BEIJING, China I June 26, 2024 I CASI Pharmaceuticals, Inc. (Nasdaq: CASI) (“CASI” or the “Company”), a biopharmaceutical company specializing in the development and commercialization of innovative therapeutic and pharmaceutical products, announced today that the Company is planning to submit an Investigational New Drug (“IND”) application to the U.S. Food and Drug Administration (“FDA”) for CID-103 for the treatment of antibody-mediated rejection (“AMR”) in kidney transplant recipients by the end of 2024. CID-103 is a fully human IgG1 anti-CD38 monoclonal antibody recognizing a unique epitope that has demonstrated an encouraging preclinical efficacy and safety profile compared to other anti-CD38 monoclonal antibodies. The Company believes that with the proceeds from the previously announced private placement financing, together with its existing cash and cash equivalents, it will have sufficient capital to complete the Phase II clinical trial for AMR.
CASI also announced that its board of directors (the “Board”) received a preliminary non-binding proposal letter (the “Proposal Letter”) dated June 21, 2024, from Dr. Wei-Wu He, Chairman of the Board and CEO of the Company, to acquire the entire business operations of the Company in China and all license-in, distribution and related rights in Asia (excluding Japan) related to all of the Company’s pipeline products, including but not limited to EVOMELA®, FOLOTYN®, CNCT19, BI-1206, CB-5339,CID-103 and Thiotepa, for an aggregate purchase price of $40.0 million, which shall include assumption of up to $20.0 million of indebtedness of the Company (the “Proposed Transaction”).
On June 25, the Board has formed a special committee comprised solely of incumbent independent directors (the “Special Committee”) to evaluate the transaction contemplated under the Proposal Letter and such other strategic and business alternatives available to the Company in respect of the Company’s business operations in China.
The Board and the Special Committee caution the Company’s shareholders and others considering trading the Company’s securities that no decisions have been made with respect to the Proposed Transaction or any alternative strategic option that the Company may pursue. There can be no assurance that any definitive offer will be received, that any definitive agreement will be executed relating to the Proposed Transaction or that any other transaction will be approved or consummated. The Company does not undertake any obligation to provide any updates with respect to any transaction, except as required under applicable law.
About CASI Pharmaceuticals
CASI Pharmaceuticals, Inc. is a biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products in China, the United States, and throughout the world. The Company is focused on acquiring, developing, and commercializing products that augment its hematology oncology therapeutic focus as well as other areas of unmet medical need. The Company intends to execute its plan to become a leader by launching medicines in the Greater China market, leveraging the Company’s China-based regulatory and commercial competencies and its global drug development expertise. The Company’s operations in China are conducted through its wholly owned subsidiary, CASI Pharmaceuticals (China) Co., Ltd., located in Beijing, China.
SOURCE: CASI Pharmaceuticals
Post Views: 257
BEIJING, China I June 26, 2024 I CASI Pharmaceuticals, Inc. (Nasdaq: CASI) (“CASI” or the “Company”), a biopharmaceutical company specializing in the development and commercialization of innovative therapeutic and pharmaceutical products, announced today that the Company is planning to submit an Investigational New Drug (“IND”) application to the U.S. Food and Drug Administration (“FDA”) for CID-103 for the treatment of antibody-mediated rejection (“AMR”) in kidney transplant recipients by the end of 2024. CID-103 is a fully human IgG1 anti-CD38 monoclonal antibody recognizing a unique epitope that has demonstrated an encouraging preclinical efficacy and safety profile compared to other anti-CD38 monoclonal antibodies. The Company believes that with the proceeds from the previously announced private placement financing, together with its existing cash and cash equivalents, it will have sufficient capital to complete the Phase II clinical trial for AMR.
CASI also announced that its board of directors (the “Board”) received a preliminary non-binding proposal letter (the “Proposal Letter”) dated June 21, 2024, from Dr. Wei-Wu He, Chairman of the Board and CEO of the Company, to acquire the entire business operations of the Company in China and all license-in, distribution and related rights in Asia (excluding Japan) related to all of the Company’s pipeline products, including but not limited to EVOMELA®, FOLOTYN®, CNCT19, BI-1206, CB-5339,CID-103 and Thiotepa, for an aggregate purchase price of $40.0 million, which shall include assumption of up to $20.0 million of indebtedness of the Company (the “Proposed Transaction”).
On June 25, the Board has formed a special committee comprised solely of incumbent independent directors (the “Special Committee”) to evaluate the transaction contemplated under the Proposal Letter and such other strategic and business alternatives available to the Company in respect of the Company’s business operations in China.
The Board and the Special Committee caution the Company’s shareholders and others considering trading the Company’s securities that no decisions have been made with respect to the Proposed Transaction or any alternative strategic option that the Company may pursue. There can be no assurance that any definitive offer will be received, that any definitive agreement will be executed relating to the Proposed Transaction or that any other transaction will be approved or consummated. The Company does not undertake any obligation to provide any updates with respect to any transaction, except as required under applicable law.
About CASI Pharmaceuticals
CASI Pharmaceuticals, Inc. is a biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products in China, the United States, and throughout the world. The Company is focused on acquiring, developing, and commercializing products that augment its hematology oncology therapeutic focus as well as other areas of unmet medical need. The Company intends to execute its plan to become a leader by launching medicines in the Greater China market, leveraging the Company’s China-based regulatory and commercial competencies and its global drug development expertise. The Company’s operations in China are conducted through its wholly owned subsidiary, CASI Pharmaceuticals (China) Co., Ltd., located in Beijing, China.
SOURCE: CASI Pharmaceuticals
Post Views: 257
