CASI Pharmaceuticals, Inc. (CASI)

- Investment to Fund Phase 1 Study in Renal Allograft Antibody-Mediated Rejection (AMR) in China SOUTH SAN FRANCISCO, CALIFORNIA / ACCESS Newswire / December 11, 2025 / CASI Pharmaceuticals, Inc. (NASDAQ:CASI, the "Company"), a clinical-stage biopharmaceutical company developing CID-103, an anti-CD38 monoclonal antibody, for patients with organ transplant rejection and autoimmune diseases, today announced that the Company has entered into a convertible note purchase agreement (the "Purchase Agreement") with ETP Global III Fund LP, a partnership controlled by Dr. Wei-Wu He (the "Purchaser"), pursuant to which the Company will issue and sell convertible notes in an aggregate principal amount of US $20 million to the Purchaser through a private placement. This investment is planned to provide runway to fund the Company through a Phase 1 study in China in renal allograft anti-body-mediated rejection (AMR) as well as development toward a stable, high concentration protein solution for subcutaneous formulation.

SOUTH SAN FRANCISCO, CALIFORNIA / ACCESS Newswire / December 8, 2025 / CASI Pharmaceuticals, Inc. (NASDAQ:CASI), a clinical-stage biopharmaceutical company developing CID-103, a potentially best-in-class, anti-CD38 monoclonal antibody, for patients with organ transplant rejection and autoimmune diseases, today announced data presented from its Phase 1 open-label study of CID-103 in adult patients with immune thrombocytopenia (ITP) at the 67th American Society of Hematology Annual Meeting and Exposition on December 7, 2025, in Orlando, Florida. This open-label Phase 1 dose escalation study assigned patients to sequential dose-escalating cohorts of intravenous infusions of CID-103 at 30 mg (n=1), 150 mg (n=1), 300 mg (n=3), 600 mg (n=3), and 900 mg (n=3), with a priming dose of CID-103 of either 30 mg or 150 mg administered prior to the cohort dose.

James Huang appointed as Non-Executive Chairman of CASI Board of Directors SOUTH SAN FRANCISCO, CALIFORNIA / ACCESS Newswire / November 19, 2025 / CASI Pharmaceuticals, Inc. (NASDAQ:CASI), a clinical-stage biopharmaceutical company focused on developing CID-103, a potential best-in-class, anti-CD38 monoclonal antibody for patients with organ transplant rejection and autoimmune diseases, today announced that its Board of Directors unanimously voted to appoint James Huang, a current independent board member, as Non-Executive Chairman of the Board, effective November 17, 2025. As part of this transition, Dr. Wei-Wu He will step down from the role as Executive Chairman and will remain a member of the Board of Directors.

SOUTH SAN FRANCISCO, CA / ACCESS Newswire / November 14, 2025 / CASI Pharmaceuticals, Inc. (NASDAQ:CASI), a clinical-stage biopharmaceutical company focused on the development of CID-103, a potential best-in-class, anti-CD38 monoclonal antibody for patients with organ transplant rejection and autoimmune diseases, today reported business and financial results for the quarter ended September 30, 2025 (the "third quarter"). "We are focused on capitalizing and advancing our CID-103 clinical program in renal allograft antibody mediated rejection (AMR), first in the U.S. under an already approved IND, followed by China where a regulatory package has been accepted and is under review," said David Cory, CEO of CASI.

SOUTH SAN FRANCISCO, CALIFORNIA / ACCESS Newswire / November 10, 2025 / CASI Pharmaceuticals, Inc. (NASDAQ:CASI), a clinical-stage biopharmaceutical company focused on developing CID-103, a potential best-in-class, anti-CD38 monoclonal antibody for patients with organ transplant rejection and autoimmune diseases, today announced that it has received a letter dated November 5, 2025, with a delisting determination from Nasdaq Stock Market LLC (the "Determination"). As previously reported, on May 5, 2025, Nasdaq notified the Company that its market value of listed securities (MVLS) had fallen below the minimum requirement of $35 million for 30 consecutive trading days, and as a result, did not comply with Listing Rule 5550(b)(2).

SOUTH SAN FRANCISCO, CALIFORNIA / ACCESS Newswire / November 4, 2025 / CASI Pharmaceuticals, Inc. (NASDAQ:CASI), a clinical-stage biopharmaceutical company focused on developing CID-103, a potential best-in-class, anti-CD38 monoclonal antibody for patients with organ transplant rejection and autoimmune diseases, today announced that the CASI management team will participate at the Guggenheim Healthcare Innovation Conference 2025 in a fireside chat at 9:30 AM ET on November 12 in Boston, MA. CASI will also host one-on-one meetings with investors at the conference.

- CID-103 is a potential best-in-class, anti-CD38 monoclonal antibody - Phase 1 dose escalation study in Immune Thrombocytopenia (ITP) results and update SOUTH SAN FRANCISCO, CA / ACCESS Newswire / November 3, 2025 / CASI Pharmaceuticals, Inc. (NASDAQ:CASI), a clinical-stage biopharmaceutical company developing CID-103, a potential best-in-class, clinical stage anti-CD38 monoclonal antibody, for patients with organ transplant rejection and autoimmune diseases, today announced that data will be presented from its Phase 1 open-label study of CID-103 in adult patients with immune thrombocytopenia (ITP) at the 67th American Society of Hematology Annual Meeting and Exposition being held December 6-9, 2025, in Orlando, Florida. Poster Presentation Details Title: A dose-escalation and safety study of CID-103 followed by a randomized, open-label, parallel-arm multi-dose study evaluating the efficacy and tolerability of CID-103 in adults with persistent or chronic immune thrombocytopenia Authors: Chen Yunfei, ZePing Zhou, Hu Zhou, Ruibin Huang, Zhenyu Yan, Jun Peng, Ming Hou, James Bussel, Alexander Zukiwski, Junping Chen, Lei Zhang Session Name: 311.

