Document And Entity Information
Document And Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2015 | Mar. 18, 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 | CASI Pharmaceuticals, Inc. | ||
Entity Central Index Key | 895,051 | ||
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 | Smaller Reporting Company | ||
Entity Public Float | $ 36,273,034 | ||
Trading Symbol | CASI | ||
Entity Common Stock, Shares Outstanding | 42,583,301 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Dec. 31, 2015 | Dec. 31, 2014 |
Current assets: | ||
Cash and cash equivalents | $ 5,131,114 | $ 10,669,919 |
Accounts receivable, net of allowance for doubtful accounts of $12,536 at December 31, 2014 | 0 | 23,727 |
Prepaid expenses and other | 438,231 | 328,150 |
Total current assets | 5,569,345 | 11,021,796 |
Property and equipment, net | 218,796 | 261,781 |
Other assets | 38,174 | 26,011 |
Total assets | 5,826,315 | 11,309,588 |
Current liabilities: | ||
Accounts payable | 884,100 | 754,628 |
Accrued liabilities | 169,464 | 164,420 |
Total current liabilities | 1,053,564 | 919,048 |
Note payable, net of discount | 1,464,970 | 1,390,015 |
Contingent rights derivative liability | 9,395,222 | 9,422,735 |
Total liabilities | $ 11,913,756 | $ 11,731,798 |
Commitments and contingencies | ||
Stockholders’ deficit: | ||
Convertible preferred stock, $1.00 par value; 5,000,000 shares authorized and 0 shares issued and outstanding at December 31, 2015 and 2014 | $ 0 | $ 0 |
Common stock, $.01 par value: 170,000,000 shares authorized at December 31, 2015 and 2014; 32,525,356 shares issued at December 31, 2015 and 2014 | 325,252 | 325,252 |
Additional paid-in capital | 434,099,890 | 432,558,698 |
Treasury stock, at cost: 79,545 shares held at December 31, 2015 and December 31, 2014 | (8,034,244) | (8,034,244) |
Accumulated deficit | (432,478,339) | (425,271,916) |
Total stockholders’ deficit | (6,087,441) | (422,210) |
Total liabilities and stockholders’ deficit | $ 5,826,315 | $ 11,309,588 |
Consolidated Balance Sheets _Pa
Consolidated Balance Sheets [Parenthetical] - USD ($) | Dec. 31, 2015 | Dec. 31, 2014 |
Allowance for Doubtful Accounts Receivable, Current | $ 12,536 | |
Convertible preferred stock, par value (in dollars per share) | $ 1 | $ 1 |
Convertible preferred stock, shares authorized | 5,000,000 | 5,000,000 |
Convertible preferred stock, shares issued | 0 | 0 |
Convertible preferred stock, shares outstanding | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Common stock, shares authorized | 170,000,000 | 170,000,000 |
Common stock, shares issued | 32,525,356 | 32,525,356 |
Treasury stock, shares held | 79,545 | 79,545 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Revenues: | ||
Product sales | $ 47,712 | $ 23,727 |
Revenues Total | 47,712 | 23,727 |
Costs and expenses: | ||
Cost of product sales | 6,274 | 7,467 |
Research and development | 4,075,572 | 2,765,492 |
General and administrative | 3,118,269 | 3,756,548 |
Acquired in-process research and development | 0 | 19,681,711 |
Costs and expenses | 7,200,115 | 26,211,218 |
Interest expense, net | 81,533 | 26,581 |
Change in fair value of contingent rights | (27,513) | (11,764) |
Net loss | $ (7,206,423) | $ (26,202,308) |
Net loss per share (basic and diluted) | $ (0.22) | $ (0.92) |
Weighted average number of shares outstanding (basic and diluted) | 32,445,811 | 28,595,402 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity (Deficit) - USD ($) | Total | Preferred Stock [Member] | Common Stock [Member] | Treasury Stock [Member] | Additional Paid-in Capital [Member] | Retained Earnings [Member] |
Balance at Dec. 31, 2013 | $ 14,942,385 | $ 0 | $ 271,198 | $ (8,034,244) | $ 421,775,039 | $ (399,069,608) |
Balance (in Shares) at Dec. 31, 2013 | 0 | 27,040,429 | ||||
Issuance of common stock pursuant to the Spectrum licensing transaction (Note 4) | 8,648,611 | $ 0 | $ 54,054 | 0 | 8,594,557 | 0 |
Issuance of common stock pursuant to the Spectrum licensing transaction (Note 4) (in shares) | 0 | 5,405,382 | ||||
Stock-based compensation expense, net of forfeitures | 2,189,102 | $ 0 | $ 0 | 0 | 2,189,102 | 0 |
Net loss | (26,202,308) | 0 | 0 | 0 | 0 | (26,202,308) |
Balance at Dec. 31, 2014 | (422,210) | $ 0 | $ 325,252 | $ (8,034,244) | 432,558,698 | $ (425,271,916) |
Balance (in shares) at Dec. 31, 2014 | 0 | 32,445,811 | ||||
Stock-based compensation expense, net of forfeitures | 1,541,192 | 1,541,192 | ||||
Net loss | (7,206,423) | $ (7,206,423) | ||||
Balance at Dec. 31, 2015 | $ (6,087,441) | $ 0 | $ 325,252 | $ (8,034,244) | $ 434,099,890 | $ (432,478,339) |
Balance (in shares) at Dec. 31, 2015 | 0 | 32,445,811 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
CASH FLOWS FROM OPERATING ACTIVITIES | ||
Net loss | $ (7,206,423) | $ (26,202,308) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 68,381 | 48,179 |
Stock-based compensation expense | 1,541,192 | 2,189,102 |
Acquired in-process research and development | 0 | 19,681,711 |
Non-cash interest | 74,955 | 25,922 |
Change in fair value of contingent rights | (27,513) | (11,764) |
Changes in operating assets and liabilities: | ||
Accounts receivable | 23,727 | (23,727) |
Prepaid expenses and other | (122,244) | (56,423) |
Accounts payable | 129,472 | 352,172 |
Accrued liabilities | 5,044 | 1,710 |
Net cash used in operating activities | (5,513,409) | (3,995,426) |
CASH FLOWS FROM INVESTING ACTIVITIES | ||
Purchases of furniture and equipment | (25,396) | (231,818) |
Cash paid for acquired in-process research and development | 0 | (234,508) |
Net cash used in investing activities | (25,396) | (466,326) |
Net decrease in cash and cash equivalents | (5,538,805) | (4,461,752) |
Cash and cash equivalents at beginning of year | 10,669,919 | 15,131,671 |
Cash and cash equivalents at end of year | 5,131,114 | 10,669,919 |
Supplemental disclosure of cash flow information: | ||
Cash paid for interest | 7,500 | 0 |
Non-cash financing activity: | ||
Common stock issued in connection with acquired in-process research and development | 0 | 8,648,611 |
Promissory note, net of discount, issued in connection with acquired in-process research and development | 0 | 1,364,093 |
Contingent rights issued in connection with acquired in-process research and development | $ 0 | $ 9,434,499 |
DESCRIPTION OF BUSINESS AND BAS
DESCRIPTION OF BUSINESS AND BASIS OF PRESENTATION | 12 Months Ended |
Dec. 31, 2015 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Basis of Accounting [Text Block] | 1. DESCRIPTION OF BUSINESS AND BASIS OF PRESENTATION CASI Pharmaceuticals, Inc. (“CASI” or the “Company”) is a late-stage biopharmaceutical company dedicated to the acquisition, development and commercialization of innovative therapeutics for the treatment of cancer and other unmet medical needs. The Company’s mission is to become a leading fully-integrated pharmaceutical company delivering new medicines to patients with unmet medical needs. The Company conducts clinical development activities internationally and focuses its commercial and marketing strategy on the China region, and in the rest of the world through partnerships. The Company’s pipeline features (1) its lead proprietary drug candidate, ENMD-2076, in multiple Phase 2 clinical trials, (2) MARQIBO ® ® The Company’s primary research and development focus is on oncology therapeutics. The Company’s strategy is to develop innovative drugs that are potential first-in-class or market-leading compounds for treatment of cancer. The implementation of its plans will include leveraging the Company’s resources in both the United States and China. In order to capitalize on the drug development and capital resources available in China, the Company is doing business in China through its wholly-owned Chinese subsidiary that will execute the China portion of the Company’s drug development strategy, including conducting clinical trials in China, pursuing local funding opportunities and strategic collaborations, and implementing the Company’s plan for development and commercialization in the China market. ENMD-2076 has received orphan drug designation from the FDA for the treatment of ovarian cancer, multiple myeloma, acute myeloid leukemia and hepatocellular carcinoma (HCC). In October 2015, the Company also received orphan drug designation from the European Medicines Agency (EMA) for the treatment of HCC. In September 2014, the Company acquired from Spectrum Pharmaceuticals, Inc. and certain of its affiliates (together referred to as “Spectrum”) exclusive rights in greater China (including Taiwan, Hong Kong and Macau) to three in-licensed oncology products, including MARQIBO ® ® The Company’s primary focus is on clinical-stage and late-stage drug candidates so that it can immediately employ its U.S. and China drug development model to accelerate clinical and regulatory progress. In addition to its clinical-and late-stage approach, the Company has two potential drug candidates in preclinical development which it will continue to evaluate in 2016. In addition to these early compounds, the Company’s pipeline includes 2ME2 (2-methoxyestradial), an orally active compound that has antiproliferative, antiangiogenic and anti-inflammatory properties. The accompanying consolidated financial statements include the accounts of CASI Pharmaceuticals, Inc. and its subsidiaries, Miikana Therapeutics, Inc. (“Miikana”) and CASI Pharmaceuticals (Beijing) Co., Ltd. (“CASI China”). CASI China is a non-stock Chinese entity with 100 LIQUIDITY RISKS AND MANAGEMENT’S PLANS Since inception, the Company has incurred significant losses from operations and has incurred an accumulated deficit of $ 432.5 25.1 10.3 14.8 The Company intends to advance clinical development of its drugs and drug candidates, and the implementation of the Company’s plans will include leveraging its resources in both the United States and China. In order to capitalize on the drug development and capital resources available in China, the Company is doing business in China through its wholly-owned Chinese subsidiary that will execute the China portion of the Company’s drug development strategy, including conducting clinical trials in China, pursuing local funding opportunities and strategic collaborations, and implementing the Company’s plan for development and commercialization in the Chinese market. The Company intends to pursue additional financing opportunities as well as opportunities to raise capital through forms of non- or less- dilutive arrangements, such as partnerships and collaborations with organizations that have capabilities and/or products that are complementary to the Company’s capabilities and products in order to continue the development of the product candidate that the Company intends to pursue to commercialization. |
