CASI Pharmaceuticals (CASI) 10-Q 15 May 18 2018 Q1 Quarterly report Financial data

Document And Entity Information

Document And Entity Information - shares	3 Months Ended
	Mar. 31, 2018	May 08, 2018
Document Information [Line Items]
Document Type	10-Q
Amendment Flag	false
Document Period End Date	Mar. 31, 2018
Document Fiscal Year Focus	2,018
Document Fiscal Period Focus	Q1
Entity Registrant Name	CASI Pharmaceuticals, Inc.
Entity Central Index Key	895,051
Current Fiscal Year End Date	--12-31
Entity Filer Category	Smaller Reporting Company
Trading Symbol	CASI
Entity Common Stock, Shares Outstanding		86,145,298

Condensed Consolidated Balance

Condensed Consolidated Balance Sheets - USD ($)	Mar. 31, 2018	Dec. 31, 2017
Current assets:
Cash and cash equivalents	$ 49,887,600	$ 43,489,935
Investments, at market	1,322,025	0
Prepaid expenses and other	876,026	322,493
Total current assets	52,085,651	43,812,428
Property and equipment, net	1,200,830	1,046,514
Other assets	70,694	242,023
Intangible assets, net	17,804,844	0
Total assets	71,162,019	45,100,965
Current liabilities:
Accounts payable	1,581,931	2,087,770
Payable to related parties	0	2,228,366
Accrued liabilities	462,136	745,961
Total current liabilities	2,044,067	5,062,097
Note payable, net of discount	1,498,931	1,498,754
Total liabilities	3,542,998	6,560,851
Commitments and contingencies
Stockholders’ equity:
Preferred stock, $1.00 par value: 5,000,000 shares authorized and 0 shares issued and outstanding at March 31, 2018 and December 31, 2017	0	0
Common stock, $.01 par value: 170,0000,000 shares authorized at March 31, 2018 and December 31, 2017; 79,721,421 shares and 69,901,625 shares issued at March 31, 2018 and December 31, 2017, respectively	797,214	699,015
Additional paid-in capital	529,389,427	498,577,372
Treasury stock, at cost: 79,545 shares held at March 31, 2018 and December 31, 2017	(8,034,244)	(8,034,244)
Accumulated other comprehensive income	527,251	0
Accumulated deficit	(455,060,627)	(452,702,029)
Total stockholders’ equity	67,619,021	38,540,114
Total liabilities and stockholders’ equity	$ 71,162,019	$ 45,100,965

Condensed Consolidated Balance3

Condensed Consolidated Balance Sheets [Parenthetical] - $ / shares	Mar. 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 (in dollars per share)	$ 0.01	$ 0.01
Common stock, shares authorized	170,000,000	170,000,000
Common stock, shares issued	79,721,421	69,901,625
Treasury stock, shares held	79,545	79,545

Condensed Consolidated Statemen

Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($)	3 Months Ended
	Mar. 31, 2018	Mar. 31, 2017
Revenues:
Product sales	$ 0	$ 0
Costs and expenses
Research and development	1,697,232	1,049,287
General and administrative	1,303,122	644,163
Acquired in-process research and development	686,998	0
Costs and expenses	3,687,352	1,693,450
Interest income, net	(6,729)	(142)
Other income	(89,713)	0
Changes in fair value of contingent rights	0	6,874
Net loss	$ (3,590,910)	$ (1,700,182)
Net loss per share (basic and diluted)	$ (0.05)	$ (0.03)
Weight average number of shares outstanding (basic and diluted)	71,215,000	60,196,574
Comprehensive loss:
Net loss	$ (3,590,910)	$ (1,700,182)
Foreign currency translation adjustment	527,251	0
Total comprehensive loss	$ (3,063,659)	$ (1,700,182)

