Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2019 | May 08, 2019 | |
Document and Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Mar. 31, 2019 | |
Document Fiscal Year Focus | 2019 | |
Document Fiscal Period Focus | Q1 | |
Entity Registrant Name | CASI Pharmaceuticals, Inc. | |
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 | 95,717,052 | |
Entity Emerging Growth Company | false | |
Entity Small Business | true |
Unaudited Condensed Consolidate
Unaudited Condensed Consolidated Balance Sheets - USD ($) | Mar. 31, 2019 | Dec. 31, 2018 |
Current assets: | ||
Cash and cash equivalents | $ 99,733,620 | $ 84,204,809 |
Investment in equity securities, at fair value | 957,589 | 912,200 |
Prepaid expenses and other | 6,993,387 | 7,447,611 |
Total current assets | 107,684,596 | 92,564,620 |
Property and equipment, net | 1,902,170 | 1,750,630 |
Intangible assets, net | 18,349,662 | 18,784,727 |
Other assets | 3,123,873 | 310,024 |
Total assets | 131,060,301 | 113,410,001 |
Current liabilities: | ||
Accounts payable | 1,383,376 | 968,048 |
Accrued liabilities | 2,120,911 | 1,406,434 |
Note payable, net of discount | 1,499,639 | 1,499,462 |
Total current liabilities | 5,003,926 | 3,873,944 |
Other liabilities | 1,843,212 | 73,591 |
Total liabilities | 6,847,138 | 3,947,535 |
Commitments and contingencies (Note 15) | ||
Redeemable noncontrolling interest, at redemption value (Note 7) | 20,016,917 | 0 |
Stockholders' equity: | ||
Preferred stock, $1.00 par value; 5,000,000 shares authorized and 0 shares issued and outstanding at March 31, 2019 and December 31, 2018 | 0 | 0 |
Common stock, $.01 par value: 170,000,000 shares authorized at March 31, 2019 and December 31, 2018; 95,796,597 shares and 95,366,813 shares issued at March 31, 2019 and December 31, 2018; 95,717,052 shares and 95,287,268 shares outstanding at March 31, 2019 and December 31, 2018, respectively | 957,965 | 953,667 |
Additional paid-in capital | 599,301,966 | 596,710,648 |
Treasury stock, at cost: 79,545 shares held at March 31, 2019 and December 31, 2018 | (8,034,244) | (8,034,244) |
Accumulated other comprehensive loss | (914,535) | (1,226,320) |
Accumulated deficit | (487,114,906) | (478,941,285) |
Total stockholders' equity | 104,196,246 | 109,462,466 |
Total liabilities, redeemable noncontrolling interest and stockholders' equity | $ 131,060,301 | $ 113,410,001 |
Unaudited Condensed Consolida_2
Unaudited Condensed Consolidated Balance Sheets [Parenthetical] - $ / shares | Mar. 31, 2019 | Dec. 31, 2018 |
Stockholders' Equity, Number of Shares, Par Value and Other Disclosures [Abstract] | ||
Preferred Stock, Par or Stated Value Per Share | $ 1 | $ 1 |
Preferred Stock, Shares Authorized | 5,000,000 | 5,000,000 |
Preferred Stock, Shares Issued | 0 | 0 |
Preferred Stock, Shares Outstanding | 0 | 0 |
Common stock, par value | $ 0.01 | $ 0.01 |
Common stock, shares authorized | 170,000,000 | 170,000,000 |
Common stock, shares issued | 95,796,597 | 95,366,813 |
Common Stock, Shares, Outstanding | 95,717,052 | 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 ($) | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Revenues: | ||
Product sales | $ 0 | $ 0 |
Costs and expenses: | ||
Research and development | 2,614,657 | 1,697,232 |
General and administrative | 5,709,687 | 1,303,122 |
Acquired in-process research and development | 0 | 686,998 |
Costs and expenses | 8,324,344 | 3,687,352 |
Interest income, net | (48,584) | (6,729) |
Foreign exchange gains | (71,109) | 0 |
Changes in fair value of investment in equity securities | (45,389) | (89,713) |
Net loss | (8,159,262) | (3,590,910) |
Less: Income attributable to redeemable noncontrolling interest | 14,359 | 0 |
Net loss attributable to CASI Pharmaceuticals, Inc. | $ (8,173,621) | $ (3,590,910) |
Net loss per share (basic and diluted) | $ (0.09) | $ (0.05) |
Weight average number of shares outstanding (basic and diluted) | 95,649,773 | 71,215,000 |
Comprehensive loss: | ||
Net loss | $ (8,159,262) | $ (3,590,910) |
Foreign currency translation adjustment | 311,785 | 527,251 |
Total comprehensive loss | (7,847,477) | (3,063,659) |
Less: Comprehensive income attributable to redeemable noncontrolling interest | 14,359 | 0 |
Comprehensive loss attributable to common stockholders | $ (7,861,836) | $ (3,063,659) |
Unaudited Condensed Consolida_4
Unaudited Condensed Consolidated Statements of Stockholders' Equity - USD ($) | Total | Preferred Stock [Member] | Common Stock [Member] | Treasury Stock [Member] | Additional Paid-in Capital [Member] | Accumulated Other Comprehensive Loss [Member] | Accumulated Deficit [Member] |
Balance at Dec. 31, 2017 | $ 38,540,114 | $ 0 | $ 699,015 | $ (8,034,244) | $ 498,577,372 | $ 0 | $ (452,702,029) |
Balance (in Shares) at Dec. 31, 2017 | 0 | 69,822,080 | |||||
Correction of immaterial error in prior year and cumulative effect adjustment due to the adoption of ASU 2016-01 | 1,232,312 | $ 0 | $ 0 | 0 | 0 | 0 | 1,232,312 |
Issuance of common stock and warrants pursuant to financing agreements | 29,790,217 | $ 0 | $ 91,865 | 0 | 29,698,352 | 0 | 0 |
Issuance of common stock and warrants pursuant to financing agreements (in shares) | 0 | 9,186,452 | |||||
Issuance of common stock for options exercised | 98,022 | $ 0 | $ 572 | 0 | 97,450 | 0 | 0 |
Issuance of common stock for options exercised (in shares) | 0 | 57,214 | |||||
Issuance of common stock from exercise of warrants | 973,660 | $ 0 | $ 5,762 | 0 | 967,898 | 0 | 0 |
Issuance of common stock from exercise of warrants (in shares) | 0 | 576,130 | |||||
Stock issuance costs | (211,685) | $ 0 | $ 0 | 0 | (211,685) | 0 | 0 |
Stock-based compensation expense, net of forfeitures | 260,040 | 0 | 0 | 0 | 260,040 | 0 | 0 |
Foreign currency translation adjustment | 527,251 | 0 | 0 | 0 | 0 | 527,251 | 0 |
Net loss attributable to CASI Pharmaceuticals, Inc. | (3,590,910) | 0 | 0 | 0 | 0 | 0 | (3,590,910) |
Balance at Mar. 31, 2018 | 67,619,021 | $ 0 | $ 797,214 | (8,034,244) | 529,389,427 | 527,251 | (455,060,627) |
