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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 reported Q3 2024 financial results with total revenue of $7.8 million, marking a 12% decrease year-over-year but a 96% increase from Q2 2024. The company reported a net loss of $8.4 million, compared to $4.5 million in Q3 2023. Key developments include CDE approval for a phase 1/2 study of CID-103 in China for chronic Immune Thrombocytopenia and progress on US IND application for renal allograft AMR. The company also initiated civil litigation against 17 former employees who joined Juventas Cell Therapy
CASI Pharmaceuticals (NASDAQ:CASI) has received Clinical Trial Application (CTA) approval from China's NMPA to conduct a phase 1/2 study of CID-103 in adult patients with chronic Immune Thrombocytopenia (ITP). The China study is part of a global study previously approved by the US FDA in May 2024. CID-103 is a fully human IgG1 anti-CD38 monoclonal antibody that has shown promising preclinical efficacy and safety compared to other anti-CD38 monoclonal antibodies.
CASI Pharmaceuticals (Nasdaq: CASI) has announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference, scheduled for September 9-11, 2024, at the Lotte New York Palace. Key members of CASI's management team, including CFO Daniel Lang and CMO Alexander Zukiwski, will be available for one-on-one investor meetings during the event.
A pre-recorded corporate presentation will be accessible to conference attendees in 'Virtual Room 1' starting at 7 a.m. Eastern Time on September 9th. Following the conference, the presentation will be made available on the Investors page of CASI's corporate website. This participation underscores CASI's commitment to engaging with investors and showcasing its progress in developing and commercializing innovative therapeutics and pharmaceutical products.
CASI Pharmaceuticals (Nasdaq: CASI) reported its Q2 2024 financial results and business updates. The company is shifting its strategy to focus on developing therapeutics for organ transplant rejection and autoimmune diseases, with CID-103, an anti-CD38 antibody, as the keystone. CASI received FDA clearance for the IND application of CID-103 for treating adults with ITP and plans to initiate a Phase 1 study by year-end. The company also expects to submit an IND for CID-103 in AMR in Q4 2024.
Financial highlights include:
- Total revenue: $4.0 million (down from $9.8 million in Q2 2023)
- Net loss: $7.0 million (improved from $10.1 million in Q2 2023)
- Cash and cash equivalents: $9.5 million as of June 30, 2024
- Received $15 million from a private placement in July 2024
CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a Cayman-based biopharmaceutical company, has reported a significant development in its ongoing dispute with Juventas. The company has filed a current report on Form 6-K with the SEC to disclose this material information. CASI, which focuses on developing and commercializing innovative therapeutics and pharmaceutical products, has made this filing to keep investors and stakeholders informed about the progress of the dispute. For detailed information, interested parties can access the full report through the SEC's EDGAR system using the provided link.
CASI Pharmaceuticals has appointed Dr. Daniel Lang as Chief Financial Officer and Senior Vice President, effective July 8, 2024. Dr. Lang brings over 30 years of experience, including roles as a physician-scientist, investor, and biotech executive. His background encompasses cardiology training at UCSF and investment roles at Farallon Capital and RS Investments Value Group. Most recently, he served as President of Athenex's cell therapy division. His appointment aims to leverage his diverse expertise for strategic shifts in CASI's anti-CD38 program focusing on antibody-mediated rejection and idiopathic thrombocytopenic purpura.
CASI Pharmaceuticals plans to submit an Investigational New Drug (IND) application to the FDA by the end of 2024 for CID-103, a monoclonal antibody for treating antibody-mediated rejection (AMR) in kidney transplant recipients. CID-103 has shown promising preclinical efficacy and safety. The company believes it has enough capital to complete a Phase II clinical trial for AMR, using proceeds from a private placement financing and existing funds.
Additionally, CASI received a non-binding proposal to acquire its entire China business for $40 million, which includes the assumption of up to $20 million in debt. The Board has formed a Special Committee to evaluate this proposal and other strategic alternatives. No final decisions have been made, and there is no assurance the transaction will proceed.
CASI Pharmaceuticals announced a $15 million private placement financing led by Venrock Healthcare Capital Partners and Foresite Capital, with participation from Panacea Venture and CEO Dr. Wei-Wu He. The financing involves selling 1,020,000 ordinary shares at $5.00 per share and pre-funded warrants for 1,980,000 shares at $4.9999 each. The transaction is expected to close in mid-July 2024, subject to customary conditions. Jefferies is acting as the placement agent. The company plans to file a registration statement with the SEC for the resale of the shares and pre-funded warrants.
On May 15, 2024, CASI Pharmaceuticals (NASDAQ: CASI) announced that the FDA has cleared their Investigational New Drug (IND) application for CID-103. This clearance supports a phase 1/2 study of CID-103 in adults with chronic Immune Thrombocytopenia (ITP), a serious autoimmune disorder. The IND application was submitted on April 12, 2024, and the FDA's approval letter was received on May 13, 2024.
CID-103 is a fully human IgG1 anti-CD38 monoclonal antibody that has shown promising preclinical efficacy and safety profiles. Dr. Wei-Wu He, CEO of CASI, highlighted the potential of CID-103 to become a new therapeutic option for ITP, aiming to reduce the disease burden for patients.
CASI Pharmaceuticals reported its Q1 2024 financial results, revealing a significant 59% decrease in total revenue to $3.4 million, compared to $8.3 million in Q1 2023. This decline is primarily due to increased competition from generic melphalan products, inventory management strategies by EVOMELA®'s distributor, and restructuring of the sales force. Despite these challenges, CASI successfully launched its second commercial product, FOLOTYN®, and administered the first patient dose in China. The company also made progress in its pipeline, with promising Phase I results for BI-1206 in China and an IND submission for CID-103 for ITP in the US. Financial highlights include a net loss of $9.5 million and a decrease in cash and investments to $18.2 million as of March 31, 2024.
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