Condensed Consolidated Stateme5

Condensed Consolidated Statement of Stockholders' Equity - 3 months ended Mar. 31, 2018 - USD ($)	Total	Preferred Stock [Member]	Common Stock [Member]	Treasury Stock [Member]	Additional Paid-in Capital [Member]	AOCI Attributable to Parent [Member]	Accumulated Deficit [Member]
Balance at Dec. 31, 2017	$ 38,540,114	$ 0	$ 699,015	$ (8,034,244)	$ 498,577,372	$ 0	$ (452,702,029)
Balance (in Shares) at Dec. 31, 2017		0	69,822,080
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	29,790,217	$ 0	$ 91,865	0	29,698,352	0	0
Issuance of common stock and warrants pursuant to financing agreements (in shares)		0	9,186,452
Issuance of common stock for options exercised	98,022	$ 0	$ 572	0	97,450	0	0
Issuance of common stock for options exercised (in shares)		0	57,214
Issuance of common stock from exercise of warrants	973,660	$ 0	$ 5,762	0	967,898	0	0
Issuance of common stock from exercise of warrants (in Shares)		0	576,130
Stock issuance costs	(211,685)	$ 0	$ 0	0	(211,685)	0	0
Stock-based compensation expense	260,040	0	0	0	260,040	0	0
Foreign currency translation adjustment	527,251	0	0	0	0	527,251	0
Net loss	(3,590,910)	0	0	0	0	0	(3,590,910)
Balance at Mar. 31, 2018	$ 67,619,021	$ 0	$ 797,214	$ (8,034,244)	$ 529,389,427	$ 527,251	$ (455,060,627)
Balance (in shares) at Mar. 31, 2018		0	79,641,876

Condensed Consolidated Stateme6

Condensed Consolidated Statements of Cash Flows - USD ($)	3 Months Ended
	Mar. 31, 2018	Mar. 31, 2017
CASH FLOWS FROM OPERATING ACTIVITIES
Net loss	$ (3,590,910)	$ (1,700,182)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization	65,822	18,528
Amortization of intangible assets	250,141	0
Stock-based compensation expense	260,040	156,250
Acquired in-process research and development	686,998	0
Unrealized gain on equity investment	(89,713)	0
Non-cash interest	177	1,869
Change in fair value of contingent rights	0	6,874
Changes in operating assets and liabilities:
Prepaid expenses and other	52,886	(17,932)
Accounts payable	(522,274)	55,371
Payable to related party	(2,228,366)	0
Accrued liabilities	(287,672)	(51,245)
Net cash used in operating activities	(5,402,871)	(1,530,467)
CASH FLOWS FROM INVESTING ACTIVITIES
Purchases of property and equipment	(155,144)	(33,509)
Acquisition of Abbreviated New Drug Applications and related items	(19,171,956)	0
Net cash used in investing activities	(19,327,100)	(33,509)
CASH FLOWS FROM FINANCING ACTIVITIES
Stock issuance costs	(211,685)	0
Proceeds from sale of common stock and warrants	29,790,217	0
Proceeds from exercise of stock options	98,022	0
Proceeds from exercise of stock warrants	973,660	0
Net cash provided by financing activities	30,650,214	0
Effect of exchange rate changes on cash and cash equivalents	477,422	0
Net increase (decrease) in cash and cash equivalents	6,397,665	(1,563,976)
Cash and cash equivalents at beginning of period	43,489,935	27,092,928
Cash and cash equivalents at end of period	$ 49,887,600	$ 25,528,952

Basis of Presentation

Basis of Presentation	3 Months Ended
	Mar. 31, 2018
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Basis of Accounting [Text Block]	1. Basis of Presentation The accompanying condensed consolidated financial statements include the accounts of CASI Pharmaceuticals, Inc. and its subsidiaries (“CASI” or “the Company”), Miikana Therapeutics, Inc. (“Miikana”) and CASI Pharmaceuticals (Beijing) Co., Ltd. (“CASI China”). The Company previously operated under a different name prior to restructuring its business in 2012 in connection with an investment led by one of the Company’s largest stockholders. CASI China is a non-stock Chinese entity with 100 The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles for interim financial information and in accordance with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, such condensed consolidated financial statements do not include all of the information and disclosures required by U.S. generally accepted accounting principles for complete consolidated financial statements. In the opinion of management, all adjustments (consisting of normal recurring adjustments) considered necessary for a fair presentation have been included. The accompanying December 31, 2017 financial information was derived from the Company’s audited financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2017. Operating results for the three month period ended March 31, 2018 are not necessarily indicative of the results that may be expected for the year ending December 31, 2018 or any other future period. For further information, refer to the Company’s audited consolidated financial statements and footnotes thereto included in its Form 10-K for the year ended December 31, 2017. Liquidity Risks and Management’s Plans Since inception, the Company has incurred significant losses from operations and has incurred an accumulated deficit of $ 455.1 15,432,091 6,172,832 50 29.3 20.7 23.8 23.4 As a result of the 2018 Financing and 2017 Closings, the Company believes that it has sufficient resources to fund its operations at least through May 15, 2019. As of March 31, 2018, approximately $ 20.9

