CASI Pharmaceuticals (CASI) 10-Q 12 Nov 19 2019 Q3 Quarterly report Financial data

Document and Entity Information

Document and Entity Information - shares	9 Months Ended
	Sep. 30, 2019	Nov. 06, 2019
Document and Entity Information [Abstract]
Document Type	10-Q
Amendment Flag	false
Document Period End Date	Sep. 30, 2019
Document Fiscal Year Focus	2019
Document Fiscal Period Focus	Q3
Entity Registrant Name	CASI PHARMACEUTICALS, INC.
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Central Index Key	0000895051
Current Fiscal Year End Date	--12-31
Entity Filer Category	Accelerated Filer
Trading Symbol	CASI
Entity Common Stock, Shares Outstanding		96,346,475
Entity Emerging Growth Company	false
Entity Shell Company	false
Entity Small Business	true

Unaudited Condensed Consolidate

Unaudited Condensed Consolidated Balance Sheets - USD ($) $ in Thousands	Sep. 30, 2019	Dec. 31, 2018
Current assets:
Cash and cash equivalents	$ 63,241	$ 84,205
Investment in equity securities, at fair value	557	912
Accounts receivable, net of allowance	2,643	0
Inventories	2,565	283
Prepaid expenses and other	4,356	7,165
Total current assets	73,362	92,565
Property and equipment, net	1,374	1,751
Intangible assets, net	17,268	18,785
Long-term investments	14,038	0
Other assets	3,028	310
Total assets	109,070	113,411
Current liabilities:
Accounts payable	4,827	968
Accrued liabilities	2,121	1,406
Note payable, net of discount	0	1,499
Total current liabilities	6,948	3,873
Other liabilities	1,292	74
Total liabilities	8,240	3,947
Commitments and contingencies (Note 16)
Redeemable noncontrolling interest, at redemption value (Note 8)	20,459	0
Stockholders' equity:
Preferred stock, $1.00 par value: 5,000,000 shares authorized and 0 shares issued and outstanding	0	0
Common Stock, $.01 par value: 250,000,000 shares and 170,000,000 shares authorized at September 30, 2019 and December 31, 2018, respectively; 96,418,603 shares and 95,366,813 shares issued at September 30, 2019 and December 31, 2018, respectively; 96,339,058 shares and 95,287,268 shares outstanding at September 30, 2019 and December 31, 2018, respectively	964	954
Additional paid-in capital	603,378	596,712
Treasury stock, at cost: 79,545 shares held at September 30, 2019 and December 31, 2018	(8,034)	(8,034)
Accumulated other comprehensive loss	(3,863)	(1,227)
Accumulated deficit	(512,074)	(478,941)
Total stockholders' equity	80,371	109,464
Total liabilities, redeemable noncontrolling interest and stockholders' equity	$ 109,070	$ 113,411

Unaudited Condensed Consolida_2

Unaudited Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares	Sep. 30, 2019	Dec. 31, 2018
Unaudited Condensed Consolidated Balance Sheets
Preferred Stock, Par or Stated Value Per Share	$ 1	$ 1
Preferred Stock, Shares Authorized	5,000,000	5,000,000
Preferred Stock, Shares Issued	0	0
Preferred Stock, Shares Outstanding	0	0
Common Stock, Par Value	$ 0.01	$ 0.01
Common Stock, Shares Authorized	250,000,000	170,000,000
Common Stock, Shares Issued	96,418,603	95,366,813
Common Stock, Shares Outstanding	96,339,058	95,287,268
Treasury stock, shares held	79,545	79,545

Unaudited Condensed Consolida_3

Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2019	Sep. 30, 2018	Sep. 30, 2019	Sep. 30, 2018
Revenues:
Product sales	$ 2,749	$ 0	$ 2,749	$ 0
Lease income	38	0	38	0
Total revenues	2,787	0	2,787	0
Costs and expenses:
Costs of goods sold	2,648	0	2,648	0
Research and development	1,829	1,806	7,423	5,233
General and administrative	7,977	6,905	20,669	12,250
Selling and marketing	975	0	975	0
Acquired in-process research and development	0	0	5,849	687
Total cost and expenses	13,429	8,711	37,564	18,170
Loss from operations	(10,642)	(8,711)	(34,777)	(18,170)
Non-operating income/(expense):
Interest income, net	414	11	783	30
Foreign exchange gains	719	0	1,269	0
Change in fair value of investment in equity securities	(160)	(56)	(355)	(67)
Net loss	(9,669)	(8,756)	(33,080)	(18,207)
Less: (loss)/income attributable to redeemable noncontrolling interest	(23)	0	53	0
Net loss attributable to CASI Pharmaceuticals, Inc.	$ (9,646)	$ (8,756)	$ (33,133)	$ (18,207)
Net loss per share (basic and diluted)	$ (0.10)	$ (0.10)	$ (0.35)	$ (0.22)
Weighted average number of common shares outstanding (basic and diluted)	95,891	86,594	95,753	81,457
Comprehensive loss:
Net loss	$ (9,669)	$ (8,756)	$ (33,080)	$ (18,207)
Foreign currency translation adjustment	(1,836)	(685)	(2,636)	(1,225)
Total comprehensive loss	(11,505)	(9,441)	(35,716)	(19,432)
Less: Comprehensive (loss)/income attributable to redeemable noncontrolling interest	(23)	0	53	0
Comprehensive loss attributable to common stockholders	$ (11,482)	$ (9,441)	$ (35,769)	$ (19,432)

Unaudited Condensed Consolida_4

Unaudited Condensed Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands	Preferred Stock [Member]	Common Stock [Member]	Treasury Stock [Member]	Additional Paid-in Capital [Member]	Common Stock to Be Issued [Member]	Accumulated Other Comprehensive Loss [Member]	Accumulated Deficit [Member]	Total
Balance at Dec. 31, 2017	$ 0	$ 699	$ (8,034)	$ 498,577	$ 0	$ 0	$ (452,702)	$ 38,540
Balance (in Shares) at Dec. 31, 2017	0	69,822,080
Accretion of redeemable noncontrolling interest								0
Correction of immaterial error in prior year and cumulative effect adjustment due to the adoption of ASU 2016-01	$ 0	$ 0	0	0	0	0	1,232	1,232
Issuance of common stock and warrants pursuant to financing agreements	$ 0	$ 224	0	86,766	0	0	0	86,990
Issuance of common stock and warrants pursuant to financing agreements (in shares)	0	22,385,038
Issuance of common stock for options exercised	$ 0	$ 1	0	257	0	0	0	258
Issuance of common stock for options exercised (in shares)	0	139,683
Repurchase of stock options to satisfy tax withholding obligations	$ 0	$ 0	0	(117)	0	0	0	(117)
Issuance of common stock from exercise of warrants	$ 0	$ 11	0	2,077	0	0	0	2,088
Issuance of common stock from exercise of warrants (in shares)	0	1,054,147
Common stock to be issued	$ 0	$ 0	0	0	1,000	0	0	1,000
Stock issuance costs	0	0	0	(756)	0	0	0	(756)
Stock-based compensation expense, net of forfeitures	0	0	0	3,518	0	0	0	3,518
Foreign currency translation adjustment	0	0	0	0	0	(1,225)	0	(1,225)
Net loss attributable to CASI Pharmaceuticals, Inc.	0	0	0	0	0	0	(18,207)	(18,207)
Balance at Sep. 30, 2018	$ 0	$ 935	(8,034)	590,322	1,000	(1,225)	(469,677)	113,321
Balance (in shares) at Sep. 30, 2018	0	93,400,948
Balance at Dec. 31, 2017	$ 0	$ 699	(8,034)	498,577	0	0	(452,702)	38,540
Balance (in Shares) at Dec. 31, 2017	0	69,822,080
Balance at Dec. 31, 2018	$ 0	$ 954	(8,034)	596,712		(1,227)	(478,941)	109,464
Balance (in shares) at Dec. 31, 2018	0	95,287,268
Balance at Jun. 30, 2018	$ 0	$ 866	(8,034)	552,093	57	(540)	(460,921)	83,521
Balance (in Shares) at Jun. 30, 2018	0	86,509,487
Issuance of common stock and warrants pursuant to financing agreements	$ 0	$ 68	0	36,432	0	0	0	36,500
Issuance of common stock and warrants pursuant to financing agreements (in shares)	0	6,809,699
Issuance of common stock for options exercised	$ 0	$ 0	0	81	0	0	0	81
Issuance of common stock for options exercised (in shares)	0	32,600
Repurchase of stock options to satisfy tax withholding obligations	$ 0	$ 0	0	(63)	0	0	0	(63)
Issuance of common stock from exercise of warrants	$ 0	$ 1	0	184	0	0	0	185
Issuance of common stock from exercise of warrants (in shares)	0	49,162
Common stock to be issued	$ 0	$ 0	0	0	943	0	0	943
Common stock to be issued (in shares)		0
Stock issuance costs	0	$ 0	0	(110)	0	0	0	(110)
Stock-based compensation expense, net of forfeitures	0	0	0	1,705	0	0	0	1,705
Foreign currency translation adjustment	0	0	0	0	0	(685)	0	(685)
Net loss attributable to CASI Pharmaceuticals, Inc.	0	0	0	0	0	0	(8,756)	(8,756)
Balance at Sep. 30, 2018	$ 0	$ 935	(8,034)	590,322	$ 1,000	(1,225)	(469,677)	113,321
Balance (in shares) at Sep. 30, 2018	0	93,400,948
Balance at Dec. 31, 2018	$ 0	$ 954	(8,034)	596,712		(1,227)	(478,941)	109,464
Balance (in Shares) at Dec. 31, 2018	0	95,287,268
Accretion of redeemable noncontrolling interest	$ 0	$ 0	0	(406)		0	0	(406)
Issuance of common stock for options exercised	$ 0	$ 1	0	113		0	0	114
Issuance of common stock for options exercised (in shares)	0	64,137
Repurchase of stock options to satisfy tax withholding obligations	$ 0	$ 0	0	(12)		0	0	(12)
Issuance of common stock from exercise of warrants	$ 0	$ 9	0	1,659		0	0	1,668
Issuance of common stock from exercise of warrants (in shares)	0	987,653
Stock issuance costs	$ 0	$ 0	0	(8)		0	0	(8)
Stock-based compensation expense, net of forfeitures	0	0	0	5,320		0	0	5,320
Foreign currency translation adjustment	0	0	0	0		(2,636)	0	(2,636)
Net loss attributable to CASI Pharmaceuticals, Inc.	0	0	0	0		0	(33,133)	(33,133)
Balance at Sep. 30, 2019	$ 0	$ 964	(8,034)	603,378		(3,863)	(512,074)	80,371
Balance (in shares) at Sep. 30, 2019	0	96,339,058
Balance at Jun. 30, 2019	$ 0	$ 958	(8,034)	600,569		(2,027)	(502,428)	89,038
Balance (in Shares) at Jun. 30, 2019	0	95,717,052
Accretion of redeemable noncontrolling interest	$ 0	$ 0	0	(245)		0	0	(245)
Issuance of common stock for options exercised	$ 0	$ 0	0	75		0	0	75
Issuance of common stock for options exercised (in shares)	0	45,875
Issuance of common stock from exercise of warrants	$ 0	$ 6	0	968		0	0	974
Issuance of common stock from exercise of warrants (in shares)	0	576,131
Stock-based compensation expense, net of forfeitures	$ 0	$ 0	0	2,011		0	0	2,011
Foreign currency translation adjustment	0	0	0	0		(1,836)	0	(1,836)
Net loss attributable to CASI Pharmaceuticals, Inc.	0	0	0	0		0	(9,646)	(9,646)
Balance at Sep. 30, 2019	$ 0	$ 964	$ (8,034)	$ 603,378		$ (3,863)	$ (512,074)	$ 80,371
Balance (in shares) at Sep. 30, 2019	0	96,339,058

