Subject:Receipt of a written response from the European Medicines Agency as apart of the 'Scientific Advice' regarding the assumptions for the newregistration process for MabionCD20

Legalbasis Article 17 para. 1 MAR - confidential information.

Reportcontent:

Inreference to the current report No. 15/2020 of March 16, 2020 regardingthe change of the drug regulatory strategy for the product with theworking name MabionCD20 (submission of a new application to the EuropeanMedicines Agency -EMA, for a marketing authorization based on a largerscale of manufacturing), the Management Board of Mabion SA (The"Company") informs that on the 1stJuly 2020, ithas received a written response from EMA as part of "Scientific Advice"(i.e. scientific consultations with representatives of EMA).

Thedocument obtained as part of "Scientific Advice" contains the Agency'sresponse to individual assumptions made by the Company regarding the newregistration process of the MabionCD20 product. In particular, the scopeof data to be included in a new registration application as well as theactivities required to generate such data, were proposed by andresponded to by the Agency.

Currently,the Company is proceeding with the analysis of the documents receivedfrom EMA with the help of external experts in regulations. Subsequently,the Company will establish work schedules in order to execute on theadvice received.

In theopinion of the Company, the consultation with EMA is allowing for asignificant reduction of uncertainties and regulatory risk, as well asfor an optimization of the time and effort required for the compilationof the Marketing Authorization Application (MAA) and its regulatoryreview.TheCompany cautions, however, that due to the specific responsibilities ofthe regulators, the content of the document is subject tointerpretation, creating a certain risk of discrepant interpretations.

In thecoming days, the Company will organize a webinar for the market todiscuss the current status and plans for the MabionCD20 project,whichwill be announced on the Company's website.