Acquisition of Abbreviated New

Acquisition of Abbreviated New Drug Applications	3 Months Ended
	Mar. 31, 2018
Acquisition of Abbreviated New Drug Applications [Abstract]
Acquisition of Abbreviated New Drug Applications [Text Block]	2. Acquisition of Abbreviated New Drug Applications On January 26, 2018, the Company entered into an Asset Purchase Agreement (the “Asset Purchase Agreement”) with Sandoz, Inc. (“Sandoz”). Pursuant to the Asset Purchase Agreement, the Company acquired a portfolio of 29 abbreviated new drug applications (“ANDAs”), including 25 ANDAs approved by the U.S. Food and Drug Administration (“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 is 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 1.2 $ 18,608,000 API 564,000 Total value $ 19,172,000 Of the total value allocated to the ANDAs, approximately $ 553,000 134,000 13 The fair values of certain acquired ANDAs 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, estimates of total addressable markets and market penetration rates, future sales growth and inflation rates, 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 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 March 31, 2018.

Intangible Assets

Intangible Assets	3 Months Ended
	Mar. 31, 2018
Goodwill and Intangible Assets Disclosure [Abstract]
Schedule of Finite-Lived Intangible Assets [Table Text Block]	3. Intangible Assets Intangible assets were acquired as part of the 2018 asset acquisition from Sandoz and include ANDAs for a total of 25 previously marketed generic products. These intangible assets were originally recorded at relative fair values based on the purchase price for the asset acquisition and are stated net of accumulated amortization. The ANDAs are being amortized over their estimated useful lives of 13 As discussed in Note 2, in January 2018, the Company purchased the Acquired Assets from Sandoz for a total purchase price of $ 18.0 1.2 Asset Gross Value Accumulated Amortization Estimated useful lives ANDAs $ 18,054,985 $ (250,141) 13 years 2018 (remaining nine months) $ 1,041,634 2019 1,388,845 2020 1,388,845 2021 1,388,845 2022 1,388,845 2023 and thereafter 11,207,830

Foreign Currency Translation

Foreign Currency Translation	3 Months Ended
	Mar. 31, 2018
Foreign Currency [Abstract]
Foreign Currency Disclosure [Text Block]	4. Foreign Currency Translation The U.S. dollar is the reporting currency of the Company. Foreign currency denominated assets and liabilities of the Company and its foreign subsidiary are translated into U.S. dollars. Accordingly, 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, using an average periodic exchange rate. In 2017, remeasurement adjustments were included in income (loss). As discussed in Note 2, 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 has been changed to the local currency of the China Renminbi (“RMB”). Beginning January 1, 2018, translation gains and losses relating to the financial statements of the Company’s China subsidiary are included as accumulated other comprehensive income in the accompanying Condensed Consolidated Balance Sheets.

Investments

Investments	3 Months Ended
	Mar. 31, 2018
Schedule of Investments [Abstract]
Investment Holdings, Schedule of Investments [Text Block]	5. Investments The Company has an equity investment in the publicly traded common stock of a 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 statement of operations each reporting period. The fair value of this security was measured using its quoted market price, a Level 1 input, and was approximately $ 1.3 In January 2016, the Financial Accounting Standards Board (“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 statement of operations and comprehensive loss.

Inventories

Inventories	3 Months Ended
	Mar. 31, 2018
Inventory Disclosure [Abstract]
Inventory Disclosure [Text Block]	6. Inventories Inventories consist of raw materials and are stated at the lower of cost or net realizable value. Cost is determined using an average cost method. The carrying value of raw materials inventory was approximately $ 430,000

Research and Development

Research and Development	3 Months Ended
	Mar. 31, 2018
Research and Development [Abstract]
Research, Development, and Computer Software Disclosure [Text Block]	7. Research and Development Research and development expenses consist primarily of compensation and other expenses related to research and development personnel, research collaborations, costs associated with pre-clinical 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.

