Document And Entity Information
Document And Entity Information - shares | 9 Months Ended | |
Sep. 30, 2016 | Nov. 04, 2016 | |
Document Information [Line Items] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Sep. 30, 2016 | |
Document Fiscal Year Focus | 2,016 | |
Document Fiscal Period Focus | Q3 | |
Entity Registrant Name | REPROS THERAPEUTICS INC. | |
Entity Central Index Key | 897,075 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Accelerated Filer | |
Trading Symbol | RPRX | |
Entity Common Stock, Shares Outstanding | 25,425,178 |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Sep. 30, 2016 | Dec. 31, 2015 |
Current Assets | ||
Cash and cash equivalents | $ 10,505 | $ 21,393 |
Prepaid expenses and other current assets | 158 | 84 |
Total current assets | 10,663 | 21,477 |
Fixed assets, net | 4 | 8 |
Total assets | 10,667 | 21,485 |
Current Liabilities | ||
Accounts payable | 1,815 | 1,969 |
Accrued expenses | 494 | 949 |
Total current liabilities | 2,309 | 2,918 |
Commitments and contingencies (note 5) | ||
Stockholders’ Equity | ||
Undesignated Preferred Stock, $.001 par value, 5,000,000 shares authorized, none issued and outstanding | 0 | 0 |
Common Stock, $.001 par value, 75,000,000 shares authorized, 25,239,134 and 24,430,461 shares issued, respectively and 25,126,784 and 24,318,111 shares outstanding, respectively | 25 | 24 |
Additional paid-in capital | 325,263 | 322,179 |
Cost of treasury stock, 112,350 shares | (1,380) | (1,380) |
Accumulated deficit | (315,550) | (302,256) |
Total stockholders’ equity | 8,358 | 18,567 |
Total liabilities and stockholders’ equity | $ 10,667 | $ 21,485 |
CONDENSED CONSOLIDATED BALANCE3
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Sep. 30, 2016 | Dec. 31, 2015 |
Common Stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common Stock, shares authorized | 75,000,000 | 75,000,000 |
Common Stock, shares issued | 25,239,134 | 24,430,461 |
Common Stock, shares outstanding | 25,126,784 | 24,318,111 |
Treasury stock, shares | 112,350 | 112,350 |
Undesignated Preferred Stock [Member] | ||
Preferred Stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred Stock, shares authorized | 5,000,000 | 5,000,000 |
Preferred Stock, issued | 0 | 0 |
Preferred Stock, outstanding | 0 | 0 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2016 | Sep. 30, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | |
Revenues and Other Income | ||||
Interest income | $ 10 | $ 1 | $ 41 | $ 3 |
Total revenues and other income | 10 | 1 | 41 | 3 |
Expenses | ||||
Research and development | 3,182 | 5,506 | 10,191 | 19,277 |
General and administrative | 997 | 1,100 | 3,144 | 3,647 |
Total expenses | 4,179 | 6,606 | 13,335 | 22,924 |
Net loss | $ (4,169) | $ (6,605) | $ (13,294) | $ (22,921) |
Loss per share - basic and diluted: | $ (0.17) | $ (0.27) | $ (0.55) | $ (0.94) |
Weighted average shares used in loss per share calculation: | ||||
Basic | 24,495 | 24,318 | 24,372 | 24,291 |
Diluted | 24,495 | 24,318 | 24,372 | 24,291 |
CONSOLIDATED STATEMENTS OF STOC
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($) $ in Thousands | Total | Common Stock [Member] | Additional Paid-in Capital [Member] | Treasury Stock [Member] | Accumulated Deficit [Member] |
Balance at Dec. 31, 2014 | $ 44,017 | $ 24 | $ 318,437 | $ (1,380) | $ (273,064) |
Balance (in shares) at Dec. 31, 2014 | 24,388,523 | 112,350 | |||
Stock based compensation | 2,925 | $ 0 | 2,925 | $ 0 | 0 |
Exercise of Series A warrants to purchase common stock for cash @$0.01 per share | 0 | $ 0 | 0 | $ 0 | 0 |
Exercise of Series A warrants to purchase common stock for cash @$0.01 per share (in shares) | 37,093 | 0 | |||
Issuance of 4,845 shares of common stock for the cashless exercise of 15,000 stock options | 0 | $ 0 | 0 | $ 0 | 0 |
Issuance of 4,845 shares of common stock for the cashless exercise of 15,000 stock options (in shares) | 4,845 | 0 | |||
Net loss | (22,921) | $ 0 | 0 | $ 0 | (22,921) |
Balance at Sep. 30, 2015 | 24,021 | $ 24 | 321,362 | $ (1,380) | (295,985) |
Balance (in shares) at Sep. 30, 2015 | 24,430,461 | 112,350 | |||
Balance at Dec. 31, 2015 | 18,567 | $ 24 | 322,179 | $ (1,380) | (302,256) |
Balance (in shares) at Dec. 31, 2015 | 24,430,461 | 112,350 | |||
Stock based compensation | 1,491 | $ 0 | 1,491 | $ 0 | 0 |
Exercise of Series A warrants to purchase common stock for cash @$0.01 per share | 0 | $ 0 | 0 | $ 0 | 0 |
Exercise of Series A warrants to purchase common stock for cash @$0.01 per share (in shares) | 1,333 | 0 | |||
