On July 9, 2024, Salarius Pharmaceuticals, Inc. was notified by researchers at The University of Texas MD Anderson Cancer Center that a patient in MDACC?s sponsored clinical trial evaluating seclidemstat (SP-2577) in combination with azacitidine in adult patients with myelodysplastic syndromes and chronic myelomonocytic leukemia experienced a serious and unexpected grade 4 adverse event. Per protocol, the U.S. Food and Drug Administration (FDA) was notified and MDACC subsequently received notification from the FDA placing the clinical trial on partial clinical hold. Under the partial clinical hold, no new patients may be enrolled at this time, but currently enrolled subjects may continue treatment and all study procedures if they are benefiting.

The Company intends to support researchers at MDACC to analyze the available data and respond to questions submitted by the FDA.