Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2022 | Nov. 08, 2022 | |
Cover | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Sep. 30, 2022 | |
Entity File Number | 0-20713 | |
Entity Registrant Name | CASI PHARMACEUTICALS, INC. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 58-1959440 | |
Entity Address, Address Line One | 9620 Medical Center Drive | |
Entity Address, Address Line Two | Suite 300 | |
Entity Address, City or Town | Rockville | |
Entity Address, State or Province | MD | |
Entity Address, Postal Zip Code | 20850 | |
City Area Code | 240 | |
Local Phone Number | 864-2600 | |
Title of 12(b) Security | Common Stock | |
Trading Symbol | CASI | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Amendment Flag | false | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q3 | |
Entity Central Index Key | 0000895051 | |
Current Fiscal Year End Date | --12-31 | |
Entity Common Stock, Shares Outstanding | 13,606,130 |
Unaudited Condensed Consolidate
Unaudited Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 26,742 | $ 38,704 |
Restricted cash | 2,500 | |
Investment in equity securities, at fair value | 6,309 | 9,868 |
Accounts receivable, net of $0 allowance for doubtful accounts | 12,560 | 9,803 |
Inventories | 5,773 | 1,907 |
Prepaid expenses and other | 1,728 | 1,688 |
Total current assets | 55,612 | 61,970 |
Property, plant and equipment, net | 13,867 | 12,712 |
Intangible assets, net | 10,049 | 12,203 |
Long-term investments | 39,780 | 40,128 |
Right of use assets | 7,666 | 9,107 |
Other assets | 932 | 2,178 |
Total assets | 127,906 | 138,298 |
Current liabilities: | ||
Accounts payable | 3,098 | 4,789 |
Bank borrowings | 3,000 | |
Accrued and other current liabilities | 23,651 | 8,397 |
Total current liabilities | 29,749 | 13,186 |
Deferred income | 2,488 | 2,828 |
Other liabilities | 12,455 | 14,325 |
Total liabilities | 44,692 | 30,339 |
Commitments and contingencies | ||
Redeemable noncontrolling interest, at redemption value | 21,503 | 23,457 |
Stockholders' equity: | ||
Preferred stock, $1.00 par value: 5,000,000 shares authorized and 0 shares issued and outstanding | 0 | 0 |
Common stock, $0.01 par value: 250,000,000 shares authorized at June 30, 2022 and December 31, 2021 13,733,459 shares and 13,987,578 shares issued at June 30, 2022 and December 31, 2021, respectively; 13,606,130 shares and 13,979,624 shares outstanding at June 30, 2022 and December 31, 2021, respectively | 1,373 | 1,399 |
Additional paid-in capital | 696,213 | 694,826 |
Treasury stock, at cost: 127,329 shares and 7,954 shares held at June 30, 2022 and December 31, 2021 | (9,068) | (8,034) |
Accumulated other comprehensive income | (1,951) | 1,954 |
Accumulated deficit | (624,856) | (605,643) |
Total stockholders' equity | 61,711 | 84,502 |
Total liabilities, redeemable noncontrolling interest and stockholders' equity | $ 127,906 | $ 138,298 |
Unaudited Condensed Consolida_2
Unaudited Condensed Consolidated Balance Sheets (Parenthetical) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Unaudited Condensed Consolidated Balance Sheets | ||
Allowance for doubtful accounts | $ 0 | $ 0 |
Preferred Stock, Par or Stated Value Per Share (in dollars per share) | $ 1 | $ 1 |
Preferred Stock, Shares Authorized (in shares) | 5,000,000 | 5,000,000 |
Preferred Stock, Shares Issued (in shares) | 0 | 0 |
Preferred Stock, Shares Outstanding (is shares) | 0 | 0 |
Common Stock, Par Value (in dollars per share) | $ 0.01 | $ 0.01 |
Authorized common stock (in shares) | 250,000,000 | 250,000,000 |
Common Stock, Shares Issued (in shares) | 13,733,459 | 13,987,578 |
Common Stock, Shares Outstanding (in shares) | 13,606,130 | 13,979,624 |
Treasury stock, Shares Held (in shares) | 127,329 | 7,954 |
Unaudited Condensed Consolida_3
Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Revenues: | ||||
Product sales | $ 10,213 | $ 8,075 | $ 27,788 | $ 20,900 |
Lease income from a related party | 37 | 60 | 110 | |
Total revenues | 10,213 | 8,112 | 27,848 | 21,010 |
Costs of revenues: | ||||
Costs of revenues | 4,247 | 3,417 | 11,555 | 8,757 |
Gross Profit | 5,966 | 4,695 | 16,293 | 12,253 |
Operating expenses: | ||||
Research and development | 3,905 | 2,895 | 11,748 | 10,408 |
General and administrative | 4,849 | 5,259 | 15,694 | 16,249 |
Selling and marketing | 3,566 | 3,433 | 10,241 | 9,508 |
Acquired in-process research and development | 0 | 0 | 0 | 6,555 |
Total operating expenses | 12,320 | 11,587 | 37,683 | 42,720 |
Loss from operations | (6,354) | (6,892) | (21,390) | (30,467) |
Non-operating income (expense): | ||||
Interest (expense)/income, net | (13) | 79 | 101 | 261 |
Other income | 11 | 487 | 60 | 540 |
Foreign exchange gains/(losses) | 637 | (6) | 2,325 | 289 |
Change in fair value of investments | 696 | (3,687) | (2,012) | (205) |
Impairment loss of long-term investments | (865) | |||
Loss before income tax expense | (5,023) | (10,019) | (20,916) | (30,447) |
Net loss | (5,023) | (10,019) | (20,916) | (30,447) |
Less: loss attributable to redeemable noncontrolling interest | (738) | (314) | (1,703) | (980) |
Accretion to redeemable noncontrolling interest redemption value | 916 | 519 | 2,264 | 1,586 |
Net loss attributable to CASI Pharmaceuticals, Inc. | $ (5,201) | $ (10,224) | $ (21,477) | $ (31,053) |
Net loss per share (basic) | $ (0.38) | $ (0.73) | $ (1.57) | $ (2.30) |
Net loss per share (diluted) | $ (0.38) | $ (0.73) | $ (1.57) | $ (2.30) |
Weighted average number of common stock outstanding (basic) | 13,606,130 | 13,979,636 | 13,668,553 | 13,486,024 |
Weighted average number of common stock outstanding (diluted) | 13,606,130 | 13,979,636 | 13,668,553 | 13,486,024 |
Comprehensive loss: | ||||
Net loss | $ (5,023) | $ (10,019) | $ (20,916) | $ (30,447) |
Foreign currency translation adjustment | (3,127) | 15 | (6,420) | 848 |
Total comprehensive loss | (8,150) | (10,004) | (27,336) | (29,599) |
Less: Comprehensive loss attributable to redeemable noncontrolling interest | (2,074) | (309) | (4,218) | (712) |
Comprehensive loss attributable to common stockholders | $ (6,076) | $ (9,695) | $ (23,118) | $ (28,887) |
Unaudited Condensed Consolida_4
Unaudited Condensed Consolidated Statements of Stockholders' Equity - USD ($) | Preferred Stock | Common Stock | Additional Paid-in Capital | Treasury Stock | Accumulated Other Comprehensive Income /(Loss) | Accumulated Deficit | Total |
Balance at Dec. 31, 2020 | $ 0 | $ 1,240,000 | $ 658,246,000 | $ (8,034,000) | $ 589,000 | $ (570,501,000) | $ 81,540,000 |
Balance (in shares) at Dec. 31, 2020 | 0 | 12,394,271 | |||||
Issuance of common stock pursuant to financing agreements | $ 159,000 | 32,341,000 | 32,500,000 | ||||
Issuance of common stock pursuant to financing agreements (in shares) | 1,585,365 | ||||||
Stock issuance costs | $ 0 | $ 0 | (2,019,000) | 0 | 0 | 0 | (2,019,000) |
Stock-based compensation expense, net of forfeitures | 0 | 0 | 1,998,000 | 0 | 0 | 0 | 1,998,000 |
Foreign currency translation adjustment | 0 | 0 | 0 | 0 | (104,000) | 0 | (104,000) |
Net loss attributable to CASI Pharmaceuticals, Inc. | 0 | 0 | (548,000) | 0 | 0 | (13,335,000) | (13,883,000) |
Balance at Mar. 31, 2021 | $ 1,399,000 | 690,018,000 | (8,034,000) | 485,000 | (583,836,000) | 100,032,000 | |
Balance (in shares) at Mar. 31, 2021 | 13,979,636 | ||||||
Balance at Dec. 31, 2020 | $ 0 | $ 1,240,000 | 658,246,000 | (8,034,000) | 589,000 | (570,501,000) | 81,540,000 |
Balance (in shares) at Dec. 31, 2020 | 0 | 12,394,271 | |||||
Net loss attributable to CASI Pharmaceuticals, Inc. | (31,053,000) | ||||||
Balance at Sep. 30, 2021 | $ 0 | $ 1,399,000 | 692,041,000 | (8,034,000) | 1,169,000 | (599,968,000) | 86,607,000 |
Balance (in shares) at Sep. 30, 2021 | 0 | 13,979,636 | |||||
Balance at Mar. 31, 2021 | $ 1,399,000 | 690,018,000 | (8,034,000) | 485,000 | (583,836,000) | 100,032,000 | |
Balance (in shares) at Mar. 31, 2021 | 13,979,636 | ||||||
Stock-based compensation expense, net of forfeitures | 1,040,000 | 1,040,000 | |||||
Foreign currency translation adjustment | 674,000 | 674,000 | |||||
Net loss attributable to CASI Pharmaceuticals, Inc. | (519,000) | (6,427,000) | (6,946,000) | ||||
Balance at Jun. 30, 2021 | $ 1,399,000 | 690,539,000 | (8,034,000) | 1,159,000 | (590,263,000) | 94,800,000 | |
Balance (in shares) at Jun. 30, 2021 | 13,979,636 | ||||||
Stock-based compensation expense, net of forfeitures | 2,021,000 | 2,021,000 | |||||
Foreign currency translation adjustment | 10,000 | 10,000 | |||||
Net loss attributable to CASI Pharmaceuticals, Inc. | (519,000) | (9,705,000) | (10,224,000) | ||||
Balance at Sep. 30, 2021 | $ 0 | $ 1,399,000 | 692,041,000 | (8,034,000) | 1,169,000 | (599,968,000) | 86,607,000 |
Balance (in shares) at Sep. 30, 2021 | 0 | 13,979,636 | |||||
Balance at Dec. 31, 2021 | $ 0 | $ 1,399,000 | 694,826,000 | (8,034,000) | 1,954,000 | (605,643,000) | 84,502,000 |
Balance (in shares) at Dec. 31, 2021 | 0 | 13,979,636 | |||||
Repurchase and retirement of common stock | $ (26,000) | (1,940,000) | (1,034,000) | $ (3,000,000) | |||
Repurchase and retirement of common stock (in shares) | (373,506) | (3,734,992) | |||||
Stock-based compensation expense, net of forfeitures | $ 0 | $ 0 | 1,908,000 | 0 | 0 | 0 | $ 1,908,000 |
Foreign currency translation adjustment | 0 | 0 | 0 | 0 | 175,000 | 0 | 175,000 |
Net loss attributable to CASI Pharmaceuticals, Inc. | 0 | 0 | (613,000) | 0 | 0 | (7,983,000) | (8,596,000) |
Balance at Mar. 31, 2022 | $ 1,373,000 | 694,181,000 | (9,068,000) | 2,129,000 | (613,626,000) | 74,989,000 | |
Balance (in shares) at Mar. 31, 2022 | 13,606,130 | ||||||
Balance at Dec. 31, 2021 | $ 0 | $ 1,399,000 | 694,826,000 | (8,034,000) | 1,954,000 | (605,643,000) | 84,502,000 |
Balance (in shares) at Dec. 31, 2021 | 0 | 13,979,636 | |||||
Net loss attributable to CASI Pharmaceuticals, Inc. | (21,477,000) | ||||||
Balance at Sep. 30, 2022 | $ 0 | $ 1,373,000 | 696,213,000 | (9,068,000) | (1,951,000) | (624,856,000) | 61,711,000 |
Balance (in shares) at Sep. 30, 2022 | 0 | 13,606,130 | |||||
Balance at Mar. 31, 2022 | $ 1,373,000 | 694,181,000 | (9,068,000) | 2,129,000 | (613,626,000) | 74,989,000 | |
Balance (in shares) at Mar. 31, 2022 | 13,606,130 | ||||||
Stock-based compensation expense, net of forfeitures | 1,923,000 | 0 | 0 | 0 | 1,923,000 | ||
Foreign currency translation adjustment | 0 | (2,289,000) | 0 | (2,289,000) | |||
Net loss attributable to CASI Pharmaceuticals, Inc. | (735,000) | 0 | 0 | (6,945,000) | (7,680,000) | ||
Balance at Jun. 30, 2022 | $ 1,373,000 | 695,369,000 | (9,068,000) | (160,000) | (620,571,000) | 66,943,000 | |
Balance (in shares) at Jun. 30, 2022 | 13,606,130 | ||||||
Stock-based compensation expense, net of forfeitures | 1,760,000 | 0 | 0 | 0 | 1,760,000 | ||
Foreign currency translation adjustment | 0 | (1,791,000) | 0 | (1,791,000) | |||
Net loss attributable to CASI Pharmaceuticals, Inc. | (916,000) | 0 | 0 | (4,285,000) | (5,201,000) | ||
Balance at Sep. 30, 2022 | $ 0 | $ 1,373,000 | $ 696,213,000 | $ (9,068,000) | $ (1,951,000) | $ (624,856,000) | $ 61,711,000 |
Balance (in shares) at Sep. 30, 2022 | 0 | 13,606,130 |
