Subject: Summary ofType B Meeting with the Food and Drug Administration (FDA) for CPL'36 inthe treatment of schizophrenia
Legal basis: Art. 17of the MAR Regulation - Inside information
Report content:
The Management Boardof Celon Pharma S.A. (the "Company", the "Issuer") informs that onOctober 2, 2025, the Company received a summary of the Type B meetingheld on October 1, 2025, containing responses to questions submitted forthe combined pre-IND and the End-of-Phase 2 Meeting.
During the meeting, adiscussion was held on the non-clinical, quality, and clinical studiesof CPL'36 conducted and continued by the Company. The main goal was toobtain the FDA's opinion on the scope of data obtained so far andacceptance of the proposed further clinical and non-clinical developmentof the PDE10a inhibitor drug candidate, CPL'36, in the treatment ofschizophrenia, within the framework of the planned Phase III clinicaltrials.
During the meeting,the FDA:
-confirmed theadequacy of the proposed preclinical study program and the relevance ofthe toxicology studies conducted to date;
-reviewed the resultsof Phase I and Phase II clinical trials of the PDE10a inhibitor CPL'36,indicating the feasibility ofcontinuing its clinical development in the indication of schizophrenia
-considered theproposed design of the Phase III studies as adequate. Based on the threeproposed studies: two four-week randomized trials in acute episodes ofschizophrenia and one long-term open-label study in which patientscontinue CPL'36 treatment - the FDA confirmed "treatment ofschizophrenia" as an adequate wording of proposed indication for thedrug;
- suggested detailsregarding patient inclusion criteria, taking into account the safety andnon-clinical data presented so far;
- reviewed theprimary and secondary endpoints, which will form the basis for theregistration indication
- providedrecommendations concerning the documentation to be submitted with theapplication to initiate the Phase III clinical trials.
The FDA's positionexpressed during the meeting with the Company, in line with regulatorypractice, does not constitute binding approval for product registration,but represents a key stage enabling the preparation and submission offinal Phase III clinical trial protocols and the New Drug Application(NDA). The Agency reserves the right to make final decisions based onthe data contained in the submitted documentation at the time ofsubmission.
The Company'sManagement Board considers the meeting very favorable. The Agencyexpressed consent to a number of facilitation measures aimed atshortening the project timeline and reducing the costs of the plannedstudies required to obtain marketing authorization for the product.
The Company plansto take the FDA's recommendations into account in developing the finalversion of the Phase III trial protocols and to communicate all FDArecommendations and meeting outcomes to partners with whom the Companyis conducting negotiations for the commercialization of the project.
The Company will keepthe market informed about further significant stages of the clinicalprogram development, in particular about the submission of documentationto the FDA and the Agency's decision regarding the initiation of thePhase III trials.