Current report 16/2025 – Summary of Type B Meeting with the Food and Drug Administration (FDA) for CPL’36 in the treatment of schizophrenia

Legal basis: Art. 17 of the MAR Regulation – Inside information

Report content:

The Management Board of Celon Pharma S.A. (the “Company”, the “Issuer”) informs that on October 2, 2025, the Company received a summary of the Type B meeting held on October 1, 2025, containing responses to questions submitted for the combined pre-IND and the End-of-Phase 2  Meeting.

During the meeting, a discussion was held on the non-clinical, quality, and clinical studies of CPL’36 conducted and continued by the Company. The main goal was to obtain the FDA’s opinion on the scope of data obtained so far and acceptance of the proposed further clinical and non-clinical development of the PDE10a inhibitor drug candidate, CPL’36, in the treatment of schizophrenia, within the framework of the planned Phase III clinical trials.

During the meeting, the FDA:

-confirmed the adequacy of the proposed preclinical study program and the relevance of the toxicology studies conducted to date;

-reviewed the results of Phase I and Phase II clinical trials of the PDE10a inhibitor CPL’36, indicating the feasibility  of continuing its clinical development in the indication of schizophrenia

-considered the proposed design of the Phase III studies as adequate. Based on the three proposed studies: two four-week randomized trials in acute episodes of schizophrenia and one long-term open-label study in which patients continue CPL’36 treatment – the FDA confirmed “treatment of schizophrenia” as an adequate wording of proposed indication for the drug;

– suggested details regarding patient inclusion criteria, taking into account the safety and non-clinical data presented so far;

– reviewed the primary and secondary endpoints, which will form the basis for the registration indication;

and provided recommendations concerning the documentation to be submitted with the application to initiate the Phase III clinical trials.

The FDA’s position expressed during the meeting with the Company, in line with regulatory practice, does not constitute binding approval for product registration, but represents a key stage enabling the preparation and submission of final Phase III clinical trial protocols and the New Drug Application (NDA). The Agency reserves the right to make final decisions based on the data contained in the submitted documentation at the time of submission.

The Company’s Management Board considers the meeting very favorable. The Agency expressed consent to a number of facilitation measures aimed at shortening the project timeline and reducing the costs of the planned studies required to obtain marketing authorization for the product.

The Company  plans to take the FDA’s recommendations into account in developing the final version of the Phase III trial protocols and to communicate all FDA recommendations and meeting outcomes to partners with whom the Company is conducting negotiations for the commercialization of the project.

The Company will keep the market informed about further significant stages of the clinical program development, in particular about the submission of documentation to the FDA and the Agency’s decision regarding the initiation of the Phase III trials.