Document And Entity Information
Document And Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Mar. 28, 2018 | Jun. 30, 2017 | |
Document Information [Line Items] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2017 | ||
Document Fiscal Year Focus | 2,017 | ||
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 | $ 35,022,789 | ||
Trading Symbol | CASI | ||
Entity Common Stock, Shares Outstanding | 79,641,876 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Dec. 31, 2017 | Dec. 31, 2016 |
Current assets: | ||
Cash and cash equivalents | $ 43,489,935 | $ 27,092,928 |
Prepaid expenses and other | 322,493 | 355,891 |
Total current assets | 43,812,428 | 27,448,819 |
Property and equipment, net | 1,046,514 | 229,591 |
Other assets | 242,023 | 34,485 |
Total assets | 45,100,965 | 27,712,895 |
Current liabilities: | ||
Accounts payable | 2,087,770 | 1,064,626 |
Payable to related party | 2,228,366 | 0 |
Accrued liabilities | 745,961 | 250,950 |
Total current liabilities | 5,062,097 | 1,315,576 |
Note payable, net of discount | 1,498,754 | 1,491,278 |
Contingent rights derivative liability | 0 | 4,122,266 |
Total liabilities | 6,560,851 | 6,929,120 |
Commitments and contingencies | ||
Stockholders’ equity: | ||
Convertible preferred stock, $1.00 par value; 5,000,000 shares authorized and 0 shares issued and outstanding at December 31, 2017 and 2016 | 0 | 0 |
Common stock, $.01 par value: 170,000,000 shares authorized at December 31, 2017 and 2016; 69,901,625 shares and 60,276,119 shares issued at December 31, 2017 and 2016, respectively | 699,015 | 602,760 |
Additional paid-in capital | 498,577,372 | 470,147,086 |
Treasury stock, at cost: 79,545 shares held at December 31, 2017 and 2016 | (8,034,244) | (8,034,244) |
Accumulated deficit | (452,702,029) | (441,931,827) |
Total stockholders’ equity | 38,540,114 | 20,783,775 |
Total liabilities and stockholders’ equity | $ 45,100,965 | $ 27,712,895 |
Consolidated Balance Sheets _Pa
Consolidated Balance Sheets [Parenthetical] - $ / shares | Dec. 31, 2017 | Dec. 31, 2016 |
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 | 69,901,625 | 60,276,119 |
Treasury stock, shares held | 79,545 | 79,545 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Revenues: | ||
Product sales | $ 0 | $ 0 |
Revenues Total | 0 | 0 |
Costs and expenses: | ||
Research and development | 7,595,182 | 4,645,560 |
General and administrative | 3,156,138 | 4,775,050 |
Costs and expenses | 10,751,320 | 9,420,610 |
Interest (income) expense, net | (1,009) | 26,090 |
Change in fair value of contingent rights | 19,891 | 6,788 |
Net loss | $ (10,770,202) | $ (9,453,488) |
Net loss per share (basic and diluted) | $ (0.18) | $ (0.17) |
Weighted average number of shares outstanding (basic and diluted) | 61,513,988 | 55,869,205 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders’ Equity - USD ($) | Total | Preferred Stock [Member] | Common Stock [Member] | Treasury Stock [Member] | Additional Paid-in Capital [Member] | Accumulated Deficit [Member] |
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 | ||||
Issuance of common stock and warrants pursuant to financing agreements | 28,100,000 | $ 0 | $ 231,276 | 0 | 27,868,724 | 0 |
Issuance of common stock and warrants pursuant to financing agreements (in shares) | 0 | 23,127,566 | ||||
Issuance of common stock from exercise of contingent purchase right | $ 46,232 | $ 0 | $ 46,232 | 0 | 0 | 0 |
Issuance of common stock from exercise of contingent purchase right (in shares) | 0 | 4,623,197 | ||||
Partial settlement of contingent purchase rights derivative | $ 5,279,744 | 0 | $ 0 | 0 | 5,279,744 | 0 |
Stock issuance costs | (96,512) | 0 | 0 | 0 | (96,512) | 0 |
Stock-based compensation expense, net of forfeitures | 2,995,240 | 0 | 0 | 0 | 2,995,240 | 0 |
Net loss | (9,453,488) | 0 | 0 | 0 | 0 | (9,453,488) |
Balance at Dec. 31, 2016 | 20,783,775 | $ 0 | $ 602,760 | (8,034,244) | 470,147,086 | (441,931,827) |
Balance (in shares) at Dec. 31, 2016 | 0 | 60,196,574 | ||||
Issuance of common stock and warrants pursuant to financing agreements | 23,884,475 | $ 0 | $ 79,519 | 0 | 23,804,956 | 0 |
Issuance of common stock and warrants pursuant to financing agreements (in shares) | 0 | 7,951,865 | ||||
Issuance of common stock from exercise of contingent purchase right | 15,191 | $ 0 | $ 15,191 | 0 | 0 | 0 |
Issuance of common stock from exercise of contingent purchase right (in shares) | 0 | 1,519,096 | ||||
Issuance of common stock for options exercised | 325,999 | $ 0 | $ 1,545 | 0 | 324,454 | 0 |
Issuance of common stock for options exercised (in shares) | 0 | 154,545 | ||||
Partial settlement of contingent purchase rights derivative | 4,142,157 | $ 0 | $ 0 | 0 | 4,142,157 | 0 |
Stock issuance costs | (491,721) | 0 | 0 | 0 | (491,721) | 0 |
Stock-based compensation expense, net of forfeitures | 650,440 | 0 | 0 | 0 | 650,440 | 0 |
Net loss | (10,770,202) | 0 | 0 | 0 | 0 | (10,770,202) |
Balance at Dec. 31, 2017 | $ 38,540,114 | $ 0 | $ 699,015 | $ (8,034,244) | $ 498,577,372 | $ (452,702,029) |
Balance (in shares) at Dec. 31, 2017 | 0 | 69,822,080 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
CASH FLOWS FROM OPERATING ACTIVITIES | ||
Net loss | $ (10,770,202) | $ (9,453,488) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 117,779 | 66,451 |
Net gain on disposal of assets | 0 | (12,459) |
Stock-based compensation expense | 650,440 | 2,995,240 |
Non-cash interest | 7,476 | 26,308 |
Change in fair value of contingent rights | 19,891 | 6,788 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other | (361) | 86,029 |
Accounts payable | 849,365 | 180,526 |
Payable to related party | 2,228,366 | 0 |
Accrued liabilities | 495,011 | 81,486 |
Net cash used in operating activities | (6,402,235) | (6,023,119) |
CASH FLOWS FROM INVESTING ACTIVITIES | ||
Purchases of property and equipment | (934,702) | (223,233) |
Proceeds from sale of property and equipment | 0 | 158,446 |
Net cash used in investing activities | (934,702) | (64,787) |
CASH FLOWS FROM FINANCING ACTIVITIES | ||
Stock issuance costs | (462,841) | (96,512) |
Proceeds from sale of common stock and warrants | 23,870,786 | 28,146,232 |
Proceeds from exercise of stock options | 325,999 | 0 |
Net cash provided by financing activities | 23,733,944 | 28,049,720 |
Net increase in cash and cash equivalents | 16,397,007 | 21,961,814 |
Cash and cash equivalents at beginning of year | 27,092,928 | 5,131,114 |
Cash and cash equivalents at end of year | 43,489,935 | 27,092,928 |
Non-cash financing activity: | ||
Warrant issued to placement agent | 28,880 | 0 |
Partial settlement of contingent rights derivative | 4,142,157 | 5,279,744 |
Non-cash investing activity: | ||
Disposal of fully depreciated property and equipment, at cost | $ 7,523 | $ 25,204 |
DESCRIPTION OF BUSINESS AND BAS
DESCRIPTION OF BUSINESS AND BASIS OF PRESENTATION | 12 Months Ended |
Dec. 31, 2017 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Basis of Accounting [Text Block] | CASI Pharmaceuticals, Inc. (“CASI” or the “Company”) is a U.S. based biopharmaceutical company dedicated to bringing high quality, cost-effective pharmaceutical products and innovative oncology therapeutics to patients. The Company intends to execute its plan to become a leading pharmaceutical company with a substantial market share in China. We are headquartered in Rockville, Maryland with established China operations that are expanding as we continue to further in-license or acquire products for our pipeline. The Company’s pipeline features (1) EVOMELA ® ® ® The Company’s focus is to bring high quality, cost-effective pharmaceutical products and innovative oncology therapeutics to patients. 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 China-based 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 transition to a commercial enterprise. 