CASI Pharmaceuticals (CASI) 10-Q 14 Aug 18 2018 Q2 Quarterly report Financial data

Document And Entity Information

Document And Entity Information - shares	6 Months Ended
	Jun. 30, 2018	Aug. 08, 2018
Document Information [Line Items]
Document Type	10-Q
Amendment Flag	false
Document Period End Date	Jun. 30, 2018
Document Fiscal Year Focus	2,018
Document Fiscal Period Focus	Q2
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		86,591,249

Condensed Consolidated Balance

Condensed Consolidated Balance Sheets - USD ($)	Jun. 30, 2018	Dec. 31, 2017
Current assets:
Cash and cash equivalents	$ 66,215,678	$ 43,489,935
Investments, at fair value	1,220,987	0
Prepaid expenses and other	977,658	322,493
Total current assets	68,414,323	43,812,428
Property and equipment, net	1,617,053	1,046,514
Other assets	221,923	242,023
Intangible assets, net	17,457,631	0
Total assets	87,710,930	45,100,965
Current liabilities:
Accounts payable	2,089,680	2,087,770
Payable to related parties	0	2,228,366
Accrued liabilities	544,803	745,961
Total current liabilities	2,634,483	5,062,097
Note payable, net of discount	1,499,108	1,498,754
Other liabilities	55,195	0
Total liabilities	4,188,786	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 June 30, 2018 and December 31, 2017	0	0
Common stock, $.01 par value: 170,0000,000 shares authorized at June 30, 2018 and December 31, 2017; 86,589,032 shares and 69,901,625 shares issued at June 30, 2018 and December 31, 2017, respectively	865,890	699,015
Common stock to be issued for 15,162 shares	56,858	0
Additional paid-in capital	552,093,693	498,577,372
Treasury stock, at cost: 79,545 shares held at June 30, 2018 and December 31, 2017	(8,034,244)	(8,034,244)
Accumulated other comprehensive loss	(539,642)	0
Accumulated deficit	(460,920,411)	(452,702,029)
Total stockholders' equity	83,522,144	38,540,114
Total liabilities and stockholders' equity	$ 87,710,930	$ 45,100,965

Condensed Consolidated Balance3

Condensed Consolidated Balance Sheets [Parenthetical] - $ / shares	Jun. 30, 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)	$ 1	$ 1
Common stock, shares authorized	1,700,000,000	1,700,000,000
Common stock, shares issued	86,589,032	69,901,625
Treasury stock, shares held	79,545	79,545
Common stock to be issued	15,162

Condensed Consolidated Statemen

Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($)	3 Months Ended		6 Months Ended
	Jun. 30, 2018	Jun. 30, 2017	Jun. 30, 2018	Jun. 30, 2017
Revenues:
Product sales	$ 0	$ 0	$ 0	$ 0
Costs and expenses:
Research and development	1,729,470	1,727,407	3,426,703	2,776,694
General and administrative	4,042,347	691,422	5,345,469	1,335,585
Acquired in-process research and development	0	0	686,998	0
Costs and expenses	5,771,817	2,418,829	9,459,170	4,112,279
Interest (income) expense, net	(13,072)	72	(19,801)	(70)
Other expense	101,038	0	11,325	0
Change in fair value of contingent rights	0	(10,319)	0	(3,445)
Net loss	$ (5,859,783)	$ (2,408,582)	$ (9,450,694)	$ (4,108,764)
Net loss per share (basic and diluted)	$ (0.07)	$ (0.04)	$ (0.12)	$ (0.07)
Weighted average number of common shares outstanding (basic and diluted)	86,029,692	60,196,574	78,663,271	60,196,574
Comprehensive loss:
Net loss	$ (5,859,783)	$ (2,408,582)	$ (9,450,694)	$ (4,108,764)
Foreign currency translation adjustment	(1,066,893)	0	(539,642)	0
Total comprehensive loss	$ (6,926,676)	$ (2,408,582)	$ (9,990,336)	$ (4,108,764)