SUMMARY OF SIGNIFICANT ACCOUNTI
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 12 Months Ended |
Dec. 31, 2015 | |
Accounting Policies [Abstract] | |
Basis of Presentation and Significant Accounting Policies [Text Block] | 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES SEGMENT INFORMATION The Company currently operates in one business segment, which is the development of targeted therapeutics primarily for the treatment of cancer. The Company is managed and operated as one business. CASI’s senior management team reports to the Board of Directors and is responsible for aligning the Company’s business strategy with its core scientific strengths, while maintaining prudent resource management, fiscal responsibility and accountability. The Company employs a drug development strategy in the United States and China to develop targeted therapeutics for the global market and its current lead drug candidate is ENMD-2076, an Aurora A and angiogenic kinase inhibitor for the treatment of cancer. The Company does not operate separate lines of business with respect to its product candidates. Accordingly, the Company does not have separately reportable segments as defined by authoritative guidance issued by the Financial Accounting Standards Board (FASB). Research and development expenses consist primarily of compensation and other expenses related to research and development personnel, research collaborations, costs associated with pre-clinical correlative testing and clinical trials of the Company’s drug candidates, including the costs of manufacturing drug substance and drug product, regulatory maintenance costs, and facilities expenses. Research and development costs are expensed as incurred. Furniture and equipment and leasehold improvements are stated at cost and are depreciated over their estimated useful lives of 3 5 68,381 48,179 DECEMBER 31, 2015 2014 Furniture and equipment $ 505,946 $ 480,550 Leasehold improvements 6,382 6,382 512,328 486,932 Less: accumulated depreciation and amortization (293,532) (225,151) $ 218,796 $ 261,781 In accordance with authoritative guidance issued by the FASB, the Company periodically evaluates the value reflected in its consolidated balance sheets of long-lived assets, such as equipment, when events and circumstances indicate that the carrying amount of an asset may not be recovered. Such events and circumstances include the use of the asset in current research and development projects, any potential alternative uses of the asset in other research and development projects in the short to medium term and restructuring plans entered into by the Company. No impairment charges were recorded in 2015 and 2014. Cash and cash equivalents include cash and highly liquid investments with original maturities of less than 90 days. Substantially all of the Company’s cash equivalents are held in short-term money market accounts. ACCOUNTS RECEIVABLE Accounts receivable are stated net of allowances for doubtful accounts. Allowances for doubtful accounts are determined on a specific item basis. Management reviews the credit worthiness of individual customers and past payment history to determine the allowance for doubtful accounts. There was an allowance for doubtful accounts of $ 12,536 For the years ended December 31, 2015 and 2014, one customer represented 100 100 FOREIGN CURRENCY TRANSLATION The U.S. dollar is the functional and reporting currency of the Company. Foreign currency denominated assets and liabilities of the Company and all of its subsidiaries are translated into U.S. dollars. Accordingly, monetary assets and liabilities are translated using the exchange rates in effect at the consolidated balance sheet date and revenues and expenses at the rates of exchange prevailing when the transactions occurred. Remeasurement adjustments are included in income (loss). The Company accounts for rent expense related to operating leases by determining total minimum rent payments on the leases over their respective periods and recognizing the rent expense on a straight-line basis. The difference between the actual amount paid and the amount recorded as rent expense in each fiscal year is recorded as an adjustment to deferred rent. Deferred rent as of December 31, 2015 and 2014 was $ 4,086 9,593 Expenses for clinical trials are incurred from planning through patient enrollment to reporting of the data. The Company estimates expenses incurred for clinical trials that are in process based on patient enrollment and based on clinical data collection and management. Costs that are associated with patient enrollment are recognized as each patient in the clinical trial completes the enrollment process. Estimated clinical trial costs related to enrollment can vary based on numerous factors, including expected number of patients in trials, the number of patients that do not complete participation in a trial, and the length of participation for each patient. Costs that are based on clinical data collection and management are recognized in the reporting period in which services are provided. In the event of early termination of a clinical trial, the Company accrues an amount based on estimates of the remaining non-cancelable obligations associated with winding down the clinical trial. As of December 31, 2015 and 2014, clinical trial accruals were $ 187,322 262,997 Income tax expense is accounted for in accordance with authoritative guidance issued by FASB. Income tax expense has been provided using the asset and liability method. Deferred tax assets and liabilities are determined based on the difference between the financial statement and tax bases of assets and liabilities as measured by the enacted tax rates that will be in effect when these differences reverse. The Company provides a valuation allowance against net deferred tax assets if, based upon the available evidence, it is not more likely than not that the deferred tax assets will be realized. The Company accounts for uncertain tax positions pursuant to the guidance of FASB Accounting Standards Codification Topic 740, Income Taxes Revenue for product sales is not recognized until it is realized or realizable and earned. Revenue is recognized when all of the following criteria are met: persuasive evidence of an arrangement exists, delivery has occurred or services have been rendered, the price to the buyer is fixed and determinable and collectibility is reasonably assured. Net loss per share (basic and diluted) was computed by dividing net loss attributable to common shareholders by the weighted average number of shares of common stock outstanding. Outstanding options and warrants totaling 10,705,647 8,568,585 The Company records compensation expense associated with service, performance, market condition based stock options and other equity-based compensation in accordance with provisions of authoritative guidance. The fair value of awards whose fair values are calculated using the Black-Scholes option pricing model is generally being amortized on a straight-line basis over the requisite service period and is recognized based on the proportionate amount of the requisite service period that has been rendered during each reporting period. The fair value of awards with market conditions, which are valued using a binomial model, is being amortized based upon the derived service period. Share based awards granted to employees with a are measured based on the probable outcome of that during the requisite service period. Awards with will be expensed if it is probable that the will be achieved. During the year ended December 31, 2014, $ 686,600 The Company has implemented all new accounting pronouncements that are in effect and that may impact the Company’s consolidated financial statements. In August 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standard Update (“ASU”) 2014-15, Presentation of Financial Statements Going Concern In May 2014, the FASB issued ASU 2014-09, Revenue from Contracts with Customers, In April 2015, the FASB issued an accounting standards update amending the presentation of debt issuance costs. These costs will now be presented as a direct reduction from the carrying amount of that debt liability. The update is effective for financial statements issued for reporting periods beginning after December 15, 2015. This guidance should be applied on a retrospective basis with disclosures for a change in accounting principle, if applicable. The Company adopted this update on January 1, 2016. The adoption of this guidance did not have an impact on the Company’s consolidated financial statements. In November 2015, the FASB issued new guidance on the balance sheet classification of deferred taxes. To simplify presentation, the new guidance requires that all deferred tax assets and liabilities, along with any related valuation allowance, be classified as noncurrent on the balance sheet . In January 2016, the FASB issued a new accounting standard on recognition and measurement of financial assets and financial liabilities. The accounting standard primarily affects the accounting for equity investments, financial liabilities under the fair value option, and the presentation and disclosure requirements for financial instruments. In addition, it includes a clarification related to the valuation allowance assessment when recognizing deferred tax assets resulting from unrealized losses on available-for-sale debt securities. The accounting guidance is effective for annual reporting periods (including interim periods within those periods) beginning after December 15, 2017. Early adoption is permitted for the provision to record fair value changes for financial liabilities under the fair value option resulting from instrument-specific credit risk in other comprehensive income. The Company is currently evaluating the impact, if any, that the pronouncement will have on the consolidated financial statements. Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of cash and cash equivalents and accounts receivable. The Company maintains its cash in bank deposit accounts, which, at times, may exceed federally insured amounts. The Company believes it is not exposed to significant credit risk on cash and cash equivalents. The carrying amount of current assets and liabilities approximates their fair values due to their short-term maturities. The preparation of consolidated financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. The Company’s most critical accounting estimates relate to accounting policies for derivatives, notes payable valuation, clinical trial accruals and share-based arrangements. Management bases its estimates on historical experience and on various other assumptions that it believes are reasonable under the circumstances. Actual results may differ from those estimates, and such differences may be material to the consolidated financial statements. The Company entered into investment agreements with Spectrum (see Note 4) resulting in a purchase price derivative. In accordance with GAAP, derivative instruments are recognized as either assets or liabilities on the consolidated balance sheets and are measured at fair value with gains or losses recognized in earnings or other comprehensive income depending on the nature of the derivative. The Company determines the fair value of derivative instruments based on available market data using appropriate valuation models, giving consideration to all of the rights and obligations of each instrument. The derivative liability is re-measured at fair value at the end of each reporting period as long as it is outstanding. |
