Legal basis: Article 17 section 1 of the Market Abuse Regulation (MAR) \u2013 inside information, time: 06:37 PM<\/p>\n\n\n\n
Content of the report:<\/p>\n\n\n\n
The Management Board of Celon Pharma S.A. (\u201cCompany\u201d, \u201cBeneficiary\u201d) hereby informs that on December 6, 2022, an agreement was signed between the Company and the Medical Research Agency (\u201cAgency\u201d) on implementing and co-funding a project entitled FGF1 Analogue: A New Therapeutic Objective for Non-alcoholic Fatty Liver Disease and Related Metabolic Diseases\u201d (\u201cAgreement\u201d and \u201cProject\u201d respectively). Information about selecting the Project for co-funding was announced by the Company in current report No. 25\/2022 on November 21, 2022.<\/p>\n\n\n\n
The total eligible cost of the Project amounts to PLN 49.9 million. Pursuant to the conditions set out in the Agreement, the Agency has granted the Beneficiary with co-funding for conducting industrial research, development works and primary research (within the meaning of the 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, Official Journal of the EU – L 187\/1 of 26 June 2014, as amended) in the amount not exceeding PLN 27.0 million, which constitutes 54% of total eligible costs of the Project. Co-funding will be transferred in the form of an advance payment or a refund, made in tranches.<\/p>\n\n\n\n
The maximum Project implementation period specified in the Agreement ends on October 31, 2028.<\/p>\n\n\n\n
The Project\u2019s objective is allowing the development of an innovative and unique drug which will constitute a structurally modified and functionally recombinant form of human protein FGF1, which, thanks to its properties eliminating the cause of developing NAFLD, obesity, hyperglycemia and other factors characterizing the metabolic syndrome, will become a new, alternative therapy for patients suffering from metabolic syndrome diseases, which will not involve adverse effects characteristic of the currently used therapies.<\/p>\n\n\n\n
Two further clinical trials have been planned as part of the Project; they will allow for testing the safety and efficacy, as well as designate a pharmacokinetic profile for the leading FGF1 analogue.<\/p>\n\n\n\n
In particular, the Agreement states that the Beneficiary must hold the entirety of economic copyrights, derivative and related rights to the works used under the Project, as well as the rights to deliverables of development works achieved as part of the Project.<\/p>\n\n\n\n
The Agreement indicated that, having agreed upon it with the Agency, the Beneficiary grants the Agency with the right to purchase a non-exclusive license limited to the territory of the Republic of Poland. Should the Agency choose to exercise the right to purchase the license, the Agency has the right to purchase a non-exclusive license limited to the territory of the Republic of Poland, at arm\u2019s length.<\/p>\n\n\n\n
Pursuant to the provisions of the Agreement, in the case no commercialization is achieved within 3 years from the end of the Project implementation, the Beneficiary is obliged to return the entirety of co-funding, together with interest.<\/p>\n\n\n\n
Based on the current knowledge and the conducted patent clearance study, the Company has not identified any obstacles to commercialization of products developed in its projects.<\/p>\n\n\n\n
In the case of commercialization by way of Beneficiary implementing serial production as part of its own economic activity, the Beneficiary undertakes to continue the subsequent clinical trial phase of the medicinal product that is the subject of the Agreement or in another indication based on the developed results, as a part of its own economic activity within 3 years from the end of the Project implementation.<\/p>\n","protected":false},"excerpt":{"rendered":"