Unaudited Condensed Consolida_5

Unaudited Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2019	Sep. 30, 2018
CASH FLOWS FROM OPERATING ACTIVITIES
Net loss	$ (33,080)	$ (18,207)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization for property and equipment	561	250
Net loss on disposal of property and equipment	1	5
Amortization of intangible assets	1,182	945
Loss on disposal of intangible assets	48	0
Stock-based compensation expense	5,320	3,518
Acquired in-process research and development	5,849	553
Change in fair value of investment in equity securities	355	67
Non-cash interest	1	1
Changes in operating assets and liabilities:
Accounts receivable	(2,643)	0
Inventory	(2,282)	(430)
Prepaid expenses and other assets	2,931	(611)
Accounts payable	3,877	(327)
Payable to related party	0	652
Accrued liabilities and other liabilities	(545)	146
Net cash used in operating activities	(18,425)	(13,438)
CASH FLOWS FROM INVESTING ACTIVITIES
Proceeds from sale of furniture and equipment	0	1
Purchases of property and equipment	(390)	(862)
Cash paid to acquired in-process research and development	(5,849)	0
Cash paid to acquire equity securities in Black Belt Tx Limited	(2,250)	0
Cash paid to acquire equity securities in Juventas Cell Therapy Ltd	(11,788)	0
Acquisition of Abbreviated New Drug Applications and related items	0	(18,608)
Net cash used in investing activities	(20,277)	(19,469)
CASH FLOWS FROM FINANCING ACTIVITIES
Repayment of notes payable	(1,500)	0
Stock issuance costs	(8)	(756)
Proceeds from sale of common stock and warrants	0	86,990
Proceeds from sale of common stock to be issued	0	1,000
Cash contribution from redeemable noncontrolling interest	20,000	0
Proceeds from exercise of stock options	114	258
Repurchase of stock options to satisfy tax withholding obligations	(12)	(117)
Proceeds from exercise of warrants	1,668	2,088
Payment of deferred offfering costs	(369)	0
Net cash provided by financing activities	19,893	89,463
Effect of exchange rate change on cash and cash equivalents	(2,155)	(1,179)
Net increase (decrease) in cash and cash equivalents	(20,964)	55,377
Cash and cash equivalents at beginning of period	84,205	43,490
Cash and cash equivalents at end of period	63,241	98,867
Supplemental disclosure of cash flow information:
Interest paid	30	0
Income taxes paid	$ 0	$ 0

Basis of Presentation

Basis of Presentation	9 Months Ended
	Sep. 30, 2019
Basis of Presentation
Basis of Presentation	1. Basis of Presentation CASI is a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, with a product portfolio that includes approved and investigational assets. Our operations in China are conducted through our wholly-owned subsidiary, CASI Pharmaceuticals (Beijing) Co., Ltd. (“CASI China”), which is located in Beijing, China. The Company recently launched its first commercial product EVOMELA ® (Melphalan for Injection) in China and has a pipeline that includes (i) an autologous CD19 CAR-T investigative product (CNCT19) being developed for the treatment of B-ALL and B-NHL; (ii) exclusive development and commercialization rights to CID-103, an anti-CD38 monoclonal antibody being developed; (iii) exclusive greater China rights to two U.S. Food and Drug Administration (FDA)-approved hematology oncology drugs, consisting of ZEVALIN ® (Ibritumomab Tiuxetan) and MARQIBO ® (Vincristine Sulfate Liposome Injection); (iv) China rights to an octreotide long acting injectable (LAI) microsphere formulation indicated for the treatment of certain symptoms associated with particular neuroendocrine cancers and acromegaly, and to a novel formulation of thiotepa, which has multiple indications and a long history of established use in the hematology/oncology setting. In addition, the Company also maintains a portfolio of FDA-approved abbreviated new drug applications ("ANDAs") and is currently assessing the development plan in China for a select subset. The Company has established and continues to expand its operational expertise and execution capability as it continues to further enhance its product and pipeline portfolio. The accompanying condensed consolidated financial statements include the accounts of the Company and its subsidiaries, in which CASI, directly or indirectly, has a controlling financial interest. These subsidiaries include Miikana Therapeutics, Inc. (“Miikana”), CASI China, CASI Pharmaceuticals (Wuxi) Co., Ltd. (“CASI Wuxi”), and CASI Biopharmaceuticals (WUXI) Co., Ltd. (“CASI Biopharmaceuticals”). 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. CASI Wuxi was established on December 26, 2018 in China to develop a future manufacturing facility in China. CASI Biopharmaceuticals is a wholly owned subsidiary of CASI Wuxi and was established in April 2019. The Company controls CASI Wuxi through 80% voting rights (see Note 8). Accordingly, the financial statements of CASI Wuxi have been consolidated in the Company’s consolidated financial statements since its inception. All inter-company balances and transactions have been eliminated in consolidation. The Company currently operates in one operating segment, which is the development of innovative therapeutics addressing cancer and other unmet medical needs for the global market. 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, 2018 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, 2018. Operating results for the three and nine month periods ended September 30, 2019 are not necessarily indicative of the results that may be expected for the year ending December 31, 2019 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, 2018. Certain line items in the prior-year unaudited condensed consolidated statement of cash flows relating to the acquired in-process research and development and inventory have been reclassified to conform to the December 31, 2018 presentation resulting in an increase in net cash used in operating activities and a decrease in net cash used in investing activities by $564,000 for the nine months ended September 30, 2018. Inventory in the amount of $283,000 as of December 31, 2018, which was included in prepaid expenses and other, has been separately presented on the condensed consolidated balance sheet as of December 31, 2018. Liquidity Risks and Management’s Plans Since inception, the Company has incurred significant losses from operations and has incurred an accumulated deficit of $512.1 million as of September 30, 2019. The Company expects to continue to incur operating losses for the foreseeable future due to, among other factors, its continuing research, clinical and product development activities. Taking into consideration the cash balance as of September 30, 2019, the Company believes that it has sufficient resources to fund its operations at least through November 12, 2020. As of September 30, 2019, approximately $5.6 million of the Company’s cash balance was held by CASI China, and approximately $28.5 million was held by CASI Wuxi. 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.

Recent Developments

Recent Developments	9 Months Ended
	Sep. 30, 2019
Recent Developments
Recent Developments	2. Recent Developments New License and Investment Agreements Black Belt Therapeutics Limited: In April 2019, the Company entered into a license agreement with Black Belt Therapeutics Limited (“Black Belt”) for exclusive worldwide rights to the investigational anti-CD38 monoclonal antibody (Mab) TSK011010. The development code for TSK011010 has been changed to CID-103 to reflect the change of ownership. CID-103 is at the IND/IMPD submission stage of development, with a Phase 1 study targeted to start in 2020. CASI is responsible for all development and commercialization activities of the CID-103. Under the terms of the agreement, CASI obtained global rights to CID-103 for an upfront payment of 5 million euros ($5,657,500) as well as certain milestone and royalty payments. Because CID-103 underlying the acquired rights has not reached technological feasibility and has no alternative uses, the Company expensed 5 million euros as acquired in-process research and development in the accompanying condensed consolidated statement of operations and comprehensive loss for the nine months ended September 30, 2019. The Company also invested 2 million euros ($2,249,600), representing 15% shareholding, as an equity investment in Black Belt TX Ltd, a newly established company of Black Belt focusing on novel immuno-oncology targets (see Note 4). Juventas Cell Therapy : In June 2019, the Company entered into a license agreement for exclusive worldwide license and commercialization rights to an autologous anti-CD19 T-cell therapy product (CNCT19) from Juventas Cell Therapy Ltd. (“Juventas”). Juventas is a China-based domestic company located in Tianjin City, China engaged in cell therapy. Juventas will continue to be responsible for the clinical development and regulatory submission and maintenance of CNCT19 with CASI’s participation on the joint steering committee. CASI will be responsible for the launch and commercialization of CNCT19 and for the payment of certain future development milestones and sales royalties. CNCT19 was engineered from the CD19 CAR-T, and is used to treat cancer patients with acute lymphoblastic leukemia and relapsed non-Hodgkin lymphoma. CNCT19 is at the clinical trial application review stage. Our partner Juventas intends to start a Phase 1 study in late 2019 or early 2020. Through our exclusive commercial collaboration with Juventas, we are targeting to launch the first domestically developed and manufactured CD19 CAR-T in China. All contingent payments will be recognized when the subsequent milestones are probable to be met (see Note 16). CASI Biopharmaceuticals also invested RMB 80 million (approximately $11.6 million), representing 16.3% shareholding, as an equity investment in Juventas (see Note 4). Sales of EVOMELA: In December 2018, CASI received China National Medical Products Administration (NMPA) approval of EVOLEMA for the use as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma, and the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate. In March 2019, CASI entered into an exclusive distribution agreement with China Resources Guokang Pharmaceuticals Co., Ltd. (“CRGK” or the “distributor”), pursuant to which it is the sole customer and distributor for the sale of EVOMELA in China. Commercial sales of EVOMELA were launched in August 2019. For the three months and nine months ended September 30, 2019, the Company recognized $2.7 million of revenues from sales of EVOMELA under this arrangement.

