Document And Entity Information
Document And Entity Information - shares | 6 Months Ended | |
Jun. 30, 2015 | Aug. 03, 2015 | |
Document Information [Line Items] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Jun. 30, 2015 | |
Document Fiscal Year Focus | 2,015 | |
Document Fiscal Period Focus | Q2 | |
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 | 24,281,018 |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Jun. 30, 2015 | Dec. 31, 2014 |
Current Assets | ||
Cash and cash equivalents | $ 32,150 | $ 46,620 |
Prepaid expenses and other current assets | 438 | 289 |
Total current assets | 32,588 | 46,909 |
Fixed assets, net | 14 | 32 |
Total assets | 32,602 | 46,941 |
Current Liabilities | ||
Accounts payable | 2,159 | 2,090 |
Accrued expenses | 699 | 834 |
Total current liabilities | $ 2,858 | $ 2,924 |
Commitments and contingencies (note 6) | ||
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, 24,393,368 and 24,388,523 shares issued, respectively and 24,281,018 and 24,276,173 shares outstanding, respectively | 24 | 24 |
Additional paid-in capital | 320,480 | 318,437 |
Cost of treasury stock, 112,350 shares | (1,380) | (1,380) |
Accumulated deficit | (289,380) | (273,064) |
Total stockholders' equity | 29,744 | 44,017 |
Total liabilities and stockholders' equity | $ 32,602 | $ 46,941 |
CONDENSED CONSOLIDATED BALANCE3
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Jun. 30, 2015 | Dec. 31, 2014 |
Common Stock, par value | $ 0.001 | $ 0.001 |
Common Stock, shares authorized | 75,000,000 | 75,000,000 |
Common Stock, shares issued | 24,393,368 | 24,388,523 |
Common Stock, shares outstanding | 24,281,018 | 24,276,173 |
Treasury stock, shares | 112,350 | 112,350 |
Undesignated Preferred Stock [Member] | ||
Preferred Stock, par value | $ 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 | 6 Months Ended | ||
Jun. 30, 2015 | Jun. 30, 2014 | Jun. 30, 2015 | Jun. 30, 2014 | |
Revenues | ||||
Interest income | $ 1 | $ 2 | $ 2 | $ 5 |
Total revenues and other income | 1 | 2 | 2 | 5 |
Expenses | ||||
Research and development | 6,450 | 7,491 | 13,771 | 15,060 |
General and administrative | 1,342 | 1,256 | 2,547 | 2,482 |
Total expenses | 7,792 | 8,747 | 16,318 | 17,542 |
Net loss | $ (7,791) | $ (8,745) | $ (16,316) | $ (17,537) |
Loss per share - basic and diluted: | $ (0.32) | $ (0.38) | $ (0.67) | $ (0.76) |
Weighted average shares used in loss per share calculation: | ||||
Basic | 24,278 | 23,102 | 24,277 | 23,068 |
Diluted | 24,278 | 23,102 | 24,277 | 23,068 |
CONSOLIDATED STATEMENTS OF STOC
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-in Capital | Treasury Stock | Accumulated Deficit |
Beginning Balance at Dec. 31, 2013 | $ 72,519 | $ 23 | $ 314,405 | $ (1,380) | $ (240,529) |
Beginning Balance (in shares) at Dec. 31, 2013 | 23,125,565 | 112,350 | |||
Stock based compensation | 1,875 | $ 0 | 1,875 | $ 0 | 0 |
Issuance of shares of common stock for the cashless exercise of stock options | 0 | $ 0 | 0 | $ 0 | 0 |
Issuance of shares of common stock for the cashless exercise of stock options (in shares) | 72,910 | 0 | |||
Exercise of stock options to purchase common stock stock for cash ($1.56 to $9.60 per share) | 147 | $ 0 | 147 | $ 0 | 0 |
Exercise of stock options to purchase common stock stock for cash ($1.56 to $9.60 per share) (in shares) | 23,334 | 0 | |||
Net loss | (17,537) | $ 0 | 0 | $ 0 | (17,537) |
Ending Balance at Jun. 30, 2014 | 57,004 | $ 23 | 316,427 | $ (1,380) | (258,066) |
Ending Balance (in shares) at Jun. 30, 2014 | 23,221,809 | 112,350 | |||
Beginning Balance at Dec. 31, 2014 | 44,017 | $ 24 | 318,437 | $ (1,380) | (273,064) |
Beginning Balance (in shares) at Dec. 31, 2014 | 24,388,523 | 112,350 | |||
Stock based compensation | 2,043 | $ 0 | 2,043 | $ 0 | 0 |
Issuance of shares of common stock for the cashless exercise of stock options | 0 | $ 0 | 0 | $ 0 | 0 |
