Welcome to our dedicated page for Casi Pharmaceuticals SEC filings (Ticker: CASI), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
The CASI Pharmaceuticals, Inc. (NASDAQ: CASI) SEC filings page on Stock Titan brings together the company’s regulatory disclosures as a foreign private issuer, including its Form 6-K current reports and other Exchange Act filings. CASI files on Form 20-F and supplements those annual reports with multiple Form 6-K submissions that incorporate press releases and transaction updates by reference into its registration statements on Form F-3.
Through these filings, CASI provides details on its status as a clinical-stage biopharmaceutical company focused on developing CID-103, an anti-CD38 monoclonal antibody for organ transplant rejection and autoimmune diseases. Investors can use the filings to track information on CID-103 clinical programs in immune thrombocytopenia (ITP) and renal allograft antibody-mediated rejection (AMR), including FDA IND clearances, Chinese CTA approvals, and descriptions of Phase 1 and Phase 1/2 study designs.
CASI’s Form 6-K reports also disclose capital structure and financing transactions, such as the US$20 million convertible note purchase agreement with ETP Global III Fund LP and the closing of individual note tranches, along with key terms like maturity, interest rate, and conversion price ranges. Financial statements furnished in quarterly updates outline revenues, costs, operating expenses, net loss, and balance sheet data, providing context on the company’s recurring operating losses and going concern disclosures.
In addition, the filings describe Nasdaq listing compliance issues, including notices of non-compliance with the market value of listed securities requirement, a delisting determination, CASI’s appeal, and an extension granted by a Nasdaq Hearings Panel to regain compliance. Other 6-Ks address regulatory developments in China, such as the expiration of the Import Drug Registration License for FOLOTYN and the resulting cessation of FOLOTYN sales in that market.
On Stock Titan, CASI’s SEC filings are updated from EDGAR and can be paired with AI-powered summaries that highlight the main points of each document, helping users quickly understand clinical, financial, and listing-related disclosures without reading every line of the underlying forms.
Panacea investment group disclosed a near-20% stake in CASI Pharmaceuticals and a board appointment. Panacea Venture Healthcare Fund II, L.P. holds 3,550,000 Ordinary Shares (purchased for approximately $6.7 million) and James Huang holds options to buy 111,571 Ordinary Shares, giving the Reporting Persons a combined beneficial interest of 3,661,571 Ordinary Shares, or 19.9% of 18,292,612 shares outstanding. The filing notes Panacea bought 1,500,000 shares from the issuer at $1.5350 per share. The Issuer announced James Huang will join CASI's Board effective October 1, 2025. The Reporting Persons state the position is for investment and reserve the right to buy, sell or pursue corporate actions after review.
CASI Pharmaceuticals, Inc. reports that its Import Drug Registration License for FOLOTYN® in China has expired, following a decision by China’s Center for Drug Evaluation not to grant the company’s May 2025 renewal application. The original license, issued in August 2020, was effective through August 25, 2025, and CASI will immediately cease commercial sales of FOLOTYN® in China under applicable regulations.
The company may continue FOLOTYN® clinical trial activities in China as permitted by relevant authorities and plans to take commercially reasonable measures regarding its FOLOTYN® commercialization plan. CASI remains focused on developing CID-103, an anti-CD38 monoclonal antibody for organ transplant rejection and autoimmune diseases, with an ongoing Phase 1/2 study in immune thrombocytopenic purpura and an FDA-cleared Phase 1 study in renal allograft antibody-mediated rejection that it plans to initiate in the third quarter of 2025.
Foresite Capital Fund VI, L.P., together with its general partner Foresite Capital Management VI, LLC and James Tananbaum, report beneficial ownership of 787,121 ordinary shares of CASI Pharmaceuticals, representing 5.1% of the outstanding class based on 15,492,581 shares outstanding. All 787,121 shares are reported as directly owned by Foresite Capital Fund VI, with the reporting persons asserting sole voting and sole dispositive power over those shares and no shared power. The filing includes a certification that the securities were not acquired to change or influence control of the issuer and indicates the holdings are held as passive investments. The filers executed a joint filing agreement.