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 EVOMELA ® ® On January 26, 2018, the Company acquired a portfolio of 25 U.S. FDA-approved abbreviated new drug applications (ANDAs), one ANDA that FDA tentatively approved, and three ANDAs that are pending FDA approval. CASI intends to select and commercialize certain products from the portfolio that offer unique market and cost-effective manufacturing opportunities in China and/or in the U.S. The Company’s primary focus is to acquire high quality, cost-effective medicines, as well as to in-license clinical-stage and late-stage drug candidates so that it can immediately employ its U.S. and China drug development model to accelerate commercialization, and clinical and regulatory progress. In addition to its high quality, cost-effective medicines, and clinical-and late-stage approach for innovative products, the Company has other potential drug candidates in preclinical development which it will continue to evaluate in 2018. 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 $ 452.7 15,432,091 6,172,832 50 29.3 20.7 23.8 23.4 As a result of the 2018 Strategic Financing and 2017 Closings the Company believes that it has sufficient resources to fund its operations at least through March 29, 2019. As of December 31, 2017, approximately $ 12.2 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 China-based subsidiary that will execute the China portion of the Company’s drug development strategy, including commercialization and 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 candidates that the Company intends to pursue to commercialization. |
SUMMARY OF SIGNIFICANT ACCOUNTI
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 12 Months Ended |
Dec. 31, 2017 | |
Accounting Policies [Abstract] | |
Basis of Presentation and Significant Accounting Policies [Text Block] | 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES The Company currently operates in one business segment, which is the development of innovative therapeutics addressing cancer and other unmet medical needs for the global market. 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 that are potential first-in-class or market-leading compounds for 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 or amortized over their estimated useful lives of 3 5 117,779 66,451 DECEMBER 31, 2017 2016 Furniture and equipment $ 1,150,052 $ 480,172 Leasehold improvements 268,734 11,435 1,418,786 491,607 Less: accumulated depreciation and amortization (372,272) (262,016) $ 1,046,514 $ 229,591 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 2017 and 2016. 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. 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). As discussed in Note 12, on January 26, 2018 the Company acquired a portfolio of ANDAs. Management believes that this transaction provides significant and permanent changes to its operations in China, allowing its subsidiary in China to generate operating revenues from the China marketplace in the future and potentially to sustain their own operations without the necessity of parent support. Accordingly, effective January 1, 2018, the functional currency of the Company’s subsidiary based in China has been changed to the local currency of the China Renminbi (“RMB”). 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, 2017 and 2016, clinical trial accruals were $ 402,773 499,028 Income tax expense is accounted for in accordance with authoritative guidance issued by the 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 17,849,331 15,923,807 The Company records compensation expense associated with service and performance 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. 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. 30,500 10,100 The Company has implemented all new accounting pronouncements that are in effect and that may impact the Company’s consolidated financial statements. In January 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2016-01, Financial InstrumentsOverall: Recognition and Measurement of Financial Assets and Financial Liabilities In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842) Leases In May 2017, the FASB issued ASU 2017-09, Compensation-Stock Compensation (Topic 718) Scope of Modification Accounting. There are no other recently issued accounting pronouncements that are expected to have a material effect on the Company’s financial position, results of operations or cash flows. 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. As of December 31, 2017, the derivative liability has been settled and is no longer outstanding. |
RELATED PARTY TRANSACTIONS
RELATED PARTY TRANSACTIONS | 12 Months Ended |
Dec. 31, 2017 | |
Related Party Transactions [Abstract] | |
Related Party Transactions Disclosure [Text Block] | 3. RELATED PARTY TRANSACTIONS In April, June 2017, and November 2017, under supply agreements with Spectrum, the Company received shipments of EVOMELA ® ® ® ® 2,705,000 155,220 2,228,366 |
LICENSE ARRANGEMENTS
LICENSE ARRANGEMENTS | 12 Months Ended |
Dec. 31, 2017 | |
Research and Development [Abstract] | |
Research, Development, and Computer Software Disclosure [Text Block] | 4. LICENSE ARRANGEMENTS The Company has certain product rights and perpetual exclusive licenses from Spectrum Pharmaceuticals, Inc. and certain of its affiliates (together referred to as “Spectrum”) to develop and commercialize the following commercial oncology drugs and drug candidates in the greater China region (which includes China, Taiwan, Hong Kong and Macau) (the “Territories”): · EVOMELA ® · MARQIBO ® · ZEVALIN ® 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 is in various stages of the regulatory and development process to obtain marketing approval for EVOMELA ® ® ® ® ® ® ® ® 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 (see Note 6) 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 0 4,122,266 As a result of the 2017 Closings that occurred during 2017 (see Note 8), Spectrum exercised its Contingent Rights and the Company issued Spectrum 1,519,096 0 4,142,157 4,623,197 5,279,744 |
NOTE PAYABLE
NOTE PAYABLE | 12 Months Ended |
Dec. 31, 2017 | |
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 7,000 26,000 |
FAIR VALUE MEASUREMENTS
FAIR VALUE MEASUREMENTS | 12 Months Ended |
Dec. 31, 2017 | |
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) approximates 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) were 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. 0 As of December 31, 2016 Level 1 Level 2 Level 3 Total Liabilities - Contingent Rights $ - $ - $ 4,122,266 $ 4,122,266 2017 2016 Balance at beginning of year $ 4,122,266 $ 9,395,222 Partial settlement of Contingent Rights (4,142,157) (5,279,744) Change in fair value of Contingent Rights 19,891 6,788 Balance at end of year $ - $ 4,122,266 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, 2017 and 2016. |
INCOME TAXES
INCOME TAXES | 12 Months Ended |
Dec. 31, 2017 | |
Income Tax Disclosure [Abstract] | |
Income Tax Disclosure [Text Block] | 7. INCOME TAXES The income tax provision is based on loss before income taxes of $ (8,658,120) (2,112,082) 368,134,000 9,593,000 2017 2016 United States $ (8,658,120) $ (7,375,974) Foreign (2,112,082) (2,077,514) Total $ (10,770,202) $ (9,453,488) DECEMBER 31, 2017 2016 Deferred income tax assets: Net operating loss carryforwards $ 96,786,000 $ 140,468,000 Research and development credit carryforward 9,592,000 9,399,000 Intangible assets 4,184,000 6,913,000 Equity-based compensation 3,812,000 5,578,000 Other 164,000 297,000 Valuation allowance for deferred income tax assets (114,538,000) (162,655,000) Net deferred income tax assets $ - $ - On December 22, 2017, H.R.1, known as the “Tax Act,” was signed into law and makes broad and complex changes to the U.S. tax code, including, but not limited to, (1) reducing the U.S. federal corporate tax rate to a flat rate of 21% for periods after December 31, 2017 and (2) requiring a one-time transition tax on certain un-repatriated earnings of foreign subsidiaries that is payable over eight years. As a result of the reduction of the corporate tax rate to 21 52,258,000 2017 2016 Tax benefit at statutory rate $ (3,662,000) $ (3,214,000) Effect of tax law change 52,258,000 - State taxes (290,000) (232,000) Net R&D credit adjustment (185,000) (105,000) Attribute expiration 50,000 - Nondeductible expenses 6,000 4,000 Change in valuation allowance (48,117,000) 3,461,000 Other 125,000 177,000 Changes in applicable tax rates (185,000) (91,000) $ - $ - The Company had $ 3,133,000 65,000 2017 2016 Unrecognized tax benefits balance at January 1 $ 3,133,000 $ 3,097,000 Additions for Tax Positions of Prior Periods 3,000 1,000 Additions for Tax Positions of Current Period 62,000 35,000 Unrecognized tax benefits balance at December 31 $ 3,198,000 $ 3,133,000 The Company recognizes interest and penalties related to uncertain tax positions as a component of income tax expense. As of December 31, 2017 and 2016, the Company had no accrued interest or penalties related to uncertain tax positions. The tax returns for all years in the Company’s major tax jurisdictions are not settled as of December 31, 2017. 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, 2017 | |