Issuance of shares of common stock for the cashless exercise of stock options (in shares) | 4,845 | 0 | |||
Net loss | (16,316) | $ 0 | 0 | $ 0 | (16,316) |
Ending Balance at Jun. 30, 2015 | $ 29,744 | $ 24 | $ 320,480 | $ (1,380) | $ (289,380) |
Ending Balance (in shares) at Jun. 30, 2015 | 24,393,368 | 112,350 |
CONSOLIDATED STATEMENTS OF STO6
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (Parenthetical) - $ / shares | 6 Months Ended | |
Jun. 30, 2015 | Jun. 30, 2014 | |
Issuance of shares of common stock for the cashless exercise of stock options | 4,845 | 72,910 |
Cashless Exercise Of Stock Options | 15,000 | 98,329 |
Maximum [Member] | ||
Exercise of stock option to purchase common stock for cash, share price | $ 9.60 | |
Minimum [Member] | ||
Exercise of stock option to purchase common stock for cash, share price | $ 1.56 |
CONDENSED CONSOLIDATED STATEME7
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2015 | Jun. 30, 2014 | |
Cash Flows from Operating Activities | ||
Net loss | $ (16,316) | $ (17,537) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 18 | 23 |
Noncash stock-based compensation | 2,043 | 1,875 |
(Increase) decrease in prepaid expenses and other current assets | (251) | (194) |
Increase (decrease) in accounts payable and accrued expenses | (66) | 532 |
Changes in operating assets and liabilities: | ||
Net cash used in operating activities | (14,572) | (15,301) |
Cash Flows from Investing Activities | ||
Capital expenditures | 0 | 0 |
Net cash used in investing activities | 0 | 0 |
Cash Flows from Financing Activities | ||
Exercise of stock options & warrants | 0 | 147 |
Proceeds from a shareholder transaction | 102 | 0 |
Net cash provided by financing activities | 102 | 147 |
Net decrease in cash and cash equivalents | (14,470) | (15,154) |
Cash and cash equivalents at beginning of period | 46,620 | 75,807 |
Cash and cash equivalents at end of period | $ 32,150 | $ 60,653 |
Organization, Operations and Li
Organization, Operations and Liquidity | 6 Months Ended |
Jun. 30, 2015 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
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, formerly known as Androxal®, is a single isomer of clomiphene citrate and is an orally active proprietary small molecule compound. We expect to rename this product candidate in the near future. 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. The Company believes that 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. Subsequently, we announced that the NDA was accepted by the FDA and the FDA assigned a Prescription Drug User Fee Act (“PDUFA”) goal date of November 30, 2015. In addition, we have announced the FDA has scheduled the advisory committee to review the Company’s NDA on November 3, 2015. 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. Product Candidate (Indication) Enclomiphene Status Next Expected Milestone(s) Secondary Hypogonadism NDA accepted and under review PDUFA date of November 30, 2015 Proellex® Uterine Fibroids Phase 2 Complete first course of treatment in a Phase 2B study (oral delivery) (Q2 2016) Complete first course of treatment in a Phase 2B study (vaginal delivery) (Q2 2016) Endometriosis Phase 2 Fully enroll Phase 2 study (oral delivery) (Q1 2016) As of June 30, 2015, we had accumulated losses of $ 289.4 32.2 2.9 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 beginning January 1, 2016 and interim periods thereafter. The guidance is not expected to have a material impact on our consolidated financial statements. In June 2014, the FASB issued Accounting Standards Update 2014-10, “Development Stage Entities (Topic 915): Elimination of Certain Financial Reporting Requirements, Including an Amendment to Variable Interest Entities Guidance in Topic 810, Consolidation.” The guidance eliminates the definition of a development stage entity thereby removing the incremental financial reporting requirements from U.S. Generally Accepted Accounting Principles for development stage entities, primarily presentation of inception to date financial information. The provisions of the amendment is effective for annual reporting periods beginning after December 15, 2015. We elected to adopt ASU 2014-10 early and as an early adopter, we are no longer providing inception-to-date financial information in our consolidated financial statements. 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. The Company is currently assessing the impact of the new standard on our consolidated financial statements. |