Unaudited Condensed Consolida_5
Unaudited Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | |
CASH FLOWS FROM OPERATING ACTIVITIES | |||||
Net loss | $ (5,023) | $ (10,019) | $ (20,916) | $ (30,447) | |
Adjustments to reconcile net loss to net cash used in operating activities: | |||||
Depreciation for property, plant and equipment | 567 | 393 | |||
Amortization of intangible assets | 965 | 1,009 | |||
Reduction in the carrying amount of the right-of-use assets | 890 | 1,031 | |||
Loss on disposal of property, plant and equipment | 65 | ||||
Stock-based compensation expense | 5,591 | 5,059 | |||
Acquired in-process research and development | 6,555 | ||||
Change in fair value of investments | (696) | 3,687 | 2,012 | 205 | |
Impairment loss of long-term investments | 865 | ||||
Government grant as a result of loan forgiveness | (472) | ||||
Changes in operating assets and liabilities: | |||||
Accounts receivable | (2,757) | (773) | |||
Inventories | (3,866) | (371) | |||
Prepaid expenses and other assets | (238) | (539) | |||
Accounts payable | (1,073) | 26 | |||
Accrued and other current liabilities and other liabilities | (1,376) | (1,770) | |||
Deferred income | (44) | (37) | |||
Net cash used in operating activities | (20,245) | (19,201) | |||
CASH FLOWS FROM INVESTING ACTIVITIES | |||||
Proceeds from disposal of property and equipment | 138 | 10 | |||
Purchases of property, plant and equipment | (2,186) | (3,730) | |||
Receipt in advance from sales of equity investment in Juventas | 16,921 | ||||
Cash paid to acquire in-process research and development | (6,555) | ||||
Receipt of repayment of Black Belt Convertible note | 172 | ||||
Net cash provided by/(used in) investing activities | 13,205 | (15,950) | |||
CASH FLOWS FROM FINANCING ACTIVITIES | |||||
Proceeds from bank borrowings | 4,001 | 709 | |||
Repayment of bank borrowings | (1,001) | (463) | |||
Repurchase of common stock | (3,000) | ||||
Stock issuance costs | (2,019) | ||||
Proceeds from sale of common stock | 32,500 | ||||
Net cash provided by financing activities | 30,727 | ||||
Effect of exchange rate change on cash and cash equivalents | (2,422) | 486 | |||
Net decrease in cash and cash equivalents | (9,462) | (3,938) | |||
Cash, cash equivalents and restricted cash at beginning of period | 38,704 | 57,064 | $ 57,064 | ||
Cash, cash equivalents and restricted cash at end of period | 29,242 | 53,126 | 29,242 | 53,126 | 38,704 |
Non-cash investing and financing activities: | |||||
Purchases of property, plant and equipment in accrued and other current liabilities | 3,111 | 2,680 | |||
Cash and cash equivalents | 26,742 | 53,126 | 26,742 | 53,126 | 38,704 |
Restricted cash | 2,500 | 2,500 | |||
Total cash, cash equivalents and restricted cash shown in the statement of cash flows | $ 29,242 | $ 53,126 | 29,242 | 53,126 | $ 38,704 |
Black Belt Tx Limited | |||||
CASH FLOWS FROM INVESTING ACTIVITIES | |||||
Cash paid to acquire convertible loan | (86) | ||||
Alesta Tx | |||||
CASH FLOWS FROM INVESTING ACTIVITIES | |||||
Cash paid to acquire convertible loan | (261) | ||||
Cleave Therapeutics, Inc | |||||
CASH FLOWS FROM INVESTING ACTIVITIES | |||||
Cash paid to acquire convertible loan | $ (5,500) | ||||
BioInvent International AB | |||||
CASH FLOWS FROM INVESTING ACTIVITIES | |||||
Proceeds from sales of equity securities | 1,294 | ||||
Precision Autoimmune Therapeutics Co., Ltd | |||||
CASH FLOWS FROM INVESTING ACTIVITIES | |||||
Cash paid to acquire equity investment | $ (2,962) |
DESCRIPTION OF BUSINESS
DESCRIPTION OF BUSINESS | 9 Months Ended |
Sep. 30, 2022 | |
DESCRIPTION OF BUSINESS | |
DESCRIPTION OF BUSINESS | 1. DESCRIPTION OF BUSINESS CASI Pharmaceuticals, Inc. (“CASI” or the “Company”) (Nasdaq: CASI) is a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products in China, the United States, and throughout the world. The Company was incorporated in 1991, and in 2012, with new leadership, the Company shifted its business strategy to China and has since built an infrastructure in China that includes sales and marketing, medical affairs, regulatory and clinical development and in the foreseeable future, manufacturing. In 2014, the Company changed its name to “CASI Pharmaceuticals, Inc.” The majority of the Company’s operations and activities are now located and conducted in China. The Company is focused on acquiring, developing and commercializing products that augment its hematology/oncology therapeutic focus as well as other areas of unmet medical need. The Company is executing its plan to become a biopharmaceutical leader by launching medicines in the greater China market, leveraging its China-based regulatory, clinical and commercial competencies and its global drug development expertise. The Company launched its first commercial product, EVOMELA ® ® Liquidity and Capital Resources Since its inception in 1991, the Company has incurred significant losses from operations and, as of September 30, 2022, had incurred an accumulated deficit of $624.9 million. The Company believes that it has sufficient resources to fund its operations at least one year beyond the date that the interim consolidated financial statements are issued. As of September 30, 2022, the Company had a balance of cash and cash equivalents and restricted cash of $29.2 million, of which $22.2 million was held in the financial institutions in the PRC. 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 or opportunities. Risks and Uncertainties Since the second quarter of 2022, due to the outbreak of Omicron and other variants of COVID-19, the lockdown in Shanghai and restrictions in other major cities in China led to limitation of access to local hospitals, which had an adverse impact on the sales of EVOMELA® for the second and the third quarters. The restrictions also adversely impacted the enrollment of patients for the CNCT19 Phase II registration studies. Recently, the pandemic gradually spread nationwide in China, and many small and medium-sized cities have been upgrading their control measures ever since the third quarter. These series of control measures are expected to adversely impact our sales activities for the remainder of 2022. Given that such COVID-19 related restrictions are beyond our control, at this stage, it is unable to assess for how long such COVID-19 related restrictions may continue in China, and the full extent to which such restrictions may directly and indirectly impact our business operations. Considering the uncertainty of the development of COVID-19 pandemic, we will continue to pay close attention on the development of the COVID-19 pandemic and dedicate resources to take any necessary measures in a timely manner to minimize the unfavorable impact on our businesses and operations. |
License and Distribution Agreem
License and Distribution Agreements | 9 Months Ended |
Sep. 30, 2022 | |
License and Distribution Agreements | |
License and Distribution Agreements | 2. License and Distribution Agreements Acrotech License Arrangements ® ® ® ® ® ® ® ® China Resources Pharmaceutical Commercial Group International Trading Co., Ltd. In March 2019, the Company entered into a three-year exclusive distribution agreement with China Resources Pharmaceutical Commercial Group International Trading Co., Ltd. (“CRPCGIT”) to appoint CRPCGIT on an exclusive basis as its distributor to distribute EVOMELA ® Precision Autoimmune Therapeutics Co., Ltd., (previously known as Beijing Tianshi Tongda Pharmaceuticals Technology Co., Ltd) In May 2022, the Company entered into a Sublicense Agreement (the “Sublicense Agreement”) with Precision Autoimmune Therapeutics Co., Ltd. (“PAT”), a company established under the laws of China, pursuant to which the Company granted PAT an exclusive (subject to the Commercialization and Co-Marketing rights), perpetual, worldwide license, with the right to freely grant further sublicenses subject to terms and conditions in the Sublicense Agreement, for the investigational anti-CD38 monoclonal antibody TSK011010 licensed and controlled by the Company from Black Belt Therapeutics Limited, in the treatment, prevention and diagnosis of autoimmune diseases, conditions and disorders in humans. Pursuant to the Sublicense Agreement, PAT will make an upfront payment of $10,000,000 equivalent in two equal instalments upon completion of its first and second financing, respectively, plus potential future payments of development and sales milestones and royalties to the Company. Also in May 2022, CASI Pharmaceuticals (China) Co., Ltd. (“CASI China”) entered into an agreement for the investment in PAT in the amount of RMB 20.0 million (approximately $3.0 million) in cash during PAT’s first equity financing (see Note 5). Juventas Biotechnology (Tianjin) Co., Ltd. (“Juventas”) In June 2019, the Company entered into a license agreement for exclusive worldwide license to commercialize an autologous anti-CD19 T-cell therapy product (CNCT19) from Juventas (the “Exclusive License Agreement”). Juventas is a China-based company engaged in cell therapy. The terms of the agreement include RMB 70 million ($10 million) of milestone payments upon the registration of Phase II clinical trial of CNCT19 and sales royalty payments. The milestone was met during the third quarter of 2020, the Company paid the milestone payment of RMB 70 million to Juventas in September 2020, and recognized it as acquired in-process research and development expenses in the consolidated statement of operations and comprehensive loss in 2020. In September 2020, Juventas and its shareholders (including CASI Biopharmaceuticals (Wuxi) Co., Ltd (“CASI Biopharmaceuticals”), a subsidiary of the Company, ) agreed to certain terms and conditions required by a new third-party investor to facilitate the Series B financing of Juventas, pursuant to which the Company agreed to amend and supplement the original licensing agreement (the "Supplementary Agreement") by agreeing to pay Juventas certain percentage of net profits generated from commercial sales of CNCT19 in addition to the royalty fee payment calculated as a percentage of net sales. The Supplementary Agreement also specifies a minimum annual target net profit to be distributed to Juventas and certain other terms and obligations. In return, the Company obtained additional equity interests in Juventas. Under the Supplementary Agreement, Juventas and the Company will jointly market CNCT19, including, but not limited to, establishing medical teams, developing medical strategies, conducting post-marketing clinical studies, establishing Standardized Cell Therapy Centers, establishing and training providers with respect to cell therapy, testing for cell therapy, and monitoring quality controls (cell collection and transfusion, etc.), and patient management (adverse reactions treatment, patients’ follow-up visits, and establishment of a database). The Company also will reimburse Juventas for a portion of Juventas’ marketing expenses as reviewed and approved by a joint commercial committee to be constituted. The Company will continue to be responsible for recruiting and establishing a sales team to commercialize CNCT19. In September 2022, CASI Biopharmaceuticals entered into an Equity Transfer Agreement to transfer its equity interest in Juventas in the amount of RMB 240.9 million (approximately $33.8 million) to a limited partnership enterprise (see Note 5). The Exclusive License Agreement is still effective after this equity transfer. BioInvent International AB In October 2020, the Company entered into an exclusive licensing agreement with BioInvent International AB (“BioInvent”) for the development and commercialization of novel anti-FcγRIIB antibody, BI-1206, in Mainland China, Taiwan, Hong Kong and Macau. BioInvent is a biotechnology company focused on the discovery and development of first-in-class immune-modulatory antibodies for cancer immunotherapy. BI-1206 is being investigated in a Phase 1/2 trial, in combination with anti-PD1 therapy Keytruda ® ® Under the terms of the agreement, BioInvent and CASI will develop BI-1206 in both hematological malignancies and solid tumors, with CASI responsible for commercialization in China and associated markets. CASI made a $5.9 million upfront payment in November 2020 to BioInvent and will pay up to $83 million in development and commercial milestone payments plus tiered royalties in the high-single to mid-double-digit range on net sales of BI-1206. Because BI-1206 underlying the acquired rights has not reached technological feasibility and has no alternative future uses, the Company expensed $5.9 million as acquired in-process research and development in 2020. 