Issuance of 807,340 shares of common stock at a weighted average share price of $2.15, net of offering costs of $145 | 1,594 | $ 1 | 1,593 | $ 0 | 0 |
Issuance of 807,340 shares of common stock at a weighted average share price of $2.15, net of offering costs of $145 (in shares) | 807,340 | 0 | |||
Net loss | (13,294) | $ 0 | 0 | $ 0 | (13,294) |
Balance at Sep. 30, 2016 | $ 8,358 | $ 25 | $ 325,263 | $ (1,380) | $ (315,550) |
Balance (in shares) at Sep. 30, 2016 | 25,239,134 | 112,350 |
CONSOLIDATED STATEMENTS OF STO6
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (Parenthetical) - USD ($) | 9 Months Ended | |
Sep. 30, 2016 | Sep. 30, 2015 | |
Issuance of shares of common stock for the cashless exercise of stock options | 15,000 | |
Common Stock Weighted Average Share price | $ 2.15 | |
Payments of Stock Issuance Costs | $ 145 | |
Series A [Member] | ||
Common Stock Price Per Share | $ 0.01 | $ 0.01 |
CONDENSED CONSOLIDATED STATEME7
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2016 | Sep. 30, 2015 | |
Cash Flows from Operating Activities | ||
Net loss | $ (13,294) | $ (22,921) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 4 | 21 |
Noncash stock-based compensation | 1,491 | 2,925 |
Increase in prepaid expenses and other current assets | (74) | (124) |
Decrease in accounts payable and accrued expenses | (609) | (433) |
Net cash used in operating activities | (12,482) | (20,532) |
Cash Flows from Investing Activities | ||
Net cash used in investing activities | 0 | 0 |
Cash Flows from Financing Activities | ||
Proceeds from issuance of common stock, net of offering costs | 1,594 | 0 |
Proceeds from a shareholder transaction | 0 | 102 |
Net cash provided by financing activities | 1,594 | 102 |
Net decrease in cash and cash equivalents | (10,888) | (20,430) |
Cash and cash equivalents at beginning of period | 21,393 | 46,620 |
Cash and cash equivalents at end of period | $ 10,505 | $ 26,190 |
Organization, Operations and Li
Organization, Operations and Liquidity | 9 Months Ended |
Sep. 30, 2016 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization, Operations and Liquidity | NOTE 1 Organization, Operations and Liquidity Repros Therapeutics Inc. (the “Company,” “RPRX,” “Repros,” or “we,” “us” or “our”) was organized on August 20, 1987. We are a biopharmaceutical company focused on the development of new drugs to treat hormonal and reproductive system disorders. Our enclomiphene product candidate, is a single isomer of clomiphene citrate and is an orally active proprietary small molecule compound. We are developing enclomiphene for the treatment of secondary hypogonadism in overweight men wishing to restore normal testicular function. Men with secondary hypogonadism exhibit low testosterone levels due to under stimulated testes but they are generally fertile. Enclomiphene is designed to treat the underlying mechanism, insufficient stimulation of the testes by the pituitary, which causes secondary hypogonadism. Secondary hypogonadism due to being overweight or obese is the single greatest cause of hypogonadism in general. On February 2, 2015, we announced that we electronically submitted our New Drug Application (“NDA”) to the Food and Drug Administration (“FDA”) for enclomiphene. The FDA accepted the NDA for review on April 1, 2015 and later assigned a Prescription Drug User Fee Act (“PDUFA”) goal date of November 30, 2015. In addition, the Division of Bone, Reproductive and Urologic Products (the “Division”) of the FDA scheduled an advisory committee meeting to review the NDA for November 3, 2015. However, the Division subsequently cancelled the scheduled advisory committee meeting due to questions that arose late in the review regarding the bioanalytical method validation that could affect interpretability of certain pivotal study data. On December 1, 2015, we announced that we had received a Complete Response Letter (“CRL”) from the FDA. A CRL informs companies that an NDA cannot be approved in its present form. In the CRL, the FDA stated that, based on recent scientific developments, the design of the enclomiphene Phase 3 studies is no longer adequate to demonstrate clinical benefit and recommended that Repros conduct an additional Phase 3 study or studies to support approval in the target population. The FDA also noted concerns regarding study entry criteria, titration and bioanalytical method validation in the Phase 3 program. Subsequently, on February 4, 