Balance (in shares) at Mar. 31, 2018 | 0 | 79,641,876 | |||||
Balance at Dec. 31, 2018 | 109,462,466 | $ 0 | $ 953,667 | (8,034,244) | 596,710,648 | (1,226,320) | (478,941,285) |
Balance (in Shares) at Dec. 31, 2018 | 0 | 95,287,268 | |||||
Accretion of redeemable noncontrolling interest | (2,558) | $ 0 | $ 0 | 0 | (2,558) | 0 | 0 |
Issuance of common stock for options exercised | 38,302 | $ 0 | $ 183 | 0 | 38,119 | 0 | 0 |
Issuance of common stock for options exercised (in shares) | 0 | 18,262 | |||||
Repurchase of stock options to satisfy tax withholding obligations | (11,749) | $ 0 | $ 0 | 0 | (11,749) | 0 | 0 |
Issuance of common stock from exercise of warrants | 695,472 | $ 0 | $ 4,115 | 0 | 691,357 | 0 | 0 |
Issuance of common stock from exercise of warrants (in shares) | 0 | 411,522 | |||||
Stock issuance costs | (6,697) | $ 0 | $ 0 | 0 | (6,697) | 0 | 0 |
Stock-based compensation expense, net of forfeitures | 1,882,846 | 0 | 0 | 0 | 1,882,846 | 0 | 0 |
Foreign currency translation adjustment | 311,785 | 0 | 0 | 0 | 0 | 311,785 | 0 |
Net loss attributable to CASI Pharmaceuticals, Inc. | (8,173,621) | 0 | 0 | 0 | 0 | 0 | (8,173,621) |
Balance at Mar. 31, 2019 | $ 104,196,246 | $ 0 | $ 957,965 | $ (8,034,244) | $ 599,301,966 | $ (914,535) | $ (487,114,906) |
Balance (in shares) at Mar. 31, 2019 | 0 | 95,717,052 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Cash Flows - USD ($) | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
CASH FLOWS FROM OPERATING ACTIVITIES | ||
Net loss | $ (8,159,262) | $ (3,590,910) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization for property and equipment | 138,880 | 65,822 |
Net loss on disposal of furniture and equipment | 1,142 | 0 |
Amortization of intangible assets | 386,673 | 250,141 |
Impairment loss related to intangible assets | 48,391 | 0 |
Stock-based compensation expense | 1,882,846 | 260,040 |
Acquired in-process research and development | 0 | 552,863 |
Change in fair value of investment in equity securities | (45,389) | (89,713) |
Non-cash interest | 177 | 177 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other assets | 702,887 | (377,087) |
Accounts payable | 404,606 | (522,274) |
Payable to related party | 0 | (2,228,366) |
Accrued liabilities and other liabilities | (579,718) | (287,672) |
Net cash used in operating activities | (5,218,767) | (5,966,979) |
CASH FLOWS FROM INVESTING ACTIVITIES | ||
Proceeds from sale of furniture and equipment | 30 | 0 |
Purchases of property and equipment | (252,071) | (155,144) |
Acquisition of abbreviated new drug applications and related items | 0 | (18,607,848) |
Net cash used in investing activities | (252,041) | (18,762,992) |
CASH FLOWS FROM FINANCING ACTIVITIES | ||
Stock issuance costs | (6,697) | (211,685) |
Proceeds from sale of common stock and warrants | 0 | 29,790,217 |
Cash contribution from redeemable noncontrolling interest | 20,000,000 | 0 |
Proceeds from exercise of stock options | 38,302 | 98,022 |
Repurchase of stock options to satisfy tax withholding obligations | (11,749) | 0 |
Proceeds from exercise of warrants | 695,472 | 973,660 |
Net cash provided by financing activities | 20,715,328 | 30,650,214 |
Effect of exchange rate change on cash and cash equivalents | 284,291 | 477,422 |
Net increase in cash and cash equivalents | 15,528,811 | 6,397,665 |
Cash and cash equivalents at beginning of period | 84,204,809 | 43,489,935 |
Cash and cash equivalents at end of period | 99,733,620 | 49,887,600 |
Supplemental disclosure of cash flow information: | ||
Interest paid | 0 | 0 |
Income taxes paid | $ 0 | $ 0 |
Basis of Presentation
Basis of Presentation | 3 Months Ended |
Mar. 31, 2019 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Basis of Accounting [Text Block] | 1. Basis of Presentation CASI Pharmaceuticals, Inc. (“CASI” or the “Company”) (Nasdaq: CASI) is a U.S. pharmaceutical company with a platform to develop and accelerate the launch of pharmaceutical products and innovative therapeutics in China, U.S., and throughout the world. The Company is focused on acquiring, licensing, developing and commercializing products that address areas of unmet medical needs. The Company intends to execute its plan to become a leading platform to launch medicines in the greater China market leveraging its China-based regulatory and commercial competencies and its global drug development expertise. The Company’s China operations are conducted through its wholly-owned subsidiary, CASI Pharmaceuticals (Beijing) Co., Ltd. (“CASI China”), which is based in Beijing, China. CASI China has established China operations that are growing as the Company continues to further in-license or acquire products for its pipeline. 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, and CASI Pharmaceuticals (Wuxi) Co., Ltd. (“CASI Wuxi”). 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 manufacturing capability in China in 2019. The Company controls CASI Wuxi by virtue of its 80% voting rights 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 month period ended March 31, 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 have been reclassified to conform to the December 31, 2018 presentation. Liquidity Risks and Management’s Plans Since inception, the Company has incurred significant losses from operations and has incurred an accumulated deficit of $487.1 million. The Company expects to continue to incur operating losses for the foreseeable future due to, among other factors, its continuing clinical and development activities. Taking into consideration the cash balance as of March 31, 2019 and its commitments to fund CASI Wuxi, the Company believes that it has sufficient resources to fund its operations at least through May 15, 2020. As of March 31, 2019, approximately $12.6 million of the Company’s cash balance was held by CASI China, and approximately $41.0 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 in China to support the Company’s dual-country approach to drug development. |