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 CID-103, an investigational anti-CD38 monoclonal antibody (Mab) (formerly known as TSK011010). The Company expects that its clinical materials and commercial inventory will be supplied by one or more contract manufacturers with whom the Company has contracted with. Under the terms of the agreement, CASI obtained global rights to CID-103 for an upfront payment of 5 million euros ($5.7 million) and would pay up to $46.3 million in development milestone payments and certain royalties based on sales milestones. In June 2021, the Company achieved the First-Patient-In (FPI) in the Phase 1 dose escalation and expansion study of CID-103, and made $750,000 milestone payment in June 2021 and €250,000 ($305,000) payment in August 2021 under the terms of the agreement. Because CID-103 underlying the acquired rights has not yet reached technological feasibility and has no alternative uses, the Company expensed 5 million euros and $1.1 million Cleave Therapeutics, Inc. In March 2021, the Company entered into an exclusive license with Cleave Therapeutics, Inc. (“Cleave”) for the development and commercialization of CB-5339, an oral novel VCP/p97 inhibitor, in both hematological malignancies and solid tumors, in Mainland China, Hong Kong, Macau and Taiwan. Cleave is a clinical-stage biopharmaceutical company focused on valosin-containing protein (VCP)/p97 as a novel target in protein homeostasis, DNA damage response and other cellular stress pathways for therapeutic use in the treatment of patients with cancer. Cleave and the Company will develop CB-5339 in both hematological malignancies and solid tumors, with CASI responsible for development and commercialization in China and associated markets. The Company paid a $5.5 million upfront payment to Cleave in 2021 and will pay up to $74 million in development and commercial milestone payments plus tiered royalties in the high-single to mid-double-digit range on net sales of CB-5339. CB-5339 is being evaluated by Cleave in a Phase 1 clinical trial in patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). Because CB-5339 has not yet reached technological feasibility and has no alternative future uses, the Company expensed the $5.5 million upfront payment as acquired in-process research and development in 2021. Pharmathen Global BV On October 29, 2019, the Company entered into an exclusive distribution agreement with Pharmathen Global BV ("Pharmathen") for the development and distribution of octreotide long acting injectable (Octreotide LAI) microsphere in China. Octreotide LAI formulations, which are approved in various European countries, are considered a standard of care for the treatment of acromegaly and the control of symptoms associated with certain neuroendocrine tumors. The terms of the agreement include an upfront payment of 1 million euros which was paid by the Company in 2019, and up to 2 million euros of additional milestone payments, of which 1.5 million euros ( $1.7 million) was paid by the Company with achievements of certain milestones and was expensed as acquired in-process research and development in 2020. CASI is 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 an agreed supply costs for the first three years . Riemser Pharma GmbH In August 2019, the Company entered into a distribution agreement in China with Riemser Pharma GmbH (“Riemser”) to a novel formulation of thiotepa, a chemotherapeutic agent, which has multiple potential indications including use as a conditioning treatment for use prior to allogenic hematopoietic stem cell transplantation. Thiotepa has a long history of established use in the hematology/oncology setting. Pursuant to the distribution agreement, CASI obtained the exclusive distribution right of the products in China, and Riemser will be responsible for manufacturing and supplying CASI with clinical materials and commercial inventory. The Company is applying for NADA registration and, subject to regulatory and marketing approvals, the Company intends to advance and commercialize this product in China. In January 2020, Riemser was acquired by Esteve Healthcare, S.L. (“ESTEVE”), an international pharmaceutical company headquartered in Barcelona, Spain. There is no contingent milestone payment due to Riemser under the agreement. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2022 | |
Summary of Significant Accounting Policies | |
Summary of Significant Accounting Policies | 3. Summary of Significant Accounting Policies Basis of Presentation The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”). Use of Estimates The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. The Company's significant accounting estimates relate to recoverability of operating lease right-of-use assets, intangible assets and long-term investments, net realizable value and obsolescence allowance for inventories, deferred tax assets and valuation allowance, allowance for doubtful accounts, stock-based arrangements and fair value of investments. 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. Recent Accounting Pronouncement s In November 2021, the FASB issued ASU 2021-10, Government Assistance (Topic 832): Disclosures by Business Entities about Government Assistance. This update requires certain annual disclosures about transactions with a government that are accounted for by applying a grant or contribution accounting model by analogy. This update is effective for annual periods beginning after December 15, 2021, and early application is permitted. This guidance should be applied either prospectively to all transactions that are reflected in financial statements at the date of initial application and new transactions that are entered into after the date of initial application or retrospectively to those transactions. The Company does not expect the impact of this guidance to have a material impact on the Company’s consolidated financial statements. In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments — Credit Losses (Topic 326) (“ASU 2016-13”) and subsequent amendments to the initial guidance including ASU No. 2018-19, ASU No. 2019-04, and ASU No. 2019-05 (collectively, “Topic 326”). Topic 326 requires entities to measure all expected credit losses for financial assets held at the reporting date based on historical experience, current conditions, and reasonable and supportable forecasts. This replaces the existing incurred loss model and is applicable to the measurement of credit losses on financial assets measured at amortized cost. This standard is effective for public business entities, excluding entities eligible to be smaller reporting companies for fiscal years beginning after December 15, 2019, including interim periods within those fiscal years. For all other entities, this standard is effective for annual and interim periods beginning after December 15, 2022 and early adoption is permitted for annual and interim periods beginning after December 15, 2018. As a smaller reporting company, the Company expects to adopt this standard in fiscal year 2023. The Company is currently assessing the impact that the adoption of this ASU will have on the consolidated financial statements. |
Revenue Related Information
Revenue Related Information | 9 Months Ended |
Sep. 30, 2022 | |
Revenue Related Information | |
Revenue Related Information | 4. The Company’s revenue is primarily consisted of sales of EVOMELA ® |
Investment in Equity Securities
Investment in Equity Securities, at Fair Value and Long-term Investments | 9 Months Ended |
Sep. 30, 2022 | |
Investment in Equity Securities, at Fair Value and Long-term Investments | |
Investment in Equity Securities, at Fair Value and Long-term Investments | 5. Investment in Equity Securities, at Fair Value and Long-term Investments Investment in Equity Securities, at Fair Value The following table summarizes the Company’s investment in equity securities at fair value as of September 30, 2022 and December 31, 2021, respectively: Gross (In thousands) unrealized Aggregate fair September 30, 2022 Classification Cost gains /(losses) value MaxCyte - equity interest Investment $ — $ 2,453 $ 2,453 BioInvent - equity interest Investment $ 4,337 $ (481) $ 3,856 Total $ 6,309 Gross (In thousands) unrealized Aggregate fair December 31, 2021 Classification Cost gains value MaxCyte - equity interest Investment $ — $ 3,866 $ 3,866 BioInvent - equity interest Investment $ 5,661 $ 341 $ 6,002 Total $ 9,868 In the second quarter of 2022, the Company sold 275,000 ordinary shares of BioInvent for $1.3 million. The Company recognized gains of $131,000 in consolidated statements of operations and comprehensive loss. For the three and nine months ended September 30, 2022, the Company recognized unrealized gains of $0.6 million and unrealized losses $2.5 million, respectively, on the Company’s equity investments. For the three and nine months ended September 30, 2021, the Company recognized unrealized losses of $3.7 million and $0.3 million, respectively, on the Company’s equity investments. Unrealized gains (losses) on the Company’s equity investments are recognized as change in fair value of investment in the consolidated statements of operations and comprehensive loss. Long-term Investments Long-term investments as of September 30, 2022 and December 31, 2021 consisted of the following: Gross Foreign Gross unrealized currency September 30, 2022 unrealized losses (including translation Aggregate (In thousands) Cost gains impairment) adjustment fair value Available-for-sale debt