License Arrangements

License Arrangements	3 Months Ended
	Mar. 31, 2018
License Arrangements Disclosure [Abstract]
License Arrangements Disclosure [Text Block]	8. License Arrangements The Company has certain product rights and perpetual exclusive licenses from Spectrum Pharmaceuticals, Inc. and certain of its affiliates (together referred to as “Spectrum”) to develop and commercialize the following commercial oncology drugs and drug candidates in the greater China region (which includes China, Taiwan, Hong Kong and Macau) (the “Territories”): EVOMELA ® MARQIBO ® ZEVALIN ® CASI is responsible for developing and commercializing these three drugs in the Territories, including the submission of import drug registration applications and conducting confirmatory clinical trials as needed. The Company is in various stages of the regulatory and development process to obtain marketing approval for EVOMELA ® ® ® ® ® ® ® ® ®

Note Payable

Note Payable	3 Months Ended
	Mar. 31, 2018
Debt Disclosure [Abstract]
Debt Disclosure [Text Block]	9. Note Payable As part of the license arrangements with Spectrum (see Note 8), the Company issued to Spectrum a $ 1.5 0.5 136,000 177 1,869

Stockholders_ Equity

Stockholders’ Equity	3 Months Ended
	Mar. 31, 2018
Stockholders' Equity Note [Abstract]
Stockholders' Equity Note Disclosure [Text Block]	10. Stockholders’ Equity Securities Purchase Agreements As described in Note 1, in March 2018, the Company entered into securities purchase agreements (the “Securities Purchase Agreements”) with certain institutional investors, accredited investors and current stockholders, pursuant to which the Company issued 15,432,091 6,172,832 50 29.3 9,043,204 3,617,279 20.7 6,388,887 2,555,553 3.24 3.69 15,062,000 2.44 5 75.4 2.69 Common Stock Sales Agreement On February 23, 2018, the Company entered into a Common Stock Sales Agreement (the “Sales Agreement”) with H.C. Wainwright & Co., LLC (“HCW”). Pursuant to the terms of the Sales Agreement, the Company may sell from time to time, at its option, shares of the Company’s common stock through HCW, as sales agent, with an aggregate sales price of up to $ 25 Any sales of Shares pursuant to the Sales Agreement will be made under the Company’s effective “shelf” registration statement (the “Registration Statement”) on Form S-3 (File No. 333-222046) which became effective on December 22, 2017 and the related prospectus supplement and the accompanying prospectus, as filed with the Securities and Exchange Commission (the “SEC”) on February 23, 2018. In March 2018, the Company issued 143,248 475,000 24.5

Net Loss Per Share

Net Loss Per Share	3 Months Ended
	Mar. 31, 2018
Earnings Per Share [Abstract]
Earnings Per Share [Text Block]	11. Net Loss Per Share Net loss per share (basic and diluted) was computed by dividing net loss applicable to common stockholders by the weighted average number of shares of common stock outstanding. Outstanding stock options and warrants totaling 11,902,287 and 9,305,165 as of March 31, 2018, respectively, were anti-dilutive and, therefore, were not included in the computation of weighted average shares used in computing diluted loss per share.