New Accounting Pronouncements
New Accounting Pronouncements | 3 Months Ended |
Mar. 31, 2019 | |
Accounting Changes and Error Corrections [Abstract] | |
New Accounting Pronouncements and Changes in Accounting Principles [Text Block] | 2. 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 · 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 $3.2 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 | 3 Months Ended |
Mar. 31, 2019 | |
Schedule of Investments [Abstract] | |
Investment in Equity Securities [Text Block] | 3. Investment in Equity Securities 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 March 31, 2019 and December 31, 2018 (see Note 12). The following table summarizes the Company’s investment as of March 31, 2019: Description Classification Cost Gross unrealized gains Aggregate fair value Common stock Investment $ - $ 957,589 $ 957,589 Unrealized gains on the Company’s equity investment for the three months ended March 31, 2019 and 2018 were $45,389 and $89,713, 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. |
Inventories
Inventories | 3 Months Ended |
Mar. 31, 2019 | |
Inventory Disclosure [Abstract] | |
Inventory Disclosure | 4. Inventories Inventories consist of raw materials and are stated at the lower of cost or net realizable value. Cost is determined using a first-in, first-out method. The carrying value of raw materials inventory was approximately $283,000 as of March 31, 2019 and is included in “prepaid expenses and other” in the accompanying condensed consolidated balance sheets. |
Leases
Leases | 3 Months Ended |
Mar. 31, 2019 | |
Leases [Abstract] | |
Leases of Lessee Disclosure [Text Block] | 5. Leases As discussed in Note 2, 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 March 31, 2019. As of March 31, 2019, the Company did not have any finance leases. All of the Company’s existing leases as of March 31, 2019 are classified as operating leases. As of March 31, 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 2.66 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 three months ended March 31, 2019 consisted of approximately $301,000 of total operating lease cost. There was no variable lease cost or sublease income for the three months ended March 31, 2019. The impact of Topic 842 on the March 31, 2019 condensed consolidated balance sheet was as follows: March 31, 2019 Other assets $ 2,833,385 Accrued liabilities $ 1,114,909 Other liabilities 1,843,212 Total lease liabilities $ 2,958,121 Supplemental cash flow information related to leases was as follows: Three Month Period ended March 31, 2019 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows $ 308,260 Right of use assets obtained in exchange for lease obligations: $ 3,030,126 A maturity analysis of our operating leases as of March 31, 2019 follows: Future undiscounted cash flows: 2019 (remaining nine months) $ 951,826 2020 1,279,327 2021 839,024 2022 144,643 Thereafter - Total 3,214,820 Discount factor (256,699 ) Lease liability 2,958,121 Amounts due within 12 months 1,114,909 Non-current lease liability $ 1,843,212 In 2018 the Company entered into a lease on behalf of CASI Wuxi. As of March 31, 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 statement 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: 2019 $ 1,311,707 2020 1,297,102 2021 856,832 2022 129,918 Thereafter - Total minimum payments $ 3,595,559 Rental expense for the year ended December 31, 2018 was approximately $916,000. |
Intangible Assets
Intangible Assets | 3 Months Ended |
Mar. 31, 2019 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Intangible Assets Disclosure [Text Block] | 6. Intangible Assets Intangible assets were acquired as part of 2018 asset acquisitions and include ANDAs for previously marketed generic products. 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. An impairment loss of $48,391 related to intangible assets was recognized in the three months ended March 31, 2019 and classified as research and development expenses. Net definite-lived intangible assets at March 31, 2019, excluding the withdrawn ANDAs discussed above consists of the following: Asset Gross Value Accumulated Amortization Estimated useful lives ANDAs $ 18,001,762 $ (1,634,155 ) 13 years TDF ANDA $ 2,035,121 $ (53,066 ) 13 years Total $ 20,036,883 $ (1,687,221 ) Expected future amortization expense is as follows as of March 31, 2019: 2019 (remaining nine months) $ 1,156,949 2020 1,542,599 2021 1,542,599 2022 1,542,599 2023 1,542,599 2024 and thereafter 11,022,317 |
Redeemable Noncontrolling Inter
Redeemable Noncontrolling Interest | 3 Months Ended |
Mar. 31, 2019 | |
Noncontrolling Interest [Abstract] | |
Noncontrolling Interest Disclosure [Text Block] | 7. 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, 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 investment in RMB of $20 million in cash (paid in March 2019). 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 to 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 interests to the redemption value is recorded in additional paid-in capital. Changes in redeemable noncontrolling interest during the three months ended March 31, 2019 are as follows: Balance as of January 1, 2019 $ - Cash contribution by Wuxi LP 20,000,000 Share of CASI Wuxi net income 14,359 Accretion of redeemable noncontrolling interest 2,558 Balance as of March 31, 2019 $ 20,016,917 |
Stockholders' Equity
Stockholders' Equity | 3 Months Ended |
Mar. 31, 2019 | |
Stockholders' Equity Note [Abstract] | |
Stockholders' Equity Note Disclosure [Text Block] | 8. Stockholders’ Equity Stock purchase warrants activity for the three months ended is as follows: Number of Warrants Weighted Average Exercise Price Outstanding at January 1, 2019 11,781,825 $ 3.98 Issued - $ - Exercised (411,522 ) $ 1.69 Expired - $ - Outstanding at March 31, 2019 11,370,303 $ 4.06 Exercisable at March 31, 2019 11,370,303 $ 4.06 All outstanding warrants are equity classified. |