securities: Alesta Therapeutics B.V. - convertible loan $ 261 $ 15 $ — $ — $ 276 Securities measured at fair value: BioInvent International AB - warrants 656 — (194) — 462 Cleave Therapeutics, Inc. - convertible loan 5,500 458 — — 5,958 Equity securities without readily determinable fair value: Alesta Therapeutics B.V. - equity interests 2,250 — (865) — 1,385 Juventas Biotechnology (Tianjin) Co., Ltd. - equity interests 23,500 6,958 — (1,569) 28,889 Juventas Biotechnology (Tianjin) Co., Ltd. - put option 491 — (521) 30 — Prepayment for investment: Precision Autoimmune Therapeutics Co., Ltd - equity interests 2,962 — — (152) 2,810 Total $ 35,620 $ 7,431 $ (1,580) $ (1,691) $ 39,780 Gross Foreign Gross unrealized currency December 31, 2021 unrealized losses (including translation Aggregate (In thousands) Cost gains impairment) adjustment fair value Available-for-sale debt securities: Alesta Therapeutics B.V. - convertible loan $ 261 $ 7 $ — $ — $ 268 Securities measured at fair value: BioInvent International AB - warrants 656 — (65) — 591 Cleave Therapeutics, Inc. - convertible loan 5,500 76 — — 5,576 Equity securities without readily determinable fair value: Alesta Therapeutics B.V. - equity interests 2,250 — (865) — 1,385 Juventas Biotechnology (Tianjin) Co., Ltd. - equity interests 23,500 6,958 — 1,850 32,308 Juventas Biotechnology (Tianjin) Co., Ltd. - put option 491 — (521) 30 — Total $ 32,658 $ 7,041 $ (1,451) $ 1,880 $ 40,128 Investment in Precision Autoimmune Therapeutics Co., Ltd., (“PAT”) In May 2022, CASI China entered into an agreement for the investment in PAT in the amount of RMB 20.0 million (approximately $3.0 million) in cash during PAT’s first equity financing. CASI China has paid all the consideration in June 2022. Upon consummation of such equity financing, CASI China will hold 15% equity interests of PAT and will hold one As of September 30, 2022, the transaction had not been consummated as the consideration from other investors has not been paid in full. Sales of Investment in Juventas Biotechnology (Tianjin) Co., Ltd. In September 2022, CASI Biopharmaceuticals entered into an equity transfer agreement (the “Equity Transfer Agreement”) with Shenzhen Jiadao Gongcheng Equity Investment Fund (Limited Partnership) (“Jiadao Gongcheng”), a third party limited partnership enterprise incorporated under the laws of China, pursuant to which CASI Biopharmaceuticals agreed to transfer to Jiadao Gongcheng all of its equity interest in Juventas in the amount of RMB 240.9 million (approximately $33.8 million). Pursuant to the Equity Transfer Agreement, CASI Biopharmaceuticals will transfer all of its rights and obligations to Jiadao Gongcheng, and Jiadao Gongcheng would make payment in two equal installments, with the first installment paid after signing the Equity Transfer Agreement and the second installment paid shortly after the completion of the registration with competent government authorities. As of September 30, 2022, CASI Biopharmaceuticals received the first installment of RMB 120.4 million (approximately $16.9 million) as advance. The transaction had not been consummated as the registration with competent governmental authorities of the transaction was still in process. |
Inventories
Inventories | 9 Months Ended |
Sep. 30, 2022 | |
Inventories | |
Inventories | 6. Inventories The Company’s inventories consist of finished goods amounted to $5.8 million and $1.9 million, as of September 30, 2022 and December 31, 2021, respectively. No write down to the carrying amount of inventory have been recorded in the three and nine months ended September 30, 2022 and 2021. |
Property, Plant and Equipment
Property, Plant and Equipment | 9 Months Ended |
Sep. 30, 2022 | |
Property, Plant and Equipment | |
Property, Plant and Equipment | 7. Property, plant and equipment consist of the following: (In thousands) September 30, December 31, 2022 2021 Furniture and equipment $ 1,169 $ 1,728 Leasehold improvements 6,944 1,133 Construction in progress 7,358 12,095 Total property, plant and equipment, gross 15,471 14,956 Accumulated depreciation and amortization (1,604) (1,817) Impairment of property, plant and equipment — (427) $ 13,867 $ 12,712 In the third quarter of 2022, CASI Wuxi obtained the Certificate for Pharmaceutical Distribution, and then transferred certain assets related to the manufacturing facility in Wuxi from construction in process to leasehold improvements and furniture and equipment and started to depreciate those assets. |
Leases
Leases | 9 Months Ended |
Sep. 30, 2022 | |
Leases | |
Leases | 8. Leases Right of use (“ROU”) assets and liabilities for operating leases 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. Liabilities for operating lease are included in accrued and other current liabilities and other liabilities (noncurrent) in the consolidated balance sheets as of September 30, 2022 and December 31, 2021. In November 2019, CASI Wuxi entered into a fifty-year lease agreement for the right to use state-owned land in China for the construction of a manufacturing facility. The land parcel is 74,028.40 square meters. The Company classifies this lease as an operating lease. The Company prepaid all of the lease payments for the land use right in 2019 in the amount of RMB 45 million (equivalent to $6.5 million). Rent expense for the nine months ended September 30, 2022 and 2021 was $1.0 million and $1.2 million, respectively. There were no variable lease costs or sublease income for leased assets for the nine months ended September 30, 2022 and 2021. Right of use assets and liabilities as of September 30, 2022 and December 31, 2021 on the condensed consolidated balance sheets were as follows: September 30, December 31, (In thousands) 2022 2021 Right of use assets $ 7,666 $ 9,107 Accrued and other current liabilities $ 922 $ 1,061 Other liabilities 634 1,105 Total lease liabilities $ 1,556 $ 2,166 Supplemental cash flow information related to leases was as follows: Nine Months Ended September 30, (In thousands) 2022 2021 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows $ 859 $ 1,087 Right of use assets obtained in exchange for lease obligations: $ 421 $ 1,661 All of the Company’s existing leases as of September 30, 2022 and December 31, 2021 were classified as operating leases. As of September 30, 2022 and December 31, 2021, the Company had seven and eight, respectively, material operating leases for land and facilities with remaining terms expiring from 2023 through 2069 and a weighted average remaining lease term of 37.92 years and 36.47 years, respectively. The Company has fair value renewal options for many of the Company’s existing leases, none of which are considered reasonably certain of being exercised or included in the minimum lease term. Weighted average discount rates used in the calculation of the lease liability as of September 30, 2022 and December 31, 2021 were 3.53% and 3.56%, respectively. 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. A maturity analysis representing the future undiscounted cash flow of the Company’s operating leases liabilities as of September 30, 2022 is as follows: (In thousands) 2022 (remaining three months) $ 266 2023 871 2024 456 Thereafter 12 Total 1,605 Discount factor (49) Lease liability 1,556 Amounts due within 12 months 922 Non-current lease liability $ 634 |
Accrued and Other Current Liabi
Accrued and Other Current Liabilities, and Other Liabilities | 9 Months Ended |
Sep. 30, 2022 | |
Accrued and Other Current Liabilities, and Other Liabilities | |
Accrued and Other Current Liabilities, and Other Liabilities | 9. Accrued and Other Current Liabilities, and Other Liabilities September 30, December 31, (In thousands) 2022 2021 Accrued and other current liabilities: Receipt in advance for sale of an investment (1) 16,921 — Payables related to property and equipment 3,111 3,288 Payroll and welfare payable $ 2,037 $ 3,336 Lease liabilities-current 922 1,061 Value-added tax and other tax payable 255 639 Deferred income-current 54 60 Other 351 13 $ 23,651 $ 8,397 Other Liabilities Profit-sharing liability to Juventas $ 11,821 $ 13,220 Lease liabilities-noncurrent 634 1,105 $ 12,455 $ 14,325 Note (1): The receipt in advance for sale of an investment represents the first installment received for sale of Juventas (see Note 5) . |
Bank Borrowings
Bank Borrowings | 9 Months Ended |
Sep. 30, 2022 | |
Bank Borrowings | |
Bank Borrowings | 10. Bank Borrowings |
Redeemable Noncontrolling Inter
Redeemable Noncontrolling Interest | 9 Months Ended |
Sep. 30, 2022 | |
Redeemable Noncontrolling Interest | |
Redeemable Noncontrolling Interest | 11. Redeemable Noncontrolling Interest Changes in redeemable noncontrolling interest during the nine month periods ended September 30, 2022 and 2021 are as follows: Nine Months Ended September 30, (In thousands) 2022 2021 Balance at beginning of period $ 23,457 $ 22,033 Share of CASI Wuxi net loss (1,703) (980) Accretion of redeemable noncontrolling interest 2,264 1,586 Foreign currency translation adjustment (2,515) 268 Balance at end of period $ 21,503 $ 22,907 |
Stockholders' Equity
Stockholders' Equity | 9 Months Ended |
Sep. 30, 2022 | |
Stockholders' Equity | |
Stockholders' Equity | 12. Stockholders’ Equity Reverse Stock Split On June 1, 2022, the Company effectuated a reverse stock split of the Company’s Common Stock (the “Reverse Stock Split”) pursuant to an amendment to its Amended and Restated Certificate of Incorporation filed on May 26, 2022. Trading of the Common Stock on a reverse stock split-adjusted basis began at the opening of trading on the Nasdaq Capital Market on June 2, 2022. After the reverse stock split, each ten (10) shares of Common Stock issued and outstanding was combined into one (1) validly issued, fully paid and non-assessable share of Common Stock. The par value per share of the Common Stock remains the same. No fractional shares were issued in connection with the Reverse Stock Split. Stockholders who would otherwise be entitled to a fractional share of Common Stock were instead entitled to receive a proportional cash payment. The Reverse Stock Split did not reduce the total number of shares of Common Stock that the Company is authorized to issue, which remains 250,000,000 shares. In addition, proportionate adjustments was made to the per share exercise price and the number of shares issuable upon the exercise of all outstanding stock options and warrants to purchase shares of Common Stock and the number of shares of Common Stock reserved for issuance pursuant to the Company’s equity incentive plans. Unless otherwise indicated, all share numbers in this report have been adjusted to reflect the Reverse Stock Split. Net loss per share was adjusted retrospectively. Stock Repurchase Program On December 15, 2021, the board of directors of the Company approved a stock repurchase program for the repurchase of up to $10 million of the Company’s Common Stock (and no more than 12,500,000 shares of the Company’s Common Stock, not adjusted to reflect the Reverse Stock Split) through open market purchases in compliance with Rule 10b-18 under the Securities Exchange Act of 1934 and through trading plans established pursuant to Rule 10b5-1 of the Securities Exchange Act from time to time. The Company established a Rule 10b5-1 trading plan to carry out the stock repurchase, which was terminated on March 31, 2022, and as of the termination of the plan, the Company has repurchased 3,734,992 shares of Common Stock (among which 2,541,245 shares of Common Stock were retired, not adjusted to reflect the Reverse Stock Split) amounted to $3.0 million. Stock Purchase Warrants In history, the Company issued shares of its common stock with accompanying warrants to certain institutional investors, accredited investors and existing stockholders. As of September 30, 2022, the outstanding exercisable |
