Quarterly Activities/Appendix 4C Cash Flow Report
| Stock | Clarity Pharmaceuticals Ltd (CU6.ASX) |
|---|---|
| Release Time | 30 Jan 2026, 10:50 a.m. |
| Price Sensitive | Yes |
Clarity Pharmaceuticals Reports Quarterly Activities and Cash Flow
- Clarity's cash position of $226.2 million provides strong balance sheet to progress products
- SECuRE trial interim data confirms 67Cu-SAR-bisPSMA has favorable safety profile and promising efficacy
- Co-PSMA trial achieved primary endpoint, results to be presented at prestigious EAU Congress 2026
Clarity Pharmaceuticals, a clinical-stage radiopharmaceutical company, has reported progress in its key programs during and since the quarter ending 31 December 2025. The company remains well funded with a cash position of $226.2 million, providing a strong balance sheet to continue advancing its products towards commercialization. The SECuRE trial, a theranostic trial evaluating 67Cu-SAR-bisPSMA, has shown continued favorable safety profile and promising efficacy in the Cohort Expansion Phase. Interim data from nine participants demonstrated that all had a reduction in prostate-specific antigen (PSA), with the majority (66.7%) showing PSA decreases of more than 50% and two participants (33.3%) showing reductions of 80% or more. Importantly, one participant with bone metastasis achieved undetectable PSA after just 3 cycles of 67Cu-SAR-bisPSMA, with no cancer detected by imaging at last assessments.The Co-PSMA Investigator-Initiated Trial, led by Prof Louise Emmett at St Vincent's Hospital Sydney, achieved its primary endpoint, detecting a significantly higher number of prostate-specific membrane antigen (PSMA)-positive prostate cancer lesions using 64Cu-SAR-bisPSMA compared to standard-of-care 68Ga-PSMA-11 PET/CT in patients with biochemical recurrence and low PSA levels. The full results will be presented at the prestigious European Association of Urology (EAU) Annual Congress 2026 in London.Clarity also announced plans to commence a pivotal Phase III registrational trial of its 64Cu-SARTATE diagnostic agent in patients with neuroendocrine tumors (NETs) following a successful End of Phase meeting with the US FDA. The company has also bolstered its copper-67 isotope supply through a new agreement with Nusano, further expanding its network of US-based suppliers.Overall, Clarity continues to make significant progress in advancing its lead prostate cancer and NET programs, with a strong financial position to support the development and commercialization of its innovative radiopharmaceutical products.
Clarity remains well funded with a cash position of $226.2 million as of 31 December 2025, providing a strong balance sheet to continue advancing its products towards commercialization.