Net Loss Per Share
Net Loss Per Share | 3 Months Ended |
Mar. 31, 2019 | |
Earnings Per Share [Abstract] | |
Earnings Per Share [Text Block] | 9. 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 30,306,159 and 21,207,452 as of March 31, 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. |
Stock-Based Compensation
Stock-Based Compensation | 3 Months Ended |
Mar. 31, 2019 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Disclosure of Compensation Related Costs, Share-based Payments [Text Block] | 10. Stock-Based Compensation As of March 31, 2019, a total of 6,302,234 shares remained available for grant under the Company’s 2011 Long-Term Incentive Plan. The Company’s net loss for the three months ended March 31, 2019 and 2018 includes $1,882,846 and $260,040, 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: Three Month Period ended March 31, 2019 2018 Research and development $ 116,215 $ 103,767 General and administrative 1,766,631 156,273 Share-based compensation expense $ 1,882,846 $ 260,040 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 three months ended March 31, 2019, approximately $27,600 was expensed for share awards with performance conditions that became probable during that period. There was no expense recorded for share awards with performance conditions during the three months ended March 31, 2018. 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 three-month periods ended March 31, 2019 and 2018: Three Month Period ended March 31, 2019 2018 Expected volatility 80.44 % 79.51 % Risk free interest rate 2.57 % 2.63 % Expected term of option 6.62 6.31 Expected dividend yield 0.00 % 0.00 % The weighted average fair value of stock options granted during the three-month periods ended March 31, 2019 and 2018 were $2.69 and $2.61, respectively. A summary of the Company's stock option plans and of changes in options outstanding under the plans during the three-month period ended March 31, 2019 is as follows: Number of Options Weighted Average Exercise Price Outstanding at January 1, 2019 18,429,308 $ 2.44 Exercised (21,362 ) $ 1.79 Granted 540,000 $ 3.72 Expired (4,090 ) $ 1.87 Forfeited (8,000 ) $ 3.43 Outstanding at March 31, 2019 18,935,856 $ 2.48 Exercisable at March 31, 2019 10,910,743 $ 1.76 Cash received from option exercises under all share-based payment arrangements for the three months ended March 31, 2019 and 2018 was $38,302 and $98,022, respectively. Upon the recommendation of the Compensation Committee, the Company’s Board of Directors (the “Board”) approved a grant of stock options to the Company’s Chairman and CEO, effective April 2, 2019. Under the terms of the grant, subject to stockholder approval and cancellation of his existing performance-based option, on April 2, 2019 he received a stock option covering 4 million shares of common stock, at an exercise price of $2.85, the closing price on the grant date, vesting at the earlier of (i) the completion of a transformative event by the Company as determined in the discretion of the Compensation Committee and (ii) the second anniversary of the date of grant. The grant is conditioned upon stockholder approval at the 2019 Annual Meeting of Stockholders and is not included in the above table. |
Income Taxes
Income Taxes | 3 Months Ended |
Mar. 31, 2019 | |
Income Tax Disclosure [Abstract] | |
Income Tax Disclosure [Text Block] | 11. 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 three months ended March 31, 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 March 31, 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 | 3 Months Ended |
Mar. 31, 2019 | |
Fair Value Disclosures [Abstract] | |
Fair Value Disclosures [Text Block] | 12. Fair Value Measurements The majority of the Company’s financial instruments (consisting principally of cash and cash equivalents, 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 3). The Company’s note payable is 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 3). The following tables presents the Company’s financial assets and liabilities accounted for at fair value on a recurring basis as of March 31, 2019 and December 31, 2018, by level within the fair value hierarchy: Description Fair Value at March 31, 2019 Level 1 Level 2 Level 3 Investment in common stock $ 957,589 $ 957,589 $ - $ - Description Fair Value at December 31, 2018 Level 1 Level 2 Level 3 Investment in common stock $ 912,200 $ 912,200 $ - $ - Financial Liabilities Measured at Fair Value on a Non-Recurring Basis In connection with entering into the various securities purchase agreements in 2018, the Company issued shares of its common stock along with detachable stock purchase warrants. The Company allocates the proceeds received to the common stock and warrants on a relative fair value basis. The fair value of the common stock is based on quoted market price for the Company’s common stock, a Level 1 input. The fair value of the stock purchase warrants is determined using the Black-Scholes-Merton option pricing model which uses Level 3 unobservable inputs. Non-Financial Assets and Liabilities Measured at Fair Value on a Recurring Basis The Company has no non-financial assets and liabilities that are measured at fair value on a recurring basis. Non-Financial Assets and Liabilities Measured at Fair Value on a Non-Recurring Basis The Company measures its long-lived assets, including property and equipment and intangible assets, at fair value on a non-recurring basis. These assets are recognized at fair value when they are deemed to be other-than-temporarily impaired. An impairment loss of $ 48,391 In 2018, the Company acquired certain ANDAs pursuant to transactions accounted for as asset acquisitions. The intangible assets acquired from Sandoz were estimated using the discounted cash flow method (an income approach), which involves the use of Level 3 inputs such as estimates for projected sales, expenses, and cash flows, expected income and value-added tax rates, and a required rate of return adjusted for both industry and Company-specific risks, among other inputs. The fair values of the remaining ANDAs were estimated using a multiple of values method (an income approach), which involved using Level 3 inputs such as estimated addressable markets and market penetration rates. The fair value of the API was estimated using Level 2 inputs, such as quoted market prices for similar API from various suppliers or other sources. |