Condensed Consolidated Stateme5

Condensed Consolidated Statement of Stockholders' Equity - 6 months ended Jun. 30, 2018 - USD ($)	Total	Preferred Stock [Member]	Common Stock [Member]	Treasury Stock [Member]	Additional Paid-in Capital [Member]	Common Stock To Be Issued [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	0	1,232,312
Issuance of common stock and warrants pursuant to financing agreements	50,490,216	$ 0	$ 155,753	0	50,334,463	0	0	0
Issuance of common stock and warrants pursuant to financing agreements (in shares)		0	15,575,339
Issuance of common stock for options exercised	176,833	$ 0	$ 1,071	0	175,762	0	0	0
Issuance of common stock for options exercised (in shares)		0	107,083
Stock option grants surrendered	(54,284)	$ 0	$ 0	0	(54,284)	0	0	0
Issuance of common stock from exercise of warrants	1,903,678	$ 0	$ 10,051	0	1,893,627	0	0	0
Issuance of common stock from exercise of warrants (in Shares)		0	1,004,985
Common stock to be issued	56,858					56,858
Stock issuance costs	(645,466)	$ 0	$ 0	0	(645,466)	0	0	0
Stock-based compensation expense	1,812,219	0	0	0	1,812,219	0	0	0
Foreign currency translation adjustment	(539,642)	0	0	0	0	0	(539,642)	0
Net loss	(9,450,694)	$ 0	$ 0	0	0	0	0	(9,450,694)
Balance (in shares) at Jun. 30, 2018		0	86,509,487
Balance at Jun. 30, 2018	$ 83,522,144	$ 0	$ 865,890	$ (8,034,244)	$ 552,093,693	$ 56,858	$ (539,642)	$ (460,920,411)

Condensed Consolidated Stateme6

Condensed Consolidated Statements of Cash Flows - USD ($)	6 Months Ended
	Jun. 30, 2018	Jun. 30, 2017
CASH FLOWS FROM OPERATING ACTIVITIES
Net loss	$ (9,450,694)	$ (4,108,764)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization	141,717	37,918
Amortization of intangible assets	597,354	0
Stock-based compensation expense	1,812,219	350,565
Acquired in-process research and development	686,998	0
Unrealized loss on equity investment	11,325	0
Non-cash interest	354	3,738
Change in fair value of contingent rights	0	(3,445)
Changes in operating assets and liabilities:
Prepaid expenses and other	(221,861)	66,870
Accounts payable	4,312	118,645
Payable to related party	(2,228,366)	0
Accrued liabilities	(134,695)	58,878
Net cash used in operating activities	(8,781,337)	(3,475,595)
CASH FLOWS FROM INVESTING ACTIVITIES
Purchases of property and equipment	(726,445)	(256,804)
Acquisition of Abbreviated New Drug Applications and related items	(19,171,956)	0
Net cash used in investing activities	(19,898,401)	(256,804)
CASH FLOWS FROM FINANCING ACTIVITIES
Stock issuance costs	(645,466)	0
Proceeds from sale of common stock and warrants	50,490,216	0
Proceeds from exercise of stock options	176,833	0
Stock option grants surrendered to satisfy tax withholding obligations	(54,284)	0
Proceeds from exercise of stock warrants	1,960,536	0
Net cash provided by financing activities	51,927,835	0
Effect of exchange rate changes on cash and cash equivalents	(522,354)	0
Net increase (decrease) in cash and cash equivalents	22,725,743	(3,732,399)
Cash and cash equivalents at beginning of period	43,489,935	27,092,928
Cash and cash equivalents at end of period	$ 66,215,678	$ 23,360,529

Basis of Presentation

Basis of Presentation	6 Months Ended
	Jun. 30, 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% 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 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 and six month periods ended June 30, 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 $460.9 million. The Company restructured its business in 2012 in connection with an investment led by one of the Company’s largest stockholders, followed by implementation of a name change to reflect its core mission and business strategy. The Company expects to continue to incur operating losses for the foreseeable future due to, among other factors, its continuing clinical activities. In 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 (the “2018 Financing”). The 2018 Financing closing included an investment from ETP Global Fund, L.P., a healthcare investment fund. The managing member of Emerging Technology Partners, LLC, which is the general partner of ETP Global Fund, L.P., is also the Executive Chairman of the Company. The 2018 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., which is the ultimate general partner of IDG-Accel Growth and IDG-Accel Investors, is also a member of the Company’s Board of Directors. In October 2017, the Company entered into securities purchase agreements for an approximately $23.8 million strategic financing. The Company held its initial closing on October 17, 2017, a second closing on October 23, 2017 and a final closing on November 20, 2017 and received approximately $23.4 million in net proceeds (collectively, the “2017 Closings”). Net proceeds from the 2018 Financing and the 2017 Closings are being used to prepare for the anticipated launch of the Company’s first commercial product in China, 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. 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 August 14, 2019. As of June 30, 2018, approximately $17.9 million of the Company’s cash balance was held by CASI China. 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.

