Medicus Pharma Ltd. (NASDAQ:MDCX) ("Medicus" or the "Company"), a biotech/life sciences company focused on advancing the clinical development programs of novel and potentially disruptive therapeutics assets, today announced the submission of Protocol SKNJCT-005 to the U.S. Food and Drug Administration (FDA) under the Company's existing Investigational New Drug (IND) application, for SkinJect® into registrational development for patients with Gorlin Syndrome, also called Nevoid Basal Cell Carcinoma Syndrome (NBCCS), a rare inherited genetic disorder associated with lifelong development of multiple basal cell carcinomas and recurrent skin cancers, often resulting in repeated surgical procedures.

The submitted protocol outlines a Phase 2b, open-label study designed to generate efficacy and safety data intended to support a future New Drug Application (NDA) for SkinJect® in Gorlin Syndrome. This submission is the latest step in the Company's strategic expansion of the SkinJect® clinical program into a high unmet need orphan indication, where treatment options are limited and currently there are no FDA-approved lesion-directed therapies specifically developed for patients with Gorlin Syndrome.