Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2018 | Mar. 25, 2019 | Jun. 30, 2018 | |
Document and Entity Information [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2018 | ||
Document Fiscal Year Focus | 2018 | ||
Document Fiscal Period Focus | FY | ||
Entity Registrant Name | CASI Pharmaceuticals, Inc. | ||
Entity Central Index Key | 0000895051 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Filer Category | Accelerated Filer | ||
Entity Public Float | $ 424,418,326 | ||
Trading Symbol | CASI | ||
Entity Common Stock, Shares Outstanding | 95,717,052 | ||
Entity Shell Company | false | ||
Entity Emerging Growth Company | false | ||
Entity Small Business | true |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Current assets: | ||
Cash and cash equivalents | $ 84,204,809 | $ 43,489,935 |
Investment in equity securities, at fair value | 912,200 | 0 |
Prepaid expenses and other | 7,447,611 | 322,493 |
Total current assets | 92,564,620 | 43,812,428 |
Property and equipment, net | 1,750,630 | 1,046,514 |
Intangible assets, net | 18,784,727 | 0 |
Other assets | 310,024 | 242,023 |
Total assets | 113,410,001 | 45,100,965 |
Current liabilities: | ||
Accounts payable | 968,048 | 2,087,770 |
Payable to related party | 0 | 2,228,366 |
Accrued liabilities | 1,406,434 | 745,961 |
Note payable, net of discount | 1,499,462 | 0 |
Total current liabilities | 3,873,944 | 5,062,097 |
Note payable, net of discount | 0 | 1,498,754 |
Other liabilities | 73,591 | 0 |
Total liabilities | 3,947,535 | 6,560,851 |
Commitments and contingencies (Note 17) | ||
Stockholders' equity: | ||
Preferred stock, $1.00 par value; 5,000,000 shares authorized and 0 shares issued and outstanding at December 31, 2018 and 2017 | 0 | 0 |
Common stock, $.01 par value: 170,000,000 shares authorized at December 31, 2018 and 2017; 95,366,813 shares and 69,901,625 shares issued at December 31, 2018 and 2017; 95,287,268 shares and 69,822,080 shares outstanding at December 31, 2018 and 2017, respectively | 953,667 | 699,015 |
Additional paid-in capital | 596,710,648 | 498,577,372 |
Treasury stock, at cost: 79,545 shares held at December 31, 2018 and 2017 | (8,034,244) | (8,034,244) |
Accumulated other comprehensive loss | (1,226,320) | 0 |
Accumulated deficit | (478,941,285) | (452,702,029) |
Total stockholders' equity | 109,462,466 | 38,540,114 |
Total liabilities and stockholders' equity | $ 113,410,001 | $ 45,100,965 |
Consolidated Balance Sheets _Pa
Consolidated Balance Sheets [Parenthetical] - $ / shares | Dec. 31, 2018 | Dec. 31, 2017 |
Preferred Stock, Par or Stated Value Per Share | $ 1 | $ 1 |
Preferred Stock, Shares Authorized | 5,000,000 | 5,000,000 |
Preferred Stock, Shares Issued | 0 | 0 |
Preferred Stock, Shares Outstanding | 0 | 0 |
Common stock, par value | $ 0.01 | $ 0.01 |
Common stock, shares authorized | 170,000,000 | 170,000,000 |
Common stock, shares issued | 95,366,813 | 69,901,625 |
Common Stock, Shares, Outstanding | 95,287,268 | 69,822,080 |
Treasury stock, shares held | 79,545 | 79,545 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Revenues: | ||
Revenues Total | $ 0 | $ 0 |
Costs and expenses: | ||
Research and development | 8,507,377 | 7,595,182 |
General and administrative | 17,997,069 | 3,156,138 |
Acquired in-process research and development | 686,998 | 0 |
Costs and expenses | 27,191,444 | 10,751,320 |
Interest income, net | (39,988) | (1,009) |
Change in fair value of investment in equity securities | 320,112 | 0 |
Change in fair value of contingent rights | 0 | 19,891 |
Net loss | $ (27,471,568) | $ (10,770,202) |
Net loss per share (basic and diluted) | $ (0.32) | $ (0.18) |
Weighted average number of shares outstanding (basic and diluted) | 84,752,152 | 61,513,988 |
Comprehensive loss: | ||
Net loss | $ (27,471,568) | $ (10,770,202) |
Foreign currency translation adjustment | (1,226,320) | 0 |
Total comprehensive loss | (28,697,888) | (10,770,202) |
Product sales [Member] | ||
Revenues: | ||
Revenues Total | $ 0 | $ 0 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity - USD ($) | Total | Accumulated Other Comprehensive Loss [Member] | Preferred Stock [Member] | Common Stock [Member] | Treasury Stock [Member] | Additional Paid-in Capital [Member] | Accumulated Deficit [Member] |
Balance at Dec. 31, 2016 | $ 20,783,775 | $ 0 | $ 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 | $ 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 | $ 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 | $ 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 | 0 | 4,142,157 | 0 |
Stock issuance costs | (491,721) | 0 | 0 | 0 | 0 | (491,721) | 0 |
Stock-based compensation expense, net of forfeitures | 650,440 | 0 | 0 | 0 | 0 | 650,440 | 0 |
Net loss | (10,770,202) | 0 | 0 | 0 | 0 | 0 | (10,770,202) |
Balance at Dec. 31, 2017 | 38,540,114 | 0 | $ 0 | $ 699,015 | (8,034,244) | 498,577,372 | (452,702,029) |
Balance (in shares) at Dec. 31, 2017 | 0 | 69,822,080 | |||||
Correction of immaterial error in prior year and cumulative effect adjustment due to the adoption of ASU 2016-01 | 1,232,312 | 0 | $ 0 | $ 0 | 0 | 0 | 1,232,312 |
Issuance of common stock and warrants pursuant to financing agreements | 87,990,216 | 0 | $ 0 | $ 225,716 | 0 | 87,764,500 | 0 |
Issuance of common stock and warrants pursuant to financing agreements (in shares) | 0 | 22,571,605 | |||||
Issuance of common stock for options exercised | 257,948 | 0 | $ 0 | $ 1,397 | 0 | 256,551 | 0 |
Issuance of common stock for options exercised (in shares) | 0 | 139,683 | |||||
Repurchase of stock options to satisfy tax withholding obligations | (117,194) | 0 | $ 0 | $ 0 | 0 | (117,194) | 0 |
Issuance of common stock from exercise of warrants | 4,960,617 | 0 | $ 0 | $ 27,539 | 0 | 4,933,078 | 0 |
Issuance of common stock from exercise of warrants (in shares) | 0 | 2,753,900 | |||||
Stock issuance costs | (821,780) | 0 | $ 0 | $ 0 | 0 | (821,780) | 0 |
Stock-based compensation expense, net of forfeitures | 6,118,121 | 0 | 0 | 0 | 0 | 6,118,121 | 0 |
Foreign currency translation adjustment | (1,226,320) | (1,226,320) | 0 | 0 | 0 | 0 | 0 |
Net loss | (27,471,568) | 0 | 0 | 0 | 0 | 0 | (27,471,568) |
Balance at Dec. 31, 2018 | $ 109,462,466 | $ (1,226,320) | $ 0 | $ 953,667 | $ (8,034,244) | $ 596,710,648 | $ (478,941,285) |
Balance (in shares) at Dec. 31, 2018 | 0 | 95,287,268 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
CASH FLOWS FROM OPERATING ACTIVITIES | ||
Net loss | $ (27,471,568) | $ (10,770,202) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization for property and equipment | 365,555 | 117,779 |
Net loss on disposal of furniture and equipment | 5,346 | 0 |
Amortization of intangible assets | 1,305,379 | 0 |
Stock-based compensation expense | 6,118,121 | 650,440 |
Acquired in-process research and development | 552,863 | 0 |
Change in fair value of investment in equity securities | 320,112 | 0 |
Non-cash interest | 708 | 7,476 |
Change in fair value of contingent rights | 0 | 19,891 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other | (7,226,256) | (361) |
Accounts payable | (1,097,170) | 849,365 |
Payable to related party | (2,228,366) | 2,228,366 |
Accrued liabilities | 771,348 | 495,011 |
Net cash used in operating activities | (28,583,928) | (6,402,235) |
CASH FLOWS FROM INVESTING ACTIVITIES | ||
Proceeds from sale of furniture and equipment | 590 | 0 |
Purchases of property and equipment | (1,131,113) | (934,702) |
Acquisition of abbreviated new drug applications and related items | (20,642,969) | 0 |
Net cash used in investing activities | (21,773,492) | (934,702) |
CASH FLOWS FROM FINANCING ACTIVITIES | ||
Stock issuance costs | (821,780) | (462,841) |
Proceeds from sale of common stock and warrants | 87,990,216 | 23,870,786 |
Proceeds from exercise of stock options | 257,948 | 325,999 |
Repurchase of stock options to satisfy tax withholding obligations | (117,194) | 0 |
Proceeds from exercise of warrants | 4,960,617 | 0 |
Net cash provided by financing activities | 92,269,807 | 23,733,944 |
Effect of exchange rate change on cash and cash equivalents | (1,197,513) | 0 |
Net increase in cash and cash equivalents | 40,714,874 | 16,397,007 |
Cash and cash equivalents at beginning of year | 43,489,935 | 27,092,928 |
Cash and cash equivalents at end of year | 84,204,809 | 43,489,935 |
Supplemental disclosure of cash flow information: | ||
Interest paid | 0 | 0 |
Income taxes paid | 0 | 0 |
Non-cash financing activity: | ||
Warrant issued to placement agent | 0 | 28,880 |
Partial settlement of contingent rights derivative | 0 | 4,142,157 |
Non-cash investing activity: | ||
Disposal of fully depreciated property and equipment, at cost | $ 14,997 | $ 7,523 |
DESCRIPTION OF BUSINESS
DESCRIPTION OF BUSINESS | 12 Months Ended |
Dec. 31, 2018 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Basis of Accounting [Text Block] | 1. DESCRIPTION OF BUSINESS CASI Pharmaceuticals, Inc. (“CASI” or the “Company”) (Nasdaq: CASI) is a U.S. pharmaceutical company with a platform to develop and accelerate the launch of pharmaceutical products and innovative therapeutics in China, U.S., and throughout the world. The Company is focused on acquiring, licensing, developing and commercializing products that address areas of unmet medical needs. The Company intends to execute its plan to become a leading platform to launch medicines in the greater China market leveraging its China-based regulatory and commercial competencies and its global drug development expertise. The Company conducts substantially all of its operations through its wholly-owned subsidiary, CASI Pharmaceuticals (Beijing) Co., Ltd. (“CASI China”), which is headquartered in Beijing, China. CASI China has established China operations that are growing as the Company continues to further in-license or acquire products for its pipeline. On December 26, 2018, the Company established CASI Pharmaceuticals (Wuxi) Co., Ltd. (“CASI Wuxi”) in China that will begin to develop a manufacturing capability in China in 2019. The Company currently operates in one operating segment, which is the development of innovative therapeutics addressing cancer and other unmet medical needs for the global market. 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 Melphalan Hydrochloride For Injection (EVOMELA ® ® ® approved in the U.S. for advanced adult Ph- acute lymphoblastic leukemia (ALL). On March 1, 2019, Spectrum sold these products, along with the licenses and contracts relating thereto, to Acrotech Biopharma L.L.C. (“Acrotech”). The Company does not expect any material adverse effect on its operations to result from the sale. In January 2018, the Company acquired a portfolio of 25 U.S. Food and Drug Administration (“FDA”) approved abbreviated new drug applications (ANDAs), and four ANDAs that are pending FDA approval, from Sandoz, Inc. (“Sandoz”). 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. In October 2018, the Company entered into an agreement with Laurus Labs Limited (“Laurus”), a company organized under the Laws of India, pursuant to which the Company acquired one U.S. FDA-approved ANDA for tenofovir disoproxil fumarate (“TDF”), which is indicated for the treatment of hepatitis B virus. As a result, the Company’s product pipeline features the following: (1) U.S. FDA approved hematology oncology drugs in-licensed for the greater China market, consisting of Melphalan Hydrochloride For Injection (EVOMELA), Ibritumomab Tiuxetan (ZEVALIN) and Vincristine Sulfate Liposome Injection (MARQIBO) , (2) a portfolio of 26 FDA-approved abbreviated new drug applications (“ANDAs”), including entecavir and TDF indicated for hepatitis B virus; and (3) four pipeline ANDAs that are pending FDA approval. The Company intends to prioritize a select subset of the ANDAs for product registration and commercialization in China. In addition to these advanced products, the Company’s pipeline includes a proprietary Phase 2 drug candidate, ENMD-2076, that the Company has previously determined not to pursue as a single agent, and instead is exploring the feasibility of combination as a clinical strategy. The Company also has proprietary early-stage immune-oncological potential candidates in preclinical development. The Company’s product mix reflects a risk-balanced approach between products in various stages of development, between products that are branded and non-branded, and between products that are proprietary and generic. The Company intends to continue building a significant product pipeline of high quality, as well as innovative drug candidates for commercialization in China and for the rest of the world. For in-licensed products, the Company uses a market-oriented approach to identify pharmaceutical candidates that it believes have the potential for gaining widespread market acceptance, either globally or in China, and for which development can be accelerated under the Company’s drug development strategy. For the Company’s FDA-approved ANDAs, the Company intends to select and commercialize certain niche products from the portfolio that complements its therapeutic focus areas and which offer unique market and cost-effective manufacturing opportunities in China and/or in the U.S. The Company believes the China operations offers a significant market and growth potential due to extraordinary increase in demand for high quality medicine coupled with regulatory reforms in China that make it easier for global pharmaceutical companies to introduce new pharmaceutical products into the country. The Company will continue to in-license clinical-stage and late-stage drug candidates, and leverage its platform and expertise, and hope to be the partner of choice to provide access to the China market. The Company expects the implementation of its plans will include leveraging the Company’s resources and expertise in both the U S and China so that the Company can maximize development and clinical strategies concurrently under U.S. FDA and China National Medical Products Administration (NMPA, formerly the China Food and Drug Administration) regulatory regimes. 