Document And Entity Information
Document And Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2015 | Feb. 26, 2016 | Jun. 30, 2015 | |
Document Information [Line Items] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2015 | ||
Document Fiscal Year Focus | 2,015 | ||
Document Fiscal Period Focus | FY | ||
Entity Registrant Name | REPROS THERAPEUTICS INC. | ||
Entity Central Index Key | 897,075 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Filer Category | Accelerated Filer | ||
Entity Public Float | $ 146,809,556 | ||
Trading Symbol | RPRX | ||
Entity Common Stock, Shares Outstanding | 24,318,111 |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 |
Current Assets | ||
Cash and cash equivalents | $ 21,393 | $ 46,620 |
Prepaid expenses and other current assets | 84 | 289 |
Total current assets | 21,477 | 46,909 |
Fixed Assets, net | 8 | 32 |
Total assets | 21,485 | 46,941 |
Current Liabilities | ||
Accounts payable | 1,969 | 2,090 |
Accrued expenses | 949 | 834 |
Total current liabilities | $ 2,918 | $ 2,924 |
Commitments and Contingencies (note 10) | ||
Stockholders' Equity | ||
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, 24,430,461 and 24,388,523 shares issued, respectively; 24,318,111 and 24,276,173 shares outstanding, respectively | 24 | 24 |
Additional paid-in capital | 322,179 | 318,437 |
Cost of treasury stock, 112,350 shares | (1,380) | (1,380) |
Accumulated deficit | (302,256) | (273,064) |
Total stockholders' equity | 18,567 | 44,017 |
Total liabilities and stockholders' equity | $ 21,485 | $ 46,941 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Dec. 31, 2015 | Dec. 31, 2014 |
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 |
Common Stock, par value | $ 0.001 | $ 0.001 |
Common Stock, shares authorized | 75,000,000 | 75,000,000 |
Common Stock, shares issued | 24,430,461 | 24,388,523 |
Common Stock, shares outstanding | 24,318,111 | 24,276,173 |
Treasury stock, shares | 112,350 | 112,350 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2015 | Sep. 30, 2015 | Jun. 30, 2015 | Mar. 31, 2015 | Dec. 31, 2014 | Sep. 30, 2014 | Jun. 30, 2014 | Mar. 31, 2014 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Revenues and other income | |||||||||||
Interest Income | $ 8 | $ 1 | $ 1 | $ 1 | $ 3 | $ 2 | $ 2 | $ 2 | $ 11 | $ 9 | $ 9 |
Total revenues and other income | 8 | 1 | 1 | 1 | 3 | 2 | 2 | 2 | 11 | 9 | 9 |
Expenses | |||||||||||
Research and development | 4,839 | 5,506 | 6,450 | 7,321 | 5,771 | 6,276 | 7,491 | 7,569 | 24,116 | 27,107 | 23,657 |
General and administrative | 1,440 | 1,100 | 1,342 | 1,205 | 1,678 | 1,277 | 1,256 | 1,226 | 5,087 | 5,437 | 4,818 |
Total expenses | 6,279 | 6,606 | 7,792 | 8,526 | 7,449 | 7,553 | 8,747 | 8,795 | 29,203 | 32,544 | 28,475 |
Net loss | $ (6,271) | $ (6,605) | $ (7,791) | $ (8,525) | $ (7,446) | $ (7,551) | $ (8,745) | $ (8,793) | $ (29,192) | $ (32,535) | $ (28,466) |
Loss per share - basic and diluted | $ (0.26) | $ (0.27) | $ (0.32) | $ (0.35) | $ (0.31) | $ (0.32) | $ (0.38) | $ (0.38) | $ (1.2) | $ (1.39) | $ (1.37) |
Shares used in loss per share calculation: | |||||||||||
Basic | 24,298 | 23,432 | 20,808 | ||||||||
Diluted | 24,298 | 23,432 | 20,808 |
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, 2012 | $ 20,873 | $ 17 | $ 234,299 | $ (1,380) | $ (212,063) |
Balance (in shares) at Dec. 31, 2012 | 17,272,505 | 112,350 | |||
Stock based compensation | 3,158 | $ 0 | 3,158 | $ 0 | 0 |
Exercise of Series B Warrants to purchase common stock for cash | 107 | $ 0 | 107 | $ 0 | 0 |
Exercise of Series B Warrants to purchase common stock for cash (in shares) | 42,849 | 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) | 5,407 | 0 | |||
Exercise of stock options to purchase common stock for cash | 83 | $ 0 | 83 | $ 0 | 0 |
Exercise of stock options to purchase common stock for cash (in shares) | 5,833 | 0 | |||
Issuance shares of common stock for the cashless exercise of Series A Warrants | 0 | $ 1 | (1) | $ 0 | 0 |
Issuance shares of common stock for the cashless exercise of Series A Warrants (in shares) | 871,634 | 0 | |||
Issuance shares of common stock for the cashless exercise of Series B Warrants | 0 | $ 1 | (1) | $ 0 | 0 |
Issuance shares of common stock for the cashless exercise of Series B Warrants (in shares) | 614,837 | 0 | |||
Issuance of common stock | 76,764 | $ 4 | 76,760 | $ 0 | 0 |
Issuance of common stock (in shares) | 4,312,500 | 0 | |||
Net loss | (28,466) | $ 0 | 0 | $ 0 | (28,466) |
Balance at Dec. 31, 2013 | 72,519 | $ 23 | 314,405 | $ (1,380) | (240,529) |
Balance (in shares) at Dec. 31, 2013 | 23,125,565 | 112,350 | |||
Stock based compensation | 3,784 | $ 0 | 3,784 | $ 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 for cash | 147 | $ 0 | 147 | $ 0 | 0 |
Exercise of stock options to purchase common stock for cash (in shares) | 23,334 | 0 | |||
Issuance shares of common stock for the cashless exercise of Series A Warrants | 0 | $ 1 | (1) | $ 0 | 0 |
Issuance shares of common stock for the cashless exercise of Series A Warrants (in shares) | 836,961 | 0 | |||
Issuance shares of common stock for the cashless exercise of Series B Warrants | 0 | $ 0 | 0 | $ 0 | $ 0 |
Issuance shares of common stock for the cashless exercise of Series B Warrants (in shares) | 329,753 | 0 | |||
Proceeds from a shareholder transaction | 102 | $ 0 | 102 | $ 0 | |
Net loss | (32,535) | 0 | 0 | 0 | $ (32,535) |
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 | 3,742 | $ 0 | 3,742 | $ 0 | 0 |
Exercise of Series B Warrants to purchase common stock for cash | 0 | $ 0 | 0 | $ 0 | 0 |
Exercise of Series B Warrants to purchase common stock for cash (in shares) | 37,093 | 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 | (29,192) | $ 0 | 0 | $ 0 | (29,192) |
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 |
CONSOLIDATED STATEMENTS OF STO6
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (Parenthetical) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Issuance of shares of common stock for the cashless exercise of Series A Warrants stock options | 837,542 | 872,133 | |
Issuance of shares of common stock for the cashless exercise of Series B Warrants stock options | 380,101 | 716,767 | |
Issuance of shares of common stock for the cashless exercise of stock options | 15,000 | 98,329 | 8,332 |
Issuance of shares of common stock, offering costs | $ 5.2 | ||
Common Stock Price Per Share | $ 19 | ||
Series B [Member] | |||
Common Stock Price Per Share | 2.49 | ||
Series A [Member] | |||
Common Stock Price Per Share | $ 0.01 | ||
Maximum [Member] | |||
Exercise of stock option to purchase common stock for cash, share price | $ 9.60 | 18.74 | |
Minimum [Member] | |||
Exercise of stock option to purchase common stock for cash, share price | $ 1.56 | $ 10.98 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Cash Flows from Operating Activities | |||
Net loss | $ (29,192) | $ (32,535) | $ (28,466) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Depreciation and amortization | 24 | 43 | 40 |
Noncash stock-based compensation | 3,742 | 3,784 | 3,158 |
Changes in operating assets and liabilities: | |||
