Casi Pharmaceuticals Stock Price, News & Analysis

CASI Pharmaceuticals, Inc. (NASDAQ: CASI) is a public, clinical-stage biopharmaceutical company focused on the development of CID-103, an anti-CD38 monoclonal antibody for patients with organ transplant rejection and autoimmune diseases. The company describes CID-103 as a fully human IgG1, clinical-stage antibody that targets a unique CD38 epitope and has shown an encouraging pre-clinical efficacy and clinical safety profile compared to other anti-CD38 monoclonal antibodies, and for which CASI owns exclusive global rights.

According to multiple company announcements and SEC filings, CASI is advancing CID-103 across several indications. The company is developing CID-103 for renal allograft antibody-mediated rejection (AMR), a serious complication following kidney transplantation, and for immune thrombocytopenia (ITP)

CID-103 clinical programs

CASI states that CID-103 is being evaluated in a multicenter, open-label Phase 1 dose-escalation study in adult patients with immune thrombocytopenia. In this study, patients are assigned to sequential dose cohorts of intravenous CID-103 at 30 mg, 150 mg, 300 mg, 600 mg, and 900 mg, with a priming dose of 30 mg or 150 mg administered prior to the cohort dose. The primary objectives include evaluating safety and tolerability of multiple escalating doses, with a primary efficacy endpoint based on platelet response over the first twelve weeks of treatment. Interim data disclosed by the company indicate that CID-103 has demonstrated a manageable safety profile in the study and that a proportion of evaluable patients have achieved the predefined platelet response criteria.

For renal allograft AMR, CASI reports that it has FDA IND clearance for a Phase 1 study in the United States and a Chinese Phase 1/2 CTA approval for adults with chronic active renal allograft AMR. The planned and approved studies are described as dose-ranging and safety-focused, evaluating tolerability and efficacy of CID-103 in this transplant-related indication.

Therapeutic focus and technology

Across its public communications, CASI emphasizes that CID-103 targets a unique CD38 epitope and is being developed for CD38-mediated diseases, including autoimmune disorders and solid organ transplant rejection. The company notes that CID-103 has shown an encouraging pre-clinical efficacy and clinical safety profile relative to other anti-CD38 monoclonal antibodies, based on its internal assessments and reported data. CASI also states that it is assessing multiple technologies for the development of a stable, high-concentration protein solution of CID-103 for subcutaneous formulation or injection, which is intended for use in later-stage registration trials or broader clinical development.

Regulatory and geographic context

CASI Pharmaceuticals is listed on the Nasdaq Stock Market under the symbol CASI and files reports with the U.S. Securities and Exchange Commission as a foreign private issuer on Form 20-F and Form 6-K. In its SEC filings, the company identifies its principal executive office as being located in Beijing, People’s Republic of China. In press releases, CASI also references operations and activities in South San Francisco, California, and notes that it conducts clinical and regulatory work in both the United States and China, including interactions with the FDA, the NMPA, and the Chinese Center for Drug Evaluation (CDE).

Commercial and legacy products

In addition to its current focus on CID-103, CASI’s disclosures reference commercial and pipeline products such as EVOMELA and FOLOTYN, which are proprietary to Acrotech Biopharma Inc. and its affiliates. The company has reported revenue associated with product sales of EVOMELA and has discussed royalty costs and distribution arrangements in China. CASI has also disclosed that it is involved in disputes and legal proceedings related to certain pipeline products, including EVOMELA and CNCT-19, and that its Import Drug Registration License for FOLOTYN in China expired after a renewal application was not granted, leading CASI to cease FOLOTYN sales in China while continuing certain clinical trial activities as permitted by authorities.

Company filings further describe a distribution agreement for EVOMELA in China, under which the company’s sole distributor may return goods close to expiration that cannot be sold, affecting revenue recognition. CASI has also referenced the development of a manufacturing facility through its subsidiary CASI Pharmaceuticals (Wuxi) Co., Ltd., with certain costs related to GMP facilities recorded into inventory.

Capital structure, financing and listing status

CASI’s SEC filings and press releases describe its status as a clinical-stage company with recurring operating losses and substantial doubt disclosed regarding its ability to continue as a going concern. The company has reported raising capital through an at-the-market facility and through a convertible note purchase agreement with ETP Global III Fund LP, a partnership controlled by Dr. Wei-Wu He. Under this agreement, CASI expects to issue up to US$20 million in convertible notes in multiple tranches, with each note bearing interest and being convertible into ordinary shares of the company at prices determined by volume-weighted average closing prices within specified limits.

CASI has also disclosed that it received notices from Nasdaq that its market value of listed securities fell below the minimum requirement set by Listing Rule 5550(b)(2). After an initial grace period, Nasdaq issued a delisting determination when compliance was not regained. CASI appealed the determination, requested a hearing, and subsequently reported that a Nasdaq Hearings Panel granted an extension to a specified date, allowing the company additional time to regain compliance while the suspension of its securities is stayed. The company states that it is working on plans and initiatives, including financing and asset divestiture efforts, in connection with its listing status.

Strategic focus and risk disclosures

Across its news releases and SEC reports, CASI highlights a strategic focus on developing CID-103 in targeted CD38-mediated disorders, particularly immune thrombocytopenia and renal allograft antibody-mediated rejection. The company notes that it is pursuing divestiture of certain assets in China and has discussed a planned transaction for those assets, subject to closing conditions. CASI’s forward-looking statements sections outline numerous risks, including potential delisting from Nasdaq, uncertainties around asset divestiture, the need for additional capital, challenges in executing its business strategy on a global basis, legal and regulatory developments in China, manufacturing capabilities, commercialization risks for its products and candidates, clinical trial uncertainties, intellectual property protection, reliance on third parties such as Juventas for CNCT-19 development and co-marketing, and disagreements with partners regarding products such as EVOMELA.

According to its disclosures, CASI’s business model centers on biopharmaceutical development, regulatory advancement, and, where applicable, commercialization of therapeutic products, with a current primary emphasis on the clinical and regulatory progress of CID-103 and related formulation work.

Key points for CASI stock research

• CASI Pharmaceuticals is a public, clinical-stage biopharmaceutical company listed on Nasdaq under the symbol CASI.
• The company is focused on CID-103, an anti-CD38 monoclonal antibody for organ transplant rejection and autoimmune diseases, with exclusive global rights.
• CID-103 is in clinical development for immune thrombocytopenia and renal allograft antibody-mediated rejection, supported by FDA IND clearance and Chinese CTA approvals.
• CASI has reported historical revenues from products such as EVOMELA and has disclosed legal disputes and licensing issues related to EVOMELA, FOLOTYN, and CNCT-19.
• The company has raised capital through equity and convertible note financings and has disclosed going concern risks and Nasdaq listing compliance challenges.
• Operations and regulatory activities span the United States and China, with principal executive offices identified in Beijing in SEC filings.