Related Party Transactions
Related Party Transactions | 3 Months Ended |
Mar. 31, 2019 | |
Related Party Transactions [Abstract] | |
Related Party Transactions Disclosure [Text Block] | 13. Related Party Transactions The Company has supply agreements with Spectrum for the purchase of EVOMELA, ZEVALIN, and MARQIBO in China for quality testing purposes to support CASI’s application for import drug registration and for commercialization purposes. The former CEO of Spectrum is also a member of CASI’s Board, and Spectrum is a greater than 10% shareholder of the Company. In 2018 and 2019, the Company entered into commercial purchase obligation commitments for EVOMELA from Spectrum totaling approximately $12.3 million. As of March 31, 2019, the Company paid $4,850,000 as a deposit for the purchase of EVOMELA expected to be delivered in 2019. The advance payments made to Spectrum are reflected as prepaid expenses and other in the accompanying condensed consolidated balance sheets as of March 31, 2019 and December 31, 2018. In April 2019, the Company paid additional deposits for EVOMELA to Spectrum totaling $2.8 million. There were no other materials purchased from Spectrum during the three months ended March 31, 2019 or 2018. As of March 31, 2019 and December 31, 2018, there were no material amounts payable to Spectrum. |
License Arrangements
License Arrangements | 3 Months Ended |
Mar. 31, 2019 | |
License Arrangements Disclosure [Abstract] | |
License Arrangements Disclosure [Text Block] | 14. License Arrangements The Company has certain product rights and perpetual exclusive licenses from Acrotech BioPharma L.L.C. (“Acrotech”) to develop and commercialize the following commercial oncology drugs and drug candidates in the greater China region (which includes China, Taiwan, Hong Kong and Macau) (the “Territories”): Melphalan Hydrochloride For Injection (EVOMELA)(“EVOMELA”); Ibritumomab Tiuxetan (ZEVALIN) (“ZEVALIN”); and Vincristine Sulfate Liposome Injection (MARQIBO), (“MARQIBO”). CASI is responsible for developing and commercializing these three drugs in the Territories, including the submission of import drug registration applications and conducting confirmatory clinical trials as needed. In March 2016, Spectrum, the former owner of EVOMELA, ZEVALIN and MARQIBO, received notification from the FDA of the grant of approval of its New Drug Application (NDA) for EVOMELA primarily for use as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma. In December 2016, the 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 is building an internal commercial team to prepare for the commercial launch EVOMELA in 2019. The Company is also preparing for a post-marketing study. The Company is in various stages of the regulatory and development process to obtain marketing approval for ZEVALIN and MARQIBO in its territorial region, with ZEVALIN commercially available in Hong Kong. In 2017, the NMPA accepted for review the Company’s import drug registration for ZEVALIN including both the antibody kit and the radioactive Yttrium-90 component. On February 12, 2019, the Company received NMPA’s approval of the Company’s CTA to allow for a confirmatory registration trial to evaluate the efficacy and safety of ZEVALIN. In 2016, the NMPA accepted for review the Company’s import drug registration application for MARQIBO. On March 4, 2019 the Company received NMPA’s approval of the Company’s CTA to allow for a confirmatory registration trial to evaluate the efficacy and safety of MARQIBO. The Company intends to advance both of these products. |
Commitments
Commitments | 3 Months Ended |
Mar. 31, 2019 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies Disclosure [Text Block] | 15. Commitments In 2018, the Company entered into purchase obligation commitments for EVOMELA from Spectrum for approximately $9.2 million. In March 2019, the Company entered into an additional purchase obligation commitment for EVOMELA from Spectrum for approximately $3.1 million. The Company expects all of the EVOMELA product to be delivered in 2019. In 2018, the Company paid $4.8 million as a deposit for the purchase of EVOMELA. The deposits made to Spectrum are reflected as prepaid expense and other in the accompanying condensed consolidated balance sheets as of March 31, 2019 and December 31, 2018. In April 2019, the Company paid additional deposits for EVOMELA to Spectrum totaling $2.8 million. In 2018, the Company committed to invest $80 million in CASI Wuxi, of which $21 million was invested in February 2019 (see Note 7). |
Subsequent Event
Subsequent Event | 3 Months Ended |
Mar. 31, 2019 | |
Subsequent Events [Abstract] | |
Subsequent Events [Text Block] | 16. Subsequent Event On April 16, 2019, the Company entered into a License Agreement (the “License Agreement”) with Black Belt Therapeutics Limited (“Black Belt”), a company established under the laws of England, pursuant to which the Company obtained an exclusive, worldwide license for an investigational anti-CD38 monoclonal antibody (Mab), CID-103. Pursuant to the License Agreement, the Company made an upfront payment of 5,000,000 euro, and will make potential future payments of development and sales milestones and royalties. The Company will also make an equity investment of 2,000,000 euro in a newly established company that will carry on the work of Black Belt in new therapeutic areas. CASI will be responsible for all development and commercialization activities worldwide. The License Agreement contains customary representations, warranties, covenants and indemnification provisions. |