Stock-Based Compensation and Wa

Stock-Based Compensation and Warrants	3 Months Ended
	Mar. 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 and Warrants The Company has adopted incentive and nonqualified stock option plans for executive, scientific and administrative personnel of the Company as well as outside directors and consultants. As of March 31, 2018, there are 11,902,287 0.86 7.37 2,478,048 1 4 The Company records compensation expense associated with stock options and other equity-based compensation in accordance with provisions of authoritative guidance. Compensation costs are recognized over the requisite service period, which is generally the option vesting term of up to three years. Awards with performance conditions will be expensed if it is probable that the performance condition will be achieved. There was no expense recorded for share awards with performance conditions during the three months ended March 31, 2018 and 2017. 260,040 156,250 Three Months period ended 2018 2017 Research and development $ 103,767 $ 67,198 General and administrative 156,273 89,052 Share-based compensation expense $ 260,040 $ 156,250 Net share-based compensation expense, per common share: Basic and diluted $ 0.004 $ 0.003 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. Three Month Period ended March 31, 2018 2017 Expected volatility 79.51 % 81.07 % Risk free interest rate 2.63 % 2.03 % Expected term of option 6.31 years 5.81 years Expected dividend yield 0.00 % 0.00 % The weighted average fair value of stock options granted during the three-month periods ended March 31, 2018 and 2017 were $ 2.61 1.04 Number of Options Weighted Average Outstanding at January 1, 2018 11,585,315 $ 1.42 Exercised (57,214) $ 1.71 Granted 391,000 $ 3.70 Expired - $ - Forfeited (16,814) $ 3.05 Outstanding at March 31, 2018 11,902,287 $ 1.50 Exercisable at March 31, 2018 8,630,758 $ 1.58 Cash received from option exercises under all share-based payment arrangements for the three months ended March 31, 2018 was $ 98,022 Warrants 2 5 Number of Warrants Weighted Average Outstanding at January 1, 2018 6,264,016 $ 2.23 Issued 3,617,279 $ 3.69 Exercised (576,130) $ 1.69 Expired - $ - Outstanding at March 31, 2018 9,305,165 $ 2.83 Exercisable at March 31, 2018 4,049,380 $ 1.69 Cash received from warrants exercised during the three months ended March 31, 2018 was $ 973,660

Income Taxes

Income Taxes	3 Months Ended
	Mar. 31, 2018
Income Tax Disclosure [Abstract]
Income Tax Disclosure [Text Block]	13. Income Taxes At December 31, 2017, the Company had a $ 3.2 During the three months ended March 31, 2018, there were no material changes to the measurement of unrecognized tax benefits in various taxing jurisdictions. The Company recognizes interest and penalties related to uncertain tax positions as a component of income tax expense. The tax returns for all years in the Company’s major tax jurisdictions are not settled as of March 31, 2018. Due to the existence of tax attribute carryforwards (which are currently offset by a full valuation allowance), the Company treats all years’ tax positions as unsettled due to the taxing authorities’ ability to modify these attributes.

Related Party Transactions

Related Party Transactions	3 Months Ended
	Mar. 31, 2018
Related Party Transactions [Abstract]
Related Party Transactions Disclosure [Text Block]	14. Related Party Transactions The Company has supply agreements with Spectrum, for the purchase of EVOMELA ® ® ®

New Accounting Pronouncements

New Accounting Pronouncements	3 Months Ended
	Mar. 31, 2018
New Accounting Pronouncements and Changes in Accounting Principles [Abstract]
New Accounting Pronouncements and Changes in Accounting Principles [Text Block]	15. New Accounting Pronouncements The Company has implemented all new accounting pronouncements that are in effect and that may impact the Company’s consolidated financial statements. In 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. Earlier application is permitted. The standard must be applied using a modified retrospective approach. The Company is currently evaluating the effect that the adoption of this ASU will have on its consolidated financial statements. 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, Inc. in January 2018 was an asset acquisition. See Note 2. 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. 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.

Commitments

Commitments	3 Months Ended
	Mar. 31, 2018
Commitments and Contingencies Disclosure [Abstract]
Commitments and Contingencies Disclosure [Text Block]	16. Commitments In March 2018, the Company committed to a purchase obligation of EVOMELA ® 5.5 In April 2018, the Company entered into a lease agreement for office space in China that continues through April 2021. Future minimum lease payments are approximately $ 334,000 561,900 561,900 140,500

Acquisition of Abbreviated Ne23

Acquisition of Abbreviated New Drug Applications (Tables)	3 Months Ended
	Mar. 31, 2018
Acquisition of Abbreviated New Drug Applications [Abstract]
Schedule Of Finite Lived Intangible Assets and API Inventory [Table Text Block]	$ 18,608,000 API 564,000 Total value $ 19,172,000

Intangible Assets (Tables)

Intangible Assets (Tables)	3 Months Ended
	Mar. 31, 2018
Goodwill and Intangible Assets Disclosure [Abstract]
Finite-lived Intangible Assets Amortization Expense [Table Text Block]	Net finite-lived intangible assets at March 31, 2018 consists of the following: Asset Gross Value Accumulated Amortization Estimated useful lives ANDAs $ 18,054,985 $ (250,141) 13 years
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: 2018 (remaining nine months) $ 1,041,634 2019 1,388,845 2020 1,388,845 2021 1,388,845 2022 1,388,845 2023 and thereafter 11,207,830