(Increase) decrease in prepaid expenses and other current assets | 103 | 3 | 216 |
Increase (decrease) in accounts payable and accrued expenses | (6) | (629) | (244) |
Net cash used in operating activities | (25,329) | (29,334) | (25,296) |
Cash Flows from Investing Activities | |||
Capital expenditures | 0 | 0 | (63) |
Net cash used in investing activities | 0 | 0 | (63) |
Cash Flows from Financing Activities | |||
Proceeds from issuance of common stock and warrants, net of offering costs | 0 | 0 | 76,764 |
Exercise of stock options & warrants | 0 | 147 | 190 |
Proceeds from a shareholder transaction | 102 | 0 | 0 |
Net cash provided by financing activities | 102 | 147 | 76,954 |
Net (decrease) increase in cash and cash equivalents | (25,227) | (29,187) | 51,595 |
Cash and cash equivalents at beginning of period | 46,620 | 75,807 | 24,212 |
Cash and cash equivalents at end of period | $ 21,393 | $ 46,620 | $ 75,807 |
ORGANIZATION AND OPERATIONS
ORGANIZATION AND OPERATIONS | 12 Months Ended |
Dec. 31, 2015 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization and Operations | 1. ORGANIZATION AND OPERATIONS: Repros Therapeutics Inc. (the “Company”, “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 primary product candidate, enclomiphene, 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 base 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. This study was fully enrolled in February 2016 and six month data is expected in the third quarter of 2016. 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. VASOMAX® has been on partial clinical hold in the U.S. since 1998, and no further development activities are planned. As of December 31, 2015, we had accumulated losses of $ 302.3 21.4 2.9 |
SUMMARY OF SIGNIFICANT ACCOUNTI
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 12 Months Ended |
Dec. 31, 2015 | |
Accounting Policies [Abstract] | |
Summary Of Significant Accounting Policies | 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES: The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. Our product candidates under development require approval from the FDA or other international regulatory agencies prior to commercial sales. There can be no assurance our product candidates will receive the necessary clearance. If we are denied clearance or clearance is delayed, it may have a material adverse impact on us. Our product candidates are concentrated in rapidly changing, highly competitive markets, which are characterized by rapid technological advances, evolving regulatory requirements and industry standards. Any failure by us to anticipate or to respond adequately to technological developments in our industry, changes in regulatory requirements or industry standards, or any significant delays in the development or introduction of products or services, could have a material adverse effect on our business, operating results and future cash flows. We have no assurance of the successful development and FDA approval or the successful commercialization of our product candidates. The Company considers all cash accounts and highly liquid investments having original maturities of three months or less to be cash and cash equivalents. Prepaid expenses and other current assets primarily consist of prepaid insurance, prepaid operating expenses and other miscellaneous assets, interest and other receivables. Fixed assets include lab equipment, furniture and leasehold improvements and are recorded at cost, less accumulated depreciation and amortization. Depreciation is computed on the straight-line method over an estimated useful life of three to five years or, in the case of leasehold improvements, amortized over the shorter of the useful life or the remaining term of the lease. Maintenance and repairs that do not improve or extend the life of assets are expensed as incurred. When assets are sold or retired, the cost and accumulated depreciation are removed from the accounts and the resulting gain or loss is included in income during the period in which the transaction occurred. Research and development (“R&D”) expenses include salaries and related employee expenses, contracted regulatory affairs activities, insurance coverage for clinical trials and prior product sales, contracted research and consulting fees, fees associated with our patent portfolio, facility costs, and internal research and development supplies. We expense R&D costs in the period they are incurred. These costs consist of direct and indirect costs associated with specific projects as well as fees paid to various entities that perform research on our behalf. We estimate accrued expenses as part of our process of preparing financial statements. Examples of areas in which subjective judgments may be required include costs associated with services provided by contract organizations for clinical trials, preclinical development and manufacturing of clinical materials. We accrue for costs incurred as the services are being provided by monitoring the status of the trials or services provided and the invoices received from our external service providers. In the case of clinical trials, a portion of the estimated cost normally relates to the projected cost to treat a patient in our trials, and we recognize this cost over the estimated term of the study based on the number of patients enrolled in the trial on an ongoing basis, beginning with patient enrollment. As actual costs become known to us, we adjust our accruals. To date, our estimates have not differed significantly from the actual costs incurred. However, subsequent changes in estimates may result in a material change in our accruals, which could also materially affect our balance sheet and results of operations. Basic loss per share is computed by dividing net loss by the weighted average number of shares of common stock outstanding during the year. Diluted loss per share is computed using the average share price for the period and applying the treasury stock method to potentially dilutive outstanding options. In applicable years all potential common stock equivalents were antidilutive and accordingly were not included in the computation. We had one stock-based compensation plan at December 31, 2015 the 2011 Equity Incentive Plan. Accounting for stock based compensation generally requires the recognition of the cost of employee services for share-based compensation based on the grant date fair value of the equity or liability instruments issued. We use the Black-Scholes option pricing model to estimate the fair value of our stock options. Expected volatility is determined using historical volatilities based on historical stock prices for a period equal to the expected term. The expected volatility assumption is adjusted if future volatility is expected to vary from historical experience. The expected term of options represents the period of time that options granted are expected to be outstanding and falls between the options' vesting and contractual expiration dates. The risk-free interest rate is based on the yield at the date of grant of a zero-coupon U.S. Treasury