• Two abstracts on Clarity's COBRA and CLARIFY trials accepted for presentation at ASCO GU 2025
• Abstract on COBRA study also selected for AUA Annual Meeting 2025
• 64Cu-SAR-bisPSMA identifies more lesions and at earlier timepoints than current PSMA PET agents

Clarity Pharmaceuticals (ASX: CU6) is pleased to announce the acceptance of two abstracts for presentation at the ASCO GU 2025 Conference on its COBRA and CLARIFY trials, as well as an abstract on the COBRA trial at the AUA Annual Meeting 2025. These conferences are among the world's most prestigious in oncology and urology, and the acceptance of these abstracts is testament to the strength of Clarity's data and the exciting prospects for the diagnostic 64Cu-SAR-bisPSMA to change the paradigm in the diagnosis and treatment of cancer. The abstracts on Clarity's COBRA trial showcase the improved efficacy of 64Cu-SAR-bisPSMA at detecting lesions compared to currently approved PSMA PET agents, and the potential for this product to become a best-in-class diagnostic. 64Cu-SAR-bisPSMA was able to identify lesions prior to detection by the standard-of-care (SOC) PSMA PET products, which are known to have low sensitivity. In a subset of participants in the COBRA study, 70% had a positive scan on same-day imaging and 90% on next-day imaging using 64Cu-SAR-bisPSMA, compared to 60% using SOC PSMA PET. The number of lesions identified by 64Cu-SAR-bisPSMA was also higher than that detected by SOC PET agents. Histopathology confirmed the presence of prostate cancer in lesions identified by 64Cu-SAR-bisPSMA in up to 78% of cases, which was considerably higher compared to less sensitive methods. Investigators stated that they would change their intended treatment plan in approximately half of their patients due to the findings of the 64Cu-SAR-bisPSMA PET.

Clarity's lead product, SAR-bisPSMA, continues generating impressive results, with 64Cu-SAR-bisPSMA showing an impeccable safety profile and impressive diagnostic performance compared to current standard-of-care PSMA PET agents. The data from the COBRA and PROPELLER trials were used to support the design of the second registrational trial with 64Cu-SAR-bisPSMA, AMPLIFY, in patients with biochemical recurrence of prostate cancer, planned to commence in the coming months.

The data from the COBRA and CLARIFY trials provides evidence to support the U.S. FDA approval of 64Cu-SAR-bisPSMA as a novel diagnostic imaging agent for newly diagnosed prostate cancer patients as well as those in biochemical recurrence of their disease, bringing Clarity closer to achieving its goal of improving treatment outcomes for people with cancer.