Stock-Based Compensation and 25

Stock-Based Compensation and Warrants (Tables)	3 Months Ended
	Mar. 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 three months ended March 31, 2018 and 2017 includes $ 260,040 156,250 Three Months period ended 2018 2017 Research and development $ 103,767 $ 67,198 General and administrative 156,273 89,052 Share-based compensation expense $ 260,040 $ 156,250 Net share-based compensation expense, per common share: Basic and diluted $ 0.004 $ 0.003
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 three-month periods ended March 31, 2018 and 2017: Three Month Period ended March 31, 2018 2017 Expected volatility 79.51 % 81.07 % Risk free interest rate 2.63 % 2.03 % Expected term of option 6.31 years 5.81 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 three-month period ended March 31, 2018 is as follows: Number of Options Weighted Average Outstanding at January 1, 2018 11,585,315 $ 1.42 Exercised (57,214) $ 1.71 Granted 391,000 $ 3.70 Expired - $ - Forfeited (16,814) $ 3.05 Outstanding at March 31, 2018 11,902,287 $ 1.50 Exercisable at March 31, 2018 8,630,758 $ 1.58
Schedule Of Warrant Activity [Table Text Block]	Warrants issued generally expire after 2 5 Number of Warrants Weighted Average Outstanding at January 1, 2018 6,264,016 $ 2.23 Issued 3,617,279 $ 3.69 Exercised (576,130) $ 1.69 Expired - $ - Outstanding at March 31, 2018 9,305,165 $ 2.83 Exercisable at March 31, 2018 4,049,380 $ 1.69

Basis of Presentation (Details

Basis of Presentation (Details Textual) - USD ($)	1 Months Ended
	Apr. 30, 2018	Mar. 31, 2018	Nov. 20, 2017	Oct. 17, 2017	Dec. 31, 2017
Description of Business and Basis of Presentation [Line Items]
Retained Earnings (Accumulated Deficit), Total		$ (455,060,627)			$ (452,702,029)
Percentage Of Ownership Interest In Non Stock Subsidiary		100.00%
Proceeds from Issuance of Common Stock		$ 29,300,000
Stock Issued During Period, Shares, New Issues		143,248
Net Proceeds From Issuance Of Common Stock		$ 475,000
Investors [Member]
Description of Business and Basis of Presentation [Line Items]
Stock Issued During Period, Shares, New Issues		15,432,091
Proceeds From Issuance Of Common Stock Gross				$ 23,800,000
Class of Warrant, Number of Warrants to Purchase Common Stock Issued During the Period		6,172,832
Second Closing [Member]
Description of Business and Basis of Presentation [Line Items]
Net Proceeds From Issuance Of Common Stock			$ 23,400,000
Private Placement [Member]
Description of Business and Basis of Presentation [Line Items]
Stock And Warrants Issued Value		$ 50,000,000
Subsequent Event [Member]
Description of Business and Basis of Presentation [Line Items]
Proceeds from Issuance of Common Stock	$ 20,700,000
CASI China [Member]
Description of Business and Basis of Presentation [Line Items]
Cash		$ 20,900,000

Acquisition of Abbreviated Ne27

Acquisition of Abbreviated New Drug Applications (Details)	3 Months Ended
	Mar. 31, 2018USD ($)
Purchase Price For The 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 Raw Materials Inventory Acquired	$ 564,000

Acquisition of Abbreviated Ne28

Acquisition of Abbreviated New Drug Applications (Details Textual) - USD ($)	1 Months Ended	3 Months Ended
	Mar. 31, 2018	Mar. 31, 2018	Mar. 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	$ 19,171,956	$ 0
Abbreviated new drug applications [Member]
Research and Development in Process		553,000
Active pharmaceutical ingredient [Member]
Research and Development in Process		134,000
Accounting Standards Update 2017-01 [Member]
Asset Acquisition Transaction Costs		$ 1,200,000

Intangible Assets (Details)

Intangible Assets (Details)	3 Months Ended
	Mar. 31, 2018USD ($)
Estimated useful lives	13 years
Abbreviated new drug applications [Member]
Gross Value	$ 18,054,985
Accumulated Amortization	$ (250,141)
Estimated useful lives	13 years