RELATED PARTY TRANSACTIONS
RELATED PARTY TRANSACTIONS | 12 Months Ended |
Dec. 31, 2015 | |
Related Party Transactions [Abstract] | |
Related Party Transactions Disclosure [Text Block] | 3. RELATED PARTY TRANSACTIONS In 2015, the Company began utilizing the services of Crown Biosciences, Inc. (“Crown Bio”) to perform certain research and development testing. The CEO of Crown Bio is also a board member of CASI. The total value of the services is $ 66,545 20,898 33,648 In October 2015, the Company entered into a material transfer and research agreement with Origene Technologies, Inc. (“Origene”) for certain research materials. The CEO of Origene is also the Chairman of the Board of CASI. No materials have been purchased as of December 31, 2015, and there is no minimum commitment associated with this agreement. |
LICENSE ARRANGEMENTS AND ACQUIS
LICENSE ARRANGEMENTS AND ACQUISITION OF IN-PROCESS RESEARCH AND DEVELOPMENT | 12 Months Ended |
Dec. 31, 2015 | |
Research and Development [Abstract] | |
Research, Development, and Computer Software Disclosure [Text Block] | 4. LICENSE ARRANGEMENTS AND ACQUISITION OF IN-PROCESS RESEARCH AND DEVELOPMENT In September 2014, the Company acquired certain product rights and perpetual exclusive licenses from Spectrum to develop and commercialize the following commercial oncology drugs and drug candidates in China, Taiwan, Hong Kong and Macau (the “Territories”): · MARQIBO ® · ZEVALIN ® · EVOMELA CASI is responsible for developing and commercializing these three drugs in the Territories, including the submission of import drug registration applications and conducting confirmatory clinical trials as needed. The Company has initiated the regulatory and development process to obtain marketing approval for MARQIBO ® ® ® ® As consideration for the acquisition from Spectrum, the Company issued a total 5,405,382 1.5 0.5 19.7 The fair value of the common stock issued was based on the closing market price of the Company’s common stock on the acquisition date. The fair value of the promissory note was measured using Level 3 unobservable inputs including primarily the Company’s estimated incremental borrowing rate as provided by a commercial lending institution. The Contingent Rights provide Spectrum with the option to acquire, at a strike price of par value, a variable number of additional shares of common stock that allows Spectrum to maintain its fully-diluted ownership percentage for a certain time period and under certain terms and conditions. These Contingent Rights will expire on the earlier of raising an aggregate of $50 million or September 17, 2019 (subject to possible extension only for certain outstanding derivative securities). Based on the terms and conditions of the Contingent Rights, the Company has determined that the Contingent Rights are a derivative financial instrument that is not indexed to its common stock and therefore is required to be accounted for at fair value, initially and on a recurring basis. The fair value of the Contingent Rights was measured using Level 3 unobservable inputs; the unobservable inputs include estimates of the Company’s future capital requirements, and the timing, probability, size and characteristics of those capital raises, among other inputs. The total estimated fair value of the Contingent Rights was $ 9,395,222 9,422,735 As a result of the Initial Closing (see Note 8), Spectrum exercised its Contingent Rights in February 2016, and the Company issued Spectrum 1,688,877 1,922,312 |
NOTE PAYABLE
NOTE PAYABLE | 12 Months Ended |
Dec. 31, 2015 | |
Debt Disclosure [Abstract] | |
Debt Disclosure [Text Block] | 5. NOTE PAYABLE As part of the license arrangements with Spectrum (see Note 4), the Company issued to Spectrum a $ 1.5 0.5 136,000 75,000 26,000 |
FAIR VALUE MEASUREMENTS
FAIR VALUE MEASUREMENTS | 12 Months Ended |
Dec. 31, 2015 | |
Fair Value Disclosures [Abstract] | |
Fair Value Disclosures [Text Block] | 6. FAIR VALUE MEASUREMENTS Fair value is the price that would be received from the sale of an asset or paid to transfer a liability assuming an orderly transaction in the most advantageous market at the measurement date. U.S. GAAP establishes a hierarchical disclosure framework which prioritizes and ranks the level of observability of inputs used in measuring fair value. These tiers include: · Level 1, defined as observable inputs such as quoted prices in active markets for identical assets; · Level 2, defined as observable inputs other than Level 1 prices such as quoted prices for similar assets; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities; and · Level 3, defined as unobservable inputs in which little or no market data exists, therefore requiring an entity to develop its own assumptions. An asset’s or liability’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. At each reporting period, the Company performs a detailed analysis of its assets and liabilities that are measured at fair value. All assets and liabilities for which the fair value measurement is based on significant unobservable inputs or instruments which trade infrequently and therefore have little or no price transparency are classified as Level 3. The inputs used in measuring the fair value of cash and cash equivalents are considered to be Level 1 in accordance with the three-tier fair value hierarchy. The fair market values are based on period-end statements supplied by the various banks and brokers that held the majority of the Company’s funds. The fair value of short-term financial instruments (primarily accounts receivable, prepaid expenses, accounts payable, accrued expenses, and other current assets and liabilities) approximate their carrying values because of their short-term nature. Financial Assets and Liabilities Measured at Fair Value on a Recurring Basis: The Contingent Rights issued to Spectrum in connection with the license arrangements (see Note 4) are considered derivative liabilities and were recorded initially at their estimated fair value, and are marked to market each reporting period until settlement. The fair value of the Contingent Rights was measured using Level 3 unobservable inputs; the unobservable inputs include estimates of the Company’s future capital requirements, and the timing, probability, size and characteristics of those capital raises, among other inputs. Generally, if the estimates of the size and probability of the Company’s future capital requirements increase, the fair value of the Contingent Rights will also increase. The following table presents the Company’s financial liabilities accounted for at fair value on a recurring basis as of December 31, 2015 and 2014 by level within the fair value hierarchy: As of December 31, 2015 Level 1 Level 2 Level 3 Total Liabilities - Contingent Rights $ - $ - $ 9,395,222 $ 9,395,222 As of December 31, 2014 Level 1 Level 2 Level 3 Total Liabilities - Contingent Rights $ - $ - $ 9,422,735 $ 9,422,735 December 31, 2014 $ 9,422,735 Change in fair value of Contingent Rights (27,513 ) Balance at December 31, 2015 $ 9,395,222 Financial Assets and Liabilities Measured at Fair Value on a Non-Recurring Basis: The promissory note issued to Spectrum in connection with the license arrangements (see Note 4) was initially recorded at its fair value using Level 3 unobservable inputs including primarily the Company’s estimated incremental borrowing rate as provided by a commercial lending institution. Non-Financial Assets and Liabilities Measured at Fair Value on a Recurring Basis: The Company does not have any non-financial assets and liabilities that are measured at fair value on a recurring basis. Non-Financial Assets and Liabilities Measured at Fair Value on a Non-Recurring Basis: The Company measures its long-lived assets, including property and equipment, at fair value on a non-recurring basis. These assets are recognized at fair value when they are deemed to be impaired. No such fair value impairment was recognized for the years ended December 31, 2015 and 2014. |
INCOME TAXES
INCOME TAXES | 12 Months Ended |
Dec. 31, 2015 | |
Income Tax Disclosure [Abstract] | |
Income Tax Disclosure [Text Block] | 7. INCOME TAXES The income tax provision is based on loss before income taxes of $ (5,670,207) (1,536,216) 352,574,000 9,291,000 20,000,000 DECEMBER 31, 2015 2014 Deferred income tax assets (liabilities): Net operating loss carryforwards $ 137,811,000 $ 135,607,000 Research and development credit carryforward 9,291,000 9,201,000 Intangible assets 7,273,000 8,079,000 Equity based compensation 4,510,000 4,316,000 Other 309,000 297,000 Valuation allowance for deferred income tax assets (159,194,000) (157,500,000) Net deferred income tax assets $ - $ - 2015 2014 Tax benefit at statutory rate $ (2,450,000) $ (8,909,000) State taxes (128,000) (1,273,000) Net R&D credit adjustment (101,000) (104,000) Attribute expiration and other - 8,000 Nondeductible expenses 5,000 4,000 Change in valuation allowance 1,694,000 9,631,000 Other 143,000 (38,000) Changes in applicable tax rates 837,000 681,000 $ - $ - The Company had $ 3,067,000 30,000 2015 2014 Unrecognized tax benefits balance at January 1 $ 3,067,000 $ 3,013,000 Additions for Tax Positions of Prior Periods - 20,000 Reductions for Tax Positions of Prior Periods (4,000) - Additions for Tax Positions of Current Period 34,000 34,000 Unrecognized tax benefits balance at December 31 $ 3,097,000 $ 3,067,000 The Company recognizes interest and penalties related to uncertain tax positions as a component of income tax expense. As of December 31, 2015 and 2014, the Company had no accrued interest or penalties related to uncertain tax positions, respectively. The tax returns for all years in the Company’s major tax jurisdictions are not settled as of December 31, 2015. Due to the existence of tax attribute carryforwards (which are currently offset by a full valuation allowance), the Company treats all years’ tax positions as unsettled due to the taxing authorities’ ability to modify these attributes. The Company believes that the total unrecognized tax benefit, if recognized, would impact the effective rate, however, such reversal may be offset by a corresponding adjustment to the valuation allowance. |