New Accounting Pronouncements (
New Accounting Pronouncements (Policies) | 3 Months Ended |
Mar. 31, 2019 | |
Accounting Policies [Abstract] | |
New Accounting Pronouncements, Policy [Policy Text Block] | Recently Adopted Pronouncements Effective January 1, 2019, the Company adopted Financial Accounting Standards Board (“FASB”) Accounting Standards Update (“ASU”) 2016-02, Leases · 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 $3.2 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 (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Schedule of Investments [Abstract] | |
Investment Holdings, Schedule of Investments [Table Text Block] | The following table summarizes the Company’s investment as of March 31, 2019: Description Classification Cost Gross unrealized gains Aggregate fair value Common stock Investment $ - $ 957,589 $ 957,589 |
Leases (Tables)
Leases (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Leases [Abstract] | |
Disclosure of Lease on Consolidated Balance Sheet [Table Text Block] | The impact of Topic 842 on the March 31, 2019 condensed consolidated balance sheet was as follows: March 31, 2019 Other assets $ 2,833,385 Accrued liabilities $ 1,114,909 Other liabilities 1,843,212 Total lease liabilities $ 2,958,121 |
Disclosure of Supplemental cash flow information related to leases [Table Text Block] | Supplemental cash flow information related to leases was as follows: Three Month Period ended March 31, 2019 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows $ 308,260 Right of use assets obtained in exchange for lease obligations: $ 3,030,126 |
Lessee, Operating Lease, Liability, Maturity [Table Text Block] | A maturity analysis of our operating leases as of March 31, 2019 follows: Future undiscounted cash flows: 2019 (remaining nine months) $ 951,826 2020 1,279,327 2021 839,024 2022 144,643 Thereafter - Total 3,214,820 Discount factor (256,699 ) Lease liability 2,958,121 Amounts due within 12 months 1,114,909 Non-current lease liability $ 1,843,212 |
Schedule of Future Minimum Rental Payments for Operating Leases [Table Text Block] | As previously disclosed in the consolidated financial statement 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: 2019 $ 1,311,707 2020 1,297,102 2021 856,832 2022 129,918 Thereafter - Total minimum payments $ 3,595,559 |
Intangible Assets (Tables)
Intangible Assets (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Finite-lived Intangible Assets Amortization Expense [Table Text Block] | Net definite-lived intangible assets at March 31, 2019, excluding the withdrawn ANDAs discussed above consists of the following: Asset Gross Value Accumulated Amortization Estimated useful lives ANDAs $ 18,001,762 $ (1,634,155 ) 13 years TDF ANDA $ 2,035,121 $ (53,066 ) 13 years Total $ 20,036,883 $ (1,687,221 ) |
Schedule of Finite-Lived Intangible Assets, Future Amortization Expense [Table Text Block] | Expected future amortization expense is as follows as of March 31, 2019: 2019 (remaining nine months) $ 1,156,949 2020 1,542,599 2021 1,542,599 2022 1,542,599 2023 1,542,599 2024 and thereafter 11,022,317 |
Redeemable Noncontrolling Int_2
Redeemable Noncontrolling Interest (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Noncontrolling Interest [Abstract] | |
Redeemable Noncontrolling Interest [Table Text Block] | Changes in redeemable noncontrolling interest during the three months ended March 31, 2019 are as follows: Balance as of January 1, 2019 $ - Cash contribution by Wuxi LP 20,000,000 Share of CASI Wuxi net income 14,359 Accretion of redeemable noncontrolling interest 2,558 Balance as of March 31, 2019 $ 20,016,917 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Stockholders' Equity Note [Abstract] | |
Schedule Of Warrant Activity [Table Text Block] | Stock purchase warrants activity for the three months ended is as follows: Number of Warrants Weighted Average Exercise Price Outstanding at January 1, 2019 11,781,825 $ 3.98 Issued - $ - Exercised (411,522 ) $ 1.69 Expired - $ - Outstanding at March 31, 2019 11,370,303 $ 4.06 Exercisable at March 31, 2019 11,370,303 $ 4.06 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Schedule of Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Table Text Block] | Three Month Period ended March 31, 2019 2018 Research and development $ 116,215 $ 103,767 General and administrative 1,766,631 156,273 Share-based compensation expense $ 1,882,846 $ 260,040 |
Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions [Table Text Block] | Three Month Period ended March 31, 2019 2018 Expected volatility 80.44 % 79.51 % Risk free interest rate 2.57 % 2.63 % Expected term of option 6.62 6.31 Expected dividend yield 0.00 % 0.00 % |
Schedule of Share-based Compensation, Stock Options, Activity [Table Text Block] | A summary of the Company's stock option plans and of changes in options outstanding under the plans during the three-month period ended March 31, 2019 is as follows: Number of Options Weighted Average Exercise Price Outstanding at January 1, 2019 18,429,308 $ 2.44 Exercised (21,362 ) $ 1.79 Granted 540,000 $ 3.72 Expired (4,090 ) $ 1.87 Forfeited (8,000 ) $ 3.43 Outstanding at March 31, 2019 18,935,856 $ 2.48 Exercisable at March 31, 2019 10,910,743 $ 1.76 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |
Schedule of Fair Value, Assets and Liabilities Measured on Recurring Basis [Table Text Block] | The following tables presents the Company’s financial assets and liabilities accounted for at fair value on a recurring basis as of March 31, 2019 and December 31, 2018, by level within the fair value hierarchy: Description Fair Value at March 31, 2019 Level 1 Level 2 Level 3 Investment in common stock $ 957,589 $ 957,589 $ - $ - Description Fair Value at December 31, 2018 Level 1 Level 2 Level 3 Investment in common stock $ 912,200 $ 912,200 $ - $ - |