Summary of Significant Accounti

Summary of Significant Accounting Policies	9 Months Ended
	Sep. 30, 2019
Summary of Significant Accounting Policies
Summary of Significant Accounting Policies	3. Summary of Significant Accounting Policies Revenue Recognition Product sales recognized in the condensed consolidated statements of operations is considered “revenue from contracts with customers” and, accordingly, the Company recognizes revenue using the following steps: · Identification of the contract, or contracts, with a customer; · Identification of the performance obligations in the contract; · Determination of the transaction price, including the identification and estimation of variable consideration; · Allocation of the transaction price to the performance obligations in the contract; and · Recognition of revenue when we satisfy a performance obligation. The Company recognizes revenue on sales of EVOMELA when the control of the product is transferred to the distributor, which occurs upon delivery of the product to the distributor, in an amount that reflects the consideration to which the Company expects to be entitled to in exchange for the product, excluding amounts collected on behalf of third parties (e.g. value-added taxes). Payment terms for these sales are due within 90 days. The arrangement does not include any variable consideration. The costs of assurance type warranties that provide the customer the right to exchange purchased product that does meet appropriate quality standards are recognized when they are probable and are reasonably estimable. As of September 30, 2019, the Company did not incur, and therefore did not defer, any material costs to obtain or fulfill contracts. The Company did not have any contract assets or contract liabilities as of September 30, 2019. Costs of Goods Sold Cost of goods sold consists primary of EVOMELA commercial drug supply costs, operational costs, and sales-based royalties related to the sale of EVOMELA. Use of Estimates The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. The Company’s significant accounting estimates relate to accounting policies for fair value determination and recoverability of intangible assets, net realizable value and obsolescence allowance for inventory, clinical trial accruals, deferred tax assets and valuation allowance, allowance for doubtful accounts, and stock-based arrangements. Management bases its estimates on historical experience and on various other assumptions that it believes are reasonable under the circumstances. Actual results may differ from those estimates, and such differences may be material to the consolidated financial statements. Foreign Currency Translation and Transactions Assets and liabilities of the Company’s PRC subsidiaries are translated into US$ using the exchange rates in effect at the consolidated balance sheet date. The revenues and expenses of these entities are translated into US$ at the weighted average exchange rates for the period. The resulting translation gains (losses) are recorded in accumulated other comprehensive income (loss) as a component of shareholders’ equity. Transactions denominated in foreign currencies are remeasured into the functional currency at the exchange rates prevailing on the transaction dates. Foreign currency denominated financial assets and liabilities are remeasured at the exchange rates prevailing at the balance sheet date. Net gains or losses resulting from foreign currency denominated transactions are recorded in foreign exchange gain (losses) in the consolidated statements of operations. Accounts Receivable and Credit Concentration CRGK is the sole customer for the sale of the Company’s EVOMELA product in China. All consolidated revenue for the three and nine months ended periods ended September 30, 2019 were generated from sales to CRGK in China, and all the Company’s accounts receivable balance as of September 30, 2019 was from CRGK. The Company extends credit to CRGK on an unsecured basis and maintains an allowance for doubtful accounts for estimated losses inherent in its accounts receivable. In establishing the required allowance, management considers the historical losses, customer’s financial condition, the amount of accounts receivables in dispute, the accounts receivables aging and the customer’s payment pattern. The Company determined that no allowance for doubtful accounts was necessary as of September 30, 2019. New Accounting Pronouncements Recently Adopted Pronouncements Effective January 1, 2019, the Company adopted Financial Accounting Standards Board (“FASB”) Accounting Standards Update (“ASU”) 2016‑02, Leases (“Topic 842”). The guidance amends the accounting requirements for leases and requires lessees to recognize assets and liabilities related to long-term leases on the balance sheets and expands disclosure requirements regarding leasing arrangements. The guidance is effective for reporting periods beginning after December 15, 2018 and early adoption is permitted. The guidance must be adopted on a modified retrospective basis and provides for certain practical expedients. The Company adopted this guidance effective January 1, 2019 using the following practical expedients: · the Company did not reassess if any expired or existing contracts are or contain leases; · the Company did not reassess the classification of any expired or existing leases. Additionally, the Company made ongoing accounting policy elections whereby it (i) does not recognize Right-of-use (“ROU”) assets or lease liabilities for short-term leases (those with original terms of 12‑months or less) and (ii) combines lease and non-lease components for facilities leases, which primarily relate to ancillary expenses such as common area maintenance charges and management fees of operating leases. Upon adoption of the new guidance on January 1, 2019, the Company recorded right of use assets of approximately $3.0 million and recognized lease liabilities of approximately $3.2 million; there was no cumulative effect impact to accumulated deficit as of January 1, 2019. No adjustments were made to prior comparative periods. In August 2018, the FASB issued ASU 2018-15, Intangibles-Goodwill and Other-Internal-Use Software (Subtopic 350-40): Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract. The new guidance requires a customer in a cloud computing arrangement (i.e., hosting arrangement) that is a service contract to follow the internal-use software guidance in ASC 350-40 to determine which implementation costs to capitalize as assets or expense as incurred. Capitalized implementation costs related to a hosting arrangement that is a service contract will be amortized over the term of the hosting arrangement, beginning when the module or component of the hosting arrangement is ready for its intended use. The update is effective for calendar-year public business entities in 2020. For all other calendar-year entities, it is effective for annual periods beginning in 2021 and interim periods in 2022. Early adoption is permitted. The Company early adopted this guidance effective January 1, 2019. The net impact to the financial statements was approximately $140,000 of capitalized cost. 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.

Investment in Equity Securities

Investment in Equity Securities, at fair value and long-term investments	9 Months Ended
	Sep. 30, 2019
Investment in Equity Securities, at fair value and long-term investments
Investment in Equity Securities, at fair value and long-term investments	4. Investment in Equity Securities, at fair value and long-term investments The Company has an equity investment in the common stock of a publicly traded company. The fair value of this security was measured using its quoted market price, a Level 1 input as of September 30, 2019 and December 31, 2018 (see Note 13). The following table summarizes the Company’s investment as of September 30, 2019: Gross (In thousands) unrealized Aggregate fair Description Classification Cost gains value Common stock Investment $ — $ 557 $ 557 Unrealized losses on the Company’s equity investment for the nine months ended September 30, 2019 and 2018 were $355,000 and $67,000, respectively, and are recognized as change in fair value of investment in equity securities in the accompanying condensed consolidated statements of operations and comprehensive loss. In April 2019, in conjunction with its license agreement entered into with Black Belt, the Company made a 2 million euro ($2,249,600) equity investment in a newly established, privately held UK Company (see Note 2). In June 2019, in conjunction with its license agreement entered into with Juventas, the Company, through its China subsidiary, made a RMB 80 million ($11,788,000) equity investment in Juventas, a privately held, China-based company (see Note 2). As the Company does not have significant influence over operating and financial policies of Black Belt TX Ltd and Juventas, and the equity interests do not have readily determinable fair value, the investments in Black Belt TX Ltd and Juventas are stated at cost minus impairment, if any, plus or minus changes resulting from observable price changes in orderly transactions for the identical or a similar investment. The Company did not record any adjustments or impairments during the quarter ended September 30, 2019.

Inventories

Inventories	9 Months Ended
	Sep. 30, 2019
Inventories
Inventories	5. Inventories Inventories consist of EVOMELA finished goods and raw materials to be used in production of ANDAs and are stated at the lower of cost or net realizable value. Cost is determined using a first-in, first-out method. The carrying value of finished goods inventory was approximately $2.4 million and raw materials was approximately $180,000 as of September 30, 2019, and the carrying value of raw materials was approximately $280,000 as of December 31, 2018, which are included in “Inventories” in the accompanying condensed consolidated balance sheets.

Leases

Leases	9 Months Ended
	Sep. 30, 2019
Leases
Leases	6. Leases As discussed in Note 3, effective January 1, 2019, the Company adopted Topic 842. At the inception of a contract, the Company determines if the arrangement is, or contains, a lease. ROU assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent its obligation to make lease payments arising from the lease. Operating lease ROU assets and liabilities are recognized at commencement date based on the present value of lease payments over the lease term. Rent expense is recognized on a straight-line basis over the lease term. The Company has made certain accounting policy elections whereby it (i) does not recognize ROU assets or lease liabilities for short-term leases (those with original terms of 12‑months or less) and (ii) combines lease and non-lease components for facilities leases, which primarily relate to ancillary expenses such as common area maintenance charges and management fees of its operating leases. Operating lease ROU assets are included in other assets (noncurrent) and operating lease liabilities (see below) are included in accrued liabilities and other liabilities (noncurrent) in the condensed consolidated balance sheets as of September 30, 2019. As of September 30, 2019, the Company did not have any finance leases. All of the Company’s existing leases as of September 30, 2019 are classified as operating leases. As of September 30, 2019, the Company has four material operating leases for facilities and office equipment with remaining terms expiring from 2021 through 2022 and a weighted average remaining lease term of 2.29 years. The Company has fair value renewal options for many of the Company’s existing leases, none of which have considered reasonably certain of being exercised or included in the minimum lease term. Discount rates used in the calculation of the lease liability is 5.4%. The discount rates reflect the estimated incremental borrowing rate, which includes an assessment of the credit rating to determine the rate that the Company would have to pay to borrow, on a collateralized basis for a similar term, an amount equal to the lease payments in a similar economic environment. Rent expense for the nine months ended September 30, 2019 consisted of approximately $957,000 of total operating lease cost. There was no variable lease costs or sublease income for the nine months ended September 30, 2019. The impact of Topic 842 on the September 30, 2019 condensed consolidated balance sheet was as follows: (In thousands) September 30, 2019 Other assets $ 2,361 Accrued liabilities 1,136 Other liabilities 1,292 Total lease liabilities $ 2,428 Supplemental cash flow information related to leases was as follows: Nine Month Period ended (In thousands) September 30, 2019 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows $ 957 Right of use assets obtained in exchange for lease obligations: $ 2,361 A maturity analysis of our operating leases as of September 30, 2019 follows: Future undiscounted cash flows: (In thousands) 2019 (remaining three months) $ 333 2020 1,337 2021 892 2022 190 Thereafter — Total 2,752 Discount factor (324) Lease liability 2,428 Amounts due within 12 months 1,136 Non-current lease liability $ 1,292 In 2018 the Company entered into a lease on behalf of CASI Wuxi. As of September 30, 2019, the underlying asset of the lease has not been made available for use by the Company. The minimum lease payments for this lease, totaling approximately $3,789,000, beginning in November 2019 and expiring in 2024, are not included in the above table. As previously disclosed in the consolidated financial statements for the year ended December 31, 2018 and under the previous lease standard (Topic 840), future minimum annual lease payments for the years subsequent to December 31, 2018 and in aggregate are as follows: (In thousands) 2019 $ 1,312 2020 1,297 2021 857 2022 130 Thereafter — Total minimum payments $ 3,596 Rental expense for the year ended December 31, 2018 was approximately $916,000.

