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CASI Pharmaceuticals Inc (CASI) is a biopharmaceutical innovator advancing therapies for oncology and immune-related disorders. This page provides investors and industry professionals with timely updates on clinical developments, regulatory milestones, and corporate announcements.
Key resources include: Press releases detailing product approvals, financial earnings reports, partnership agreements, and progress across the company’s pipeline. Track updates on therapies like EVOMELA® for multiple myeloma and CID-103 for immune-mediated conditions.
Bookmark this page to stay informed about CASI’s strategic initiatives in hematologic oncology and global commercialization efforts. Check regularly for verified updates directly from the company and trusted sources.
CASI Pharmaceuticals announced that the China National Medical Products Administration has accepted the new drug application for CNCT19, an investigational CAR-T therapy targeting relapsed/refractory B-Cell Acute Lymphoblastic Leukemia (r/r B-ALL). This marks CNCT19 as the first CAR-T therapy for B-ALL submitted for NDA and the potential first domestically developed CD19-directed CAR-T therapy in China. The registrational trial showed a 100% drug production success rate and promising efficacy results with an 82.1% overall response rate.
CASI Pharmaceuticals reported a 26% increase in third-quarter revenue, reaching $10.2 million from $8.1 million year-over-year, attributed mainly to EVOMELA sales. During this period, research and development expenses rose to $3.9 million, reflecting ongoing clinical projects like BI-1206 and CID-103. Notably, costs of revenues increased to $4.2 million, while general and administrative expenses decreased to $4.8 million. Despite strong performance in sales, the ongoing COVID-related restrictions in China may impact future revenue.
CASI Pharmaceuticals, Inc. (NASDAQ: CASI) announced an agreement to transfer its 12.0098% equity interest in Juventas Biotechnology to Shenzhen Jiadao Gongcheng for RMB 240.87 million (USD 34.03 million). The transaction will be executed in two installments, aiding CASI's cash flow until at least the end of 2023. CEO Wei-Wu He expressed confidence in CNCT-19, a CAR-T therapy targeting CD19, which Juventas will submit for NDA to the NMPA in 2022. This strategic move is expected to enhance CASI's balance sheet and support the development of its pipeline projects.
CASI Pharmaceuticals has initiated the first patient enrollment in a Phase 1 study of BI-1206 in China, targeting relapsed/refractory Non-Hodgkin's Lymphoma (NHL). This monoclonal antibody has shown promising early efficacy and tolerable safety in previous trials. The study aims to assess safety and clinical activity, potentially addressing unmet medical needs in NHL treatment. CASI's partnership with BioInvent marks a significant milestone, with expectations for valuable data generation to enhance treatment options.
CASI Pharmaceuticals reported financial results for Q2 2022, showcasing $8.6 million in EVOMELA® sales, a 19% increase from the previous year. The company's total revenues rose due to resilient sales strategies adapting to COVID-19 challenges.
Research and development expenses rose to $3.9 million from $2.3 million year-over-year, driven by CID-103 expenses. The company maintains $18.9 million in cash as of June 30, 2022, while focusing on the upcoming launch of CNCT19 in China and progressing BI-1206's regulatory framework.
CASI Pharmaceuticals (Nasdaq: CASI) will host a conference call on August 12, 2022, at 8:00 A.M. EST to discuss its second quarter financial results. The call will feature updates from the Chairman & CEO concerning the company's business and milestones. Investors can join the call by dialing specific numbers provided in the announcement. CASI Pharmaceuticals specializes in developing innovative therapeutics and pharmaceutical products in China and the U.S., focusing on hematology and oncology.
CASI Pharmaceuticals announced that its partner, Precision Autoimmune Therapeutics (PAT), has successfully completed a first-round financing of approximately $21 million. CASI holds a 15% equity stake in PAT. As part of a sub-license agreement for CID-103, PAT will pay CASI $5 million as the first installment. The financing enables PAT to advance the development of CID-103, a monoclonal antibody targeting autoimmune diseases, without impacting CASI's budget during challenging funding conditions.
CASI Pharmaceuticals, Inc. (NASDAQ: CASI) announced a 1-for-10 reverse stock split effective June 1, 2022, at 5:00 p.m. ET. This decision, approved by stockholders at the Annual Meeting on May 25, aims to meet NASDAQ's minimum bid price requirement. Following the split, approximately 13,606,249 shares will remain outstanding. The reverse split is expected to enhance the company's ability to access capital markets and support future growth in hematology and oncology therapeutics. CASI will trade post-split under the same NASDAQ symbol beginning June 2, 2022.
CASI Pharmaceuticals has signed a sublicensing agreement with Tianshi Pharmaceuticals, granting Tianshi exclusive global rights to CID-103, an investigational anti-CD38 monoclonal antibody, for autoimmune indications. CASI will receive an upfront payment of $10 million in two installments, in addition to future milestone and royalty payments. CASI will also hold 15% equity in Tianshi after the latter's financing round, which includes investments totaling 140 million RMB. CASI retains commercialization rights in the U.S. for CID-103 in autoimmune and hematology-oncology fields.
CASI Pharmaceuticals reported a strong first quarter of 2022 with $9.0 million in EVOMELA sales, reflecting a 58% year-over-year increase. The company aims to build on its 100% growth target achieved in 2021. In 2022, CASI focuses on advancing its therapeutic portfolio, including the CNCT-19 NDA submission and expected launch in China. Its research investments decreased slightly to $4.0 million, while total cash and cash equivalents stood at $29.3 million.