Acquisition of Abbreviated New

Acquisition of Abbreviated New Drug Applications	6 Months Ended
	Jun. 30, 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 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) following the guidance contained in Accounting Standards Update (“ASU”) 2017-01. The total purchase price, along with approximately $1.2 million of transaction expenses, was allocated to the Acquired Assets based on their relative 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 was immediately expensed as acquired in-process research and development since the underlying ANDAs have not been approved by the FDA, and of the total value allocated to the API, approximately $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 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 June 30, 2018.

Intangible Assets

Intangible Assets	6 Months Ended
	Jun. 30, 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 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 six months ended June 30, 2018. As discussed in Note 2, in January 2018, the Company purchased the Acquired Assets from Sandoz for a total purchase price of $18.0 million. The total purchase price, along with transaction expenses of approximately $1.2 million, was allocated to the ANDAs and API acquired based on their relative fair values. Net finite-lived intangible assets at June 30, 2018 consists of the following: Asset Gross Value Accumulated Amortization Estimated useful lives ANDAs $ 18,054,985 $ (597,354 ) 13 years Expected future amortization expense is as follows for the years ending December 31: 2018 (remaining six months) $ 694,421 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	6 Months Ended
	Jun. 30, 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”). The change in functional currency did not have a material impact on the consolidated financial statements. 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 loss in the accompanying Condensed Consolidated Balance Sheets.

Investments

Investments	6 Months Ended
	Jun. 30, 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 $1.2 million as of June 30, 2018. 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 statements of operations and comprehensive loss.

Inventories

Inventories	6 Months Ended
	Jun. 30, 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 as of June 30, 2018 and is included in “prepaid expenses and other assets” in the accompanying condensed consolidated balance sheets.

Research and Development

Research and Development	6 Months Ended
	Jun. 30, 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	6 Months Ended
	Jun. 30, 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	6 Months Ended
	Jun. 30, 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 million 0.5% secured promissory note originally due March 17, 2016 which was subsequently amended and extended to September 17, 2019. All other terms remain the same. 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 condensed consolidated balance sheets. For the six months ended June 30, 2018 and 2017, the Company recognized $354 and $3,738 of non-cash interest expense, respectively, related to the amortization of the debt discount, using the effective interest rate method.

Stockholders' Equity

Stockholders' Equity	6 Months Ended
	Jun. 30, 2018
Stockholders' Equity Note [Abstract]
Stockholders' Equity Note Disclosure [Text Block]	10. Stockholders’ Equity Securities Purchase Agreements As described in Note 1, in 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 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 will become exercisable on September 17, 2018 at a $3.69 per share exercise price and will expire on March 21, 2023. The fair value of the 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%. The Securities Purchase Agreements and warrants each include additional customary representations, warranties and covenants. The Company filed a resale registration covering the shares of common stock issued and the shares of common stock underlying the warrants on Form S-3 (File No. 333-226206) which became effective on August 8, 2018. 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 million (the “Shares”). 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 Shares under the Sales Agreement resulting in net proceeds to the Company of approximately $475,000. As of June 30, 2018, approximately $24.5 million remained available under the Sales Agreement.