Intangible Assets

Intangible Assets	9 Months Ended
	Sep. 30, 2019
Intangible Assets
Intangible Assets	7. Intangible Assets Intangible assets include ANDAs that were acquired as part of 2018 asset acquisitions and include for previously US marketed generic products and capitalized cost related to a cloud computing arrangement (CCA). These intangible assets were originally recorded at relative estimated fair values based on the purchase price for the asset acquisitions and are stated net of accumulated amortization. The ANDAs are being amortized over their estimated useful lives of 13 years, using the straight-line method. Management reviews finite-lived intangible assets for impairment whenever events or changes in circumstances indicate that the carrying amount may not be recoverable, in a manner similar to that for property and equipment. Loss on disposal of $48,000 related to the withdrawal of ANDAs was recognized in the three months ended March 31, 2019 and classified as research and development expenses. The cloud computing arrangement is being amortized over its useful life of 5 years. Net definite-lived intangible assets at September 30, 2019, excluding the withdrawn ANDAs discussed above consists of the following: (In thousands) Asset Purchase Price Accumulated Amortization Estimated useful lives ANDAs $ 18,002 $ (2,704) 13 years TDF ANDA 2,035 (192) 13 years Others 167 (40) 5 years Total $ 20,204 $ (2,936) The changes in intangible assets for the nine months ended September 30, 2019 are as follows: (In thousands) Balance as of December 31, 2018 $ 18,785 Additions 168 Disposal (48) Amortization expense (1,182) Foreign currency translation adjustment (455) Balance as of September 30, 2019 $ 17,268 Expected future amortization expense is as follows as of September 30, 2019: (In thousands) 2019 (remaining three months) $ 383 2020 1,532 2021 1,532 2022 1,532 2023 1,532 2024 and thereafter 10,757

Redeemable Noncontrolling Inter

Redeemable Noncontrolling Interest	9 Months Ended
	Sep. 30, 2019
Redeemable Noncontrolling Interest
Redeemable Noncontrolling Interest	8. Redeemable Noncontrolling Interest As discussed in Note 1, on December 26, 2018, the Company, together with Wuxi Jintou Huicun Investment Enterprise, a limited partnership organized under Chinese law (“Wuxi LP”) established CASI Wuxi to build and operate a manufacturing facility in the Wuxi Huishan Economic Development Zone in Jiangsu Province, China. The Company holds 80% of the equity interests in CASI Wuxi and will invest, over time, $80 million in CASI Wuxi. The Company’s investment will consist of (i) $21 million in cash (paid in February 2019), (ii) a transfer of selected ANDAs valued at $30 million (transferred in May 2019), and (iii) an additional $29 million cash payment within three years from the date of establishment of CASI Wuxi. Wuxi LP holds 20% of the equity interest in CASI Wuxi through its investment in RMB of $20 million in cash (paid in March 2019). As the transfer of ANDAs valued at $30 million was to the Company’s consolidated subsidiary (CASI Wuxi), the Company recognized the transfer of the ANDAs at their carrying value and did not recognize a gain on the transfer. Pursuant to the investment contract between the Company and Wuxi LP and Articles of Association of CASI Wuxi, the Company has the call option to purchase the 20% equity interest in CASI Wuxi held by Wuxi LP at any time within 5 years from the date of establishment of CASI Wuxi (i.e. up to December 26, 2023). Wuxi LP has the put option to require the Company to redeem the 20% equity interest in CASI Wuxi at any time after December 26, 2023. The redemption value under both the Company’s embedded put option and Wuxi LP’s embedded call option is equal to $20 million plus interest at the bank loan interest rate issued by the People’s Bank of China for the period beginning with the initial capital contribution by Wuxi LP to the date of redemption. In addition, Wuxi LP has the put option to require the Company to redeem the 20% equity interest in CASI Wuxi at $20 million upon the occurrence of any of the following conditions: (i) the Company fails to fulfill its investment obligation to CASI Wuxi; (ii) CASI Wuxi suffers serious losses, discontinued operation, dissolution, goes into process of bankruptcy liquidation; or (iii) the Company substantially violates the investment contract and Articles of Association of CASI Wuxi. The investment of Wuxi LP in CASI Wuxi is treated as redeemable noncontrolling interest and is classified outside of permanent equity on the consolidated balance sheets because (1) the noncontrolling interest is not mandatorily redeemable financial instruments, and (2) it is redeemable at the option of the holder, or upon the occurrence of an event that is not solely within the control of the Company. The Company initially recorded the redeemable noncontrolling interest at its fair value of $20 million. The carrying amount of the redeemable noncontrolling interest is subsequently recorded at the greater of the amount of (1) the initial carrying amount, increased or decreased for the redeemable noncontrolling interest’s share of net income or loss in CASI Wuxi or (2) the redemption value, assuming the noncontrolling interest is redeemable at the balance sheet date. Accretion of the carrying amount of redeemable noncontrolling interest to the redemption value is recorded in additional paid-in capital. Changes in redeemable noncontrolling interest during the three and nine month periods ended September 30, 2019 are as follows: (In thousands) Three month period Nine month period Balance at beginning of period $ 20,237 $ — Cash contribution by Wuxi LP — 20,000 Share of CASI Wuxi net income (loss) (23) 53 Accretion of redeemable noncontrolling interest 245 406 Balance as of September 30, 2019 $ $

Stockholders' Equity

Stockholders' Equity	9 Months Ended
	Sep. 30, 2019
Stockholders' Equity
Stockholders' Equity	9. Stockholders’ Equity Stock purchase warrants activity for the nine months ended September 30, 2019 is as follows: Weighted Average Number of Warrants Exercise Price Outstanding at January 1, 2019 11,781,825 $ 3.98 Issued — $ — Exercised (987,653) $ 1.69 Expired — $ — Outstanding at September 30, 2019 $ 4.19 Exercisable at September 30, 2019 10,794,172 $ 4.19 All outstanding warrants are equity classified. Common Stock Sales Agreements 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. On July 19, 2019, the Company entered into an amendment to the Sales Agreement reducing the maximum amount that may be sold under the Sales Agreement to $20 million. In 2018, the Company issued 143,248 shares under the Sales Agreement resulting in net proceeds to the Company of approximately $475,000. As of September 30, 2019, approximately $19.5 million remained available under the Sales Agreement. On July 19, 2019, the Company entered into an Open Market Sale Agreement SM with Jefferies LLC (the “Open Market Agreement”). Pursuant to the terms of the Open Market Agreement, the Company may elect to sell from time to time, at its option, up to $30 million in shares of the Company’s common stock, through Jefferies LLC, as sales agent. Any sales of shares pursuant to the Open Market Agreement will be made under the Company’s Registration Statement and the related prospectus supplement and the accompanying prospectus, as filed with the SEC on July 19, 2019. As of September 30, 2019, there have been no sales made under the Open Market Agreement.

Net Loss Per Share

Net Loss Per Share	9 Months Ended
	Sep. 30, 2019
Net Loss Per Share
Net Loss Per Share	10. Net Loss Per Share Net loss per share (basic and diluted) was computed by dividing net loss attributable to common stockholders, considering the accretions to redemption value of the redeemable noncontrolling interest, by the weighted average number of shares of common stock outstanding. Outstanding stock options and warrants totaling 29,457,753 and 31,810,540 as of September 30, 2019 and 2018, respectively, were anti-dilutive and, therefore, were not included in the computation of weighted average shares used in computing diluted loss per share. The following table sets forth the basic and diluted net loss per share computation and provides a reconciliation of the numerator and denominator for the periods presented: Nine Month Period ended September 30, (In thousands, except per share data) 2019 2018 Numerator: Net loss $ (33,080) $ (18,207) Accretion to redeemable non-controlling interest redemption value (406) — Numerator for basic and diluted net loss per share calculation (33,486) (18,207) Denominator: Weighted average number of common shares 95,753 81,457 Denominator for basic and diluted net loss per share calculation 95,753 81,457 Net loss per share —Basic and diluted $ (0.35) $ (0.22)

Stock-Based Compensation

Stock-Based Compensation	9 Months Ended
	Sep. 30, 2019
Stock-Based Compensation
Stock-Based Compensation	11. Stock-Based Compensation In June 2019, 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 20,230,000 to 25,230,000 to be available for grants and awards. As of September 30, 2019, a total of 11,526,634 shares remained available for grant under the Company’s 2011 Long-Term Incentive Plan. The Company’s net loss for the nine months ended September 30, 2019 and 2018 includes $5,320,000 and $3,518,000, 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: Nine Month Period ended September 30, (In thousands) 2019 2018 Research and development $ 359 $ 232 General and administrative 4,961 3,286 Share-based compensation expense $ 5,320 $ 3,518 Compensation expense related to stock options is recognized over the requisite service period, which is generally the option vesting term of up to five years. Awards with performance conditions are expensed when it is probable that the performance condition will be achieved. For the nine months ended September 30, 2019, approximately $58,000 was expensed for share awards with performance conditions that became probable during that period. For the nine months ended September 30, 2018, approximately $31,000 was expensed for share awards with performance conditions that became probable during that period. The Company uses the Black-Scholes-Merton valuation model to estimate the fair value of service based and performance-based stock options granted to employees. Option valuation models, including Black-Scholes-Merton, require the input of highly subjective assumptions, and changes in the assumptions used can materially affect the grant date fair value of an award. These assumptions include the risk- free rate of interest, expected dividend yield, expected volatility, and the expected life of the award. Following are the weighted-average assumptions used in valuing the stock options granted to employees during the nine month periods ended September 30, 2019 and 2018: Nine Month Period ended September 30, 2019 2018 Expected volatility 77.36 % 78.79 % Risk free interest rate 1.87 % 2.80 % Expected term of option years years Expected dividend yield 0.00 % 0.00 % The weighted average fair value of stock options granted during the nine month periods ended September 30, 2019 and 2018 were $2.20 and $4.51, respectively. A summary of the Company’s stock option plans and of changes in options outstanding under the plans during the nine month period ended September 30, 2019 is as follows: Weighted Average Number of Options Exercise Price Outstanding at January 1, 2019 18,429,308 $ 2.44 Exercised (67,237) $ 1.69 Granted 5,634,808 $ 3.00 Expired (6,090) $ 3.28 Forfeited (1,327,208) $ 1.07 Cancelled (4,000,000) $ 3.22 Outstanding at September 30, 2019 $ 2.55 Exercisable at September 30, 2019 11,579,326 $ 1.96 Cash received from option exercises under all share-based payment arrangements for the nine months ended September 30, 2019 and 2018 was $114,000 and $258,000, respectively. In April 2019, a performance-based option award to the Company’s Chairman and CEO, covering 4 million shares of common stock was cancelled, which was accompanied by a concurrent grant of replacement award. The replacement grant of stock options was approved by the Company’s stockholders at the 2019 Annual Meeting on June 20, 2019. Under the terms of the grant, the Chairman and CEO received a stock option covering 4 million shares of common stock, at an exercise price of $2.85, vesting upon the earlier of (i) the completion of a transformative event by the Company as determined at the discretion of the Company's compensation committee and (ii) April 2, 2021, the second anniversary of the date of his appointment as CEO. At the date of cancellation, the performance condition of the option award was not expected to vest based on the original vesting conditions, and therefore no compensation cost was recognized on the cancellation date.