Stockholders' Equity Note [Abstract] | |
Stockholders' Equity Note Disclosure [Text Block] | 8. STOCKHOLDERS’ EQUITY SECURITIES PURCHASE AGREEMENTS As described in Note 1, on March 19, 2018, the Company entered into securities purchase agreements (the “Securities Purchase Agreements”) with certain institutional investors, accredited investors and current stockholders, pursuant to which the Company is issuing 15,432,091 shares of its common stock with accompanying warrants to purchase 6,172,832 50 29.3 20.7 3.24 3.69 As described in Note 1, on October 13, 2017, the Company entered into securities purchase agreements with certain institutional investors, accredited investors and current stockholders pursuant to which the Company agreed to sell 7,951,865 1,590,373 23,855,595 23.4 0.20 3.00 April 17, 2018 April 17, 2020 3.75 1,558,566 0.98 2.5 85.4 1.54 In connection with the 2017 Offering, the Company issued to its placement agent or its designees warrants to purchase 48,133 3.75 4 April 17, 2018 April 17, 2019 28,880 0.60 1.5 77.8 On September 20, 2015, the Company entered into stock purchase agreements with certain institutional and accredited investors for a $ 25.1 20,658,434 1.19 4,131,686 20 0.125 The warrants became exercisable three months after issuance at $1.69 per share exercise price, and expire three years from the date the warrants become exercisable. On January 15, 2016, the Company completed the first closing and received approximately $ 10.3 10.2 8,448,613 1.19 1,689,722 0.125 The warrants became exercisable on April 15, 2016 at $1.69 per share exercise price, and will expire on April 15, 2019. 321,047 0.19 3.25 70.1 1.08 On June 24, 2016, the Company completed the second closing and received approximately $ 6.0 4,906,118 1.19 981,223 0.125 The warrants became exercisable on September 23, 2016 at $1.69 per share exercise price, and will expire on September 23, 2019 431,738 0.44 3.25 70.4 0.76 On July 5, 2016, the Company completed the third closing and received $ 1.0 823,045 1.19 164,609 0.125 The warrants became exercisable on October 4, 2016 at $1.69 per share exercise price, and will expire on October 4, 2019. 67,490 0.41 3.25 70.6 0.66 On October 3, 2016, the Company completed the final closing and received $ 7.8 6,480,655 1.19 1,296,129 0.125 The warrants became exercisable on January 2, 2017 at $1.69 per share exercise price, and will expire on January 2, 2020. 544,374 0.42 3.25 71.4 0.91 On October 24, 2016, the Company entered into and closed on a stock purchase agreement with an accredited investor, pursuant to which the Company agreed to sell to the investor in a private placement an aggregate of 2,469,135 1.190 493,827 20 0.125 3.0 The warrants became exercisable on January 23, 2017 at $1.69 per share exercise price, and will expire on January 23, 2020. 306,173 0.62 3.25 72.2 1.00 The Company granted registration rights to all of the investors and filed a resale registration statement covering the shares of common stock and the shares of common stock underlying the warrants on December 2, 2016. The registration statement was declared effective by the SEC on December 21, 2016. COMMON STOCK SALES AGREEMENT On February 23, 2018, the Company entered into a Common Stock Sales Agreement (the “Sales Agreement”) with H.C. Wainwright & Co., LLC (“HCW”). Pursuant to the terms of the Sales Agreement, the Company may sell from time to time, at its option, shares of the Company’s common stock through HCW, as sales agent, with an aggregate sales price of up to $ 25 Any sales of Shares pursuant to the Sales Agreement will be made under the Company’s effective “shelf” registration statement (the “Registration Statement”) on Form S-3 (File No. 333-222046) which became effective on December 22, 2017 and the related prospectus supplement and the accompanying prospectus, as filed with the Securities and Exchange Commission (the “SEC”) on February 23, 2018. Under the terms of the Sales Agreement, the Company may sell shares of its common stock through HCW by any method permitted that is deemed an “at the market offering” as defined in Rule 415 under the Securities Act of 1933, as amended (the “Securities Act”). HCW will use its commercially reasonable efforts consistent with its normal trading and sales practices to sell the Company’s common stock from time to time, based upon the Company’s instructions (including any price, time or size limits or other customary parameters or conditions the Company may impose). Actual sales will depend on a variety of factors to be determined by the Company from time to time, including (among others) market conditions, the trading price of the Company’s common stock, capital needs and determinations by the Company of the appropriate sources of funding for the Company. The Company is not obligated to make any sales of common stock under the Sales Agreement and the Company cannot provide any assurances that it will issue any shares pursuant to the Sales Agreement. The Company will pay a commission rate of up to 3.0 The Company or HCW upon notice to the other, may suspend the offering of the Shares under the Sales Agreement at any time. The offering of the Shares pursuant to the Sales Agreement will terminate upon the sale of Shares in an aggregate offering amount equal to $25 million, or sooner if either the Company or HCW terminate the Sales Agreement pursuant to its terms. Through March 2018, the Company issued 143,248 475,000 |
SHARE-BASED COMPENSATION AND WA
SHARE-BASED COMPENSATION AND WARRANTS | 12 Months Ended |
Dec. 31, 2017 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Disclosure of Compensation Related Costs, Share-based Payments [Text Block] | 9. SHARE-BASED COMPENSATION AND WARRANTS 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 2017, the Company’s shareholders approved an amendment to the 2011 Long-Term Incentive Plan, increasing the number of shares reserved for issuance from 11,230,000 14,230,000 11,585,315 0.86 7.37 2,225,000 2,852,234 1 4 The Company records compensation expense associated with stock options and other equity-based compensation in accordance with provisions of authoritative guidance. Compensation costs are recognized over the requisite service period, which is generally the option vesting term of up to three years. Awards with 30,500 10,100 650,440 2,995,240 2017 2016 Research and development $ 271,733 $ 746,027 General and administrative 378,707 2,249,213 Share-based compensation expense $ 650,440 $ 2,995,240 Net share-based compensation expense, per common share: Basic and diluted $ 0.01 $ 0.05 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. Option valuation models, including Black-Scholes-Merton, 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 estimated the forfeiture rate for 2016 based on historical forfeiture experience for similar levels of employees to whom options were granted. Beginning in 2017, in accordance with authoritative guidance, forfeitures were no longer required to be estimated. Years ended December 31, 2017 2016 Expected volatility 78.88 % 82.12 % Risk free interest rate 1.96 % 1.29 % Expected term of option 6.29 years 5.33 years Forfeiture rate - *3.00 % Expected dividend yield - - *- In 2016, authoritative guidance required forfeitures to be estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. Throughout 2016, forfeitures were estimated at 3% and the actual forfeiture rate was 6% for 2016. The Company adjusted