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21-Feb-2023

BioSenic receives EUR 1 million from Pregene in accordance with terminated license agreement and expect new negotiations on common revisited grounds

Following the regaining of ALLOB global rights, BioSenic has received a final payment from Pregene linked to a previously achieved development milestone which has a significant impact on the financial fundamentals of BioSenic

BioSenic continues to conduct preliminary discussions with Pregene, Link Health and other potential partners to move forward with the development and commercialization of ALLOB in other geographies, including the US

Mont-Saint-Guibert, Belgium, February 21, 2023 – BioSenic (Euronext Brussels and Paris: BIOS), the clinical stage company specializing in serious autoimmune / inflammatory diseases and cell repair, today announces it has received EUR 1 million (minus 6 percent taxes) from Pregene. 

On October 5 2020, BioSenic, Pregene and Link Health Pharma Co., Ltd (“Link Health”) signed an exclusive license agreement for the manufacturing, clinical development and commercialization of ALLOB in China (including Hong Kong and Macau), Taiwan, Singapore, South Korea, and Thailand). 

Following new legislation and regulatory internal rules Pregene informed BioSenic that they had to terminate their agreement, A statement from Pregene read: “Our termination was necessitated by regulatory reasons. Due to the introduction of new laws and regulations, projects involving foreign human cells and related clinical trials will be prohibited in mainland China.”

As such, Pregene’s participation in all activities ceased and all data and information related to ALLOB were transferred back to BioSenic. 

As per the terminated license agreement, Pregene owed BioSenic a payment further to the achievement of development milestone. BioSenic has now received a payment of EUR 1 million (minus 6 percent taxes) from Pregene after achieving this milestone a few months ago and as a final payment for any remaining amount due.

ALLOB is being developed to improve the efficacy and safety of bone cell therapy, through the use of partially differentiated bone-forming cells derived from bone marrow mesenchymal stem cells of healthy adult donors. ALLOB is currently in Phase IIb trials for the treatment of patients with high-risk tibial fractures.

Although Chinese regulatory changes have halted establishment of ALLOB in the Chinese market, BioSenic has started preliminary discussions with Pregene, Link Health and other potential partners to move forward with the development and commercialization of ALLOB in other geographies, including the US. This expansion to other markets will enable the global potential of ALLOB to be realized, giving patients with bone disorders, worldwide access to life-changing bone cell therapy.

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Last Updated: 21-Feb-2023