Income Taxes

Income Taxes	9 Months Ended
	Sep. 30, 2019
Income Taxes
Income Taxes	12. Income Taxes At December 31, 2018, the Company had a $3.0 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, 2018. During the nine months ended September 30, 2019, 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 September 30, 2019. 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.

Fair Value Measurements

Fair Value Measurements	9 Months Ended
	Sep. 30, 2019
Fair Value Measurements
Fair Value Measurements	13. Fair Value Measurements The majority of the Company’s financial instruments (consisting principally of cash and cash equivalents, account receivable, accounts payable and accrued liabilities) are carried at cost which approximates their fair values due to the short-term nature of the instruments. The Company’s investment in equity securities is carried at fair value (see Note 4). The Company also had a note payable which was paid off during the three months ended September 30, 2019(see Note 14). The notes payable was carried at amortized cost which approximates fair value due to its classification as a short-term note payable. Fair value is the price that would be received from the sale of an asset or paid to transfer a liability assuming an orderly transaction in the most advantageous market at the measurement date. U.S. GAAP establishes a hierarchical disclosure framework which prioritizes and ranks the level of observability of inputs used in measuring fair value. These tiers include: · Level 1—Quoted prices (unadjusted) in active markets that are accessible at the measurement date for identical assets or liabilities. The fair value hierarchy gives the highest priority to Level 1 inputs. · Level 2—Observable market-based inputs other than quoted prices in active markets for identical assets or liabilities. · Level 3—Unobservable inputs are used when little or no market data is available. The fair value hierarchy gives the lowest priority to Level 3 inputs. Financial Assets and Liabilities Measured at Fair Value on a Recurring Basis The Company evaluates financial assets and liabilities subject to fair value measurements on a recurring basis to determine the appropriate level at which to classify them each reporting period. This determination requires the Company to make subjective judgments as to the significance of inputs used in determining fair value and where such inputs lie within the hierarchy. The Company has an equity investment in the common stock of publicly traded company. The Company’s investment in this equity security is carried at its estimated fair value, with changes in fair value reported in the consolidated statement of operations and comprehensive loss each reporting period (see Note 4). The fair value of the common stock is based on quoted market price for the investee's common stock, a Level 1 input. The following tables presents the Company’s financial assets and liabilities accounted for at fair value on a recurring basis as of September 30, 2019 and December 31, 2018, by level within the fair value hierarchy: (In thousands) Fair Value at Description September 30, 2019 Level 1 Level 2 Level 3 Investment in common stock $ 557 $ 557 $ — $ — Fair Value at Description December 31, 2018 Level 1 Level 2 Level 3 Investment in common stock $ 912 $ 912 $ — $ — Financial Assets and Liabilities Measured at Fair Value on a Non-Recurring Basis The Company has no financial assets and liabilities that are measured at fair value on a non-recurring basis. Non-Financial Assets and Liabilities Measured at Fair Value on a Recurring Basis The Company has no non-financial assets and liabilities that are measured at fair value on a recurring basis. Non-Financial Assets and Liabilities Measured at Fair Value on a Non-Recurring Basis The Company has no non-financial assets and liabilities that are measured at fair value on a non-recurring basis.

Related Party Transactions

Related Party Transactions	9 Months Ended
	Sep. 30, 2019
Related Party Transactions
Related Party Transactions	14. Related Party Transactions In June 2019, CASI Pharmaceuticals, Inc. entered into a license agreement for exclusive worldwide license and commercialization rights to CNCT19 from Juventas (see Note 2). Transactions with Juventas are considered to be related party transactions as the Company’s CEO and Chairman is the chairman and one of the founding shareholders of Juventas. A committee of independent directors of CASI negotiated the terms of the investment and license agreements and recommended that the board of directors approve the transaction. The Company’s CEO did not participate in the committee’s deliberations or the board of directors’ approval of the transaction. On July 1, 2019 the Company entered into a one-year equipment lease with Juventas for 80,000 RMB (approximately $15,000) a month, which is classified as an operating lease. During the three months ended September 30, 2019, the Company recognized lease income of $38,000. The Company expects to recognize approximately $38,000 of additional lease income in 2019 and approximately $76,000 of additional lease income in 2020 related to this lease. There were no other material transactions with Juventas entered into during the nine months ended September 30, 2019. The Company had certain product rights and perpetual exclusive licenses from Spectrum Pharmaceuticals, Inc. (“Spectrum”) to develop and commercialize EVOMELA (Melphalan Hydrochloride For Injection) (“EVOMELA”), ZEVALIN (Ibritumomab Tiuxetan) (“ZEVALIN”) and MARQIBO (Vincristine Sulfate Liposome Injection) (“MARQIBO”) in the greater China region. Spectrum is a greater than a 10% shareholder of the Company. Based on the original licenses, the Company had supply agreements with Spectrum for the purchase of EVOMELA, ZEVALIN, and MARQIBO in China for quality testing purposes to support the Company’s application for import drug registration and for commercialization purposes. On March 1, 2019, Spectrum completed the sale of its portfolio of seven FDA-approved hematology/oncology products including EVOMELA, MARQIBO, and ZEVALIN to Acrotech Biopharma L.L.C. ("Acrotech"). The original supply agreements with Spectrum for EVOMELA, MARQIBO, and ZEVALIN were assumed by Acrotech; Spectrum agreed to continue with a short-term supply agreement for EVOMELA for the initial commercial product supply for the greater China region. As part of the license arrangements with Spectrum, the Company issued to Spectrum a $1.5 million 0.5% secured promissory note originally due March 17, 2016, which was subsequently amended and extended to September 17, 2019. The Company paid this note and accrued interest in full during the three month period ended September 30, 2019. In 2018, the Company entered into commercial purchase obligation commitments for EVOMELA from Spectrum totaling approximately $9.2 million under the short-term supply agreement for EVOMELA. As of September 30, 2019, the Company has paid $7.6 million relating to the manufacturing and purchase of the EVOMELA commercial product supply. These advance payments are included in the prepaid expenses and other in the accompanying condensed consolidated balance sheets, of which $3.1 million was recorded as of September 30, 2019 and $4.6 million recorded as of December 31, 2018. The Company also incurred estimated expenses of $2.6 million of other material costs related to EVOMELA for the three and nine month period ended September 30, 2019.

Acrotech License Arrangements

Acrotech License Arrangements	9 Months Ended
	Sep. 30, 2019
Acrotech License Arrangements
Acrotech License Arrangements	15. Acrotech License Arrangements The Company has certain product rights and perpetual exclusive licenses from Acrotech to develop and commercialize the following commercial oncology drugs and drug candidates in the greater China region (which includes China, Taiwan, Hong Kong and Macau) (the “Territories”): - Melphalan Hydrochloride For Injection (EVOMELA); - Ibritumomab Tiuxetan (ZEVALIN); and - Vincristine Sulfate Liposome Injection (MARQIBO). CASI is responsible for developing and commercializing these three drugs in the Territories, including the submission of import drug registration applications and conducting confirmatory clinical trials as needed. In March 2016, Spectrum, the former owner of EVOMELA, received notification from the U.S. Food and Drug Administration (“FDA”) of the grant of approval of its New Drug Application (NDA) for EVOMELA primarily for use as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma. In December 2016, the China National Medical Products Administration (“NMPA”) accepted for review the Company’s import drug registration application for EVOMELA and in 2017 granted priority review of the import drug registration clinical trial application (CTA). On December 3, 2018 the Company received NMPA’s approval for importation, marketing and sales in China for EVOMELA. The Company has in place an experienced commercial team with a successful track record to execute the commercial sales of EVOMELA that launched in August 2019. The Company is also preparing to undertake a required post approval commitment study in 2020. The Company is in the process of advancing the development of ZEVALIN in China. In 2017, the NMPA accepted for review the Company’s import drug registration for ZEVALIN including both the antibody kit and the radioactive Yttrium-90 component. On February 12, 2019, the Company received NMPA’s approval of the Company’s CTA to conduct a registration trial to evaluate the efficacy and safety of ZEVALIN. The Company intends to initiate a ZEVALIN registration trial in China in 2020. In 2016, the NMPA accepted for review the Company’s import drug registration application for MARQIBO. On March 4, 2019 the Company received NMPA’s approval of the Company’s MARQIBO CTA. The Company is currently evaluating the development strategy and options in an evolving standard of care environment for the approved niche indication.

Commitments

Commitments	9 Months Ended
	Sep. 30, 2019
Commitments
Commitments	16. Commitments In 2018, the Company entered into purchase obligation commitments for EVOMELA from Spectrum for approximately $9.2 million (see Note 14). All of these EVOMELA purchase commitments have been delivered as of October 2019. In 2018, the Company committed to invest $80 million in CASI Wuxi, of which $21 million in cash was invested in February 2019 and ANDAs with fair value of $37 million were transferred in May 2019 (see Note 8). In conjunction with both the Black Belt and Juventas agreements entered into during the three months ended June 30, 2019 (see Note 2), the Company is responsible for certain milestone and royalty payments. As of September 30, 2019, no milestones have been achieved.