- Industry veteran brings over 35 years of biotech experience as a successful entrepreneur and investor - Operating experience to significantly enhance development program of CID-103 (anti-CD38 mAb) SOUTH SAN FRANCISCO, CA / ACCESS Newswire / September 26, 2025 / CASI Pharmaceuticals, Inc. (NASDAQ:CASI), a clinical-stage biopharmaceutical company focused on developing innovative therapies for patients with organ transplant rejection and autoimmune diseases, today announced the appointment of James Huang as an Independent Director to the CASI Board of Directors, effective as of October 1, 2025. Mr. Huang brings over 35 years of experience building and investing in biopharma companies globally.

SOUTH SAN FRANCISCO, CA / ACCESS Newswire / September 3, 2025 / CASI Pharmaceuticals, Inc. (NASDAQ:CASI), a clinical-stage biopharmaceutical company focused on developing innovative therapies for patients with organ transplant rejection and autoimmune diseases, today announced that David Cory, CEO, will present a company update at the H.C. Wainwright 27th Annual Global Investment Conference on September 8, 2025 at 10:00 AM ET.

- Industry veteran brings extensive senior level leadership and expertise in biologics development, strategic partnerships, mergers and acquisitions across biotech and large pharma organizations - Operating experience to significantly enhance development program of CID-103 (anti-CD38 mAb) SOUTH SAN FRANCISCO, CA / ACCESS Newswire / September 2, 2025 / CASI Pharmaceuticals, Inc. (NASDAQ:CASI), a clinical-stage biopharmaceutical company focused on developing innovative therapies for patients with organ transplant rejection and autoimmune diseases, today announced the appointment of Barbara Krebs-Pohl, PhD as an Independent Director to the CASI Board of Directors. Dr. Krebs-Pohl is a highly respected leader in the biotechnology sector with over 27 years of experience, particularly in development, business strategy and alliance creation.

SOUTH SAN FRANCISCO, CALIFORNIA / ACCESS Newswire / August 29, 2025 / CASI Pharmaceuticals, Inc. (NASDAQ:CASI), a clinical-stage biopharmaceutical company focused on developing innovative therapies for patients with organ transplant rejection and autoimmune diseases, today reported business and financial results for the quarter ended June 30, 2025 (the "second quarter"). "We are focused on advancing our CID-103 program, a potentially best-in-class anti-CD38 monoclonal antibody," said David Cory, CEO of CASI.

SAN FRANCISCO, CA / ACCESS Newswire / August 28, 2025 / CASI Pharmaceuticals, Inc. (NASDAQ:CASI), a clinical-stage biopharmaceutical company focused on developing innovative therapies for patients with organ transplant rejection and autoimmune diseases, today announced that David Cory, CEO, will participate in a fireside chat at the Cantor Global Healthcare Conference on Wednesday, September 3 at 11:30 AM ET in New York City. CASI will also host one-on-one meetings with investors at the conference.

CID-103 is a potential best-in-class, anti-CD38 monoclonal antibody; binds to unique CD38 epitope Phase 1 study in adults with active and chronic active renal allograft AMR planned to initiate AMR is a leading cause of kidney transplant loss, leading to dialysis and/or repeat renal transplant SAN FRANCISCO, CA / ACCESS Newswire / August 4, 2025 / CASI Pharmaceuticals, Inc. (NASDAQ:CASI), a clinical-stage biopharmaceutical company focused on developing innovative therapies for patients with organ transplant rejection and autoimmune diseases, today announced FDA clearance of an IND application for CID-103, an anti-CD38 monoclonal antibody in adults with active and chronic active renal allograft antibody mediated rejection (AMR). The Phase 1 clinical trial is a dose-ranging and safety study evaluating the tolerability and efficacy of CID-103 in patients with AMR.

-- David Cory is an industry veteran, bringing more than 30 years of operational experience, in private and public, emerging-stage biotech and large pharma companies with an established track record of building and leading high performing operating teams and financing in the capital markets with over $1B+ raised and multiple company exits by acquisition -- CID-103 is a potential best in class, anti-CD38 monoclonal antibody, currently dosing in a multi-center Phase 1/2 study in adults with chronic immune thrombocytopenia (ITP); IND submitted to support future clinical trials in adults with renal allograft antibody-mediated rejection (AMR) BEIJING, CN / ACCESS Newswire / July 21, 2025 / CASI Pharmaceuticals, Inc. (NASDAQ:CASI), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, today announced the appointment of David Cory as Chief Executive Officer and a member of the Board of Directors. Wei-Wu He, Ph.D.

BEIJING, CHINA / ACCESS Newswire / May 19, 2025 / CASI Pharmaceuticals, Inc. (Nasdaq:CASI), ("CASI" or the "Company"), a Cayman incorporated biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, announced that it will host a live conference call and webcast at 8:00 a.m. PT/11:00 a.m.