stock compensation expense for 2016 based on the actual forfeiture rate. The weighted average fair value of stock options granted was $ 0.73 0.75 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 Remaining Aggregate Intrinsic Number of Options Exercise Price Contractual Term Value In Years Outstanding at December 31, 2015 6,694,744 $ 1.99 Exercised - $ - Granted 4,213,518 $ 1.00 Expired (856,512) $ 2.24 Forfeited (516,444) $ 1.14 Outstanding at December 31, 2016 9,535,306 $ 1.57 Exercised (154,545) $ 2.11 Granted 3,199,500 $ 1.05 Expired (978,070) $ 1.64 Forfeited (16,876) $ 0.92 Outstanding at December 31, 2017 11,585,315 $ 1.42 7.46 $ 21,730,182 Exercisable at December 31, 2017 8,468,971 $ 1.57 6.78 $ 14,781,148 The aggregate intrinsic value is calculated as the difference between (i) the closing price of the common stock at December 31, 2017 and (ii) the 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. The intrinsic value of options exercised during the year ended December 31, 2017 totaled approximately $ 168,000 326,000 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, 2017 Life in Years Price December 31, 2017 Price $0.00 - $1.00 3,950,656 8.9 $ 0.93 1,538,965 $ 0.87 $1.01 - $2.00 7,083,119 7.0 $ 1.53 6,378,466 $ 1.57 $2.01 - $3.00 375,000 4.2 $ 2.24 375,000 $ 2.24 $3.01 - $7.00 122,000 3.0 $ 6.24 122,000 $ 6.24 $7.01 - $8.00 54,540 1.5 $ 7.26 54,540 $ 7.26 11,585,315 7.5 $ 1.42 8,468,971 $ 1.57 As of December 31, 2017, there was approximately $ 544,000 1.8 Warrants 2 5 Weighted Average Number of Shares Exercise Price Outstanding at December 31, 2015 4,010,903 $ 2.27 Issued 4,625,510 $ 1.69 Exercised - $ - Expired (2,247,912) $ 2.91 Outstanding at December 31, 2016 6,388,501 $ 1.60 Issued 1,638,506 $ 3.75 Exercised - $ - Expired (1,762,991) $ 1.46 Outstanding at December 31, 2017 6,264,016 $ 2.23 Exercisable at December 31, 2017 4,625,510 $ 1.69 |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 12 Months Ended |
Dec. 31, 2017 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies Disclosure [Text Block] | 10. COMMITMENTS AND CONTINGENCIES COMMITMENTS ENMD-2076. 2 3 4 4 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. The Company does not expect to pay royalties for ZEVALIN ® ® ® ® As of December 31, 2017, the Company also has purchase obligation commitments, in the normal course of business, for clinical trial contracts totaling approximately $ 300,000 In March 2018, the Company committed to a purchase obligation of EVOMELA ® The Company leases its principal executive offices in Rockville, MD under a lease agreement that continues through December 31, 2019. The Company leases office space in China under a lease agreement that continues through June 2018. The Company also leases lab space in China that continues through May 2022. 2018 $ 337,030 2019 259,459 2020 183,378 2021 191,691 2022 44,172 Thereafter - Total minimum payments $ 1,015,730 Rental expense for the years ended December 31, 2017 and 2016 was approximately $ 440,000 328,000 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, 2017 | |
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) Plan 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 $ 70,167 30,300 |
SUBSEQUENT EVENT
SUBSEQUENT EVENT | 12 Months Ended |
Dec. 31, 2017 | |
Subsequent Events [Abstract] | |
Subsequent Events [Text Block] | 12. SUBSEQUENT EVENT On January 26, 2018, the Company entered into an Asset Purchase Agreement (the “Asset Purchase Agreement”) by and between the Company and Sandoz Inc. (“Sandoz”), pursuant to which the Company acquired a portfolio of 25 U.S. FDA-approved ANDAs, 1 ANDA that FDA tentatively approved, 3 ANDAs that are pending FDA approval, and manufacturing and other information related to the products (the “Assets”). The purchase of the Assets closed simultaneously with the execution of the Asset Purchase Agreement. Pursuant to the Asset Purchase Agreement, the purchase price for the Assets was $ 18 |
SUMMARY OF SIGNIFICANT ACCOUN19
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 12 Months Ended |
Dec. 31, 2017 | |
Accounting Policies [Abstract] | |
Segment Reporting, Policy [Policy Text Block] | SEGMENT INFORMATION The Company currently operates in one business segment, which is the development of innovative therapeutics addressing cancer and other unmet medical needs for the global market. 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 that are potential first-in-class or market-leading compounds for 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 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 or amortized over their estimated useful lives of 3 5 117,779 66,451 DECEMBER 31, 2017 2016 Furniture and equipment $ 1,150,052 $ 480,172 Leasehold improvements 268,734 11,435 1,418,786 491,607 Less: accumulated depreciation and amortization (372,272) (262,016) $ 1,046,514 $ 229,591 |
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 2017 and 2016. |
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. |
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). As discussed in Note 12, on January 26, 2018 the Company acquired a portfolio of ANDAs. Management believes that this transaction provides significant and permanent changes to its operations in China, allowing its subsidiary in China to generate operating revenues from the China marketplace in the future and potentially to sustain their own operations without the necessity of parent support. Accordingly, effective January 1, 2018, the functional currency of the Company’s subsidiary based in China has been changed to the local currency of the China Renminbi (“RMB”). |
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, 2017 and 2016, clinical trial accruals were $ 402,773 499,028 |
Income Tax, Policy [Policy Text Block] | INCOME TAXES Income tax expense is accounted for in accordance with authoritative guidance issued by the 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 17,849,331 15,923,807 |
Share-based Compensation, Option and Incentive Plans Policy [Policy Text Block] | SHARE-BASED COMPENSATION The Company records compensation expense associated with service and performance 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. 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. 30,500 10,100 |
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 January 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2016-01, Financial InstrumentsOverall: Recognition and Measurement of Financial Assets and Financial Liabilities In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842) Leases In May 2017, the FASB issued ASU 2017-09, Compensation-Stock Compensation (Topic 718) Scope of Modification Accounting. There are no other recently issued accounting pronouncements that are expected to have a material effect on the Company’s financial position, results of operations or cash flows. |
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. As of December 31, 2017, the derivative liability has been settled and is no longer outstanding. |
SUMMARY OF SIGNIFICANT ACCOUN20
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Accounting Policies [Abstract] | |
Property, Plant and Equipment [Table Text Block] | Property and equipment consists of the following: DECEMBER 31, 2017 2016 Furniture and equipment $ 1,150,052 $ 480,172 Leasehold improvements 268,734 11,435 1,418,786 491,607 Less: accumulated depreciation and amortization (372,272) (262,016) $ 1,046,514 $ 229,591 |
FAIR VALUE MEASUREMENTS (Tables
FAIR VALUE MEASUREMENTS (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
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, 2016 by level within the fair value hierarchy. The Contingent Rights were fully settled during 2017 resulting in a $ 0 As of December 31, 2016 Level 1 Level 2 Level 3 Total Liabilities - Contingent Rights $ - $ - $ 4,122,266 $ 4,122,266 |
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: 2017 2016 Balance at beginning of year $ 4,122,266 $ 9,395,222 Partial settlement of Contingent Rights (4,142,157) (5,279,744) Change in fair value of Contingent Rights 19,891 6,788 Balance at end of year $ - $ 4,122,266 |
INCOME TAXES (Tables)
