Core Viewpoint - CASI Pharmaceuticals has announced a $20 million investment through a convertible note purchase agreement to fund a Phase 1 study in China for renal allograft antibody-mediated rejection (AMR) and to develop a stable, high concentration protein solution for subcutaneous formulation [1][5]. Group 1: Investment Details - The investment will be made in tranches and is subject to multiple closings, contingent on the Purchaser's satisfaction with the Company's business results and financial status [2]. - Each convertible note will mature in 36 months, bearing an interest rate of 12% per annum, and can be converted into ordinary shares at a specified conversion price [3]. Group 2: Company Overview - CASI Pharmaceuticals is a clinical-stage biopharmaceutical company developing CID-103, an anti-CD38 monoclonal antibody aimed at treating organ transplant rejection and autoimmune diseases [4][5]. - CID-103 has shown promising pre-clinical efficacy and clinical safety, and the company has received FDA IND clearance for a Phase 1 study in the U.S. [5].

Core Insights - CASI Pharmaceuticals, Inc. is developing CID-103, an anti-CD38 monoclonal antibody aimed at treating organ transplant rejection and autoimmune diseases [1] - The company presented data from a Phase 1 open-label study of CID-103 for immune thrombocytopenia (ITP) at the 67th American Society of Hematology Annual Meeting [1] Study Details - The Phase 1 study involved adult patients with ITP and utilized a dose escalation approach with intravenous infusions of CID-103 [1] - Patients were assigned to sequential dose-escalating cohorts receiving CID-103 at doses of 30 mg (n=1), 150 mg (n=1), 300 mg (n=3), 600 mg (n=3), and 900 mg (n=3) [1] - A priming dose of CID-103 was administered prior to the cohort dose, either at 30 mg or 150 mg [1]

Core Viewpoint - CASI Pharmaceuticals has appointed James Huang as Non-Executive Chairman of the Board, effective November 17, 2025, marking a significant leadership transition within the company [1] Group 1: Leadership Changes - James Huang, previously an independent board member, has been unanimously voted in as Non-Executive Chairman of CASI Pharmaceuticals [1] - Dr. Wei-Wu He will step down from his role as Executive Chairman but will continue to serve as a member of the Board of Directors [1]

Financial Performance - Revenues for Q3 2025 were $3.1 million, a 60% decrease from $7.8 million in Q3 2024, primarily due to estimated goods returns for EVOMELA[8] - Revenues for Q3 2025 decreased to $3,075,000 from $7,793,000 in Q3 2024, representing a decline of 60.5%[24] - Net loss for Q3 2025 was $10.9 million, compared to $8.4 million in Q3 2024, attributed to the decrease in revenues[11] - Net loss for Q3 2025 increased to $10,883,000 compared to a net loss of $8,395,000 in Q3 2024, an increase of 29.7%[24] - Net loss per share (basic and diluted) for Q3 2025 was $(0.67), compared to $(0.55) in Q3 2024, indicating a worsening loss per share[24] - Total comprehensive loss for the nine months ended September 2025 was $35,512,000, compared to $25,156,000 in the same period of 2024, an increase of 41.1%[24] Expenses - Cost of revenue for Q3 2025 was $2.4 million, a 35% decrease compared to $3.7 million in the same period last year[9] - General and administrative expenses for Q3 2025 were $4.9 million, a 14% decrease from $5.7 million in Q3 2024[10] - Research and development expenses for Q3 2025 were $1.4 million, stable compared to $1.5 million in the same period last year[9] - Research and development expenses for the nine months ended September 2025 were $5,073,000, slightly down from $5,251,000 in the same period of 2024, a decrease of 3.4%[24] - General and administrative expenses for the nine months ended September 2025 increased to $18,709,000 from $16,456,000 in 2024, an increase of 7.6%[24] - Selling and marketing expenses for the nine months ended September 2025 were $13,793,000, up from $13,069,000 in 2024, an increase of 5.5%[24] - Total operating expenses for Q3 2025 were $11,383,000, a reduction from $12,509,000 in Q3 2024, reflecting a decrease of 9.0%[24] Cash and Financing - As of September 30, 2025, cash and cash equivalents were $4.7 million, down from $13.5 million as of December 31, 2024[11] - The company raised approximately $5.7 million from an at-the-market facility during Q3 2025[7] Research and Development - CID-103 is in a Phase 1 dose-escalation study for immune thrombocytopenia (ITP), with dosing at the highest dose of 900 mg ongoing[6] - The company plans to present results of the ongoing Phase 1 study of CID-103 at the ASH 2025 meeting on December 7, 2025[3] Business Strategy - The company is targeting completion of the divestiture of its China business in Q2 2026[6] Shareholder Information - The weighted average number of ordinary shares outstanding increased to 16,049,321 in Q3 2025 from 15,294,393 in Q3 2024, an increase of 4.9%[24]

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 all ...