Net Loss Per Share
Net Loss Per Share | 9 Months Ended |
Sep. 30, 2022 | |
Net Loss Per Share | |
Net Loss Per Share | 13. 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. As of September 30, 2022 and December 31, 2021, outstanding stock options totaling 3,415,729 and 3,324,368, respectively, and outstanding warrants both totaling 617,277, were anti-dilutive, and therefore, were not included in the computation of weighted average shares used in computing diluted loss per share. Pursuant to the reverse stock split, net loss per share was adjusted retrospectively. 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: Three Months Ended September 30, Nine Months Ended September 30, (In thousands, except share and per share data) 2022 2021 2022 2021 Numerator: Net loss attributable to CASI Pharmaceuticals, Inc. $ (5,201) (10,224) $ (21,477) $ (31,053) Denominator: Weighted average number of common stock 13,606,130 13,979,636 13,668,553 13,486,024 Denominator for basic and diluted net loss per share calculation 13,606,130 13,979,636 13,668,553 13,486,024 Net loss per share — Basic and diluted $ (0.38) $ (0.73) $ (1.57) $ (2.30) |
Stock-Based Compensation
Stock-Based Compensation | 9 Months Ended |
Sep. 30, 2022 | |
Stock-Based Compensation | |
Stock-Based Compensation | 14. Stock-Based Compensation The Company has adopted various stock compensation plans for executive, scientific and administrative personnel of the Company, as well as outside directors and consultants. The stock-based compensation expenses are recorded as components of research and development expense, sales and marketing expense, and general and administrative expense, as follows: Nine Months Ended September 30, (In thousands) 2022 2021 Research and development $ 504 $ 251 Sales and Marketing 183 212 General and administrative 4,904 4,596 Stock-based compensation expense $ 5,591 $ 5,059 |
Income Taxes
Income Taxes | 9 Months Ended |
Sep. 30, 2022 | |
Income Taxes | |
Income Taxes | 15. Income Taxes At December 31, 2021, the Company had a $1.4 million unrecognized tax benefit. The Company recorded a full valuation allowance on the deferred tax asset after offsetting unrecognized tax benefit recognized in the consolidated financial statements as of December 31, 2021. During the nine months ended September 30, 2022, there were no material changes to the measurement of unrecognized tax benefits in various tax jurisdictions. |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2022 | |
Fair Value Measurements | |
Fair Value Measurements | 16. Fair Value Measurements Financial instruments of the Company primarily consist of cash and cash equivalents, investment in equity securities, accounts receivable, long-term investments, accounts payable, accrued liabilities, notes payable and bank borrowings. As of September 30, 2022 and December 31, 2021, the carrying amount of cash and cash equivalents, accounts receivable, accounts payable, accrued liabilities, notes payable and bank borrowings were carried at cost which approximates their fair values due to the short-term nature of the instruments. 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 equity investments in the common stock of two publicly traded companies. The Company’s investments in these equity securities are carried at their estimated fair value, with changes in fair value reported in the consolidated statement of operations and comprehensive loss each reporting period. The fair value of the common stock is based on quoted market price for the investees’ common stock, a Level 1 input. The Company has an equity investment in the warrants of a publicly traded company. The Company’s investment 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. The fair value of the warrants was measured using observable market-based inputs other than quoted prices in active markets for identical assets, level 2 inputs. The Company uses the Black-Scholes-Merton valuation model to estimate the fair value of warrants. Option valuation models, including Black-Scholes-Merton, require the input of highly subjective assumptions, and changes in the assumptions used can materially affect the fair value determination of a warrant. The Company has an investment in the convertible debt of Alesta Therapeutics B.V.. The Company’s investment 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 using Level 3 input. The Company has an investment in the convertible debt of Cleave. The Company’s investment 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 using Level 3 input. The unpaid balance for this convertible debt amounted to $5.8 million and $5.6 million as of September 30, 2022 and December 31, 2021, respectively. The following tables present the Company’s financial assets accounted for at fair value on a recurring basis as of September 30, 2022 and December 31, 2021, by level within the fair value hierarchy: (In thousands) Fair Value at Description September 30, 2022 Level 1 Level 2 Level 3 Investments classified as Current and non-Current Assets Investments in common stock $ 6,309 $ 6,309 $ — $ — Investment in warrants - Designated as investment measured at FVTPL $ 462 $ — $ 462 $ — Investment in convertible loan - AFS $ 276 $ — $ — $ 276 Investment in convertible loan - Designated as investment measured at FVTPL $ 5,958 $ — $ — $ 5,958 Quantitative Information about Level 3 Fair Value Measurements Fair Value at Valuation Unobservable Description September 30, 2022 Techniques Input Average/Median Investment in convertible loan - Designated as investment measured at FVTPL $ 5,958 Discounted cash flow Discount rate 20%/20% (In thousands) Fair Value at Description December 31, 2021 Level 1 Level 2 Level 3 Investments classified as Current and non-Current Assets Investments in common stock $ 9,868 $ 9,868 $ — $ — Investment in warrants - Designated as investment measured at FVTPL $ 591 $ — $ 591 $ — Investment in convertible loan - AFS $ 268 $ — $ — $ 268 Investment in convertible loan - Designated as investment measured at FVTPL $ 5,576 $ — $ — $ 5,576 Quantitative Information about Level 3 Fair Value Measurements Fair Value at Valuation Unobservable Description December 31, 2021 Techniques Input Average/Median Investment in convertible loan - Designated as investment measured at FVTPL $ 5,576 Discounted cash flow Discount rate 20%/20% Financial Assets and Liabilities Measured at Fair Value on a Non-Recurring Basis The Company measures equity investments without readily determinable fair values at its cost, minus impairment, if any, plus or minus changes resulting from observable transactions of identical or similar securities of the same issuer. Non-Financial Assets and Liabilities Measured at Fair Value on a Recurring Basis The Company had no non-financial assets and liabilities Non-Financial Assets and Liabilities Measured at Fair Value on a Non-Recurring Basis The Company had no non-financial assets and liabilities |
Related Party Transactions
Related Party Transactions | 9 Months Ended |
Sep. 30, 2022 | |
Related Party Transactions | |
Related Party Transactions | 17. Related Party Transactions Transactions with Juventas. On July 1, 2019 the Company entered into a one-year equipment lease with Juventas, which is classified as an operating lease. Transactions with Juventas are considered to be related party transactions as the Company’s Chairman and CEO is the chairman and one of the founding shareholders of Juventas. The lease was renewed for another year in July 2020 and in June 2021. In June 2022, the Company and Juventas entered into a lab equipment transfer contract, pursuant to which the previous leasing agreement was terminated and the Company transferred the equipment to Juventas. Total consideration for the transfer was RMB 900,000 ($138,000) in cash. |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2022 | |
Commitments and Contingencies | |
Commitments and Contingencies | 18. Commitments and Contingencies In conjunction with the Cleave agreement entered into during 2021 (see Note 2), the Company is responsible for certain milestone and royalty payments. As of September 30, 2022, no milestones had been achieved. In conjunction with the BioInvent agreement entered into during 2020 (see Note 2), the Company is responsible for certain milestone and royalty payments. As of September 30, 2022, no milestones had been achieved. In conjunction with the Black Belt agreement entered into during 2019 (see Note 2), the Company is responsible for certain milestone and royalty payments. In June 2021, the Company achieved the First-Patient-In (FPI) in the Phase 1 dose escalation and expansion study of CID-103, and made $750,000 milestone payment in June 2021 and 250,000 euros ($305,000) in August 2021. As of September 30, 2022, no other milestones had been achieved. In conjunction with the Pharmathen agreement entered into during 2019 (see Note 2), the Company is responsible for one remaining milestone payment. As of September 30, 2022, the remaining milestone had not been achieved. To develop a GMP manufacturing facility, in November 2019, CASI Wuxi entered into a lease agreement of a state-owned land and committed to invest in land use right and property, plant and equipment for RMB1 billion (equivalent to $143 million) by August 2022. In February 2022, the Company has reached an alignment with the Wuxi local government that the original three-year investment plan will be extended with details regarding the plan under negotiation, and most of the construction work related to the Wuxi land has not started yet. In 2020, CASI Wuxi entered into a lease agreement with local government for a manufactory building next to the leased land and a series of contracts for the construction and equipment. The total contract amount entered into for this manufacturing facility is approximately RMB 174.5 million (approximately $24.5 million), and the commitment under these contracts was RMB 59.2 million (approximately $8.3 million) as of September 30, 2022. The Company is subject in the normal course of business to various legal proceedings in which claims for monetary or other damages may be asserted. Management does not believe such legal proceedings, unless otherwise disclosed herein, are material. |
Subsequent Events
Subsequent Events | 9 Months Ended |
Sep. 30, 2022 | |