INCOME TAXES (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Income Tax Disclosure [Abstract] | |
Schedule of Income before Income Tax, Domestic and Foreign [Table Text Block] | For financial reporting purposes, loss before taxes includes the following components: 2017 2016 United States $ (8,658,120) $ (7,375,974) Foreign (2,112,082) (2,077,514) Total $ (10,770,202) $ (9,453,488) |
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. Significant components of the Company’s deferred income tax assets and liabilities as of December 31, 2017 and 2016 are as follows: DECEMBER 31, 2017 2016 Deferred income tax assets: Net operating loss carryforwards $ 96,786,000 $ 140,468,000 Research and development credit carryforward 9,592,000 9,399,000 Intangible assets 4,184,000 6,913,000 Equity-based compensation 3,812,000 5,578,000 Other 164,000 297,000 Valuation allowance for deferred income tax assets (114,538,000) (162,655,000) 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: 2017 2016 Tax benefit at statutory rate $ (3,662,000) $ (3,214,000) Effect of tax law change 52,258,000 - State taxes (290,000) (232,000) Net R&D credit adjustment (185,000) (105,000) Attribute expiration 50,000 - Nondeductible expenses 6,000 4,000 Change in valuation allowance (48,117,000) 3,461,000 Other 125,000 177,000 Changes in applicable tax rates (185,000) (91,000) $ - $ - |
Schedule of Unrecognized Tax Benefits Roll Forward [Table Text Block] | A reconciliation of the beginning and ending amount of gross unrecognized tax benefits is as follows: 2017 2016 Unrecognized tax benefits balance at January 1 $ 3,133,000 $ 3,097,000 Additions for Tax Positions of Prior Periods 3,000 1,000 Additions for Tax Positions of Current Period 62,000 35,000 Unrecognized tax benefits balance at December 31 $ 3,198,000 $ 3,133,000 |
SHARE-BASED COMPENSATION AND 23
SHARE-BASED COMPENSATION AND WARRANTS (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Schedule of Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Table Text Block] | The Company’s net loss for the years ended December 31, 2017 and 2016 includes $ 650,440 2,995,240 2017 2016 Research and development $ 271,733 $ 746,027 General and administrative 378,707 2,249,213 Share-based compensation expense $ 650,440 $ 2,995,240 Net share-based compensation expense, per common share: Basic and diluted $ 0.01 $ 0.05 |
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, 2017 and 2016: Years ended December 31, 2017 2016 Expected volatility 78.88 % 82.12 % Risk free interest rate 1.96 % 1.29 % Expected term of option 6.29 years 5.33 years Forfeiture rate - *3.00 % Expected dividend yield - - *- In 2016, authoritative guidance required forfeitures to be estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. Throughout 2016, forfeitures were estimated at 3% and the actual forfeiture rate was 6% for 2016. The Company adjusted stock compensation expense for 2016 based on the actual forfeiture rate. |
Schedule of Share-based Compensation, Stock Options, Activity [Table Text Block] | Weighted Average Weighted Average Remaining Aggregate Intrinsic Number of Options Exercise Price Contractual Term Value In Years Outstanding at December 31, 2015 6,694,744 $ 1.99 Exercised - $ - Granted 4,213,518 $ 1.00 Expired (856,512) $ 2.24 Forfeited (516,444) $ 1.14 Outstanding at December 31, 2016 9,535,306 $ 1.57 Exercised (154,545) $ 2.11 Granted 3,199,500 $ 1.05 Expired (978,070) $ 1.64 Forfeited (16,876) $ 0.92 Outstanding at December 31, 2017 11,585,315 $ 1.42 7.46 $ 21,730,182 Exercisable at December 31, 2017 8,468,971 $ 1.57 6.78 $ 14,781,148 |
Schedule of Share-based Compensation, Shares Authorized under Stock Option Plans, by Exercise Price Range [Table Text Block] | The following summarizes information about stock options granted to employees and directors outstanding at December 31, 2017: 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, 2017 Life in Years Price December 31, 2017 Price $0.00 - $1.00 3,950,656 8.9 $ 0.93 1,538,965 $ 0.87 $1.01 - $2.00 7,083,119 7.0 $ 1.53 6,378,466 $ 1.57 $2.01 - $3.00 375,000 4.2 $ 2.24 375,000 $ 2.24 $3.01 - $7.00 122,000 3.0 $ 6.24 122,000 $ 6.24 $7.01 - $8.00 54,540 1.5 $ 7.26 54,540 $ 7.26 11,585,315 7.5 $ 1.42 8,468,971 $ 1.57 |
Schedule Of Warrant Activity [Table Text Block] | 2 5 Weighted Average Number of Shares Exercise Price Outstanding at December 31, 2015 4,010,903 $ 2.27 Issued 4,625,510 $ 1.69 Exercised - $ - Expired (2,247,912) $ 2.91 Outstanding at December 31, 2016 6,388,501 $ 1.60 Issued 1,638,506 $ 3.75 Exercised - $ - Expired (1,762,991) $ 1.46 Outstanding at December 31, 2017 6,264,016 $ 2.23 Exercisable at December 31, 2017 4,625,510 $ 1.69 |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of Future Minimum Rental Payments for Operating Leases [Table Text Block] | The future minimum payments under its facilities leases are as follows: 2018 $ 337,030 2019 259,459 2020 183,378 2021 191,691 2022 44,172 Thereafter - Total minimum payments $ 1,015,730 |
DESCRIPTION OF BUSINESS AND B25
DESCRIPTION OF BUSINESS AND BASIS OF PRESENTATION (Details Textual) - USD ($) | 1 Months Ended | 2 Months Ended | 9 Months Ended | ||||||
Mar. 29, 2018 | Oct. 17, 2017 | Jun. 24, 2016 | Nov. 20, 2017 | Dec. 31, 2018 | Mar. 31, 2018 | Mar. 19, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Description of Business and Basis of Presentation [Line Items] | |||||||||
Retained Earnings (Accumulated Deficit), Total | $ (452,702,029) | $ (441,931,827) | |||||||
Percentage Of Ownership Interest In Non Stock Subsidiary | 100.00% | ||||||||
Investors [Member] | |||||||||
Description of Business and Basis of Presentation [Line Items] | |||||||||
Proceeds From Issuance Of Common Stock Gross | $ 23,800,000 | ||||||||
Second Closing [Member] | |||||||||
Description of Business and Basis of Presentation [Line Items] | |||||||||
Proceeds from Issuance of Common Stock | $ 6,000,000 | ||||||||
Net Proceeds From Issuance Of Common Stock | $ 23,400,000 | ||||||||
Subsequent Event [Member] | |||||||||
Description of Business and Basis of Presentation [Line Items] | |||||||||
Proceeds from Issuance of Common Stock | $ 29,300,000 | ||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 6,172,832 | 6,172,832 | |||||||
Net Proceeds From Issuance Of Common Stock | $ 475,000 | ||||||||
Subsequent Event [Member] | Private Placement [Member] | |||||||||
Description of Business and Basis of Presentation [Line Items] | |||||||||
Stock And Warrants To Be Issued Value | $ 50,000,000 | ||||||||
Scenario, Forecast [Member] | |||||||||
Description of Business and Basis of Presentation [Line Items] | |||||||||
Additional Gross Proceeds From Issuance Of Common Stock To Be Received | $ 20,700,000 | ||||||||
Stock To Be Issued, Shares | 15,432,091 | ||||||||
CASI China [Member] | |||||||||
Description of Business and Basis of Presentation [Line Items] | |||||||||
Cash | $ 12,200,000 |
SUMMARY OF SIGNIFICANT ACCOUN26
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details) - USD ($) | Dec. 31, 2017 | Dec. 31, 2016 |
Property, Plant and Equipment [Line Items] | ||
Furniture and equipment | $ 1,150,052 | $ 480,172 |
Leasehold improvements | 268,734 | 11,435 |
Property, Plant and Equipment, Gross | 1,418,786 | 491,607 |
Less: accumulated depreciation and amortization | (372,272) | (262,016) |
Property, Plant and Equipment, Net | $ 1,046,514 | $ 229,591 |
SUMMARY OF SIGNIFICANT ACCOUN27
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details Textual) - USD ($) | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Accounting Policies [Line Items] | ||
Clinical Trial Accruals | $ 402,773 | $ 499,028 |
Depreciation | 117,779 | 66,451 |
Allocated Share-based Compensation Expense | $ 30,500 | $ 10,100 |
Options And Warrants [Member] | ||
Accounting Policies [Line Items] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 17,849,331 | 15,923,807 |
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, 2017 | Dec. 31, 2016 | |
Research and Development Expense, Total | $ 7,595,182 | $ 4,645,560 |
Accounts Payable, Related Parties, Current | 2,228,366 | 0 |
Spectrum [Member] | ||
Research and Development Expense, Total | 2,705,000 | $ 155,220 |
