• Clarity renews focus on breast cancer with new SAR-trastuzumab product
• Pre-clinical data shows dose-response reduction in tumour size and improved survival
• Clarity signs supply agreement with EirGenix for clinical-grade trastuzumab biosimilar

Clarity Pharmaceuticals is pleased to announce the addition of a new asset, 64/67Cu-SAR-trastuzumab, into its Targeted Copper Theranostic (TCT) portfolio. Pre-clinical data on SAR-trastuzumab has recently been published, and Clarity has signed a Supply Agreement with EirGenix, Inc. for the clinical development and future commercial supply of a clinical-grade GMP trastuzumab biosimilar, EG12014. This new theranostic asset will initially focus on breast cancer and, combined with Clarity's other products like SAR-Bombesin, SARTATE and SAR-bisPSMA, will bolster the company's renewed focus on this important indication. The pre-clinical evidence shows that 67Cu-SAR-trastuzumab significantly reduced the growth of HER2-expressing tumours in a dose-dependent manner and improved the survival of mice treated with the product. Clarity intends to conduct a Phase 1/2a theranostic study with 64/67Cu-SAR-trastuzumab in HER2-positive breast cancer patients to address a significant unmet clinical need, as a considerable proportion of patients will relapse or develop resistance to standard treatments, and metastatic disease remains incurable. Clarity is uniquely positioned to address large markets with its proven track record of using great science to make novel products and the commercialisation of the 'perfect pairing' of copper isotopes, which offer advantages in terms of efficacy, supply and manufacturing.

Clarity has not provided any high-importance, price-sensitive forward-looking financial metrics or other company-specific metrics in the announcement.

Clarity is excited to have entered into the Supply Agreement for trastuzumab with EirGenix and progress to the next step in its radioimmunotherapy program. The company is committed to advancing its SAR-Bombesin, SARTATE and SAR-bisPSMA products in breast cancer, complementing the existing focus on prostate cancer, neuroblastoma and neuroendocrine tumours, as it continues to build a commanding pipeline of radiopharmaceuticals to better treat children and adults with cancer.