bond whose maturity period equals the option's expected term. Our net operating losses from inception to date have resulted principally from costs incurred in conducting clinical trials and in research and development activities related to efforts to develop our products and from the associated administrative costs required to support those efforts. We have recorded a deferred tax asset for our net operating losses (“NOL”); however, as the Company has incurred net operating losses since inception, and since there is no certainty of future profits, a valuation allowance has been provided in full on our deferred tax assets in the accompanying consolidated financial statements. Additionally, during 2013, the Company completed an analysis of its section 382 limit. Based on this analysis, the Company concluded that the amount of NOL carryforwards and the credits available to offset taxable income is limited under section 382. Accordingly, if the Company generates taxable income in any year in excess of its then annual limitation, the Company may be required to pay federal income taxes even though it has unexpired NOL carryforwards. Additionally, because U.S. tax laws limit the time during which NOLs and tax credit carryforwards may be applied against future taxable income and tax liabilities, the Company may not be able to take full advantage of its NOLs and tax credit carryforwards for federal income tax purposes. Future public and private stock placements may create additional limitations on the Company’s NOLs, credits and other tax attributes. 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 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, 2014. 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. |
FIXED ASSETS
FIXED ASSETS | 12 Months Ended |
Dec. 31, 2015 | |
Property, Plant and Equipment [Abstract] | |
Fixed Assets | 3. FIXED ASSETS: December 31, 2015 2014 Laboratory equipment $ 20 $ 20 Office equipment 101 101 Furniture and fixtures 18 18 Leasehold improvements 77 77 Total fixed assets 216 216 Less Accumulated depreciation and amortization 208 184 Net Fixed Assets $ 8 $ 32 Depreciation was $24,000, $43,000 and $40,000 for the years ended December 31, 2015, 2014 and 2013, respectively. |
OPERATING LEASES
OPERATING LEASES | 12 Months Ended |
Dec. 31, 2015 | |
Leases, Operating [Abstract] | |
Operating Leases | 4. OPERATING LEASES: The Company leases laboratory and office space, pursuant to leases accounted for as operating leases. The lease for the Company’s laboratory and office space expires in June 2020. Rental expense for the years ended December 31, 2015, 2014 and 2013, was approximately $ 87,000 74,000 79,000 2016 $ 79 2017 82 2018 84 2019 87 2020 44 Total $ 376 |
ACCRUED EXPENSES
ACCRUED EXPENSES | 12 Months Ended |
Dec. 31, 2015 | |
Accrued Expenses [Abstract] | |
Accrued Expenses | 5. ACCRUED EXPENSES: December 31, 2015 2014 Personnel related costs $ 544 $ 458 Research and development costs 300 284 Other 105 92 Total $ 949 $ 834 |
FEDERAL INCOME TAXES
FEDERAL INCOME TAXES | 12 Months Ended |
Dec. 31, 2015 | |
Income Tax Disclosure [Abstract] | |
Federal Income Taxes | 6. FEDERAL INCOME TAXES: The Company has had net operating losses since inception and, therefore, has not been subject to federal income taxes. As of December 31, 2015, the Company has accumulated approximately $1.4 million of research and development tax credits. As of December 31, 2015, the Company had approximately $235.7 million of NOL carryforwards for federal income tax purposes. Additionally, approximately $12.2 million of NOLs and approximately $838,000 of research and development tax credits will expire in 2018. The NOLs will expire from 2018 through 2035. The research and development credits will expire from 2018 through 2022. The Tax Reform Act of 1986 provided for a limitation on the use of NOL and tax credit carryforwards following certain ownership changes that could limit the Company’s ability to utilize these NOLs and tax credits. The limitation is generally referred to as the “section 382 limit” after the IRC section. The issuance of stock, together with changes in stock ownership, resulted in multiple ownership changes for federal income tax purposes. During 2013, the Company completed an analysis of its section 382 limit. Based on this analysis, the Company concluded that the amount of NOL carryforwards and the credits available to offset taxable income is limited under section 382. Accordingly, if the Company generates taxable income in any year in excess of its then annual limitation, the Company may be required to pay federal income taxes even though it has unexpired NOL carryforwards. Additionally, because U.S. tax laws limit the time during which NOLs and tax credit carryforwards may be applied against future taxable income and tax liabilities, the Company may not be able to take full advantage of its NOLs and tax credit carryforwards for federal income tax purposes. Future public and private stock placements may create additional limitations on the Company’s NOLs, credits and other tax attributes. The Company’s net operating losses from inception to date have resulted principally from costs incurred in conducting clinical trials and in research and development activities related to efforts to develop products and from the associated administrative costs required to support those efforts. The Company has recorded a deferred tax asset for its net operating losses; however, as the Company has incurred operating losses since inception, and since there is no certainty of future profits, a valuation allowance has been provided in full on the deferred tax assets in the accompanying consolidated financial statements. December 31, 2014 2014 Net operating loss carryforwards $ 80,127 $ 71,472 Research and development tax credits 1,384 1,384 Inventory reserve 1,510 1,510 Total deferred tax assets 83,021 74,366 Less Valuation allowance (83,021) (74,366) Net deferred tax assets $ $ The Company adopted FIN 48 in 2007. The Company has no unrecognized tax benefits that should be accrued under FIN 48. The Company’s policy is to record interest and penalties on income taxes as a component of the income tax provision. The Company’s only taxing jurisdictions are the United States and Texas. The Company’s tax years from 1998 to the present remain open for federal examination due to the net operating loss carryforwards. Texas has a four year statute of limitations so that returns filed since 2011 remain open for state examination. |
STOCKHOLDERS' EQUITY
STOCKHOLDERS' EQUITY | 12 Months Ended |
Dec. 31, 2015 | |
Stockholders' Equity Note [Abstract] | |
