Clarity Pharmaceuticals (CU6) Investor Presentation summary

Company overview

• Clarity Pharmaceuticals develops next-generation radiopharmaceuticals for cancer treatment, focusing on both children and adults.

• The company is a global leader in Targeted Copper Theranostics (TCTs), utilizing copper-64 for imaging and copper-67 for therapy.

• SAR Technology platform underpins a broad pipeline, protected by 29 patent families, with products in clinical and preclinical development.

• The team comprises 58 employees, 71% female, with significant expertise in corporate finance, operations, and radiopharmaceuticals.

• Clarity is listed on the ASX (CU6), with a market cap of ~A$2.4B and A$136.5M cash at bank as of June 2024.

Technology and competitive advantages

• SAR Technology enables highly specific and stable chelation of copper isotopes, minimizing leakage and maximizing targeting precision.

• Copper-64 and copper-67 offer optimal half-lives, shelf life, and production scalability compared to traditional isotopes like gallium-68 and lutetium-177.

• TCTs provide logistical and environmental benefits, including mass production on cyclotrons, no reliance on nuclear reactors, and no long-lived waste.

• SAR-bisPSMA, a dual-targeting molecule, demonstrates superior tumour uptake, retention, and detection of smaller lesions compared to monomeric PSMA agents.

• Diagnostic and therapeutic products can be centrally manufactured and distributed, with up to 48-hour shelf life for diagnostics.

Clinical development and results

• SECURE Phase I/IIa trial in metastatic castrate-resistant prostate cancer (mCRPC) shows strong safety and efficacy for 67Cu-SAR-bisPSMA.

• Up to 92% PSA reduction and significant tumour volume shrinkage observed after one or two doses in heavily pre-treated patients.

• 78% of patients in certain cohorts achieved >35% PSA reduction after a single dose; 44% achieved >80% reduction.

• Adverse events were mostly mild or moderate, with no Grade 4/5 events and no dose-limiting toxicities observed.

• Imaging shows prolonged tumour retention and rapid clearance from non-tumour tissues, supporting targeted delivery.