• Clarity signs agreement with Theragenics for large-scale copper-64 production
• Theragenics' facility with 14 cyclotrons can produce up to 2,000 patient doses per day
• Expands Clarity's network of high-volume copper-64 manufacturers in the US

Clarity Pharmaceuticals (ASX: CU6), a clinical-stage radiopharmaceutical company, has announced the signing of a large-scale Manufacturing Supply Agreement for copper-64 with Theragenics. The agreement relates to Theragenics' 134,000 square foot production facility with a fleet of 14 cyclotrons near Atlanta, Georgia, a major US transport hub. This will enable centralized, large-scale copper-64 (Cu-64 or 64Cu) production ahead of the anticipated commercial launch of Clarity's 64Cu-SAR-bisPSMA product upon successful completion of its Phase III registrational trials and FDA approval. Theragenics has substantial cyclotron expertise with 40 years of routine radiometal production and considerable experience in producing radioisotopes for medical use. The company has the capacity to produce around 100Ci (3.7 TBq) of copper-64 per day on a single cyclotron, which translates into around 2,000 patient doses per day at 200 MBq per dose with a 48-hour shelf life. This agreement, combined with Clarity's existing copper-64 supply agreements with SpectronRx and Nusano, further enhances the company's broad network of high-volume copper-64 manufacturers in distinct US geographies. This network is designed to support commercial-scale demand across multiple large oncology indications with secure, seamless, and abundant supply of the diagnostic isotope copper-64, made possible by its 12.7-hour half-life, which is unique in the radiopharmaceutical commercial space.

Clarity Pharmaceuticals is nearing the commercialization of its 64Cu-SAR-bisPSMA product, with two Phase III registrational trials (AMPLIFY and CLARIFY) nearing completion and three Fast Track Designations from the FDA. The company is working to ensure a secure, reliable, and abundant supply and manufacturing strategy to support the commercial launch and accelerated market expansion of 64Cu-SAR-bisPSMA, subject to FDA approval.