Medicus Pharma Ltd. (NASDAQ:MDCX) ("Medicus" or the "Company"), a precision guided, biotech/life sciences company focused on advancing novel and potentially disruptive therapeutic assets, today announced that an abridged Clinical Study Report (CSR) for SKNJCT-003 (NCT06608238) has been posted on ClinicalTrials.gov, providing transparent public access to the efficacy, safety, drug-delivery and clinical findings from the completed Phase 2 study. 

Publication of the abridged CSR represents an important scientific milestone for SkinJect® and provides a transparent public record of the completed Phase 2 findings. The Company believes the dataset provides the clinical foundation for its focused development strategy, prioritizing the FDA-authorized SKNJCT-005 program in Gorlin syndrome patients with multiple basal cell carcinoma lesions, while pursuing strategic partnership opportunities to advance SkinJect® in nodular basal cell carcinoma (BCC).

The randomized, double-blind, multicenter Phase 2 study enrolled 90 patients across ten U.S. investigative sites and evaluated two dose levels of SkinJect® compared with a device-only microneedle comparator. All 90 enrolled patients completed the study without treatment discontinuations or study withdrawals, providing a complete clinical dataset for efficacy and safety evaluation.

The completed SKNJCT-003 CSR represents the definitive analysis of the Phase 2 program and incorporates the full clinical, pathological, and translational dataset generated during SKNJCT-003. Final efficacy analyses were conducted in the modified intent-to-treat population representing patients with centrally confirmed nodular basal cell carcinoma, providing what the Company believes to be the most clinically relevant assessment of SkinJect®’s therapeutic performance in its intended target population.