Stockholders’ Equity | 7. STOCKHOLDERS’ EQUITY: OFFERINGS On June 25, 2013, we completed a public offering of 4,312,500 19.00 76.8 On February 8, 2011, we completed an underwritten public offering of 690,000 2,760,000 2,070,000 1,690,500 17.15 0.01 2.45 2.49 10.7 0.18 131.66 5.4 5.3 2,066,418 1,108,518 The Series B Warrants were callable by the Company in the event that the Company’s stock trades at $8.00 or more for a period of 20 trading days over any consecutive 30 trading day period. 20 LOSS PER SHARE 2015 2014 2013 Net loss $ (29,192) $ (32,535) $ (28,466) Weighted average common shares outstanding 24,298 23,432 20,808 Basic loss per share $ (1.20) $ (1.39) $ (1.37) Weighted average common and dilutive potential common shares outstanding: Weighted average common shares outstanding 24,298 23,432 20,808 Assumed exercise of stock options 24,298 23,432 20,808 Diluted loss per share $ (1.20) $ (1.39) $ (1.37) Other potential common stock of 3,087,063 2,910,157 4,031,793 2,502 39,595 877,137 429,704 809,805 |
STOCK OPTION PLANS
STOCK OPTION PLANS | 12 Months Ended |
Dec. 31, 2015 | |
Share-based Arrangements with Employees and Nonemployees [Abstract] | |
Stock Option Plans | 8. STOCK OPTION PLANS: As of December 31, 2015, there were 686,635 Stock Weighted Remaining Aggregate Outstanding at December 31, 2012 1,885,683 6.92 Granted 505,000 13.37 Exercised (14,165) 10.31 $ 144.4 Forfeited/cancelled (31,667) 11.87 Outstanding at December 31, 2013 2,344,851 8.22 Granted 351,000 17.24 Exercised (121,663) 5.27 $ 1,721.1 Forfeited/cancelled (133,330) 11.65 Outstanding at December 31, 2014 2,440,858 9.48 Granted 442,333 8.29 Exercised (15,000) 5.24 $ 37.5 Forfeited/cancelled (213,334) 12.09 Outstanding at December 31, 2015 2,654,857 9.09 5.87 Exercisable at December 31, 2015 2,181,444 8.71 5.25 Range Of Exercise Prices Number Weighted Weighted Number Weighted $ 1.33 to $ 4.00 253,138 3.9 $ 2.32 253,138 $ 2.32 4.01 to 5.00 757,312 4.4 4.50 757,312 4.50 5.01 to 8.00 426,993 5.8 5.91 403,669 5.83 8.01 to 10.00 444,000 8.4 8.63 136,661 9.01 10.01 to 20.00 666,914 6.9 15.32 539,911 15.12 21.00 to 50.80 106,500 4.2 33.54 90,753 35.76 2,654,857 2,181,444 2015 2014 2013 R&D expense $ 2,100 $ 1,924 $ 1,839 G&A expense 1,642 1,860 1,319 Total expense $ 3,742 $ 3,784 $ 3,158 At December 31, 2015, there was approximately $ 3.0 1.6 2015 2014 2013 Risk-free interest rate 1.62 % 2.2 % 1.5 % Expected term 7 years 7 years 7 years Volatility 96 % 89 % 94 % Dividend yield Fair value $ 6.69 $ 13.41 $ 10.53 Expected term represents the period that the Company’s stock-based awards are expected to be outstanding. The Company’s historical stock option exercise experience does not provide a reasonable basis upon which to estimate expected term. As such, the simplified method was used to calculate the expected term. Due to our net operating loss position there are no anticipated windfall tax benefits upon exercise of options. The Black-Scholes option pricing model and other existing models were developed for use in estimating the fair value of traded options that have no vesting restrictions and are fully transferable. In addition, option valuation models require the input of and are highly sensitive to subjective assumptions including the expected stock price volatility. The Company’s employee stock options have characteristics significantly different from those of traded options and changes in the subjective input assumptions can materially affect the fair value estimate. |
LICENSE, RESEARCH AND DEVELOPME
LICENSE, RESEARCH AND DEVELOPMENT AGREEMENTS | 12 Months Ended |
Dec. 31, 2015 | |
Research and Development [Abstract] | |
License, Research And Development Agreements | 9. LICENSE, RESEARCH AND DEVELOPMENT AGREEMENTS: NATIONAL INSTITUTES OF HEALTH (NIH) In 1999, we licensed rights to Proellex® from the National Institutes of Health (“NIH”) under an exclusive, worldwide license in the field of treatment of human endocrinologic pathologies or conditions in steroid-sensitive tissues which expires upon the expiration of the last licensed patent. Under the terms of the agreement, we are obligated to meet certain developmental milestones as outlined in a commercial development plan, which has been amended and revised from time to time as circumstances warrant. We have amended the agreement to provide us with rights to certain second generation compounds under certain circumstances. We provide annual updates to the NIH on the progress of our development of Proellex®. The NIH has the ability to terminate the agreement for lack of payment or if we are not meeting milestones as outlined in the commercial development plan and for other reasons as outlined in the agreement. Although we believe that we have a good working relationship with the NIH, there can be no assurance that all of the objectives and conditions in the commercial development plan will be met on a timely basis or at all, or that, if we fail to meet any of such objectives, the NIH will agree to amend this agreement to our satisfaction. Failure to comply with the material terms contained in the license agreement could result in termination of such agreement, which would prohibit us from further development of Proellex® and severely harm our business prospects. The NIH retains, on behalf of the government, a nonexclusive, nontransferable, worldwide license to practice the inventions licensed under the licensed patents by or on behalf of the government. For the purpose of encouraging basic research, the NIH retains the right to grant nonexclusive research licenses to third parties. Due to the work that was done on Proellex® at the NIH prior to our license agreement, the government also has certain rights to use the product in the event of a national emergency pursuant to the Patent and Trademark Laws Amendments Act of 1980, as amended. |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 12 Months Ended |
Dec. 31, 2015 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 10. COMMITMENTS AND CONTINGENCIES: See footnote 5 for a discussion of our operating lease commitments. Therapeutic uses of our enclomiphene product candidate are covered in the United States by nine issued U.S. patents and eight pending patent applications. Foreign coverage of therapeutic uses of our enclomiphene product candidate includes 79 111 two 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 7,759,360 Rights Plan Our shareholder rights plan expired in accordance with its terms on September 13, 2015. While we did not extend or renew the plan, we are not prohibited from adopting, without shareholder approval, a shareholder rights plan that may discourage any potential acquirer from acquiring more than a specific percentage of our outstanding common stock. Upon this type of acquisition without approval of our Board of Directors, all other holders of common stock would have the right to purchase a specified amount of shares at a substantial discount from market price. |
QUARTERLY FINANCIAL INFORMATION
QUARTERLY FINANCIAL INFORMATION (UNAUDITED) | 12 Months Ended |
Dec. 31, 2015 | |
Quarterly Financial Information Disclosure [Abstract] | |
