Date: 30-Sep-2020

CASI Pharmaceuticals Announces Restructuring Of Partnership With Juventas Cell Therapy Ltd

  • CASI and Juventas to co-commercialize and co-market CD19 CAR-T (CNCT19) therapy
  • CASI increases its equity position in Juventas
  • CASI receives co-commercial rights to second pipeline product

ROCKVILLE, Md. and BEIJINGSept. 29, 2020 /PRNewswire/ -- CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, today announced a restructuring of its partnership with Juventas Cell Therapy Ltd. relating to CNCT19, an investigational CD19 CAR-T Cell therapy. Juventas is currently developing CNCT19 for the treatment of patients with relapsed B-cell Non-Hodgkin lymphoma and B-cell acute lymphoblastic leukemia, and expects to initiate registration trials in early 2021.Larry Zhang, CASI's President, commented, "We continue to be very enthusiastic about the innovative work Juventas is doing in the hematological malignancy space and look forward to our continued partnership with Juventas as we build a stronger and more integrated team. With the restructuring in place, Juventas now can attract new capital to help fund its upcoming trials and build out a world-class GMP manufacturing facility for commercial production of CNCT19. At the same time, we are reducing CASI's exposure to Juventas' future financial needs while ensuring that CNCT19 clinical development remains on track. CASI is committed to the commercial success of this program."

Mr. Zhang continued, "Importantly, we are also pleased to increase our equity position in Juventas which we believe will have significant upside potential for its shareholders in the China financial marketplace. As one of its major shareholders and with rights to designate a seat on the board of directors, we will continue to ensure the financial success of our investment."

Under the terms of the original licensing agreement between CASI and Juventas, CASI obtained a worldwide license for the commercialization of CNCT19 and Juventas was responsible for the clinical development, manufacturing and supply of CNCT19. As part of the original agreement, CASI Biopharmaceuticals (Wuxi) Co., Ltd ("CASI Wuxi Bio") invested in Juventas' Series A financing. The original agreement also provided that CASI would be responsible for payment of certain sales royalties and a development milestone in the amount of RMB 70 million upon the initiation of the registration trials.

Effective as of September 22, 2020, Juventas and its shareholders (including CASI Wuxi Bio) agreed to certain terms and conditions in connection with Juventas' Series B financing. In order to facilitate the Series B financing, CASI agreed to restructure its partnership with Juventas by amending and supplementing its original licensing agreement (the "Supplementary Agreement"). Under the Supplementary Agreement, CASI and Juventas will partner to co-commercialize CNCT19 and jointly be responsible for forming an integrated marketing team to carry out marketing activities, and CASI will continue to be responsible for recruiting and establishing a sales team to commercialize CNCT19. In addition, the Supplementary Agreement provides CASI with co-commercial rights to a second pipeline product from Juventas, subject to certain terms and conditions.