Current Report No. 8/2025 – Execution of agreement on support for a Celon Pharma S.A. project under the National Recovery and Resilience Plan
Subject: Execution of agreement on support for a Celon Pharma S.A. project under the National Recovery and Resilience Plan
Legal basis: Article 17(1) of Regulation (EU) No. 596/2014 of the European Parliament and of the Council of 16 April 2014 on market abuse (Market Abuse Regulation – MAR) – inside information
Date and time of disclosure: 6 May 2025, 15:48 CET
Report content:
With reference to Current Report No. 2/2025 of 6 February 2025 concerning the qualification of three projects of Celon Pharma S.A. (the “Company”, the “Beneficiary”) for co-financing under the call for proposals announced by the Medical Research Agency (the “Agency”) for entrepreneurs to conduct research in the area of drug safety, innovative therapies and medicines of the future, implemented under the National Recovery and Resilience Plan (Competition No. 2024/ABM/05/KPO), the Management Board of the Company announces that on 6 May 2025 it received a copy of the agreement duly signed by both parties between the Company and the Agency (the “Agreement”) concerning the granting of support for the project:
“SimOn – enhancing drug safety through the development of a scalable manufacturing process for a biosimilar anti-PD-1 monoclonal antibody for use in cancer immunotherapy” (the “Project”).
The total eligible cost of the Project amounts to PLN 14.95 million. Under the terms of the Agreement, the Agency awarded the Beneficiary co-financing for the conduct of industrial research (within the meaning of Commission Regulation (EU) No. 651/2014 of 17 June 2014 declaring certain categories of aid compatible with the internal market in application of Articles 107 and 108 of the Treaty, OJ EU L 187/1 of 26 June 2014, as amended) in the amount not exceeding PLN 9.71 million, representing 65% of the total eligible costs. The co-financing will be disbursed in the form of a one-off advance payment and reimbursement, paid in tranches.
The Project is scheduled for completion by the end of March 2026.
The Agreement provides, in particular, that all proprietary copyrights, related rights, derivative rights to works created under the Project, rights to databases used in the Project (including those not qualifying as works), as well as rights to inventions, utility models, industrial designs and the results of scientific research or development work arising from the Project, must remain vested in the Beneficiary.
Pursuant to the provisions of the Agreement, the Beneficiary is obliged to develop, conduct research and commercialise the Project within five years from the Project’s completion date. In the event of failure to commercialise, the Beneficiary shall be required to return the entirety of the funding received.
Based on its current knowledge and patent clearance analysis, the Company does not identify any barriers to the commercialisation of the product being developed under the Project.
Information concerning the objectives and significance of the Project was provided by the Company in Current Report No. 2/2025. The Company also informed, by way of Current Report No. 7/2025 of 29 April 2025, of the execution of agreements concerning support for the other two projects qualified for co-financing.