Net Loss Per Share

Net Loss Per Share	6 Months Ended
	Jun. 30, 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 17,059,368 and 11,416,701 as of June 30, 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	6 Months Ended
	Jun. 30, 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. 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. As of June 30, 2018, there are 17,059,368 shares issuable under options previously granted and currently outstanding, with exercise prices ranging from $0.86 to $8.23. 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 June 30, 2018, 8,245,174 shares remained available for grant under the Company’s 2011 Long-Term Incentive Plan. On March 13, 2018, upon the recommendation of the Compensation Committee of the Board of Directors (the “Board”), the Board approved a grant of stock options to the Company’s Executive Chairman exercisable for 1 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 million shares of common stock that will vest if, within 18 months of the date of grant, specific operational and strategic milestones are achieved. Both grants were approved by the Company’s stockholders at the 2018 Annual Meeting of Stockholders. 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 five 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 six months ended June 30, 2018 and 2017. The Company’s net loss for the six months ended June 30, 2018 and 2017 includes $1,812,219 and $350,565, 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: Six Month Period ended June 30, 2018 2017 Research and development $ 162,516 $ 171,326 General and administrative 1,649,703 179,239 Share-based compensation expense $ 1,812,219 $ 350,565 Net share-based compensation expense, per common share: Basic and diluted $ 0.02 $ 0.01 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. Following are the weighted-average assumptions used in valuing the stock options granted to employees during the six-month periods ended June 30, 2018 and 2017: Six Month Period ended June 30, 2018 2017 Expected volatility 78.97 % 78.34 % Risk free interest rate 2.79 % 1.82 % Expected term of option 5.65 years 5.66 years Expected dividend yield 0.00 % 0.00 % The weighted average fair value of stock options granted during the six-month periods ended June 30, 2018 and 2017 were $4.53 and $0.77, respectively. A summary of the Company's stock option plans and of changes in options outstanding under the plans during the six-month period ended June 30, 2018 is as follows: Number of Options Weighted Average Exercise Price Outstanding at January 1, 2018 11,585,315 $ 1.42 Exercised (115,283 ) $ 1.53 Granted 5,886,000 $ 3.47 Expired - $ - Forfeited (296,664 ) $ 1.67 Outstanding at June 30, 2018 17,059,368 $ 2.13 Exercisable at June 30, 2018 8,692,437 $ 1.56 Cash received from option exercises under all share-based payment arrangements for the six months ended June 30, 2018 was $176,833. There were no option exercises during the six months ended June 30, 2017. Warrants Warrants issued generally expire after 2-5 years from the date of issuance. Stock warrant activity is as follows: Number of Warrants Weighted Average Outstanding at January 1, 2018 6,264,016 $ 2.23 Issued 6,172,832 $ 3.69 Exercised (1,020,147 ) $ 1.92 Expired - $ - Outstanding at June 30, 2018 11,416,701 $ 3.05 Exercisable at June 30, 2018 5,243,869 $ 2.29 Cash received from warrants exercised during the six months ended June 30, 2018 was $1,960,535. There were no warrants exercised during the six months ended June 30, 2017.

Income Taxes

Income Taxes	6 Months Ended
	Jun. 30, 2018
Income Tax Disclosure [Abstract]
Income Tax Disclosure [Text Block]	13. Income Taxes At December 31, 2017, the Company had a $3.2 million unrecognized tax benefit. The Company recorded a full valuation allowance on the net deferred tax asset recognized in the consolidated financial statements as of December 31, 2017. During the six months ended June 30, 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 June 30, 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	6 Months Ended
	Jun. 30, 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	6 Months Ended
	Jun. 30, 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 Leases In January 2017, the FASB issued ASU No. 2017-01, Clarifying the Definition of a Business 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	6 Months Ended
	Jun. 30, 2018
Commitments and Contingencies Disclosure [Abstract]
Commitments and Contingencies Disclosure [Text Block]	16. Commitments In March 2018 and June 2018, the Company committed to purchase obligations for EVOMELA ® 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 $259,000 in 2018, $561,900 in 2019, $561,900 in 2020 and $140,500 in 2021. In June 2018, $464,000, followed by manufacturing at supply prices to be agreed.

Acquisition of Abbreviated Ne23

Acquisition of Abbreviated New Drug Applications (Tables)	6 Months Ended
	Jun. 30, 2018
Acquisition of Abbreviated New Drug Applications [Abstract]
Schedule Of Finite Lived Intangible Assets and API Inventory [Table Text Block]	ANDAs $ 18,608,000 API 564,000 Total value $ 19,172,000

Intangible Assets (Tables)

