Clarity signs copper-67 Supply Agreement with Nusano

SYDNEY, Oct. 16, 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 signing of a Supply Agreement for copper-67 with Nusano, Inc. ("Nusano").

Nusano's 190,000 square foot state-of-the-art facility in West Valley City, Utah is expected to begin operations in late 2025 with copper-67 isotope supply planned to commence in mid-2026. The proprietary accelerator-based technologies employed by Nusano are particularly well suited for high-volume mass production of copper-67. Nusano is uniquely positioned to regularly supply this therapeutic isotope for both Clarity's clinical trials and commercial use based on the ease of production and readily available target material. Importantly, Nusano is setting up its own enriched stable isotope production for copper-67 starting materials in the near future, further reducing supply chain risks while allowing for a fully integrated production process in the United States.

The copper-67 supply from Nusano further expands Clarity's growing network of US-based suppliers, including NorthStar Medical Radioisotopes, LLC ("NorthStar") and Idaho State University Idaho Accelerator Center (IAC).

Dr Alan Taylor, Executive Chairperson of Clarity Pharmaceuticals, commented: "We are excited to continue growing our supply network for copper-67 in preparation for a registrational Phase III clinical trial with ⁶⁷Cu-SAR-bisPSMA, our lead product aimed at improving the treatment paradigm for men suffering with prostate cancer. With outstanding preliminary clinical trial data generated to date from our Phase I/IIa SECuRE trial and a Fast Track Designation in the US for this optimised product, we look forward to progressing our theranostic program, pending final study findings.

"Building reliable, abundant, sustainable and cost-effective supply goes hand-in-hand with our clinical development to allow us to swiftly scale manufacturing when needed. We have seen in the past the challenges associated with growing isotope supply with lutetium-177, which relies heavily on an ageing fleet of nuclear reactors, ultimately affecting care for oncology patients waiting for their treatments. We believe, the shift away from limited nuclear reactor-based supply to more easily scalable accelerator-based methods is a prerequisite for radiopharmaceuticals to grow sustainably into the large oncology sector. By employing copper-67, we can avoid many of the drawbacks of other therapeutic isotopes. Its production requires only electricity and readily available starting materials. With Nusano's alternative production methods, we are further differentiating our supply and look forward to having numerous pathways to producing large quantities of copper-67."

Nusano's Chief Executive Officer, Chris Lowe, commented, "Nusano is commercialising a breakthrough radioisotope production platform in 2025 capable of producing more than 25 radioisotopes for life science applications. We are excited to deepen our relationship with Clarity through the signing of this Supply Agreement for copper-67 to enable their clinical and commercial efforts with a dependable supply of radioisotopes from our world-class production facility in Utah.

"Clarity is in a unique position with their copper-67 program, being the only radiopharmaceutical company with ongoing clinical trials utilising this important isotope, and we look forward to working together as they continue to progress their program toward registrational trials and commercialisation."

Additional Disclosure

The Supply Agreement is effective as of 16 October 2025 and is for an initial period of 3 years with automatic renewal for successive 2-year periods. Cancellation provisions are aligned with industry standard rates.

Disclaimer

⁶⁷Cu-SAR-bisPSMA is an unregistered product. The safety and efficacy of ⁶⁷Cu-SAR-bisPSMA have not been assessed by health authorities such as the US Food and Drug Administration (FDA) or the Therapeutic Goods Administration (TGA). There is no guarantee that this product will become commercially available.

About Nusano

Nusano is a privately held physics company working to stabilize supply chains, advance American national security by reducing dependency on foreign supply, and enable once-in-a-generation innovations in fields ranging from healthcare to nuclear energy. The company is commercializing platform technologies for radioisotope production, stable isotope enrichment, and advanced separation techniques. Together, these proprietary systems and methods are poised to supply the fight against cancer, fuel the nuclear renaissance, and deliver critical minerals for the modern world. For more, visit nusano.com.

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

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