Subsequent Event

Subsequent Event	9 Months Ended
	Sep. 30, 2019
Subsequent Event
Subsequent Event	17. Subsequent Event Pharmathen Global BV: On October 29, 2019. the Company entered into an exclusive distribution agreement with Pharmathen Global BV for the development and distribution of octreotide long acting injectable (LAI) microsphere in China. Octreotide LAI formulations are considered a standard of care for the treatment of acromegaly and for the control of symptoms associated with certain neuroendocrine tumors. Pharmathen has received marketing authorization for its version of Octreotide LAI in Germany and the Czech Republic, and the regulatory submissions are currently under review in the UK and France. The Company anticipates starting the process for CTA submission to the China NMPA in 2019. The terms of the agreement include an upfront payment of 1 million euros, and up to 2 million euros of additional milestone payments. CASI will be responsible for the development, import drug registration, product approval and commercialization in China. CASI has a 10-year non-royalty exclusive distribution period after the product launch at agreed supply costs for the first three years.

Summary of Significant Accoun_2

Summary of Significant Accounting Policies (Policies)	9 Months Ended
	Sep. 30, 2019
Summary of Significant Accounting Policies
Revenue Recognition	Revenue Recognition Product sales recognized in the condensed consolidated statements of operations is considered “revenue from contracts with customers” and, accordingly, the Company recognizes revenue using the following steps: · Identification of the contract, or contracts, with a customer; · Identification of the performance obligations in the contract; · Determination of the transaction price, including the identification and estimation of variable consideration; · Allocation of the transaction price to the performance obligations in the contract; and · Recognition of revenue when we satisfy a performance obligation. The Company recognizes revenue on sales of EVOMELA when the control of the product is transferred to the distributor, which occurs upon delivery of the product to the distributor, in an amount that reflects the consideration to which the Company expects to be entitled to in exchange for the product, excluding amounts collected on behalf of third parties (e.g. value-added taxes). Payment terms for these sales are due within 90 days. The arrangement does not include any variable consideration. The costs of assurance type warranties that provide the customer the right to exchange purchased product that does meet appropriate quality standards are recognized when they are probable and are reasonably estimable. As of September 30, 2019, the Company did not incur, and therefore did not defer, any material costs to obtain or fulfill contracts. The Company did not have any contract assets or contract liabilities as of September 30, 2019.
Costs of Goods Sold	Costs of Goods Sold Cost of goods sold consists primary of EVOMELA commercial drug supply costs, operational costs, and sales-based royalties related to the sale of EVOMELA.
Use of Estimates	Use of Estimates The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. The Company’s significant accounting estimates relate to accounting policies for fair value determination and recoverability of intangible assets, net realizable value and obsolescence allowance for inventory, clinical trial accruals, deferred tax assets and valuation allowance, allowance for doubtful accounts, and stock-based arrangements. Management bases its estimates on historical experience and on various other assumptions that it believes are reasonable under the circumstances. Actual results may differ from those estimates, and such differences may be material to the consolidated financial statements.
Foreign Currency Translation and Transactions	Foreign Currency Translation and Transactions Assets and liabilities of the Company’s PRC subsidiaries are translated into US$ using the exchange rates in effect at the consolidated balance sheet date. The revenues and expenses of these entities are translated into US$ at the weighted average exchange rates for the period. The resulting translation gains (losses) are recorded in accumulated other comprehensive income (loss) as a component of shareholders’ equity. Transactions denominated in foreign currencies are remeasured into the functional currency at the exchange rates prevailing on the transaction dates. Foreign currency denominated financial assets and liabilities are remeasured at the exchange rates prevailing at the balance sheet date. Net gains or losses resulting from foreign currency denominated transactions are recorded in foreign exchange gain (losses) in the consolidated statements of operations.
Accounts Receivable and Credit Concentration	Accounts Receivable and Credit Concentration CRGK is the sole customer for the sale of the Company’s EVOMELA product in China. All consolidated revenue for the three and nine months ended periods ended September 30, 2019 were generated from sales to CRGK in China, and all the Company’s accounts receivable balance as of September 30, 2019 was from CRGK. The Company extends credit to CRGK on an unsecured basis and maintains an allowance for doubtful accounts for estimated losses inherent in its accounts receivable. In establishing the required allowance, management considers the historical losses, customer’s financial condition, the amount of accounts receivables in dispute, the accounts receivables aging and the customer’s payment pattern. The Company determined that no allowance for doubtful accounts was necessary as of September 30, 2019.
New Accounting Pronouncements	New Accounting Pronouncements Recently Adopted Pronouncements Effective January 1, 2019, the Company adopted Financial Accounting Standards Board (“FASB”) Accounting Standards Update (“ASU”) 2016‑02, Leases (“Topic 842”). The guidance amends the accounting requirements for leases and requires lessees to recognize assets and liabilities related to long-term leases on the balance sheets and expands disclosure requirements regarding leasing arrangements. The guidance is effective for reporting periods beginning after December 15, 2018 and early adoption is permitted. The guidance must be adopted on a modified retrospective basis and provides for certain practical expedients. The Company adopted this guidance effective January 1, 2019 using the following practical expedients: · the Company did not reassess if any expired or existing contracts are or contain leases; · the Company did not reassess the classification of any expired or existing leases. Additionally, the Company made ongoing accounting policy elections whereby it (i) does not recognize Right-of-use (“ROU”) assets or lease liabilities for short-term leases (those with original terms of 12‑months or less) and (ii) combines lease and non-lease components for facilities leases, which primarily relate to ancillary expenses such as common area maintenance charges and management fees of operating leases. Upon adoption of the new guidance on January 1, 2019, the Company recorded right of use assets of approximately $3.0 million and recognized lease liabilities of approximately $3.2 million; there was no cumulative effect impact to accumulated deficit as of January 1, 2019. No adjustments were made to prior comparative periods. In August 2018, the FASB issued ASU 2018-15, Intangibles-Goodwill and Other-Internal-Use Software (Subtopic 350-40): Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract. The new guidance requires a customer in a cloud computing arrangement (i.e., hosting arrangement) that is a service contract to follow the internal-use software guidance in ASC 350-40 to determine which implementation costs to capitalize as assets or expense as incurred. Capitalized implementation costs related to a hosting arrangement that is a service contract will be amortized over the term of the hosting arrangement, beginning when the module or component of the hosting arrangement is ready for its intended use. The update is effective for calendar-year public business entities in 2020. For all other calendar-year entities, it is effective for annual periods beginning in 2021 and interim periods in 2022. Early adoption is permitted. The Company early adopted this guidance effective January 1, 2019. The net impact to the financial statements was approximately $140,000 of capitalized cost. 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.

Investment in Equity Securiti_2

Investment in Equity Securities, at fair value and long-term investments (Tables)	9 Months Ended
	Sep. 30, 2019
Investment in Equity Securities, at fair value and long-term investments
Schedule of investment	Gross (In thousands) unrealized Aggregate fair Description Classification Cost gains value Common stock Investment $ — $ 557 $ 557

Leases (Tables)

Leases (Tables)	9 Months Ended
	Sep. 30, 2019
Leases
Schedule of impact of Topic 842 on condensed consolidated balance sheet	(In thousands) September 30, 2019 Other assets $ 2,361 Accrued liabilities 1,136 Other liabilities 1,292 Total lease liabilities $ 2,428
Schedule of supplemental cash flow information	Nine Month Period ended (In thousands) September 30, 2019 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows $ 957 Right of use assets obtained in exchange for lease obligations: $ 2,361
Schedule of future undiscounted cash flows	(In thousands) 2019 (remaining three months) $ 333 2020 1,337 2021 892 2022 190 Thereafter — Total 2,752 Discount factor (324) Lease liability 2,428 Amounts due within 12 months 1,136 Non-current lease liability $ 1,292
Schedule of future minimum annual lease payments	(In thousands) 2019 $ 1,312 2020 1,297 2021 857 2022 130 Thereafter — Total minimum payments $ 3,596

Intangible Assets (Tables)

Intangible Assets (Tables)	9 Months Ended
	Sep. 30, 2019
Intangible Assets
Schedule of net definite-lived intangible assets	(In thousands) Asset Purchase Price Accumulated Amortization Estimated useful lives ANDAs $ 18,002 $ (2,704) 13 years TDF ANDA 2,035 (192) 13 years Others 167 (40) 5 years Total $ 20,204 $ (2,936)
Schedule of changes in intangible assets	(In thousands) Balance as of December 31, 2018 $ 18,785 Additions 168 Disposal (48) Amortization expense (1,182) Foreign currency translation adjustment (455) Balance as of September 30, 2019 $ 17,268
Schedule of expected future amortization expense	(In thousands) 2019 (remaining three months) $ 383 2020 1,532 2021 1,532 2022 1,532 2023 1,532 2024 and thereafter 10,757

Redeemable Noncontrolling Int_2

Redeemable Noncontrolling Interest (Tables)	9 Months Ended
	Sep. 30, 2019
Redeemable Noncontrolling Interest
Schedule of changes in redeemable noncontrolling interest	(In thousands) Three month period Nine month period Balance at beginning of period $ 20,237 $ — Cash contribution by Wuxi LP — 20,000 Share of CASI Wuxi net income (loss) (23) 53 Accretion of redeemable noncontrolling interest 245 406 Balance as of September 30, 2019 $ $

Stockholders' Equity (Tables)

Stockholders' Equity (Tables)	9 Months Ended
	Sep. 30, 2019
Stockholders' Equity
Schedule of stock purchase warrants activity	Weighted Average Number of Warrants Exercise Price Outstanding at January 1, 2019 11,781,825 $ 3.98 Issued — $ — Exercised (987,653) $ 1.69 Expired — $ — Outstanding at September 30, 2019 $ 4.19 Exercisable at September 30, 2019 10,794,172 $ 4.19

Net Loss Per Share (Tables)

Net Loss Per Share (Tables)	9 Months Ended
	Sep. 30, 2019
Net Loss Per Share
Schedule of basic and diluted net loss per share	Nine Month Period ended September 30, (In thousands, except per share data) 2019 2018 Numerator: Net loss $ (33,080) $ (18,207) Accretion to redeemable non-controlling interest redemption value (406) — Numerator for basic and diluted net loss per share calculation (33,486) (18,207) Denominator: Weighted average number of common shares 95,753 81,457 Denominator for basic and diluted net loss per share calculation 95,753 81,457 Net loss per share —Basic and diluted $ (0.35) $ (0.22)