Quarterly Financial Information (Unaudited) | 11. QUARTERLY FINANCIAL INFORMATION (UNAUDITED): First Quarter Second Quarter Third Quarter Fourth Quarter Ended Ended Ended Ended March 31, June 30, September 30, December 31, 2015 2015 2015 2015 (In thousands except per share amounts) Revenues and other income: Interest income $ 1 $ 1 $ 1 $ 8 Total revenues and other income 1 1 1 8 Expenses: Research and development 7,321 6,450 5,506 4,839 General and administrative 1,205 1,342 1,100 1,440 Total expenses 8,526 7,792 6,606 6,279 Net loss $ (8,525) $ (7,791) $ (6,605) $ (6,271) Net loss per share basic and diluted $ (0.35) $ (0.32) $ (0.27) $ (0.26) Shares used in loss per share calculation 24,276 24,278 24,318 24,318 First Quarter Second Quarter Third Quarter Fourth Quarter Ended Ended Ended Ended March 31, June 30, September 30, December 31, 2014 2014 2014 2014 (In thousands except per share amounts) Revenues and other income: Interest income $ 2 $ 2 $ 2 $ 3 Total revenues and other income 2 2 2 3 Expenses: Research and development 7,569 7,491 6,276 5,771 General and administrative 1,226 1,256 1,277 1,678 Total expenses 8,795 8,747 7,553 7,449 Net loss $ (8,793) $ (8,745) $ (7,551) $ (7,446) Net loss per share basic and diluted $ (0.38) $ (0.38) $ (0.32) $ (0.31) Shares used in loss per share calculation 23,033 23,102 23,347 24,234 |
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS | 12 Months Ended |
Dec. 31, 2015 | |
Subsequent Events [Abstract] | |
Subsequent Events | 12. SUBSEQUENT EVENTS: The Series A and Series B Warrants included in our February 8, 2011 underwritten public offering described in Footnote 7 expired on February 8, 2016. |
SUMMARY OF SIGNIFICANT ACCOUN20
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 12 Months Ended |
Dec. 31, 2015 | |
Accounting Policies [Abstract] | |
USE OF ESTIMATES | USE OF ESTIMATES The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. |
CERTAIN RISKS AND UNCERTAINTIES | CERTAIN RISKS AND UNCERTAINTIES Our product candidates under development require approval from the FDA or other international regulatory agencies prior to commercial sales. There can be no assurance our product candidates will receive the necessary clearance. If we are denied clearance or clearance is delayed, it may have a material adverse impact on us. Our product candidates are concentrated in rapidly changing, highly competitive markets, which are characterized by rapid technological advances, evolving regulatory requirements and industry standards. Any failure by us to anticipate or to respond adequately to technological developments in our industry, changes in regulatory requirements or industry standards, or any significant delays in the development or introduction of products or services, could have a material adverse effect on our business, operating results and future cash flows. We have no assurance of the successful development and FDA approval or the successful commercialization of our product candidates. |
CASH AND CASH EQUIVALENTS | CASH AND CASH EQUIVALENTS The Company considers all cash accounts and highly liquid investments having original maturities of three months or less to be cash and cash equivalents. |
PREPAID EXPENSES AND OTHER CURRENT ASSETS | PREPAID EXPENSES AND OTHER CURRENT ASSETS Prepaid expenses and other current assets primarily consist of prepaid insurance, prepaid operating expenses and other miscellaneous assets, interest and other receivables. |
FIXED ASSETS | FIXED ASSETS Fixed assets include lab equipment, furniture and leasehold improvements and are recorded at cost, less accumulated depreciation and amortization. Depreciation is computed on the straight-line method over an estimated useful life of three to five years or, in the case of leasehold improvements, amortized over the shorter of the useful life or the remaining term of the lease. Maintenance and repairs that do not improve or extend the life of assets are expensed as incurred. When assets are sold or retired, the cost and accumulated depreciation are removed from the accounts and the resulting gain or loss is included in income during the period in which the transaction occurred. |
RESEARCH AND DEVELOPMENT EXPENSE | RESEARCH AND DEVELOPMENT EXPENSE Research and development (“R&D”) expenses include salaries and related employee expenses, contracted regulatory affairs activities, insurance coverage for clinical trials and prior product sales, contracted research and consulting fees, fees associated with our patent portfolio, facility costs, and internal research and development supplies. We expense R&D costs in the period they are incurred. These costs consist of direct and indirect costs associated with specific projects as well as fees paid to various entities that perform research on our behalf. We estimate accrued expenses as part of our process of preparing financial statements. Examples of areas in which subjective judgments may be required include costs associated with services provided by contract organizations for clinical trials, preclinical development and manufacturing of clinical materials. We accrue for costs incurred as the services are being provided by monitoring the status of the trials or services provided and the invoices received from our external service providers. In the case of clinical trials, a portion of the estimated cost normally relates to the projected cost to treat a patient in our trials, and we recognize this cost over the estimated term of the study based on the number of patients enrolled in the trial on an ongoing basis, beginning with patient enrollment. As actual costs become known to us, we adjust our accruals. To date, our estimates have not differed significantly from the actual costs incurred. However, subsequent changes in estimates may result in a material change in our accruals, which could also materially affect our balance sheet and results of operations. |
LOSS PER SHARE | 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 year. Diluted loss per share is computed using the average share price for the period and applying the treasury stock method to potentially dilutive outstanding options. In applicable years all potential common stock equivalents were antidilutive and accordingly were not included in the computation. |
SHARE-BASED COMPENSATION | SHARE-BASED COMPENSATION We had one stock-based compensation plan at December 31, 2015 the 2011 Equity Incentive Plan. Accounting for stock based compensation generally requires the recognition of the cost of employee services for share-based compensation based on the grant date fair value of the equity or liability instruments issued. We use the Black-Scholes option pricing model to estimate the fair value of our stock options. Expected volatility is determined using historical volatilities based on historical stock prices for a period equal to the expected term. The expected volatility assumption is adjusted if future volatility is expected to vary from historical experience. The expected term of options represents the period of time that options granted are expected to be outstanding and falls between the options' vesting and contractual expiration dates. The risk-free interest rate is based on the yield at the date of grant of a zero-coupon U.S. Treasury bond whose maturity period equals the option's expected term. |