Subsequent Events | |
Subsequent Events | 19. Subsequent Event In October 2022, pursuant to the Equity Transfer Agreement entered into between CASI Biopharmaceuticals and Jiadao Gongcheng for the sales of the equity interest in Juventas, the registration with competent governmental authorities of the transaction has been completed. In October 2022, the Company sold all the ordinary shares of MaxCyte for $2.4 million. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2022 | |
Summary of Significant Accounting Policies | |
Basis of Presentation | Basis of Presentation The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”). |
Use of Estimates | 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 recoverability of operating lease right-of-use assets, intangible assets and long-term investments, net realizable value and obsolescence allowance for inventories, deferred tax assets and valuation allowance, allowance for doubtful accounts, stock-based arrangements and fair value of investments. 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. |
Recent Accounting Pronouncements | Recent Accounting Pronouncement s In November 2021, the FASB issued ASU 2021-10, Government Assistance (Topic 832): Disclosures by Business Entities about Government Assistance. This update requires certain annual disclosures about transactions with a government that are accounted for by applying a grant or contribution accounting model by analogy. This update is effective for annual periods beginning after December 15, 2021, and early application is permitted. This guidance should be applied either prospectively to all transactions that are reflected in financial statements at the date of initial application and new transactions that are entered into after the date of initial application or retrospectively to those transactions. The Company does not expect the impact of this guidance to have a material impact on the Company’s consolidated financial statements. In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments — Credit Losses (Topic 326) (“ASU 2016-13”) and subsequent amendments to the initial guidance including ASU No. 2018-19, ASU No. 2019-04, and ASU No. 2019-05 (collectively, “Topic 326”). Topic 326 requires entities to measure all expected credit losses for financial assets held at the reporting date based on historical experience, current conditions, and reasonable and supportable forecasts. This replaces the existing incurred loss model and is applicable to the measurement of credit losses on financial assets measured at amortized cost. This standard is effective for public business entities, excluding entities eligible to be smaller reporting companies for fiscal years beginning after December 15, 2019, including interim periods within those fiscal years. For all other entities, this standard is effective for annual and interim periods beginning after December 15, 2022 and early adoption is permitted for annual and interim periods beginning after December 15, 2018. As a smaller reporting company, the Company expects to adopt this standard in fiscal year 2023. The Company is currently assessing the impact that the adoption of this ASU will have on the consolidated financial statements. |
Investment in Equity Securiti_2
Investment in Equity Securities, at Fair Value and Long-term Investments (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Investment in Equity Securities, at Fair Value and Long-term Investments | |
Schedule of investment | Gross (In thousands) unrealized Aggregate fair September 30, 2022 Classification Cost gains /(losses) value MaxCyte - equity interest Investment $ — $ 2,453 $ 2,453 BioInvent - equity interest Investment $ 4,337 $ (481) $ 3,856 Total $ 6,309 Gross (In thousands) unrealized Aggregate fair December 31, 2021 Classification Cost gains value MaxCyte - equity interest Investment $ — $ 3,866 $ 3,866 BioInvent - equity interest Investment $ 5,661 $ 341 $ 6,002 Total $ 9,868 |
Schedule of components of long-term investments | Long-term investments as of September 30, 2022 and December 31, 2021 consisted of the following: Gross Foreign Gross unrealized currency September 30, 2022 unrealized losses (including translation Aggregate (In thousands) Cost gains impairment) adjustment fair value Available-for-sale debt securities: Alesta Therapeutics B.V. - convertible loan $ 261 $ 15 $ — $ — $ 276 Securities measured at fair value: BioInvent International AB - warrants 656 — (194) — 462 Cleave Therapeutics, Inc. - convertible loan 5,500 458 — — 5,958 Equity securities without readily determinable fair value: Alesta Therapeutics B.V. - equity interests 2,250 — (865) — 1,385 Juventas Biotechnology (Tianjin) Co., Ltd. - equity interests 23,500 6,958 — (1,569) 28,889 Juventas Biotechnology (Tianjin) Co., Ltd. - put option 491 — (521) 30 — Prepayment for investment: Precision Autoimmune Therapeutics Co., Ltd - equity interests 2,962 — — (152) 2,810 Total $ 35,620 $ 7,431 $ (1,580) $ (1,691) $ 39,780 Gross Foreign Gross unrealized currency December 31, 2021 unrealized losses (including translation Aggregate (In thousands) Cost gains impairment) adjustment fair value Available-for-sale debt securities: Alesta Therapeutics B.V. - convertible loan $ 261 $ 7 $ — $ — $ 268 Securities measured at fair value: BioInvent International AB - warrants 656 — (65) — 591 Cleave Therapeutics, Inc. - convertible loan 5,500 76 — — 5,576 Equity securities without readily determinable fair value: Alesta Therapeutics B.V. - equity interests 2,250 — (865) — 1,385 Juventas Biotechnology (Tianjin) Co., Ltd. - equity interests 23,500 6,958 — 1,850 32,308 Juventas Biotechnology (Tianjin) Co., Ltd. - put option 491 — (521) 30 — Total $ 32,658 $ 7,041 $ (1,451) $ 1,880 $ 40,128 |
Property, Plant and Equipment (
Property, Plant and Equipment (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Property, Plant and Equipment | |
Schedule of property and equipment | (In thousands) September 30, December 31, 2022 2021 Furniture and equipment $ 1,169 $ 1,728 Leasehold improvements 6,944 1,133 Construction in progress 7,358 12,095 Total property, plant and equipment, gross 15,471 14,956 Accumulated depreciation and amortization (1,604) (1,817) Impairment of property, plant and equipment — (427) $ 13,867 $ 12,712 |
Leases (Tables)
Leases (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Leases | |
Schedule of right of use assets and liabilities on condensed balance sheet | September 30, December 31, (In thousands) 2022 2021 Right of use assets $ 7,666 $ 9,107 Accrued and other current liabilities $ 922 $ 1,061 Other liabilities 634 1,105 Total lease liabilities $ 1,556 $ 2,166 |
Schedule of supplemental cash flow information | Nine Months Ended September 30, (In thousands) 2022 2021 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows $ 859 $ 1,087 Right of use assets obtained in exchange for lease obligations: $ 421 $ 1,661 |
Schedule of future undiscounted cash flows | (In thousands) 2022 (remaining three months) $ 266 2023 871 2024 456 Thereafter 12 Total 1,605 Discount factor (49) Lease liability 1,556 Amounts due within 12 months 922 Non-current lease liability $ 634 |
Accrued and Other Current Lia_2
Accrued and Other Current Liabilities, and Other Liabilities (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Accrued and Other Current Liabilities, and Other Liabilities | |
Schedule of accrued and other current liabilities and other liabilities | September 30, December 31, (In thousands) 2022 2021 Accrued and other current liabilities: Receipt in advance for sale of an investment (1) 16,921 — Payables related to property and equipment 3,111 3,288 Payroll and welfare payable $ 2,037 $ 3,336 Lease liabilities-current 922 1,061 Value-added tax and other tax payable 255 639 Deferred income-current 54 60 Other 351 13 $ 23,651 $ 8,397 Other Liabilities Profit-sharing liability to Juventas $ 11,821 $ 13,220 Lease liabilities-noncurrent 634 1,105 $ 12,455 $ 14,325 |
Redeemable Noncontrolling Int_2
Redeemable Noncontrolling Interest (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Redeemable Noncontrolling Interest | |
Schedule of changes in redeemable noncontrolling interest | Nine Months Ended September 30, (In thousands) 2022 2021 Balance at beginning of period $ 23,457 $ 22,033 Share of CASI Wuxi net loss (1,703) (980) Accretion of redeemable noncontrolling interest 2,264 1,586 Foreign currency translation adjustment (2,515) 268 Balance at end of period $ 21,503 $ 22,907 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Net Loss Per Share | |
Schedule of basic and diluted net loss per share | Three Months Ended September 30, Nine Months Ended September 30, (In thousands, except share and per share data) 2022 2021 2022 2021 Numerator: Net loss attributable to CASI Pharmaceuticals, Inc. $ (5,201) (10,224) $ (21,477) $ (31,053) Denominator: Weighted average number of common stock 13,606,130 13,979,636 13,668,553 13,486,024 Denominator for basic and diluted net loss per share calculation 13,606,130 13,979,636 13,668,553 13,486,024 Net loss per share — Basic and diluted $ (0.38) $ (0.73) $ (1.57) $ (2.30) |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Stock-Based Compensation | |
Schedule of compensation expense | Nine Months Ended September 30, (In thousands) 2022 2021 Research and development $ 504 $ 251 Sales and Marketing 183 212 General and administrative 4,904 4,596 Stock-based compensation expense $ 5,591 $ 5,059 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
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, 2022 Level 1 Level 2 Level 3 Investments classified as Current and non-Current Assets Investments in common stock $ 6,309 $ 6,309 $ — $ — Investment in warrants - Designated as investment measured at FVTPL $ 462 $ — $ 462 $ — Investment in convertible loan - AFS $ 276 $ — $ — $ 276 Investment in convertible loan - Designated as investment measured at FVTPL $ 5,958 $ — $ — $ 5,958 Quantitative Information about Level 3 Fair Value Measurements Fair Value at Valuation Unobservable Description September 30, 2022 Techniques Input Average/Median Investment in convertible loan - Designated as investment measured at FVTPL $ 5,958 Discounted cash flow Discount rate 20%/20% (In thousands) Fair Value at Description December 31, 2021 Level 1 Level 2 Level 3 Investments classified as Current and non-Current Assets Investments in common stock $ 9,868 $ 9,868 $ — $ — Investment in warrants - Designated as investment measured at FVTPL $ 591 $ — $ 591 $ — Investment in convertible loan - AFS $ 268 $ — $ — $ 268 Investment in convertible loan - Designated as investment measured at FVTPL $ 5,576 $ — $ — $ 5,576 Quantitative Information about Level 3 Fair Value Measurements Fair Value at Valuation Unobservable Description December 31, 2021 Techniques Input Average/Median Investment in convertible loan - Designated as investment measured at FVTPL $ 5,576 Discounted cash flow Discount rate 20%/20% |
DESCRIPTION OF BUSINESS (Detail
DESCRIPTION OF BUSINESS (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 | Sep. 30, 2021 | Dec. 31, 2020 |