STOCKHOLDERS' EQUITY
STOCKHOLDERS' EQUITY | 12 Months Ended |
Dec. 31, 2015 | |
Stockholders' Equity Note [Abstract] | |
Stockholders' Equity Note Disclosure [Text Block] | 8. STOCKHOLDERS’ EQUITY SECURITIES PURCHASE AGREEMENTS As described in Note 1, on September 20, 2015, the Company entered into stock purchase agreements with certain institutional and accredited investors (the “Investors”) for a $ 25.1 20,658,434 1.19 4,131,686 20 0.125 1.69 The offering was expected to close after satisfaction of certain regulatory and customary closing conditions, with the net proceeds being subject to payment of offering expenses, including fees and expenses to be finalized prior to the closing. On January 15, 2016, the Company completed the Initial Closing and received approximately $ 10.3 10.2 8,448,613 1.19 1,689,722 0.125 1.69 321,047 0.19 3.25 70.1 1.08 The Company and Investors are working to close on the remaining $ 14.8 The Company has granted registration rights to the Investors and has agreed to file a resale registration statement covering the shares of common stock and the shares of common stock underlying the warrants within 120 days of the closing. |
SHARE-BASED COMPENSATION
SHARE-BASED COMPENSATION | 12 Months Ended |
Dec. 31, 2015 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Disclosure of Compensation Related Costs, Share-based Payments [Text Block] | 9. SHARE-BASED COMPENSATION The Company has adopted incentive and nonqualified stock option plans for executive, scientific and administrative personnel of the Company as well as outside directors and consultants. In June 2015, the Company’s shareholders approved an amendment to the 2011 Long-Term Incentive Plan, increasing the number of shares reserved for issuance from 5,730,000 8,230,000 6,694,744 1.30 19.36 963,000 1,957,876 On September 17, 2014, the vesting of all of the performance condition options awarded in 2014 became probable as a result of the Spectrum transaction discussed in Note 4. Therefore, for the year ended December 31, 2014, non-cash compensation expense of $ 686,600 For the year ended December 31, 2015, no expense was recorded for share awards with performance conditions. The Company’s net loss for the years ended December 31, 2015 and 2014 includes $ 1,541,192 2,189,102 2015 2014 Research and development $ 747,285 $ 690,409 General and administrative 793,907 1,498,693 Share-based compensation expense $ 1,541,192 $ 2,189,102 Net share-based compensation expense, per common share: Basic and diluted $ 0.05 $ 0.08 Stock Options The Company uses the Black-Scholes-Merton valuation model to estimate the fair value of service based and performance based stock options granted to employees. For market condition based options, the Company uses a binomial model to estimate fair value. These option valuation models require the input of highly subjective assumptions, and changes in the assumptions used can materially affect the grant date fair value of an award. These assumptions include the risk free rate of interest, expected dividend yield, expected volatility, and the expected life of the award. Expected VolatilityVolatility is a measure of the amount by which a financial variable such as a share price has fluctuated (historical volatility) or is expected to fluctuate (expected volatility) during a period. The Company uses the historical volatility based on the daily price observations of its common stock during the period immediately preceding the share-based award grant that is equal in length to the award’s expected term. The Company believes that historical volatility represents the best estimate of future long term volatility. Risk-Free Interest RateThis is the average interest rate consistent with the yield available on a U.S. Treasury note (with a term equal to the expected term of the underlying grants) at the date the option was granted. Expected Term of OptionsThis is the period of time that the options granted are expected to remain outstanding. The Company uses a simplified method for estimating the expected term of service based awards granted. For performance based and market based awards, the expected term of service is based on the derived service period. Expected Dividend YieldThe Company has never declared or paid dividends on its common stock and does not anticipate paying any dividends in the foreseeable future. As such, the dividend yield percentage is assumed to be zero. Forfeiture RateThis is the estimated percentage of options granted that are expected to be forfeited or cancelled on an annual basis before becoming fully vested. The Company estimates the forfeiture rate based on historical forfeiture experience for similar levels of employees to whom options were granted. Years ended December 31, 2015 2014 Expected volatility 85.17 % 102.41 % Risk free interest rate 1.57 % 1.78 % Expected term of option 5.67 years 5.63 years Forfeiture rate *3.00 % *3.00 % Expected dividend yield - - *-Throughout 2015 and 2014, forfeitures were estimated at 3 0 1 The weighted average fair value of stock options granted was $ 1.02 1.44 Share-based compensation expense recognized in the consolidated statements of operations is based on awards ultimately expected to vest, net of estimated forfeitures. The authoritative guidance requires forfeitures to be estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. Weighted Average Weighted Average Aggregate Number Exercise Remaining Intrinsic of Options Price Contractual Term In years Value Outstanding at December 31, 2013 3,586,394 $ 2.69 Exercised - $ - Granted 1,090,000 $ 1.83 Expired (107,168) $ 6.21 Forfeited (11,544) $ 1.78 Outstanding at December 31, 2014 4,557,682 $ 2.40 Exercised - $ - Granted 2,775,000 $ 1.43 Expired (637,938) $ 2.47 Forfeited - $ - Outstanding at December 31, 2015 6,694,744 $ 1.99 7.80 $ - Vested and expected to vest at December 31, 2015 6,634,597 $ 1.99 7.73 $ - Exercisable at December 31, 2015 4,689,850 $ 2.20 7.30 $ - The aggregate intrinsic value is calculated as the difference between (i) the closing price of the common stock at December 31, 2015 and (ii) the weighted average exercise price of the underlying awards, multiplied by the number of options that had an exercise price less than the closing price on the last trading day of the year. There were no options exercised in 2015 or 2014. Options Outstanding Options Exercisable Weighted Average Weighted Weighted Number Remaining Average Number Average Range of Outstanding at Contractual Exercise Exercisable at Exercise Exercise Prices December 31, 2015 Life in Years Price December 31, 2015 Price $0.00 - $2.00 5,982,678 8.1 $ 1.68 3,977,784 $ 1.77 $2.01 - $5.00 475,000 6.2 $ 2.26 475,000 $ 2.26 $5.01 - $10.00 176,540 4.6 $ 6.56 176,540 $ 6.56 $10.01 - $15.00 5,268 2.0 $ 13.75 5,268 $ 13.75 $15.01 - $20.00 55,258 0.9 $ 17.64 55,258 $ 17.64 6,694,744 7.8 $ 1.99 4,689,850 $ 2.20 As of December 31, 2015, there was approximately $ 966,000 1.2 Warrants 3 5 Weighted Average Number of Shares Exercise Price Outstanding at December 31, 2013 4,321,565 $ 2.31 Granted - $ - Exercised - $ - Expired 310,662 $ 2.83 Outstanding at December 31, 2014 4,010,903 $ 2.27 Granted - $ - Exercised - $ - Expired $ - Outstanding at December 31, 2015 4,010,903 $ 2.27 Exercisable at December 31, 2015 4,010,903 $ 2.27 |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 12 Months Ended |
Dec. 31, 2015 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies Disclosure [Text Block] | 10. COMMITMENTS AND CONTINGENCIES COMMITMENTS ENMD-2076. In January 2006, the Company acquired Miikana, a private biotechnology company. Pursuant to the Merger Agreement, the Company acquired all of the outstanding capital stock of Miikana Therapeutics, Inc. In 2008, the Company initiated a Phase 1 clinical trial with its Aurora A and angiogenic kinase inhibitor, ENMD-2076, in patients with solid tumors. A dosing of the first patient with ENMD-2076 triggered a purchase price adjustment milestone of $ 2 3 4 9 4 MKC-1. The Company acquired rights to MKC-1, a Phase 2 clinical candidate licensed from Hoffman-LaRoche, Inc. (“Roche”) by Miikana in April 2005. Under the terms of the agreement, Roche may be entitled to receive future payments upon successful completion of Phase 3 developmental milestones. The Company does not anticipate reaching any of these milestones in 2016. Roche is also eligible to receive royalties on sales and certain one-time payments based on attainment of annual sales milestones. The Company is also obligated to make certain “success fee” payments to ProPharma based on successful completion of developmental milestones under the Roche license agreement. MKC-1 is currently not under active clinical evaluation and the Company has no plans to advance the program. 