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 commercial launches. In December 2018, the Company received NMPA approval of Melphalan Hydrochloride For Injection (EVOMELA), for: use as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma, and the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate. The Company intends to begin commercializing this drug through CASI China beginning in 2019 using EVOMELA supplied through Spectrum and its suppliers. All future needs will be sourced from Acrotech and its suppliers. The Company is building an internal commercial team to prepare for the launch of its first commercial product, Melphalan Hydrochloride for Injection (EVOMELA) in 2019. As part of the strategy to support the Company’s future clinical and commercial manufacturing needs and to manage its supply chain for certain products, the Company has established CASI Wuxi to construct a cGMP manufacturing facility in Wuxi, China. The site is currently in the design and engineering phase with construction expected to begin in 2019. Through CASI China, the Company will focus on China market devoting more resources and investment going forward. Liquidity Risks and Management’s Plans Since inception, the Company has incurred significant losses from operations and has incurred an accumulated deficit of $478.9 million The Company expects to continue to incur operating losses for the foreseeable future due to, among other factors, its continuing clinical and development activities. In September 2018, the Company entered into securities purchase agreements with certain institutional investors, accredited investors and current stockholders, pursuant to which the Company agreed to sell up to 9,048,504 shares of its common stock with accompanying warrants to purchase 2,714,548 shares of its common stock in a $48.5 million private placement (the “September 2018 Offering”). The Company held its initial closing on September 24, 2018 and second closing on October 10, 2018, receiving total gross proceeds of $37.5 million. The Company does not expect to receive any further proceeds from the September 2018 Offering. In March 2018, the Company entered into securities purchase agreements pursuant to which the Company issued 15,432,091 shares of its common stock with accompanying warrants to purchase 6,172,832 shares of its common stock and received $50 million in gross proceeds in a private placement. This financing included an investment from ETP Global Fund, L.P., a healthcare investment fund; the managing member of Emerging Technology Partners, LLC (the general partner of ETP Global Fund, L.P.) is the Company’s Executive Chairman of the Board of Directors. The financing also included an investment from IDG-Accel China Growth Fund III L.P. (“IDG-Accel Growth”) and IDG-Accel China III Investors L.P. (“IDG-Accel Investors”); a director and shareholder of IDG-Accel China Growth Fund GP III Associates Ltd. (the ultimate general partner of IDG-Accel Growth and IDG-Accel Investors) is a member of the Company’s Board of Directors. Net proceeds from the 2018 financings are being used to prepare for the launch of the Company’s first commercial product in China, Melphalan Hydrochloride For Injection (EVOMELA), to support the Company’s business development activities, to advance the development of the Company’s pipeline, to support its marketing and commercial planning activities, and for other general corporate purposes. 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. In November 2018, the Company committed to invest up to $80 million in cash and assets in CASI Wuxi in furtherance of its drug development strategy in China and made an initial cash investment of $21 million in February 2019 (see Note 8). Taking into consideration the cash balance as of December 31, 2018 and its commitments to fund CASI Wuxi, the Company believes that it has sufficient resources to fund its operations at least through March 29, 2020. The Company intends to continue to exercise tight controls over operating expenditures and will continue to pursue opportunities, as required, to raise additional capital and will also actively pursue non- or less-dilutive capital raising arrangements in China to support the Company’s dual-country approach to drug development. 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, 2018 | |
Accounting Policies [Abstract] | |
Basis of Presentation and Significant Accounting Policies [Text Block] | 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Basis of Presentation The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”). Use of Estimates The preparation of consolidated financial statements in conformity with U.S. GAAP 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 fair value determination and recoverability of intangible assets, clinical trial accruals, deferred tax assets and liabilities and valuation allowance, and stock-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. Consolidation and Foreign Currency Matters 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% of its interest owned by CASI. CASI China received approval for a business license from the Beijing Industry and Commercial Administration in August 2012 and has operating facilities in Beijing. All inter-company balances and transactions have been eliminated in consolidation. The Company’s reporting currency is the U.S. dollar. Prior to 2018, the functional currency of the Company’s subsidiary based in China was the U.S dollar. However, as discussed in Note 3, 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, and that it may allow its subsidiary in China to generate operating revenues from the China marketplace in the future and potentially sustain its own operations without the necessity of parent support. Accordingly, effective January 1, 2018, the functional currency of the Company’s subsidiary based in China was changed to the local currency of the China Renminbi (“RMB”). Upon the change in functional currency, there was no material impact on the consolidated financial statements. Accordingly, beginning January 1, 2018 translation gains and losses relating to the financial statements of the Company’s China subsidiaries are included as accumulated other comprehensive loss in the accompanying consolidated balance sheets. 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 estimated using an average periodic exchange rate. Net gains or losses resulting from foreign currency denominated transactions are included in the consolidated statements of operations. There were no material gains or losses from foreign currency exchange transactions for the years ended December 31, 2018 and 2017. Concentrations of Risk Credit Concentration Risk Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of cash and cash equivalents. The Company maintains its U.S. and RMB cash in bank deposit accounts, which, at times, may exceed regulated insured limits. The Company believes it is not exposed to significant credit risk on cash and cash equivalents. Vendor Concentration Risk The Company has a sole supplier for its EVOMELA product. To date, it has been sourced solely from Spectrum and its suppliers, and all future needs will be sourced from Acrotech and its suppliers. The Company’s ability to qualify other providers of EVOMELA is limited by FDA regulations. Fair Value of Financial Instruments The majority of the Company’s financial instruments (consisting principally of cash and cash equivalents, prepaid expenses, accounts payable, and accrued liabilities) are carried at cost which approximates their fair values due to the short-term nature of the instruments. The Company’s investment in equity securities is carried at fair value (see Note 5). The Company’s Note Payable is carried at amortized cost which approximates fair value due to its classification as a short-term note payable. See Note 14 for additional fair value disclosures. Cash and Cash Equivalents Cash and cash equivalents include cash and highly liquid investments with original maturities of less than 90 days. Inventories Inventories consist of raw materials and are stated at the lower of cost or net realizable value. Cost is determined using a first-in, first-out method. The carrying value of raw materials inventory was approximately $283,000 as of December 31, 2018 and is included in “prepaid expenses and other assets” in the accompanying consolidated balance sheets. Impairment of Long-Lived Assets In accordance with authoritative guidance issued by the Financial Accounting Standards Board (“FASB”), the Company evaluates the value reflected in its consolidated balance sheets of long-lived assets, such as property and equipment and definitive-lived intangible assets, 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. Recoverability of the long-lived asset is measured by a comparison of the carrying amount of the asset to future undiscounted net cash flows expected to be generated by the asset. If such assets are considered to be impaired, the impairment to be recognized is measured by the amount by which the carrying amount of the assets exceeds the estimated fair value of the assets. No impairment charges were recorded in 2018 and 2017. Research and Development Expenses Research and development expenses consist primarily of compensation and other expenses related to research and development personnel, research collaborations, costs associated with pre-clinical testing and clinical trials of the Company’s product candidates, including the costs of manufacturing drug substance and drug product, regulatory maintenance costs, and facilities expenses, along with the amortization of acquired ANDAs. Research and development costs are expensed as incurred. 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 when a patient drops out of a trial. 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. At December 31, 2018 and 2017, clinical trial accruals were $150,893 and $402,773, respectively, and are included in accounts payable in the accompanying consolidated balance sheets. Stock-Based Compensation The Company records compensation expense associated with service and performance-based stock options in accordance with provisions of authoritative guidance. The estimated fair value of service-based awards is generally amortized on a straight-line basis over the requisite service period and is recognized based on the proportionate amount of the requisite service period that has been rendered during each reporting period. The estimated fair value of performance-based awards is measured on the grant date and is recognized when it is determined that it is probable that the performance condition will be achieved. Income Taxes Income tax expense is recognized 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 uses a recognition threshold and a measurement attribute for the financial statement recognition and measurement of tax positions taken or expected to be taken in a tax return. For those benefits to be recognized, a tax position must be more-likely-than-not to be sustained upon examination by taxing authorities. The Company recognizes interest and penalties related to uncertain tax positions, if any, in income tax expense. As of December 31, 2018 and 2017, the Company did not accrue any interest related to uncertain tax positions. To date, there have been no interest or penalties charged to the Company in relation to the underpayment of income taxes. 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 30,211,133 and 17,849,331 as of December 31, 2018 and 2017, respectively, were anti-dilutive and, therefore, were not included in the computation of weighted average shares used in computing diluted loss per share. New Accounting Pronouncements Recently Adopted Pronouncements In January 2016, the FASB issued ASU 2016-01, “Financial Instruments–Overall: Recognition and Measurement of Financial Assets and Financial Liabilities.” In February 2018, the FASB issued ASU 2018-03, “Technical Corrections and Improvements to Financial Instruments–Overall: Recognition and Measurement of Financial Assets and Financial Liabilities.” The accounting standards primarily affect the accounting for equity investments, financial liabilities under the fair value option, and the presentation and disclosure requirements for financial instruments. In addition, it includes a clarification related to the valuation allowance assessment when recognizing deferred tax assets resulting from unrealized losses on available-for-sale debt securities. The accounting guidance is effective for annual reporting periods (including interim periods within those periods) beginning after December 15, 2017. The Company adopted ASU 2016-01 and ASU 2018-03 on January 1, 2018 and recorded a cumulative effect adjustment that decreased accumulated deficit by approximately $1.2 million. Effective January 1, 2018, the adoption date, changes in the fair value of the Company’s investments in equity securities are recognized in the consolidated statements of operations and comprehensive loss (see Note 5). In January 2017, the FASB issued ASU No. 2017-01, Clarifying the Definition of a Business (Topic 805). The amendments in the update provide a screen to determine when a set is not a business. If the screen is not met, the amendments in the update (1) require that to be considered a business, a set must include, at a minimum, an input and a substantive process that together significantly contribute to the ability to create output and (2) remove the evaluation of whether a market participant could replace missing elements. The amendments provide a framework to assist entities in evaluating whether both an input and a substantive process are present. Lastly, the amendments in the update narrow the definition of the term output so that the term is consistent with how outputs are described in Topic 606. The ASU is effective for annual periods and interim periods within those annual periods beginning after December 15, 2017; earlier adoption is permitted under certain criteria. The Company adopted this ASU on January 1, 2018. While this ASU did not have a material effect on the Company’s financial statements on the date of adoption, the Company did follow the new guidance in determining that its acquisition of ANDAs from Sandoz in January 2018 and from Laurus Labs in October 2018 were asset acquisitions (see Notes 3 and 4). In May 2017, the FASB issued ASU 2017-09, Compensation-Stock Compensation (Topic 718) Scope of Modification Accounting . ASU 2017-09 provides clarification on when modification accounting should be used for changes to the terms or conditions of a share-based payment award. This ASU does not change the accounting for modifications but clarifies that modification accounting guidance should only be applied if there is a change to the value, vesting conditions, or award classification and would not be required if the changes are considered non-substantive. This ASU is effective for fiscal years beginning after December 15, 2017, including interim periods within those fiscal years. The Company adopted ASU 2017-09 in the first quarter of 2018 and the adoption of this ASU did not have a material effect on the consolidated financial statements. In June 2018, the FASB issued ASU 2018-07, Compensation-Stock Compensation (Topic 718) Improvements to Nonemployee Share-Based Payment Accounting which includes updated guidance for share-based payment awards issued to non-employees. The updated standard aligns the accounting for share-based payment awards for non-employees with employees, except for guidance related to the attribution of compensation costs for non-employees. This ASU is effective for fiscal years beginning after December 15, 2018, including interim periods within those annual periods for public business entities, with early adoption permitted. The Company early adopted this standard on October 1, 2018. The adoption of this ASU did not have a material impact on the Company’s consolidated financial statements. Unadopted Pronouncements In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842). ASU 2016-02 supersedes existing lease guidance, including Accounting Standards Codification (ASC) 840 - Leases. Among other things, the new standard requires recognition of a right-of-use asset and liability for future lease payments for contracts that meet the definition of a lease. This ASU is effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years. The standard must be applied using a modified retrospective approach. In July 2018, the FASB issued ASU 2018-11, Leases (Topic 842) Targeted Improvements, which offers a transition option to entities adopting the new lease standard. Under the transition option, entities can recognize a cumulative effect adjustment to the opening balance of retained earnings of the year in which the new lease standard is adopted, rather than in the earliest period presented in their financial statements. The Company plans to elect the transition option provided, which will not require adjustments to comparative periods nor require modified disclosures in those comparative periods. Upon adoption, the Company expects to elect the transition package of practical expedients permitted within the new standard, which among other things, allows the carryforward of the historical lease classification. While the Company has not completed its analysis, based on its current lease portfolio the Company currently estimates that the adoption ASC 842 will result in approximately $2.5 million to $3.5 million of right of use assets and lease liabilities being reflected on its Consolidated Balance Sheet. 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. |
