CASI Pharmaceuticals, Inc 6-K, filed Sep 26, 2025
CASI Pharmaceuticals, Inc. (CASIF)
About this 6-K
CASI Pharmaceuticals, Inc filed this 6-K on September 26, 2025.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE
13a-16 OR 15d-16 UNDER
THE SECURITIES EXCHANGE ACT OF 1934
For the month of September, 2025
Commission File Number 001-41666
CASI PHARMACEUTICALS, INC.
(Translation of registrant’s name into English)
1701-1702, China Central Office Tower 1
No. 81 Jianguo Road, Chaoyang District
Beijing, 100025
People’s Republic of China
(Address of principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F. Form 20-F x Form 40-F ¨
INCORPORATION BY REFERENCE
The information included in this Report on Form 6-K, including Exhibits 99.1, is hereby incorporated by reference into the Company's Registration Statements on Form F-3 (File No. 333-283998 and No. 333-281621) (including any prospectuses forming a part of such registration statement) and is to be a part thereof from the date on which this Report on Form 6-K is filed, to the extent not superseded by documents or reports subsequently filed or furnished.
EXHIBIT INDEX
| Exhibit No. | Description | |
| 99.1 | Press Release of CASI Pharmaceuticals, Inc. dated September 26, 2025 |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| CASI Pharmaceuticals, Inc. | ||
| By: | /s/ David Cory | |
| Name: | David Cory | |
| Title: | CEO | |
| Date: September 26, 2025 | ||
Exhibit 99.1
CASI Pharmaceuticals Appoints James Huang to Board of Directors
| - | 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, California / September 26, 2025 / ACCESS NEWSWIRE / -- 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. As Founder and Managing Partner of Panacea Venture, and previously Managing Partner at Kleiner Perkins (KPCB) China and Vivo Ventures, he has guided numerous cross-border companies through critical stages of growth, financing, and global expansion. Earlier in his career, he held senior roles in business development, sales & marketing, and research & development at Tularik Inc. (acquired by Amgen), GlaxoSmithKline LLC, Bristol-Myers Squibb and ALZA Corp. (acquired by Johnson & Johnson). Mr. Huang serves as a member of the board of directors of Kindstar Globalgene Technology, Inc., Connect Biopharma Holdings Limited, Lee’s Pharmaceutical Holdings Limited, Atara Biotherapeutics, Inc., and several private companies. He received an M.B.A. from the Stanford Graduate School of Business and a B.S. degree in chemical engineering from the University of California, Berkeley.
“I am honored to join the CASI Board as the company embarks on a pivotal new chapter with a sharpened U.S. focus and a commitment to rapidly advance clinical development of CID-103 in autoimmune diseases and antibody-mediated rejection in solid organ transplants,” said Mr. Huang. “I look forward to partnering with company leadership to bring strategic perspective, principled governance, and long-term alignment with shareholders as CASI establishes itself as a U.S.-centric clinical-stage leader in autoimmune and transplant medicine.”
David Cory, CEO of CASI, added, “As our CID-103 anti-CD38 program progresses in the clinic and delivers data across diverse patient populations and indications, we expect James’ global perspective and proven ability to scale companies will be invaluable. I am very pleased to welcome James to our Board and look forward to working closely with him as we drive CASI toward its next phase of growth.”
Panacea Venture is a current CASI Pharmaceuticals shareholder and, in connection with Mr. Huang’s appointment to the Board, plans to acquire up to approximately 1.5 million newly issued shares of CASI Pharmaceuticals common stock from CASI in a registered transaction.
About CASI Pharmaceuticals
CASI Pharmaceuticals, Inc. is a publicly-traded, biopharmaceutical company focused on developing CID-103, an anti-CD38 monoclonal antibody for organ transplant rejection and autoimmune diseases.
CID-103 is a fully human IgG1, potentially best-in-class, clinical stage, anti-CD38 monoclonal antibody which targets a unique epitope and has demonstrated an encouraging pre-clinical efficacy and clinical safety profile compared to other anti-CD38 monoclonal antibodies, and for which CASI owns exclusive global rights. CASI is actively recruiting and dosing patients in a Phase 1 / 2 study in immune thrombocytopenic purpura (ITP). In parallel, CASI recently received FDA IND clearance to conduct a Phase 1/2 study in renal allograft antibody-mediated rejection (AMR) with plans for first patient in Q1 2026.