2016, the Company attended a meeting with the FDA reviewers and senior leaders to discuss resolution of issues identified during the NDA review. The meeting covered a broad range of topics surrounding the NDA data as well as emerging agency and expert thinking regarding the treatment of hypogonadism. The Company believes based on the meeting that the FDA is not closed to considering secondary hypogonadism as an indication. Additionally, in January 2016, the Company initiated a Phase 2 double-blind, placebo controlled, proof of concept study, ZA-205, in obese secondary hypogonadal men to assess the impact of enclomiphene on metabolic parameters and quality of life under a diet and exercise regimen. On August 15, 2016, we reported six month interim results from this study. Additionally, on September 12, 2016, we reported that we successfully submitted a European centralized marketing authorization application (“MAA”) for enclomiphene for the treatment of secondary hypogonadism. This MAA was subsequently accepted by the European Medicines Agency (“EMA”) and, as previously reported, has assigned the United Kingdom as the primary rapporteur and France as the co-rapporteur for the application review. We expect to receive questions relating to this application by the end of January 2017. On September 26, 2016, the Company announced that it will participate in a public Advisory Committee Meeting held by the Bone, Reproductive and Urologic Drugs Division of the FDA. The purpose of the meeting will be to discuss appropriate clinical trial design features, including acceptable endpoints for demonstrating clinical benefit, for drugs intended to treat secondary hypogonadism while preserving or improving testicular function, including spermatogenesis. Proellex®, our product candidate for female reproductive health, is a new chemical entity that acts as a selective blocker of the progesterone receptor and is being developed for the treatment of symptoms associated with uterine fibroids and endometriosis. On December 29, 2014, we announced that we have initiated two Phase 2B studies for low dose Proellex® in the treatment of uterine fibroids and are currently conducting a Phase 2 study in the treatment of endometriosis. All three of these Proellex® studies were fully enrolled in January 2016. On April 12, 2016, we announced positive clinical data for the vaginal application of Proellex® in women with severe menstrual bleeding due to uterine fibroids. Additionally, on May 18, 2016, we announced that oral administration of Proellex®, at doses of both 6 and 12 mg, achieved significant reduction in excessive menstrual bleeding, the key symptom of uterine fibroids. On September 7, 2016, we announced positive clinical data for the first course of treatment in premenopausal women with confirmed moderate to severe endometriosis. Product Candidate (Indication) Enclomiphene Status Next Expected Milestone(s) Secondary Hypogonadism MAA accepted October 2016; NDA submitted/Complete Response Letter received Proellex® Uterine Fibroids Phase 2 Complete second course of treatment in a Phase 2B study (oral delivery) (Q4 2016) Complete second course of treatment in a Phase 2B study (vaginal delivery) (Q4 2016) Endometriosis Phase 2 Topline data reported September 2016 On August 9, 2016, we entered into an Equity Distribution Agreement (the “Equity Distribution Agreement”) with Ladenburg Thalmann & Co. Inc. (“Ladenburg”), pursuant to which we may issue and sell from time to time through Ladenburg, as sales agent and/or principal, shares of our common stock having an aggregate offering price of up to $ 10 3 807,340 2.15 1.6 52,000 298,394 2.12 614,000 19,000 As of September 30, 2016, we had accumulated losses of $ 315.6 10.5 2.3 These financial statements are unaudited; however, in the opinion of management, these statements reflect all adjustments necessary for a fair statement of the results for the periods reported. All such adjustments are of a normal recurring nature unless disclosed otherwise. These financial statements, including notes, have been prepared in accordance with the applicable rules of the SEC and do not include all of the information and disclosures required by U.S. GAAP for complete financial statements. These interim financial statements should be read in conjunction with the financial statements and notes thereto included in our 2015 Annual Report on Form 10-K. The results of operations for the third quarter and first nine months