INCOME TAXES | INCOME TAXES Our net operating losses from inception to date have resulted principally from costs incurred in conducting clinical trials and in research and development activities related to efforts to develop our products and from the associated administrative costs required to support those efforts. We have recorded a deferred tax asset for our net operating losses (“NOL”); however, as the Company has incurred net operating losses since inception, and since there is no certainty of future profits, a valuation allowance has been provided in full on our deferred tax assets in the accompanying consolidated financial statements. Additionally, during 2013, the Company completed an analysis of its section 382 limit. Based on this analysis, the Company concluded that the amount of NOL carryforwards and the credits available to offset taxable income is limited under section 382. Accordingly, if the Company generates taxable income in any year in excess of its then annual limitation, the Company may be required to pay federal income taxes even though it has unexpired NOL carryforwards. Additionally, because U.S. tax laws limit the time during which NOLs and tax credit carryforwards may be applied against future taxable income and tax liabilities, the Company may not be able to take full advantage of its NOLs and tax credit carryforwards for federal income tax purposes. Future public and private stock placements may create additional limitations on the Company’s NOLs, credits and other tax attributes. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements 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 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, 2014. 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. |
FIXED ASSETS (Tables)
FIXED ASSETS (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Property, Plant and Equipment [Abstract] | |
Property, Plant and Equipment | Fixed assets are as follows (in thousands): December 31, 2015 2014 Laboratory equipment $ 20 $ 20 Office equipment 101 101 Furniture and fixtures 18 18 Leasehold improvements 77 77 Total fixed assets 216 216 Less Accumulated depreciation and amortization 208 184 Net Fixed Assets $ 8 $ 32 |
OPERATING LEASES (Tables)
OPERATING LEASES (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Leases, Operating [Abstract] | |
Future Minimum Rental Payments for Operating Lease | Future minimum lease payments under non-cancelable leases with original terms in excess of one year as of December 31, 2015, are as follows (in thousands): 2016 $ 79 2017 82 2018 84 2019 87 2020 44 Total $ 376 |
ACCRUED EXPENSES (Tables)
ACCRUED EXPENSES (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Accrued Expenses [Abstract] | |
Accrued Expenses | Accrued expenses consist of the following (in thousands): December 31, 2015 2014 Personnel related costs $ 544 $ 458 Research and development costs 300 284 Other 105 92 Total $ 949 $ 834 |
FEDERAL INCOME TAXES (Tables)
FEDERAL INCOME TAXES (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Schedule of Investments [Abstract] | |
Schedule of Deferred Tax Assets and Liabilities | The tax effects of temporary differences that give rise to significant portions of the deferred tax assets are as follows (in thousands): December 31, 2014 2014 Net operating loss carryforwards $ 80,127 $ 71,472 Research and development tax credits 1,384 1,384 Inventory reserve 1,510 1,510 Total deferred tax assets 83,021 74,366 Less Valuation allowance (83,021) (74,366) Net deferred tax assets $ $ |
STOCKHOLDERS' EQUITY (Tables)
STOCKHOLDERS' EQUITY (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Stockholders' Equity Note [Abstract] | |
Calculation of Loss Per Share | The following table presents information necessary to calculate loss per share for the three years ended December 31, 2015, 2014 and 2013 (in thousands, except per share amounts): 2015 2014 2013 Net loss $ (29,192) $ (32,535) $ (28,466) Weighted average common shares outstanding 24,298 23,432 20,808 Basic loss per share $ (1.20) $ (1.39) $ (1.37) Weighted average common and dilutive potential common shares outstanding: Weighted average common shares outstanding 24,298 23,432 20,808 Assumed exercise of stock options 24,298 23,432 20,808 Diluted loss per share $ (1.20) $ (1.39) $ (1.37) |
STOCK OPTION PLANS (Tables)
STOCK OPTION PLANS (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Share-based Arrangements with Employees and Nonemployees [Abstract] | |
Schedule of Share-based Compensation, Stock Options, Activity | A summary of the status of the Company’s outstanding options at December 31, 2015, 2014, and 2013 and changes during the years then ended is presented in the tables below: Stock Weighted Remaining Aggregate Outstanding at December 31, 2012 1,885,683 6.92 Granted 505,000 13.37 Exercised (14,165) 10.31 $ 144.4 Forfeited/cancelled (31,667) 11.87 Outstanding at December 31, 2013 2,344,851 8.22 Granted 351,000 17.24 Exercised (121,663) 5.27 $ 1,721.1 Forfeited/cancelled (133,330) 11.65 Outstanding at December 31, 2014 2,440,858 9.48 Granted 442,333 8.29 Exercised (15,000) 5.24 $ 37.5 Forfeited/cancelled (213,334) 12.09 Outstanding at December 31, 2015 2,654,857 9.09 5.87 Exercisable at December 31, 2015 2,181,444 8.71 5.25 |
Schedule of Share-based Compensation, Shares Authorized under Stock Option Plans, by Exercise Price Range | The following table summarizes information about stock options outstanding at December 31, 2015: Range Of Exercise Prices Number Weighted Weighted Number Weighted $ 1.33 to $ 4.00 253,138 3.9 $ 2.32 253,138 $ 2.32 4.01 to 5.00 757,312 4.4 4.50 757,312 4.50 5.01 to 8.00 426,993 5.8 5.91 403,669 5.83 8.01 to 10.00 444,000 8.4 8.63 136,661 9.01 10.01 to 20.00 666,914 6.9 15.32 539,911 15.12 21.00 to 50.80 106,500 4.2 33.54 90,753 35.76 2,654,857 2,181,444 |
Schedule of Employee Service Share-based Compensation, Allocation of Recognized Period Costs | Stock-based compensation is outlined in the following table (in thousands): 2015 2014 2013 R&D expense $ 2,100 $ 1,924 $ 1,839 G&A expense 1,642 1,860 1,319 Total expense $ 3,742 $ 3,784 $ 3,158 |
Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions | Estimated fair values of stock options granted have been determined using the Black-Scholes option pricing model with the following weighted average assumptions: 2015 2014 2013 Risk-free interest rate 1.62 % 2.2 % 1.5 % Expected term 7 years 7 years 7 years Volatility 96 % 89 % 94 % Dividend yield Fair value $ 6.69 $ 13.41 $ 10.53 |
QUARTERLY FINANCIAL INFORMATI27
QUARTERLY FINANCIAL INFORMATION (UNAUDITED) (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Quarterly Financial Information Disclosure [Abstract] | |