Accounts Payable, Related Parties, Current | $ 2,228,366 |
LICENSE ARRANGEMENTS (Details T
LICENSE ARRANGEMENTS (Details Textual) - USD ($) | 12 Months Ended | |||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2014 | Dec. 31, 2015 | |
License Arrangements [Line Items] | ||||
Fair Value, Measurement with Unobservable Inputs Reconciliations, Recurring Basis, Liability Value | $ 0 | $ 4,122,266 | $ 9,395,222 | |
Notes Payable, Noncurrent | 1,498,754 | 1,491,278 | ||
Licensing Agreements [Member] | ||||
License Arrangements [Line Items] | ||||
Fair Value, Measurement with Unobservable Inputs Reconciliations, Recurring Basis, Liability Value | 0 | $ 4,122,266 | ||
Spectrum [Member] | ||||
License Arrangements [Line Items] | ||||
Fair Value, Measurement with Unobservable Inputs Reconciliations, Recurring Basis, Liability Value | $ 0 | |||
Stock Issued During Period, Shares, New Issues | 1,519,096 | 4,623,197 | ||
Adjustments to Additional Paid in Capital, Stock Issued for Liability | $ 4,142,157 | $ 5,279,744 | ||
Spectrum Pharmaceuticals [Member] | ||||
License Arrangements [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 | |||
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). | |||
Aggregate Amount Of Funds Raised Before Contingent Rights Expire | $ 50,000,000 |
NOTE PAYABLE (Details Textual)
NOTE PAYABLE (Details Textual) - USD ($) | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Notes Payable [Line Items] | ||
Amortization of Debt Discount (Premium) | $ 7,000 | $ 26,000 |
Spectrum Pharmaceuticals [Member] | ||
Notes Payable [Line Items] | ||
Debt Instrument, Interest Rate, Stated Percentage | 0.50% | |
Debt Instrument Initial Discount Upon Issuance | $ 136,000 | |
Debt Instrument, Face Amount | $ 1,500,000 |
FAIR VALUE MEASUREMENTS (Detail
FAIR VALUE MEASUREMENTS (Details) - USD ($) | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |||
Liabilities - Contingent Rights | $ 0 | $ 4,122,266 | $ 9,395,222 |
Fair Value, Inputs, Level 1 [Member] | |||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |||
Liabilities - Contingent Rights | 0 | ||
Fair Value, Inputs, Level 2 [Member] | |||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |||
Liabilities - Contingent Rights | 0 | ||
Fair Value, Inputs, Level 3 [Member] | |||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |||
Liabilities - Contingent Rights | $ 4,122,266 |
FAIR VALUE MEASUREMENTS (Deta32
FAIR VALUE MEASUREMENTS (Details 1) - USD ($) | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ||
Balance at beginning of year | $ 4,122,266 | $ 9,395,222 |
Partial settlement of Contingent Rights | (4,142,157) | (5,279,744) |
Change in fair value of Contingent Rights | 19,891 | 6,788 |
Balance at end of year | $ 0 | $ 4,122,266 |
FAIR VALUE MEASUREMENTS (Deta33
FAIR VALUE MEASUREMENTS (Details Textual) - USD ($) | Dec. 31, 2017 | Dec. 31, 2016 |
Derivative Liability, Noncurrent | $ 0 | $ 4,122,266 |
INCOME TAXES (Details)
INCOME TAXES (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
United States | $ (8,658,120) | $ (7,375,974) |
Foreign | (2,112,082) | (2,077,514) |
Total | $ (10,770,202) | $ (9,453,488) |
INCOME TAXES (Details 1)
INCOME TAXES (Details 1) - USD ($) | Dec. 31, 2017 | Dec. 31, 2016 |
Deferred income tax assets: | ||
Net operating loss carryforwards | $ 96,786,000 | $ 140,468,000 |
Research and development credit carryforward | 9,592,000 | 9,399,000 |
Intangible assets | 4,184,000 | 6,913,000 |
Equity based compensation | 3,812,000 | 5,578,000 |
Other | 164,000 | 297,000 |
Valuation allowance for deferred income tax assets | (114,538,000) | (162,655,000) |
Net deferred income tax assets | $ 0 | $ 0 |
INCOME TAXES (Details 2)
INCOME TAXES (Details 2) - USD ($) | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Effective Income Tax Rate Reconciliation Line Items [Line Items] | ||
Tax benefit at statutory rate | $ (3,662,000) | $ (3,214,000) |
Effect of tax law change | 52,258,000 | 0 |
State taxes | (290,000) | (232,000) |
Net R&D credit adjustment | (185,000) | (105,000) |
Attribute expiration | 50,000 | 0 |
Nondeductible expenses | 6,000 | 4,000 |
Change in valuation allowance | (48,117,000) | 3,461,000 |
Other | 125,000 | 177,000 |
Changes in applicable tax rates | (185,000) | (91,000) |
Total | $ 0 | $ 0 |
INCOME TAXES (Details 3)
INCOME TAXES (Details 3) - USD ($) | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Schedule Of Unrecognized Tax Benefits Roll Forward [Line Items] | ||
Unrecognized tax benefits balance at January 1 | $ 3,133,000 | $ 3,097,000 |
Additions for Tax Positions of Prior Periods | 3,000 | 1,000 |
Additions for Tax Positions of Current Period | 62,000 | 35,000 |
Unrecognized tax benefits balance at December 31 | $ 3,198,000 | $ 3,133,000 |
INCOME TAXES (Details Textual)
INCOME TAXES (Details Textual) - USD ($) | 12 Months Ended | |||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Income Tax Contingency [Line Items] | ||||
Unrecognized Tax Benefits | $ 3,198,000 | $ 3,133,000 | $ 3,097,000 | |
Operating Loss Carryforwards | $ 368,134,000 | |||
Operating Loss Carryforwards Expiration Period | expire in years 2018 through 2038 | |||
Operating Loss Carryforwards, Limitations on Use | NOL and tax credit carryforwards may become subject to an annual limitation in the event of certain cumulative changes in the ownership interest of significant shareholders over a three-year period in excess of 50% | |||
Effective Income Tax Rate Reconciliation, Effect of tax law change , Amount | $ 52,258,000 | 0 | ||
Scenario, Forecast [Member] | ||||
Income Tax Contingency [Line Items] | ||||
Effective Income Tax Rate Reconciliation, at Federal Statutory Income Tax Rate, Percent | 21.00% | |||
UNITED STATES | ||||
Income Tax Contingency [Line Items] | ||||
Income (Loss) from Continuing Operations before Income Taxes, Extraordinary Items, Noncontrolling Interest | (8,658,120) | |||
CHINA | ||||
Income Tax Contingency [Line Items] | ||||
Income (Loss) from Continuing Operations before Income Taxes, Extraordinary Items, Noncontrolling Interest | (2,112,082) | |||
Research Tax Credit Carryforward [Member] | ||||
Income Tax Contingency [Line Items] | ||||
Unrecognized Tax Benefits | 65,000 | $ 3,133,000 | ||
Tax Credit Carryforward, Amount | $ 9,593,000 |
STOCKHOLDERS' EQUITY (Details T
STOCKHOLDERS' EQUITY (Details Textual) - USD ($) | Oct. 13, 2017 | Oct. 03, 2016 | Jul. 05, 2016 | Jan. 15, 2016 | Mar. 29, 2018 | Mar. 19, 2018 | Feb. 23, 2018 | Nov. 20, 2017 | Oct. 24, 2016 | Jun. 24, 2016 | Sep. 20, 2015 | Nov. 20, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Mar. 31, 2018 |
Percentage of Warrant Coverage On Purchase Price | 20.00% | |||||||||||||||
Class Of Warrant Or Right Maturity Period Description | The warrants became exercisable on January 23, 2017 at $1.69 per share exercise price, and will expire on January 23, 2020. | |||||||||||||||
Fair Value Of Warrant Issued | $ 306,173 | |||||||||||||||
Fair Value Assumptions Fair Value | $ 0.62 | |||||||||||||||
Fair Value Assumptions, Expected Term | 3 years 3 months | |||||||||||||||
Fair Value Assumptions, Risk Free Interest Rate | 1.00% | |||||||||||||||
Fair Value Assumptions, Expected Volatility Rate | 72.20% | |||||||||||||||
Warrants Issued | 493,827 | |||||||||||||||
Sale of Stock, Price Per Share | $ 1.190 | |||||||||||||||
Proceeds from Issuance or Sale of Equity | $ 3,000,000 | |||||||||||||||
Common Stock, Shares, Issued | 2,469,135 | 69,901,625 | 60,276,119 | |||||||||||||
Stock Issued During Period, Value, Other | $ 23,884,475 | $ 28,100,000 | ||||||||||||||
Price Per Share and Warrant | $ 0.125 | |||||||||||||||
Scenario, Forecast [Member] | ||||||||||||||||
Stock To Be Issued, Shares | 15,432,091 | |||||||||||||||
Additional Gross Proceeds From Issuance Of Common Stock To Be Received | $ 20,700,000 | |||||||||||||||
Investors [Member] | ||||||||||||||||
Stock To Be Issued, Shares | 20,658,434 | |||||||||||||||
Shares Issued, Price Per Share | $ 1.19 | |||||||||||||||
Percentage of Warrant Coverage On Purchase Price | 20.00% | |||||||||||||||
Class Of Warrant Or Right Maturity Period Description | The warrants became exercisable three months after issuance at $1.69 per share exercise price, and expire three years from the date the warrants become exercisable. | |||||||||||||||