Basis of Presentation (Details
Basis of Presentation (Details Textual) - USD ($) | Mar. 31, 2019 | Dec. 31, 2018 |
Description of Business and Basis of Presentation [Line Items] | ||
Retained Earnings (Accumulated Deficit) | $ (487,114,906) | $ (478,941,285) |
Percentage Of Ownership Interest In Non Stock Subsidiary | 100.00% | |
CASI China [Member] | ||
Description of Business and Basis of Presentation [Line Items] | ||
Cash | $ 12,600,000 | |
CASI Wuxi [Member] | ||
Description of Business and Basis of Presentation [Line Items] | ||
Percentage Of Ownership Interest In Non Stock Subsidiary | 80.00% | |
Cash | $ 41,000,000 |
New Accounting Pronouncements_2
New Accounting Pronouncements (Details Textual) - USD ($) | Mar. 31, 2019 | Jan. 01, 2019 |
Operating Lease, Right-of-Use Asset | $ 3,030,126 | |
Operating Lease, Liability | $ 2,958,121 | |
Accounting Standards Update 2016-02 [Member] | ||
Operating Lease, Right-of-Use Asset | $ 3 | |
Operating Lease, Liability | $ 3.2 |
Investment in Equity Securiti_3
Investment in Equity Securities (Details) - Common Stock [Member] | 3 Months Ended |
Mar. 31, 2019USD ($) | |
Cost | $ 0 |
Gross unrealized gains | 957,589 |
Aggregate fair value | $ 957,589 |
Investment in Equity Securiti_4
Investment in Equity Securities (Details Textual) - USD ($) | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Fair Value, Adjustment Disclosure [Abstract] | ||
Change in fair value of investment in equity securities | $ (45,389) | $ (89,713) |
Inventories (Details Textual)
Inventories (Details Textual) | Mar. 31, 2019USD ($) |
Raw Materials [Member] | |
Inventory [Line Items] | |
Inventory, Raw Materials, Net of Reserves | $ 283,000 |
Leases (Details)
Leases (Details) | Mar. 31, 2019USD ($) |
Operating Lease, Liability | $ 2,958,121 |
Other Assets [Member] | |
Operating Lease, Liability | 2,833,385 |
Accrued liabilities [Member] | |
Operating Lease, Liability | 1,114,909 |
Other Liabilities [Member] | |
Operating Lease, Liability | $ 1,843,212 |
Leases (Details 1)
Leases (Details 1) | 3 Months Ended |
Mar. 31, 2019USD ($) | |
Cash paid for amounts included in the measurement of lease liabilities: | |
Operating cash flows | $ 308,260 |
Right of use assets obtained in exchange for lease obligations: | $ 3,030,126 |
Leases (Details 2)
Leases (Details 2) | Mar. 31, 2019USD ($) |
Leases [Abstract] | |
2019 (remaining nine months) | $ 951,826 |
2020 | 1,279,327 |
2021 | 839,024 |
2022 | 144,643 |
Thereafter | 0 |
Total | 3,214,820 |
Discount factor | (256,699) |
Lease liability | 2,958,121 |
Amounts due within 12 months | 1,114,909 |
Non-current lease liability | $ 1,843,212 |
Leases (Details 3)
Leases (Details 3) - USD ($) | Mar. 31, 2019 | Dec. 31, 2018 |
Leases [Abstract] | ||
2019 | $ 1,311,707 | |
2020 | 1,297,102 | |
2021 | 856,832 | |
2022 | 129,918 | |
Thereafter | 0 | |
Total minimum payments | $ 3,789,000 | $ 3,595,559 |
Leases (Details Textual)
Leases (Details Textual) - USD ($) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2019 | Dec. 31, 2018 | |
Leases [Abstract] | ||
Operating Lease, Weighted Average Remaining Lease Term | 2 years 7 months 27 days | |
Operating Lease, Cost | $ 301,000 | |
Operating Leases, Future Minimum Payments Due | $ 3,789,000 | $ 3,595,559 |
Operating Leases, Rent Expense, Net | $ 916,000 |
Intangible Assets (Details)
Intangible Assets (Details) | 3 Months Ended |
Mar. 31, 2019USD ($) | |
Finite-Lived Intangible Assets [Line Items] | |
Gross Value | $ 20,036,883 |
Accumulated Amortization | (1,687,221) |
Abbreviated New Drug Applications [Member] | |
Finite-Lived Intangible Assets [Line Items] | |
Gross Value | 18,001,762 |
Accumulated Amortization | $ (1,634,155) |
Estimated useful lives | 13 years |
Abbreviated New Drug Applications TDF [Member] | |
Finite-Lived Intangible Assets [Line Items] | |
Gross Value | $ 2,035,121 |
Accumulated Amortization | $ (53,066) |
Estimated useful lives | 13 years |
Intangible Assets (Details 1)
Intangible Assets (Details 1) | Mar. 31, 2019USD ($) |
Goodwill and Intangible Assets Disclosure [Abstract] | |
2019 (remaining nine months) | $ 1,156,949 |
2020 | 1,542,599 |
2021 | 1,542,599 |
2022 | 1,542,599 |
2023 | 1,542,599 |
2024 and thereafter | $ 11,022,317 |
Intangible Assets (Details Text
Intangible Assets (Details Textual) - USD ($) | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Finite-Lived Intangible Assets [Line Items] | ||
Impairment of Intangible Assets, Finite-lived | $ 48,391 | $ 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 | $ 48,391 |
Redeemable Noncontrolling Int_3
Redeemable Noncontrolling Interest (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Noncontrolling Interest [Abstract] | ||
Balance as of January 1, 2019 | $ 0 | |
Cash contribution by Wuxi LP | 20,000,000 | $ 0 |
Share of CASI Wuxi net income | 14,359 | $ 0 |
Accretion of redeemable noncontrolling interest | (2,558) | |
Balance as of March 31, 2019 | $ 20,016,917 |
Redeemable Noncontrolling Int_4
Redeemable Noncontrolling Interest (Details Textual) - USD ($) | 3 Months Ended | |||
Mar. 31, 2019 | Feb. 28, 2019 | Dec. 31, 2018 | Dec. 26, 2018 | |
Noncontrolling Interest [Line Items] | ||||
Redeemable Noncontrolling Interest, Equity, Redemption Value | $ 20,016,917 | $ 0 | ||
CASI Wuxi [Member] | ||||
Noncontrolling Interest [Line Items] | ||||
Equity Method Investment, Ownership Percentage | 20.00% | |||
Payments to Acquire Investments | $ 20,000,000 | |||
CASI Wuxi [Member] | ||||
Noncontrolling Interest [Line Items] | ||||
Equity Method Investment, Ownership Percentage | 80.00% | |||
Investment Commitment | $ 80,000,000 | |||
Initial Cash Investment | $ 21,000,000 | |||
Value of a future transfer of selected ANDAs | 30,000,000 | |||
Payments To Be Paid Within Three Years | $ 29,000,000 | |||
CASI Wuxi [Member] | Call Option [Member] | ||||
Noncontrolling Interest [Line Items] | ||||
Equity Method Investment, Ownership Percentage | 20.00% | |||
CASI Wuxi [Member] | Put Option [Member] | ||||
