Recent Insider Transactions • Apr 23
CEO, MD & Executive Director recently sold AU$1.1m worth of stock On the 20th of April, Michelle Parker sold around 361k shares on-market at roughly AU$3.06 per share. This transaction amounted to 26% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. This was Michelle's only on-market trade for the last 12 months. Breakeven Date Change • Apr 08
No longer forecast to breakeven The 4 analysts covering Clarity Pharmaceuticals no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of AU$17.2m in 2028. New consensus forecast suggests the company will make a loss of AU$14.2m in 2028. Announcement • Apr 01
Clarity Pharmaceuticals Publishes Co-PSMA Clinical Trial Data In European Urology Journal Clarity Pharmaceuticals announced the results from the Co-PSMA (NCT06907641) investigator-initiated trial (IIT) are now published in European Urology, the official journal of the European Association of Urology (EAU) Congress 2026 with an impressive impact factor of 25.2. This prospective phase II trial provides the first comparative evidence that 24-hour 64Cu-SAR-bisPSMA positron emission tomography (PET) /computed tomography (CT) significantly outperforms 68Ga-PSMA-11 PET/CT in detecting tumour deposits in men with early biochemical recurrence (BCR) after radical prostatectomy, with more than double the per-patient detection rate and substantially lower false-negative findings. The increased detection rate translated into a 44% management change rate, underscoring the real-world therapeutic impact of improved lesion detection at low prostate-specific antigen (PSA) levels. These data suggest that delayed imaging with a bivalent prostate-specific membrane antigen (PSMA) ligand may redefine the diagnostic pathway in early biochemical recurrence, potentially enabling more precise and timely salvage treatment strategies. The Co-PSMA trial met its primary endpoint, demonstrating that 64Cu-SAR-bisPSMA (next-day imaging) identified more than twice as many cancer lesions per patient than 68Ga-PSMA-11 (mean per patient lesion 1.26 vs. 0.48, respectively, p). The publication provides further methodological and clinical insights supporting the interpretation of the findings. The median interval between 68Ga-PSMA-11 and 64Cu-SAR-bisPSMA imaging was only 2 days (interquartile range [IQR]: 1 – 8 days), ruling out differences in lesion detection due to disease progression. This result is corroborated by previous findings from the COBRA trial, which demonstrated that 64Cu-SAR-bisPSMA was able to detect prostate cancer lesions that were still undetectable 6 months later with standard of care (SOC) PSMA imaging agents. Acquisition times were consistent across 68Ga-PSMA-11 and both same-day and next-day 64Cu-SAR-bisPSMA scans, with PET scans acquired for 2 minutes per bed position. At 24 hours, 64Cu-SAR-bisPSMA demonstrated higher lesion uptake compared to 68Ga-PSMA-11 (median maximum standardised uptake value [SUVmax] 13.6 vs. 5.3), and lower background bladder activity (median SUVmax 12.0 vs. 34.5), improving tumour-to-background contrast. These imaging attributes, which allow better visualisation of the fossa and thus detection of low volume local recurrence, likely contributed to an almost perfect agreement across the three independent blinded readers for the 64Cu-SAR-bisPSMA scans, whereas the agreement was lower for 68Ga-PSMA-11. This means the readers reached the same conclusions when assessing the 64Cu-SAR-bisPSMA scans far more often than when assessing the 68Ga-PSMA-11 scans in a blinded fashion (almost perfect level of agreement for 64Cu-SAR-bisPSMA, Cohen's Kappa 0.94 vs. 0.75 for 68Ga-PSMA-11). These imaging findings translated into clinically meaningful changes in patient care, with a marked difference between 64Cu-SAR-bisPSMA and 68Ga-PSMA-11 (planned management changes observed in 44% of patients following 64Cu-SAR-bisPSMA imaging). The two most common modifications in treatment plan were changes from observation to active treatment (12/22), and changes in the radiation field (9/22). Active planned management increased from 66% based on 68Ga-PSMA-11 results to 90% based on 64Cu-SAR-bisPSMA findings. This highlights the impact of 64Cu-SAR-bisPSMA on the management of patients with BCR and low PSA levels, a population in whom SOC PSMA PET scans frequently fail to visualise prostate cancer lesions. This is the first time that a PSMA-targeted imaging agent has demonstrated significantly improved imaging characteristics compared to those currently available, potentially marking an important step forward in imaging technology akin to that seen in the evolution from 18F-Choline/Flucyclovine to PSMA-targeted PET/CT. This leap in PET imaging technology has the potential to improve treatment decisions and outcomes in patients with biochemical results following radical prostatectomy. 
