CASI Pharmaceuticals Plans IND Submission for CID-103 and Receives Non-Binding Acquisition Proposal for China Business

CASI Pharmaceuticals, Inc., a biopharmaceutical firm listed on Nasdaq, revealed its intention to file an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for CID-103 by the end of 2024. CID-103 is aimed at treating antibody-mediated rejection (AMR) in kidney transplant patients. This monoclonal antibody, CID-103, is unique for its fully human IgG1 anti-CD38 profile and has shown promising preclinical efficacy and safety compared to other antibodies in the same category. CASI believes that its current funding, boosted by a recent private placement, will suffice to complete a Phase II clinical trial for AMR.

Additionally, CASI disclosed that its board of directors received a proposal from Dr. Wei-Wu He, the Chairman and CEO of the company, to acquire CASI’s operations in China along with all rights related to its pipeline products in Asia, excluding Japan. This proposal, dated June 21, 2024, outlines a potential acquisition for $40 million, including the assumption of up to $20 million in company debt.

To evaluate this proposal, as well as other strategic opportunities, the board has appointed a special committee consisting solely of independent directors. Both the board and the special committee have urged caution among shareholders and prospective investors, emphasizing that no concrete decisions have been made regarding the proposal or any other strategic alternatives. They also noted that there is no certainty about receiving a definitive offer, executing any agreement, or consummating any transaction.

CASI Pharmaceuticals focuses on developing and commercializing innovative therapeutics for unmet medical needs, especially in hematology and oncology. The company has a strategic focus on becoming a leader in the Greater China market, leveraging its regulatory and commercial expertise in China and its global drug development capabilities. CASI operates through its fully owned subsidiary in Beijing, CASI Pharmaceuticals (China) Co., Ltd.

The company reiterates that it will not provide updates on the proposal or any other potential transactions except as required by law.