CytRx Highlights Strategic Purchase of Arimoclomol by KemPharm, Inc.

CytRx Corporation (OTCQB: CYTR) (“CytRx” or the “Company”), a biopharmaceutical innovator focused on research and development of life-saving cancer therapeutics, is pleased to highlight the strategic purchase of arimoclomol by KemPharm, Inc. (“KemPharm”).

KemPharm is a specialty biopharmaceutical company focused on the discovery and development of novel treatments for rare central nervous system ("CNS") diseases. KemPharm has announced a definitive agreement with Orphazyme A/S ("Orphazyme") to acquire arimoclomol, a first-in-class heat shock protein potentiator being developed as a treatment for Niemann-Pick disease type C ("NPC"). NPC is a rare neurodegenerative disease characterized by abnormal accumulation of cholesterol and lipids in neuronal tissues. Under the terms of the agreement, KemPharm will purchase substantially all of the assets and operations of Orphazyme, including arimoclomol, for a cash payment of USD $12.8 million. The transaction is expected to close on or before June 1, 2022.

CytRx licensed arimoclomol to Orphazyme for milestones and royalties on sales, and CytRx expects the terms of its license with Orphazyme to remain intact as the arimoclomol asset transfers to KemPharm.

In the press release issued by KemPharm, Travis Mickle, Ph.D., President and Chief Executive Officer of KemPharm stated, “The acquisition of arimoclomol aligns perfectly with our strategy to build KemPharm’s value via the advancement and commercialization of novel treatments that address rare CNS conditions, including our lead clinical candidate, KP1077 in idiopathic hypersomnia. We have carefully evaluated the CRL issued by the FDA and the minutes from the subsequent Type A meeting, as well as the data that has been generated from the development work performed to date. We believe the efficacy signal for arimoclomol in NPC is convincing and that there is a viable regulatory path that could enable a successful NDA resubmission. KemPharm has significant experience with challenging regulatory situations, having successfully led or participated in three FDA product approvals, two of which followed an initial CRL. We welcome the opportunity to work with the FDA on the resubmission of the NDA for arimoclomol in NPC, which we expect to file as early as the first quarter of 2023.”