Revision of Prior Years' Financ
Revision of Prior Years' Financial Statements | 6 Months Ended |
Jun. 30, 2015 | |
Quantifying Prior Year Misstatements Corrected in Current Year Financial Statements [Abstract] | |
Revision Of Prior Years’ Financial Statements | NOTE 2 Revision of Prior Years’ Financial Statements While preparing its financial statements for the year ended December 31, 2014, the Company identified a prior period error related to the accounting for patent costs. As disclosed in its prior filings, historically the Company had capitalized patent related costs associated with its drug candidates, enclomiphene and Proellex®. However, the Company has now concluded that these costs should have been expensed as research and development costs since the related products were, at the time the costs were incurred, in the development phase and had not been approved by the FDA. The Company concluded this error was not material individually or in the aggregate to any of the prior reporting periods, and therefore, no restatements of previously issued financial statements were necessary. However, if the entire correction had been recorded in the fourth quarter of 2014, the cumulative impact would have been material to the fourth quarter of 2014, and would have impacted the comparability to prior periods. As such, revisions for the prior periods are reflected in the financial statements herein. The quarter ended June 30, 2015 was not affected. At December 31, 2013, accumulated deficit and shareholders’ equity were reported as ($ 237,623 75,425 240,529 72,519 Three months ended June 30, 2014 Six months ended June 30, 2014 As As previously As previously As reported Correction revised reported Correction revised Research and development $ 7,450 $ 41 $ 7,491 $ 14,775 $ 285 $ 15,060 Total expenses 8,706 41 8,747 17,257 285 17,542 Net loss (8,704) (41) (8,745) (17,252) (285) (17,537) Loss per share basic and diluted (0.38) (0.00) (0.38) (0.75) (0.01) (0.76) Six months ended June 30, 2014 As previously reported Correction As revised Net cash used in operating activities $ (14,773) $ (528) $ (15,301) Net cash used in investing activities (528) 528 (0) |
Accrued Expenses
Accrued Expenses | 6 Months Ended |
Jun. 30, 2015 | |
Accrued Expenses [Abstract] | |
Accrued Expenses | NOTE 3 Accrued Expenses June 30, 2015 December 31, 2014 Research and development costs $ 556 $ 284 Personnel related costs 56 458 Other 87 92 Total $ 699 $ 834 |
Loss Per Share
Loss Per Share | 6 Months Ended |
Jun. 30, 2015 | |
Earnings Per Share [Abstract] | |
Loss Per Share | NOTE 4 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 net loss per share is computed by dividing net loss by the weighted average number of shares of common stock and dilutive common stock equivalents outstanding. Given that the Company is in a loss position for each of the periods presented, there is no difference between basic and diluted net loss per share since the effect of common stock equivalents would be anti-dilutive and, therefore, they are excluded from the diluted net loss per share calculation. Three Months Ended June 30, Six Months Ended June 30, 2015 2014 2015 2014 Net loss $ (7,791) $ (8,745) $ (16,316) $ (17,537) Average common shares outstanding 24,278 23,102 24,277 23,068 Basic and diluted loss per share $ (0.32) $ (0.38) $ (0.67) $ (0.76) Potential common stock of 3,237,907 4,086,553 39,595 0.01 429,704 2.49 877,137 0.01 809,805 2.49 |