of 2016 are not necessarily indicative of the results to be expected for the full year. In March 2016, the FASB issued ASU 2016-09, CompensationStock Compensation (ASC Topic 718): Improvements to Employee Share-Based Payment Accounting. The new standard simplifies the accounting for stock-based compensation, including amendments on how both taxes related to stock-based compensation and cash payments made to taxing authorities are recorded. ASU 2016-09 is effective for annual reporting periods beginning on or after December 15, 2016, and interim periods within those annual periods and early application is permitted, with any adjustments reflected as of the beginning of the fiscal year of adoption. We are currently evaluating the impact of this standard on our consolidated financial statements. In February 2016, FASB issued ASU 2016-02, Leases (ASC Topic 842), which supersedes ASC Topic 840, Leases. The new standard is intended to increase transparency and comparability of organizations by recognizing lease assets and lease liabilities on the balance sheet and disclosing key information about leasing arrangements. The new guidance is effective for financial statements issued for annual reporting periods beginning after December 15, 2018, and early application is permitted. We are currently evaluating the impact of this standard on our consolidated financial statements. In November 2015, the FASB issued ASU No. 2015-17, “Balance Sheet Classification of Deferred Taxes” (“ASU 2015-17”), which requires entities to present deferred tax assets and deferred tax liabilities as noncurrent in a classified balance sheet. The ASU simplifies the current guidance in ASC Topic 740, Income Taxes, which requires entities to separately present deferred tax assets and liabilities as current and noncurrent in a classified balance sheet. ASU 2015-17 is effective for fiscal years beginning after December 15, 2016, and interim periods within those annual periods. Early adoption is permitted for all entities as of the beginning of an interim or annual reporting period. The Company expects that this guidance will have no effect on the Consolidated Financial Statements. In August 2014, the FASB issued Accounting Standards Update No. 2014-15, “Presentation of Financial Statements - Going Concern.” The new standard requires management to evaluate whether there are conditions or events that raise substantial doubt about an entity’s ability to continue as a going concern for both annual and interim reporting periods. This guidance is effective for us for the fiscal year ending December 31, 2016 and annual and interim periods thereafter. We have assessed the guidance and its impact on the Company and made the required disclosures. In May 2014, the FASB issued Accounting Standards Update 2014-09, “Revenue from Contracts with Customers” (“ASU 2014-09”). ASU 2014-09 is a comprehensive new revenue recognition model requiring a company to recognize revenue to depict the transfer of goods or services to a customer at an amount reflecting the consideration it expects to receive in exchange for those goods or services. In adopting ASU 2014-09, companies may use either a full retrospective or a modified retrospective approach. Additionally, this guidance requires improved disclosures regarding the nature, amount, timing and uncertainty of revenue and cash flows arising from contracts with customers. On July 9, 2015, the FASB voted to delay the effective date of this standard by one year. This deferral resulted in ASU 2014-09 being effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2017, with early adoption being permitted for annual periods beginning after December 15, 2016. Entities have the option of using either a full retrospective or a modified retrospective approach to adopt the guidance. The Company is currently assessing the effects this guidance may have on its consolidated financial statements, as well as the method of transition that the Company will use in adopting the new standard. |
Accrued Expenses
Accrued Expenses | 9 Months Ended |
Sep. 30, 2016 | |
Accrued Expenses [Abstract] | |
Accrued Expenses | NOTE 2 Accrued Expenses Accrued expenses consist of the following (in thousands): September 30, 2016 December 31, 2015 Research and development costs $ 354 $ 300 Personnel related costs 57 544 Other 83 105 Total $ 494 $ 949 |
Loss Per Share
Loss Per Share | 9 Months Ended |
Sep. 30, 2016 | |
Earnings Per Share [Abstract] | |
