Radiopharm Theranostics (ASX: RAD) makes operational and clinical progress in FY23

Highlights

• In FY23, the company witnessed clinical progress across RAD 101, RAD301 and RAD201.
• A strategic agreement was signed with Lantheus for nanobody development. Partnership with GenesisCare to drive radiopharmaceutical development.
• Radiopharm Ventures, LLC, a joint venture was launched with the University of Texas MD Anderson Cancer Center.
• Ga68‐ Trivehexin (RAD 301) and DUNP19 technology secured Orphan Drug Designation by the US FDA.

Radiopharm Theranostics Limited (ASX: RAD) focused on research activities and clinical trials during the financial year ended 30 June 2023. The period saw significant clinical progress, joint ventures, acquisitions, strategic agreements, supply agreements and achievements of regulatory milestones.

In FY23, the company obtained an R&D tax refund of over AU$1.55 million, under the Australian Government’s R&D tax incentive.

Radiopharm also progressed efforts for a secondary listing on the Nasdaq Capital Market with process initiated in February 2023.

Clinical progress

RAD 101 – Imperial College London’s F‐18 Pivalate (RAD 101) attained Phase 2a data in the brain metastases trial, with considerable tumour uptake, independent and consistent from the tumour origin. Later, the company highlighted the benefit of PET scan with F-18 Pivalate in identifying metabolic activity in patients with brain metastases, offering enhanced images. The company has an exclusive worldwide licence forthe Pivalate platform technology.

RAD301 – In late 2022, the US FDA IND (Investigational New Drug Application) approval was granted to RAD’s αVβ6 Integrin (RAD301) technology.

RAD201 – Positive imaging data regarding HER2 nanobody (RAD201) was published in the European Journal of Nuclear Medicine & Molecular Imaging, indicating that RAD201 has a positive biodistribution and high accumulation in all active HER2-positive tumour sites.

Agreements inked in financial year 2023

In August 2022, the company entered into a strategic agreement with Lantheus for the development of nanobody NM-01. In a concurrent agreement, the company acquired NM-01 imaging rights from NanoMab for the Chinese market and global IP rights for any therapeutic use.

In September, a joint venture – Radiopharm Ventures, LLC was launched between RAD and the University of Texas MD Anderson Cancer Center with the aim to develop radiopharmaceutical therapeutic products for cancer.  

The company also concluded the acquisition of Pharma15 Corporation through its subsidiary company, Radiopharm Theranostics (USA) Inc. 

Radiopharm entered into a two-year strategic research collaboration with GenesisCare to develop radiopharmaceuticals for certain hard-to-treat, complex cancers. Under the arrangement, the Contract Research Organisation of GenesisCare and Imaging Research Organisation would collaborate to conduct a Phase 1 clinical trial in Australia, with the inclusion of RAD’s platform of radiopharmaceutical nanobodies.

Regulatory milestones

DUNP19 technology secured Orphan Drug Designation by the US FDA for the treatment of osteosarcoma. Also, Rare Pediatric Disease designation was granted to this technology by the US FDA.  

Ga68‐ Trivehexin (RAD 301) has been given Orphan Drug Designation by the US FDA. 

Concerning F18-pivalate (RAD 101), the company has completed a pre-IND meeting with the FDA, indicating the achievement of significant milestones towards the IND application for the late-stage clinical trial.

Multiple supply agreements inked in FY23

RAD inked a contract with the Nuclear Science and Technology Organisation (ANSTO), under which isotope non‐carrier‐added lutetium‐177 was supplied to RAD for its trials in Australia.

A supply agreement was signed with TerThera for isotope Terbium‐161 (Tb‐161).

Another clinical supply agreement was inked with NorthStar Medical Radioisotopes for the provision of Actinium‐225. It will be used in those trials that involve targeted alpha therapy in several disease areas.

All in all, Radiopharm closed FY23 with significant operational and clinical progress, paving the way for further development milestones in the upcoming period.