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CASI Pharmaceuticals, Inc. (symbol: CASI) is a biopharmaceutical company dedicated to the development and commercialization of innovative therapeutic and pharmaceutical products in China, the United States, and globally. The company's core focus is on hematology-oncology, tackling unmet medical needs through advanced treatments and collaborative efforts.
CASI’s product pipeline includes:
- EVOMELA®: Melphalan hydrochloride for injection, used as a high-dose conditioning treatment prior to hematopoietic progenitor cell transplantation in patients with multiple myeloma. It is a significant contributor to CASI’s revenue.
- CNCT19: An autologous CD19 CAR-T cell therapy product designed for patients with B-cell acute lymphoblastic leukemia (B-ALL) and B-cell non-Hodgkin lymphoma. This product, developed in collaboration with Juventas, has recently received market approval in China, marking a critical milestone in cell therapy.
- CID-103: An anti-CD38 monoclonal antibody for the treatment of multiple myeloma. CID-103 has shown promising preclinical efficacy and safety profiles.
- FOLOTYN®: Pralatrexate injection, a treatment for relapsed or refractory peripheral T-cell lymphoma in China, demonstrating a significant impact in addressing critical medical needs.
- BI-1206: A first-in-class FcγRIIB monoclonal antibody under development for relapsed/refractory non-Hodgkin lymphoma in combination with rituximab.
- CB-5339: An oral novel VCP/p97 inhibitor for the treatment of hematological malignancies and solid tumors, currently preparing for clinical trials in China.
CASI's recent achievements include the successful commercialization of FOLOTYN® in China and receiving regulatory approval for CNCT19. Despite competitive pressures, EVOMELA continues to play a critical role in the treatment of multiple myeloma in China, with nearly 10,000 patients treated in 2023.
The company faced challenges such as decreased revenues due to competition and restructuring but remains committed to advancing its pipeline. CASI is also actively involved in arbitration with Juventas over the commercialization rights of CNCT19, asserting its legal rights vigorously.
CASI's forward-looking strategy involves leveraging its regulatory and commercial competencies in China, combined with its global drug development expertise, to launch innovative therapies and maintain market leadership in hematology-oncology.
For more detailed information, visit www.casipharmaceuticals.com.
CASI Pharmaceuticals, Inc. (Nasdaq: CASI) announces that partner Juventas completed a $65 million financing and has initiated the first patient enrollment in a Phase II registration study for CNCT19 (CD19 CAR-T) in China targeting relapsed/refractory B-cell non-Hodgkin lymphoma. CASI's CEO, Dr. Wei-Wu He, views this as a significant milestone and emphasized Juventas' progress in clinical trials. CASI holds a 16% stake in Juventas, highlighting a collaborative co-development and investment strategy aimed at enhancing shareholder returns.
CASI Pharmaceuticals reported Q3 2020 revenues of $4.2 million from EVOMELA, significantly up from $2.7 million year-over-year. The company anticipates full-year revenue to exceed $14 million. R&D expenses grew to $2.8 million, primarily for CID-103's development, while general and administrative costs fell to $5.3 million. The net loss increased to $16.8 million compared to $9.7 million in Q3 2019. Cash and equivalents rose to $74.6 million following a public offering generating $43.7 million.
CASI Pharmaceuticals, Inc. (NASDAQ: CASI) will host a conference call on November 9, 2020, at 4:30 p.m. ET to review its third quarter highlights. The call will provide updates on recent business developments and upcoming milestones. Interested participants can join via phone, with specific numbers for the U.S. and international callers. The Chairman & CEO will lead the discussion, and the call will also be recorded for later replay. CASI focuses on developing and commercializing therapeutics in hematology oncology, primarily in China and the U.S.
BioInvent International AB and CASI Pharmaceuticals have signed an exclusive licensing agreement for the development and commercialization of the anti-FcγRIIB antibody, BI-1206, in Greater China. CASI will handle commercialization, while BioInvent will receive a $5 million upfront payment and could earn up to $83 million in development and commercial milestones, along with royalties on net sales. The agreement includes a $7 million investment in BioInvent shares. BI-1206 is currently under clinical investigation for solid tumors and non-Hodgkin lymphoma.
CASI Pharmaceuticals, Inc. (Nasdaq: CASI) has announced that research on CID-103, an anti-CD38 monoclonal antibody, will be presented at the AABB Virtual Annual Meeting from October 3-5, 2020. The presentation, titled 'CID-103: Decreased RBC Binding and Interference with Pretransfusion Test Methods', will take place on October 4, 2020. CID-103 aims to provide enhanced efficacy against malignancies expressing CD38, with Phase 1 trials expected to begin in early 2021. CASI holds exclusive global rights to CID-103.
CASI Pharmaceuticals, Inc. (Nasdaq: CASI) has restructured its partnership with Juventas Cell Therapy for the development of CNCT19, an investigational CD19 CAR-T therapy targeting B-cell malignancies. The new agreement reduces CASI's financial exposure while allowing Juventas to attract capital for upcoming trials. CASI will maintain co-commercial rights, receive up to 50% of net profits from CNCT19 sales, and has increased its equity stake in Juventas to 19.65%. The restructuring aims to streamline operations and ensure the successful commercialization of CNCT19.
CASI Pharmaceuticals has announced that its CEO, Dr. Wei-Wu He, will present at two virtual conferences in September 2020. The H.C. Wainwright 22nd Annual Global Investment Conference is scheduled for September 14 at 12:30 PM EDT, followed by the Oppenheimer Fall Healthcare Life Sciences & MedTech Summit on September 23 at 1:40 PM EDT. Webcasts will be accessible on the company's website, with archived replays available for 90 days. CASI Pharmaceuticals focuses on innovative therapeutics, especially in hematology and oncology in China and the U.S.
CASI Pharmaceuticals reported its Q2 2020 financial results, with revenues of $2.7 million from EVOMELA sales, affected by a manufacturer change and COVID-19. The company expects EVOMELA revenue to reach at least $10 million for the year, anticipating improved margins in H2 2020. Clinical trials for CNCT19 are progressing, with registration trials expected in Q1 2021. CASI raised $43.7 million in a public offering, enhancing its financial position. The net loss narrowed to $8.5 million from $15.3 million in Q2 2019. Cash reserves decreased to $44.9 million from $53.9 million.
CASI Pharmaceuticals, Inc. (Nasdaq: CASI) has scheduled a conference call for August 10, 2020, at 4:30 p.m. ET to discuss its second quarter highlights. The call will include insights from the Company's Chairman & CEO regarding ongoing business developments and future milestones. CASI specializes in biopharmaceuticals with products like EVOMELA®, which is approved in China for multiple myeloma treatment. The call can be accessed via various international phone numbers and will be recorded for later playback.
CASI Pharmaceuticals announced a public offering of 20,000,000 shares of its common stock at $1.90 per share, aiming to raise approximately $38 million before expenses. Underwriters have the option to purchase an additional 3,000,000 shares within 30 days. The offering is set to close around July 24, 2020. Proceeds will be utilized for working capital, product advancement, and corporate purposes. The offering is part of a previously established shelf registration with the SEC.
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