Loss Per Share | NOTE 3 Loss Per Share Basic loss per share is computed by dividing net loss by the weighted average number of shares of common stock outstanding during the period. Diluted loss per share is computed using the average shares outstanding for the period and applying the treasury stock method to potentially dilutive outstanding options. In all applicable periods, all potential common stock equivalents were anti-dilutive and, accordingly, were not included in the computation of diluted loss per share. Three Months Ended September 30, Nine Months Ended September 30, 2016 2015 2016 2015 Net loss $ (4,169) $ (6,605) $ (13,294) $ (22,921) Average common shares outstanding 24,495 24,318 24,372 24,291 Basic and diluted loss per share $ (0.17) $ (0.27) $ (0.55) $ (0.94) Potential common stock of 2,792,357 3,199,147 2,502 0.01 429,704 2.49 February 8, 2016 |
Stock-Based Compensation
Stock-Based Compensation | 9 Months Ended |
Sep. 30, 2016 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Stock-Based Compensation | NOTE 4 Stock-Based Compensation During the nine month period ended September 30, 2016, the Compensation Committee of the Company’s Board of Directors approved grants of options to purchase 290,000 100,000 25,000 165,000 152,500 |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2016 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | NOTE 5 Commitments and Contingencies Therapeutic uses of our enclomiphene product candidate are covered in the United States by nine issued U.S. patents and ten pending patent applications. Foreign coverage of therapeutic uses of our enclomiphene product candidate includes 82 107 2 |
Organization, Operations and 13
Organization, Operations and Liquidity (Policies) | 9 Months Ended |
Sep. 30, 2016 | |
Accounting Policies [Abstract] | |
Basis of Accounting, Policy [Policy Text Block] | Basis of Presentation These financial statements are unaudited; however, in the opinion of management, these statements reflect all adjustments necessary for a fair statement of the results for the periods reported. All such adjustments are of a normal recurring nature unless disclosed otherwise. These financial statements, including notes, have been prepared in accordance with the applicable rules of the SEC and do not include all of the information and disclosures required by U.S. GAAP for complete financial statements. These interim financial statements should be read in conjunction with the financial statements and notes thereto included in our 2015 Annual Report on Form 10-K. The results of operations for the third quarter and first nine months of 2016 are not necessarily indicative of the results to be expected for the full year. |
New Accounting Pronouncements, Policy [Policy Text Block] | Recent Accounting Pronouncements In March 2016, the FASB issued ASU 2016-09, CompensationStock Compensation (ASC Topic 718): Improvements to Employee Share-Based Payment Accounting. The new standard simplifies the accounting for stock-based compensation, including amendments on how both taxes related to stock-based compensation and cash payments made to taxing authorities are recorded. ASU 2016-09 is effective for annual reporting periods beginning on or after December 15, 2016, and interim periods within those annual periods and early application is permitted, with any adjustments reflected as of the beginning of the fiscal year of adoption. We are currently evaluating the impact of this standard on our consolidated financial statements. In February 2016, FASB issued ASU 2016-02, Leases (ASC Topic 842), which supersedes ASC Topic 840, Leases. The new standard is intended to increase transparency and comparability of organizations by recognizing lease assets and lease liabilities on the balance sheet and disclosing key information about leasing arrangements. The new guidance is effective for financial statements issued for annual reporting periods beginning after December 15, 2018, and early application is permitted. We are currently evaluating the impact of this standard on our consolidated financial statements. In November 2015, the FASB issued ASU No. 2015-17, “Balance Sheet Classification of Deferred Taxes” (“ASU 2015-17”), which requires entities to present deferred tax assets and deferred tax liabilities as noncurrent in a classified balance sheet. The ASU simplifies the current guidance in ASC Topic 740, Income Taxes, which requires entities to separately present deferred tax assets and liabilities