaining available to be sold under the ATM Sales Agreement. On September 29, 2017, the Company completed a private placement of units consisting of an aggregate of 5,483,320 shares of common stock and warrants to purchase an aggregate of 3,289,988 shares of its common stock for net proceeds of $45,648, after deducting placement agent fees and other offering expenses. The purchasers in the private placement consisted solely of accredited investors that included certain institutional and existing stockholders, including a member of the Company’s board of directors. The warrants, which have five year terms expiring on September 29, 2022, are immediately exercisable and have a per share exercise price of $9.02. 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 $21,069 using the Black-Scholes Model with the following assumptions: expected volatility of 97%, risk free interest rate of 1.92%, expected life of five years and no dividends. The net proceeds from the private placement were allocated to the common stock and warrants based upon their relative fair values. On November 14, 2014, the Company completed a private placement of units consisting of an aggregate of 6,431,111 shares of common stock and warrants to purchase an aggregate of 6,430,948 shares of its common stock for net proceeds of $42,814, after deducting offering expenses. The net proceeds from the private placement were allocated to the common stock and warrants based upon the fair value method. Similarly, the offering expenses were allocated between the common stock and warrants with the portion allocated to common stock offset against the proceeds allocated to stockholders’ equity, whereas the portion allocated to the warrants was expensed immediately. The warrants have a per share exercise price of $8.50, became exercisable on May 6, 2015 and will continue to be exercisable for four years thereafter. In March 2018, certain holders of warrants issued in November 2014 exercised warrants covering 1,111,082 shares of common stock in a cashless exercise for which the Company issued an aggregate of 674,579 shares of common stock upon exercise. |
University of Tennessee Researc
University of Tennessee Research Foundation License Agreements | 9 Months Ended |
Sep. 30, 2018 | |
University of Tennessee Research Foundation License Agreements | |
University of Tennessee Research Foundation License Agreements | 5. University of Tennessee Research Foundation License Agreements 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. The Company and UTRF also entered into a license agreement (the “SARD License Agreement”) in March 2015 pursuant to which the Company was granted exclusive worldwide rights in all existing SARD technologies owned or controlled by UTRF, including all improvements thereto. Under the SARD License Agreement, the Company is obligated to employ active, diligent efforts to conduct preclinical research and development activities for the SARD program to advance one or more lead compounds into clinical development. The Company is also obligated to pay UTRF annual license maintenance fees, low single-digit royalties on net sales of products and additional royalties on sublicense revenues, depending on the state of development of a clinical product candidate at the time it is sublicensed. |
Business and Basis of Present_2
Business and Basis of Presentation (Policies) | 9 Months Ended |
Sep. 30, 2018 | |
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 filed with the Securities and Exchange Commission on March 13, 2018. Operating results for the three and nine months ended September 30, 2018 are not necessarily indicative of the results that may be expected for the entire fiscal year ending December 31, 2018. |
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. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments The carrying amounts of the Company’s financial instruments (which include cash, cash equivalents, short-term investments, and accounts payable) approximate their fair values. The Company’s financial assets and liabilities are classified within a three-level fair value hierarchy that prioritizes the inputs used to measure fair value, which is defined as follows: Level 1 — Quoted prices in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date Level 2 — Inputs other than quoted prices in active markets that are observable for the asset or liability, either directly or indirectly Level 3 — Inputs that are unobservable for the asset or liability As the Company has the positive intent and ability to hold its certificates of deposit classified as short-term investments 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. |
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, 2018 and December 31, 2017, 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. |
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, 2018 and December 31, 2017, net of the valuation allowance, the net deferred tax assets were reduced to zero. Income taxes are described more fully in Note 8 to the Company’s financial statements included in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 13, 2018. |
Other Income, net | Other Income, net Other income, net consists of foreign currency transaction gains and losses, interest earned on the Company’s cash, cash equivalents and short-term investments, and other non-operating income or expense. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In February 2016, the Financial Accounting Standards Board issued Accounting Standard Update (“ASU”) 2016-02, Leases (Topic 842). This ASU requires that lessees recognize assets and liabilities on the balance sheet for the present value of the rights and obligations created by all leases with terms of more than 12 months. The ASU also will require disclosures designed to give financial statement users information on the amount, timing, and uncertainty of cash flows arising from leases. This new guidance will be effective for the Company as of January 1, 2019. The Company does not expect the adoption of the standard update to have a significant impact on its financial position or results of operations. |