ACQUISITION OF ABBREVIATED NEW
ACQUISITION OF ABBREVIATED NEW DRUG APPLICATIONS FROM SANDOZ | 12 Months Ended |
Dec. 31, 2018 | |
Acquisition Of Abbreviated New Drug Applications From Sandoz [Abstract] | |
Acquisition Of Abbreviated New Drug Applications From Sandoz [Text Block] | 3. ACQUISITION OF ABBREVIATED NEW DRUG APPLICATIONS FROM SANDOZ On January 26, 2018, the Company entered into an Asset Purchase Agreement (the “Asset Purchase Agreement”) with Sandoz. Pursuant to the Asset Purchase Agreement, the Company acquired a portfolio of 29 ANDAs, including 25 ANDAs approved by the FDA and four pipeline ANDAs that are pending FDA approval, limited quantities of certain active pharmaceutical ingredient (“API”), and certain manufacturing and other information related to the products (collectively, the ANDAs, API and other information are referred to as the “Acquired Assets”). To facilitate the sale and transition, the parties also entered into several limited term ancillary arrangements. The Acquired Assets enhance the Company’s strategic focus to build a robust pipeline and commercialize quality drug candidates in China. The Company intends to select and commercialize certain products from the portfolio that have unique market and cost-effective manufacturing opportunities in China (and potentially in the U.S.). The total purchase price for the Acquired Assets was $18.0 million in cash. The Company accounted for the purchase of the Acquired Assets as an asset acquisition (consisting of a concentrated group of similar identifiable assets, including ANDAs and API). The total purchase price, along with approximately $1.2 million of transaction expenses, was allocated to the Acquired Assets based on their relative estimated fair values, as follows: ANDAs $ 18,608,000 API 564,000 Total value $ 19,172,000 Of the total value allocated to the ANDAs, approximately $553,000 $134,000 was immediately expensed as acquired in-process research and development since the Company does not intend to use all of the API. The allocated cost of the capitalized ANDAs will be amortized over their estimated useful lives of 13 years. The capitalized API will be expensed in the period it is used or if its value is otherwise impaired. The fair values of certain acquired ANDAs were estimated using the discounted cash flow method (an income approach), which involves the use of unobservable Level 3 inputs (see Note 14). The ANDAs will be tested for impairment when events or circumstances indicate that the carrying value of the asset may not be recoverable; no such triggering events were identified during the period from the date of acquisition to December 31, 2018. |
ACQUISITION OF ABBREVIATED NE_2
ACQUISITION OF ABBREVIATED NEW DRUG APPLICATION FROM LAURUS LABS | 12 Months Ended |
Dec. 31, 2018 | |
Acquisition Of Abbreviated New Drug Applications From Laurus Labs [Abstract] | |
ACQUISITION OF ABBREVIATED NEW DRUG APPLICATION FROM LAURUS LABS [Text Block] | 4. ACQUISITION OF ABBREVIATED NEW DRUG APPLICATION FROM LAURUS LABS In October 2018, the Company entered into an agreement with Laurus, pursuant to which the Company acquired from Laurus one U.S. FDA-approved ANDAs for TDF, which is indicated for the treatment of hepatitis B virus. The total purchase consideration was $3.0 million. In October 2018, the Company made an initial payment of $700,000, and in December 2018, CASI paid $1.3 million as the second milestone was achieved. The Company accounted for the purchase of the TDF ANDA as an asset acquisition and recognized both payments to Laurus, along with $35,121 of transaction expenses, as the cost of the acquired intangible asset (see Note 14). The remaining $1.0 million of contingent consideration will be recorded as an increase to the intangible asset when the subsequent milestones are met. The Company is amortizing the acquired intangible asset over its estimated useful life of 13 years; any subsequent increase in asset cost as a result of recognizing the contingent consideration will be expensed on a straight-line basis over the asset’s remaining life. |
INVESTMENT IN EQUITY SECURITIES
INVESTMENT IN EQUITY SECURITIES | 12 Months Ended |
Dec. 31, 2018 | |
Schedule of Investments [Abstract] | |
INVESTMENT IN EQUITY SECURITIES [Text Block] | 5. INVESTMENT IN EQUITY SECURITIES The Company has an equity investment in the common stock (see Note 14). The following table summarizes the Company’s investment as of December 31, 2018: Description Classification Cost Gross unrealized gains Aggregate fair value Common stock Investment $ - $ 912,200 $ 912,200 Unrealized loss on the Company’s equity investment for year ended December 31, 2018 was $ 320,112 |
PROPERTY AND EQUIPMENT
PROPERTY AND EQUIPMENT | 12 Months Ended |
Dec. 31, 2018 | |
Property, Plant and Equipment [Abstract] | |
PROPERTY AND EQUIPMENT [Text Block] | 6. PROPERTY AND EQUIPMENT Furniture and equipment are stated at cost and are depreciated over their estimated useful lives of 3 5 Depreciation and amortization expense is determined on a straight-line basis. Depreciation and amortization expense was $ 365,555 117,779 Property and equipment consists of the following: December 31, 2018 2017 Furniture and equipment $ 1,697,294 $ 1,150,052 Leasehold improvements 739,390 268,734 2,436,684 1,418,786 Less: accumulated depreciation and amortization (686,054 ) (372,272 ) $ 1,750,630 $ 1,046,514 The Company did not identify and recognize any impairment of its property and equipment in 2018 and 2017. |
INTANGIBLE ASSETS
INTANGIBLE ASSETS | 12 Months Ended |
Dec. 31, 2018 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Intangible Assets Disclosure [Text Block] | 7. INTANGIBLE ASSETS Intangible assets were acquired as part of the 2018 asset acquisitions from Sandoz and Laurus and include ANDAs for a total of 26 previously marketed generic products (see Notes 3 and 4). These intangible assets were originally recorded at relative estimated fair values based on the purchase price for the asset acquisitions and are stated net of accumulated amortization. The ANDAs are being amortized over their estimated useful lives of 13 years, using the straight-line method. Management reviews finite-lived intangible assets for impairment whenever events or changes in circumstances indicate that the carrying amount may not be recoverable, in a manner similar to that for property and equipment. No impairment losses related to intangible assets were recognized in the year ended December 31, 2018. Net definite-lived intangible assets at December 31, 2018 consists of the following: Asset Gross Value Accumulated Amortization Estimated useful lives ANDAs $ 18,054,985 $ (1,291,775 ) 13 years TDF ANDA $ 2,035,121 $ (13,604 ) 13 years Total $ 20,090,106 $ (1,305,379 ) Expected future amortization expense is as follows for the years ending December 31: 2019 $ 1,546,691 2020 1,546,691 2021 1,546,691 2022 1,546,691 2023 1,546,691 2024 and thereafter 11,051,272 |
ESTABLISHMENT OF CASI WUXI
ESTABLISHMENT OF CASI WUXI | 12 Months Ended |
Dec. 31, 2018 | |
Establishment Of Operating Segment [Abstract] | |
Establishment Of Operating Segment [Text Block] | 8. ESTABLISHMENT OF CASI WUXI On December 26, 2018, the Company established CASI Wuxi to build and operate a manufacturing facility in the Wuxi Huishan Economic Development Zone in Jiangsu Province, China. The Company will invest, over time, $ 80 21 29 |
NOTE PAYABLE
NOTE PAYABLE | 12 Months Ended |
Dec. 31, 2018 | |
Debt Disclosure [Abstract] | |
Debt Disclosure [Text Block] | 9. NOTE PAYABLE As part of the license arrangements with Spectrum (see Note 16), the Company issued to Spectrum a $1.5 million 0.5% secured promissory note originally due March 17, 2016, which was subsequently amended and extended to September 17, 2019. The promissory note was recorded initially at its fair value, giving rise to a discount of approximately $136,000; the promissory note is presented as note payable, net of discount in the accompanying Consolidated Balance Sheets. For each of the years ended December 31, 2018 and 2017, the Company recognized $7,500 of interest expense related to the promissory note. |
STOCKHOLDERS' EQUITY
STOCKHOLDERS' EQUITY | 12 Months Ended |
Dec. 31, 2018 | |
Stockholders' Equity Note [Abstract] | |
Stockholders' Equity Note Disclosure [Text Block] | 10. STOCKHOLDERS' EQUITY The Company had 170 million of authorized common stock and 5 million of authorized preferred stock at December 31, 2018 and 2017. The Company held 79,545 of shares of common stock in treasury at its acquisition cost at December 31, 2018 and 2017. In September 2018, the Company entered into securities purchase agreements with certain institutional investors, accredited investors and current stockholders, pursuant to which the Company 9,048,504 shares of its common stock with accompanying warrants to purchase 2,714,548 shares of its common stock in a $48.5 million private placement. The purchase price for each share of common stock and warrant was $5.36. The warrants are exercisable on March 23, 2019 at a $7.19 per share exercise price and expire on September 24, 2021. In September and October 2018, the Company completed two closings and issued a total of 6,996,266 shares of its common stock with accompanying warrants to purchase 2,098,877 shares of its common stock and received $37.5 million in gross proceeds. The estimated fair value of the equity-classified warrants issued is $6,254,653 or $2.98 per warrant, calculated using the Black-Scholes-Merton valuation model with a contractual life of 3 years, an assumed volatility of 88.39%, and a risk-free interest rate of 2.89%. In March 2018, the Company entered into securities purchase agreements with certain institutional investors, accredited investors and current stockholders, pursuant to which the Company issued 15,432,091 shares of its common stock with accompanying warrants to purchase 6,172,832 shares of its common stock and received $50 million in gross proceeds in a private placement. The purchase price for each share of common stock and warrant was $3.24. The warrants became exercisable on September 17, 2018 at a $3.69 per share exercise price and will expire on March 21, 2023. The estimated fair value of the equity-classified warrants issued is $15,062,000, or $2.44 per warrant, calculated using the Black-Scholes-Merton valuation model with a contractual life of 5 years, an assumed volatility of 75.4%, and a risk-free interest rate of 2.69%. In February 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 million. 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. In 2018, the Company issued 143,248 Shares under the Sales Agreement resulting in net proceeds to the Company of approximately $475,000. As of December 31, 2018, approximately $24.5 million remained available under the Sales Agreement. In October 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 shares of its common stock and warrants exercisable for up to 1,590,373 shares of its common stock (exclusive of the Agent Warrants described below) in a registered direct offering (the “2017 Offering”) for gross proceeds of $23,855,595. The Company received approximately $23.4 million after offering expenses and issued 7,951,865 shares of common stock. The shares and warrants were sold together, consisting of one share of common stock and a warrant to purchase 0.20 shares of common stock for each share of common stock purchased, at a combined offering price of $3.00. The warrants are exercisable beginning on April 17, 2018 and expire on April 17, 2020. The warrants have an exercise price of $3.75 per share. The estimated fair value of the equity-classified warrants issued is $1,558,566, calculated using the Black-Scholes-Merton valuation model value of $0.98 with a contractual life of 2.5 years, an assumed volatility of 85.4%, and a risk-free interest rate of 1.54%. In connection with the 2017 Offering, the Company issued to its placement agent or its designees warrants to purchase 48,133 shares of common stock at an exercise price of $3.75 per share of common stock (the “Agent Warrants”), representing the number of warrants equal to an aggregate of 4% of the number of shares sold to investors placed by the placement agent in the 2017 Offering, excluding investments made by certain China-focused investors that were placed by the Company. The Agent Warrants are exercisable beginning on April 17, 2018 and expire on April 17, 2019. The estimated fair value of the equity-classified warrants issued is $28,880, calculated using the Black-Scholes-Merton valuation model value of $0.60 with a contractual life of 1.5 years, an assumed volatility of 77.8%, and a risk-free interest rate of 1.54%. Stock purchase warrants activity for 2018 and 2017 is as follows: Weighted Average Number of Shares Exercise Price 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 Issued 8,271,709 $ 4.58 Exercised (2,753,900 ) $ 1.80 Expired - - Outstanding at December 31, 2018 11,781,825 $ 3.98 Exercisable at December 31, 2018 9,682,948 $ 3.28 All outstanding warrants are equity classified. |