Schedule of Quarterly Financial Information | First Quarter Second Quarter Third Quarter Fourth Quarter Ended Ended Ended Ended March 31, June 30, September 30, December 31, 2015 2015 2015 2015 (In thousands except per share amounts) Revenues and other income: Interest income $ 1 $ 1 $ 1 $ 8 Total revenues and other income 1 1 1 8 Expenses: Research and development 7,321 6,450 5,506 4,839 General and administrative 1,205 1,342 1,100 1,440 Total expenses 8,526 7,792 6,606 6,279 Net loss $ (8,525) $ (7,791) $ (6,605) $ (6,271) Net loss per share basic and diluted $ (0.35) $ (0.32) $ (0.27) $ (0.26) Shares used in loss per share calculation 24,276 24,278 24,318 24,318 First Quarter Second Quarter Third Quarter Fourth Quarter Ended Ended Ended Ended March 31, June 30, September 30, December 31, 2014 2014 2014 2014 (In thousands except per share amounts) Revenues and other income: Interest income $ 2 $ 2 $ 2 $ 3 Total revenues and other income 2 2 2 3 Expenses: Research and development 7,569 7,491 6,276 5,771 General and administrative 1,226 1,256 1,277 1,678 Total expenses 8,795 8,747 7,553 7,449 Net loss $ (8,793) $ (8,745) $ (7,551) $ (7,446) Net loss per share basic and diluted $ (0.38) $ (0.38) $ (0.32) $ (0.31) Shares used in loss per share calculation 23,033 23,102 23,347 24,234 |
ORGANIZATION AND OPERATIONS (Ad
ORGANIZATION AND OPERATIONS (Additional Information) (Details) - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 |
Product Information [Line Items] | ||||
Deficit accumulated during the development stage | $ 302,300 | |||
Cash and cash equivalents | 21,393 | $ 46,620 | $ 75,807 | $ 24,212 |
Accounts payable and accrued expenses | $ 2,900 |
FIXED ASSETS (Details)
FIXED ASSETS (Details) - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 |
Property, Plant and Equipment [Line Items] | ||
Total fixed assets | $ 216 | $ 216 |
Less - Accumulated depreciation and amortization | 208 | 184 |
Net Fixed Assets | 8 | 32 |
Laboratory Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Total fixed assets | 20 | 20 |
Office Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Total fixed assets | 101 | 101 |
Leaseholds and Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Total fixed assets | 77 | 77 |
Furniture and Fixtures [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Total fixed assets | $ 18 | $ 18 |
FIXED ASSETS (Additional inform
FIXED ASSETS (Additional information) (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Property, Plant and Equipment [Line Items] | |||
Depreciation | $ 24,000 | $ 43,000 | $ 40,000 |
OPERATING LEASES (Details)
OPERATING LEASES (Details) $ in Thousands | Dec. 31, 2015USD ($) |
Operating Leased Assets [Line Items] | |
2,016 | $ 79 |
2,017 | 82 |
2,018 | 84 |
2,019 | 87 |
2,020 | 44 |
Total | $ 376 |
OPERATING LEASES (Additional in
OPERATING LEASES (Additional information) (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Leases Operating [Line Items] | |||
Operating Leases, Rent Expense, Net | $ 87,000 | $ 74,000 | $ 79,000 |
ACCRUED EXPENSES (Details)
ACCRUED EXPENSES (Details) - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 |
Schedule Of Accrued Liabilities [Line Items] | ||
Personnel related costs | $ 544 | $ 458 |
Research and development costs | 300 | 284 |
Other | 105 | 92 |
Total | $ 949 | $ 834 |
FEDERAL INCOME TAXES (Details)
FEDERAL INCOME TAXES (Details) - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 |
Schedule of Investments [Line Items] | ||
Net operating loss carryforwards | $ 80,127 | $ 71,472 |
Research and development tax credits | 1,384 | 1,384 |
Inventory reserve | 1,510 | 1,510 |
Total deferred tax assets | 83,021 | 74,366 |
Less - Valuation allowance | (83,021) | (74,366) |
Net deferred tax assets | $ 0 | $ 0 |
FEDERAL INCOME TAXES (Additiona
FEDERAL INCOME TAXES (Additional information) (Details) - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Schedule of Investments [Line Items] | ||
Deferred Tax Assets, Operating Loss Carryforwards, Domestic | $ 1.4 | $ 838,000 |
Deferred Tax Assets Additional Operating Loss Carryforwards Domestic | 235.7 | |
Estimated Carryforwards To Offset Taxable Income Per Year | $ 12.2 |
STOCKHOLDERS' EQUITY (Details)
STOCKHOLDERS' EQUITY (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2015 | Sep. 30, 2015 | Jun. 30, 2015 | Mar. 31, 2015 | Dec. 31, 2014 | Sep. 30, 2014 | Jun. 30, 2014 | Mar. 31, 2014 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Net loss | $ (6,271) | $ (6,605) | $ (7,791) | $ (8,525) | $ (7,446) | $ (7,551) | $ (8,745) | $ (8,793) | $ (29,192) | $ (32,535) | $ (28,466) |
Weighted average common shares outstanding | 24,298 | 23,432 | 20,808 | ||||||||
Basic loss per share | $ (1.20) | $ (1.39) | $ (1.37) | ||||||||
Weighted average common and dilutive potential common shares outstanding: | |||||||||||
Weighted average common shares outstanding | 24,298 | 23,432 | 20,808 | ||||||||
Assumed exercise of stock options | 0 | 0 | 0 | ||||||||
Weighted Average Number of Shares Outstanding, Diluted | 24,298 | 23,432 | 20,808 | ||||||||
Diluted loss per share | $ (1.20) | $ (1.39) | $ (1.37) |
STOCKHOLDERS' EQUITY (Additiona
STOCKHOLDERS' EQUITY (Additional information) (Details) | Feb. 08, 2011USD ($)$ / shares$ / Warrantshares | Jun. 25, 2013USD ($)$ / sharesshares | Dec. 31, 2015$ / sharesshares | Dec. 31, 2014$ / sharesshares | Dec. 31, 2013$ / sharesshares |
Stockholders Equity Note [Line Items] | |||||
Issuance of common stock, share | 2,760,000 | ||||
Warrants price per unit | $ / Warrant | 17.15 | ||||
Stock Issued During Period Units New Issues | 690,000 | ||||
Gross proceeds from public offering | $ | $ 10,700,000 | ||||
Sale of Stock, Description of Transaction | The Series B Warrants were callable by the Company in the event that the Companys stock trades at $8.00 or more for a period of 20 trading days over any consecutive 30 trading day period. | ||||
Equity Method Investment, Ownership Percentage | 20.00% | ||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ / shares | $ 0.01 | ||||
Public Offering [Member] | |||||
Stockholders Equity Note [Line Items] | |||||
Issuance of common stock, share | 4,312,500 | ||||
Sale of Stock, Price Per Share | $ / shares | $ 19 | ||||
Proceeds from Issuance of Private Placement | $ | $ 76,800,000 | ||||
Employee Stock Option [Member] | |||||
Stockholders Equity Note [Line Items] | |||||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 3,087,063 | 2,910,157 | 4,031,793 | ||
Series A Warrants [Member] | |||||
Stockholders Equity Note [Line Items] | |||||
Stock Issued During Period Warrants New Issues | 2,070,000 | ||||
Stock Issued During Period Shares Exercise Of Warrants | 2,066,418 | ||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ / shares | $ 0.01 | ||||
Series A Warrants [Member] | Employee Stock Option [Member] | |||||
Stockholders Equity Note [Line Items] | |||||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 2,502 | 39,595 | 877,137 | ||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ / shares | $ 0.01 | $ 0.01 | $ 0.01 | ||
Series B Warrant [Member] | |||||
Stockholders Equity Note [Line Items] | |||||
Stock Issued During Period Warrants New Issues | 1,690,500 | ||||
Warrants Convertible Conversion Ratio | $ | 2.45 | ||||
Stock Issued During Period Shares Exercise Of Warrants | 1,108,518 | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 429,704 | 429,704 | 809,805 | ||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ / shares | $ 2.49 | $ 2.49 | $ 2.49 | ||
Series A and B [Member] | |||||
Stockholders Equity Note [Line Items] | |||||
Fair Value Assumptions, Risk Free Interest Rate | 0.18% | ||||
Fair Value Assumptions, Expected Volatility Rate | 131.66% | ||||
