Casi Pharmaceuticals Inc Stock Price, News & Analysis

CASI Pharmaceuticals, Inc. (NASDAQ: CASI) has successfully completed a redomiciliation merger, transitioning the company to be incorporated in the Cayman Islands. As part of this move, each share of CASI's common stock will convert into an ordinary share of CASI Cayman, which will continue to trade under the same NASDAQ symbol 'CASI'. This strategic decision aims to leverage regulatory and commercial competencies in China and enhance its position in the biopharmaceutical market, focusing on hematology oncology and unmet medical needs globally.

CASI Pharmaceuticals has received approval from the NMPA for its Clinical Trial Application for CB-5339, a VCP/p97 inhibitor, targeting Multiple Myeloma. The Phase 1 trial aims to assess the safety, pharmacokinetics, and preliminary efficacy of CB-5339 as a single agent in China, with enrollment expected to start in 2023. This development aligns with CASI's strategy to enhance its oncology portfolio and leverage its regulatory expertise in the Greater China market.

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.