EMPLOYEE RETIREMENT PLAN
EMPLOYEE RETIREMENT PLAN | 12 Months Ended |
Dec. 31, 2018 | |
Retirement Benefits [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 U.S. 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 $151,148 and $70,167 in 2018 and 2017, respectively. |
STOCK-BASED COMPENSATION
STOCK-BASED COMPENSATION | 12 Months Ended |
Dec. 31, 2018 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Disclosure of Compensation Related Costs, Share-based Payments [Text Block] | 12. STOCK-BASED COMPENSATION The Company has adopted various stock compensation plans for executive, scientific and administrative personnel of the Company, as well as outside directors and consultants. In June 2018, the Company’s stockholders approved an amendment to the 2011 Long-Term Incentive Plan, increasing the number of shares of common stock reserved for issuance from 14,230,000 to 20,230,000 to be available for grants and awards. Stock options granted under the plans generally vest over periods varying from immediately to one to five years, are not transferable and generally expire ten years from the date of grant. As of December 31, 2018, a total of 6,834,234 shares remained available for grant under the Company’s 2011 Long-Term Incentive Plan. The Company’s net loss for the twelve months ended December 31, 2018 and 2017 includes $6,118,121 and $650,440, respectively, of non-cash compensation expense related to the Company’s share-based compensation awards. The compensation expense related to the Company’s share-based compensation arrangements is recorded as components of general and administrative expense and research and development expense, as follows: 2018 2017 Research and development $ 740,398 $ 271,733 General and administrative 5,377,723 378,707 Total share-based compensation expense $ 6,118,121 $ 650,440 Compensation expense related to stock options is recognized over the requisite service period, which is generally the option vesting term of up to five years. Awards with performance conditions are expensed when it is probable that the performance condition will be achieved. For the years ended December 31, 2018 and 2017, $643,875 and $30,500, respectively was expensed for share awards with performance conditions that became probable during that period. 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 Volatility —Volatility 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 Rate —This 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 Options —This 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 awards, the expected term of service is based on the derived service period. Expected Dividend Yield —The 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. Following are the weighted-average assumptions used in valuing the stock options granted to employees during the years ended December 31, 2018 and 2017: Year ended December 31, 2018 2017 Expected volatility 78.78 % 78.88 % Risk free interest rate 2.80 % 1.96 % Expected term of option 5.77 years 6.29 years Expected dividend yield 0.00 % 0.00 % The weighted average fair value of stock options granted was $4.49 and $0.73 in 2018 and 2017, respectively. A summary of the Company's stock option plans and of changes in options outstanding under the plans during the years ended December 31, 2018 and 2017 is as follows: Weighted Average Weighted Average Remaining Number of Options Exercise Price Contractual Term in Years Aggregate Intrinsic Value Outstanding at December 31, 2016 9,535,306 $ 1.57 Exercised (154,545 ) $ 2.11 $ 168,000 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 Exercised (156,283 ) $ 1.65 $ 643,000 Granted 7,336,000 $ 4.01 Expired (285,594 ) $ 1.55 Forfeited (50,130 ) $ 3.28 Outstanding at December 31, 2018 18,429,308 $ 2.44 7.61 $ 33,694,004 Exercisable at December 31, 2018 9,755,668 $ 1.57 6.21 $ 24,728,420 The aggregate intrinsic value is calculated as the difference between (i) the closing price of the common stock at December 31, 2018 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. Cash received from option exercises under all share-based payment arrangements for the year ended December 31, 2018 and 2017 was approximately $258,000 and $326,000, respectively. In March 2018, the Compensation Committee of the Board of Directors (the “Board”) approved a grant of stock options to the Company’s Executive Chairman exercisable for 1.0 million shares of common stock that will vest and become exercisable on the first anniversary date of the grant. In addition, the Board approved the grant of a performance-based option covering 4.0 million shares of common stock that will vest if, within 18 months of the date of grant, specific operational and strategic milestones are achieved. The following summarizes information about stock options that are outstanding at December 31, 2018: 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, 2018 Life in Years Price December 31, 2018 Price $0.00 - $1.00 3,754,554 7.95 $ 0.93 2,458,613 $ 0.90 $1.01 - $2.00 6,859,938 5.98 $ 1.53 6,606,410 $ 1.54 $2.01 - $4.00 5,931,000 8.83 $ 3.18 425,788 $ 2.44 $4.01 - $7.00 1,642,000 9.10 $ 6.25 125,541 $ 6.25 $7.01 - $9.00 241,816 8.22 $ 8.01 139,316 $ 8.00 18,429,308 7.61 $ 2.44 9,755,668 $ 1.57 As of December 31, 2018, there was approximately $8,844,000 of total unrecognized compensation cost related to non-vested stock options, excluding not-probable performance condition options. That cost is expected to be recognized over a weighted-average period of 3 years. |
INCOME TAXES
INCOME TAXES | 12 Months Ended |
Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |
Income Tax Disclosure [Text Block] | 13. INCOME TAXES As a result of net operating losses, the Company did not recognize a consolidated provision (benefit) for income taxes in either period. For financial reporting purposes, loss before taxes includes the following components: 2018 2017 United States $ (19,819,835 ) $ (8,658,120 ) China (7,651,733 ) (2,112,082 ) Total $ (27,471,568 ) $ (10,770,202 ) 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, 2018 and 2017 are as follows: December 31, 2018 2017 Deferred income tax assets: Net operating loss carryforwards $ 97,701,000 $ 96,786,000 Research and development credit carryforward 8,957,000 9,592,000 Intangible assets 4,378,000 4,184,000 Equity-based compensation 4,075,000 3,812,000 Other 81,000 164,000 Valuation allowance for deferred income tax assets (115,192,000 ) (114,538,000 ) Net deferred income tax assets $ - $ - The Company has U.S. federal and state net operating loss (NOL) carryforwards of approximately $380,904,000 at December 31, 2018. The Company also has People’s Republic of China (“PRC”) NOL carryforwards of approximately $13,066,000 at December 31, 2018. U.S. federal NOL carryforwards generated prior to 2018 begin to expire in 2019. The Company also has research and experimentation (“R&E”) tax credit carryforwards of approximately $8,957,000 as of December 31, 2018 that begin to expire in 2019. Under the provisions of the Internal Revenue Code, the NOL and tax credit carryforwards are subject to review and possible adjustment by the Internal Revenue Service and state tax authorities. 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%, as defined under Sections 382 and 383 of the Internal Revenue Code of 1986, respectively, as well as similar state tax provisions. This could limit the amount of tax attributes that the Company can utilize annually to offset future taxable income or tax liabilities. The amount of the annual limitation, if any, will be determined based on the value of the Company immediately prior to the ownership change. Subsequent ownership changes may further affect the limitation in future years. For financial reporting purposes, a valuation allowance has been recognized to reduce the net deferred tax assets to zero due to uncertainties with respect to the Company's ability to generate taxable income in the future sufficient to realize the benefit of 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%, U.S. generally accepted accounting principles require companies to re-value their deferred tax assets and liabilities as of the date of enactment, with resulting tax effects accounted for in the reporting period of enactment. As a result of this revaluation, the Company reduced its pre-valuation allowance deferred tax asset by $52,258,000 in the year ended December 31, 2017, with a corresponding decrease in the valuation allowance on its net deferred tax assets. The Company has no unrepatriated earnings in any of its foreign subsidiaries as they incurred losses since inception. A reconciliation of the provision for income taxes to the federal statutory rate is as follows: 2018 2017 Tax benefit at statutory rate $ (5,769,000 ) $ (3,662,000 ) Effect of tax law change - 52,258,000 State taxes (1,098,000 ) (290,000 ) Net R&E credit adjustment (7,000 ) (185,000 ) Net operating loss expiration 7,200,000 50,000 Nondeductible expenses 29,000 6,000 Change in valuation allowance 654,000 (48,117,000 ) Other (75,000 ) 125,000 Changes in applicable tax rates (934,000 ) (185,000 ) $ - $ - The Company had $3,198,000 of unrecognized tax benefits as of December 31, 2017 related to net R&E tax credit carryforwards. For the year ended December 31, 2018, there were net reduction of unrecognized tax benefits of $212,000 related to R&E tax credits. The Company has a full valuation allowance at December 31, 2018 and 2017 against the full amount of its net deferred tax assets and, therefore, there was no impact on the Company’s financial position. The Company does not expect significant changes to the unrecognized benefit during 2019. A reconciliation of the beginning and ending amount of gross unrecognized tax benefits is as follows: 2018 2017 Unrecognized tax benefits balance at January 1 $ 3,198,000 $ 3,133,000 Additions for Tax Positions of Prior Periods - 3,000 Reductions for Tax Positions of Prior Periods (214,000 ) - Additions for Tax Positions of Current Period 2,000 62,000 Unrecognized tax benefits balance at December 31 $ 2,986,000 $ 3,198,000 Due to the existence of tax attribute carryforwards (which are currently offset by a full valuation allowance), all of the Company’s tax returns since 1998 are open to examination by the taxing authorities. |
FAIR VALUE MEASUREMENTS
FAIR VALUE MEASUREMENTS | 12 Months Ended |
Dec. 31, 2018 | |
Fair Value Disclosures [Abstract] | |
Fair Value Disclosures [Text Block] | 14. 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—Quoted prices (unadjusted) in active markets that are accessible at the measurement date for identical assets or liabilities. The fair value hierarchy gives the highest priority to Level 1 inputs. Level 2—Observable market-based inputs other than quoted prices in active markets for identical assets or liabilities. Level 3—Unobservable inputs are used when little or no market data is available. The fair value hierarchy gives the lowest priority to Level 3 inputs. Financial Assets and Liabilities Measured at Fair Value on a Recurring Basis The Company evaluates financial assets and liabilities subject to fair value measurements on a recurring basis to determine the appropriate level at which to classify them each reporting period. This determination requires the Company to make subjective judgments as to the significance of inputs used in determining fair value and where such inputs lie within the hierarchy. The Company has an equity investment in the common stock of publicly traded company. Beginning on January 1, 2018 with the adoption of ASU 2016-01, the Company’s investment in this equity security is considered a trading security and is carried at its estimated fair value, with changes in fair value reported in the consolidated statement of operations and comprehensive loss each reporting period (see Note 5). As part of the consideration for the licensing arrangements with Spectrum (see Note 16), the Company issued Spectrum certain contingent rights (“Contingent Rights”) to purchase additional shares of its common stock, which Contingent Rights expire upon the occurrence of certain events. The Contingent Rights provided 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, and expired on the earlier of raising an aggregate of $50 million or September 17, 2019. Based on the terms and conditions of the Contingent Rights, the Company determined that the Contingent Rights were a derivative financial instrument that is not indexed to its common stock and therefore was required to be accounted for at fair value, initially and on a recurring basis. The fair value of the Contingent Rights was measured using Level 3 unobservable inputs; the unobservable inputs included estimates of the Company’s future capital requirements, and the timing, probability, size and characteristics of those capital raises, among other inputs. Spectrum exercised its Contingent Rights and the Company issued Spectrum 1,519,096 shares of common stock during 2017. As a result of the exercise, the contingent right liability was fully settled as of December 31, 2018 and 2017. The following tables presents the Company’s financial assets and liabilities accounted for at fair value on a recurring basis as of December 31, 2018 and December 31, 2017, by level within the fair value hierarchy: Description Fair Value at December 31, 2018 Level 1 Level 2 Level 3 Investment in common stock $ 912,200 $ 912,200 $ - $ - Contingent Rights $ - $ - $ - $ - Description Fair Value at December 31, 2017 Level 1 Level 2 Level 3 Investment in common stock $ 1,232,312 $ 1,232,312 $ - $ - Contingent Rights $ - $ - $ - $ - The following table sets forth a summary of changes in the fair value of Level 3 liabilities measured at fair value on a recurring basis for the year ended December 31, 2017: Description Balance at December 31, 2016 Change in Fair value Settled in 2017 Balance at December 31, 2017 Contingent Rights $ 4,122,266 $ 19,891 $ (4,142,157 ) $ - Financial Liabilities Measured at Fair Value on a Non-Recurring Basis In connection with entering into the various securities purchase agreements in 2018 and 2017, the Company issued shares of its common stock along with detachable stock purchase warrants. The Company allocates the proceeds received to the common stock and warrants on a relative fair value basis. The fair value of the common stock is based on quoted market price for the Company’s common stock, a Level 1 input. The fair value of the stock purchase warrants is determined using the Black-Scholes-Merton option pricing model which uses Level 3 unobservable inputs. See Note 10 for discussion of the unobservable inputs used to estimate the fair value of the equity-classified stock purchase warrants. Non-Financial Assets and Liabilities Measured at Fair Value on a Recurring Basis The Company has no 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 and intangible assets, at fair value on a non-recurring basis. These assets are recognized at fair value when they are deemed to be other-than-temporarily impaired. No such fair value impairment was recognized in the years ended December 31, 2018 and 2017. In 2018 the Company acquired certain ANDAs pursuant to transactions accounted for as asset acquisitions. The intangible assets acquired from Sandoz (see Note 3) were estimated using the discounted cash flow method (an income approach), which involves the use of Level 3 inputs such as estimates for projected sales, expenses, and cash flows, expected income and value-added tax rates, and a required rate of return adjusted for both industry and Company-specific risks, among other inputs. The fair values of the remaining ANDAs were estimated using a multiple of values method (an income approach), which involved using Level 3 inputs such as estimated addressable markets and market penetration rates. The fair value of the API was estimated using Level 2 inputs, such as quoted market prices for similar API from various suppliers or other sources. The intangible asset acquired from Laurus (see Note 4) was recognized at its estimate fair value which was determined based on the total purchase price paid (including transaction expenses) since only one asset was acquired. |