Warrants To Be Issued | 4,131,686 | |||||||||||||||
Stock And Warrants To Be Issued Value | $ 25,100,000 | |||||||||||||||
Price Per Share and Warrant | $ 0.125 | |||||||||||||||
Subsequent Event [Member] | ||||||||||||||||
Proceeds from Issuance of Common Stock | $ 29,300,000 | |||||||||||||||
Net Proceeds From Issuance Of Common Stock | $ 475,000 | |||||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 6,172,832 | 6,172,832 | ||||||||||||||
Stock Issued During Period, Shares, New Issues | 143,248 | |||||||||||||||
Warrant Term | 5 years | |||||||||||||||
Price Per Share and Warrant | $ 3.24 | |||||||||||||||
Subsequent Event [Member] | Investors [Member] | ||||||||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 3.69 | |||||||||||||||
Subsequent Event [Member] | H.C. Wainwright Co., LLC [Member] | ||||||||||||||||
Commision Precentage on Gross Sale Price | 3.00% | |||||||||||||||
Subsequent Event [Member] | H.C. Wainwright Co., LLC [Member] | Maximum [Member] | ||||||||||||||||
Aggregate Sales Price | $ 25,000,000 | |||||||||||||||
Second Closing [Member] | ||||||||||||||||
Class Of Warrant Or Right Maturity Period Description | The warrants became exercisable on September 23, 2016 at $1.69 per share exercise price, and will expire on September 23, 2019 | |||||||||||||||
Fair Value Of Warrant Issued | $ 431,738 | |||||||||||||||
Fair Value Assumptions Fair Value | $ 0.44 | |||||||||||||||
Fair Value Assumptions, Expected Term | 3 years 3 months | |||||||||||||||
Fair Value Assumptions, Risk Free Interest Rate | 0.76% | |||||||||||||||
Fair Value Assumptions, Expected Volatility Rate | 70.40% | |||||||||||||||
Warrants Issued | 981,223 | |||||||||||||||
Proceeds from Issuance of Common Stock | $ 6,000,000 | |||||||||||||||
Sale of Stock, Number of Shares Issued in Transaction | 4,906,118 | |||||||||||||||
Sale of Stock, Price Per Share | $ 1.19 | |||||||||||||||
Net Proceeds From Issuance Of Common Stock | $ 23,400,000 | |||||||||||||||
Price Per Share and Warrant | $ 0.125 | |||||||||||||||
First Closing [Member] | ||||||||||||||||
Shares Issued, Price Per Share | $ 1.19 | |||||||||||||||
Class Of Warrant Or Right Maturity Period Description | The warrants became exercisable on April 15, 2016 at $1.69 per share exercise price, and will expire on April 15, 2019. | |||||||||||||||
Fair Value Of Warrant Issued | $ 321,047 | |||||||||||||||
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 | |||||||||||||||
Sale of Stock, Number of Shares Issued in Transaction | 8,448,613 | |||||||||||||||
Net Proceeds From Issuance Of Common Stock | $ 10,200,000 | |||||||||||||||
Price Per Share and Warrant | $ 0.125 | |||||||||||||||
Third Closing [Member] | ||||||||||||||||
Class Of Warrant Or Right Maturity Period Description | The warrants became exercisable on October 4, 2016 at $1.69 per share exercise price, and will expire on October 4, 2019. | |||||||||||||||
Fair Value Of Warrant Issued | $ 67,490 | |||||||||||||||
Fair Value Assumptions Fair Value | $ 0.41 | |||||||||||||||
Fair Value Assumptions, Expected Term | 3 years 3 months | |||||||||||||||
Fair Value Assumptions, Risk Free Interest Rate | 0.66% | |||||||||||||||
Fair Value Assumptions, Expected Volatility Rate | 70.60% | |||||||||||||||
Warrants Issued | 164,609 | |||||||||||||||
Proceeds from Issuance of Common Stock | $ 1,000,000 | |||||||||||||||
Sale of Stock, Number of Shares Issued in Transaction | 823,045 | |||||||||||||||
Sale of Stock, Price Per Share | $ 1.19 | |||||||||||||||
Price Per Share and Warrant | $ 0.125 | |||||||||||||||
Final Closing [Member] | ||||||||||||||||
Class Of Warrant Or Right Maturity Period Description | The warrants became exercisable on January 2, 2017 at $1.69 per share exercise price, and will expire on January 2, 2020. | |||||||||||||||
Fair Value Of Warrant Issued | $ 544,374 | |||||||||||||||
Fair Value Assumptions Fair Value | $ 0.42 | |||||||||||||||
Fair Value Assumptions, Expected Term | 3 years 3 months | |||||||||||||||
Fair Value Assumptions, Risk Free Interest Rate | 0.91% | |||||||||||||||
Fair Value Assumptions, Expected Volatility Rate | 71.40% | |||||||||||||||
Warrants Issued | 1,296,129 | |||||||||||||||
Proceeds from Issuance of Common Stock | $ 7,800,000 | |||||||||||||||
Sale of Stock, Number of Shares Issued in Transaction | 6,480,655 | |||||||||||||||
Sale of Stock, Price Per Share | $ 1.19 | |||||||||||||||
Price Per Share and Warrant | $ 0.125 | |||||||||||||||
Securities Purchase Agreements [Member] | ||||||||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 3.75 | |||||||||||||||
Fair Value Of Warrant Issued | $ 1,558,566 | |||||||||||||||
Fair Value Assumptions Fair Value | $ 0.98 | |||||||||||||||
Fair Value Assumptions, Expected Term | 2 years 6 months | |||||||||||||||
Fair Value Assumptions, Risk Free Interest Rate | 1.54% | |||||||||||||||
Fair Value Assumptions, Expected Volatility Rate | 85.40% | |||||||||||||||
Proceeds from Issuance of Common Stock | $ 23,855,595 | |||||||||||||||
Sale of Stock, Price Per Share | $ 3 | |||||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 1,590,373 | |||||||||||||||
Class of Warrant or Right, Number of Securities Called by Each Warrant or Right | 0.20 | |||||||||||||||
Class Of Warrant Or Right Expiration Date | Apr. 17, 2018 | |||||||||||||||
Class of Warrant or Right, Date from which Warrants or Rights Exercisable | Apr. 17, 2020 | |||||||||||||||
Stock Issued During Period, Value, Other | $ 23,400,000 | |||||||||||||||
Stock Issued During Period | 7,951,865 | |||||||||||||||
Securities Purchase Agreements [Member] | Agent Warrants [Member] | ||||||||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 3.75 | |||||||||||||||
Fair Value Of Warrant Issued | $ 28,880 | |||||||||||||||
Fair Value Assumptions Fair Value | $ 0.60 | |||||||||||||||
Fair Value Assumptions, Expected Term | 1 year 6 months | |||||||||||||||
Fair Value Assumptions, Risk Free Interest Rate | 1.54% | |||||||||||||||
Fair Value Assumptions, Expected Volatility Rate | 77.80% | |||||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 48,133 | |||||||||||||||
Class Of Warrant Or Right Expiration Date | Apr. 17, 2018 | |||||||||||||||
Class of Warrant or Right, Date from which Warrants or Rights Exercisable | Apr. 17, 2019 | |||||||||||||||
Agent Warrants Percentage | 4.00% | |||||||||||||||
Private Placement [Member] | Subsequent Event [Member] | ||||||||||||||||
Stock And Warrants To Be Issued Value | $ 50,000,000 |
SHARE-BASED COMPENSATION AND 40
SHARE-BASED COMPENSATION AND WARRANTS (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Stock-based compensation expense | $ 650,440 | $ 2,995,240 | $ 2,995,240 |
Net share-based compensation expense, per common share: | |||
Basic and diluted (in dollars per share) | $ 0.01 | $ 0.05 | |
Research and Development Expense [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Stock-based compensation expense | $ 271,733 | $ 746,027 | |
General and Administrative Expense [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Stock-based compensation expense | $ 378,707 | $ 2,249,213 |
SHARE-BASED COMPENSATION AND 41
SHARE-BASED COMPENSATION AND WARRANTS (Details 1) | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected volatility | 78.88% | 82.12% | |
Risk-free interest rate | 1.96% | 1.29% | |
Expected term of option | 6 years 3 months 14 days | 5 years 3 months 29 days | |
Forfeiture rate | 0.00% | 3.00% | [1] |
Expected dividend yield | 0.00% | 0.00% | |
[1] | In 2016, authoritative guidance required forfeitures to be estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. Throughout 2016, forfeitures were estimated at 3% and the actual forfeiture rate was 6% for 2016. The Company adjusted stock compensation expense for 2016 based on the actual forfeiture rate. |
SHARE-BASED COMPENSATION AND 42
SHARE-BASED COMPENSATION AND WARRANTS (Details 2) - Employee Stock Option [Member] - USD ($) | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Outstanding - Number of Options, Beginning Balance | 9,535,306 | 6,694,744 |
Exercised - Number of Options | (154,545) | 0 |