2ME2 NCD (2-methoxyestradiol, NanoCrystal Dispersion, 2ME2 NCD) for Oncology. In January 2006, the Company entered into a License Agreement with Elan Corporation, plc (“Elan”) in which the Company has been granted rights to utilize Elan’s proprietary NanoCrystal Technology in connection with the development of the oncology product candidate, 2ME2 using its nanocrystal dispersion formulation. Under the terms of the License Agreement, Elan is eligible to receive payments upon the achievement of certain milestones and to receive royalty payments based on sales of 2ME2 NCD. Additionally, under the agreement and the corresponding Services Agreement, Elan has the right to manufacture the Company’s 2ME2 NCD. Milestones related to the initiation of Phase 2 clinical trials for 2ME2 NCD have been paid and there are no additional milestones achieved as of December 31, 2015. The Company has discontinued clinical development of the NCD formulation of 2ME2. Endostatin and Angiostatin for Eye Diseases. The Company is a party to a February 2004 agreement with Children’s Medical Center Corporation (“CMCC”) and Alchemgen Therapeutics pertaining to Endostatin and Angiostatin proteins, programs which have been discontinued by the Company, and pursuant to which Alchemgen received rights to market Endostatin and Angiostatin in Asia. In April 2008, the Company was advised that Alchemgen Therapeutics ceased operations, therefore eliminating the Company’s ability to receive any royalties from Alchemgen under the agreement. However, the Company is a party to a sublicense agreement with Oxford BioMedica PLC (“Oxford”) to develop and market Endostatin and Angiostatin for ophthalmologic (eye) diseases. Pursuant to this sublicense, the Company is eligible to receive a portion of upfront payments and royalties from Oxford based on a portion of the payments received and net sales of gene products of Endostatin and Angiostatin and certain development milestone payments. There was no royalty payment received in 2015 or 2014. The Company does not control the drug development efforts of Oxford and has no information or control over when or whether any milestones will be reached that would result in additional payments to the Company in 2016 or beyond. Pursuant to the Company’s commitments for ENMD-2076, it could potentially pay $ 4 41 With respect to the Company’s in-licensed drug candidates for the Greater China market, the Company does not have to pay any milestone payments or royalties to Spectrum; however, CASI is responsible for paying royalties or milestones, if and when applicable, owed by Spectrum to upstream licensors that licensed related technology to Spectrum in accordance with the terms of the relevant upstream licenses, and only to the extent of the Greater China portion of such upstream royalties or milestones. The Company’s sales of Zevalin in Hong Kong are subject to royalties. In 2015, the Company paid royalties of approximately $ 9,500 ® ® ® As of December 31, 2015, the Company also has purchase obligation commitments, in the normal course of business, for clinical trial contracts totaling approximately $ 690,000 The Company leases its principal executive offices in Rockville, MD under a lease agreement that continues through December 31, 2016. Effective February 23, 2016, the Company extended the lease through December 31, 2019, under the same terms. The Company leases office space in China under a lease agreement that continues through June 2017. Effective February 1, 2016, the Company renewed a one year lease in China for lab space. 2016 $ 350,744 2017 265,773 2018 159,959 2019 84,000 Thereafter - Total minimum payments $ 860,476 Rental expense for the years ended December 31, 2015 and 2014 was approximately $ 309,000 240,000 CONTINGENCIES The Company is subject in the normal course of business to various legal proceedings in which claims for monetary or other damages may be asserted. Management does not believe such legal proceedings, unless otherwise disclosed herein, are material. |
EMPLOYEE RETIREMENT PLAN
EMPLOYEE RETIREMENT PLAN | 12 Months Ended |
Dec. 31, 2015 | |
Compensation and Retirement Disclosure [Abstract] | |
Compensation and Employee Benefit Plans [Text Block] | 11. EMPLOYEE RETIREMENT PLAN The Company sponsors the CASI Pharmaceuticals, Inc. 401(k) and Trust. The plan covers substantially all employees and enables participants to contribute a portion of salary and wages on a tax-deferred basis. Contributions to the plan by the Company are discretionary. Contributions by the Company totaled approximately $ 29,200 28,400 |
SUMMARY OF SIGNIFICANT ACCOUN18
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 12 Months Ended |
Dec. 31, 2015 | |
Accounting Policies [Abstract] | |
Segment Reporting, Policy [Policy Text Block] | SEGMENT INFORMATION The Company currently operates in one business segment, which is the development of targeted therapeutics primarily for the treatment of cancer. The Company is managed and operated as one business. CASI’s senior management team reports to the Board of Directors and is responsible for aligning the Company’s business strategy with its core scientific strengths, while maintaining prudent resource management, fiscal responsibility and accountability. The Company employs a drug development strategy in the United States and China to develop targeted therapeutics for the global market and its current lead drug candidate is ENMD-2076, an Aurora A and angiogenic kinase inhibitor for the treatment of cancer. The Company does not operate separate lines of business with respect to its product candidates. Accordingly, the Company does not have separately reportable segments as defined by authoritative guidance issued by the Financial Accounting Standards Board (FASB). |
Research and Development Expense, Policy [Policy Text Block] | Research and development expenses consist primarily of compensation and other expenses related to research and development personnel, research collaborations, costs associated with pre-clinical correlative testing and clinical trials of the Company’s drug candidates, including the costs of manufacturing drug substance and drug product, regulatory maintenance costs, and facilities expenses. Research and development costs are expensed as incurred. |
Property, Plant and Equipment, Policy [Policy Text Block] | PROPERTY AND EQUIPMENT Furniture and equipment and leasehold improvements are stated at cost and are depreciated over their estimated useful lives of 3 5 68,381 48,179 DECEMBER 31, 2015 2014 Furniture and equipment $ 505,946 $ 480,550 Leasehold improvements 6,382 6,382 512,328 486,932 Less: accumulated depreciation and amortization (293,532) (225,151) $ 218,796 $ 261,781 |
Impairment or Disposal of Long-Lived Assets, Policy [Policy Text Block] | IMPAIRMENT OF LONG-LIVED ASSETS In accordance with authoritative guidance issued by the FASB, the Company periodically evaluates the value reflected in its consolidated balance sheets of long-lived assets, such as equipment, when events and circumstances indicate that the carrying amount of an asset may not be recovered. Such events and circumstances include the use of the asset in current research and development projects, any potential alternative uses of the asset in other research and development projects in the short to medium term and restructuring plans entered into by the Company. No impairment charges were recorded in 2015 and 2014. |
Cash and Cash Equivalents, Policy [Policy Text Block] | CASH AND CASH EQUIVALENTS Cash and cash equivalents include cash and highly liquid investments with original maturities of less than 90 days. Substantially all of the Company’s cash equivalents are held in short-term money market accounts. |
Receivables, Policy [Policy Text Block] | ACCOUNTS RECEIVABLE Accounts receivable are stated net of allowances for doubtful accounts. Allowances for doubtful accounts are determined on a specific item basis. Management reviews the credit worthiness of individual customers and past payment history to determine the allowance for doubtful accounts. There was an allowance for doubtful accounts of $ 12,536 For the years ended December 31, 2015 and 2014, one customer represented 100 100 |
Foreign Currency Transactions and Translations Policy [Policy Text Block] | FOREIGN CURRENCY TRANSLATION The U.S. dollar is the functional and reporting currency of the Company. Foreign currency denominated assets and liabilities of the Company and all of its subsidiaries are translated into U.S. dollars. Accordingly, monetary assets and liabilities are translated using the exchange rates in effect at the consolidated balance sheet date and revenues and expenses at the rates of exchange prevailing when the transactions occurred. Remeasurement adjustments are included in income (loss). |
Deferred Charges, Policy [Policy Text Block] | DEFERRED RENT The Company accounts for rent expense related to operating leases by determining total minimum rent payments on the leases over their respective periods and recognizing the rent expense on a straight-line basis. The difference between the actual amount paid and the amount recorded as rent expense in each fiscal year is recorded as an adjustment to deferred rent. Deferred rent as of December 31, 2015 and 2014 was $ 4,086 9,593 |
Expenses For Clinical Trials [Policy Text Block] | EXPENSES FOR CLINICAL TRIALS Expenses for clinical trials are incurred from planning through patient enrollment to reporting of the data. The Company estimates expenses incurred for clinical trials that are in process based on patient enrollment and based on clinical data collection and management. Costs that are associated with patient enrollment are recognized as each patient in the clinical trial completes the enrollment process. Estimated clinical trial costs related to enrollment can vary based on numerous factors, including expected number of patients in trials, the number of patients that do not complete participation in a trial, and the length of participation for each patient. Costs that are based on clinical data collection and management are recognized in the reporting period in which services are provided. In the event of early termination of a clinical trial, the Company accrues an amount based on estimates of the remaining non-cancelable obligations associated with winding down the clinical trial. As of December 31, 2015 and 2014, clinical trial accruals were $ 187,322 262,997 |
Income Tax, Policy [Policy Text Block] | Income tax expense is accounted for in accordance with authoritative guidance issued by FASB. Income tax expense has been provided using the asset and liability method. Deferred tax assets and liabilities are determined based on the difference between the financial statement and tax bases of assets and liabilities as measured by the enacted tax rates that will be in effect when these differences reverse. The Company provides a valuation allowance against net deferred tax assets if, based upon the available evidence, it is not more likely than not that the deferred tax assets will be realized. The Company accounts for uncertain tax positions pursuant to the guidance of FASB Accounting Standards Codification Topic 740, Income Taxes |
Revenue Recognition, Policy [Policy Text Block] | REVENUE RECOGNITION Revenue for product sales is not recognized until it is realized or realizable and earned. Revenue is recognized when all of the following criteria are met: persuasive evidence of an arrangement exists, delivery has occurred or services have been rendered, the price to the buyer is fixed and determinable and collectibility is reasonably assured. |
Earnings Per Share, Policy [Policy Text Block] | NET LOSS PER SHARE Net loss per share (basic and diluted) was computed by dividing net loss attributable to common shareholders by the weighted average number of shares of common stock outstanding. Outstanding options and warrants totaling 10,705,647 8,568,585 |