Intangible Assets (Tables)	6 Months Ended
	Jun. 30, 2018
Goodwill and Intangible Assets Disclosure [Abstract]
Finite-lived Intangible Assets Amortization Expense [Table Text Block]	Net finite-lived intangible assets at June 30, 2018 consists of the following: Asset Gross Value Accumulated Amortization Estimated useful lives ANDAs $ 18,054,985 $ (597,354 ) 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 six months) $ 694,421 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)	6 Months Ended
	Jun. 30, 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 six months ended June 30, 2018 and 2017 includes $1,812,219 and $350,565, 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: Six Month Period ended June 30, 2018 2017 Research and development $ 162,516 $ 171,326 General and administrative 1,649,703 179,239 Share-based compensation expense $ 1,812,219 $ 350,565 Net share-based compensation expense, per common share: Basic and diluted $ 0.02 $ 0.01
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 six-month periods ended June 30, 2018 and 2017: Six Month Period ended June 30, 2018 2017 Expected volatility 78.97 % 78.34 % Risk free interest rate 2.79 % 1.82 % Expected term of option 5.65 years 5.66 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 six-month period ended June 30, 2018 is as follows: Number of Options Weighted Average Exercise Price Outstanding at January 1, 2018 11,585,315 $ 1.42 Exercised (115,283 ) $ 1.53 Granted 5,886,000 $ 3.47 Expired - $ - Forfeited (296,664 ) $ 1.67 Outstanding at June 30, 2018 17,059,368 $ 2.13 Exercisable at June 30, 2018 8,692,437 $ 1.56
Schedule Of Warrant Activity [Table Text Block]	Warrants issued generally expire after 2-5 years from the date of issuance. Stock warrant activity is as follows: Number of Warrants Weighted Average Outstanding at January 1, 2018 6,264,016 $ 2.23 Issued 6,172,832 $ 3.69 Exercised (1,020,147 ) $ 1.92 Expired - $ - Outstanding at June 30, 2018 11,416,701 $ 3.05 Exercisable at June 30, 2018 5,243,869 $ 2.29

Basis of Presentation (Details

Basis of Presentation (Details Textual) - USD ($)	1 Months Ended			6 Months Ended
	Mar. 31, 2018	Nov. 20, 2017	Oct. 17, 2017	Jun. 30, 2018	Dec. 31, 2017
Description of Business and Basis of Presentation [Line Items]
Retained Earnings (Accumulated Deficit)				$ (460,920,411)	$ (452,702,029)
Percentage Of Ownership Interest In Non Stock Subsidiary				100.00%
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]
Proceeds from Issuance of Common Stock and Warrants Gross				$ 50,000,000
CASI China [Member]
Description of Business and Basis of Presentation [Line Items]
Cash				$ 17,900,000

Acquisition of Abbreviated Ne27

Acquisition of Abbreviated New Drug Applications (Details)	6 Months Ended
	Jun. 30, 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		6 Months Ended
	Jan. 31, 2018	Jun. 30, 2018	Jun. 30, 2017	Jun. 30, 2018	Jun. 30, 2017
Research and Development in Process		$ 0	$ 0	$ 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)	6 Months Ended
	Jun. 30, 2018USD ($)
Estimated useful lives	13 years
Abbreviated new drug applications [Member]
Gross Value	$ 18,054,985
Accumulated Amortization	$ (597,354)
Estimated useful lives	13 years

Intangible Assets (Details 1)

Intangible Assets (Details 1)	Jun. 30, 2018USD ($)
2018 (remaining Six months)	$ 694,421
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	6 Months Ended
	Jan. 31, 2018	Jun. 30, 2018	Jun. 30, 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 ($)	6 Months Ended
	Jun. 30, 2018	Dec. 31, 2017
Short-term Investments	$ 1,220,987	$ 0
Cumulative Effect on Retained Earnings, Net of Tax	$ 1,232,312

Inventories (Details Textual)

Inventories (Details Textual)	Jun. 30, 2018USD ($)
Raw Materials [Member]
Inventory, Raw Materials, Net of Reserves	$ 430,000

Note Payable (Details Textual)

Note Payable (Details Textual) - USD ($)	6 Months Ended
	Jun. 30, 2018	Jun. 30, 2017
Notes Payable [Line Items]
Amortization of Debt Discount (Premium)	$ 354	$ 3,738
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	6 Months Ended
	Mar. 31, 2018	Apr. 30, 2018	Jun. 30, 2018	Feb. 23, 2018
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		6,172,832
Stock Issued During Period, Shares, New Issues		15,432,091
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
Fair Value Assumptions Fair Value		$ 2.44
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		2.69%
Securities Purchase Agreements [Member] | Measurement Input, Price Volatility [Member]
Fair Value Assumptions rate		75.40%
Private Placement [Member]
Stock Issued During Period, Value, New Issues		$ 50,000,000

Net Loss Per Share (Details Tex

Net Loss Per Share (Details Textual)	6 Months Ended
	Jun. 30, 2018shares
Employee Stock Option [Member]
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount	17,059,368
Warrant [Member]
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount	11,416,701