Stock-Based Compensation (Table

Stock-Based Compensation (Tables)	9 Months Ended
	Sep. 30, 2019
Stock-Based Compensation
Schedule of compensation expense	Nine Month Period ended September 30, (In thousands) 2019 2018 Research and development $ 359 $ 232 General and administrative 4,961 3,286 Share-based compensation expense $ 5,320 $ 3,518
Schedule of weighted-average assumptions used in valuing the stock options	Nine Month Period ended September 30, 2019 2018 Expected volatility 77.36 % 78.79 % Risk free interest rate 1.87 % 2.80 % Expected term of option years years Expected dividend yield 0.00 % 0.00 %
Schedule of stock option plans and of changes in options outstanding under the plans	Weighted Average Number of Options Exercise Price Outstanding at January 1, 2019 18,429,308 $ 2.44 Exercised (67,237) $ 1.69 Granted 5,634,808 $ 3.00 Expired (6,090) $ 3.28 Forfeited (1,327,208) $ 1.07 Cancelled (4,000,000) $ 3.22 Outstanding at September 30, 2019 $ 2.55 Exercisable at September 30, 2019 11,579,326 $ 1.96

Fair Value Measurements (Tables

Fair Value Measurements (Tables)	9 Months Ended
	Sep. 30, 2019
Fair Value Measurements
Schedule of financial assets and liabilities accounted for at fair value on a recurring basis	(In thousands) Fair Value at Description September 30, 2019 Level 1 Level 2 Level 3 Investment in common stock $ 557 $ 557 $ — $ — Fair Value at Description December 31, 2018 Level 1 Level 2 Level 3 Investment in common stock $ 912 $ 912 $ — $ —

Basis of Presentation (Details)

Basis of Presentation (Details) - USD ($)	9 Months Ended
	Sep. 30, 2018	Sep. 30, 2019	Dec. 31, 2018
Description of Business and Basis of Presentation [Line Items]
Percentage Of Ownership Interest In Non Stock Subsidiary		100.00%
Increase (Decrease) in Net Cash Used in Operating Activities	$ 564,000
Increase (Decrease) in Net Cash Used in Investing Activities	$ (564,000)
Inventory, Net		$ 2,565,000	$ 283,000
Retained Earnings (Accumulated Deficit)		(512,074,000)	$ (478,941,000)
CASI China [Member]
Description of Business and Basis of Presentation [Line Items]
Cash		$ 5,600,000
CASI Wuxi [Member]
Description of Business and Basis of Presentation [Line Items]
Percentage Of Ownership Interest In Non Stock Subsidiary		80.00%
Cash		$ 28,500,000

Recent Developments (Details)

Recent Developments (Details)	1 Months Ended				3 Months Ended		9 Months Ended
	Jun. 30, 2019CNY (¥)	Jun. 30, 2019USD ($)	Apr. 30, 2019EUR (€)	Apr. 30, 2019USD ($)	Sep. 30, 2019USD ($)	Sep. 30, 2018USD ($)	Sep. 30, 2019USD ($)	Sep. 30, 2018USD ($)
Revenues					$ 2,787,000	$ 0	$ 2,787,000	$ 0
EVOMELA [Member]
Revenues					$ 2,700,000		$ 2,700,000
Black Belt Therapeutics Limited [Member]
Upfront Payment			€ 5,000,000	$ 5,657,500
Black Belt TX Limited [Member]
Payments to Acquire Equity Method Investments			€ 2,000,000	$ 2,249,600
Equity Method Investment, Ownership Percentage			15.00%	15.00%
Juventas Cell Therapy Ltd [Member]
Payments to Acquire Equity Method Investments	¥ 80,000,000	$ 11,788,000
Equity Method Investment, Ownership Percentage	16.30%	16.30%
License Agreement Terms [Member] | Black Belt Therapeutics Limited [Member]
Upfront Payment | €			€ 5,000,000

Summary of Significant Accoun_3

Summary of Significant Accounting Policies (Details) - USD ($)	1 Months Ended
	Jan. 31, 2019	Sep. 30, 2019	Jan. 01, 2019
Operating Lease, Right-of-Use Asset		$ 2,361,000
Operating Lease, Liability		2,428,000
CRGK [Member]
Accounts Receivable, Allowance for Credit Loss		$ 0
Accounting Standards Update 2016-02 [Member]
Operating Lease, Right-of-Use Asset			$ 3,000,000
Operating Lease, Liability			$ 3,200,000
Accounting Standards Update 2018-15 [Member]
New Accounting Pronouncement or Change in Accounting Principle, Effect	$ 140,000

Investment in Equity Securiti_3

Investment in Equity Securities, at fair value and long-term investments - Summary of Investment (Details) - Common Stock [Member]	9 Months Ended
	Sep. 30, 2019USD ($)
Cost	$ 0
Gross unrealized gains	557,000
Aggregate fair value	$ 557,000

Investment in Equity Securiti_4

Investment in Equity Securities, at fair value and long-term investments - Additional Information (Details)	1 Months Ended				3 Months Ended		9 Months Ended
	Jun. 30, 2019CNY (¥)	Jun. 30, 2019USD ($)	Apr. 30, 2019EUR (€)	Apr. 30, 2019USD ($)	Sep. 30, 2019USD ($)	Sep. 30, 2018USD ($)	Sep. 30, 2019USD ($)	Sep. 30, 2018USD ($)
Change in fair value of investment in equity securities					$ 160,000	$ 56,000	$ 355,000	$ 67,000
Juventas Cell Therapy Ltd [Member]
Payments to Acquire Equity Method Investments	¥ 80,000,000	$ 11,788,000
Black Belt TX Limited [Member]
Payments to Acquire Equity Method Investments			€ 2,000,000	$ 2,249,600

Inventories (Details)

Inventories (Details) - USD ($)	Sep. 30, 2019	Dec. 31, 2018
Inventories
Inventory, Finished Goods, Net of Reserves	$ 2,400,000
Inventory, Raw Materials, Net of Reserves	$ 180,000	$ 280,000

Leases - Impact of Topic 842 (D

Leases - Impact of Topic 842 (Details) $ in Thousands	Sep. 30, 2019USD ($)
Operating Lease, Liability	$ 2,428
Other Current Assets [Member]
Operating Lease, Liability	2,361
Accounts Payable and Accrued Liabilities [Member]
Operating Lease, Liability	1,136
Other Liabilities [Member]
Operating Lease, Liability	$ 1,292

Leases - Supplemental Cash Flow

Leases - Supplemental Cash Flow (Details) $ in Thousands	9 Months Ended
	Sep. 30, 2019USD ($)
Cash paid for amounts included in the measurement of lease liabilities:
Operating cash flows	$ 957
Right of use assets obtained in exchange for lease obligations:	$ 2,361

Leases - Future Undiscounted Ca

Leases - Future Undiscounted Cash Flows (Details) $ in Thousands	Sep. 30, 2019USD ($)
Leases
2019 (remaining nine months)	$ 333
2020	1,337
2021	892
2022	190
Thereafter	0
Total	2,752
Discount factor	(324)
Lease liability	2,428
Amounts due within 12 months	1,136
Non-current lease liability	$ 1,292

Leases - Future Annual Lease Pa

Leases - Future Annual Lease Payments (Details) $ in Thousands	Dec. 31, 2018USD ($)
Leases
2019	$ 1,312
2020	1,297
2021	857
2022	130
Thereafter	0
Total minimum payments	$ 3,596

Leases - Additional Information

Leases - Additional Information (Details)	9 Months Ended	12 Months Ended
	Sep. 30, 2019USD ($)lease	Dec. 31, 2018USD ($)
Number of Operating Leases | lease	4
Operating Lease, Weighted Average Remaining Lease Term	2 years 3 months 15 days
Operating Lease, Weighted Average Discount Rate, Percent	5.40%
Operating Lease, Cost	$ 957,000
Operating Leases, Future Minimum Payments Due	2,752,000
Operating Leases, Rent Expense, Net		$ 916,000
CASI Wuxi [Member]
Operating Leases, Future Minimum Payments Due	$ 3,789,000

Intangible Assets - Net Definit

Intangible Assets - Net Definite-lived Intangible Assets (Details) $ in Thousands	9 Months Ended
	Sep. 30, 2019USD ($)
Finite-Lived Intangible Assets [Line Items]
Gross Value	$ 20,204
Accumulated Amortization	(2,936)
Abbreviated New Drug Applications [Member]
Finite-Lived Intangible Assets [Line Items]
Gross Value	18,002
Accumulated Amortization	$ (2,704)
Estimated useful lives	13 years
Abbreviated New Drug Applications TDF [Member]
Finite-Lived Intangible Assets [Line Items]
Gross Value	$ 2,035
Accumulated Amortization	$ (192)
Estimated useful lives	13 years
Cloud Computing Arrangement [Member]
Finite-Lived Intangible Assets [Line Items]
Estimated useful lives	5 years
Others [Member]
Finite-Lived Intangible Assets [Line Items]
Gross Value	$ 167
Accumulated Amortization	$ (40)
Estimated useful lives	5 years

Intangible Assets - Changes in

Intangible Assets - Changes in intangible assets (Details) - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2019	Sep. 30, 2018
Intangible Assets
Balance as of December 31, 2018	$ 18,785
Additions	168
Disposal	(48)
Amortization expenses	(1,182)	$ (945)
Foreign currency translation adjustments	(455)
Balance as of September 30, 2019	$ 17,268

Intangible Assets - Expected Fu

Intangible Assets - Expected Future Amortization Expense (Details) $ in Thousands	Sep. 30, 2019USD ($)
Intangible Assets
2019 (remaining three months)	$ 383
2020	1,532
2021	1,532
2022	1,532
2023	1,532
2024 and thereafter	$ 10,757

Intangible Assets - Additional

Intangible Assets - Additional Information (Details) - USD ($)	9 Months Ended
	Sep. 30, 2019	Sep. 30, 2018
Finite-Lived Intangible Assets [Line Items]
Impairment of Intangible Assets, Finite-lived	$ 48,000	$ 0
Abbreviated New Drug Applications [Member]
Finite-Lived Intangible Assets [Line Items]
Finite-Lived Intangible Asset, Useful Life	13 years
Impairment of Intangible Assets, Finite-lived	$ 48,000
Cloud Computing Arrangement [Member]
Finite-Lived Intangible Assets [Line Items]
Finite-Lived Intangible Asset, Useful Life	5 years