Noncontrolling Interest [Line Items] | ||||
Equity Method Investment, Ownership Percentage | 20.00% |
Stockholders' Equity (Details)
Stockholders' Equity (Details) - Warrant [Member] | 3 Months Ended |
Mar. 31, 2019$ / sharesshares | |
Outstanding at Number of Warrants, Beginning Balance | shares | 11,781,825 |
Issued Number of Warrants | shares | 0 |
Exercised Number of Warrants | shares | (411,522) |
Expired Number of Warrants | shares | 0 |
Outstanding at Number of Warrants, Ending Balance | shares | 11,370,303 |
Exercisable Number of Warrants | shares | 11,370,303 |
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 | 4.06 |
Exercisable Weighted Average Exercise Price | $ / shares | $ 4.06 |
Net Loss Per Share (Details Tex
Net Loss Per Share (Details Textual) - shares | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Earnings Per Share [Abstract] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 30,306,159 | 21,207,452 |
Stock-Based Compensation (Detai
Stock-Based Compensation (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock-based compensation expense | $ 1,882,846 | $ 260,040 |
Research and Development Expense [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock-based compensation expense | 116,215 | 103,767 |
General and Administrative Expense [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock-based compensation expense | $ 1,766,631 | $ 156,273 |
Stock-Based Compensation (Det_2
Stock-Based Compensation (Details 1) | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | ||
Expected volatility | 80.44% | 79.51% |
Risk-free interest rate | 2.57% | 2.63% |
Expected term of option | 6 years 7 months 13 days | 6 years 3 months 21 days |
Expected dividend yield | 0.00% | 0.00% |
Stock-Based Compensation (Det_3
Stock-Based Compensation (Details 2) - Employee Stock Option [Member] | 3 Months Ended |
Mar. 31, 2019$ / sharesshares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Outstanding - Number of Options, Beginning Balance | shares | 18,429,308 |
Exercised - Number of Options | shares | (21,362) |
Granted - Number of Options | shares | 540,000 |
Expired - Number of Options | shares | (4,090) |
Forfeited - Number of Options | shares | (8,000) |
Outstanding - Number of Options, Ending Balance | shares | 18,935,856 |
Exercisable - Number of Options | shares | 10,910,743 |
Outstanding - Weighted Average Exercise Price, Beginning balance | $ / shares | $ 2.44 |
Exercised - Weighted Average Exercise Price | $ / shares | 1.79 |
Granted - Weighted Average Exercise Price | $ / shares | 3.72 |
Expired - Weighted Average Exercise Price | $ / shares | 1.87 |
Forfeited - Weighted Average Exercise Price | $ / shares | 3.43 |
Outstanding - Weighted Average Exercise Price, Ending Balance | $ / shares | 2.48 |
Exercisable - Weighted Average Exercise Price | $ / shares | $ 1.76 |
Stock-Based Compensation (Det_4
Stock-Based Compensation (Details Textual) - USD ($) | Apr. 02, 2019 | Mar. 31, 2019 | Mar. 31, 2018 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Weighted Average Grant Date Fair Value | $ 2.69 | $ 2.61 | |
Share-based Compensation | $ 1,882,846 | $ 260,040 | |
Performance Share Based Compensation Expense | 27,600 | 0 | |
Share Based Payment Cash Received from Stock Option Exercises | $ 38,302 | $ 98,022 | |
Subsequent Event [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
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 | ||
Minimum [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share Based Compensation Arrangement By Share Based Payment Award Equity Instruments Other Than Options Granted Expire Terms | 1 year | ||
Long Term Incentive Plan2011 [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant | 6,302,234 |
Income Taxes (Details Textual)
Income Taxes (Details Textual) $ in Millions | Dec. 31, 2018USD ($) |
Income Tax Disclosure [Abstract] | |
Unrecognized Tax Benefits | $ 3 |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - USD ($) | Mar. 31, 2019 | Dec. 31, 2018 |
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ||
Investment in common stock | $ 957,589 | $ 912,200 |
Fair Value, Inputs, Level 1 [Member] | ||
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ||
Investment in common stock | 957,589 | 912,200 |
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 |
Fair Value Measurements (Deta_2
Fair Value Measurements (Details Textual) - USD ($) | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Finite-Lived Intangible Assets [Line Items] | ||
Impairment of Intangible Assets, Finite-lived | $ 48,391 | $ 0 |
Abbreviated New Drug Applications [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Impairment of Intangible Assets, Finite-lived | $ 48,391 |
Related Party Transactions (Det
Related Party Transactions (Details Textual) - Spectrum [Member] - EVOMELA [Member] - USD ($) | Apr. 30, 2019 | Mar. 31, 2019 |
Related Party Transaction [Line Items] | ||
Purchase Obligation | $ 12,300,000 | |
Prepaid Expenses and Other Current Assets [Member] | ||
Related Party Transaction [Line Items] | ||
Advance Payment on Contract for Purchase | $ 2,800,000 | $ 4,850,000 |
Commitments (Details Textual)
Commitments (Details Textual) - USD ($) $ in Millions | 3 Months Ended | 12 Months Ended | ||
Mar. 31, 2019 | Dec. 31, 2018 | Apr. 30, 2019 | Feb. 28, 2019 | |
Spectrum [Member] | EVOMELA [Member] | ||||
Purchase obligation to purchase materials | $ 3.1 | $ 9.2 | ||
Additional Advance payment On Contract For Purchase | $ 2.8 | |||
Spectrum [Member] | EVOMELA [Member] | Prepaid Expenses and Other Current Assets [Member] | ||||
Advance Payment on Contract for Purchase | 4.8 | |||
CASI Wuxi [Member] | ||||
Initial Cash Investment | $ 21 | |||
Total Future Investment | $ 80 |
Subsequent Event (Details Textu
Subsequent Event (Details Textual) - Subsequent Event [Member] | Apr. 16, 2019EUR (€) |
Subsequent Event [Line Items] | |
Upfront Payment For a License For a Drug | € 5,000,000 |
Future Equity Investments | € 2,000,000 |