Granted - Number of Options | 3,199,500 | 4,213,518 |
Expired - Number of Options | (978,070) | (856,512) |
Forfeited - Number of Options | (16,876) | (516,444) |
Outstanding - Number of Options, Ending Balance | 11,585,315 | 9,535,306 |
Exercisable - Number of Options | 8,468,971 | |
Outstanding - Weighted Average Exercise Price, Beginning balance | $ 1.57 | $ 1.99 |
Exercised - Weighted Average Exercise Price | 2.11 | 0 |
Granted - Weighted Average Exercise Price | 1.05 | 1 |
Expired - Weighted Average Exercise Price | 1.64 | 2.24 |
Forfeited - Weighted Average Exercise Price | 0.92 | 1.14 |
Outstanding - Weighted Average Exercise Price, Ending Balance | 1.42 | $ 1.57 |
Exercisable - Weighted Average Exercise Price | $ 1.57 | |
Outstanding - Weighted Average Remaining Contractual Term In Years | 7 years 5 months 16 days | |
Exercisable - Weighted Average Remaining Contractual Term In Years | 6 years 9 months 11 days | |
Outstanding - Aggregate Intrinsic Value | $ 21,730,182 | |
Exercisable - Aggregate Intrinsic Value | $ 14,781,148 |
SHARE-BASED COMPENSATION AND 43
SHARE-BASED COMPENSATION AND WARRANTS (Details 3) | 12 Months Ended |
Dec. 31, 2017$ / sharesshares | |
Number Of Options Outstanding at December 31,2017 | shares | 11,585,315 |
Number Of Options Outstanding Weighted Average Remaining Contractual Life in Years | 7 years 6 months |
Number Of Options Outstanding Weighted Average Exercise Price | $ 1.42 |
Number Of Options Exercisable at December 31, 2017 | shares | 8,468,971 |
Number Of Options Exercisable Weighted Average Exercise Price | $ 1.57 |
Range One [Member] | |
Range of Exercise Prices Lower Range Limit | 0 |
Range of Exercise Prices Upper Range Limit | $ 1 |
Number Of Options Outstanding at December 31,2017 | shares | 3,950,656 |
Number Of Options Outstanding Weighted Average Remaining Contractual Life in Years | 8 years 10 months 24 days |
Number Of Options Outstanding Weighted Average Exercise Price | $ 0.93 |
Number Of Options Exercisable at December 31, 2017 | shares | 1,538,965 |
Number Of Options Exercisable Weighted Average Exercise Price | $ 0.87 |
Range Two [Member] | |
Range of Exercise Prices Lower Range Limit | 1.01 |
Range of Exercise Prices Upper Range Limit | $ 2 |
Number Of Options Outstanding at December 31,2017 | shares | 7,083,119 |
Number Of Options Outstanding Weighted Average Remaining Contractual Life in Years | 7 years |
Number Of Options Outstanding Weighted Average Exercise Price | $ 1.53 |
Number Of Options Exercisable at December 31, 2017 | shares | 6,378,466 |
Number Of Options Exercisable Weighted Average Exercise Price | $ 1.57 |
Range Three [Member] | |
Range of Exercise Prices Lower Range Limit | 2.01 |
Range of Exercise Prices Upper Range Limit | $ 3 |
Number Of Options Outstanding at December 31,2017 | shares | 375,000 |
Number Of Options Outstanding Weighted Average Remaining Contractual Life in Years | 4 years 2 months 12 days |
Number Of Options Outstanding Weighted Average Exercise Price | $ 2.24 |
Number Of Options Exercisable at December 31, 2017 | shares | 375,000 |
Number Of Options Exercisable Weighted Average Exercise Price | $ 2.24 |
Range Four [Member] | |
Range of Exercise Prices Lower Range Limit | 3.01 |
Range of Exercise Prices Upper Range Limit | $ 7 |
Number Of Options Outstanding at December 31,2017 | shares | 122,000 |
Number Of Options Outstanding Weighted Average Remaining Contractual Life in Years | 3 years |
Number Of Options Outstanding Weighted Average Exercise Price | $ 6.24 |
Number Of Options Exercisable at December 31, 2017 | shares | 122,000 |
Number Of Options Exercisable Weighted Average Exercise Price | $ 6.24 |
Range Five [Member] | |
Range of Exercise Prices Lower Range Limit | 7.01 |
Range of Exercise Prices Upper Range Limit | $ 8 |
Number Of Options Outstanding at December 31,2017 | shares | 54,540 |
Number Of Options Outstanding Weighted Average Remaining Contractual Life in Years | 1 year 6 months |
Number Of Options Outstanding Weighted Average Exercise Price | $ 7.26 |
Number Of Options Exercisable at December 31, 2017 | shares | 54,540 |
Number Of Options Exercisable Weighted Average Exercise Price | $ 7.26 |
SHARE-BASED COMPENSATION AND 44
SHARE-BASED COMPENSATION AND WARRANTS (Details 4) - Warrant [Member] - $ / shares | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Outstanding at Number of Warrants, Beginning Balance | 6,388,501 | 4,010,903 |
Issued Number of Warrants | 1,638,506 | 4,625,510 |
Exercised Number of Warrants | 0 | 0 |
Expired Number of Warrants | (1,762,991) | (2,247,912) |
Outstanding at Number of Warrants, Ending Balance | 6,264,016 | 6,388,501 |
Exercisable Number of Warrants | 4,625,510 | |
Outstanding Weighted Average Exercise Price, Beginning Balance | $ 1.60 | $ 2.27 |
Issued Weighted Average Exercise Price | 3.75 | 1.69 |
Exercised Weighted Average Exercise Price | 0 | 0 |
Expired Weighted Average Exercise Price | 1.46 | 2.91 |
Outstanding Weighted Average Exercise Price, at Ending Balance | 2.23 | $ 1.60 |
Exercisable Weighted Average Exercise Price | $ 1.69 |
SHARE-BASED COMPENSATION AND 45
SHARE-BASED COMPENSATION AND WARRANTS (Details Textual) - USD ($) | 12 Months Ended | ||||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | Mar. 13, 2018 | Jun. 30, 2017 | |
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 | $ 0.73 | $ 0.75 | |||
Share-based Compensation, Total | $ 650,440 | $ 2,995,240 | $ 2,995,240 | ||
Allocated Share-based Compensation Expense | 30,500 | 10,100 | |||
Proceeds from Stock Options Exercised | 325,999 | 0 | |||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period, Intrinsic Value | 168,000 | ||||
Unrecognized Share Based Compensation Cost Expected To Be Recognized Over Weighted Average Period | $ 544,000 | ||||
Unrecognized Share Based Compensation Cost Expected To Be Recognized Over Weighted Average Period | 1 year 9 months 18 days | ||||
Performance Shares [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Allocated Share-based Compensation Expense | $ 30,500 | $ 10,100 | |||
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 | 2,225,000 | ||||
Executive Chairman [Member] | Subsequent Event [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercisable, Number | 1,000,000 | ||||
Executive Chairman [Member] | Performance Based Option [Member] | Subsequent Event [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercisable, Number | 4,000,000 | ||||
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 | 2 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 | 2,852,234 | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number, Ending Balance | 11,585,315 | ||||
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 | 14,230,000 | ||||
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range, Upper Range Limit | $ 7.37 | ||||
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 | 11,230,000 | ||||
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range, Lower Range Limit | $ 0.86 |
COMMITMENTS AND CONTINGENCIES46
COMMITMENTS AND CONTINGENCIES (Details) | Dec. 31, 2017USD ($) |
2,018 | $ 337,030 |
2,019 | 259,459 |
2,020 | 183,378 |
2,021 | 191,691 |
2,022 | 44,172 |
Thereafter | 0 |
Total minimum payments | $ 1,015,730 |
COMMITMENTS AND CONTINGENCIES47
COMMITMENTS AND CONTINGENCIES (Details Textual) - USD ($) | 1 Months Ended | 12 Months Ended | |||
Mar. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2010 | Dec. 31, 2008 | |
Purchase obligation to purchase materials | $ 300,000 | ||||
Operating Leases, Rent Expense | 440,000 | $ 328,000 | |||
Subsequent Event [Member] | |||||
Purchase obligation to purchase materials | $ 5,500,000 | ||||
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] | |||||
Payable And Contingent Upon Certain Milestones | $ 4,000,000 |
EMPLOYEE RETIREMENT PLAN (Detai
EMPLOYEE RETIREMENT PLAN (Details Textual) - USD ($) | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Defined Benefit Plan, Contributions by Employer | $ 70,167 | $ 30,300 |
SUBSEQUENT EVENT (Details Textu
SUBSEQUENT EVENT (Details Textual) $ in Millions | 1 Months Ended |
Jan. 26, 2018USD ($) | |
Sandoz Inc [Member] | Subsequent Event [Member] | |
Payments to Acquire Intangible Assets | $ 18 |