“We are honored to receive the ODD from the FDA. This designation underscores the potential of SLS009 to address a significant unmet medical need for patients with AML,” said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. “SLS009 is a novel and highly selective CDK9 inhibitor that has already shown a favorable safety profile, strong initial efficacy signals, and evidence of anti-tumor activity. With the support of this ODD, we look forward to accelerating SLS009 clinical development and bringing new hope to those suffering from this devastating disease.”