Stock-Based Compensation
Stock-Based Compensation | 6 Months Ended |
Jun. 30, 2015 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Stock-Based Compensation | NOTE 5 Stock-Based Compensation During the three month period ended June 30, 2015, the Compensation Committee of the Company’s Board of Directors approved grants of options to purchase 30,000 25,000 5,000 399,000 374,000 25,000 56,250 |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2015 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | NOTE 6 Commitments and Contingencies Therapeutic uses of our enclomiphene product candidate are covered in the United States by nine issued U.S. patents and nine pending patent applications. Foreign coverage of therapeutic uses of our enclomiphene product candidate includes 76 issued foreign patents and 100 foreign pending patent applications. The issued patents and pending applications relate to methods for treating certain conditions including the treatment of testosterone deficiency in men, the treatment of diabetes mellitus Type 2, the treatment of metabolic syndrome and conditions associated therewith, and the treatment of infertility in hypogonadal men. Enclomiphene (the trans-isomer of clomiphene) is purified from clomiphene citrate. A third party individual holds two issued patents related to the use of anti-estrogen such as clomiphene citrate and others for use in the treatment of androgen deficiency and disorders related thereto. We requested re-examination of one of these patents by the U.S. Patent and Trademark Office (“PTO”) based on prior art. The patent holder amended the claims in the re-examination proceedings, which led the PTO to determine that the amended claims were patentable in view of those publications under consideration and a re-examination certificate was issued. We subsequently filed a second request for re-examination by the PTO in light of a number of additional publications. The request was granted and all of the claims were finally rejected by the PTO in the re-examination. The patent holder appealed the rejections to the PTO Board of Patent Appeals and Interferences (the “PTO Board”) which ultimately reversed the rejections of several dependent claims in view of those publications under consideration. The patent holder filed a Notice of Appeal to the Federal Circuit on September 28, 2010 contesting the rejections maintained by the PTO Board. A decision was rendered by the Court of Appeals for the Federal Circuit on December 12, 2011, affirming the rejection of the appealed claims. The PTO issued an Ex Parte Reexamination Certificate on April 29, 2013, canceling the rejected claims and confirming the patentability of the remaining claims. Nevertheless, we believe that our development of enclomiphene does not infringe any of the remaining claims and that all of the remaining claims are invalid on various grounds including additional prior art publications. We also believe that the second of these two patents is invalid in view of published prior art not considered by the PTO. If necessary, we intend to vigorously defend any and all claims that may be brought by the holder of such patents in a court of competent jurisdiction in order to develop enclomiphene further. Adverse determinations in litigation proceedings could require us to seek licenses which may not be available on commercially reasonable terms, or at all, or subject us to significant liabilities, in which case we may not be able to successfully commercialize or out-license enclomiphene until such patents expire or are otherwise no longer in force. On July 19, 2013, we received a letter from Dr. Harry Fisch threatening to file a lawsuit against us and two of our executive officers (Joseph S. Podolski, President and Chief Executive Officer and Ron Wiehle, Executive Vice President), seeking addition of Dr. Harry Fisch