RELATED PARTY TRANSACTIONS
RELATED PARTY TRANSACTIONS | 12 Months Ended |
Dec. 31, 2018 | |
Related Party Transactions [Abstract] | |
Related Party Transactions Disclosure [Text Block] | 15. RELATED PARTY TRANSACTIONS The Company has supply agreements with Spectrum for the purchase of EVOMELA, ZEVALIN, and MARQIBO in China for quality testing purposes to support CASI’s application for import drug registration and for commercialization purposes. The former CEO of Spectrum is also a member of CASI’s Board and Spectrum is the Company’s largest shareholder. In 2018, the Company entered into commercial purchase obligation commitments for EVOMELA from Spectrum for approximately $9.2 million. As of December 31, 2018, the Company paid $4,850,000 as a deposit for the purchase of EVOMELA expected to be delivered in 2019. The advance payments made to Spectrum are reflected as prepaid expense and other in the accompanying consolidated balance sheet as of December 31, 2018. Additionally, the Company incurred and paid $120,000 to Spectrum in 2018 for services to support the development of MARQIBO, which is included in research and development expense for the year ended December 31, 2018. In 2017, under supply agreements with Spectrum, the Company received shipments of EVOMELA, ZEVALIN, and MARQIBO, in China for quality testing purposes to support CASI’s application for import drug registration. The total cost of the materials was approximately $2,705,000, which is included in research and development expense for the year ended December 31, 2017. As of December 31, 2017, the amount payable to Spectrum totaling $2,228,366 is reflected as a related party payable in the accompanying consolidated balance sheet. As of December 31, 2018, there were no material amounts payable to Spectrum. Emerging Technology Partners, LLC (“ETP”) incurred approximately $1.5 million of expenses on the Company’s behalf for due diligence and related services (the “Services”) for certain business development activities. The Company’s Executive Chairman is the founder and managing member of ETP. The expenses incurred in connection with the Services is included as general and administrative expenses in the accompanying consolidated statement of operations for the year ended December 31, 2018; the amount was paid in October 2018. The Company’s Executive Chairman, and the Company’s Chief Executive Officer played a key role in identifying and securing potential investors for the September 2018 Offering. As a result, the Company did not have to pay a commission to, or incur additional expenses for, a placement agent. In exchange for their services, which were deemed to be outside the scope of their responsibilities as officers and directors of the Company, the Company paid $1,380,000 and $120,000 to the Executive Chairman and the Chief Executive Officer, respectively. These payments are included as general and administrative expenses in the accompanying consolidated statement of operations for the year ended December 31, 2018; the amount was paid in October 2018. |
LICENSE ARRANGEMENTS
LICENSE ARRANGEMENTS | 12 Months Ended |
Dec. 31, 2018 | |
License Arrangements Disclosure [Abstract] | |
License Arrangements Disclosure [Text Block] | 16. LICENSE ARRANGEMENTS The Company has certain product rights and perpetual exclusive licenses from Acrotech 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”): Melphalan Hydrochloride For Injection (EVOMELA)(“EVOMELA”); Ibritumomab Tiuxetan (ZEVALIN) (“ZEVALIN”); and Vincristine Sulfate Liposome Injection (MARQIBO) , (“MARQIBO”). 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. In March 2016, Spectrum received notification from the FDA of the grant of approval of its New Drug Application (NDA) for EVOMELA primarily for use as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma. In December 2016, the NMPA accepted for review the Company’s import drug registration application for EVOMELA and in 2017 granted priority review of the import drug registration clinical trial application (CTA). On December 3, 2018 the Company received NMPA’s approval for importation, marketing and sales in China for EVOMELA. The Company is building an internal commercial team to prepare for the commercial launch EVOMELA in 2019. The Company is also preparing for a post-marketing study. The Company is in various stages of the regulatory and development process to obtain marketing approval for ZEVALIN and MARQIBO in its territorial region, with ZEVALIN commercially available in Hong Kong. In 2017, the NMPA accepted for review the Company’s import drug registration for ZEVALIN including both the antibody kit and the radioactive Yttrium-90 component. On February 12, 2019, the Company received NMPA’s approval of the Company’s CTA to allow for a confirmatory registration trial to evaluate the efficacy and safety of ZEVALIN. In 2016, the NMPA accepted for review the Company’s import drug registration application for MARQIBO. On March 4, 2019 the Company received NMPA’s approval of the Company’s CTA to allow for a confirmatory registration trial to evaluate the efficacy and safety of MARQIBO. The Company intends to advance both of these products. |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 12 Months Ended |
Dec. 31, 2018 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies Disclosure [Text Block] | 17. COMMITMENTS AND CONTINGENCIES In 2018, the Company entered into purchase obligation commitments for EVOMELA from Spectrum for approximately $9.2 million. The Company expects all of the EVOMELA product to be delivered in 2019. As of December 31, 2018, the Company paid $4.8 million as a deposit for the purchase of EVOMELA. The deposits made to Spectrum are reflected as prepaid expense and other in the accompanying consolidated balance sheet. In 2018, the Company committed to invest $80 million in CASI Wuxi, of which $21 million was invested in February 2019 (see Note 8). In 2006, the Company acquired Miikana, a private biotechnology company. Pursuant to the Merger Agreement, the Company acquired all of the outstanding capital stock of Miikana Therapeutics, Inc. In 2008, the Company initiated a Phase 1 clinical trial with its Aurora A and angiogenic kinase inhibitor, ENMD-2076, in patients with solid tumors. A dosing of the first patient with ENMD-2076 triggered a purchase price adjustment milestone of $2 million, which the Company opted to pay in stock. As ENMD-2076 successfully completed Phase 1 clinical trials and advanced to Phase 2, the dosing of the first patient in 2010 triggered an additional purchase price adjustment milestone of $3 million, which was paid in stock in 2010. Under the terms of the merger agreement, the former Miikana stockholders may earn up to an additional $4 million of potential payments upon the satisfaction of additional clinical and regulatory milestones for ENMD-2076. As of December 31, 2018, the $4 million potential milestone payment remains, payable in cash or shares of stock at the Company’s option, related to the ENMD-2076 program and the dosing of the first patient in a Phase 3 pivotal trial. With respect to the Company’s in-licensed drug candidates from Spectrum 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, if any, are subject to royalties. The Company does not expect to pay royalties for ZEVALIN in China and Taiwan until commercial activities begin which will not occur until after ZEVALIN receives marketing approval from the regulatory agencies and which is not expected to occur in 2019. The Company does not anticipate any payment obligations for its MARQIBO program in 2019. The Company does anticipate sales of EVOMELA in 2019 which is expected to result in royalty payment obligations in 2019. In April 2018, the Company entered into a lease agreement for office space in China that continues through April 2021. In October 2018, the Company entered into a lease agreement for additional office space in China that continues through November 2021. The Company also leases lab space in China that continues through May 2022. In October 2018, the Company amended the lease for its principal executive offices in Rockville, MD, effective November 1, 2018 to increase the total space covered under the lease to 6,068 square feet. The Company also extended the lease term from December 31, 2019 to July 31, 2022. The future minimum payments under its facilities leases are as follows: 2019 $ 1,311,707 2020 1,297,102 2021 856,832 2022 129,918 Thereafter - Total minimum payments $ 3,595,559 Rental expense for the years ended December 31, 2018 and 2017 was approximately $916,000 and $440,000, respectively. In 2018 the Company entered into a lease on behalf of CASI Wuxi; the minimum lease payments for this lease, totaling approximately $3,789,000 beginning in November 2019 and expiring in 2024 are not included in the above table. 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. |
SUBSEQUENT EVENT
SUBSEQUENT EVENT | 12 Months Ended |
Dec. 31, 2018 | |
Subsequent Events [Abstract] | |
Subsequent Events [Text Block] | 18. SUBSEQUENT EVENT In March 2019, the Company entered into an exclusive distribution agreement with China Resources Guokang Pharmaceuticals Co., Ltd. (“CRGK”), pursuant to which CRGK will be the exclusive distributor of EVOMELA in the People’s Republic of China (excluding Hong Kong, Macau and Taiwan). |
SUMMARY OF SIGNIFICANT ACCOUN_2
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
Basis of Accounting, Policy [Policy Text Block] | Basis of Presentation The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”). |
Use of Estimates, Policy [Policy Text Block] | Use of Estimates The preparation of consolidated financial statements in conformity with U.S. GAAP 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 fair value determination and recoverability of intangible assets, clinical trial accruals, deferred tax assets and liabilities and valuation allowance, and stock-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. |
Foreign Currency Transactions and Translations Policy [Policy Text Block] | Consolidation and Foreign Currency Matters 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% of its interest owned by CASI. CASI China received approval for a business license from the Beijing Industry and Commercial Administration in August 2012 and has operating facilities in Beijing. All inter-company balances and transactions have been eliminated in consolidation. The Company’s reporting currency is the U.S. dollar. Prior to 2018, the functional currency of the Company’s subsidiary based in China was the U.S dollar. However, as discussed in Note 3, 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, and that it may allow its subsidiary in China to generate operating revenues from the China marketplace in the future and potentially sustain its own operations without the necessity of parent support. Accordingly, effective January 1, 2018, the functional currency of the Company’s subsidiary based in China was changed to the local currency of the China Renminbi (“RMB”). Upon the change in functional currency, there was no material impact on the consolidated financial statements. Accordingly, beginning January 1, 2018 translation gains and losses relating to the financial statements of the Company’s China subsidiaries are included as accumulated other comprehensive loss in the accompanying consolidated balance sheets. 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 estimated using an average periodic exchange rate. Net gains or losses resulting from foreign currency denominated transactions are included in the consolidated statements of operations. There were no material gains or losses from foreign currency exchange transactions for the years ended December 31, 2018 and 2017. |
Concentration Risk, Credit Risk, Policy [Policy Text Block] | Concentrations of Risk Credit Concentration Risk Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of cash and cash equivalents. The Company maintains its U.S. and RMB cash in bank deposit accounts, which, at times, may exceed regulated insured limits. The Company believes it is not exposed to significant credit risk on cash and cash equivalents. Vendor Concentration Risk The Company has a sole supplier for its EVOMELA product. To date, it has been sourced solely from Spectrum and its suppliers, and all future needs will be sourced from Acrotech and its suppliers. The Company’s ability to qualify other providers of EVOMELA is limited by FDA regulations. |
Fair Value of Financial Instruments, Policy [Policy Text Block] | Fair Value of Financial Instruments The majority of the Company’s financial instruments (consisting principally of cash and cash equivalents, prepaid expenses, accounts payable, and accrued liabilities) are carried at cost which approximates their fair values due to the short-term nature of the instruments. The Company’s investment in equity securities is carried at fair value (see Note 5). The Company’s Note Payable is carried at amortized cost which approximates fair value due to its classification as a short-term note payable. See Note 14 for additional fair value disclosures. |
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. |
Inventory, Policy [Policy Text Block] | Inventories Inventories consist of raw materials and are stated at the lower of cost or net realizable value. Cost is determined using a first-in, first-out method. The carrying value of raw materials inventory was approximately $283,000 as of December 31, 2018 and is included in “prepaid expenses and other assets” in the accompanying consolidated balance sheets. |
