Salarius Pharmaceuticals, Inc. announced that it participated in a Type B End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) to receive guidance regarding the development program for seclidemstat to treat Ewing sarcoma. The Company has received the final meeting minutes and is amending the current clinical trial protocol to reflect guidance agreed to with FDA during the EOP2 meeting. Based on the advice received from the FDA and the new clinical data Salarius shared during the meeting process, Salarius is preparing an amendment to the Ewing sarcoma clinical trial protocol and plans to submit the amended protocol in the coming months.

The Company believes that the guidance provided by the FDA will support continued development by a potential partner or acquirer. The Company-sponsored Ewing sarcoma clinical trials focuses on seclidemstat in combination with topotecan and cyclophosphamide (TC) chemotherapy as a treatment for relapsed and refractory Ewing sarcoma from the FDA. In addition to the Ewing sarcom a clinical trial, Salarius is also exploring seclidemstat's potential in several cancers with high unmet medical need, with an investigator-initiated Phase 1/2 clinical study in hematologic cancers at MD Anderson Cancer Center.