THIS PRESENTATION CONTAINS FORWARD-LOOKING STATEMENTS THAT INVOLVE CERTAIN RISKS AND UNCERTAINTIES. ACTUAL RESULTS COULD DIFFER MATERIALLY FROM THOSE EXPRESSED OR IMPLIED IN THESE FORWARD-LOOKING STATEMENTS AS A RESULT OF VARIOUS RISKS AND UNCERTAINTIES, INCLUDING THOSE RISK FACTORS DISCUSSED IN THE ANNUAL AND QUARTERLY REPORTS THAT CYTRX FILES WITH THE U.S. SECURITIES AND EXCHANGE COMMISSION.
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CytRx Highlights
CytRx's milestone and royalty agreement with Orphazyme for arimoclomol represents potential near term payments to CytRx
Orphazyme has filed a New Drug Application (NDA) with the FDA for arimoclomol for NPC, which is currently under Priority Review with a target action date of June 17, 2021
It also submitted a Marketing Authorisation Application with EMEA authorities for arimoclomol for NPC
ImmunityBio has initiated a Phase 2 registrational-intent study for first-line and second-line locally advanced or metastatic pancreatic cancer, which includes aldoxorubicin
Centurion BioPharma is a private oncology drug development company focused on cancer and has completed extensive pre-clinical work for its ultra high potency LADRTM drug candidates and albumin companion diagnostic (ACDx)
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CytRx has potential milestone/royalty payments and a subsidiary called Centurion BioPharma
Orphazyme
Milestones
and Royalties
ImmunityBio
Milestones
and Royalties
Centurion
BioPharma
Pipeline
Orphazyme: Approximately $100M in potential milestones; plus royalties on arimoclomol
ImmunityBio: $343M in potential milestones; plus
royalties on aldoxorubicin
Oncology drug development with a companion
diagnostic
Centurion BioPharma is a subsidiary of CytRx
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CytRx milestones and royalties from Orphazyme for Arimoclomol
Orphazyme
Milestones
and Royalties
Orphazyme: up to approximately $100M in
milestones
in addition to royalties on arimoclomol
Niemann-Pick disease ("NPC")
Orphazyme filed an NDA with the FDA with Priority Review, and a target action date of June 17, 2021; also submitted an MAA with the EMA, both for arimoclomol for Niemann-Pick disease Type C (NPC).
Orphazyme has also received Breakthrough Therapy Designation for NPC.
Orphazyme launched an Early Access Program for NPC in January 2020 to further accelerate access to treatment with arimoclomol for people living with NPC.
Total worldwide patients approximately 3,000.
Expected price range is $300,000 - $600,000; market potential $600 Million.
Go to market in US Q3 2021 and EU/RoW H2 2021.
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CytRx Corporation published this content on 21 May 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 20 May 2021 00:03:03 UTC.
LadRx Corp is a biopharmaceutical research and development company specializing in oncology. The Company focuses on the discovery, research and clinical development of anti-cancer drug candidates that employ technologies that target chemotherapeutic drugs to solid tumors and reduce off-target toxicities. The Companyâs linker activated drug release (LADR) technology platform consists of an organic backbone that is attached to a chemo toxic agent. The LADR backbone is to first target and deliver the chemo toxic agent to the tumor environment, and then to release the chemo toxic agent within the tumor. The LADR Technology offers the opportunity for multiple pipeline drugs. The LADR development efforts are focused on two classes of ultra-high potency albumin-binding drugs. These LADR-based drugs, LADRs 7, 8, 9, and 10, combine the proprietary LADR backbone with derivatives of the auristatin and maytansinoid drug classes.
LADRX CORPORATION 
