CASI PHARMACEUTICALS ANNOUNCES ITS PARTNER, PRECISION AUTOIMMUNE THERAPEUTICS CO., LTD HAS COMPLETED FIRST-ROUND FINANCING OF $21 MILLION

~ Precision Autoimmune Therapeutics (PAT) Announced the completion of first-round financing of the equivalent of approximately US $21 million ~

~ CASI holds 15% equity stake in PAT ~

~ PAT will pay CASI US $5 million equivalent as the first installment of upfront payment of the CID-103 sub-license agreement ~

ROCKVILLE, Md. and BEIJING, July 8, 2022 /PRNewswire/ -- CASI Pharmaceuticals, Inc. (NASDAQ: CASI), a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, today announced that Precision Autoimmune Therapeutics Co., Ltd., (PAT), previously known as Beijing Tianshi Tongda Pharmaceuticals Technology Co., Ltd (TIANSHI), has completed the first-round financing which raised RMB140 million (approximately $21 million). After completion of the first-round financing, CASI holds a 15% stake in PAT.

On May 25, 2022, CASI and PAT entered into a worldwide sub-license agreement for the investigational anti-CD38 monoclonal antibody, CID-103, for the treatment, prevention, and diagnosis of autoimmune diseases, conditions, and disorders in humans. Under the terms of the agreement, CASI maintains exclusive US commercialization and co-marketing rights of CID-103 in autoimmune indications in the United States. CASI also has the co-commercial rights in the autoimmune-derived hematology indications for CID-103 in China, but is not obligated to co-commercialize those programs. Upon the completion of PAT's first-round of financing, PAT will pay CASI US $5 million equivalent as the first part of two-installments upfront payment under the license agreement.

Wei-Wu He, Ph.D., CASI's Chairman and Chief Executive Officer, said "The successful completion of PAT's first-round financing allows PAT to move forward with the CID-103 autoimmune development program. By partnering with PAT, the development of CID-103 in the autoimmune indications will proceed external to CASI's budget during a period of challenging biotech funding. Partnership with PAT will accelerate the development and potential commercialization of CID-103 in autoimmune disease, autoimmune-derived hematology indications, both are mutually beneficial to the PAT and CASI shareholders."

Precision Autoimmune Therapeutics Co., Ltd., (PAT), known as Beijing Tianshi Tongda Pharmaceuticals Technology Co., Ltd., is a clinical stage innovative drug development company focused on the precision therapeutics for patients with autoimmune and inflammatory diseases. Through the High Dimension Precision Medicine HDPM platform, PAT significantly improves the success rate of innovative drug development. PAT aims to provide safer and more effective drugs for patients worldwide suffering from autoimmune and inflammatory diseases.

CID-103 is a fully human IgG1 anti-CD38 monoclonal antibody that recognizes a unique epitope on CD38. It was engineered to have strong activity against CD38 malignant cells and to reduce certain safety issues observed with existing treatments. Preclinical data of CID-103 demonstrates enhanced activity against a broad array of malignancies which express CD38 and demonstrates a better preclinical safety profile when compared to other CD38 mAbs. These attributes offer the potential for accelerated development and regulatory review, including rapid advancement into earlier lines of therapy.

CASI Pharmaceuticals, Inc. is a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products in China, the United States, and throughout the world. The Company is focused on acquiring, developing, and commercializing products that augment its hematology oncology therapeutic focus as well as other areas of unmet medical need. The Company intends to execute its plan to become a leader by launching medicines in the Greater China market, leveraging the Company's China-based regulatory and commercial competencies and its global drug development expertise. The Company's operations in China are conducted through its wholly-owned subsidiary, CASI Pharmaceuticals (China) Co., Ltd., located in Beijing, China. The Company has built a commercial team of more than 100 hematology and oncology sales and marketing specialists based in China. More information on CASI is available at www.casipharmaceuticals.com.

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act with respect to the outlook for expectations for future financial or business performance, revenue growth, strategies, expectations and goals. Forward-looking statements are subject to numerous assumptions, risks and uncertainties, which change over time. Forward-looking statements speak only as of the date they are made, and we assume no duty to update forward-looking statements. New factors emerge from time to time, and it is not possible for us to predict which factors will arise. In addition, we cannot assess the impact of each factor on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Actual results could differ materially from those currently anticipated due to a number of factors.

SOURCE CASI Pharmaceuticals, Inc.

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