as current and noncurrent in a classified balance sheet. ASU 2015-17 is effective for fiscal years beginning after December 15, 2016, and interim periods within those annual periods. Early adoption is permitted for all entities as of the beginning of an interim or annual reporting period. The Company expects that this guidance will have no effect on the Consolidated Financial Statements. In August 2014, the FASB issued Accounting Standards Update No. 2014-15, “Presentation of Financial Statements - Going Concern.” The new standard requires management to evaluate whether there are conditions or events that raise substantial doubt about an entity’s ability to continue as a going concern for both annual and interim reporting periods. This guidance is effective for us for the fiscal year ending December 31, 2016 and annual and interim periods thereafter. We have assessed the guidance and its impact on the Company and made the required disclosures. In May 2014, the FASB issued Accounting Standards Update 2014-09, “Revenue from Contracts with Customers” (“ASU 2014-09”). ASU 2014-09 is a comprehensive new revenue recognition model requiring a company to recognize revenue to depict the transfer of goods or services to a customer at an amount reflecting the consideration it expects to receive in exchange for those goods or services. In adopting ASU 2014-09, companies may use either a full retrospective or a modified retrospective approach. Additionally, this guidance requires improved disclosures regarding the nature, amount, timing and uncertainty of revenue and cash flows arising from contracts with customers. On July 9, 2015, the FASB voted to delay the effective date of this standard by one year. This deferral resulted in ASU 2014-09 being effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2017, with early adoption being permitted for annual periods beginning after December 15, 2016. Entities have the option of using either a full retrospective or a modified retrospective approach to adopt the guidance. The Company is currently assessing the effects this guidance may have on its consolidated financial statements, as well as the method of transition that the Company will use in adopting the new standard. |
Organization, Operations and 14
Organization, Operations and Liquidity (Tables) | 9 Months Ended |
Sep. 30, 2016 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Product Development Pipeline | Our product development pipeline, with dates as expected as of the date of this report, is summarized in the table below: Product Candidate (Indication) Enclomiphene Status Next Expected Milestone(s) Secondary Hypogonadism MAA accepted October 2016; NDA submitted/Complete Response Letter received Proellex® Uterine Fibroids Phase 2 Complete second course of treatment in a Phase 2B study (oral delivery) (Q4 2016) Complete second course of treatment in a Phase 2B study (vaginal delivery) (Q4 2016) Endometriosis Phase 2 Topline data reported September 2016 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 9 Months Ended |
Sep. 30, 2016 | |
Accrued Expenses [Abstract] | |
Accrued Expenses | Accrued expenses consist of the following (in thousands): September 30, 2016 December 31, 2015 Research and development costs $ 354 $ 300 Personnel related costs 57 544 Other 83 105 Total $ 494 $ 949 |
Loss Per Share (Tables)
Loss Per Share (Tables) | 9 Months Ended |
Sep. 30, 2016 | |
Earnings Per Share [Abstract] | |
Calculation of Loss Per Share | The following table presents information necessary to calculate loss per share for the three and nine month periods ended September 30, 2016 and 2015 (in thousands, except per share amounts): Three Months Ended September 30, Nine Months Ended September 30, 2016 2015 2016 2015 Net loss $ (4,169) $ (6,605) $ (13,294) $ (22,921) Average common shares outstanding 24,495 24,318 24,372 24,291 Basic and diluted loss per share $ (0.17) $ (0.27) $ (0.55) $ (0.94) |
Organization, Operations and 17
Organization, Operations and Liquidity (Product Development Pipeline) (Details) | 9 Months Ended |
Sep. 30, 2016 | |
Enclomiphene [Member] | Secondary Hypogonadism [Member] | |
Product Information [Line Items] | |
Status | MAA accepted October 2016; NDA submitted/Complete Response Letter received |
Proellex [Member] | Uterine Fibroids [Member] | |
Product Information [Line Items] | |
Status | Phase 2 |
Next Expected Milestone(s) | Complete second course of treatment in a Phase 2B study (oral delivery) (Q4 2016) Complete second course of treatment in a Phase 2B study (vaginal delivery) (Q4 2016) |