as an inventor on three of our patents, U.S. Patent Nos. 7,173,064, 7,737,185 and 7,759,360, covering therapeutic uses of enclomiphene. We believe that these allegations are without merit and on August 2, 2013, we commenced a lawsuit against Dr. Fisch in the U.S. District Court for the Southern District of Texas seeking a declaratory judgment that he should not be added as inventor to any of these patents. On October 2, 2013, Dr. Fisch filed counterclaims to our complaint seeking correction of inventorship of the three patents at issue to name Dr. Fisch as a co-inventor of the applications leading to these patents. Dr. Fisch subsequently stipulated that he does not claim to be a co-inventor of U.S. Patent No. 7,173,064. The court granted summary judgment in favor of the Company on separate equitable and legal grounds, and entered judgment on December 23, 2014. Our request for attorney’s fees was denied. On February 9, 2015, Dr. Fisch filed a notice of appeal of the summary judgment rulings to the United States Court of Appeals for the Federal Circuit. Dr. Fisch filed his opening appeal brief on May 20, 2015. Our opposition brief was filed on August 6, 2015. Oral argument on appeal remains to be scheduled. |
Organization, Operations and 14
Organization, Operations and Liquidity (Policies) | 6 Months Ended |
Jun. 30, 2015 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Recent Accounting Pronouncements | Recent Accounting Pronouncements 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 beginning January 1, 2016 and interim periods thereafter. The guidance is not expected to have a material impact on our consolidated financial statements. In June 2014, the FASB issued Accounting Standards Update 2014-10, “Development Stage Entities (Topic 915): Elimination of Certain Financial Reporting Requirements, Including an Amendment to Variable Interest Entities Guidance in Topic 810, Consolidation.” The guidance eliminates the definition of a development stage entity thereby removing the incremental financial reporting requirements from U.S. Generally Accepted Accounting Principles for development stage entities, primarily presentation of inception to date financial information. The provisions of the amendment is effective for annual reporting periods beginning after December 15, 2015. We elected to adopt ASU 2014-10 early and as an early adopter, we are no longer providing inception-to-date financial information in our consolidated financial statements. 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. The Company is currently assessing the impact of the new standard on our consolidated financial statements. |
Organization, Operations and 15
Organization, Operations and Liquidity (Tables) | 6 Months Ended |
Jun. 30, 2015 | |
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 NDA accepted and under review PDUFA date of November 30, 2015 Proellex® Uterine Fibroids Phase 2 Complete first course of treatment in a Phase 2B study (oral delivery) (Q2 2016) Complete first course of treatment in a Phase 2B study (vaginal delivery) (Q2 2016) Endometriosis Phase 2 Fully enroll Phase 2 study (oral delivery) (Q1 2016) |
Revision of Prior Years' Fina16
Revision of Prior Years' Financial Statements (Tables) | 6 Months Ended |
Jun. 30, 2015 | |
Quantifying Prior Year Misstatements Corrected in Current Year Financial Statements [Abstract] | |
Schedule of Error Corrections and Prior Period Adjustments | The effects of the error correction on the consolidated statements of operations for the three and six month periods ended June 30, 2014 are as follows (in thousands): Three months ended June 30, 2014 Six months ended June 30, 2014 As As previously As previously As reported Correction revised reported Correction revised Research and development $ 7,450 $ 41 $ 7,491 $ 14,775 $ 285 $ 15,060 Total expenses 8,706 41 8,747 17,257 285 17,542 Net loss (8,704) (41) (8,745) (17,252) (285) (17,537) Loss per share basic and diluted (0.38) (0.00) (0.38) (0.75) (0.01) (0.76) |