Core Viewpoint - CASI Pharmaceuticals has received a delisting determination from Nasdaq due to its market value of listed securities falling below the minimum requirement of $35 million for 30 consecutive trading days, and the company has appealed this decision to regain compliance [2][3]. Company Update - CASI Pharmaceuticals, Inc. is focused on developing CID-103, an anti-CD38 monoclonal antibody aimed at treating organ transplant rejection and autoimmune diseases [5][6]. - The company was notified on May 5, 2025, that it did not comply with Nasdaq Listing Rule 5550(b)(2) due to its market value falling below the required threshold [2]. - CASI has appealed the delisting determination and requested a hearing to present a plan for regaining compliance, which will temporarily stay the suspension of its securities [3][4]. Product Development - CID-103 is a fully human IgG1 monoclonal antibody that has shown promising pre-clinical efficacy and clinical safety compared to other anti-CD38 monoclonal antibodies [6]. - The company has received FDA IND clearance to conduct a Phase 1 study in the U.S. for renal allograft antibody-mediated rejection, with plans to enroll the first patient in the first quarter of 2026 [6]. - CASI is also actively recruiting patients for an ongoing Phase 1 study in immune thrombocytopenia (ITP) and is exploring technologies for developing a stable, high concentration protein solution for subcutaneous injection [6].

Core Insights - CASI Pharmaceuticals, Inc. is developing CID-103, a potential best-in-class anti-CD38 monoclonal antibody for organ transplant rejection and autoimmune diseases [1] - The company announced that data from its Phase 1 open-label study of CID-103 in adult patients with immune thrombocytopenia (ITP) will be presented at the 67th American Society of Hematology Annual Meeting [1] Company Overview - CASI Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on innovative therapies for serious diseases [1] - CID-103 is being investigated for its efficacy in treating patients with immune thrombocytopenia, a condition characterized by low platelet counts [1] Study Details - The Phase 1 study is a dose-escalation and safety study followed by a randomized, open-label, parallel-arm multi-dose study [1] - The study evaluates the efficacy and tolerability of CID-103 in adults with persistent or chronic immune thrombocytopenia [1] - The presentation will take place during the session named 311 at the annual meeting scheduled for December 6-9, 2025, in Orlando, Florida [1]

Core Insights - CASI Pharmaceuticals has appointed James Huang as an Independent Director, effective October 1, 2025, bringing over 35 years of biotech experience [1] Company Overview - CASI Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing innovative therapies for organ transplant rejection and autoimmune diseases [1] Leadership Impact - The appointment of James Huang is expected to significantly enhance the development program of CID-103, an anti-CD38 monoclonal antibody [1]

Financial Performance - Revenues for Q2 2025 were $4.2 million, a 5% increase from $4.0 million in Q2 2024[8] - Revenues for Q2 2025 increased to $4,175,000, up 4.9% from $3,979,000 in Q2 2024[21] - Gross profit for the first half of 2025 was $5,677,000, representing a 46.4% increase compared to $3,873,000 in the same period of 2024[21] - Total operating expenses rose to $13,183,000 in Q2 2025, up 21.4% from $10,856,000 in Q2 2024[21] - Net loss for Q2 2025 was $13.4 million, compared to $7.0 million in Q2 2024[11] - Net loss for Q2 2025 was $13,375,000, compared to a net loss of $6,965,000 in Q2 2024, reflecting a 92.5% increase in losses[21] - Net loss per share for the first half of 2025 was $1.56, compared to $1.23 in the same period of 2024[21] - Total comprehensive loss for the first half of 2025 was $24,591,000, compared to $16,713,000 in the same period of 2024, indicating a significant increase in overall losses[21] Expenses - Cost of revenue for Q2 2025 was $2.1 million, an 11% increase from $1.9 million in Q2 2024[8] - Research and development expenses for Q2 2025 were $1.7 million, up 31% from $1.3 million in Q2 2024, primarily for CID-103 development[9] - Research and development expenses for Q2 2025 were $1,724,000, an increase from $1,254,000 in Q2 2024[21] - Selling and marketing expenses for Q2 2025 were $5.0 million, a 14% increase from $4.4 million in Q2 2024, due to increased marketing efforts[10] - Selling and marketing expenses increased to $4,960,000 in Q2 2025, compared to $4,425,000 in Q2 2024[21] - The company reported a foreign exchange loss of $415,000 in Q2 2025, compared to a gain of $265,000 in Q2 2024[21] Cash Position - Cash and cash equivalents as of June 30, 2025, were $6.7 million, down from $13.5 million as of December 31, 2024[12] Business Developments - The company entered into a definitive agreement to sell 100% equity interests in its Chinese subsidiaries for an aggregate purchase price of $20.0 million[5] - FDA clearance was received for the IND application of CID-103 for antibody-mediated rejection in renal allografts, with a Phase 1 study planned for Q3 2025[3][6] - CID-103 is currently in a Phase 1/2 dose-escalation study for immune thrombocytopenic purpura (ITP)[14] - The company expects to retain rights related to CID-103 in Japan and non-Asian regions after the asset divestiture[7] Shareholder Information - The weighted average number of ordinary shares outstanding increased to 15,505,897 in Q2 2025 from 13,519,328 in Q2 2024[21]

Core Insights - CASI Pharmaceuticals (凯信远达) experienced a stock price increase of 4.03% on August 25, reaching $2.455 per share, with a total market capitalization of $38.0345 million [1] - For the fiscal year ending March 31, 2025, CASI reported total revenue of $6.24 million, reflecting an 83.04% year-over-year growth, while the net profit attributable to shareholders was -$10.75 million, a decrease of 12.83% year-over-year [1] Company Overview - CASI Pharmaceuticals is a Nasdaq-listed biopharmaceutical company based in Rockville, Maryland, USA, focused on providing advanced treatment solutions for blood cancers in Chinese patients [2] - The company has a wholly-owned subsidiary in Beijing and joint ventures and research centers in Wuxi with local government [2] - CASI's product and research pipeline covers multiple disease areas, including multiple myeloma, B-cell non-Hodgkin lymphoma, and acute lymphoblastic leukemia [2]