BioSenic provides First Quarter 2023 Business Update

REGULATED INFORMATION

ALLOB Phase IIb topline results foreseen in July/August 2023
Ongoing discussions for key partnerships with lead clinical assets

Mont-Saint-Guibert, Belgium, May 22^nd, 2023 7.00am CET – BioSenic (Euronext Brussels and Paris: BIOS), the clinical stage company specializing in serious autoimmune and inflammatory diseases and cell repair, today announces its business update for the first quarter, ended 31 March 2023.

Key highlights

• Strengthening of Executive Committee and Board of Directors with the appointments of Dr Carole Nicco as Chief Scientific Officer, Dr Lieven Huysse as Chief Medical Officer and Yves Sagot as Independent Director.
  
  
• In February 2023, BioSenic announced it received EUR 1 million from Pregene in accordance with the terminated license agreement.
  
  
• In February 2023, BioSenic announced an optimization its ongoing Phase IIb clinical trial with its allogeneic bone cell therapy product, ALLOB and completion of patient recruitment.
  
  
• In March 2023, BioSenic announced that it has used the statistical analysis capabilities of Artialis to study the results of the Phase III JTA-004 trial in the subset of patients with the most painful and inflammatory form of knee osteoarthritis (OA). This allows BioSenic to distinguish a group of patients, representing about one third of the total patients, who show a pain-relieving effect of JTA-004 not only superior to placebo but also to the active comparator. This new post-hoc analysis changes the therapeutic profile of the molecule and potentially allows for the possibility of stratifying patients for a new, optimized Phase III clinical study.
  
  
• In March 2023, BioSenic published new data providing additional details about the mechanism of action of its lead API arsenic trioxide (ATO) to prevent autoimmune diseases has now been published in a peer-reviewed paper (Frontiers in Immunology). This new data shows that combination of ATO with copper salts can allow BioSenic to work towards reducing the dosage of ATO in future trials overall and maintain efficacy. This new formulation data has been completed following pre-clinical activities and does not constitute data validated through clinical trial.