Schedule Of Error Corrections And Prior Period Adjustments Cash flows | The effects of the error correction on the consolidated statements of cash flows for the six month period ended June 30, 2014 are as follows (in thousands): Six months ended June 30, 2014 As previously reported Correction As revised Net cash used in operating activities $ (14,773) $ (528) $ (15,301) Net cash used in investing activities (528) 528 (0) |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 6 Months Ended |
Jun. 30, 2015 | |
Accrued Expenses [Abstract] | |
Accrued Expenses | Accrued expenses consist of the following (in thousands): June 30, 2015 December 31, 2014 Research and development costs $ 556 $ 284 Personnel related costs 56 458 Other 87 92 Total $ 699 $ 834 |
Loss Per Share (Tables)
Loss Per Share (Tables) | 6 Months Ended |
Jun. 30, 2015 | |
Earnings Per Share [Abstract] | |
Calculation of Loss Per Share | The following table presents information necessary to calculate loss per share for the three and six month periods ended June 30, 2015 and 2014 (in thousands, except per share amounts): Three Months Ended June 30, Six Months Ended June 30, 2015 2014 2015 2014 Net loss $ (7,791) $ (8,745) $ (16,316) $ (17,537) Average common shares outstanding 24,278 23,102 24,277 23,068 Basic and diluted loss per share $ (0.32) $ (0.38) $ (0.67) $ (0.76) |
Organization, Operations and 19
Organization, Operations and Liquidity (Product Development Pipeline) (Details) | 6 Months Ended |
Jun. 30, 2015 | |
Enclomiphene [Member] | Secondary Hypogonadism [Member] | |
Product Information [Line Items] | |
Status | NDA accepted and under review |
Next Expected Milestone(s) | PDUFA date of November 30, 2015 |
Proellex [Member] | Uterine Fibroids 1 [Member] | |
Product Information [Line Items] | |
Status | Phase 2 |
Next Expected Milestone(s) | Complete first course of treatment in a Phase 2B study (oral delivery) (Q2 2016) Complete first course of treatment in a Phase 2B study (vaginal delivery) (Q2 2016) |
Proellex [Member] | Endometriosis [Member] | |
Product Information [Line Items] | |
Status | Phase 2 |
Next Expected Milestone(s) | Fully enroll Phase 2 study (oral delivery) (Q1 2016) |
Organization, Operations and 20
Organization, Operations and Liquidity (Additional Information) (Details) - USD ($) $ in Thousands | Jun. 30, 2015 | Dec. 31, 2014 | Jun. 30, 2014 | Dec. 31, 2013 |
Product Information [Line Items] | ||||
Deficit accumulated during the development stage | $ 289,400 | |||
Cash and cash equivalents | 32,150 | $ 46,620 | $ 60,653 | $ 75,807 |
Accounts payable and accrued expenses | $ 2,900 |
Revision of Prior Years' Fina21
Revision of Prior Years' Financial Statements (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2015 | Jun. 30, 2014 | Jun. 30, 2015 | Jun. 30, 2014 | |
Quantifying Misstatement in Current Year Financial Statements [Line Items] | ||||
Research and development | $ 6,450 | $ 7,491 | $ 13,771 | $ 15,060 |
Total expenses | 7,792 | 8,747 | 16,318 | 17,542 |
Net loss | $ (7,791) | $ (8,745) | $ (16,316) | $ (17,537) |
Loss per share - basic and diluted | $ (0.32) | $ (0.38) | $ (0.67) | $ (0.76) |
As Previously Reported [Member] | ||||
Quantifying Misstatement in Current Year Financial Statements [Line Items] | ||||
Research and development | $ 7,450 | $ 14,775 | ||
Total expenses | 8,706 | 17,257 | ||
Net loss | $ (8,704) | $ (17,252) | ||
Loss per share - basic and diluted | $ (0.38) | $ (0.75) | ||
Correction [Member] | ||||
Quantifying Misstatement in Current Year Financial Statements [Line Items] | ||||
Research and development | $ 41 | $ 285 | ||
Total expenses | 41 | 285 | ||
Net loss | $ (41) | $ (285) | ||
Loss per share - basic and diluted | $ 0 | $ (0.01) |
Revision of Prior Years' Fina22
Revision of Prior Years' Financial Statements (Details 1) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2015 | Jun. 30, 2014 | |