Share-based Compensation, Option and Incentive Plans Policy [Policy Text Block] | SHARE-BASED COMPENSATION The Company records compensation expense associated with service, performance, market condition based stock options and other equity-based compensation in accordance with provisions of authoritative guidance. The fair value of awards whose fair values are calculated using the Black-Scholes option pricing model is generally being amortized on a straight-line basis over the requisite service period and is recognized based on the proportionate amount of the requisite service period that has been rendered during each reporting period. The fair value of awards with market conditions, which are valued using a binomial model, is being amortized based upon the derived service period. Share based awards granted to employees with a are measured based on the probable outcome of that during the requisite service period. Awards with will be expensed if it is probable that the will be achieved. During the year ended December 31, 2014, $ 686,600 |
New Accounting Pronouncements, Policy [Policy Text Block] | NEW ACCOUNTING PRONOUNCEMENTS The Company has implemented all new accounting pronouncements that are in effect and that may impact the Company’s consolidated financial statements. In August 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standard Update (“ASU”) 2014-15, Presentation of Financial Statements Going Concern In May 2014, the FASB issued ASU 2014-09, Revenue from Contracts with Customers, In April 2015, the FASB issued an accounting standards update amending the presentation of debt issuance costs. These costs will now be presented as a direct reduction from the carrying amount of that debt liability. The update is effective for financial statements issued for reporting periods beginning after December 15, 2015. This guidance should be applied on a retrospective basis with disclosures for a change in accounting principle, if applicable. The Company adopted this update on January 1, 2016. The adoption of this guidance did not have an impact on the Company’s consolidated financial statements. In November 2015, the FASB issued new guidance on the balance sheet classification of deferred taxes. To simplify presentation, the new guidance requires that all deferred tax assets and liabilities, along with any related valuation allowance, be classified as noncurrent on the balance sheet . In January 2016, the FASB issued a new accounting standard on recognition and measurement of financial assets and financial liabilities. The accounting standard primarily affects the accounting for equity investments, financial liabilities under the fair value option, and the presentation and disclosure requirements for financial instruments. In addition, it includes a clarification related to the valuation allowance assessment when recognizing deferred tax assets resulting from unrealized losses on available-for-sale debt securities. The accounting guidance is effective for annual reporting periods (including interim periods within those periods) beginning after December 15, 2017. Early adoption is permitted for the provision to record fair value changes for financial liabilities under the fair value option resulting from instrument-specific credit risk in other comprehensive income. The Company is currently evaluating the impact, if any, that the pronouncement will have on the consolidated financial statements. |
Fair Value Of Financial Instruments And Concentrations Of Risk [Policy Text Block] | FAIR VALUE OF FINANCIAL INSTRUMENTS AND CONCENTRATIONS OF CREDIT RISK Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of cash and cash equivalents and accounts receivable. The Company maintains its cash in bank deposit accounts, which, at times, may exceed federally insured amounts. The Company believes it is not exposed to significant credit risk on cash and cash equivalents. The carrying amount of current assets and liabilities approximates their fair values due to their short-term maturities. |
Use of Estimates, Policy [Policy Text Block] | USE OF ESTIMATES The preparation of consolidated financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. The Company’s most critical accounting estimates relate to accounting policies for derivatives, notes payable valuation, clinical trial accruals and share-based arrangements. Management bases its estimates on historical experience and on various other assumptions that it believes are reasonable under the circumstances. Actual results may differ from those estimates, and such differences may be material to the consolidated financial statements. |
Derivatives, Policy [Policy Text Block] | DERIVATIVES The Company entered into investment agreements with Spectrum (see Note 4) resulting in a purchase price derivative. In accordance with GAAP, derivative instruments are recognized as either assets or liabilities on the consolidated balance sheets and are measured at fair value with gains or losses recognized in earnings or other comprehensive income depending on the nature of the derivative. The Company determines the fair value of derivative instruments based on available market data using appropriate valuation models, giving consideration to all of the rights and obligations of each instrument. The derivative liability is re-measured at fair value at the end of each reporting period as long as it is outstanding. |
SUMMARY OF SIGNIFICANT ACCOUN19
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Accounting Policies [Abstract] | |
Property, Plant and Equipment [Table Text Block] | DECEMBER 31, 2015 2014 Furniture and equipment $ 505,946 $ 480,550 Leasehold improvements 6,382 6,382 512,328 486,932 Less: accumulated depreciation and amortization (293,532) (225,151) $ 218,796 $ 261,781 |
FAIR VALUE MEASUREMENTS (Tables
FAIR VALUE MEASUREMENTS (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |
Fair Value, Liabilities Measured on Recurring Basis [Table Text Block] | The following table presents the Company’s financial liabilities accounted for at fair value on a recurring basis as of December 31, 2015 and 2014 by level within the fair value hierarchy: As of December 31, 2015 Level 1 Level 2 Level 3 Total Liabilities - Contingent Rights $ - $ - $ 9,395,222 $ 9,395,222 As of December 31, 2014 Level 1 Level 2 Level 3 Total Liabilities - Contingent Rights $ - $ - $ 9,422,735 $ 9,422,735 |
Fair Value, Inputs, Level 3 [Member] | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Table Text Block] | The following table presents the changes in the Company’s financial liabilities accounted for at fair value on a recurring basis using Level 3 unobservable inputs: December 31, 2014 $ 9,422,735 Change in fair value of Contingent Rights (27,513 ) Balance at December 31, 2015 $ 9,395,222 |
INCOME TAXES (Tables)
INCOME TAXES (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Income Tax Disclosure [Abstract] | |
Schedule of Deferred Tax Assets and Liabilities [Table Text Block] | Deferred income taxes reflect the net effect of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. DECEMBER 31, 2015 2014 Deferred income tax assets (liabilities): Net operating loss carryforwards $ 137,811,000 $ 135,607,000 Research and development credit carryforward 9,291,000 9,201,000 Intangible assets 7,273,000 8,079,000 Equity based compensation 4,510,000 4,316,000 Other 309,000 297,000 Valuation allowance for deferred income tax assets (159,194,000) (157,500,000) Net deferred income tax assets $ - $ - |
Schedule of Effective Income Tax Rate Reconciliation [Table Text Block] | A reconciliation of the provision for income taxes to the federal statutory rate is as follows: 2015 2014 Tax benefit at statutory rate $ (2,450,000) $ (8,909,000) State taxes (128,000) (1,273,000) Net R&D credit adjustment (101,000) (104,000) Attribute expiration and other - 8,000 Nondeductible expenses 5,000 4,000 Change in valuation allowance 1,694,000 9,631,000 Other 143,000 (38,000) Changes in applicable tax rates 837,000 681,000 $ - $ - |
Schedule of Unrecognized Tax Benefits Roll Forward [Table Text Block] | 2015 2014 Unrecognized tax benefits balance at January 1 $ 3,067,000 $ 3,013,000 Additions for Tax Positions of Prior Periods - 20,000 Reductions for Tax Positions of Prior Periods (4,000) - Additions for Tax Positions of Current Period 34,000 34,000 Unrecognized tax benefits balance at December 31 $ 3,097,000 $ 3,067,000 |
SHARE-BASED COMPENSATION (Table
SHARE-BASED COMPENSATION (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Schedule of Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Table Text Block] | 2015 2014 Research and development $ 747,285 $ 690,409 General and administrative 793,907 1,498,693 Share-based compensation expense $ 1,541,192 $ 2,189,102 Net share-based compensation expense, per common share: Basic and diluted $ 0.05 $ 0.08 |
Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions [Table Text Block] | Following are the weighted-average assumptions used in valuing the stock options granted to employees during the years ended December 31, 2015 and 2014: Years ended December 31, 2015 2014 Expected volatility 85.17 % 102.41 % Risk free interest rate 1.57 % 1.78 % Expected term of option 5.67 years 5.63 years Forfeiture rate *3.00 % *3.00 % Expected dividend yield - - *-Throughout 2015 and 2014, forfeitures were estimated at 3 0 1 |
Schedule of Share-based Compensation, Stock Options, Activity [Table Text Block] | Weighted Average Weighted Average Aggregate Number Exercise Remaining Intrinsic of Options Price Contractual Term In years Value Outstanding at December 31, 2013 3,586,394 $ 2.69 Exercised - $ - Granted 1,090,000 $ 1.83 Expired (107,168) $ 6.21 Forfeited (11,544) $ 1.78 Outstanding at December 31, 2014 4,557,682 $ 2.40 Exercised - $ - Granted 2,775,000 $ 1.43 Expired (637,938) $ 2.47 Forfeited - $ - Outstanding at December 31, 2015 6,694,744 $ 1.99 7.80 $ - Vested and expected to vest at December 31, 2015 6,634,597 $ 1.99 7.73 $ - Exercisable at December 31, 2015 4,689,850 $ 2.20 7.30 $ - |
Schedule of Share-based Compensation, Shares Authorized under Stock Option Plans, by Exercise Price Range [Table Text Block] | Options Outstanding Options Exercisable Weighted Average Weighted Weighted Number Remaining Average Number Average Range of Outstanding at Contractual Exercise Exercisable at Exercise Exercise Prices December 31, 2015 Life in Years Price December 31, 2015 Price $0.00 - $2.00 5,982,678 8.1 $ 1.68 3,977,784 $ 1.77 $2.01 - $5.00 475,000 6.2 $ 2.26 475,000 $ 2.26 $5.01 - $10.00 176,540 4.6 $ 6.56 176,540 $ 6.56 $10.01 - $15.00 5,268 2.0 $ 13.75 5,268 $ 13.75 $15.01 - $20.00 55,258 0.9 $ 17.64 55,258 $ 17.64 6,694,744 7.8 $ 1.99 4,689,850 $ 2.20 |
