Clarity’s SECuRE Trial Shows 67% PSA Reduction; $226M Cash Supports Growth

Financial Strength Fuels Clinical Momentum

Clarity Pharmaceuticals closed 2025 with a solid cash reserve of $226.2 million, providing a strong financial foundation to advance its clinical programs and expand its supply chain. The company’s operating cash outflows of $25.1 million for the quarter align with its strategic investments in late-stage trials and manufacturing capabilities, signalling disciplined capital deployment as it moves closer to commercialisation.

SECuRE Trial, Promising Therapeutic Advances in Prostate Cancer

The Phase I/IIa SECuRE trial, evaluating the theranostic agent Cu-SAR-bisPSMA in metastatic castrate-resistant prostate cancer, continues to deliver encouraging interim data. The Safety Review Committee recently endorsed continuation without protocol changes, reflecting a favourable safety profile. Notably, one participant with bone metastases achieved undetectable prostate-specific antigen (PSA) levels after three treatment cycles, with imaging confirming no detectable disease and only mild adverse effects reported. These outcomes bolster confidence in Cu-SAR-bisPSMA’s therapeutic potential.

Diagnostic Trials Show Superior Performance

On the diagnostic front, the Co-PSMA Investigator-Initiated Trial led by Prof Louise Emmett at St Vincent’s Hospital Sydney met its primary endpoint by detecting significantly more PSMA-positive prostate cancer lesions using Cu-SAR-bisPSMA compared to the current standard-of-care Ga-PSMA-11 PET/CT. This head-to-head superiority is set to be showcased at the European Association of Urology Congress in March 2026, underscoring the product’s potential to improve early detection and staging in patients with biochemical recurrence and low PSA levels.

Meanwhile, Clarity’s two pivotal Phase III diagnostic trials, AMPLIFY and CLARIFY, are progressing recruitment. AMPLIFY targets patients with biochemical recurrence, while CLARIFY focuses on those with high-risk prostate cancer prior to radical prostatectomy. Both trials aim to provide robust evidence to support regulatory approval and market entry.

Expanding Pipeline and Supply Chain Resilience

Beyond prostate cancer, Clarity is advancing Cu-SARTATE for neuroendocrine tumours (NETs), with a Phase III registrational trial expected to commence in 2026 following a positive End of Phase meeting with the US FDA. The company’s Discovery Program is also progressing novel theranostics like Cu-SAR-bisFAP, targeting fibroblast activation protein across multiple cancers, with compelling preclinical data presented at international conferences.

To underpin clinical and future commercial supply, Clarity has secured a supply agreement with Nusano, Inc., whose state-of-the-art Utah facility will provide copper-67 isotopes starting in 2026. This complements existing US-based suppliers and supports a vertically integrated manufacturing model designed to mitigate geopolitical and supply chain risks that have challenged the radiopharmaceutical sector.

Regulatory Recognition and Market Potential

Clarity’s lead agent, SAR-bisPSMA, benefits from three FDA Fast Track Designations covering both diagnostic and therapeutic indications, reflecting the high quality and unmet clinical need addressed by its products. With the US prostate cancer diagnostic market projected to grow beyond US$3 billion by 2029, Clarity is well positioned to disrupt current standards with its next-generation copper-based radiopharmaceuticals.