Xspray Pharma publishes its Annual Report 2022

Regulatory press release 2023-03-29

Xspray Pharma AB (publ) today publishes its Annual Report for the financial year 2022. The Annual Report is attached to this press release and available on the company’s website: https://xspraypharma.com/investors/financial-reports/

An extract from the CEO-letter from Per Andersson, CEO of Xspray Pharma:
 
“We made important progress during 2022 in completing our first product intended for launch and commercialization in the US. The product is XS004 brand-named Dasynoc, our amorphous version of dastinib intended for treatment of chronic myeloid leukemia (CML) and acute lymphatic leukemia (ALL) which are blood cancer diseases. During the year we were able to present new research data that shows that Dasynoc can have clear clinical benefits. We also made an application to the FDA, Federal Drug Administration, in the US for market approval of Dasynoc and received regulatory approval from the Italian Medicines Agency, AIFA, for commercial production of the product. We have thus initiated production of the required stock of Dasynoc ahead of a launch which is planned for the second half of 2023. After the financial year, we also presented our commercialization strategy by which we have signed an agreement with EVERSANA, a third party service provider giving us access to a specialized, established and scalable US sales organization covering the entire US. EVERSANA has extensive experience in selling PKI-drugs and will be responsible for the US launch of Dasynoc at an optimized cost while Xspray Pharma maintains strategic and financial ownership of the product.”