Company Announcements

SYDNEY , Dec. 24, 2025 /PRNewswire/ -- Clarity Pharmaceuticals (ASX: CU6) ("Clarity" or "Company"), a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for patients with cancer, is pleased to announce the acceptance of an abstract on the Co-PSMA (NCT06907641)^[1] Investigator-Initiated Trial (IIT), led by Prof Louise Emmett at St Vincent's Hospital Sydney, for oral presentation at the upcoming European Association of Urology (EAU) Congress 2026, Europe's biggest urological conference, to be held 13-16 March 2026 in London, UK^[2].

Co-PSMA's official study title is "Comparative performance of ⁶⁴Copper [⁶⁴Cu]-SAR-bisPSMA vs. ⁶⁸Ga-PSMA-11 PET CT for the detection of prostate cancer recurrence in the setting of biochemical failure following radical prostatectomy". This Phase II IIT evaluated the performance of Clarity's diagnostic product, ⁶⁴Cu-SAR-bisPSMA, in a head-to-head comparison to standard-of-care (SOC) ⁶⁸Ga-PSMA-11 in 50 patients with low prostate-specific antigen (PSA) who were candidates for curative salvage therapy. Eligible patients were required to have had radical prostatectomy with no salvage therapy and a PSA level between 0.2 and 0.75 ng/mL.

The results to be presented by Prof Emmett at the EAU Congress 2026 will expand on the earlier findings that the trial met its primary endpoint, demonstrating that ⁶⁴Cu-SAR-bisPSMA positron emission tomography (PET) / computed tomography (CT) detected significantly more lesions per patient than the SOC, ⁶⁸Ga-PSMA-11 PET/CT^[3]. These results further build on the growing body of evidence showing that ⁶⁴Cu-SAR-bisPSMA improves the detection of prostate cancer, compared to the current SOC prostate-specific membrane antigen (PSMA) PET agents which are known to have low sensitivity, especially in patients with low PSA levels^[4],[5].

Clarity's Executive Chairperson, Dr Alan Taylor, commented, "⁶⁴Cu-SAR-bisPSMA has been purposely developed at the benchtop to overcome the many shortfalls of the current SOC PSMA imaging agents. With the molecule only being invented some 7 years ago, we have already demonstrated at the cellular level, in animal models and now in multiple clinical trials, that ⁶⁴Cu-SAR-bisPSMA is clearly differentiated from the competitors. In a very short amount of time, we have moved from invention to two registrational Phase III trials, both to complete recruitment next year, continuing to build on strong evidence generated to date of the improved diagnostic performance of our product through various clinical trials and real-world evidence (compassionate use supply). We reported earlier that our optimised agent detects more lesions in this IIT head-to-head comparison against the SOC product^[3]. We also know that ⁶⁴Cu-SAR-bisPSMA identifies more as well as smaller lesions and was able to do so earlier than SOC PSMA PET agents in our Phase II COBRA trial^[6]. The full results from Co-PSMA will again reinforce the mounting data showing how ⁶⁴Cu-SAR-bisPSMA can outperform SOC PSMA PET products.

"We are committed to a rigorous scientific and clinical development process, which has delivered exceptional results to date. The acceptance of the Co-PSMA data by this world-leading urology conference for an oral presentation is a testament to its strength and quality. This recognition not only highlights the impact of this research but also underscores the significant potential of ⁶⁴Cu-SAR-bisPSMA to advance PSMA imaging and improve prostate cancer management. The abstract summary will be announced in mid-February, followed by the oral presentation in mid-March 2026.

"Prof Emmett is a global key opinion leader in the field of urologic nuclear medicine, with a strong track record of highly regarded scientific publications as well as extensive clinical experience. We are honoured to continue working together on our registrational AMPLIFY^[7] and CLARIFY^[8] trials and trust that her unique expertise and commitment to providing the best available patient care will help us to get closer to our mutual goal of improving detection and treatment paradigm for prostate cancer patients.

"With two US Food and Drug Administration (FDA) Fast Track Designations for ⁶⁴Cu-SAR-bisPSMA and two ongoing registrational trials, we are extremely excited to enter the USD 2 billion PSMA PET imaging market as it is further expected to grow to over USD 3 billion by 2029 with not only a clearly differentiated agent, but also a product with substantial logistical benefits over the current competitors."

About SAR-bisPSMA

SAR-bisPSMA derives its name from the word "bis", which reflects a novel approach of connecting two PSMA-targeting agents to Clarity's proprietary sarcophagine (SAR) technology that securely holds copper isotopes inside a cage-like structure, called a chelator. Unlike other commercially available chelators, the SAR technology prevents copper leakage into the body. SAR-bisPSMA is a Targeted Copper Theranostic that can be used with isotopes of copper-64 (Cu-64 or ⁶⁴Cu) for imaging and copper-67 (Cu-67 or ⁶⁷Cu) for therapy.

Disclaimer

⁶⁴Cu-SAR-bisPSMA is an unregistered product. The safety and efficacy of ⁶⁴Cu-SAR-bisPSMA have not been assessed by health authorities such as the US FDA or the Therapeutic Goods Administration (TGA). There is no guarantee that this product will become commercially available.

About Prostate Cancer

Prostate cancer is the second most common cancer diagnosed in men globally and the fifth leading cause of cancer death in men worldwide^[9]. Prostate cancer is the second-leading causes of cancer death in American men. The American Cancer Institute estimates in 2025 there will be about 313,780 new cases of prostate cancer in the US and around 35,770 deaths from the disease^[10].

About Clarity Pharmaceuticals

Clarity is a clinical stage radiopharmaceutical company focused on the treatment of serious diseases. The Company is a leader in innovative radiopharmaceuticals, developing Targeted Copper Theranostics based on its SAR Technology Platform for the treatment of cancers.

www.claritypharmaceuticals.com

 

This announcement has been authorised for release by the Executive Chairperson.

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SOURCE Clarity Pharmaceuticals