Warrant Activity To Non Employees [Table Text Block] | 3 5 Weighted Average Number of Shares Exercise Price Outstanding at December 31, 2013 4,321,565 $ 2.31 Granted - $ - Exercised - $ - Expired 310,662 $ 2.83 Outstanding at December 31, 2014 4,010,903 $ 2.27 Granted - $ - Exercised - $ - Expired $ - Outstanding at December 31, 2015 4,010,903 $ 2.27 Exercisable at December 31, 2015 4,010,903 $ 2.27 |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of Future Minimum Rental Payments for Operating Leases [Table Text Block] | 2016 $ 350,744 2017 265,773 2018 159,959 2019 84,000 Thereafter - Total minimum payments $ 860,476 |
DESCRIPTION OF BUSINESS AND B24
DESCRIPTION OF BUSINESS AND BASIS OF PRESENTATION (Details Textual) - USD ($) | Jan. 15, 2016 | Jan. 31, 2016 | Dec. 31, 2015 | Sep. 30, 2015 | Dec. 31, 2014 |
Description of Business and Basis of Presentation [Line Items] | |||||
Retained Earnings (Accumulated Deficit), Total | $ (432,478,339) | $ (425,271,916) | |||
Percentage Of Ownership Interest In Non Stock Subsidiary | 100.00% | ||||
Subsequent Event [Member] | Initial Closing [Member] | |||||
Description of Business and Basis of Presentation [Line Items] | |||||
Proceeds from Issuance of Common Stock | $ 10,300,000 | $ 10,300,000 | |||
Subsequent Event [Member] | Second Closing [Member] | |||||
Description of Business and Basis of Presentation [Line Items] | |||||
Stock purchase Program, Remaining Authorized Issue Amount | $ 14,800,000 | ||||
Investorms [Member] | |||||
Description of Business and Basis of Presentation [Line Items] | |||||
Maximum Stock To Be Issued | $ 25,100,000 |
SUMMARY OF SIGNIFICANT ACCOUN25
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details) - USD ($) | Dec. 31, 2015 | Dec. 31, 2014 |
Property, Plant and Equipment [Line Items] | ||
Furniture and equipment | $ 505,946 | $ 480,550 |
Leasehold improvements | 6,382 | 6,382 |
Property, Plant and Equipment, Gross | 512,328 | 486,932 |
Less: accumulated depreciation and amortization | (293,532) | (225,151) |
Property, Plant and Equipment, Net | $ 218,796 | $ 261,781 |
SUMMARY OF SIGNIFICANT ACCOUN26
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details Textual) - USD ($) | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Accounting Policies [Line Items] | ||
Clinical Trial Accruals | $ 187,322 | $ 262,997 |
Depreciation | 68,381 | 48,179 |
Allowance for doubtful accounts | 12,536 | |
Deferred Rent Credit, Current | 4,086 | 9,593 |
Performance Shares [Member] | ||
Accounting Policies [Line Items] | ||
Allocated Share-based Compensation Expense | $ 0 | $ 686,600 |
Options And Warrants [Member] | ||
Accounting Policies [Line Items] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 10,705,647 | 8,568,585 |
One Customer [Member] | Sales Revenue, Net [Member] | ||
Accounting Policies [Line Items] | ||
Concentration Risk, Percentage | 100.00% | 100.00% |
One Customer [Member] | Accounts Receivable [Member] | ||
Accounting Policies [Line Items] | ||
Concentration Risk, Percentage | 100.00% | |
Minimum [Member] | ||
Accounting Policies [Line Items] | ||
Property, Plant and Equipment, Useful Life | 3 years | |
Maximum [Member] | ||
Accounting Policies [Line Items] | ||
Property, Plant and Equipment, Useful Life | 5 years |
RELATED PARTY TRANSACTIONS (Det
RELATED PARTY TRANSACTIONS (Details Textual) - USD ($) | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Research and Development Expense, Total | $ 4,075,572 | $ 2,765,492 |
Crown Biosciences, Inc [Member] | ||
Related Party Transaction, Amounts of Transaction | 66,545 | |
Research and Development Expense, Total | 33,648 | |
Due to Related Parties, Current | $ 20,898 |
LICENSE ARRANGEMENTS AND ACQU28
LICENSE ARRANGEMENTS AND ACQUISITION OF IN-PROCESS RESEARCH AND DEVELOPMENT (Details Textual) - USD ($) | 1 Months Ended | 12 Months Ended | |
Feb. 29, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
License Arrangements and Acquisition of In Process Research and Development [Line Items] | |||
Fair Value, Measurement with Unobservable Inputs Reconciliations, Recurring Basis, Liability Value | $ 9,395,222 | $ 9,422,735 | |
Debt Instrument, Maturity Date, Description | March 2,017 | ||
Notes Payable, Noncurrent | $ 1,464,970 | 1,390,015 | |
Contingent Rights Expiration | These Contingent Rights will expire on the earlier of raising an aggregate of $50 million or September 17, 2019 (subject to possible extension only for certain outstanding derivative securities). | ||
Licensing Agreements [Member] | |||
License Arrangements and Acquisition of In Process Research and Development [Line Items] | |||
Fair Value, Measurement with Unobservable Inputs Reconciliations, Recurring Basis, Liability Value | $ 9,395,222 | 9,422,735 | |
Spectrum [Member] | |||
License Arrangements and Acquisition of In Process Research and Development [Line Items] | |||
Stock Issued During Period, Shares, New Issues | 1,688,877 | ||
Adjustments to Additional Paid in Capital, Stock Issued for Liability | $ 1,922,312 | ||
Spectrum Pharmaceuticals [Member] | |||
License Arrangements and Acquisition of In Process Research and Development [Line Items] | |||
Contingent Consideration Fair Value Of License | $ 19,700,000 | ||
Stock Issued During Period, Shares, Acquisitions | 5,405,382 | ||
Debt Instrument, Interest Rate, Stated Percentage | 0.50% | ||
Notes Payable, Noncurrent | $ 1,500,000 |
NOTE PAYABLE (Details Textual)
NOTE PAYABLE (Details Textual) - USD ($) | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Notes Payable [Line Items] | ||
Amortization of Debt Discount (Premium) | $ 75,000 | $ 26,000 |
Notes Payable, Noncurrent | 1,464,970 | $ 1,390,015 |
Spectrum Pharmaceuticals [Member] | ||
Notes Payable [Line Items] | ||
Debt Instrument, Interest Rate, Stated Percentage | 0.50% | |
Debt Instrument, Unamortized Discount (Premium), Net | $ 136,000 | |
Notes Payable, Noncurrent | $ 1,500,000 |
FAIR VALUE MEASUREMENTS (Detail
FAIR VALUE MEASUREMENTS (Details) - USD ($) | Dec. 31, 2015 | Dec. 31, 2014 |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ||
Liabilities - Contingent Rights | $ 9,395,222 | $ 9,422,735 |
Fair Value, Inputs, Level 1 [Member] | ||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ||
Liabilities - Contingent Rights | 0 | 0 |
Fair Value, Inputs, Level 2 [Member] | ||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ||
Liabilities - Contingent Rights | 0 | 0 |
Fair Value, Inputs, Level 3 [Member] | ||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ||
Liabilities - Contingent Rights | $ 9,395,222 | $ 9,422,735 |
FAIR VALUE MEASUREMENTS (Deta31
FAIR VALUE MEASUREMENTS (Details 1) | 12 Months Ended |
Dec. 31, 2015USD ($) | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |
December 31, 2014 | $ 9,422,735 |
Change in fair value of Contingent Rights | (27,513) |
Balance at December 31, 2015 | $ 9,395,222 |
INCOME TAXES (Details)
INCOME TAXES (Details) - USD ($) | Dec. 31, 2015 | Dec. 31, 2014 |
Deferred income tax assets (liabilities): | ||
Net operating loss carryforwards | $ 137,811,000 | $ 135,607,000 |
Research and development credit carryforward | 9,291,000 | 9,201,000 |
Intangible assets | 7,273,000 | 8,079,000 |
Equity based compensation | 4,510,000 | 4,316,000 |
Other | 309,000 | 297,000 |
Valuation allowance for deferred income tax assets | (159,194,000) | (157,500,000) |
Net deferred income tax assets | $ 0 | $ 0 |
INCOME TAXES (Details 1)
INCOME TAXES (Details 1) - USD ($) | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Schedule Of Unrecognized Tax Benefits Roll Forward [Line Items] | ||
Tax benefit at statutory rate | $ (2,450,000) | $ (8,909,000) |
State taxes | (128,000) | (1,273,000) |
Net R&D credit adjustment | (101,000) | (104,000) |
Attribute expiration and other | 0 | 8,000 |
Nondeductible expenses | 5,000 | 4,000 |
Change in valuation allowance | 1,694,000 | 9,631,000 |
Other | 143,000 | (38,000) |
Changes in applicable tax rates | 837,000 | 681,000 |
Total | $ 0 | $ 0 |
INCOME TAXES (Details 2)
INCOME TAXES (Details 2) - USD ($) | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Schedule Of Unrecognized Tax Benefits Roll Forward [Line Items] | ||
Unrecognized tax benefits balance at January 1 | $ 3,067,000 | $ 3,013,000 |
Additions for Tax Positions of Prior Periods | 0 | 20,000 |
Reductions for Tax Positions of Prior Periods | (4,000) | 0 |
Additions for Tax Positions of Current Period | 34,000 | 34,000 |
Unrecognized tax benefits balance at December 31 | $ 3,097,000 | $ 3,067,000 |
INCOME TAXES (Details Textual)
INCOME TAXES (Details Textual) - USD ($) | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Income Tax Contingency [Line Items] | |||
Unrecognized Tax Benefits | $ 3,097,000 | $ 3,067,000 | $ 3,013,000 |
Operating Loss Carryforwards | $ 352,574,000 | ||
Operating Loss Carryforwards Expiration Period | expire in years 2018 through 2035 | ||
UNITED STATES | |||
Income Tax Contingency [Line Items] | |||
Income (Loss) from Continuing Operations before Income Taxes, Extraordinary Items, Noncontrolling Interest | $ (5,670,207) | ||
CHINA | |||
Income Tax Contingency [Line Items] | |||
Income (Loss) from Continuing Operations before Income Taxes, Extraordinary Items, Noncontrolling Interest | (1,536,216) | ||
Research Tax Credit Carryforward [Member] | |||
Income Tax Contingency [Line Items] | |||
Unrecognized Tax Benefits | 30,000 | $ 3,067,000 | |
Tax Credit Carryforward, Amount | 9,291,000 | ||
Employee Stock Option [Member] | |||
Income Tax Contingency [Line Items] | |||
Operating Loss Carryforwards | $ 20,000,000 |
STOCKHOLDERS' EQUITY (Details T
STOCKHOLDERS' EQUITY (Details Textual) - USD ($) | Jan. 15, 2016 | Jan. 31, 2016 | Sep. 20, 2015 | Dec. 31, 2015 |
Class Of Warrant Or Right Maturity Period Description | The warrants will become exercisable on April 15, 2016 at $1.69 per share exercise price, and will expire on April 15, 2019. | |||
Investors [Member] | ||||
Stock To Be Issued, Value | $ 25,100,000 | |||
Stock To Be Issued, Shares | 20,658,434 | |||
Percentage of Warrant Coverage On Purchase Price | 20.00% | |||
Warrants Purchase Price Per share | $ 0.125 | |||
Class of Warrant or Right, Exercise Price of Warrants or Rights | 1.69 | |||
Shares To Be Issued Per Share | $ 1.19 | |||
Warrants To Be Issued | 4,131,686 | |||
Subsequent Event [Member] | ||||
Fair Value Of Warrant Issued | $ 321,047 | |||
Initial Closing [Member] | Subsequent Event [Member] | ||||
Warrants Purchase Price Per share | $ 0.125 | |||
Class of Warrant or Right, Exercise Price of Warrants or Rights | 1.69 | |||
Fair Value Assumptions Fair Value | $ 0.19 | |||
Fair Value Assumptions, Expected Term | 3 years 3 months | |||
Fair Value Assumptions, Risk Free Interest Rate | 1.08% | |||