Fair Value Assumptions, Expected Term | 6 months | ||||
Warrants Not Settleable in Cash, Fair Value Disclosure | $ | $ 5,400,000 | ||||
Additional Paid in Capital, Common Stock | $ | $ 5,300,000 |
STOCK OPTION PLANS (Details)
STOCK OPTION PLANS (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Share-Based Arrangements With Employees and Nonemployees [Line Items] | |||
Stock Options, Beginning Balance | 2,440,858 | 2,344,851 | 1,885,683 |
Stock Options, Granted | 442,333 | 351,000 | 505,000 |
Stock Options, Exercised | (15,000) | (121,663) | (14,165) |
Stock Options, Forfeited/cancelled | (213,334) | (133,330) | (31,667) |
Stock Options, Ending balance | 2,654,857 | 2,440,858 | 2,344,851 |
Exercisable at December 31, 2015 | 2,181,444 | ||
Weighted average exercise price, Beginning Balance | $ 9.48 | $ 8.22 | $ 6.92 |
Weighted average exercise price, Granted | 8.29 | 17.24 | 13.37 |
Weighted average exercise price, Exercised | 5.24 | 5.27 | 10.31 |
Weighted average exercise price, Forfeited/cancelled | 12.09 | 11.65 | 11.87 |
Weighted average exercise price, Ending Balance | 9.09 | $ 9.48 | $ 8.22 |
Exercisable at December 31, 2015 | $ 8.71 | ||
Remaining Weighted Average Contractual Term (Years) | 5 years 10 months 13 days | ||
Remaining Weighted Average Contractual Term (Years), Exercisable at December 31, 2015 | 5 years 3 months | ||
Aggregate Intrinsice Value, Exercised | $ 37,500 | $ 1,721,100 | $ 144,400 |
STOCK OPTION PLANS (Details 1)
STOCK OPTION PLANS (Details 1) - $ / shares | 12 Months Ended | |||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | |
Number Outstanding | 2,654,857 | 2,440,858 | 2,344,851 | 1,885,683 |
Weighted Average Remaining Life | 5 years 10 months 13 days | |||
Outstanding Weighted Average Exercise Price | $ 9.09 | $ 9.48 | $ 8.22 | $ 6.92 |
Number Exercisable | 2,181,444 | |||
Exercisable Weighted Average Exercise Price | $ 8.71 | |||
Range One [Member] | ||||
Range Of Exercise Prices, Lower Range Limit | 1.33 | |||
Range Of Exercise Prices, Upper Range Limit | $ 4 | |||
Number Outstanding | 253,138 | |||
Weighted Average Remaining Life | 3 years 10 months 24 days | |||
Outstanding Weighted Average Exercise Price | $ 2.32 | |||
Number Exercisable | 253,138 | |||
Exercisable Weighted Average Exercise Price | $ 2.32 | |||
Range Two [Member] | ||||
Range Of Exercise Prices, Lower Range Limit | 4.01 | |||
Range Of Exercise Prices, Upper Range Limit | $ 5 | |||
Number Outstanding | 757,312 | |||
Weighted Average Remaining Life | 4 years 4 months 24 days | |||
Outstanding Weighted Average Exercise Price | $ 4.50 | |||
Number Exercisable | 757,312 | |||
Exercisable Weighted Average Exercise Price | $ 4.50 | |||
Range Three [Member] | ||||
Range Of Exercise Prices, Lower Range Limit | 5.01 | |||
Range Of Exercise Prices, Upper Range Limit | $ 8 | |||
Number Outstanding | 426,993 | |||
Weighted Average Remaining Life | 5 years 9 months 18 days | |||
Outstanding Weighted Average Exercise Price | $ 5.91 | |||
Number Exercisable | 403,669 | |||
Exercisable Weighted Average Exercise Price | $ 5.83 | |||
Range Four [Member] | ||||
Range Of Exercise Prices, Lower Range Limit | 8.01 | |||
Range Of Exercise Prices, Upper Range Limit | $ 10 | |||
Number Outstanding | 444,000 | |||
Weighted Average Remaining Life | 8 years 4 months 24 days | |||
Outstanding Weighted Average Exercise Price | $ 8.63 | |||
Number Exercisable | 136,661 | |||
Exercisable Weighted Average Exercise Price | $ 9.01 | |||
Range Five [Member] | ||||
Range Of Exercise Prices, Lower Range Limit | 10.01 | |||
Range Of Exercise Prices, Upper Range Limit | $ 20 | |||
Number Outstanding | 666,914 | |||
Weighted Average Remaining Life | 6 years 10 months 24 days | |||
Outstanding Weighted Average Exercise Price | $ 15.32 | |||
Number Exercisable | 539,911 | |||
Exercisable Weighted Average Exercise Price | $ 15.12 | |||
Range Six Member [Member] | ||||
Range Of Exercise Prices, Lower Range Limit | 21 | |||
Range Of Exercise Prices, Upper Range Limit | $ 50.80 | |||
Number Outstanding | 106,500 | |||
Weighted Average Remaining Life | 4 years 2 months 12 days | |||
Outstanding Weighted Average Exercise Price | $ 33.54 | |||
Number Exercisable | 90,753 | |||
Exercisable Weighted Average Exercise Price | $ 35.76 |
STOCK OPTION PLANS (Details 2)
STOCK OPTION PLANS (Details 2) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Allocated Share-based Compensation Expense | $ 3,742 | $ 3,784 | $ 3,158 |
Research and Development Expense [Member] | |||
Allocated Share-based Compensation Expense | 2,100 | 1,924 | 1,839 |
General and Administrative Expense [Member] | |||
Allocated Share-based Compensation Expense | $ 1,642 | $ 1,860 | $ 1,319 |
STOCK OPTION PLANS (Details 3)
STOCK OPTION PLANS (Details 3) - $ / shares | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Risk-free interest rate | 1.62% | 2.20% | 1.50% |
Expected term | 7 years | 7 years | 7 years |
Volatility | 96.00% | 89.00% | 94.00% |
Dividend yield | 0.00% | 0.00% | 0.00% |
Fair value | $ 6.69 | $ 13.41 | $ 10.53 |
STOCK OPTION PLANS (Additional
STOCK OPTION PLANS (Additional information) (Details) $ in Millions | 12 Months Ended |
Dec. 31, 2015USD ($)shares | |
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant | shares | 686,635 |
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized, Period for Recognition | 1 year 7 months 6 days |
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized | $ | $ 3 |
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Period | 3 years |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Additional Information) (Details) | 12 Months Ended |
Dec. 31, 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 | 79 |
Number of pending patent applications | 111 |
Third Party [Member] | |
Commitments and Contingencies [Line Items] | |
Number of patents | 2 |
QUARTERLY FINANCIAL INFORMATI44
QUARTERLY FINANCIAL INFORMATION (UNAUDITED) (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2015 | Sep. 30, 2015 | Jun. 30, 2015 | Mar. 31, 2015 | Dec. 31, 2014 | Sep. 30, 2014 | Jun. 30, 2014 | Mar. 31, 2014 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Revenues and other income | |||||||||||
Interest Income | $ 8 | $ 1 | $ 1 | $ 1 | $ 3 | $ 2 | $ 2 | $ 2 | $ 11 | $ 9 | $ 9 |
Total revenues and other income | 8 | 1 | 1 | 1 | 3 | 2 | 2 | 2 | 11 | 9 | 9 |
Expenses: | |||||||||||
Research and development | 4,839 | 5,506 | 6,450 | 7,321 | 5,771 | 6,276 | 7,491 | 7,569 | 24,116 | 27,107 | 23,657 |
General and Administrative | 1,440 | 1,100 | 1,342 | 1,205 | 1,678 | 1,277 | 1,256 | 1,226 | 5,087 | 5,437 | 4,818 |
Total expenses | 6,279 | 6,606 | 7,792 | 8,526 | 7,449 | 7,553 | 8,747 | 8,795 | 29,203 | 32,544 | 28,475 |
Net loss | $ (6,271) | $ (6,605) | $ (7,791) | $ (8,525) | $ (7,446) | $ (7,551) | $ (8,745) | $ (8,793) | $ (29,192) | $ (32,535) | $ (28,466) |
Net loss per share - basic and diluted | $ (0.26) | $ (0.27) | $ (0.32) | $ (0.35) | $ (0.31) | $ (0.32) | $ (0.38) | $ (0.38) | $ (1.2) | $ (1.39) | $ (1.37) |
Shares used in loss per share calculation | 24,318 | 24,318 | 24,278 | 24,276 | 24,234 | 23,347 | 23,102 | 23,033 |