Highlights

  • First patient dosed in the SECuRE Phase 1/2 trial of Cu-SAR-bispecific for mCRPC
  • Copper-67 radiopharmaceutical platform differentiates Clarity from PSMA ligand-based competitors
  • Theranostics approach enables both imaging (Cu-64) and therapy (Cu-67) using the same targeting molecule
  • PROPELLER Phase 1/2 prostate cancer imaging trial also advancing in parallel

Clarity Pharmaceuticals Limited (ASX:CU6), trading at A$0.74 as at 30 October 2026, is an Australian radiopharmaceutical company that has achieved a pivotal clinical milestone with the dosing of the first patient in its SECuRE Phase 1/2 clinical trial of its Cu-SAR-bispecific therapeutic candidate for metastatic castration-resistant prostate cancer (mCRPC), advancing what management believes to be a differentiated copper-based theranostics approach to cancer treatment.

SECuRE Trial: First Patient Dosed

Clarity's SECuRE (Systematic Evaluation of Copper Theranostics in Recurrent Disease) trial is a Phase 1/2 clinical study evaluating the safety and preliminary efficacy of Cu-SAR-bispecific as a therapeutic agent for patients with metastatic castration-resistant prostate cancer who have progressed on available treatments. The trial doses patients with Clarity's copper-67 labelled SAR-bispecific construct, which is designed to deliver a therapeutic radiation dose selectively to prostate cancer cells expressing PSMA and a second target antigen on the cancer cell surface. The bispecific targeting mechanism is intended to achieve higher target specificity than single-target PSMA ligands, potentially reducing off-target radiation to normal tissues. First patient dosing marks the transition of SECuRE from a preclinical program to active human clinical evaluation, representing a significant de-risking milestone for the Clarity pipeline.

Copper Theranostics: A Differentiated Radiopharmaceutical Platform

Clarity's theranostics platform is built on the unique properties of copper isotopes. Copper-64 (Cu-64) emits positron radiation that enables PET imaging of cancer with high resolution, while copper-67 (Cu-67) emits beta particle radiation at a tissue penetration range suitable for cancer cell killing. Because the same SAR (Sarcophagine) chelation chemistry is used to attach both Cu-64 and Cu-67 to the targeting molecule, the same construct can be used for both imaging and therapy – a theranostics approach that allows clinicians to first image a patient's cancer using Cu-64 to confirm target expression and drug delivery, and then treat the same patient using Cu-67 with confidence in the therapy's precision targeting. This diagnostic-then-therapeutic approach is a key clinical and commercial advantage for Clarity's platform.

PROPELLER Trial: Imaging Program

In parallel with the SECuRE therapy trial, Clarity is advancing its PROPELLER Phase 1/2 trial of Cu-64-SAR-bispecific as an imaging agent for prostate cancer staging and restaging. PROPELLER evaluates whether Clarity's Cu-64 imaging agent can identify prostate cancer lesions with equivalent or superior sensitivity and specificity compared to commercially approved PSMA PET imaging agents. If successful, PROPELLER would support the development of a Clarity imaging product that could be used as a companion diagnostic to select patients for SECuRE therapy, creating an integrated theranostics workflow.

Capital Position and Development Pathway

Clarity has been funded through a series of capital raisings to support the advancement of its clinical programs. The Company's primary focus is on the execution of the SECuRE and PROPELLER clinical trials, the generation of clinical data to support regulatory submissions, and ongoing preclinical work to develop next-generation constructs in the Clarity pipeline. Management has emphasised the importance of generating early clinical signals from SECuRE that demonstrate on-target activity and manageable safety in mCRPC patients, which would support the progression of the program into an expanded cohort and the generation of efficacy data for regulatory discussions.