Impairment or Disposal of Long-Lived Assets, Policy [Policy Text Block] | Impairment of Long-Lived Assets In accordance with authoritative guidance issued by the Financial Accounting Standards Board (“FASB”), the Company evaluates the value reflected in its consolidated balance sheets of long-lived assets, such as property and equipment and definitive-lived intangible assets, 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. Recoverability of the long-lived asset is measured by a comparison of the carrying amount of the asset to future undiscounted net cash flows expected to be generated by the asset. If such assets are considered to be impaired, the impairment to be recognized is measured by the amount by which the carrying amount of the assets exceeds the estimated fair value of the assets. No impairment charges were recorded in 2018 and 2017. |
Research and Development Expense, Policy [Policy Text Block] | Research and Development Expenses Research and development expenses consist primarily of compensation and other expenses related to research and development personnel, research collaborations, costs associated with pre-clinical testing and clinical trials of the Company’s product candidates, including the costs of manufacturing drug substance and drug product, regulatory maintenance costs, and facilities expenses, along with the amortization of acquired ANDAs. Research and development costs are expensed as incurred. 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 when a patient drops out of a trial. 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. At December 31, 2018 and 2017, clinical trial accruals were $150,893 and $402,773, respectively, and are included in accounts payable in the accompanying consolidated balance sheets. |
Share-based Compensation,Option and Incentive Plans Policy [Policy Text Block] | Stock-Based Compensation The Company records compensation expense associated with service and performance-based stock options in accordance with provisions of authoritative guidance. The estimated fair value of service-based awards is generally amortized on a straight-line basis over the requisite service period and is recognized based on the proportionate amount of the requisite service period that has been rendered during each reporting period. The estimated fair value of performance-based awards is measured on the grant date and is recognized when it is determined that it is probable that the performance condition will be achieved. |
Income Tax, Policy [Policy Text Block] | Income Taxes Income tax expense is recognized 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 uses a recognition threshold and a measurement attribute for the financial statement recognition and measurement of tax positions taken or expected to be taken in a tax return. For those benefits to be recognized, a tax position must be more-likely-than-not to be sustained upon examination by taxing authorities. The Company recognizes interest and penalties related to uncertain tax positions, if any, in income tax expense. As of December 31, 2018 and 2017, the Company did not accrue any interest related to uncertain tax positions. To date, there have been no interest or penalties charged to the Company in relation to the underpayment of income taxes. |
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 30,211,133 and 17,849,331 as of December 31, 2018 and 2017, respectively, were anti-dilutive and, therefore, were not included in the computation of weighted average shares used in computing diluted loss per share. |
New Accounting Pronouncements, Policy [Policy Text Block] | New Accounting Pronouncements Recently Adopted Pronouncements In January 2016, the FASB issued ASU 2016-01, “Financial Instruments–Overall: Recognition and Measurement of Financial Assets and Financial Liabilities.” In February 2018, the FASB issued ASU 2018-03, “Technical Corrections and Improvements to Financial Instruments–Overall: Recognition and Measurement of Financial Assets and Financial Liabilities.” The accounting standards primarily affect the accounting for equity investments, financial liabilities under the fair value option, and the presentation and disclosure requirements for financial instruments. In addition, it includes a clarification related to the valuation allowance assessment when recognizing deferred tax assets resulting from unrealized losses on available-for-sale debt securities. The accounting guidance is effective for annual reporting periods (including interim periods within those periods) beginning after December 15, 2017. The Company adopted ASU 2016-01 and ASU 2018-03 on January 1, 2018 and recorded a cumulative effect adjustment that decreased accumulated deficit by approximately $1.2 million. Effective January 1, 2018, the adoption date, changes in the fair value of the Company’s investments in equity securities are recognized in the consolidated statements of operations and comprehensive loss (see Note 5). In January 2017, the FASB issued ASU No. 2017-01, Clarifying the Definition of a Business (Topic 805). The amendments in the update provide a screen to determine when a set is not a business. If the screen is not met, the amendments in the update (1) require that to be considered a business, a set must include, at a minimum, an input and a substantive process that together significantly contribute to the ability to create output and (2) remove the evaluation of whether a market participant could replace missing elements. The amendments provide a framework to assist entities in evaluating whether both an input and a substantive process are present. Lastly, the amendments in the update narrow the definition of the term output so that the term is consistent with how outputs are described in Topic 606. The ASU is effective for annual periods and interim periods within those annual periods beginning after December 15, 2017; earlier adoption is permitted under certain criteria. The Company adopted this ASU on January 1, 2018. While this ASU did not have a material effect on the Company’s financial statements on the date of adoption, the Company did follow the new guidance in determining that its acquisition of ANDAs from Sandoz in January 2018 and from Laurus Labs in October 2018 were asset acquisitions (see Notes 3 and 4). In May 2017, the FASB issued ASU 2017-09, Compensation-Stock Compensation (Topic 718) Scope of Modification Accounting . ASU 2017-09 provides clarification on when modification accounting should be used for changes to the terms or conditions of a share-based payment award. This ASU does not change the accounting for modifications but clarifies that modification accounting guidance should only be applied if there is a change to the value, vesting conditions, or award classification and would not be required if the changes are considered non-substantive. This ASU is effective for fiscal years beginning after December 15, 2017, including interim periods within those fiscal years. The Company adopted ASU 2017-09 in the first quarter of 2018 and the adoption of this ASU did not have a material effect on the consolidated financial statements. In June 2018, the FASB issued ASU 2018-07, Compensation-Stock Compensation (Topic 718) Improvements to Nonemployee Share-Based Payment Accounting which includes updated guidance for share-based payment awards issued to non-employees. The updated standard aligns the accounting for share-based payment awards for non-employees with employees, except for guidance related to the attribution of compensation costs for non-employees. This ASU is effective for fiscal years beginning after December 15, 2018, including interim periods within those annual periods for public business entities, with early adoption permitted. The Company early adopted this standard on October 1, 2018. The adoption of this ASU did not have a material impact on the Company’s consolidated financial statements. Unadopted Pronouncements In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842). ASU 2016-02 supersedes existing lease guidance, including Accounting Standards Codification (ASC) 840 - Leases. Among other things, the new standard requires recognition of a right-of-use asset and liability for future lease payments for contracts that meet the definition of a lease. This ASU is effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years. The standard must be applied using a modified retrospective approach. In July 2018, the FASB issued ASU 2018-11, Leases (Topic 842) Targeted Improvements, which offers a transition option to entities adopting the new lease standard. Under the transition option, entities can recognize a cumulative effect adjustment to the opening balance of retained earnings of the year in which the new lease standard is adopted, rather than in the earliest period presented in their financial statements. The Company plans to elect the transition option provided, which will not require adjustments to comparative periods nor require modified disclosures in those comparative periods. Upon adoption, the Company expects to elect the transition package of practical expedients permitted within the new standard, which among other things, allows the carryforward of the historical lease classification. While the Company has not completed its analysis, based on its current lease portfolio the Company currently estimates that the adoption ASC 842 will result in approximately $2.5 million to $3.5 million of right of use assets and lease liabilities being reflected on its Consolidated Balance Sheet. 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. |
ACQUISITION OF ABBREVIATED NE_3
ACQUISITION OF ABBREVIATED NEW DRUG APPLICATIONS FROM SANDOZ (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Acquisition Of Abbreviated New Drug Applications From Sandoz [Abstract] | |
Schedule Of Finite Lived Intangible Assets And Active Pharmaceutical Ingredient Inventory [Table Text Block] | ANDAs $ 18,608,000 API 564,000 Total value $ 19,172,000 |
INVESTMENT IN EQUITY SECURITI_2
INVESTMENT IN EQUITY SECURITIES (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Schedule of Investments [Abstract] | |
Investment Holdings, Schedule of Investments [Table Text Block] | The following table summarizes the Company’s investment as of December 31, 2018: Description Classification Cost Gross unrealized gains Aggregate fair value Common stock Investment $ - $ 912,200 $ 912,200 |
PROPERTY AND EQUIPMENT (Tables)
PROPERTY AND EQUIPMENT (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Property, Plant and Equipment [Abstract] | |
Property, Plant and Equipment [Table Text Block] | Property and equipment consists of the following: December 31, 2018 2017 Furniture and equipment $ 1,697,294 $ 1,150,052 Leasehold improvements 739,390 268,734 2,436,684 1,418,786 Less: accumulated depreciation and amortization (686,054 ) (372,272 ) $ 1,750,630 $ 1,046,514 |
INTANGIBLE ASSETS (Tables)
INTANGIBLE ASSETS (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Finite-lived Intangible Assets Amortization Expense [Table Text Block] | Net definite-lived intangible assets at December 31, 2018 consists of the following: Asset Gross Value Accumulated Amortization Estimated useful lives ANDAs $ 18,054,985 $ (1,291,775 ) 13 years TDF ANDA $ 2,035,121 $ (13,604 ) 13 years Total $ 20,090,106 $ (1,305,379 ) |
Schedule of Finite-Lived Intangible Assets, Future Amortization Expense [Table Text Block] | Expected future amortization expense is as follows for the years ending December 31: 2019 $ 1,546,691 2020 1,546,691 2021 1,546,691 2022 1,546,691 2023 1,546,691 2024 and thereafter 11,051,272 |
STOCKHOLDERS' EQUITY (Tables)
STOCKHOLDERS' EQUITY (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Stockholders' Equity Note [Abstract] | |
Schedule Of Warrant Activity [Table Text Block] | Stock purchase warrants activity for 2018 and 2017 is as follows: Weighted Average Number of Shares Exercise Price 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 Issued 8,271,709 $ 4.58 Exercised (2,753,900 ) $ 1.80 Expired - - Outstanding at December 31, 2018 11,781,825 $ 3.98 Exercisable at December 31, 2018 9,682,948 $ 3.28 |
STOCK-BASED COMPENSATION (Table
STOCK-BASED COMPENSATION (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
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 twelve months ended December 31, 2018 and 2017 includes $6,118,121 and $650,440, respectively, of non-cash compensation expense related to the Company’s share-based compensation awards. The compensation expense related to the Company’s share-based compensation arrangements is recorded as components of general and administrative expense and research and development expense, as follows: 2018 2017 Research and development $ 740,398 $ 271,733 General and administrative 5,377,723 378,707 Total share-based compensation expense $ 6,118,121 $ 650,440 |
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, 2018 and 2017: Year ended December 31, 2018 2017 Expected volatility 78.78 % 78.88 % Risk free interest rate 2.80 % 1.96 % Expected term of option 5.77 years 6.29 years Expected dividend yield 0.00 % 0.00 % |
Schedule of Share-based Compensation, Stock Options, Activity [Table Text Block] | A summary of the Company's stock option plans and of changes in options outstanding under the plans during the years ended December 31, 2018 and 2017 is as follows: Weighted Average Weighted Average Remaining Number of Options Exercise Price Contractual Term in Years Aggregate Intrinsic Value Outstanding at December 31, 2016 9,535,306 $ 1.57 Exercised (154,545 ) $ 2.11 $ 168,000 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 Exercised (156,283 ) $ 1.65 $ 643,000 Granted 7,336,000 $ 4.01 Expired (285,594 ) $ 1.55 Forfeited (50,130 ) $ 3.28 Outstanding at December 31, 2018 18,429,308 $ 2.44 7.61 $ 33,694,004 Exercisable at December 31, 2018 9,755,668 $ 1.57 6.21 $ 24,728,420 |
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 that are outstanding at December 31, 2018: 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, 2018 Life in Years Price December 31, 2018 Price $0.00 - $1.00 3,754,554 7.95 $ 0.93 2,458,613 $ 0.90 $1.01 - $2.00 6,859,938 5.98 $ 1.53 6,606,410 $ 1.54 $2.01 - $4.00 5,931,000 8.83 $ 3.18 425,788 $ 2.44 $4.01 - $7.00 1,642,000 9.10 $ 6.25 125,541 $ 6.25 $7.01 - $9.00 241,816 8.22 $ 8.01 139,316 $ 8.00 18,429,308 7.61 $ 2.44 9,755,668 $ 1.57 |
INCOME TAXES (Tables)
INCOME TAXES (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |
Schedule of Income before Income Tax, Domestic and Foreign [Table Text Block] | As a result of net operating losses, the Company did not recognize a consolidated provision (benefit) for income taxes in either period. For financial reporting purposes, loss before taxes includes the following components: 2018 2017 United States $ (19,819,835 ) $ (8,658,120 ) China (7,651,733 ) (2,112,082 ) Total $ (27,471,568 ) $ (10,770,202 ) |