Description of Business and Basis of Presentation [Line Items] | ||||
Accumulated deficit | $ (624,856) | $ (605,643) | ||
Cash and cash equivalents and restricted cash | 29,242 | $ 38,704 | $ 53,126 | $ 57,064 |
CASI China | ||||
Description of Business and Basis of Presentation [Line Items] | ||||
Cash and cash equivalents and restricted cash | $ 22,200 |
License and Distribution Agre_2
License and Distribution Agreements (Details) ¥ in Millions | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||||||||||||||||||||
Oct. 29, 2019 | May 31, 2022 USD ($) installment | Aug. 31, 2021 USD ($) | Aug. 31, 2021 EUR (€) | Jun. 30, 2021 USD ($) | Mar. 31, 2021 USD ($) | Nov. 30, 2020 USD ($) | Sep. 30, 2020 USD ($) | Sep. 30, 2020 CNY (¥) | Apr. 30, 2019 USD ($) | Apr. 30, 2019 EUR (€) | Mar. 31, 2019 | Sep. 30, 2022 USD ($) | Mar. 31, 2022 | Sep. 30, 2021 USD ($) | Sep. 30, 2020 CNY (¥) | Sep. 30, 2022 USD ($) | Sep. 30, 2021 USD ($) | Dec. 31, 2021 USD ($) | Dec. 31, 2020 USD ($) | Dec. 31, 2020 EUR (€) | Dec. 31, 2019 EUR (€) | Sep. 30, 2022 CNY (¥) | Aug. 31, 2021 EUR (€) | |
License and Distribution Agreements | ||||||||||||||||||||||||
Research and Development Asset Acquired Other than through Business Combination, Writeoff, Statement of Income or Comprehensive Income [Extensible Enumeration] | Acquired in-process research and development | |||||||||||||||||||||||
Acquired in-process research and development | $ 0 | $ 0 | $ 0 | $ 6,555,000 | ||||||||||||||||||||
China Resources Guokang Pharmaceuticals Co., Ltd | ||||||||||||||||||||||||
License and Distribution Agreements | ||||||||||||||||||||||||
Non Royalty Exclusive Distribution Period | 3 years | |||||||||||||||||||||||
Non royalty exclusive distribution additional period | 2 years | |||||||||||||||||||||||
Beijing Tianshi Tongda Pharmaceuticals Technology Co., Ltd | ||||||||||||||||||||||||
License and Distribution Agreements | ||||||||||||||||||||||||
Upfront payment | $ 10,000,000 | |||||||||||||||||||||||
Number of installments for upfront payment | installment | 2 | |||||||||||||||||||||||
Pharmathen Global BV | ||||||||||||||||||||||||
License and Distribution Agreements | ||||||||||||||||||||||||
Upfront payment | € | € 1,000,000 | |||||||||||||||||||||||
Non Royalty Exclusive Distribution Period | 10 years | |||||||||||||||||||||||
Additional milestone payments paid | $ 1,700,000 | € 1,500,000 | ||||||||||||||||||||||
Non-royalty exclusive distribution period at agreed cost | 3 years | |||||||||||||||||||||||
Pharmathen Global BV | Maximum | ||||||||||||||||||||||||
License and Distribution Agreements | ||||||||||||||||||||||||
Additional milestone payments paid | € | € 2,000,000 | |||||||||||||||||||||||
Black Belt Therapeutics Ltd | ||||||||||||||||||||||||
License and Distribution Agreements | ||||||||||||||||||||||||
Upfront payment | $ 5,700,000 | € 5,000,000 | € 5,000,000 | |||||||||||||||||||||
Milestone payment | $ 305,000 | € 250,000 | $ 750,000 | |||||||||||||||||||||
Accrued milestone payment | $ 305,000 | € 250,000 | ||||||||||||||||||||||
In-process research and development expensed | $ 1,100,000 | |||||||||||||||||||||||
Potential milestones and royalties of up to | $ 46,300,000 | |||||||||||||||||||||||
Cleave Therapeutics, Inc | ||||||||||||||||||||||||
License and Distribution Agreements | ||||||||||||||||||||||||
Upfront payment | $ 5,500,000 | |||||||||||||||||||||||
Acquired in-process research and development | $ 5,500,000 | |||||||||||||||||||||||
Cleave Therapeutics, Inc | Maximum | ||||||||||||||||||||||||
License and Distribution Agreements | ||||||||||||||||||||||||
Milestone payment | $ 74,000,000 | |||||||||||||||||||||||
Juventas Cell Therapy Ltd. | ||||||||||||||||||||||||
License and Distribution Agreements | ||||||||||||||||||||||||
Milestone payment | $ 10,000,000 | ¥ 70 | ¥ 70 | |||||||||||||||||||||
Equity attributable to noncontrolling interest | 33,800,000 | 33,800,000 | ¥ 240.9 | |||||||||||||||||||||
BioInvent International AB | ||||||||||||||||||||||||
License and Distribution Agreements | ||||||||||||||||||||||||
Upfront payment | $ 5,900,000 | |||||||||||||||||||||||
Acquired in-process research and development | $ 5,900,000 | |||||||||||||||||||||||
BioInvent International AB | Maximum | ||||||||||||||||||||||||
License and Distribution Agreements | ||||||||||||||||||||||||
Potential milestones and royalties of up to | $ 83,000,000 | |||||||||||||||||||||||
Riemser Pharma GmbH | ||||||||||||||||||||||||
License and Distribution Agreements | ||||||||||||||||||||||||
Contingent milestone payment | $ 0 | $ 0 |
Investment in Equity Securiti_3
Investment in Equity Securities, at Fair Value and Long-term Investments - Summary of Investments (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | |
Gross unrealized gains /(losses) | $ 696 | $ (3,687) | $ (2,012) | $ (205) | |
Common Stock | |||||
Equity securities at fair value | 6,309 | 6,309 | $ 9,868 | ||
Common Stock | MaxCyte Inc. | |||||
Gross unrealized gains /(losses) | 2,453 | 3,866 | |||
Equity securities at fair value | 2,453 | 2,453 | 3,866 | ||
Common Stock | BioInvent International AB | |||||
Cost | 4,337 | 4,337 | 5,661 | ||
Gross unrealized gains /(losses) | (481) | 341 | |||
Equity securities at fair value | $ 3,856 | $ 3,856 | $ 6,002 |
Investment in Equity Securiti_4
Investment in Equity Securities, at Fair Value and Long-term Investments - Summary of Long-term investments (Details) - USD ($) $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2022 | Dec. 31, 2021 | |
Schedule Of Long Term Investments | ||
Cost | $ 35,620 | $ 32,658 |
Gross unrealized gains | 7,431 | 7,041 |
Gross unrealized losses (including impairment) | (1,580) | (1,451) |
Foreign currency translation adjustment | (1,691) | 1,880 |
Aggregate fair value | 39,780 | 40,128 |
Alesta Tx | Available-for-sale debt securities | Convertible loan | ||
Schedule Of Long Term Investments | ||
Cost | 261 | 261 |
Gross unrealized gains | 15 | 7 |
Aggregate fair value | 276 | 268 |
Alesta Tx | Equity securities without readily determinable fair value | Equity Securities | ||
Schedule Of Long Term Investments | ||
Cost | 2,250 | 2,250 |
Gross unrealized losses (including impairment) | (865) | (865) |
Aggregate fair value | 1,385 | 1,385 |
Juventas Cell Therapy Ltd. | Equity securities without readily determinable fair value | Equity Securities | ||
Schedule Of Long Term Investments | ||
Cost | 23,500 | 23,500 |
Gross unrealized gains | 6,958 | 6,958 |
Foreign currency translation adjustment | (1,569) | 1,850 |
Aggregate fair value | 28,889 | 32,308 |
Juventas Cell Therapy Ltd. | Equity securities without readily determinable fair value | Put option | ||
Schedule Of Long Term Investments | ||
Cost | 491 | 491 |
Gross unrealized losses (including impairment) | (521) | (521) |
Foreign currency translation adjustment | 30 | 30 |
BioInvent International AB | Securities measured at fair value | Warrants | ||
Schedule Of Long Term Investments | ||
Cost | 656 | 656 |
Gross unrealized losses (including impairment) | (194) | (65) |
Aggregate fair value | 462 | 591 |
Cleave Therapeutics, Inc | Securities measured at fair value | Convertible loan | ||
Schedule Of Long Term Investments | ||
Cost | 5,500 | 5,500 |
Gross unrealized gains | 458 | 76 |
Aggregate fair value | 5,958 | $ 5,576 |
Precision Autoimmune Therapeutics Co., Ltd | Prepayment for investment | Equity Securities | ||
Schedule Of Long Term Investments | ||
Cost | 2,962 | |
Foreign currency translation adjustment | (152) | |
Aggregate fair value | $ 2,810 |
Investment in Equity Securiti_5
Investment in Equity Securities, at Fair Value and Long-term Investments (Details) ¥ in Millions | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||||||
Oct. 31, 2022 USD ($) | May 31, 2022 USD ($) | Sep. 30, 2022 USD ($) | Jun. 30, 2022 USD ($) shares | Sep. 30, 2021 USD ($) | Sep. 30, 2022 USD ($) | Sep. 30, 2022 CNY (¥) | Sep. 30, 2021 USD ($) | Sep. 30, 2022 CNY (¥) | May 31, 2022 CNY (¥) | |
Unrealized gains | $ 600,000 | |||||||||
Unrealized losses | $ (3,700,000) | $ (2,500,000) | $ (300,000) | |||||||
MaxCyte Inc. | Subsequent Events. | ||||||||||
Proceeds from sales of equity securities | $ 2,400,000 | |||||||||
BioInvent International AB | Common Stock | ||||||||||
Number of ordinary shares sold | shares | 275,000 | |||||||||
Proceeds from sales of equity securities | $ 1,300,000 | |||||||||
Gain on equity securities | $ 131,000 | |||||||||
Juventas Cell Therapy Ltd. | ||||||||||
Equity attributable to noncontrolling interest | $ 33,800,000 | 33,800,000 | ¥ 240.9 | |||||||
Proceeds from sale of investment | $ 16,900,000 | ¥ 120.4 | ||||||||
Precision Autoimmune Therapeutics Co., Ltd | ||||||||||
Percentage of interest in board seats | 33.33% | |||||||||
Aggregate consideration for equity investment | $ 3,000,000 | ¥ 20 | ||||||||
Precision Autoimmune Therapeutics Co., Ltd | CASI (China) | ||||||||||
Percentage of equity held in joint venture | 15% |
Inventories (Details)
Inventories (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | |
Inventories | |||||
Finished goods | $ 5,800 | $ 5,800 | $ 1,900 | ||
Inventory write down | $ 0 | $ 0 | $ 0 | $ 0 |
Property, Plant and Equipment_2
Property, Plant and Equipment (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Property, Plant and Equipment | ||
Furniture and equipment | $ 1,169 | $ 1,728 |
Leasehold improvements | 6,944 | 1,133 |
Construction in progress | 7,358 | 12,095 |
Total property, plant and equipment, gross | 15,471 | 14,956 |
Accumulated depreciation and amortization | (1,604) | (1,817) |
Impairment of property, plant and equipment | (427) | |
Total property, plant and equipment, net | $ 13,867 | $ 12,712 |
Leases - (Details)
Leases - (Details) $ in Thousands, ¥ in Millions | 1 Months Ended | 9 Months Ended | 12 Months Ended | ||
Nov. 30, 2019 USD ($) m² | Nov. 30, 2019 CNY (¥) m² | Sep. 30, 2022 USD ($) lease | Sep. 30, 2021 USD ($) | Dec. 31, 2021 lease | |
Rent expenses | $ 1,000 | $ 1,200 | |||
Number of operating lease | lease | 7 | 8 | |||
Weighted average remaining lease term | 37 years 11 months 1 day | 36 years 5 months 19 days | |||
Weighted average discount rates | 3.53% | 3.56% | |||
Variable lease costs | $ 0 | 0 | |||
Sublease income | $ 0 | $ 0 | |||
CASI Wuxi | |||||
Term of lease contract | 50 years | 50 years | |||
Land parcel area (in square meters) | m² | 74,028.40 | 74,028.40 | |||
Prepaid lease payments for the land use right | $ 6,500 | ¥ 45 |
Leases - Right of Use Assets an
Leases - Right of Use Assets and Liabilities (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Right of use assets | $ 7,666 | $ 9,107 |
Operating Lease, Liability | $ 1,556 | $ 2,166 |
Operating Lease, Right-of-Use Asset, Statement of Financial Position [Extensible Enumeration] | Right of use assets | Right of use assets |
Operating Lease, Liability, Current, Statement of Financial Position [Extensible List] | Accrued And Other Liabilities, Current | Accrued And Other Liabilities, Current |
Operating Lease, Liability, Noncurrent, Statement of Financial Position [Extensible List] | Other Liabilities, Noncurrent | Other Liabilities, Noncurrent |
