Current report No. 7/2021 – The recommendation of the National Centre for Research and Development to co-fund a project for an inhaled drug candidate for the treatment of inflammatory and fibrotic lung diseases, including COVID-19 complications

February 10, 2021

Date: February 10, 2021, time: 5:42 PM

Legal basis: Article 17 section 1 of the Market Abuse Regulation (MAR) - confidential information.

Content of the report:

Management Board of Celon Pharma S.A. (the “Company”) wishes to announce that on 10 February 2021 it received information that the Company’s application for co-funding of a project entitled “In vivo validation, toxicological development and implementation into clinical trials and the Company’s activities of an inhalation drug candidate for the treatment of inflammatory and fibrotic lung diseases including COVID-19 complications”, submitted to a competition under the Smart Growth Operational Programme 2014-2020, measure 1.1/submeasure 1.1.1. was recommended for co-funding by the National Centre for Research and Development.

The total project cost was estimated at PLN 46.9 million and the recommended value of the co-funding is PLN 27.2 million.

The aim of the project is non-clinical and clinical confirmation of the efficacy and safety of the CPL116 compound – an JAK/ROCK kinase inhibitor developed at Celon Pharma S.A., administered by inhalation for the following indications: asthma, chronic obstructive pulmonary disease (COPD) and idiopathic pulmonary fibrosis (IPF). Chronic inflammatory and fibrotic respiratory diseases affect millions of people around the world. It is expected that administration by inhalation will reduce the dosage and limit the occurrence of adverse effects. The scope of works covered by the project includes the manufacture of an Active Pharmaceutical Ingredient (API) according to GMP (Good Manufacturing Practice) standards, as well as conducting pre-clinical trials to confirm the drug's efficacy and pharmacokinetic profile when administered by inhalation. In subsequent stages, the Company plans to develop a formulation using a modern dry powder inhaler (DPI) and to conduct a toxicological study on administration of the compound by inhalation. The final stage of the works will be the evaluation of the developed inhalation drug in Phase I and II clinical trials.

The final amount of the co-funding may change. The Company will announce the conclusion of the co-funding agreement in a separate current report.