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, 2018 and 2017 are as follows: December 31, 2018 2017 Deferred income tax assets: Net operating loss carryforwards $ 97,701,000 $ 96,786,000 Research and development credit carryforward 8,957,000 9,592,000 Intangible assets 4,378,000 4,184,000 Equity-based compensation 4,075,000 3,812,000 Other 81,000 164,000 Valuation allowance for deferred income tax assets (115,192,000 ) (114,538,000 ) 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: 2018 2017 Tax benefit at statutory rate $ (5,769,000 ) $ (3,662,000 ) Effect of tax law change - 52,258,000 State taxes (1,098,000 ) (290,000 ) Net R&E credit adjustment (7,000 ) (185,000 ) Net operating loss expiration 7,200,000 50,000 Nondeductible expenses 29,000 6,000 Change in valuation allowance 654,000 (48,117,000 ) Other (75,000 ) 125,000 Changes in applicable tax rates (934,000 ) (185,000 ) $ - $ - |
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: 2018 2017 Unrecognized tax benefits balance at January 1 $ 3,198,000 $ 3,133,000 Additions for Tax Positions of Prior Periods - 3,000 Reductions for Tax Positions of Prior Periods (214,000 ) - Additions for Tax Positions of Current Period 2,000 62,000 Unrecognized tax benefits balance at December 31 $ 2,986,000 $ 3,198,000 |
FAIR VALUE MEASUREMENTS (Tables
FAIR VALUE MEASUREMENTS (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |
Schedule of Fair Value, Assets and Liabilities Measured on Recurring Basis [Table Text Block] | The following tables presents the Company’s financial assets and liabilities accounted for at fair value on a recurring basis as of December 31, 2018 and December 31, 2017, by level within the fair value hierarchy: Description Fair Value at December 31, 2018 Level 1 Level 2 Level 3 Investment in common stock $ 912,200 $ 912,200 $ - $ - Contingent Rights $ - $ - $ - $ - Description Fair Value at December 31, 2017 Level 1 Level 2 Level 3 Investment in common stock $ 1,232,312 $ 1,232,312 $ - $ - Contingent Rights $ - $ - $ - $ - |
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 sets forth a summary of changes in the fair value of Level 3 liabilities measured at fair value on a recurring basis for the year ended December 31, 2017: Description Balance at December 31, 2016 Change in Fair value Settled in 2017 Balance at December 31, 2017 Contingent Rights $ 4,122,266 $ 19,891 $ (4,142,157 ) $ - |
COMMITMENTS AND CONTINGENCIES (
COMMITMENTS AND CONTINGENCIES (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
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: 2019 $ 1,311,707 2020 1,297,102 2021 856,832 2022 129,918 Thereafter - Total minimum payments $ 3,595,559 |
DESCRIPTION OF BUSINESS (Detail
DESCRIPTION OF BUSINESS (Details Textual) - USD ($) | 1 Months Ended | 2 Months Ended | ||||||||
Oct. 10, 2018 | Sep. 30, 2018 | Mar. 31, 2018 | Oct. 31, 2018 | Apr. 30, 2018 | Feb. 28, 2019 | Dec. 31, 2018 | Nov. 30, 2018 | Sep. 24, 2018 | Dec. 31, 2017 | |
Description of Business and Basis of Presentation [Line Items] | ||||||||||
Retained Earnings (Accumulated Deficit) | $ (478,941,285) | $ (452,702,029) | ||||||||
Proceeds From Issuance Of Common Stock And Warrants Gross | $ 37,500,000 | |||||||||
Stock Issued During Period, Shares, New Issues | 6,996,266 | |||||||||
Number Of Warrants To Purchase Common Stock Issued During The Period | 2,098,877 | |||||||||
Investor [Member] | ||||||||||
Description of Business and Basis of Presentation [Line Items] | ||||||||||
Stock To Be Issued, Shares | 9,048,504 | 9,048,504 | ||||||||
Warrants To Be Issued | 2,714,548 | 2,714,548 | ||||||||
Proceeds From Issuance Of Common Stock And Warrants Gross | $ 37,500,000 | |||||||||
Stock Issued During Period, Shares, New Issues | 15,432,091 | |||||||||
Number Of Warrants To Purchase Common Stock Issued During The Period | 6,172,832 | |||||||||
CASI Wuxi [Member] | ||||||||||
Description of Business and Basis of Presentation [Line Items] | ||||||||||
Total Future Investment | $ 80,000,000 | |||||||||
Private Placement [Member] | ||||||||||
Description of Business and Basis of Presentation [Line Items] | ||||||||||
Proceeds From Issuance Of Common Stock And Warrants Gross | $ 50,000,000 | |||||||||
Private Placement [Member] | Investor [Member] | ||||||||||
Description of Business and Basis of Presentation [Line Items] | ||||||||||
Stock And Warrants To Be Issued Value | $ 48,500,000 | $ 48,500,000 | ||||||||
Subsequent Event [Member] | CASI Wuxi [Member] | ||||||||||
Description of Business and Basis of Presentation [Line Items] | ||||||||||
Initial Cash Investment | $ 21,000,000 |
SUMMARY OF SIGNIFICANT ACCOUN_3
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details Textual) - USD ($) | Jan. 02, 2018 | Dec. 31, 2018 | Dec. 31, 2017 |
Accounting Policies [Line Items] | |||
Clinical Trial Accruals | $ 150,893 | $ 402,773 | |
Inventory, Gross | 283,000 | ||
Cumulative Effect on Retained Earnings, Net of Tax | $ 1,200,000 | $ 1,232,312 | |
Options And Warrants [Member] | |||
Accounting Policies [Line Items] | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 30,211,133 | 17,849,331 | |
Minimum [Member] | Accounting Standards Update 2016-02 [Member] | |||
Accounting Policies [Line Items] | |||
Operating Lease, Right Of Use Asset (Liability) | $ 2,500,000 | ||
Maximum [Member] | Accounting Standards Update 2016-02 [Member] | |||
Accounting Policies [Line Items] | |||
Operating Lease, Right Of Use Asset (Liability) | $ 3,500,000 |
ACQUISITION OF ABBREVIATED NE_4
ACQUISITION OF ABBREVIATED NEW DRUG APPLICATIONS FROM SANDOZ (Details) | 12 Months Ended |
Dec. 31, 2018USD ($) | |
Purchase Price For Finite lived Intangible Assets Acquired | $ 19,172,000 |
Abbreviated New Drug Applications [Member] | |
Purchase Price For Finite lived Intangible Assets Acquired | 18,608,000 |
Active Pharmaceutical Ingredient [Member] | |
Purchase Price For Finite lived Intangible Assets Acquired | $ 564,000 |
ACQUISITION OF ABBREVIATED NE_5
ACQUISITION OF ABBREVIATED NEW DRUG APPLICATIONS FROM SANDOZ (Details Textual) - USD ($) | 1 Months Ended | 12 Months Ended | |
Jan. 26, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | |
Research and Development in Process | $ 686,998 | $ 0 | |
Finite-Lived Intangible Asset, Useful Life | 13 years | ||
Payments to Acquire Intangible Assets | $ 18,000,000 | $ 20,642,969 | $ 0 |
Abbreviated New Drug Applications [Member] | |||
Research and Development in Process | 553,000 | ||
Asset Acquisition Transaction Costs | $ 1,200,000 | ||
Finite-Lived Intangible Asset, Useful Life | 13 years | ||
Active Pharmaceutical Ingredient [Member] | |||
Research and Development in Process | $ 134,000 |
ACQUISITION OF ABBREVIATED NE_6
ACQUISITION OF ABBREVIATED NEW DRUG APPLICATION FROM LAURUS LABS (Details Textual) - USD ($) | 1 Months Ended | 12 Months Ended | ||
Dec. 31, 2018 | Oct. 31, 2018 | Jan. 26, 2018 | Dec. 31, 2018 | |
Finite-Lived Intangible Asset, Useful Life | 13 years | |||
Abbreviated New Drug Applications [Member] | ||||
Asset Acquisition Transaction Costs | $ 1,200,000 | |||
Finite-Lived Intangible Asset, Useful Life | 13 years | |||
Laurus Lab [Member] | ||||
Purchase Price Of Drug | $ 3,000,000 | |||
Upfront Payment For Drug | $ 700,000 | |||
Asset Acquisition Transaction Costs | $ 35,121 | |||
Contingent Consideration Paid | $ 1,300,000 | 1,300,000 | ||
Remaining Amount Of Future Contingent Consideration | $ 1,000,000 | |||
Laurus Lab [Member] | Abbreviated New Drug Applications [Member] | ||||
Finite-Lived Intangible Asset, Useful Life | 13 years |
INVESTMENT IN EQUITY SECURITI_3
INVESTMENT IN EQUITY SECURITIES (Details) - Common Stock [Member] | 12 Months Ended |
Dec. 31, 2018USD ($) | |
Cost | $ 0 |
Gross unrealized gains | 912,200 |
Aggregate fair value | $ 912,200 |
INVESTMENT IN EQUITY SECURITI_4
INVESTMENT IN EQUITY SECURITIES (Details Textual) - USD ($) | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Jan. 01, 2018 | |
Change in fair value of investment in equity securities | $ 320,112 | $ 0 | |
Equity Method Investments | 1,200,000 | $ 1,200,000 | |
Equity Method Investments, Fair Value Disclosure | 1,200,000 | ||
Accumulated Other Comprehensive Income (Loss), Net of Tax | (1,226,320) | 0 | 1,200,000 |
Retained Earnings (Accumulated Deficit) | $ (478,941,285) | (452,702,029) | |
Common Stock [Member] | |||
Equity Method Investments | $ 0 | ||
Accounting Standards Update 2016-01 [Member] | |||
Accumulated Other Comprehensive Income (Loss), Net of Tax | 1,200,000 | ||
Retained Earnings (Accumulated Deficit) | $ 1,200,000 |
PROPERTY AND EQUIPMENT (Details
PROPERTY AND EQUIPMENT (Details) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Furniture and equipment | $ 1,697,294 | $ 1,150,052 |
Leasehold improvements | 739,390 | 268,734 |
Property, Plant and Equipment, Gross | 2,436,684 | 1,418,786 |
Less: accumulated depreciation and amortization | (686,054) | (372,272) |
Property, Plant and Equipment, Net | $ 1,750,630 | $ 1,046,514 |
PROPERTY AND EQUIPMENT (Detai_2
PROPERTY AND EQUIPMENT (Details Textual) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Depreciation, Depletion and Amortization | $ 365,555 | $ 117,779 |
Maximum [Member] | ||
Property, Plant and Equipment, Useful Life | 5 years | |
Minimum [Member] | ||
Property, Plant and Equipment, Useful Life | 3 years |
INTANGIBLE ASSETS (Details)
INTANGIBLE ASSETS (Details) | 12 Months Ended |
Dec. 31, 2018USD ($) | |
Gross Value | $ 20,090,106 |
Accumulated Amortization | $ (1,305,379) |
Estimated useful lives | 13 years |
Abbreviated New Drug Applications [Member] | |
Gross Value | $ 18,054,985 |
Accumulated Amortization | $ (1,291,775) |
Estimated useful lives | 13 years |
Abbreviated New Drug Applications TDF [Member] | |
Gross Value | $ 2,035,121 |
Accumulated Amortization | $ (13,604) |
Estimated useful lives | 13 years |
INTANGIBLE ASSETS (Details 1)
INTANGIBLE ASSETS (Details 1) | Dec. 31, 2018USD ($) |
2019 | $ 1,546,691 |
2020 | 1,546,691 |
2021 | 1,546,691 |
2022 | 1,546,691 |
2023 | 1,546,691 |
2024 and thereafter | $ 11,051,272 |
INTANGIBLE ASSETS (Details Text
INTANGIBLE ASSETS (Details Textual) | 12 Months Ended |
Dec. 31, 2018 | |
Finite-Lived Intangible Asset, Useful Life | 13 years |
ESTABLISHMENT OF CASI WUXI (De
ESTABLISHMENT OF CASI WUXI (Details Textual) - CASI Wuxi [Member] - USD ($) $ in Millions | 1 Months Ended | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2018 | Feb. 28, 2019 | |
Investment Commitment | $ 80 | $ 80 | |
Payments To Be Paid Within Three Years | 29 | ||
Future Investment | $ 20 | 20 | |
Subsequent Event [Member] | |||
Initial Cash Investment | $ 21 | ||
Abbreviated New Drug Applications [Member] | |||
Value of a future transfer of selected ANDAs | $ 30 |
NOTE PAYABLE (Details Textual)
NOTE PAYABLE (Details Textual) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Notes Payable [Line Items] | ||
Interest Expense | $ 7,500 | $ 7,500 |
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 |
STOCKHOLDERS' EQUITY (Details)
STOCKHOLDERS' EQUITY (Details) - Warrant [Member] - $ / shares | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Outstanding at Number of Warrants, Beginning Balance | 6,264,016 | 6,388,501 |
Issued Number of Warrants | 8,271,709 | 1,638,506 |
Exercised Number of Warrants | (2,753,900) | 0 |
Expired Number of Warrants | 0 | (1,762,991) |
Outstanding at Number of Warrants, Ending Balance | 11,781,825 | 6,264,016 |
Exercisable Number of Warrants | 9,682,948 | |
Outstanding Weighted Average Exercise Price, Beginning Balance | $ 2.23 | $ 1.60 |
Issued Weighted Average Exercise Price | 4.58 | 3.75 |
Exercised Weighted Average Exercise Price | 1.80 | 0 |
Expired Weighted Average Exercise Price | 0 | 1.46 |
Outstanding Weighted Average Exercise Price, at Ending Balance | 3.98 | $ 2.23 |
Exercisable Weighted Average Exercise Price | $ 3.28 |
STOCKHOLDERS' EQUITY (Details T
STOCKHOLDERS' EQUITY (Details Textual) | 1 Months Ended | 2 Months Ended | 12 Months Ended | |||||||||
Oct. 10, 2018USD ($) | Sep. 30, 2018USD ($)$ / sharesshares | Sep. 17, 2018$ / shares | Mar. 31, 2018USD ($)$ / sharesshares | Oct. 31, 2017USD ($)$ / sharesshares | Oct. 31, 2018USD ($)$ / sharesshares | Apr. 30, 2018USD ($) | Dec. 31, 2018USD ($)shares | Dec. 31, 2017USD ($)shares | Mar. 23, 2019$ / shares | Sep. 24, 2018USD ($)shares | Feb. 28, 2018USD ($) | |
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ / shares | $ 3.75 | |||||||||||
Fair Value Of Warrant Issued | $ | $ 1,558,566 | |||||||||||
Fair Value Assumptions Fair Value | $ / shares | $ 0.60 | |||||||||||
FairValueAssumptionsExpectedTerms | 2 years 6 months | |||||||||||
Fair Value Assumptions Risk Free Interest Rates | 1.54% | |||||||||||
Fair Value Assumptions Expected Volatility Rates | 85.4 | |||||||||||
Proceeds from Issuance of Common Stock | $ | $ 23,855,595 | |||||||||||
Sale of Stock, Price Per Share | $ / shares | $ 3 | |||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 1,590,373 | |||||||||||
Stock Issued During Period, Shares, New Issues | 6,996,266 | |||||||||||
Class of Warrant or Right, Number of Securities Called by Each Warrant or Right | 0.20 | |||||||||||
Stock Issued During Period, Value, Other | $ | $ 23,400,000 | $ 87,990,216 | $ 23,884,475 | |||||||||
Agent Warrants Percentage | 4.00% | |||||||||||
Stock Issued During Period | 7,951,865 | |||||||||||
Price Per Share and Warrant | $ / shares | $ 3.24 | |||||||||||
Common Stock, Shares Authorized | 170,000,000 | 170,000,000 | ||||||||||
Treasury Stock, Shares | 79,545 | 79,545 | ||||||||||
Number of Warrants to Purchase Common Stock Issued During the Period | 2,098,877 | |||||||||||
Proceeds from Issuance of Common Stock and Warrants Gross | $ | $ 37,500,000 | |||||||||||
Preferred Stock, Shares Authorized | 5,000,000 | 5,000,000 | ||||||||||
Remaining Dollar Amount Available Under Sales Agreement | $ | $ 24,500,000 | |||||||||||
Measurement Input, Expected Term [Member] | ||||||||||||
Fair Value Assumptions Term | 3 years | |||||||||||
Investors [Member] | ||||||||||||
Stock To Be Issued, Shares | 9,048,504 | 9,048,504 | ||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ / shares | $ 3.69 | |||||||||||
Warrants To Be Issued | 2,714,548 | 2,714,548 | ||||||||||
Stock Issued During Period, Shares, New Issues | 15,432,091 | |||||||||||
Class Of Warrant Or Right Expiration Date | Mar. 21, 2023 | |||||||||||
Price Per Share and Warrant | $ / shares | $ 5.36 | |||||||||||
Number of Warrants to Purchase Common Stock Issued During the Period | 6,172,832 | |||||||||||
Proceeds from Issuance of Common Stock and Warrants Gross | $ | $ 37,500,000 | |||||||||||
H.C. Wainwright Co., LLC [Member] | Maximum [Member] | ||||||||||||
Aggregate Sales Price | $ | $ 25,000,000 | |||||||||||
Securities Purchase Agreements [Member] | ||||||||||||
Fair Value Of Warrant Issued | $ | $ 15,062,000 | $ 6,254,653 | ||||||||||
Fair Value Assumptions Fair Value | $ / shares | $ 2.44 | $ 0.98 | $ 2.98 | |||||||||