Fair Value Assumptions, Expected Volatility Rate | 70.10% | |||
Warrants Issued | 1,689,722 | |||
Proceeds from Issuance of Common Stock | $ 10,300,000 | $ 10,300,000 | ||
Sale of Stock, Number of Shares Issued in Transaction | 8,448,613 | |||
Sale of Stock, Price Per Share | $ 1.19 | |||
Net Proceeds From Issuance Of Common Stock | $ 10,200,000 | |||
Second Closing [Member] | Subsequent Event [Member] | ||||
Stock purchase Program, Remaining Authorized Issue Amount | $ 14,800,000 |
SHARE-BASED COMPENSATION (Detai
SHARE-BASED COMPENSATION (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock-based compensation expense | $ 1,541,192 | $ 2,189,102 |
Net share-based compensation expense, per common share: | ||
Basic and diluted (in dollars per share) | $ 0.05 | $ 0.08 |
Research and Development Expense [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock-based compensation expense | $ 747,285 | $ 690,409 |
General and Administrative Expense [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock-based compensation expense | $ 793,907 | $ 1,498,693 |
SHARE-BASED COMPENSATION (Det38
SHARE-BASED COMPENSATION (Details 1) | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected volatility | 85.17% | 102.41% | |
Risk-free interest rate | 1.57% | 1.78% | |
Expected term of option | 5 years 8 months 1 day | 5 years 7 months 17 days | |
Forfeiture rate | [1] | 3.00% | 3.00% |
Expected dividend yield | 0.00% | 0.00% | |
[1] | Throughout 2015 and 2014, forfeitures were estimated at 3%; the actual forfeiture rate was 0% and 1% for 2015 and 2014, respectively. The Company adjusted stock compensation expense for 2015 and 2014 based on the actual forfeiture rate. |
SHARE-BASED COMPENSATION (Det39
SHARE-BASED COMPENSATION (Details 2) - USD ($) | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Outstanding - Number of Options, Beginning Balance | 4,557,682 | 3,586,394 |
Granted - Number of Options | 2,775,000 | 1,090,000 |
Exercised - Number of Options | 0 | 0 |
Expired - Number of Options | (637,938) | (107,168) |
Forfeited - Number of Options | 0 | (11,544) |
Outstanding - Number of Options, Ending Balance | 6,694,744 | 4,557,682 |
Vested and expected to vest - Number of Options | 6,634,597 | |
Exercisable - Number of Options | 4,689,850 | |
Outstanding - Weighted Average Exercise Price, Beginning balance | $ 2.40 | $ 2.69 |
Granted - Weighted Average Exercise Price | 1.43 | 1.83 |
Exercised - Weighted Average Exercise Price | 0 | 0 |
Expired - Weighted Average Exercise Price | 2.47 | 6.21 |
Forfeited - Weighted Average Exercise Price | 0 | 1.78 |
Outstanding - Weighted Average Exercise Price, Ending Balance | 1.99 | $ 2.40 |
Vested and expected to vest - Weighted Average Exercise Price | 1.99 | |
Exercisable - Weighted Average Exercise Price | $ 2.20 | |
Outstanding - Weighted Average Remaining Contractual Term In Years | 7 years 9 months 18 days | |
Vested and expected to vest - Weighted Average Remaining Contractual Term In Years | 7 years 8 months 23 days | |
Exercisable - Weighted Average Remaining Contractual Term In Years | 7 years 3 months 18 days | |
Outstanding - Aggregate Intrinsic Value | $ 0 | |
Vested and expected to vest - Aggregate Intrinsic Value | 0 | |
Exercisable - Aggregate Intrinsic Value | $ 0 |
SHARE-BASED COMPENSATION (Det40
SHARE-BASED COMPENSATION (Details 3) | 12 Months Ended |
Dec. 31, 2015$ / sharesshares | |
Number Of Options Outstanding at December 31,2015 | shares | 6,694,744 |
Number Of Options Outstanding Weighted Average Remaining Contractual Life in Years | 7 years 9 months 18 days |
Number Of Options Outstanding Weighted Average Exercise Price | $ 1.99 |
Number Of Options Exercisable at December 31, 2015 | shares | 4,689,850 |
Number Of Options Exercisable Weighted Average Exercise Price | $ 2.20 |
Range One [Member] | |
Range of Exercise Prices Lower Range Limit | 0 |
Range of Exercise Prices Upper Range Limit | $ 2 |
Number Of Options Outstanding at December 31,2015 | shares | 5,982,678 |
Number Of Options Outstanding Weighted Average Remaining Contractual Life in Years | 8 years 1 month 6 days |
Number Of Options Outstanding Weighted Average Exercise Price | $ 1.68 |
Number Of Options Exercisable at December 31, 2015 | shares | 3,977,784 |
Number Of Options Exercisable Weighted Average Exercise Price | $ 1.77 |
Range Two [Member] | |
Range of Exercise Prices Lower Range Limit | 2.01 |
Range of Exercise Prices Upper Range Limit | $ 5 |
Number Of Options Outstanding at December 31,2015 | shares | 475,000 |
Number Of Options Outstanding Weighted Average Remaining Contractual Life in Years | 6 years 2 months 12 days |
Number Of Options Outstanding Weighted Average Exercise Price | $ 2.26 |
Number Of Options Exercisable at December 31, 2015 | shares | 475,000 |
Number Of Options Exercisable Weighted Average Exercise Price | $ 2.26 |
Range Three [Member] | |
Range of Exercise Prices Lower Range Limit | 5.01 |
Range of Exercise Prices Upper Range Limit | $ 10 |
Number Of Options Outstanding at December 31,2015 | shares | 176,540 |
Number Of Options Outstanding Weighted Average Remaining Contractual Life in Years | 4 years 7 months 6 days |
Number Of Options Outstanding Weighted Average Exercise Price | $ 6.56 |
Number Of Options Exercisable at December 31, 2015 | shares | 176,540 |
Number Of Options Exercisable Weighted Average Exercise Price | $ 6.56 |
Range Four [Member] | |
Range of Exercise Prices Lower Range Limit | 10.01 |
Range of Exercise Prices Upper Range Limit | $ 15 |
Number Of Options Outstanding at December 31,2015 | shares | 5,268 |
Number Of Options Outstanding Weighted Average Remaining Contractual Life in Years | 2 years |
Number Of Options Outstanding Weighted Average Exercise Price | $ 13.75 |
Number Of Options Exercisable at December 31, 2015 | shares | 5,268 |
Number Of Options Exercisable Weighted Average Exercise Price | $ 13.75 |
Range Five [Member] | |
Range of Exercise Prices Lower Range Limit | 15.01 |
Range of Exercise Prices Upper Range Limit | $ 20 |
Number Of Options Outstanding at December 31,2015 | shares | 55,258 |
Number Of Options Outstanding Weighted Average Remaining Contractual Life in Years | 10 months 24 days |
Number Of Options Outstanding Weighted Average Exercise Price | $ 17.64 |
Number Of Options Exercisable at December 31, 2015 | shares | 55,258 |
Number Of Options Exercisable Weighted Average Exercise Price | $ 17.64 |
SHARE-BASED COMPENSATION (Det41
SHARE-BASED COMPENSATION (Details 4) - Warrant [Member] - $ / shares | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Outstanding at Number of Shares, Beginning Balance | 4,010,903 | 4,321,565 |
Granted Number of Shares | 0 | 0 |
Exercised Number of Shares | 0 | 0 |
Expired Number of Shares | 310,662 | |
Outstanding at Number of Share, Ending Balance | 4,010,903 | 4,010,903 |
Exercisable Number of Shares | 4,010,903 | |
Outstanding Weighted Average Exercise Price, Beginning Balance | $ 2.27 | $ 2.31 |
Granted Weighted Average Exercise Price | 0 | 0 |
Exercised Weighted Average Exercise Price | 0 | 0 |
Expired Weighted Average Exercise Price | 0 | 2.83 |
Outstanding Weighted Average Exercise Price, at Ending Balance | 2.27 | $ 2.27 |
Exercisable Weighted Average Exercise Price | $ 2.27 |
SHARE-BASED COMPENSATION (Det42
SHARE-BASED COMPENSATION (Details Textual) - USD ($) | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Weighted Average Grant Date Fair Value | $ 1.02 | $ 1.44 | |
Share-based Compensation, Total | $ 1,541,192 | $ 2,189,102 | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number, Ending Balance | 6,694,744 | 4,557,682 | 3,586,394 |
Share Based Compensation Estimated Forfeiture Rate | 3.00% | 3.00% | |
Unrecognized Share Based Compensation Cost Expected To Be Recognized Over Weighted Average Period | $ 966,000 | ||
Share Based Compensation Actual Forfeiture Rate | 0.00% | 1.00% | |
Unrecognized Share Based Compensation Cost Expected To Be Recognized Over Weighted Average Period | 1 year 2 months 12 days | ||
Performance Shares [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Allocated Share-based Compensation Expense | $ 0 | $ 686,600 | |
Certain Board Members Officers And Employees [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share Based Compensation Arrangement By Share Based Payment Award Options Granted Subject To Achievement | 963,000 | ||
Maximum [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share Based Compensation Arrangement By Share Based Payment Award Equity Instruments Other Than Options Granted Expire Terms | 5 years | ||
Minimum [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share Based Compensation Arrangement By Share Based Payment Award Equity Instruments Other Than Options Granted Expire Terms | 3 years | ||
Long Term Incentive Plan2011 [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant | 1,957,876 | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number, Ending Balance | 6,694,744 | ||
Long Term Incentive Plan2011 [Member] | Maximum [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant | 8,230,000 | ||
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range, Upper Range Limit | $ 19.36 | ||
Long Term Incentive Plan2011 [Member] | Minimum [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant | 5,730,000 | ||
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range, Lower Range Limit | $ 1.30 |
COMMITMENTS AND CONTINGENCIES43
COMMITMENTS AND CONTINGENCIES (Details) | Dec. 31, 2015USD ($) |
2,016 | $ 350,744 |
2,017 | 265,773 |
2,018 | 159,959 |
2,019 | 84,000 |
Thereafter | 0 |
Total minimum payments | $ 860,476 |
COMMITMENTS AND CONTINGENCIES44
COMMITMENTS AND CONTINGENCIES (Details Textual) - USD ($) | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Business Combination Consideration Milestone Achievement | $ 4,000,000 | |
Additional Amount Upon Milestone Obligation Achievement | 41,000,000 | |
Purchase Obligation Commitment For Clinical Trial Contracts | 690,000 | |
Operating Leases, Rent Expense | 309,000 | $ 240,000 |
Payments for Royalties | 9,500 | |
Additional Amount Due Upon Achievement of Certain Milestone | 4,000,000 | |
Phase One [Member] | ||
Business Combination Consideration Milestone Achievement | 2,000,000 | |
Phase Two [Member] | ||
Business Combination Consideration Milestone Achievement | 3,000,000 | |
Phase Three [Member] | ||
Business Combination Consideration Milestone Achievement | 4,000,000 | |
Phase Four [Member] | ||
Payable And Contingent Upon Certain Milestones | $ 9,000,000 |
EMPLOYEE RETIREMENT PLAN (Detai
EMPLOYEE RETIREMENT PLAN (Details Textual) - USD ($) | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Defined Benefit Plan, Contributions by Employer | $ 29,200 | $ 28,400 |