Casi Pharmaceuticals Inc Stock Price, News & Analysis

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.