Class Of Warrant Or Right Expiration Date | Sep. 24, 2021 | Apr. 17, 2020 | ||||||||||
Class of Warrant or Right, Date from which Warrants or Rights Exercisable | Mar. 23, 2019 | Apr. 17, 2018 | ||||||||||
Securities Purchase Agreements [Member] | Measurement Input, Expected Term [Member] | ||||||||||||
Fair Value Assumptions Term | 5 years | |||||||||||
Securities Purchase Agreements [Member] | Measurement Input, Risk Free Interest Rate [Member] | ||||||||||||
Fair Value Assumptions Rate | 2.89% | 2.69% | ||||||||||
Securities Purchase Agreements [Member] | Measurement Input, Price Volatility [Member] | ||||||||||||
Fair Value Assumptions Rate | 88.39% | 75.40% | ||||||||||
Securities Purchase Agreements [Member] | Agent Warrants [Member] | ||||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ / shares | $ 3.75 | |||||||||||
Fair Value Of Warrant Issued | $ | $ 28,880 | |||||||||||
FairValueAssumptionsExpectedTerms | 1 year 6 months | |||||||||||
Fair Value Assumptions Risk Free Interest Rates | 1.54% | |||||||||||
Fair Value Assumptions Expected Volatility Rates | 77.8 | |||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 48,133 | |||||||||||
Class Of Warrant Or Right Expiration Date | Apr. 17, 2019 | |||||||||||
Class of Warrant or Right, Date from which Warrants or Rights Exercisable | Apr. 17, 2018 | |||||||||||
Private Placement [Member] | ||||||||||||
Proceeds from Issuance of Common Stock and Warrants Gross | $ | $ 50,000,000 | |||||||||||
Private Placement [Member] | Investors [Member] | ||||||||||||
Stock And Warrants To Be Issued Value | $ | $ 48,500,000 | $ 48,500,000 | ||||||||||
Sales Agreement [Member] | ||||||||||||
Net Proceeds From Issuance Of Common Stock | $ | $ 475,000 | |||||||||||
Stock Issued During Period, Shares, New Issues | 143,248 | |||||||||||
Warrant [Member] | Subsequent Event [Member] | Investors [Member] | ||||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ / shares | $ 7.19 |
EMPLOYEE RETIREMENT PLAN (Detai
EMPLOYEE RETIREMENT PLAN (Details Textual) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Defined Benefit Plan, Plan Assets, Contributions by Employer | $ 151,148 | $ 70,167 |
STOCK-BASED COMPENSATION (Detai
STOCK-BASED COMPENSATION (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock-based compensation expense | $ 6,118,121 | $ 650,440 |
Research and Development Expense [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock-based compensation expense | 740,398 | 271,733 |
General and Administrative Expense [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock-based compensation expense | $ 5,377,723 | $ 378,707 |
STOCK-BASED COMPENSATION (Det_2
STOCK-BASED COMPENSATION (Details 1) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected volatility | 78.78% | 78.88% |
Risk-free interest rate | 2.80% | 1.96% |
Expected term of option | 5 years 9 months 7 days | 6 years 3 months 14 days |
Expected dividend yield | 0.00% | 0.00% |
STOCK-BASED COMPENSATION (Det_3
STOCK-BASED COMPENSATION (Details 2) - Employee Stock Option [Member] - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Outstanding - Number of Options, Beginning Balance | 11,585,315 | 9,535,306 |
Exercised - Number of Options | (156,283) | (154,545) |
Granted - Number of Options | 7,336,000 | 3,199,500 |
Expired - Number of Options | (285,594) | (978,070) |
Forfeited - Number of Options | (50,130) | (16,876) |
Outstanding - Number of Options, Ending Balance | 18,429,308 | 11,585,315 |
Exercisable - Number of Options | 9,755,668 | |
Outstanding - Weighted Average Exercise Price, Beginning balance | $ 1.42 | $ 1.57 |
Exercised - Weighted Average Exercise Price | 1.65 | 2.11 |
Granted - Weighted Average Exercise Price | 4.01 | 1.05 |
Expired - Weighted Average Exercise Price | 1.55 | 1.64 |
Forfeited - Weighted Average Exercise Price | 3.28 | 0.92 |
Outstanding - Weighted Average Exercise Price, Ending Balance | 2.44 | $ 1.42 |
Exercisable - Weighted Average Exercise Price | $ 1.57 | |
Outstanding - Weighted Average Remaining Contractual Term In Years | 7 years 7 months 10 days | |
Exercisable - Weighted Average Remaining Contractual Term In Years | 6 years 2 months 16 days | |
Outstanding - Aggregate Intrinsic Value | $ 33,694,004 | |
Exercisable - Aggregate Intrinsic Value | 24,728,420 | |
Exercised - Aggregate Intrinsic Value | $ 643,000 | $ 168,000 |
STOCK-BASED COMPENSATION (Det_4
STOCK-BASED COMPENSATION (Details 3) | 12 Months Ended |
Dec. 31, 2018$ / sharesshares | |
Number Of Options Outstanding at December 31,2018 | shares | 18,429,308 |
Number Of Options Outstanding Weighted Average Remaining Contractual Life in Years | 7 years 7 months 10 days |
Number Of Options Outstanding Weighted Average Exercise Price | $ 2.44 |
Number Of Options Exercisable at December 31, 2018 | shares | 9,755,668 |
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 31,2018 | shares | 3,754,554 |
Number Of Options Outstanding Weighted Average Remaining Contractual Life in Years | 7 years 11 months 12 days |
Number Of Options Outstanding Weighted Average Exercise Price | $ 0.93 |
Number Of Options Exercisable at December 31, 2018 | shares | 2,458,613 |
Number Of Options Exercisable Weighted Average Exercise Price | $ 0.90 |
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 31,2018 | shares | 6,859,938 |
Number Of Options Outstanding Weighted Average Remaining Contractual Life in Years | 5 years 11 months 23 days |
Number Of Options Outstanding Weighted Average Exercise Price | $ 1.53 |
Number Of Options Exercisable at December 31, 2018 | shares | 6,606,410 |
Number Of Options Exercisable Weighted Average Exercise Price | $ 1.54 |
Range Three [Member] | |
Range of Exercise Prices Lower Range Limit | 2.01 |
Range of Exercise Prices Upper Range Limit | $ 4 |
Number Of Options Outstanding at December 31,2018 | shares | 5,931,000 |
Number Of Options Outstanding Weighted Average Remaining Contractual Life in Years | 8 years 9 months 29 days |
Number Of Options Outstanding Weighted Average Exercise Price | $ 3.18 |
Number Of Options Exercisable at December 31, 2018 | shares | 425,788 |
Number Of Options Exercisable Weighted Average Exercise Price | $ 2.44 |
Range Four [Member] | |
Range of Exercise Prices Lower Range Limit | 4.01 |
Range of Exercise Prices Upper Range Limit | $ 7 |
Number Of Options Outstanding at December 31,2018 | shares | 1,642,000 |
Number Of Options Outstanding Weighted Average Remaining Contractual Life in Years | 9 years 1 month 6 days |
Number Of Options Outstanding Weighted Average Exercise Price | $ 6.25 |
Number Of Options Exercisable at December 31, 2018 | shares | 125,541 |
Number Of Options Exercisable Weighted Average Exercise Price | $ 6.25 |
Range Five [Member] | |
Range of Exercise Prices Lower Range Limit | 7.01 |
Range of Exercise Prices Upper Range Limit | $ 9 |
Number Of Options Outstanding at December 31,2018 | shares | 241,816 |
Number Of Options Outstanding Weighted Average Remaining Contractual Life in Years | 8 years 2 months 19 days |
Number Of Options Outstanding Weighted Average Exercise Price | $ 8.01 |
Number Of Options Exercisable at December 31, 2018 | shares | 139,316 |
Number Of Options Exercisable Weighted Average Exercise Price | $ 8 |
STOCK-BASED COMPENSATION (Det_5
STOCK-BASED COMPENSATION (Details Textual) - USD ($) | 12 Months Ended | |||
Dec. 31, 2018 | Dec. 31, 2017 | Jun. 30, 2018 | Mar. 31, 2018 | |
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 | $ 4.49 | $ 0.73 | ||
Share-based Compensation | $ 6,118,121 | $ 650,440 | ||
Performance Share Based Compensation Expense | 643,875 | 30,500 | ||
Share Based Payment Cash Received from Stock Option Exercises | 258,000 | $ 326,000 | ||
Unrecognized Share Based Compensation Cost Expected To Be Recognized Over Weighted Average Period | $ 8,844,000 | |||
Unrecognized Share Based Compensation Cost Expected To Be Recognized Over Weighted Average Period | 3 years | |||
Executive Chairman [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] | ||||
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 | 1 year | |||
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 | 6,834,234 | |||
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 | 20,230,000 | |||
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 | 14,230,000 |
INCOME TAXES (Details)
INCOME TAXES (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
United States | $ (19,819,835) | $ (8,658,120) |
China | (7,651,733) | (2,112,082) |
Total | $ (27,471,568) | $ (10,770,202) |
INCOME TAXES (Details 1)
INCOME TAXES (Details 1) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Deferred income tax assets: | ||
Net operating loss carryforwards | $ 97,701,000 | $ 96,786,000 |
Research and development credit carryforward | 8,957,000 | 9,592,000 |
Intangible assets | 4,378,000 | 4,184,000 |
Equity based compensation | 4,075,000 | 3,812,000 |
Other | 81,000 | 164,000 |
Valuation allowance for deferred income tax assets | (115,192,000) | (114,538,000) |
Net deferred income tax assets | $ 0 | $ 0 |
INCOME TAXES (Details 2)
INCOME TAXES (Details 2) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Effective Income Tax Rate Reconciliation Line Items [Line Items] | ||
Tax benefit at statutory rate | $ (5,769,000) | $ (3,662,000) |
Effect of tax law change | 0 | 52,258,000 |
State taxes | (1,098,000) | (290,000) |
Net R&D credit adjustment | (7,000) | (185,000) |
Net operating loss expiration | 7,200,000 | 50,000 |
Nondeductible expenses | 29,000 | 6,000 |
Change in valuation allowance | 654,000 | (48,117,000) |
Other | (75,000) | 125,000 |
Changes in applicable tax rates | (934,000) | (185,000) |
Total | $ 0 | $ 0 |
INCOME TAXES (Details 3)
INCOME TAXES (Details 3) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Unrecognized tax benefits balance at January 1 | $ 3,198,000 | $ 3,133,000 |
Additions for Tax Positions of Prior Periods | 0 | 3,000 |
Reductions for Tax Positions of Prior Periods | (214,000) | 0 |
Additions for Tax Positions of Current Period | 2,000 | 62,000 |
Unrecognized tax benefits balance at December 31 | $ 2,986,000 | $ 3,198,000 |
INCOME TAXES (Details Textual)
INCOME TAXES (Details Textual) - USD ($) | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Income Tax Contingency [Line Items] | |||
Unrecognized Tax Benefits | $ 2,986,000 | $ 3,198,000 | $ 3,133,000 |
Tax Credit Carryforward, Amount | $ 8,957,000 | ||
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, at Federal Statutory Income Tax Rate, Percent | 21.00% | ||
Effective Income Tax Rate Reconciliation, Effect of tax law change , Amount | $ 0 | $ 52,258,000 | |
State and Local Jurisdiction [Member] | |||
Income Tax Contingency [Line Items] | |||
Operating Loss Carryforwards | 380,904,000 | ||
Foreign Tax Authority [Member] | |||
Income Tax Contingency [Line Items] | |||
Operating Loss Carryforwards | 13,066,000 | ||
Research Tax Credit Carryforward [Member] | |||
Income Tax Contingency [Line Items] | |||
Unrecognized Tax Benefits | $ 212,000 |
FAIR VALUE MEASUREMENTS (Detail
FAIR VALUE MEASUREMENTS (Details) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Investment in common stock | $ 912,200 | $ 1,232,312 |
Contingent Rights | 0 | 0 |
Fair Value, Inputs, Level 1 [Member] | ||
Investment in common stock | 912,200 | 1,232,312 |
Contingent Rights | 0 | 0 |
Fair Value, Inputs, Level 2 [Member] | ||
Investment in common stock | 0 | 0 |
Contingent Rights | 0 | 0 |
Fair Value, Inputs, Level 3 [Member] | ||
Investment in common stock | 0 | 0 |
Contingent Rights | $ 0 | $ 0 |
FAIR VALUE MEASUREMENTS (Deta_2
FAIR VALUE MEASUREMENTS (Details 1) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ||
Balance at beginning of year | $ 0 | $ 4,122,266 |
Partial settlement of Contingent Rights | $ 0 | (4,142,157) |
Change in fair value of Contingent Rights | 19,891 | |
Balance at end of year | $ 0 |
FAIR VALUE MEASUREMENTS (Deta_3
FAIR VALUE MEASUREMENTS (Details Textual) - shares | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Contingent Rights Description of Terms on Expiry | The Contingent Rights provided 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, and expired on the earlier of raising an aggregate of $50 million or September 17, 2019. | |
Spectrum [Member] | ||
Stock Issued During Period Shares Exercise Of Contingent Purchase Right | 1,519,096 |
RELATED PARTY TRANSACTIONS (Det
RELATED PARTY TRANSACTIONS (Details Textual) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Accounts Payable, Related Parties, Current | $ 0 | $ 2,228,366 |
Board of Directors Chairman [Member] | ||
Related Party Transaction, Expenses from Transactions with Related Party | 1,380,000 | |
Chief Executive Officer [Member] | ||
Related Party Transaction, Expenses from Transactions with Related Party | 120,000 | |
Spectrum [Member] | ||
Related Party Transaction, Purchases from Related Party | $ 2,705,000 | |
Spectrum [Member] | EVOMELA [Member] | ||
Purchase Obligation | 9,200,000 | |
Spectrum [Member] | EVOMELA [Member] | Prepaid Expenses and Other Current Assets [Member] | ||
Advance Payment on Contract for Purchase | 4,850,000 | |
Spectrum [Member] | MARQIBO [Member] | Research and Development Expense [Member] | ||
Related Party Transaction, Expenses from Transactions with Related Party | 120,000 | |
Emerging Technology Partners LLC [Member] | General and Administrative Expense [Member] | ||
Business Development | $ 1,500,000 |
COMMITMENTS AND CONTINGENCIES_2
COMMITMENTS AND CONTINGENCIES (Details) | Dec. 31, 2018USD ($) |
2019 | $ 1,311,707 |
2020 | 1,297,102 |
2021 | 856,832 |
2022 | 129,918 |
Thereafter | 0 |
Total minimum payments | $ 3,595,559 |
COMMITMENTS AND CONTINGENCIES_3
COMMITMENTS AND CONTINGENCIES (Details Textual) | 12 Months Ended | ||||
Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) | Mar. 31, 2019USD ($) | Feb. 28, 2019USD ($) | Nov. 01, 2018ft² | |
Operating Leases, Rent Expense | $ 916,000 | $ 440,000 | |||
Rockville MD Office [Member] | |||||
Properties Subject To Ground Leases | ft² | 6,068 | ||||
Spectrum [Member] | EVOMELA [Member] | |||||
Purchase obligation to purchase materials | 9,200,000 | ||||
Spectrum [Member] | EVOMELA [Member] | Prepaid Expenses and Other Current Assets [Member] | |||||
Advance Payment on Contract for Purchase | 4,800,000 | ||||
CASI Wuxi [Member] | |||||
Operating Leases, Future Minimum Payments Due | 3,789,000 | ||||
Total Future Investment | 80,000,000 | ||||
Subsequent Event [Member] | Spectrum [Member] | EVOMELA [Member] | |||||
Purchase Commitment, Remaining Minimum Amount Committed | $ 3,100,000 | ||||
Subsequent Event [Member] | CASI Wuxi [Member] | |||||
Initial Cash Investment | $ 21,000,000 | ||||
Phase One [Member] | |||||
Business Combination Consideration Milestone Achievement | 2,000,000 | ||||
Phase Two [Member] | |||||
Business Combination Consideration Milestone Achievement | 3,000,000 | ||||
Phase Three [Member] | |||||
Business Combination Consideration Milestone Achievement | $ 4,000,000 |