LadRx Corporation Overview

LadRx is a biopharmaceutical company focused on discovering and developing new therapeutics to treat patients with high unmet needs.

LadRx has a milestone and royalty agreement with Orphazyme A/S (Nasdaq - "ORPH") for arimoclomol. Arimoclomol was recently sold to KemPharm, subject to approval on June 1, 2022. The agreement can provide LadRx with potential milestones plus royalties paid on arimoclomol. Orphazyme is currently studying arimoclomol in clinical trials for Nieman-Pick disease Type C (NPC) and Gaucher disease. Orphazyme filed an NDA with the FDA with Priority Review and received a Complete Response Letter on June 17, 2021. They held a Type A meeting with the FDA in October 2021 and are now formulating a plan to address the FDA’s concerns and then file an NDA in 1Q23. They will be working with the regulators to find a possible path forward. NPC is a severely debilitating and fatal disease that predominantly affects children. Orphazyme has also received FDA Breakthrough Therapy Designation for arimoclomol for NPC. They launched an Early Access Program for NPC in January 2020 to further accelerate access to treatment with arimoclomol for people living with NPC. For LadRx, this milestone and royalty agreement could represent potential near-term value for our company.

LadRx also has a milestone and royalty agreement with ImmunityBio, Inc. for aldoxorubicin which is an improved version of the widely used chemotherapeutic agent doxorubicin. The agreement can provide LadRx with up to $343M in potential milestones + royalties paid on aldoxorubicin. Royalties are increasing double digits on soft tissue sarcomas and increasing single digits in all other indications. ImmunityBio is headed by Dr. Patrick Soon-Shiong, the inventor of Abraxane and an albumin research pioneer in oncology. ImmunityBio has highlighted aldoxorubicin as one of three separate modalities of its platform. They announced initiation of a phase 2 registrational-intent study using aldoxorubicin in combination with immunotherapy in metastatic pancreatic cancer. ImmunityBio, to date, plans to use aldoxorubicin in studies in glioblastoma and Kaposi Sarcoma in addition to metastatic pancreatic cancer. ImmunityBio is reviewing options in Soft Tissue Sarcoma. This milestone and royalty agreement could provide significant payments to LadRx in multiple tumor types for aldoxorubicin.