Intangible Assets (Details 1)

Intangible Assets (Details 1)	Mar. 31, 2018USD ($)
2018 (remaining nine months)	$ 1,041,634
2,019	1,388,845
2,020	1,388,845
2,021	1,388,845
2,022	1,388,845
2023 and thereafter	$ 11,207,830

Intangible Assets (Details Text

Intangible Assets (Details Textual) - USD ($)	1 Months Ended	3 Months Ended
	Mar. 31, 2018	Mar. 31, 2018	Mar. 31, 2017
Finite-Lived Intangible Asset, Useful Life		13 years
Payments to Acquire Intangible Assets	$ 18,000,000	$ 19,171,956	$ 0
Accounting Standards Update 2017-01 [Member]
Asset Acquisition Transaction Costs		$ 1,200,000

Investments (Details Textual)

Investments (Details Textual) - USD ($)	3 Months Ended
	Mar. 31, 2018	Dec. 31, 2017
Short-term Investments	$ 1,322,025	$ 0
Cumulative Effect on Retained Earnings, Net of Tax	$ 1,232,312

Inventories (Details Textual)

Inventories (Details Textual)	Mar. 31, 2018USD ($)
Raw Materials [Member]
Inventory, Raw Materials, Net of Reserves	$ 430,000

Note Payable (Details Textual)

Note Payable (Details Textual) - USD ($)	3 Months Ended
	Mar. 31, 2018	Mar. 31, 2017
Notes Payable [Line Items]
Amortization of Debt Discount (Premium)	$ 177	$ 1,869
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 T

Stockholders’ Equity (Details Textual) - USD ($)	1 Months Ended		2 Months Ended
	Apr. 30, 2018	Mar. 31, 2018	Apr. 30, 2018	Feb. 23, 2018
Proceeds from Issuance of Common Stock		$ 29,300,000
Net Proceeds From Issuance Of Common Stock		$ 475,000
Stock Issued During Period, Shares, New Issues		143,248
Price Per Share and Warrant		$ 3.24
Remaining Dollar Amount Available Under Sales Agreement		$ 24,500,000
Investors [Member]
Class of Warrant or Right, Exercise Price of Warrants or Rights		$ 3.69
Class of Warrant or Right, Number of Securities Called by Warrants or Rights		3,617,279
Stock Issued During Period, Shares, New Issues		9,043,204
H.C. Wainwright Co., LLC [Member] | Maximum [Member]
Aggregate Sales Price				$ 25,000,000
Subsequent Event [Member]
Proceeds from Issuance of Common Stock	$ 20,700,000
Subsequent Event [Member] | Investors [Member]
Class of Warrant or Right, Number of Securities Called by Warrants or Rights	6,172,832		6,172,832
Stock Issued During Period, Shares, New Issues			15,432,091
Subsequent Event [Member] | Current Stockholders [Member]
Class of Warrant or Right, Number of Securities Called by Warrants or Rights	2,555,553		2,555,553
Stock Issued During Period, Shares, New Issues			6,388,887
Securities Purchase Agreements [Member] | Subsequent Event [Member]
Fair Value Of Warrant Issued	$ 15,062,000		$ 15,062,000
Fair Value Assumptions Fair Value			$ 2.44
Fair Value Assumptions, Expected Term			5 years
Fair Value Assumptions, Risk Free Interest Rate			2.69%
Fair Value Assumptions, Expected Volatility Rate			75.40%
Private Placement [Member] | Subsequent Event [Member]
Stock Issued During Period, Value, New Issues			$ 50,000,000

Net Loss Per Share (Details Tex

Net Loss Per Share (Details Textual)	3 Months Ended
	Mar. 31, 2018shares
Employee Stock Option [Member]
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount	11,902,287
Warrant [Member]
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount	9,305,165

Stock-Based Compensation and 37

Stock-Based Compensation and Warrants (Details) - USD ($)	3 Months Ended
	Mar. 31, 2018	Mar. 31, 2017
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Stock-based compensation expense	$ 260,040	$ 156,250
Net share-based compensation expense, per common share:
Basic and diluted (in dollars per share)	$ 0.004	$ 0.003
Research and Development Expense [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Stock-based compensation expense	$ 103,767	$ 67,198
General and Administrative Expense [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Stock-based compensation expense	$ 156,273	$ 89,052

