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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 (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.
CASI Pharmaceuticals (Nasdaq: CASI) will host a conference call on May 12, 2022, at 8:00 a.m. EST to discuss its first-quarter 2022 financial results. The call will include updates from the Chairman & CEO on business developments and milestones. Interested parties can join the call by dialing the provided numbers, and a replay will be available afterwards. CASI focuses on developing innovative therapeutics in hematology oncology, particularly in the China market, through its wholly-owned subsidiary in Beijing.
CASI Pharmaceuticals, Inc. (Nasdaq: CASI) announced on March 30, 2022, that it was provisionally identified by the SEC under the Holding Foreign Companies Accountable Act (HFCAA) for using an auditor not subject to PCAOB inspection. This was expected by CASI following their recent Form 10K filing on March 28, 2022. The company is exploring strategic options to comply with HFCAA requirements. CASI focuses on developing therapeutics in oncology, particularly for the Greater China market, leveraging its subsidiary in Beijing.
CASI Pharmaceuticals reported $9.12 million in EVOMELA® revenue for Q4 2021, marking 100% growth for the year, with total revenue reaching $30 million. The company aims for continued growth through its commercial franchise in 2022, with anticipated milestones including NDA filing for CNCT19 and initiation of BI-1206 Phase I trials. Despite increased R&D and marketing costs leading to a net loss of $35.8 million, CASI’s cash position stands at $38.7 million. The company sees EVOMELA as central to its operations moving forward.
CASI Pharmaceuticals (Nasdaq: CASI) announced a conference call scheduled for March 28, 2022, at 8:00 a.m. EDT, to review its financial results for Q4 and the year ended December 31, 2021. The call will be led by the Company's Chairman & CEO, who will discuss business updates and upcoming milestones. Investors can access the call via a local and international dialing system, with a replay option available afterward.
CASI focuses on developing innovative therapeutics in hematology and oncology, primarily targeting the greater China market.
CASI Pharmaceuticals (Nasdaq: CASI) has renewed an exclusive distribution agreement with China Resources Pharmaceutical Commercial Group for EVOMELA® (melphalan) sales in China. This partnership has contributed to rapid revenue growth, reaching $30 million in 2021. The collaboration enhances distribution efficiency, increasing accessibility for healthcare providers and patients. CASI aims to strengthen its market position in China through this agreement and its dedicated hematology oncology sales team.
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