Proellex [Member] | Endometriosis [Member] | |
Product Information [Line Items] | |
Status | Phase 2 |
Next Expected Milestone(s) | Topline data reported September 2016 |
Organization, Operations and 18
Organization, Operations and Liquidity (Additional Information) (Details) - USD ($) | Aug. 09, 2016 | Nov. 08, 2016 | Sep. 30, 2016 | Sep. 30, 2016 | Sep. 30, 2015 | Dec. 31, 2015 | Dec. 31, 2014 |
Product Information [Line Items] | |||||||
Deficit accumulated during the development stage | $ 315,600,000 | $ 315,600,000 | |||||
Cash and cash equivalents | 10,505,000 | 10,505,000 | $ 26,190,000 | $ 21,393,000 | $ 46,620,000 | ||
Accounts payable and accrued expenses | 2,300,000 | 2,300,000 | |||||
Proceeds From Issuance Of Common Stock | 1,594,000 | $ 0 | |||||
Ladenburg Thalmann Co. Inc [Member] | |||||||
Product Information [Line Items] | |||||||
Commission Revenue,Percentage | 3.00% | ||||||
Stock Issunance Cost | $ 52,000 | $ 52,000 | |||||
Proceeds from Issuance Initial Public Offering | $ 10,000,000 | ||||||
Stock Issued During Period, Shares, New Issues | 807,340 | ||||||
Shares Issued, Price Per Share | $ 2.15 | $ 2.15 | |||||
Proceeds From Issuance Of Common Stock | $ 1,600,000 | ||||||
Ladenburg Thalmann Co. Inc [Member] | Subsequent Event [Member] | |||||||
Product Information [Line Items] | |||||||
Stock Issunance Cost | $ 19,000 | ||||||
Stock Issued During Period, Shares, New Issues | 298,394 | ||||||
Shares Issued, Price Per Share | $ 2.12 | ||||||
Proceeds From Issuance Of Common Stock | $ 614,000 |
Accrued Expenses (Details)
Accrued Expenses (Details) - USD ($) $ in Thousands | Sep. 30, 2016 | Dec. 31, 2015 |
Schedule Of Accrued Liabilities [Line Items] | ||
Research and development costs | $ 354 | $ 300 |
Personnel related costs | 57 | 544 |
Other | 83 | 105 |
Total | $ 494 | $ 949 |
Loss Per Share (Calculation of
Loss Per Share (Calculation of Loss Per Share) (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2016 | Sep. 30, 2015 | Sep. 30, 2016 | Sep. 30, 2015 | |
Net loss | $ (4,169) | $ (6,605) | $ (13,294) | $ (22,921) |
Average common shares outstanding (in shares) | 24,495 | 24,318 | 24,372 | 24,291 |
Basic and diluted loss per share (in dollars per share) | $ (0.17) | $ (0.27) | $ (0.55) | $ (0.94) |
Loss Per Share (Additional Info
Loss Per Share (Additional Information) (Details) - $ / shares | 9 Months Ended | |
Sep. 30, 2016 | Sep. 30, 2015 | |
Earnings Per Share Disclosure [Line Items] | ||
Class of Stock Warrants or Right, Warrants Expiration Date | Feb. 8, 2016 | |
Maximum [Member] | ||
Earnings Per Share Disclosure [Line Items] | ||
Anti-dilutive shares of common stock excluded from computation of earning per share | 2,792,357 | 3,199,147 |
Series A Warrants [Member] | ||
Earnings Per Share Disclosure [Line Items] | ||
Anti-dilutive shares of common stock excluded from computation of earning per share | 2,502 | |
Warrants, exercise price per share | $ 0.01 | |
Series B Warrants [Member] | ||
Earnings Per Share Disclosure [Line Items] | ||
Anti-dilutive shares of common stock excluded from computation of earning per share | 429,704 | |
Warrants, exercise price per share | $ 2.49 |
Stock-Based Compensation (Addit
Stock-Based Compensation (Additional Information) (Details) | 9 Months Ended |
Sep. 30, 2016shares | |
Vested Options One [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested, Number of Shares | 100,000 |
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Period | 2 years |
Vested Options Two [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested, Number of Shares | 25,000 |
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Period | 1 year |
Vested Options Three [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested, Number of Shares | 165,000 |
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Period | 3 years |
2011 Equity Incentive Plan [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross | 290,000 |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Forfeitures in Period | 152,500 |
Commitments and Contingencies (
Commitments and Contingencies (Additional Information) (Details) | 9 Months Ended |
Sep. 30, 2016 | |
Foreign [Member] | |
Commitments and Contingencies [Line Items] | |
Number of patents | 82 |
Number of pending patent applications | 107 |
Third Party [Member] | |
Commitments and Contingencies [Line Items] | |
Number of patents | 2 |