BEIJING, May 15, 2024 /PRNewswire/ -- CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a biopharmaceutical company specializing in the development and commercialization of innovative therapeutic and pharmaceutical products announced today the following: On April 12, 2024 CASI submitted the IND application to the FDA for CID-103 to support a phase 1/2 study of CID-103 in adults with chronic Immune Thrombocytopenia (ITP). On May 13, 2024 CASI received a letter from FDA indicating that study may proceed. CID-103 is ...

BEIJING, April 8, 2024 /PRNewswire/ -- CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a Cayman incorporated biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, today reported that it has furnished a current report on Form 6-K to disclose material development relating to its dispute with Juventas. For details, please visit below link: https://www.sec.gov/Archives/edgar/data/1962738/000196273824000014/tmb-20240408x6k.htm About CASI Pharmaceutica ...

CASI PHARMACEUTICALS ANNOUNCES FOURTH QUARTER AND FULL-YEAR 2023 BUSINESS AND FINANCIAL RESULTS BEIJING, China (March 28, 2024) CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a Cayman incorporated biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, today reported business and financial results for the year ended December 31, 2023, and provided an update on key highlights for 2023. CASI reported fourth quarter 2023 revenue of $6.9 million for E ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR 12(g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023. OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITI ...

BEIJING and LUND, Sweden, March 5, 2024 /PRNewswire/ -- CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a biopharmaceutical company specializing in the development and commercialization of innovative therapeutic and pharmaceutical products, and BioInvent International AB ("BioInvent") (Nasdaq Stockholm: BINV), a biotech company focused on the discovery and development of novel and first-in-class immune-modulatory antibodies for cancer immunotherapy, today announced preliminary encouraging efficacy data for BI-12 ...

BEIJING, Feb. 16, 2024 /PRNewswire/ -- CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a biopharmaceutical company specializing in the development and commercialization of innovative therapeutic and pharmaceutical products, proudly announced the administration of the first dose of FOLOTYN® (Pralatrexate Injection) to a patient in China. This remarks a pivotal step in CASI's commitment to addressing critical medical needs in peripheral T-cell lymphoma in China market. FOLOTYN® (Pralatrexate) is a dihydrofolate re ...

www.casipharmaceuticals.com Exhibit 99.1 CASI PHARMACEUTICALS ANNOUNCES FOURTH QUARTER AND FULL-YEAR 2022 FINANCIAL RESULTS BEIJING, China (April 26, 2023) CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a Cayman incorporated biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, today reported financial results for the year ended December 31, 2022, and provided an update on key highlights for 2022. Wei-Wu He, Ph.D., CASI's Chairman and Chief Exec ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR 12(g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022. OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITI ...

Financial Data and Key Metrics Changes - Revenue for the second quarter of 2022 was $8.6 million, a 19% increase compared to $7.2 million in the same period last year [20] - Revenue from EVOMELA sales increased by 19% year-over-year despite challenges from COVID-related lockdowns [4][20] - Cash and cash equivalents at the end of the quarter stood at $18.9 million [20] Business Line Data and Key Metrics Changes - EVOMELA generated $8.6 million in revenue for Q2 2022, with a notable increase from the previous year [9][20] - The company entered into a sub-license agreement with Precision Autoimmune Therapeutics, which includes an upfront payment of $10 million [7][20] Market Data and Key Metrics Changes - COVID-related lockdowns in major cities in China, particularly Shanghai, impacted sales and access to hospitals, affecting revenue generation [4][25] - The company anticipates that the revenue will recover as restrictions ease, although the unpredictability of COVID-19 remains a concern [25][26] Company Strategy and Development Direction - The strategic focus for 2022 is to advance the development and commercialization of the product portfolio, including the anticipated launch of CNCT19 in China [5] - The company aims to maintain its focus on the hematology-oncology market while exploring opportunities in autoimmune diseases through partnerships [28] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the recovery of revenue despite the challenges posed by COVID-19, highlighting the resilience of the sales and marketing team [25][26] - The company is well-financed into 2023, with a combination of cash reserves and a new loan agreement [20][30] Other Important Information - A ten-to-one reverse stock split was executed to meet Nasdaq listing requirements, resulting in approximately 13.6 million shares outstanding [6] - The company is preparing for the anticipated NDA filing for CNCT19 in the second half of 2022, with expected approval in 2023 [34] Q&A Session Summary Question: Challenges due to COVID and resolution timeline - Management acknowledged significant revenue impact from COVID lockdowns in Shanghai but noted recovery in some areas [25][26] Question: Details on the Precision Autoimmune Therapeutics deal - The partnership was chosen due to the potential of CD38 in treating autoimmune diseases and the financial backing from local venture capital [28][30] Question: Timing for CNCT19 NDRL listing and competition - The NDA for CNCT19 is expected to be filed in 2022, with approval likely in 2023; competition from other CAR-T therapies is acknowledged but the company believes in its competitive pricing [34][35] Question: Additional steps before CNCT19 launch - Sufficient manufacturing capacity is in place for the first year, with no anticipated issues at approval [39] Question: Timeline for BI-1206 and Thiotepa development - Submission for Thiotepa is expected within four to six months, while BI-1206 is moving forward with plans to initiate patient dosing soon [41]