Quantifying Misstatement in Current Year Financial Statements [Line Items] | ||
Net cash used in operating activities | $ (14,572) | $ (15,301) |
Net cash used in investing activities | $ 0 | 0 |
As Previously Reported [Member] | ||
Quantifying Misstatement in Current Year Financial Statements [Line Items] | ||
Net cash used in operating activities | (14,773) | |
Net cash used in investing activities | (528) | |
Correction [Member] | ||
Quantifying Misstatement in Current Year Financial Statements [Line Items] | ||
Net cash used in operating activities | (528) | |
Net cash used in investing activities | $ 528 |
Revision of Prior Years' Fina23
Revision of Prior Years' Financial Statements (Additional information) (Details) - USD ($) $ in Thousands | Jun. 30, 2015 | Dec. 31, 2014 | Jun. 30, 2014 | Dec. 31, 2013 |
Quantifying Misstatement in Current Year Financial Statements [Line Items] | ||||
Shareholders’ Equity | $ 29,744 | $ 44,017 | $ 57,004 | $ 72,519 |
Retained Earnings (Accumulated Deficit) | $ (289,380) | $ (273,064) | (240,529) | |
Scenario, Previously Reported [Member] | ||||
Quantifying Misstatement in Current Year Financial Statements [Line Items] | ||||
Shareholders’ Equity | 75,425 | |||
Retained Earnings (Accumulated Deficit) | $ (237,623) |
Accrued Expenses (Details)
Accrued Expenses (Details) - USD ($) $ in Thousands | Jun. 30, 2015 | Dec. 31, 2014 |
Schedule Of Accrued Liabilities [Line Items] | ||
Research and development costs | $ 556 | $ 284 |
Personnel related costs | 56 | 458 |
Other | 87 | 92 |
Total | $ 699 | $ 834 |
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 | 6 Months Ended | ||
Jun. 30, 2015 | Jun. 30, 2014 | Jun. 30, 2015 | Jun. 30, 2014 | |
Net loss | $ (7,791) | $ (8,745) | $ (16,316) | $ (17,537) |
Average common shares outstanding | 24,278 | 23,102 | 24,277 | 23,068 |
Basic and diluted loss per share | $ (0.32) | $ (0.38) | $ (0.67) | $ (0.76) |
Loss Per Share (Additional Info
Loss Per Share (Additional Information) (Details) - $ / shares | Jun. 30, 2015 | Jun. 30, 2014 |
Maximum [Member] | ||
Earnings Per Share Disclosure [Line Items] | ||
Anti-dilutive shares of common stock excluded from computation of earning per share | 3,237,907 | 4,086,553 |
Series A Warrants [Member] | ||
Earnings Per Share Disclosure [Line Items] | ||
Anti-dilutive shares of common stock excluded from computation of earning per share | 39,595 | 877,137 |
Warrants, exercise price per share | $ 0.01 | $ 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 | 809,805 |
Warrants, exercise price per share | $ 2.49 | $ 2.49 |
Stock-Based Compensation (Addit
Stock-Based Compensation (Additional Information) (Details) - Jun. 30, 2015 - 2011 Equity Incentive Plan Member - shares | Total | Total |
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 | 30,000 | 399,000 |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Forfeitures in Period | 56,250 | |
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 | 5,000 | 374,000 |
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Period | 3 years | 3 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 | 25,000 |
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Period | 1 year | 1 year |
Commitments and Contingencies (
Commitments and Contingencies (Additional Information) (Details) | 6 Months Ended |
Jun. 30, 2015 | |
Joseph S. Podolski | |
Commitments and Contingencies [Line Items] | |
Issued Patent Number | 7,173,064 |
Ron Wiehle | |
Commitments and Contingencies [Line Items] | |
Issued Patent Number | 7,737,185 |
Dr. Harry Fisch | |
Commitments and Contingencies [Line Items] | |
Issued Patent Number | 7,759,360 |
Foreign [Member] | |
Commitments and Contingencies [Line Items] | |
Number of patents | 76 |
Number of pending patent applications | 100 |
Third Party [Member] | |
Commitments and Contingencies [Line Items] | |
Number of patents | 2 |