Stock-Based Compensation and 37

Stock-Based Compensation and Warrants (Details) - USD ($)	6 Months Ended
	Jun. 30, 2018	Jun. 30, 2017
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Share-based compensation expense	$ 1,812,219	$ 350,565
Net share-based compensation expense, per common share:
Basic and diluted (in dollars per share)	$ 0.02	$ 0.01
Research and Development Expense [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Share-based compensation expense	$ 162,516	$ 171,326
General and Administrative Expense [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Share-based compensation expense	$ 1,649,703	$ 179,239

Stock-Based Compensation and 38

Stock-Based Compensation and Warrants (Details 1)	6 Months Ended
	Jun. 30, 2018	Jun. 30, 2017
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Expected volatility	78.97%	78.34%
Risk free interest rate	2.79%	1.82%
Expected term of option	5 years 7 months 24 days	5 years 7 months 28 days
Expected dividend yield	0.00%	0.00%

Stock-Based Compensation and 39

Stock-Based Compensation and Warrants (Details 2) - Employee Stock Option [Member]	6 Months Ended
	Jun. 30, 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	(115,283)
Granted - Number of Options | shares	5,886,000
Expired - Number of Options | shares	0
Forfeited - Number of Options | shares	(296,664)
Outstanding - Number of Options, Ending Balance | shares	17,059,368
Exercisable - Number of Options | shares	8,692,437
Outstanding - Weighted Average Exercise Price, Beginning Balance | $ / shares	$ 1.42
Exercised - Weighted Average Exercise Price | $ / shares	1.53
Granted - Weighted Average Exercise Price | $ / shares	3.47
Expired - Weighted Average Exercise Price | $ / shares	0
Forfeited - Weighted Average Exercise Price | $ / shares	1.67
Outstanding - Weighted Average Exercise Price, Ending Balance | $ / shares	2.13
Exercisable - Weighted Average Exercise Price | $ / shares	$ 1.56

Stock-Based Compensation and 40

Stock-Based Compensation and Warrants (Details 3) - Warrant [Member]	6 Months Ended
	Jun. 30, 2018$ / sharesshares
Outstanding at Number of Warrants, Beginning Balance | shares	6,264,016
Issued Number of Warrants | shares	6,172,832
Exercised Number of Warrants | shares	(1,020,147)
Expired Number of Warrants | shares	0
Outstanding at Number of Warrants, Ending Balance | shares	11,416,701
Exercisable Number of Warrants | shares	5,243,869
Outstanding Weighted Average Exercise Price, Beginning Balance | $ / shares	$ 2.23
Issued Weighted Average Exercise Price | $ / shares	3.69
Exercised Weighted Average Exercise Price | $ / shares	1.92
Expired Weighted Average Exercise Price | $ / shares	0
Outstanding Weighted Average Exercise Price, Ending Balance | $ / shares	3.05
Exercisable Weighted Average Exercise Price | $ / shares	$ 2.29

Stock-Based Compensation and 41

Stock-Based Compensation and Warrants (Details Textual) - USD ($)	6 Months Ended
	Jun. 30, 2018	Jun. 30, 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	$ 4.53	$ 0.77
Share-based Compensation	$ 1,812,219	$ 350,565
Proceeds from Stock Options Exercised	176,833	0
Proceeds from Warrant Exercises	$ 1,960,536	$ 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	8,245,174
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number, Ending Balance	17,059,368
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	$ 8.23
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized	20,230,000
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
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized	14,230,000

Income Taxes (Details Textual)

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

Related Party Transactions (Det

Related Party Transactions (Details Textual) - USD ($)	3 Months Ended		6 Months Ended
	Jun. 30, 2018	Jun. 30, 2017	Jun. 30, 2018	Jun. 30, 2017
Research and Development Expense	$ 1,729,470	$ 1,727,407	$ 3,426,703	$ 2,776,694
Spectrum [Member]
Research and Development Expense				$ 477,000

Commitments (Details Textual)

Commitments (Details Textual) - USD ($)	3 Months Ended	6 Months Ended
	Mar. 31, 2018	Jun. 30, 2018	Dec. 31, 2017
Purchase obligation to purchase materials	$ 5,500,000	$ 2,700,000
Operating Lease, Future Minimum Payments, Current			$ 259,000
Operating Lease, Future Minimum Payments, in Two Years			561,900
Operating Lease, Future Minimum Payments, in Three Years			561,900
Operating Lease, Future Minimum Payments, in Four Years			$ 140,500
Other Commitment		$ 464,000