On November 14, 2023 CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, reported business and financial results for the third quarter ended September 30, 2023 (Press release, CASI Pharmaceuticals, NOV 14, 2023, View Source [SID1234637664]).

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Dr. Wei-Wu He, Chairman and CEO of CASI Pharmaceuticals, stated, "We are delighted to announce that our partner Juventas has received approval from the China National Medical Products Administration (NMPA) for Inaticabtagene Autoleucel (anti-CD 19 CAR-T Cell Therapy) for the treatment of B-cell acute lymphoblastic leukemia (r/r B-ALL) in China. As exclusive marketing partner of Juventas, we are extremely proud of this achievement. This marks a significant milestone as Inaticabtagene Autoleucel is the first commercialized cell therapy for B-ALL in China. Our sales and marketing team is actively preparing for the commercial launch."

Dr. He further added, "Our sales revenue for the third quarter of 2023 was $8.8 million, representing a decrease of 13.5% compared to the same period last year and a decrease of 10% from the second quarter of 2023. The third quarter EVOMELA sales performance was impacted by the recent launch of an undifferentiated generic formulation of melphalan for injection product. Despite market challenges, CASI remains committed to advancing our product pipeline. Some of our noteworthy recent achievements include the license transfer of Folotyn with an expected launch in Q1 2024, progress in the clinical development of BI-1206, transitioning CID-103 development to China for malignant hematology indications, and the acquisition of global rights for CB-5339 from Cleave Therapeutics. CASI Pharmaceuticals continues to strive for milestones and seek new synergistic opportunities in the coming quarters."

Third Quarter 2023 Financial Highlights

Revenue consists of product sales of EVOMELA. Revenue was $8.8 million for the three months ended September 30, 2023, compared to $10.2 million for the three months ended September 30, 2022.
Costs of revenues were $3.6 million for the three months ended September 30, 2023, compared to $4.2 million for the three months ended September 30, 2022. The decrease is in line with the decrease in revenue.
Research and development expenses for the three months ended September 30, 2023 were $2.4 million, compared with $3.9 million for the three months ended September 30, 2022. The decrease is mainly attributable to reduced research and development expenses on certain projects, such as CID-103.
General and administrative expenses for the three months ended September 30, 2023 were $5.5 million, compared with $4.8 million for the three months ended September 30, 2022.
Selling and marketing expenses for the three months ended September 30, 2023 were $2.5 million, compared with $3.6 million for the three months ended September 30, 2022. The decrease is mainly attributable to reduced commercial activities given the recent market environment.
As of September 30, 2023, CASI had cash, cash equivalents and short-term investments of $34.2 million.