Pursuant to a May 2025 announcement that CASI had entered into an equity and asset transfer agreement with Kaixin Pharmaceuticals to divest CASI China business, the company plans to complete divestiture in Q2 2026.
More information on CASI is available at www.casipharmaceuticals.com.
Forward Looking Statements
This announcement contains forward-looking statements. These statements are made under the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as "will," "expects," "anticipates," "future," "intends," "plans," "believes," "estimates," "confident" and similar statements. Among other things, the business outlook and quotations from management in this announcement, as well as the Company's strategic and operational plans, contain forward-looking statements. The Company may also make written or oral forward-looking statements in its periodic reports to the U.S. Securities and Exchange Commission (the "SEC"), in its annual report to shareholders, in press releases and other written materials and in oral statements made by its officers, directors or employees to third parties. Statements that are not historical facts, including statements about the Company's beliefs and expectations, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties. A number of factors could cause actual results to differ materially from those contained in any forward-looking statement, including but not limited to the following: uncertainties related to the possibility that the transaction for the divestiture of certain assets in China (the “Transaction”) will not occur as planned if events arise that result in the termination of the Equity and Assets Transfer Agreement, or if one or more of the various closing conditions to the Transaction are not satisfied or waived; the possibility that our plan with respect to our business operations after the consummation of the Transaction can be implemented successfully; our recurring operating losses have raised substantial doubt regarding our ability to continue as a going concern; the possibility that we may be delisted from trading on The Nasdaq Capital Market if we fail to satisfy applicable continued listing standards; the volatility in the market price of our ordinary shares; the risk of substantial dilution of existing shareholders in future share issuances; the difficulty of executing our business strategy on a global basis including China; our inability to enter into strategic partnerships for the development, commercialization, manufacturing and distribution of our proposed product candidates or future candidates; legal or regulatory developments in China that adversely affect our ability to operate in China; our lack of experience in manufacturing products and uncertainty about our resources and capabilities to do so on a clinical or commercial scale; risks relating to the commercialization, if any, of our products and proposed products (such as marketing, safety, regulatory, patent, product liability, supply, competition and other risks); our inability to predict when or if our product candidates will be approved for marketing by the U.S. Food and Drug Administration, European Medicines Agency, PRC National Medical Products Administration, or other regulatory authorities; our inability to receive approval for renewal of license of our existing products; the risks relating to the need for additional capital and the uncertainty of securing additional funding on favorable terms; the risks associated with our product candidates, and the risks associated with our other early-stage products under development; the risk that result in preclinical and clinical models are not necessarily indicative of clinical results; uncertainties relating to preclinical and clinical trials, including delays to the commencement of such trials; our ability to protect our intellectual property rights; the lack of success in the clinical development of any of our products; and our dependence on third parties; the risks related to our dependence on Juventas to conduct the clinical development of CNCT19 and to partner with us to co-market CNCT19; risks related to our dependence on Juventas to ensure the patent protection and prosecution for CNCT19; the risk related to the Company's ongoing development of and regulatory application for CID-103 with respect to the treatment of antibody-mediated rejection for organ transplant and the license arrangements of CID-103; risks relating to interests of our largest shareholder and our Chairman that differ from our other shareholders; risks related to the development of a new manufacturing facility by CASI Pharmaceuticals (Wuxi) Co., Ltd. and risks related to our disagreement with Acrotech with respect to the termination of agreements regarding EVOMELA®. Further information regarding these and other risks is included in the Company's filings with the SEC. All information provided herein is as of the date of this announcement, and the Company undertakes no obligation to update any forward-looking statement, except as required under applicable law. We caution readers not to place undue reliance on any forward-looking statements contained herein.
EVOMELA® is proprietary to Acrotech Biopharma Inc. and its affiliates. FOLOTYN® is proprietary to Acrotech Biopharma Inc and its affiliates. The Company is currently involved in disputes and legal proceedings related to certain pipeline products, including EVOMELA® and CNCT-19. Please refer to the Company’s earlier SEC filing for further information.
COMPANY CONTACT:
Ingrid Choong, PhD
650-619-6115
ingridc@casipharmaceuticals.com