ISAB today announces that the deadline for the formal completion of its FDA BAA project has been extended by six months, with an updated completion date of March 29^th 2025, at latest. The project has been extended due to the extensive volume of data to be presented in the report and the extension was agreed upon at the suggestion of the FDA.

All the laboratory work and data for the project has been finalized and submitted to the FDA, including the study’s key PBPK (physiologically based pharmacokinetic) models.

The remaining part of the project is the finalization of the project report, in accordance with FDA regulations.

ISAB plans to be able to release top-line data from the report before the end of 2024, as previously communicated.

CEO Manoush Masarrat: “Our collaboration with FDA has been very positive. This is a project that clearly represents a major opportunity for ISAB to evaluate the methodology and data generated by our DissolvIt^® module and where we today lack a recommended standard method of high enough quality. We look forward to finalizing the report in the near-term future and communicating the results ‘of the project”.

For more information on Inhalation Sciences, please contact:

Manoush Masarrat, CEO

E-mail: manoush.masarrat@inhalation.se

Mobile: +46 (0)73 628 9153

About Inhalations Sciences Sweden AB (publ)

Inhalation Sciences Sweden AB (publ) develops and commercializes world-leading instruments and services for research into inhalation. The company’s patented lab instruments PreciseInhale® and DissolvIt^® enable researchers in the pharma industry to make drug pipeline decisions at an early stage, saving time and resources for R&D departments, and enables researchers in academic institutions to define how aerosols and small particles impact our lungs, whether new pollutants or life-saving drugs that power human development.