Redeemable Noncontrolling Int_3

Redeemable Noncontrolling Interest - Changes (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2019	Sep. 30, 2018	Sep. 30, 2019	Sep. 30, 2018
Redeemable Noncontrolling Interest
Balance at beginning of period	$ 20,237		$ 0
Cash contribution by Wuxi LP	0		20,000	$ 0
Share of CASI Wuxi net income (loss)	(23)	$ 0	53	0
Accretion of redeemable noncontrolling interest	245		406	$ 0
Balance at end of period	$ 20,459		$ 20,459

Redeemable Noncontrolling Int_4

Redeemable Noncontrolling Interest - Additional Information (Details) - USD ($) $ in Thousands	3 Months Ended	9 Months Ended
	Sep. 30, 2019	Sep. 30, 2019	Feb. 28, 2019	Dec. 31, 2018	Dec. 26, 2018
Noncontrolling Interest [Line Items]
Redeemable Noncontrolling Interest, Equity, Redemption Value	$ 20,459	$ 20,459		$ 0
CASI Wuxi [Member]
Noncontrolling Interest [Line Items]
Equity Method Investment, Ownership Percentage					80.00%
Investment Commitment					$ 80,000
Initial Cash Investment			$ 21,000
Value of a future transfer of selected ANDAs		30,000
Payments To Be Paid Within Three Years		$ 29,000
Call Option To Purchase Investment Period		5 years
Payments to Acquire Investments		$ 20,000
CASI Wuxi [Member] | Call Option [Member]
Noncontrolling Interest [Line Items]
Equity Method Investment, Ownership Percentage	20.00%	20.00%
CASI Wuxi [Member] | Put Option [Member]
Noncontrolling Interest [Line Items]
Equity Method Investment, Ownership Percentage	20.00%	20.00%
CASI Wuxi [Member]
Noncontrolling Interest [Line Items]
Initial Cash Investment			$ 21,000
Payments to Acquire Investments	$ 20,000

Stockholders' Equity (Details)

Stockholders' Equity (Details) - Warrant [Member]	9 Months Ended
	Sep. 30, 2019$ / sharesshares
Outstanding at Number of Warrants, Beginning Balance | shares	11,781,825
Issued Number of Warrants | shares	0
Exercised Number of Warrants | shares	(987,653)
Expired Number of Warrants | shares	0
Outstanding at Number of Warrants, Ending Balance | shares	10,794,172
Exercisable Number of Warrants | shares	10,794,172
Outstanding Weighted Average Exercise Price, Beginning Balance | $ / shares	$ 3.98
Issued Weighted Average Exercise Price | $ / shares	0
Exercised Weighted Average Exercise Price | $ / shares	1.69
Expired Weighted Average Exercise Price | $ / shares	0
Outstanding Weighted Average Exercise Price, at Ending Balance | $ / shares	4.19
Exercisable Weighted Average Exercise Price | $ / shares	$ 4.19

Stockholders' Equity - Addition

Stockholders' Equity - Additional Information (Details) - USD ($)	Jul. 19, 2019	Sep. 30, 2019	Dec. 31, 2018
Remaining Dollar Amount Available Under Sales Agreement		$ 19,500,000
Open Market Sale Agreement [Member]
Sale of Stock, Number of Shares Issued in Transaction		0
Maximum Sales Price from Issuance of Common Stock	$ 30,000,000
Amendment To Open Sale Agreement [Member]
Maximum Sales Price from Issuance of Common Stock	$ 20,000,000
Sales Agreement [Member]
Stock Issued During Period, Shares, New Issues			143,248
Net Proceeds From Issuance Of Common Stock			$ 475,000

Net Loss Per Share (Details)

Net Loss Per Share (Details) - shares	9 Months Ended
	Sep. 30, 2019	Sep. 30, 2018
Net Loss Per Share
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount	29,457,753	31,810,540

Net Loss Per Share - Basic and

Net Loss Per Share - Basic and diluted net loss per share computation (Details) - USD ($) $ / shares in Units, $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2019	Sep. 30, 2018	Sep. 30, 2019	Sep. 30, 2018
Numerator:
Net loss	$ (9,669)	$ (8,756)	$ (33,080)	$ (18,207)
Accretion to redeemable non-controlling interest redemption value	$ (245)		(406)	0
Numerator for basic and diluted net loss per share calculation			$ (33,486)	$ (18,207)
Denominator:
Weighted average number of common shares			95,753	81,457
Denominator for basic and diluted net loss per share calculation			95,753	81,457
Net loss per share - Basic and diluted	$ (0.10)	$ (0.10)	$ (0.35)	$ (0.22)

Stock-Based Compensation - Comp

Stock-Based Compensation - Compensation Expense (Details) - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2019	Sep. 30, 2018
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Stock-based compensation expense	$ 5,320	$ 3,518
Research and Development Expense [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Stock-based compensation expense	359	232
General and Administrative Expense [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Stock-based compensation expense	$ 4,961	$ 3,286

Stock-Based Compensation - Weig

Stock-Based Compensation - Weighted-Average Assumptions (Details)	9 Months Ended
	Sep. 30, 2019	Sep. 30, 2018
Stock-Based Compensation
Expected volatility	77.36%	78.79%
Risk-free interest rate	1.87%	2.80%
Expected term of option	6 years 18 days	5 years 9 months 7 days
Expected dividend yield	0.00%	0.00%

Stock-Based Compensation - Opti

Stock-Based Compensation - Options Outstanding (Details) - $ / shares	Apr. 02, 2019	Sep. 30, 2019
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Granted - Number of Options	4,000,000
Granted - Weighted Average Exercise Price	$ 2.85
Employee Stock Option [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Outstanding - Number of Options, Beginning Balance		18,429,308
Exercised - Number of Options		(67,237)
Granted - Number of Options		5,634,808
Expired - Number of Options		(6,090)
Forfeited - Number of Options		(1,327,208)
Cancelled - Number of Options		(4,000,000)
Outstanding - Number of Options, Ending Balance		18,663,581
Exercisable - Number of Options		11,579,326
Outstanding - Weighted Average Exercise Price, Beginning balance		$ 2.44
Exercised - Weighted Average Exercise Price		1.69
Granted - Weighted Average Exercise Price		3
Expired - Weighted Average Exercise Price		3.28
Forfeited - Weighted Average Exercise Price		1.07
Cancelled - Weighted Average Exercise Price		3.22
Outstanding - Weighted Average Exercise Price, Ending Balance		2.55
Exercisable - Weighted Average Exercise Price		$ 1.96

Stock-Based Compensation - Addi

Stock-Based Compensation - Additional Information (Details) - USD ($)	Apr. 02, 2019	Sep. 30, 2019	Sep. 30, 2018	May 31, 2019
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		$ 2.20	$ 4.51
Share-based Compensation		$ 5,320,000	$ 3,518,000
Performance Share Based Compensation Expense		58,000	31,000
Share Based Payment Cash Received from Stock Option Exercises		$ 114,000	$ 258,000
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross	4,000,000
Share-based Compensation Arrangements by Share-based Payment Award, Options, Grants in Period, Weighted Average Exercise Price	$ 2.85
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
Long Term Incentive Plan2011 [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Common Stock, Capital Shares Reserved for Future Issuance		25,230,000		20,230,000
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant		11,526,634

Income Taxes (Details)

Income Taxes (Details) $ in Millions	Dec. 31, 2018USD ($)
Income Taxes
Unrecognized Tax Benefits	$ 3

Fair Value Measurements (Detail

Fair Value Measurements (Details) - USD ($) $ in Thousands	Sep. 30, 2019	Dec. 31, 2018
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items]
Investment in common stock	$ 557	$ 912
Fair Value, Inputs, Level 1 [Member]
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items]
Investment in common stock	557	912
Fair Value, Inputs, Level 2 [Member]
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items]
Investment in common stock	0	0
Fair Value, Inputs, Level 3 [Member]
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items]
Investment in common stock	$ 0	$ 0

Related Party Transactions (Det

Related Party Transactions (Details)	Jul. 01, 2019CNY (¥)	Jul. 01, 2019USD ($)	Sep. 30, 2019USD ($)	Sep. 30, 2019USD ($)	Sep. 17, 2019USD ($)	Dec. 31, 2018USD ($)
Related Party Transaction [Line Items]
Debt Instrument, Face Amount					$ 1,500,000
Debt Instrument, Interest Rate, Stated Percentage					0.50%
Spectrum [Member] | Prepaid Expenses and Other Current Assets [Member]
Related Party Transaction [Line Items]
Advance Payment on Contract for Purchase			$ 7,600,000	$ 7,600,000		$ 4,600,000
Spectrum [Member] | EVOMELA [Member]
Related Party Transaction [Line Items]
Purchase Obligation			9,200,000	9,200,000
Advance Payment on Contract for Purchase			3,100,000	3,100,000
Amount of Expense Incurred			$ 2,600,000	$ 2,600,000
Juventas Cell Therapy Ltd [Member]
Related Party Transaction [Line Items]
Lessor, Operating Lease, Term of Contract	1 year	1 year
Operating Lease, Lease Income, Lease Payments	¥ 80,000	$ 15,000
Operating Lease, Lease Income		$ 38,000

Commitments (Details)

Commitments (Details) - USD ($) $ in Millions	9 Months Ended	12 Months Ended
	Sep. 30, 2019	Dec. 31, 2018	Feb. 28, 2019
Spectrum [Member] | EVOMELA [Member]
Purchase obligation to purchase materials	$ 9.2
CASI Wuxi [Member]
Initial Cash Investment			$ 21
Total Future Investment		$ 80
Investment Fair Value		$ 37

Subsequent Event (Details)

Subsequent Event (Details) - Subsequent Event [Member] - Pharmathen Global BV [Member]	Oct. 29, 2019EUR (€)
Subsequent Event [Line Items]
Upfront Payment For a License For a Drug	€ 1,000,000
Non Royalty Exclusive Distribution Period	10 years
Non Royalty Exclusive Distribution, Supply Cost Determination, Period Considered	3 years
Maximum [Member]
Subsequent Event [Line Items]
Additional milestone payments	€ 2,000,000