Production Initiated for VAL001

Respiratorius announces that the development of the novel formulation of VAL001 has been completed and production initiated.

characteristics of sodium valproate contained in a pellet formulation. This tailored release profile will be evaluated in a pharmacokinetic (PK) phase I study in healthy subjects.

The submission processes for initiating the PK study are in progress, with the ethical committee submission already completed. Positive evaluation and approvals from all necessary regulatory bodies for study start are expected before end of 2021.

In parallel with the product related activities and regulatory approval processes, progress has been made in the prosecution of the patent applications for VAL001, where patent office actions have been responded to in multiple countries

"Intitiating production of our VAL001 drug product is a significant milestone enabling a novel product for pretreatment of DLBCL patients before R-CHOP immunochemotherapy, says CEO Johan Drott in a comment.

This disclosure contains information that Respiratorius is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). The information was submitted for publication, through the agency of the contact person, on 13-10-2021 13:31 CET.

Johan Drott

President Respiratorius AB

+46 709-22 41 40

johan.drott@respiratorius.com

Respiratorius AB (publ) is developing drug candidates with the goal to launch drugs for common diseases cancer, chronic obstructive pulmonary disease (COPD) and severe asthma. In addition, the project portfolio is a project for improved diagnosis of certain cardiovascular diseases.