Subsequent Events | Subsequent Events The Company has evaluated all events or transactions that occurred after September 30, 2018 up through the date the condensed financial statements were issued. There were no material recognizable or nonrecognizable subsequent events during the period evaluated. |
Share-Based Compensation (Table
Share-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
Share-Based Compensation | |
Summary of share-based compensation expense | Three Months Ended Nine Months Ended 2018 2017 2018 2017 Research and development expenses $ $ $ $ General and administrative expenses Total share-based compensation $ $ $ $ |
Schedule of assumptions used to estimate fair value of options granted | Nine Months Ended 2018 2017 Expected price volatility Risk-free interest rate Weighted average expected life in years 7 years 6.9 years |
Summary of stock option transactions | Number of Shares Weighted Average Options outstanding at December 31, 2017 $ Options granted Options exercised ) Options forfeited or expired ) Options outstanding at September 30, 2018 |
Summary of RSU transactions | Number of Shares Nonvested RSUs at December 31, 2017 RSUs granted — RSUs vested ) RSUs forfeited — Nonvested RSUs at September 30, 2018 — |
Business and Basis of Present_3
Business and Basis of Presentation (Details) - USD ($) $ in Thousands | Sep. 30, 2018 | Dec. 31, 2017 |
Income Taxes | ||
Net deferred tax assets | $ 0 | $ 0 |
Share-Based Compensation - Shar
Share-Based Compensation - Share-Based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
Share-based compensation expense | ||||
Total share-based compensation | $ 482 | $ 944 | $ 1,801 | $ 2,349 |
Share-based compensation expense related to deferred compensation arrangements for non-employee directors | 124 | 124 | ||
Research and development expenses | ||||
Share-based compensation expense | ||||
Total share-based compensation | 92 | 368 | 627 | 782 |
General and administrative expenses | ||||
Share-based compensation expense | ||||
Total share-based compensation | 390 | 576 | 1,174 | 1,567 |
Director | General and administrative expenses | ||||
Share-based compensation expense | ||||
Share-based compensation expense related to deferred compensation arrangements for non-employee directors | $ 41 | $ 41 | $ 124 | $ 124 |
Share-Based Compensation - Stoc
Share-Based Compensation - Stock Option Activity (Details) - $ / shares | 9 Months Ended | |
Sep. 30, 2018 | Sep. 30, 2017 | |
Stock-based compensation options granted | ||
Expected price volatility (as a percent) | 93.10% | 88.50% |
Risk-free interest rate (as a percent) | 2.40% | 2.20% |
Weighted average expected life in years | 7 years | 6 years 10 months 24 days |
Number of Shares | ||
Options outstanding at the beginning of the period (in shares) | 1,900,496 | |
Options granted (in shares) | 472,000 | |
Options exercised (in shares) | (6,000) | |
Options forfeited or expired (in shares) | (3,299) | |
Options outstanding at the end of the period (in shares) | 2,363,197 | |
Weighted Average Exercise Price Per Share | ||
Options outstanding at the beginning of the period (in dollars per share) | $ 13.84 | |
Options granted (in dollars per share) | 13.32 | |
Options exercised (in dollars per share) | 17.23 | |
Options forfeited or expired (in dollars per share) | 171.83 | |
Options outstanding at the end of the period (in dollars per share) | $ 13.51 |
Share-Based Compensation - RSU
Share-Based Compensation - RSU Activity - (Details) - Restricted Stock Units (RSUs) | 9 Months Ended |
Sep. 30, 2018shares | |
Number of Shares | |
Nonvested RSUs at the beginning of the period (in shares) | 380,500 |
RSUs vested (in shares) | (380,500) |
Basic and Diluted Net Loss Pe_2
Basic and Diluted Net Loss Per Share (Details) - shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
Basic and Diluted Net Loss Per Share | ||||
Weighted average potential shares of common stock excluded from calculation of diluted net income (loss) per share | 10,971,031 | 8,741,251 | 11,265,025 | 8,574,822 |
Stockholders' Equity (Details)
Stockholders' Equity (Details) - USD ($) $ / shares in Units, $ in Thousands | May 16, 2018 | Sep. 29, 2017 | May 06, 2015 | Nov. 14, 2014 | Mar. 31, 2018 | Sep. 30, 2018 | Sep. 30, 2017 | Feb. 09, 2018 |
Common Stock | ||||||||
Net proceeds from the issuance of common stock | $ 24,474 | $ 45,648 | ||||||
At-The-Market Equity Offering | ||||||||
Common Stock | ||||||||
Common stock value that may be sold under the At-the-Market Equity Offering Sales Agreement | $ 50,000 | |||||||
Common stock sold under the ATM Sales Agreement | 1,501,501 | |||||||
Net proceeds from the issuance of common stock | $ 24,474 | |||||||
Remaining common stock value that is available and may be sold under the At-the-Market Equity Offering Sales Agreement | $ 25,000 | |||||||
Private Placement, September 2017 | ||||||||
Common Stock | ||||||||
Shares issued under private placement | 5,483,320 | |||||||
Warrants issued to purchase shares under private placement | 3,289,988 | |||||||
Net proceeds from private placement after deducting offering expenses | $ 45,648 | |||||||
Exercise price (in dollars per share) | $ 9.02 | |||||||
Warrant term | 5 years | |||||||
Estimated fair value of warrants | $ 21,069 | |||||||
Expected volatility of warrants (as a percent) | 97.00% | |||||||
Risk-free interest rate of warrants (as a percent) | 1.92% | |||||||
Expected life of warrants | 5 years | |||||||
Expected dividends on warrants (in dollars per share) | $ 0 | |||||||
Private Placement, November 2014 | ||||||||
Common Stock | ||||||||
Shares issued under private placement | 6,431,111 | |||||||
Warrants issued to purchase shares under private placement | 6,430,948 | |||||||
Net proceeds from private placement after deducting offering expenses | $ 42,814 | |||||||
Exercise price (in dollars per share) | $ 8.50 | |||||||
Warrant term | 4 years | |||||||
Common stock issued upon exercise of warrants | 674,579 | |||||||
Warrants exercised | 1,111,082 |