Operating Lease, Liability, Statement of Financial Position [Extensible List] | us-gaap:AccruedLiabilitiesCurrent, Other Liabilities, Noncurrent | us-gaap:AccruedLiabilitiesCurrent, Other Liabilities, Noncurrent |
Accrued Liabilities-Current | ||
Operating Lease, Liability | $ 922 | $ 1,061 |
Operating Lease, Liability, Current, Statement of Financial Position [Extensible List] | Accrued And Other Liabilities, Current | Accrued And Other Liabilities, Current |
Other Liabilities-Long Term | ||
Operating Lease, Liability | $ 634 | $ 1,105 |
Operating Lease, Liability, Noncurrent, Statement of Financial Position [Extensible List] | Other Liabilities, Noncurrent | Other Liabilities, Noncurrent |
Leases - Supplemental Cash Flow
Leases - Supplemental Cash Flow (Details) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Cash paid for amounts included in the measurement of lease liabilities: | ||
Operating cash flows | $ 859 | $ 1,087 |
Right of use assets obtained in exchange for lease obligations | $ 421 | $ 1,661 |
Leases - Future Undiscounted Ca
Leases - Future Undiscounted Cash Flows (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Leases | ||
2022 (remaining three months) | $ 266 | |
2023 | 871 | |
2024 | 456 | |
Thereafter | 12 | |
Total | 1,605 | |
Discount factor | (49) | |
Lease liability | 1,556 | $ 2,166 |
Amounts due within 12 months | 922 | 1,061 |
Non-current lease liability | $ 634 | $ 1,105 |
Accrued and Other Current Lia_3
Accrued and Other Current Liabilities, and Other Liabilities (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Accrued and Other Current Liabilities, and Other Liabilities | ||
Receipt in advance for sale of an investment (1) | $ 16,921 | |
Payables related to property and equipment | 3,111 | $ 3,288 |
Payroll and welfare payable | 2,037 | 3,336 |
Lease liabilities-current | $ 922 | $ 1,061 |
Operating Lease, Liability, Current, Statement of Financial Position [Extensible List] | Accrued and other current liabilities | Accrued and other current liabilities |
Value-added tax and other tax payable | $ 255 | $ 639 |
Deferred income-current | 54 | 60 |
Other | 351 | 13 |
Accrued and other current liabilities | 23,651 | 8,397 |
Profit-sharing liability to Juventas | 11,821 | 13,220 |
Lease liabilities-noncurrent | $ 634 | $ 1,105 |
Operating Lease, Liability, Noncurrent, Statement of Financial Position [Extensible List] | Other Liabilities | Other Liabilities |
Other Liabilities | $ 12,455 | $ 14,325 |
Bank Borrowings (Details)
Bank Borrowings (Details) $ in Thousands, ¥ in Millions | 9 Months Ended | ||||
Sep. 30, 2022 USD ($) | Sep. 30, 2021 USD ($) | Jun. 30, 2022 USD ($) | Jun. 30, 2022 CNY (¥) | May 31, 2022 USD ($) | |
Bank Borrowings | |||||
Amount matured | $ 4,001 | $ 709 | |||
East West Bank | |||||
Bank Borrowings | |||||
Maximum borrowing | $ 10,000 | ||||
Amount outstanding | $ 3,000 | ||||
China CITIC Bank Corporation Limited | |||||
Bank Borrowings | |||||
Maximum borrowing | $ 3,000 | ¥ 20 | |||
Amount outstanding | $ 1,000 | ¥ 6.7 | |||
Interest rate | 3.98% | 3.98% |
Redeemable Noncontrolling Int_3
Redeemable Noncontrolling Interest - Changes in Redeemable Noncontrolling Interest (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Redeemable Noncontrolling Interest | ||||
Balance at beginning of period | $ 23,457 | $ 22,033 | ||
Share of CASI Wuxi net loss | $ (738) | $ (314) | (1,703) | (980) |
Accretion of redeemable noncontrolling interest | 2,264 | 1,586 | ||
Foreign currency translation adjustment | (2,515) | 268 | ||
Balance at end of period | $ 21,503 | $ 22,907 | $ 21,503 | $ 22,907 |
Stockholders' Equity (Details)
Stockholders' Equity (Details) $ / shares in Units, $ in Thousands | 3 Months Ended | ||||
Jun. 01, 2022 shares | Mar. 31, 2022 USD ($) shares | Sep. 30, 2022 $ / shares shares | Dec. 31, 2021 $ / shares shares | Dec. 15, 2021 USD ($) shares | |
Common stock par value (in dollars per share) | $ / shares | $ 0.01 | $ 0.01 | |||
Authorized common stock (in shares) | 250,000,000 | 250,000,000 | 250,000,000 | ||
Common stock in treasury (in shares) | 127,329 | 7,954 | |||
Repurchase of common stock (in shares) | 3,734,992 | ||||
Repurchase of common stock | $ | $ 3,000 | ||||
Shares issued | 2,541,245 | ||||
Warrants outstanding (in shares) | 617,277 | ||||
Warrants exercisable (in shares) | 617,277 | ||||
Reverse stock split | 10 | ||||
Maximum | |||||
Stock repurchase program, Authorized amount | $ | $ 10,000 | ||||
Stock repurchase program, Number of shares authorized to be repurchased | 12,500,000 | ||||
Weighted Average | |||||
Warrants outstanding, exercise price | $ / shares | $ 36.9 | ||||
Warrants exercisable, exercise price | $ / shares | $ 36.9 |
Net Loss Per Share (Details)
Net Loss Per Share (Details) - shares | 9 Months Ended | 12 Months Ended |
Sep. 30, 2022 | Dec. 31, 2021 | |
Options | ||
Antidilutive securities excluded from computation of earnings per share amount | 3,415,729 | 3,324,368 |
Warrant | ||
Antidilutive securities excluded from computation of earnings per share amount | 617,277 | 617,277 |
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, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Sep. 30, 2021 | Jun. 30, 2021 | Mar. 31, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Numerator: | ||||||||
Net loss attributable to CASI Pharmaceuticals, Inc. | $ (5,201) | $ (7,680) | $ (8,596) | $ (10,224) | $ (6,946) | $ (13,883) | $ (21,477) | $ (31,053) |
Denominator: | ||||||||
Weighted average number of common stock | 13,606,130 | 13,979,636 | 13,668,553 | 13,486,024 | ||||
Denominator for basic and diluted net loss per share calculation | 13,606,130 | 13,979,636 | 13,668,553 | 13,486,024 | ||||
Net loss per share (basic) | $ (0.38) | $ (0.73) | $ (1.57) | $ (2.30) | ||||
Net loss per share (diluted) | $ (0.38) | $ (0.73) | $ (1.57) | $ (2.30) |
Stock-Based Compensation - Comp
Stock-Based Compensation - Compensation Expense (Details) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Share-based Compensation Arrangement by Share-based Payment Award | ||
Stock-based compensation expense | $ 5,591 | $ 5,059 |
Research and development | ||
Share-based Compensation Arrangement by Share-based Payment Award | ||
Stock-based compensation expense | 504 | 251 |
Sales and Marketing | ||
Share-based Compensation Arrangement by Share-based Payment Award | ||
Stock-based compensation expense | 183 | 212 |
General and administrative | ||
Share-based Compensation Arrangement by Share-based Payment Award | ||
Stock-based compensation expense | $ 4,904 | $ 4,596 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) $ in Millions | Sep. 30, 2022 | Dec. 31, 2021 |
Income Taxes | ||
Unrecognized tax benefits | $ 0 | $ 1.4 |
Fair Value Measurements - Finan
Fair Value Measurements - Financial and Non-Financial Assets and Liabilities (Details) - Recurring - USD ($) $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2022 | Dec. 31, 2021 | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis | ||
Investments in common stock | $ 6,309 | $ 9,868 |
Investment in warrants - Designated as investment measured at FVTPL | 462 | 591 |
Investment in convertible loan-AFS | 276 | 268 |
Investment in convertible loan-Designated as investment measured at FVTPL | 5,958 | 5,576 |
Level 1 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis | ||
Investments in common stock | 6,309 | 9,868 |
Investment in warrants - Designated as investment measured at FVTPL | 0 | 0 |
Investment in convertible loan-AFS | 0 | 0 |
Investment in convertible loan-Designated as investment measured at FVTPL | 0 | 0 |
Level 2 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis | ||
Investments in common stock | 0 | 0 |
Investment in warrants - Designated as investment measured at FVTPL | 462 | 591 |
Investment in convertible loan-AFS | 0 | 0 |
Investment in convertible loan-Designated as investment measured at FVTPL | 0 | 0 |
Level 3 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis | ||
Investments in common stock | 0 | 0 |
Investment in warrants - Designated as investment measured at FVTPL | 0 | 0 |
Investment in convertible loan-AFS | 276 | 268 |
Investment in convertible loan-Designated as investment measured at FVTPL | $ 5,958 | $ 5,576 |
Level 3 | Discount rate | Average | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis | ||
Investment in convertible loan using measurement alternative, measurement input | 20% | 20% |
Level 3 | Discount rate | Median | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis | ||
Investment in convertible loan using measurement alternative, measurement input | 20% | 20% |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis | ||
Unpaid balance convertible debt | $ 5,800 | $ 5,600 |
Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis | ||
Non-financial assets, measured at fair value | 0 | |
Non-financial liabilities, measured at fair value | 0 | |
Non-recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis | ||
Non-financial assets, measured at fair value | 0 | |
Non-financial liabilities, measured at fair value | $ 0 |
Related Party Transactions (Det
Related Party Transactions (Details) ¥ in Thousands, $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||||
Jun. 30, 2022 USD ($) | Jun. 30, 2022 CNY (¥) | Mar. 31, 2022 shares | Sep. 30, 2021 USD ($) | Sep. 30, 2022 USD ($) | Sep. 30, 2021 USD ($) | Jul. 01, 2019 | |
Related Party Transaction | |||||||
Lease income | $ | $ 37 | $ 60 | $ 110 | ||||
Shares issued | shares | 2,541,245 | ||||||
Juventas Cell Therapy Ltd. | |||||||
Related Party Transaction | |||||||
Term of lease contract | 1 year | ||||||
Costs of leased equipment | $ 138,000 | ¥ 900,000 |
Commitments and Contingencies (
Commitments and Contingencies (Details) ¥ in Millions | 1 Months Ended | 9 Months Ended | |||||||
Aug. 31, 2021 USD ($) | Aug. 31, 2021 EUR (€) | Jun. 30, 2021 USD ($) | Nov. 30, 2019 USD ($) | Nov. 30, 2019 CNY (¥) | Sep. 30, 2022 USD ($) Milestone | Sep. 30, 2021 USD ($) | Sep. 30, 2022 CNY (¥) | Aug. 31, 2021 EUR (€) | |
Payment for property improvements | $ | $ 2,186,000 | $ 3,730,000 | |||||||
CASI Wuxi | |||||||||
Fixed assets investment, commitment amount | 8,300,000 | ¥ 59.2 | |||||||
Land use right and property, plant and equipment, commitment amount | $ 143,000,000 | ¥ 1,000 | |||||||
CASI Wuxi | Building | |||||||||
Contractual obligation | $ 24,500,000 | ¥ 174.5 | |||||||
Cleave Therapeutics, Inc | |||||||||
Number of milestones achieved | 0 | ||||||||
BioInvent International AB | |||||||||
Number of milestones achieved | 0 | ||||||||
Black Belt Therapeutics Ltd | |||||||||
Number of milestones achieved | 0 | ||||||||
Milestone payment | $ 305,000 | € 250,000 | $ 750,000 | ||||||
Accrued milestone payment | $ 305,000 | € 250,000 | |||||||
Pharmathen Global BV | |||||||||
Number of milestone payments yet to be paid | 1 |
Subsequent Event (Details)
Subsequent Event (Details) $ in Millions | 1 Months Ended |
Oct. 31, 2022 USD ($) | |
Subsequent Events | MaxCyte Inc. | |
Subsequent Events | |
Proceeds from sales of equity securities | $ 2.4 |