Stock-Based Compensation and 38

Stock-Based Compensation and Warrants (Details 1)	3 Months Ended
	Mar. 31, 2018	Mar. 31, 2017
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Expected volatility	79.51%	81.07%
Risk free interest rate	2.63%	2.03%
Expected term of option	6 years 3 months 22 days	5 years 9 months 22 days
Expected dividend yield	0.00%	0.00%

Stock-Based Compensation and 39

Stock-Based Compensation and Warrants (Details 2) - Employee Stock Option [Member]	3 Months Ended
	Mar. 31, 2018$ / sharesshares
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Outstanding - Number of Options, Beginning Balance | shares	11,585,315
Exercised - Number of Options | shares	(57,214)
Granted - Number of Options | shares	391,000
Expired - Number of Options | shares	0
Forfeited - Number of Options | shares	(16,814)
Outstanding - Number of Options, Ending Balance | shares	11,902,287
Exercisable - Number of Options | shares	8,630,758
Outstanding - Weighted Average Exercise Price, Beginning balance | $ / shares	$ 1.42
Exercised - Weighted Average Exercise Price | $ / shares	1.71
Granted - Weighted Average Exercise Price | $ / shares	3.7
Expired - Weighted Average Exercise Price | $ / shares	0
Forfeited - Weighted Average Exercise Price | $ / shares	3.05
Outstanding - Weighted Average Exercise Price, Ending Balance | $ / shares	1.50
Exercisable - Weighted Average Exercise Price | $ / shares	$ 1.58

Stock-Based Compensation and 40

Stock-Based Compensation and Warrants (Details 3) - Warrant [Member]	3 Months Ended
	Mar. 31, 2018$ / sharesshares
Outstanding at Number of Warrants, Beginning Balance | shares	6,264,016
Issued Number of Warrants | shares	3,617,279
Exercised Number of Warrants | shares	(576,130)
Expired Number of Warrants | shares	0
Outstanding at Number of Warrants, Ending Balance | shares	9,305,165
Exercisable Number of Warrants | shares	4,049,380
Outstanding Weighted Average Exercise Price, Beginning Balance | $ / shares	$ 2.23
Issued Weighted Average Exercise Price | $ / shares	3.69
Exercised Weighted Average Exercise Price | $ / shares	1.69
Expired Weighted Average Exercise Price | $ / shares	0
Outstanding Weighted Average Exercise Price, at Ending Balance | $ / shares	2.83
Exercisable Weighted Average Exercise Price | $ / shares	$ 1.69

Stock-Based Compensation and 41

Stock-Based Compensation and Warrants (Details Textual) - USD ($)	3 Months Ended
	Mar. 31, 2018	Mar. 31, 2017	Mar. 13, 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	$ 2.61	$ 1.04
Share-based Compensation, Total	$ 260,040	$ 156,250
Proceeds from Stock Options Exercised	98,022	0
Proceeds from Warrant Exercises	$ 973,660	$ 0
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	2 years
Long Term Incentive Plan2011 [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant	2,478,048
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number, Ending Balance	11,902,287
Long Term Incentive Plan2011 [Member] | Maximum [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range, Upper Range Limit	$ 7.37
Long Term Incentive Plan2011 [Member] | Minimum [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range, Lower Range Limit	$ 0.86

Income Taxes (Details Textual)

Income Taxes (Details Textual) $ in Millions	Dec. 31, 2017USD ($)
Income Tax Contingency [Line Items]
Unrecognized Tax Benefits	$ 3.2

Commitments (Details Textual)

Commitments (Details Textual) - USD ($)	3 Months Ended
	Mar. 31, 2018	Dec. 31, 2017
Purchase obligation to purchase materials	$ 5,500,000
Operating Leases, Future Minimum Payments Receivable, Current		$ 334,000
Operating Leases, Future Minimum Payments Receivable, in Two Years		561,900
Operating Leases, Future Minimum Payments Receivable, in Three Years		561,900
Operating Leases, Future Minimum Payments Receivable, in Four Years		$ 140,500