Clarity Pharmaceuticals (CU6) investor relations material

Diagnostic rationale

• Sensitivity requires a reference standard; detection rate and scan positivity are not equivalent measures.

• FDA-approved PSMA PET pre-prostatectomy studies reported pelvic-node sensitivity of 27%–47%; none met its predefined sensitivity primary endpoint, with cross-study comparison limitations.

Product characteristics

• SAR-bisPSMA uses a proprietary bivalent structure with two PSMA-targeting molecules, designed to increase tumour uptake and retention.

• The 64Cu isotope has a 12.7-hour half-life; stated product shelf life is up to 48 hours and imaging window is 1–30 hours post-administration.

• The SAR platform uses copper isotopes 64Cu/67Cu for imaging and therapy; more than 750 patients and 1,500 scans across six trials and compassionate use in Australia and the US.

Clinical evidence

• In PROPELLER, same-day 64Cu-SAR-bisPSMA showed 2–3x higher uptake and tumour-to-background ratio than 68Ga-PSMA-11; total lesions detected were 49 vs 38, a 1.3x increase.

• In PROPELLER participants with discordant lesion findings, 64Cu-SAR-bisPSMA detected more lesions in 73% vs 27% for 68Ga-PSMA-11; a single related Grade 1 adverse event was reported among 30 participants.

• In COBRA, next-day imaging increased average lesions identified from 70 to 129 and PSMA-positive participants from 53% to 71% vs same-day imaging.

• In a COBRA subset, next-day 64Cu-SAR-bisPSMA detected 53 lesions vs 20 on standard-of-care PSMA PET performed up to six months later.

• In the 50-participant Co-PSMA trial, next-day imaging detected 2.6x more lesions per participant than 68Ga-PSMA-11; positive scans were 78% vs 36%, and true-positive rates were 71% vs 29%.