• Clarity has entered into a Commercial Manufacturing Agreement with SpectronRx for 64Cu-SAR-bisPSMA
• SpectronRx's facility in Indiana will provide on-demand commercial-scale manufacturing of both copper-64 and 64Cu-SAR-bisPSMA
• The Agreement includes an option to expand into similar additional sites, substantially increasing the manufacturing capacity

Clarity Pharmaceuticals has entered into a Commercial Manufacturing Agreement with SpectronRx for its lead diagnostic product, 64Cu-SAR-bisPSMA. SpectronRx's facility in Indiana will provide on-demand commercial-scale manufacturing of both copper-64 and 64Cu-SAR-bisPSMA under one roof and enable distribution to all 50 states. The facility is capable of producing up to 400,000 patient-ready doses of 64Cu-SAR-bisPSMA annually. The agreement also includes an option to expand into similar additional sites, substantially increasing the manufacturing capacity of patient-ready doses of 64Cu-SAR-bisPSMA in regional hubs spread throughout the US. This will provide a multi-layered and abundant supply approach, which is unique in the radiopharmaceutical space. The Commercial Supply Agreement supplements Clarity's current supply and manufacturing agreements for isotope and product, creating a robust and reliable supply chain for the commercial rollout of 64Cu-SAR-bisPSMA upon successful completion of Clarity's Phase III registrational trials and subsequent US FDA approval. The agreement leverages the benefits of copper-64, including its optimal half-life of 12.7 hours, to overcome the logistical issues inherent to current-generation diagnostics that rely on isotopes with shorter half-lives. This will enable broad, on-demand distribution and access to 64Cu-SAR-bisPSMA for cancer patients across the US.

The agreement enables production of up to 400,000 patient-ready doses of 64Cu-SAR-bisPSMA annually at the Indiana facility by the time of commercialisation.

The agreement includes options to expand integrated 64Cu-SAR-bisPSMA manufacturing to additional locations in the US, substantially increasing overall production capacity in the number of regional hubs throughout the US, providing a multi-layered and abundant supply approach.